Public Health (Human Tissues, Cells And Organs) Act 2009 (Gibraltar)

Public Health (Human Tissues, Cells And Organs) Act 2009

Published: 2009-12-01

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Unlimited Searches
Weekly Updates on New Laws
Access to 5,345,848 Global Laws from 110 Countries
View the Original Law Side-by-Side with the Translation

Subscribe Now for only USD$40 per month.

Public Health (Human Tissues, Cells and Organs)

2009-53

PUBLIC HEALTH (HUMAN TISSUES, CELLS AND

ORGANS) ACT 2009

Principal Act

Act. No. 2009-53 Commencement 1.12.2009

Assent 21.12.2009

Amending

enactments

Relevant current

provisions

Commencement

date

LN. 2012/151 Long title, ss. 1A, 1B, 2-27, 28A-

28W, 29, Schs. 5, 6 & 12

1.11.2012

2014/157 Schs. 2 & 3 17.6.2014

English sources:

None cited

Transposing:

Directive 2004/23/EC

Directive 2006/17/EC

Directive 2006/86/EC

Directive 2010/53/EU

Directive 2012/39/EU

EU Legislation/International Agreements involved:

Public Health (Human Tissues, Cells and Organs)

2009-53

ARRANGEMENT OF SECTIONS

Section

PRELIMINARY

1. Title and commencement.

1A. Interpretation: general.

PART 1

HUMAN TISSUES AND CELLS

1B. Designation of the competent authority.

2. Interpretation of Part 1.

3. Renumbered.

4. Application of Part 1.

5. Requirements for authorisation.

6. Authorisation of tissue establishment or procurement organisations.

7. Suspension or revocation of authorisation.

8. Responsible person for tissue establishment.

9. Requirements for the procurement and supervision of procurement

of human tissues and cells.

10. Quality management and notification and reporting to the competent

authority of serious adverse events and reactions.

11. Notification of serious adverse reactions.

12. Notification of serious adverse events.

13. Donor selection, evaluation and testing criteria.

14. Tissue and cell reception, processing, storage and distribution.

15. Principles governing tissue and cell donation and voluntary unpaid

donation.

16. Traceability and labelling of tissues and cells.

17. Import and export of human tissues and cells.

18. Relations between tissue establishments and third parties.

19. Objections to refusals of authorisation or suspension or revocation of

authorisation.

20. Disclosure of information by tissue establishments and data

protection.

21. Inspections.

22. Authorised persons.

23. Taking of samples by authorised persons.

24. Records to be kept by the competent authority.

25. Communication of information between competent authorities and to

the Commission.

26. Offences and penalties.

27. Offence to import below standard tissues and cells into Gibraltar.

28. Reports by the competent authority.

PART 2

Public Health (Human Tissues, Cells and Organs)

2009-53

HUMAN ORGANS

28A. Subject matter and application of this Part.

28B. Interpretation of Part 2.

28C. Framework and compliance with licensing conditions and directions.

28D. Licensing requirement for procurement and transplantation activity.

28E. Granting of licences.

28F. Preconditions to grant of a licence.

28G. Consequences of failure, etc.

28H. Guidance and directions.

28I. Records, reports and information.

28J. The principles of organ donation.

28K. The quality and safety of living donation.

28L. Serious adverse events and serious adverse reactions.

28M. Traceability.

28N. Organs sent to another country.

28O. The Authority and European organ exchange organisations.

28P. Control and audit by way of inspections.

28Q. Appropriate statements.

28R. Seizure in the course of inspection or search.

28S. Requirements when exercising power of inspection or search.

28T. Protection of personal data, confidentiality and security of

processing.

28U. Offences and penalties.

28V. Offences by bodies corporate.

28W. Reports to the Commission.

PART 3

MISCELLANEOUS

29. Regulations.

SCHEDULE 1

Selection criteria for donors of tissues or cells or both (except donors of

reproductive cells).

SCHEDULE 2

Laboratory tests required for donors (except donors of reproductive cells).

SCHEDULE 3

Selection criteria and laboratory tests required for donors of reproductive

cells.

SCHEDULE 4

Cell or tissue or both donation and procurement procedures and reception at

the tissue establishment.

SCHEDULE 5

Public Health (Human Tissues, Cells and Organs)

2009-53

Requirements for authorisation of tissue establishments.

SCHEDULE 6

Requirements for the authorisation of tissue and cell preparation processes

at the tissue establishments.

SCHEDULE 7

Notification of serious adverse reactions.

SCHEDULE 8

Notification of Serious Adverse Events

SCHEDULE 9

Annual Notification Format

SCHEDULE 10

Information on the minimum donor or recipient or both data set to be kept

SCHEDULE 11

Information contained in the European Coding System

SCHEDULE 12

Organ and Donor Characterisation

Public Health (Human Tissues, Cells and Organs)

2009-53

AN ACT TO TRANSPOSE INTO THE LAW OF GIBRALTAR

DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF

THE COUNCIL OF 31 MARCH 2004 ON SETTING STANDARDS OF

QUALITY AND SAFETY FOR THE DONATION, PROCUREMENT,

TESTING, PROCESSING, PRESERVATION, STORAGE AND

DISTRIBUTION OF HUMAN TISSUES AND CELLS; COMMISSION

DIRECTIVE 2006/17/EC OF 8 FEBRUARY 2006 IMPLEMENTING

DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF

THE COUNCIL AS REGARDS CERTAIN TECHNICAL

REQUIREMENTS FOR THE DONATION, PROCUREMENT AND

TESTING OF HUMAN TISSUES AND CELLS; COMMISSION

DIRECTIVE 2006/86/EC OF 24 OCTOBER 2006 IMPLEMENTING

DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF

THE COUNCIL AS REGARDS TRACEABILITY REQUIREMENTS,

NOTIFICATION OF SERIOUS ADVERSE REACTIONS AND EVENTS

AND CERTAIN TECHNICAL REQUIREMENTS FOR THE CODING,

PROCESSING, PRESERVATION, STORAGE AND DISTRIBUTION OF

HUMAN TISSUES AND CELLS; DIRECTIVE 2010/53/EU OF THE

EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 7 JULY 2010

ON STANDARDS OF QUALITY AND SAFETY OF HUMAN ORGANS

INTENDED FOR TRANSPLANTATION; AND FOR CONNECTED

PURPOSES.

PRELIMINARY

Title and commencement.

1. This Act may be cited as the Public Health (Human Tissues, Cells and

Organs) Act 2009 and shall be deemed to have come into operation on 1

December 2009.

Interpretation: general.

1A. In this Act−

“Commission” means the European Commission;

“functions” includes powers and duties, and references to the

performance of functions include, with respect to powers and

duties, references to the exercise of powers and the carrying out of

the duties;

“Gibraltar Health Authority” means the Gibraltar Health Authority

established by section 3 of the Medical (Gibraltar Health

Authority) Act 1987;

“inspect” includes search;

Public Health (Human Tissues, Cells and Organs)

2009-53

“inspection” means formal and objective control to identify

problems in accordance with standards adopted to assess

compliance with this Act;

“Minister” means the Minister with responsibility for Health;

“premises” means any place, ship or other vessel, aircraft, railway

wagon or other vehicle, and includes a container used to transport

relevant things;

“quality management” means the coordinated activities to direct

and control an organisation with regard to quality;

“quality system” means the organisational structure, defined

responsibilities, procedures, processes, and resources for

implementing quality management and includes all activities which

contribute to quality, directly or indirectly;

“record” includes, in addition to a record in writing

(a) a disc, tape, sound-track or other device in which information,

sounds or signals are embodied so as to be capable (with or

without the aid of some other instrument) of being reproduced

in legible or audible form;

(b) a film, tape or other device in which visual images are

embodied so as to be capable (with or without the aid of some

other instrument) of being reproduced in visual form; and

and any reference to a copy of a record includes

(i) in the case of a record to which paragraph (a) of this

definition applies, a transcript of the sounds or signals

embodied therein;

(ii) in the case of a record to which paragraph (b) of this

definition applies, a still reproduction of the images

embodied therein; and

(iii) in the case of a record to which paragraphs (a) and (b) of

this definition apply, such a transcript together with such

a still reproduction.

PART 1

HUMAN TISSUES AND CELLS

Public Health (Human Tissues, Cells and Organs)

2009-53

Designation of the competent authority.

1B.(1) The Minister is designated as the competent authority for the

purpose of this Act.

(2) The Minister may enter into a contractual arrangement with a person

for the purpose of that person assisting the Minister to perform any of his

functions as competent authority under this Act.

Interpretation of Part 1.

2.(1) In this Part, unless the context otherwise requires

“allogeneic use” means cells or tissues removed from one person and

applied to another;

“authorised person” means a person appointed under section 22(1);

“autologous use” means cells or tissues removed from and applied in the

same person;

“cells” means individual human cells or a collection of human cells when

not bound by any form of connective tissue;

“Commission” means the European Commission;

“critical” means potentially having an effect on the quality or safety or

both of or having contact with the cells and tissues;

“direct use” means any procedure where cells are donated and used

without any banking;

“distribution” means transportation and delivery of tissues or cells

intended for human applications;

“donation” means donating human tissues or cells intended for human

applications;

“donor” means every human source, whether living or deceased, of

human cells or tissues;

“functions” includes powers and duties, and references to the

performance of functions include, with respect to powers and

duties, references to the exercise of powers and the carrying out of

the duties;

Public Health (Human Tissues, Cells and Organs)

2009-53

“Gibraltar Health Authority” means the Gibraltar Health Authority

established by section 3 of the Medical (Gibraltar Health

Authority) Act, 1987;

“human application” means the use of tissues or cells on or in a human

recipient and extra-corporal applications;

“implementing Directives” means Commission Directive 2006/17/EC of

8 February, 2006, implementing Directive 2004/23/EC of the

European Parliament and of the Council as regards certain

technical requirements for the donation, procurement and testing of

human tissues and cells and Commission Directive 2006/86/EC of

24 October 2006 implementing Directive 2004/23/EC of the

European Parliament and of the Council as regards traceability

requirements, notification of serious adverse reactions and events

and certain technical requirements for the coding, processing,

preservation, storage and distribution of human tissues and cells;

“inspect” includes search;

“inspection” means formal and objective control to identify problems in

accordance with standards adopted to assess compliance with this

Part;

“Minister” means the Minister with responsibility for Health;

“organ” means a differentiated and vital part of the human body, formed

by different tissues, that maintains its structure, vascularisation and

capacity to develop physiological functions with an important level

of autonomy;

“organisation responsible for human application” means a health care

establishment or a unit of a hospital or another body which carries

out human application of human tissues and cells;

“partner donation” means the donation of reproductive cells between a

man and a woman who declare that they have an intimate physical

relationship;

“premises” means any place, ship or other vessel, aircraft, railway wagon

or other vehicle, and includes a container used to transport relevant

things;

“prescribed activity” means an activity to which this Part applies, and

that is specified in section 4(1);

“preservation” means the use of chemical agents, alterations in

environmental conditions or other means during processing to

Public Health (Human Tissues, Cells and Organs)

2009-53

prevent or retard biological or physical deterioration of cells or

tissues;

“principal Directive” means Directive 2004/23/EC of the European

Parliament and of the Council of 31 March, 2004 setting standards

of quality and safety for the donation, procurement, testing,

processing, preservation, storage and distribution of human tissues

and cells;

“processing” means all operations involved in the preparation,

manipulation, preservation and packaging of tissues or cells

intended for human applications;

“procurement” means a process by which tissue or cells are made

available;

“procurement organisation” means a health care establishment or a unit

of a hospital or another body that undertakes the procurement of

human tissues and cells and that may not be accredited, designated,

authorised or licensed as a tissue establishment;

“quality management” means the coordinated activities to direct and

control an organisation with regard to quality;

“quality system” means the organisational structure, defined

responsibilities, procedures, processes, and resources for

implementing quality management and includes all activities which

contribute to quality, directly or indirectly;

“quarantine” means the status of retrieved tissue or cells, or tissue

isolated physically or by other effective means, whilst awaiting a

decision on their acceptance or rejection;

“record” includes, in addition to a record in writing

(a) a disc, tape, sound-track or other device in which information,

sounds or signals are embodied so as to be capable (with or

without the aid of some other instrument) of being reproduced

in legible or audible form;

(b) a film, tape or other device in which visual images are

embodied so as to be capable (with or without the aid of some

other instrument) of being reproduced in visual form; and

and any reference to a copy of a record includes

Public Health (Human Tissues, Cells and Organs)

2009-53

(i) in the case of a record to which paragraph (a) of this

definition applies, a transcript of the sounds or signals

embodied therein;

(ii) in the case of a record to which paragraph (b) of this

definition applies, a still reproduction of the images

embodied therein; and

(iii) in the case of a record to which paragraphs (a) and (b) of

this definition apply, such a transcript together with such

a still reproduction;

“relevant thing” means

(a) any tissue or cells; or

(b) any article or substance used in the donation, procurement,

processing preservation or storage of any tissue or cells or

products manufactured from tissues and cells;

“reporting year” means the period of 12 months ending on 31 December;

“reproductive cells” means all tissues and cells intended to be used for

the purpose of assisted reproduction;

“responsible person”, in relation to a tissue establishment, means the

person who has been designated under section 8 as the responsible

person for that tissue establishment;

“serious adverse event” means any untoward occurrence associated with

the procurement, testing, processing, storage or distribution of

tissues and cells

(a) that might lead to the transmission of a communicable disease,

to death or life-threatening, disabling or incapacitating

conditions for patients; or

(b) which might result in, or prolong, hospitalisation or morbidity;

“serious adverse reaction” means an unintended response, including a

communicable disease, in the donor or in the recipient associated

with procurement or human application of tissues and cells

(a) that is fatal, life-threatening, disabling or incapacitating; or

(b) which results in, or prolongs, hospitalisation or morbidity;

Public Health (Human Tissues, Cells and Organs)

2009-53

“site” means any premises at which any prescribed activity or activities

are carried out;

“Standard Operating Procedures” (SOPs) means written instructions

describing the steps in a specific process, including the materials

and methods to be used and the expected end product;

“storage” means maintaining the tissues and cells under appropriate

controlled conditions until distribution;

“tissue” means all constituent parts of the human body formed by cells;

“tissue establishment” means a tissue bank or a unit of a hospital or

another body where activities of processing, preservation, storage

or distribution of human tissues and cells are undertaken which

may also be responsible for procurement or testing of tissues and

cells;

“traceability” means the ability to locate and identify the tissue or cell or

both during any step from procurement, through processing, testing

and storage, to distribution to the recipient or disposal, which also

implies the ability to identify the donor and the tissue establishment

or the manufacturing facility receiving, processing or storing the

tissue or cells or both and the ability to identify the recipients at the

medical facility or facilities applying the tissue or cells or both to

the recipients; traceability also covers the ability to locate and

identify all relevant data relating to products and materials coming

into contact with those tissues or cells or both;

“validation” (or ‘qualification’ in the case of equipment or environments)

means establishing documented evidence that provides a high

degree of assurance that a specific process, SOP, piece of

equipment or environment will consistently produce a product

meeting its predetermined specifications and quality attributes; a

process is validated to evaluate the performance of a system with

regard to its effectiveness based on intended use.

(2) Any term used but not defined in this Part shall be construed in

accordance with the provisions of the principal Directive and the

implementing Directives.

3. Renumbered as 1B.

Application of Part 1.

4.(1) This Act shall, subject to subsection (2), apply to any activity as

prescribed in this subsection that consists of any aspect of

Public Health (Human Tissues, Cells and Organs)

2009-53

(a) the donation, procurement, testing, processing, preservation,

storage or distribution of tissues or cells intended for human

applications;

(b) the donation, procurement, testing, processing, preservation,

storage or distribution of manufactured products derived from

tissues and cells intended for human consumption,

save that, where manufactured products referred to in paragraph (b) are

covered by other laws of Gibraltar implementing Community obligations,

this Part shall only apply to the donation, procurement and testing of such

manufactured products.

(2) This Act shall not apply to

(a) tissues and cells used as an autologous graft within the same

surgical procedure;

(b) blood and blood components as defined by the Public Health

(Blood Safety and Quality) Act 2007;

same purpose as the entire organ in the human body.

(3) This Act shall apply to tissues and cells that are applied to the human

body in clinical trials.

(4) This Act shall apply to the coding, processing, preservation, storage

and distribution of

(a) human tissues and cells intended for human applications; and

(b) manufactured products derived from human tissues and cells

intended for human applications, where those products are not

covered by other EC Directives.

(5) The provisions of sections 5(2)(b), 9(1)(c) and 10(6) to (8) of this Part

concerning traceability and the reporting of serious adverse reactions and

events, shall also apply to the donation, procurement and testing of human

tissues and cells.

(6) This Act shall apply without prejudice to the Data Protection Act 2004

on the protection of individuals with regard to the processing of personal

data and on the free movement of such data.

Requirements for authorisation.

5.(1) No person shall carry out any prescribed activity–

Public Health (Human Tissues, Cells and Organs)

2009-53

(a) unless that person has been granted an authorisation under

section 6; and

(b) otherwise than in accordance with any conditions to which the

authorisation is subject.

(2) Tissue establishments shall comply with–

(a) the requirements for the accreditation, designation,

authorisation or licensing of tissue establishments as required

by Article 28(a) of the principal Directive; and

(b) the requirements set out in Schedule 5.

(3) Pending a decision on the requirements of Article 28(a) of the

principal Directive, tissue establishments shall comply with the standards

set by the competent authority under section 6(2).

Authorisation of tissue establishment or procurement, organisations.

6.(1) Subject to subsection (2), the competent authority may grant an

authorisation to a tissue establishment to carry out any prescribed activity at

a specified site or sites, having satisfied itself that the tissue establishment

(a) complies with the requirements referred to in Article 28(a) of

the principal Directive; and

(b) complies with other relevant requirements of the implementing

Directives and this Part.

(2) Pending decisions on the requirements pursuant to paragraphs (a), (c),

(g) and (h) of Article 28 of the principal Directive, the competent authority

shall set appropriate standards of quality and safety in respect of the matters

referred to in paragraphs (a), (c), (g) and (h) of Article 28 of the principal

Directive and the competent authority will have regard to these standards in

respect of the matters referred to in those paragraphs when granting

authorisations until such decisions have been made.

(3) An application for authorisation under subsection (1) shall be made to

the competent authority.

(4) All applications for authorisation shall–

(a) include all relevant information as determined by the

competent authority; and

(b) be accompanied by the prescribed fee.

Public Health (Human Tissues, Cells and Organs)

2009-53

(5) The competent authority may–

(a) grant or refuse any authorisation applied for under subsection

(3); and

(b) grant such authorisation–

(i) in respect of particular sites or prescribed activities only;

and

(ii) subject to conditions.

(6) Where the competent authority grants an authorisation, in the case of

prescribed activities the competent authority shall give notice in writing to

the tissue establishment specifying the prescribed activities which the tissue

establishment may undertake under this Part at each site in respect of which

authorisation is granted, and if the grant is subject to conditions, the

conditions which apply to the undertaking of those activities.

(7) Subject to the requirements of subsection (8), the competent authority

may at any time remove or vary any of the conditions referred to in

subsection 5(b)(ii), or may impose additional conditions.

(8) Where the competent authority removes or varies any condition or

imposes any additional condition under subsection (7), the competent

authority shall serve a notice on the tissue establishment concerned which

shall–

(a) give details of the conditions which the competent authority

proposes to remove, or of the variation which he proposes to

make to any existing conditions, or of any additional condition

which he proposes to impose;

(b) give the reasons for his decision; and

date on which the notice is served, from which the removal or

variation of any condition, or the imposition of any additional

condition shall apply.

(9) A tissue establishment shall not make any substantial change in the

prescribed activities which it undertakes without the prior written approval

of the competent authority.

(10) Any application by a tissue establishment for approval to make a

substantial change in its activities shall be–

(a) made in writing to the competent authority; and

Public Health (Human Tissues, Cells and Organs)

2009-53

(b) accompanied by the prescribed fee.

(11) For the purpose of this section, a substantial change in a tissue

establishment’s activities is any change–

(a) to the site or sites from which the tissue establishment operates

or to the prescribed activities to be carried out at each site, and

which would result in a failure to comply with the

requirements of this Part; or

(b) to the quality system, as set out in accordance with Article

28(c) of the principal Directive, which is likely to have a

substantial impact on the conduct of, or might compromise the

safety of, any of the prescribed activities which the tissue

establishment has been authorised to undertake under this

section.

(12) The competent authority may authorise–

(a) the tissue and cell preparation processes, which the tissue

establishment may carry out in accordance with the

requirements set out in Article 28(g) of the principal Directive;

(b) the direct distribution of specific tissues and cells from where

the procurement is carried out to a health care establishment

for immediate transplantation in accordance with the

requirements set out in Article 28(i) of the principal Directive;

requirements of this Part in respect of procurement

organisations; and

(d) the laboratories that carry out the tests required for donors in

accordance with this Part.

Suspension or revocation of authorisation.

7.(1) Subject to subsection (2), the competent authority may suspend or

revoke the authorisation of a tissue establishment in respect of a site or sites

or prescribed activity or both, on one or more of the following grounds–

(a) that the tissue establishment or process has not complied with

the requirements of this Part;

(b) that a prescribed activity has not been or cannot be carried out

pursuant to the requirements of this Part;

Public Health (Human Tissues, Cells and Organs)

2009-53

human application in such a state that they could be safely

used; or

(d) that the information given by the tissue establishment under

sections 6(4) and 19(3) was false or incomplete in any material

respect.

(2) Subject to subsection (3), before suspending or revoking the

authorisation of a tissue establishment, the competent authority shall serve

notice on the tissue establishment stating that it intends to suspend or revoke

the authorisation with effect from the date specified in the notice which

shall be not less than 7 days from the date on which the notice is served.

(3) Where the competent authority considers that it is necessary in the

interests of safety, it may, by a notice served on a tissue establishment,

suspend or revoke its authorisation with immediate effect.

(4) Where–

(a) the tissue establishment has failed, in any material respect, to

comply with the requirements of this Part; or

(b) the information given by the tissue establishment under

sections 6(4) and 19(3) was false or incomplete in any material

respect,

and the competent authority considers that the failure in question is not

sufficiently serious to warrant suspension or revocation of the authorisation

of the tissue establishment in the first instance, the competent authority may

serve a notice on the responsible person of the tissue establishment in

accordance with subsection (5).

(5) A notice served under this subsection shall–

(a) identify the requirements of this Part in respect of which the

tissue establishment has failed to comply with or, in the case of

false or incomplete information, the further information which

is required;

(b) identify the action which the tissue establishment is required to

take; and

take the action identified in paragraph (b).

(6) If the tissue establishment fails to comply with the requirements set

out in the notice within the specified timescale, the competent authority

Public Health (Human Tissues, Cells and Organs)

2009-53

may, by a notice served on the tissue establishment, suspend or revoke the

authorisation of the tissue establishment.

(7) A suspension or revocation under subsection (6) shall take effect–

(a) in a case where the competent authority considers that it is

necessary in the interests of safety, immediately; or

(b) in all other cases, from a date specified in the notice.

(8) Any suspension under subsection (1) or (6) shall be for such period as

the competent authority shall consider necessary having regard to the

reasons for the suspension.

(9) The suspension or revocation of an authorisation under subsection (1)

or (6) may be total, or may be limited to a particular prescribed activity or to

one or more prescribed activities carried out at a particular site or sites, or to

a particular tissue or cell.

Responsible person for tissue establishment.

8.(1) Subject to subsection (2), a tissue establishment shall designate a

person who is responsible for the following functions–

(a) ensuring that all prescribed activities are carried out in

accordance with the requirements of this Part;

(b) providing information to the competent authority as required

under section 6; and

requirements under sections 9, 10, 11, 12, 14, 15, 16, 18, 19

and 20.

(2) A tissue establishment shall not designate a person under subsection

(1) unless that person has–

(a) a diploma, certificate or other evidence of formal qualification

in the field of medical or biological sciences awarded on

completion of–

(i) a university course of study; or

(ii) a course recognised as an equivalent course by the

competent authority; and

(b) practical post-graduate experience in areas of work relevant to

the responsibilities of the responsible person under this Part for

Public Health (Human Tissues, Cells and Organs)

2009-53

at least 2 years, in an establishment (or more than one

establishment) in any Member State lawfully undertaking

activities related to the collection or testing (or both) of tissues

and cells, or to their procurement, storage and distribution.

(3) The competent authority shall, from time to time, publish in the

Gazette details of courses recognised by it for the purpose of subsection

(2)(a)(ii).

(4) Tissue establishments shall inform the competent authority of the

name of the responsible person referred to in subsection (1).

(5) The responsible person may delegate any of the functions specified in

subsection (1) to other persons who shall be qualified by training and

experience to perform them.

(6) Tissue establishments shall notify the competent authority of the name

of any persons to whom functions have been delegated by the responsible

person under subsection (5), and the specific functions which have been

delegated to such persons.

(7) Where the responsible person or a person to whom functions have

been delegated under subsection (5) is permanently or temporarily replaced,

the tissue establishment shall, without delay, provide the competent

authority with the name of the replacement, details of his qualifications and

the date on which the replacement began his duties.

(8) If the competent authority considers that the responsible person does

not meet the requirements of subsection (2), it shall serve a notice to that

effect on the tissue establishment.

(9) If, within 14 days of receiving a notice in accordance with subsection

(8), a tissue establishment is not able to demonstrate to the reasonable

satisfaction of the competent authority that the responsible person meets the

requirements of subsection (2), it shall, without delay–

(a) relieve him of the duties of responsible person in respect of the

tissue establishment;

(b) appoint a new responsible person in his place; and

responsible person and provide details of the name and

qualifications of the person appointed.

Requirements for the procurement and supervision of procurement of

human tissues and cells.

Public Health (Human Tissues, Cells and Organs)

2009-53

9.(1) Tissue establishments shall ensure that

(a) tissue and cell procurement and testing

(i) take place in conditions authorised for that purpose;

(ii) are carried out by persons with appropriate training and

expertise;

(b) the tests required for donors are carried out by a qualified

laboratory authorised by the competent authority; and

with the requirements set out in Schedule 6.

(2) The competent authority shall ensure that the tissue and cell donation

and procurement procedures and the reception of tissues and cells at the

tissue establishment comply with the requirements set out in Schedule 4.

(3) A tissue establishment shall ensure that appropriate control measures

are in place for the procurement of tissues and cells.

(4) With the exception of partner donation of reproductive cells for direct

use, the competent authority shall authorise the procurement of human

tissues and cells only when the following requirements are met

(a) procurement of human tissues and cells shall be carried out by

persons who have successfully completed a training

programme specified by a clinical team specialising in the

tissues and cells to be procured, or a tissue establishment

authorised for procurement;

(b) the tissue establishment or procurement organisation shall have

written agreements with the staff or clinical teams responsible

for donor selection, unless they are employed by the same

organisation or establishment, specifying the procedures to be

followed to assure compliance with the selection criteria for

donors set out in Schedule 1;

written agreements with the staff or clinical teams responsible

for tissue or cell procurement, unless they are employed by the

same establishment or organisation, specifying the type or

types of tissues or cells or test samples to be procured and the

protocols to be followed;

(d) there shall be Standard Operating Procedures (SOPs)

Public Health (Human Tissues, Cells and Organs)

2009-53

(i) for the verification of

(aa) donor identity;

(bb) the details of donor or donor family consent or

authorisation;

(cc) the assessment of the selection criteria for

donors as detailed in section 13;

(dd) the assessment of the laboratory tests required

for donors as detailed in section 13;

(ii) describing the procedures for procurement, packaging,

labelling and transportation of the tissues and cells to the

point of arrival at the tissue establishment or, in the case

of direct distribution of tissues and cells, to the clinical

team responsible for their application, or in the case of

tissue or cell samples, to the laboratory for testing, in

accordance with Schedule 4;

(e) procurement shall take place in appropriate facilities, following

procedures that minimise bacterial or other contamination of

procured tissues and cells, in accordance with Schedule 4;

(f) procurement materials and equipment shall be managed in

accordance with the standards and specifications laid down in

point 1.3 of Schedule 4 and with due regard to relevant

national and international regulations, standards and guidelines

covering the sterilisation of medicines and medical devices.

Qualified, sterile instruments and procurement devices shall be

used for tissue and cell procurement;

(g) procurement of tissues and cells from living donors shall take

place in an environment that ensures their health, safety and

privacy;

(h) where appropriate, the staff and equipment necessary for body

reconstruction of deceased donors shall be provided. Such

reconstruction shall be completed effectively;

(i) the procedures for the procurement of tissues and cells shall be

carried out in accordance with the requirements specified in

Schedule 4;

(j) a unique identifying code shall be allocated to the donor and

the donated tissues and cells, during procurement or at the

tissue establishment, to ensure proper identification of the

Public Health (Human Tissues, Cells and Organs)

2009-53

donor and the traceability of all donated material and the coded

data shall be entered in a register maintained for the purpose;

(k) donor documentation shall be maintained in accordance with

point 1.4 of Schedule 4.

Quality management and notification and reporting to the competent

authority of serious adverse events and reactions.

10.(1) A tissue establishment shall–

(a) establish and maintain a quality system based on the principles

of good practice and in accordance with the requirements set

out under Article 28(c) of the principal Directive;

(b) ensure that all testing and processes are validated;

includes at least documentation on the following

(i) SOPs,

(ii) guidelines,

(iii) training and reference manuals,

(iv) reporting forms,

(v) donor records, and

(vi) information on the final destination of tissues and cells,

and that this documentation is readily available for inspection

by the competent authority.

(2) Tissue establishments shall ensure that the data necessary to ensure

traceability are in accordance with section 16.

(3) Tissue establishments, through the responsible person, shall notify the

competent authority of, and provide the competent authority with, a report

analysing the cause of and ensuing outcome of

(a) any serious adverse events and reactions, which may influence

the quality and safety of tissues and cells and which may be

attributable to any prescribed activity; and

Public Health (Human Tissues, Cells and Organs)

2009-53

(b) any serious adverse reactions observed during or after clinical

applications, which may be linked to the quality and safety of

tissues and cells.

(4) A tissue establishments, through the responsible person, shall

(a) ensure that an accurate, rapid and verifiable procedure is in

place, which will enable the establishment to recall from

distribution any product which may be related to any

notification referred to in subsection (3);

(b) keep a record of its activities, including the types and quantities

of tissues or cells or both procured, tested, preserved,

processed, stored and distributed, or otherwise disposed of, and

on the origin and destination of the tissues and cells intended

for human applications, in accordance with Schedule 4; and

accessible, to the competent authority.

(5) All persons using human tissues and cells regulated by this Part shall

report any relevant information to establishments engaged in the donation,

procurement, testing processing, storage or distribution of human tissue and

cells in order to facilitate traceability and ensure quality and safety control.

Notification of serious adverse reactions.

11.(1) The competent authority shall ensure that

(a) procurement organisations have procedures in place to retain

the records of tissues and cells procured and to notify tissue

establishments without delay of any serious adverse reactions

in the living donor which may influence the quality and safety

of tissues and cells;

(b) organisations responsible for human application of tissues and

cells have procedures in place to retain the records of tissues

and cells applied and to notify tissue establishments without

delay of any serious adverse reactions observed during and

after clinical application which may be linked to the quality

and safety of tissues and cells; and

application provide information to the organisation responsible

for human application of tissues and cells about how that

organisation should report serious adverse reactions as referred

to in paragraph (b).

Public Health (Human Tissues, Cells and Organs)

2009-53

(2) The competent authority shall ensure that tissue establishments

(a) have procedures in place to communicate to the competent

authority without delay all relevant available information about

suspected serious adverse reactions as referred to in subsection

(1)(a) and (b); and

(b) have procedures in place to communicate to the competent

authority without delay the conclusion of the investigation to

analyse the cause and the ensuing outcome.

(3) The competent authority shall ensure that

(a) the responsible person designated under section 8 notifies the

competent authority of the information included in the notification

set out in Part A of Schedule 7;

(b) tissue establishments notify the competent authority of the actions

taken with respect to other implicated tissues and cells that have

been distributed for human applications; and

conclusion of the investigation, supplying at least the information

set out in Part B of Schedule 7.

Notification of serious adverse events.

12. The competent authority shall ensure that

(a) procurement organisations and tissue establishments have

procedures in place to retain the records and to notify tissue

establishments without delay of any serious adverse events that

occur during procurement which may influence the quality or

safety or both of human tissues and cells;

(b) organisations responsible for human application of tissues and cells

have procedures in place to notify tissue establishments without

delay of any serious adverse events that may influence the quality

and safety of the tissues and cells; and

human application information about how that organisation should

report serious adverse events to them that may influence the quality

and safety of the tissues and cells.

(2) In the case of assisted reproduction, any type of gamete or embryo

misidentification or mix-up shall be considered to be a serious adverse

event. All persons or procurement organisations or organisations

Public Health (Human Tissues, Cells and Organs)

2009-53

responsible for human application performing assisted reproduction shall

report such events to the supplying tissue establishments for investigation

and notification to the competent authority.

(3) The competent authority shall ensure that tissue establishments

(a) have procedures in place to communicate to the competent

authority without delay all relevant available information about

suspected serious adverse events as referred to in subsection (1)(a)

and (b); and

(b) have procedures in place to communicate to the competent

authority without delay the conclusion of the investigation to

analyse the cause and the ensuing outcome.

(4) The competent authority shall ensure that

(a) the responsible person designated under section 8 notifies the

competent authority of the information included in the

notification set out in Part A of Schedule 8;

(b) tissue establishments evaluate serious adverse events to

identify preventable causes within the process; and

conclusion of the investigation, supplying at least the

information set out in Part B of Schedule 8.

Donor selection, evaluation and testing criteria.

13.(1) Tissue establishments shall ensure that

(a) donors of tissues and cells, except donors of reproductive cells,

undergo the biological tests set out in point 1 of Schedule 2;

(b) the tests referred to in paragraph (a) are carried out in

compliance with the general requirements set out in point 2 of

Schedule 2;

in points 1, 2 and 3 of Schedule 3; and

(d) the tests referred to in paragraph (c) are carried out in

compliance with the general requirements set out in point 4 of

Schedule 3.

(2) Tissue establishments shall ensure that donors comply with the

selection criteria set out in

Public Health (Human Tissues, Cells and Organs)

2009-53

(a) Schedule 1 for donors of tissues and cells, except donors of

reproductive cells; and

(b) Schedule 3 for donors of reproductive cells.

(3) Tissues and cells shall not be procured unless the information required

under subsection (4) has been provided by the tissue establishment or

procurement organisation to the donor (in the case of a living adult donor)

or the next of kin (in the case of a deceased donor or a person who is unable

to give consent) and informed consent has been given for such procurement.

(4) The person in charge of the donation process in a tissue establishment

or procurement organisation, prior to the procurement of such tissues or

cells or both, in relation to living donors, shall ensure that–

(a) the donor, or the donor’s next of kin, (in the case of a person

who is unable to give consent) has been properly informed of

at least those aspects relating to the donation and procurement

process outlined in paragraph (c);

(b) the information is given by a trained person able to transmit it

in an appropriate and clear manner, using terms that are easily

understood by the donor;

(i) the purpose and nature of the procurement, its

consequences and risks,

(ii) analytical tests, if they are performed,

(iii) recording and protection of donor data,

(iv) medical confidentiality,

(v) therapeutic purpose and potential benefits,

(vi) the applicable safeguards intended to protect the donor;

(d) the donor is informed that he has the right to receive the

confirmed results of the analytical tests, clearly explained; and

(e) information is given on the necessity for requiring the

applicable mandatory consent, certification and authorisation in

order that the tissue or cell or both procurement can be carried

out.

Public Health (Human Tissues, Cells and Organs)

2009-53

(5) The person in charge of the donation and procurement processes in a

tissue establishment or procurement organisation, prior to the procurement

of such tissues or cells or both, in relation to deceased donors, shall ensure

that–

(a) all information is given and all necessary consents and

authorisations are obtained in accordance with this Part; and

(b) the confirmed results of the donor’s evaluation are

communicated and clearly explained to the relevant persons in

accordance with this Part.

(6) The tissue establishment or procurement organisation shall, in relation

to the donation and procurement of tissues and cells

(a) put and keep in place procedures for the evaluation of donors;

(b) apply selection and evaluation criteria for all donors of tissues

or cells or both in accordance with this section; and

and report to donors any relevant abnormal findings from the

evaluations, and tests.

(7) In the case of autologous donation, the suitability criteria of the donor

shall be established in accordance with the requirements in point 2.1 of

Schedule 1.

Tissue and cell reception, processing, storage and distribution.

14.(1) Tissue establishments shall ensure that human tissue and cells and

associated documentation comply with the requirements set out in Schedule

(2) Tissue establishments shall ensure that the reception of tissues and

cells at the tissue establishment complies with the requirements set out in

Schedule 4.

(3) Tissue establishments shall verify and record the fact that the

packaging of tissues and cells received complies with the requirements of

point 1.5 of Schedule 4.

(4) Tissues and cells that do not comply with point 1.5 of Schedule 4,

shall be discarded.

(5) Tissue establishments shall document the acceptance or rejection of

received tissues or cells.

Public Health (Human Tissues, Cells and Organs)

2009-53

(6) Tissue establishments shall ensure that human tissues and cells are

correctly identified at all times. Each delivery or batch of tissues or cells

shall be assigned an identifying code, in accordance with section 16.

(7) Tissue establishments shall hold tissue and cells in quarantine until

such time as the requirements relating to donation, testing and information

have been met in accordance with section 13.

(8) Tissue establishments shall

(a) include in their SOPs all processes that affect quality and

safety and shall ensure that they are carried out under

controlled conditions;

(b) ensure that the equipment used, the working environment and

process design, validation and control conditions are in

compliance with the requirements in Article 28(h) of the

principal Directive;

preparation of tissues and cells shall also meet the criteria laid

down in paragraphs (a) and (b) of this subsection;

(d) include in their SOPs special provisions for the handling of

tissue and cells to be discarded, in order to prevent the

contamination of other tissues or cells, the processing

environment or personnel;

(e) ensure that all procedures associated with the storage of tissues

and cells are documented in the SOPs and that the storage

conditions comply with the requirements under Article 28(h) of

the principal Directive;

(f) ensure that all storage processes are carried out under

controlled conditions;

(g) establish and apply procedures for the control of packaging and

storage areas, in order to prevent any situation arising that

might adversely affect the functioning or integrity of tissues

and cells; and

(h) not distribute processed tissues or cells until the requirements

laid down in this Part are met.

(9) Tissue establishments shall have agreements and procedures in place

to ensure that, in the event of termination of activities for whatever reason,

stored tissues and cells shall be transferred to other tissue establishment or

establishments authorised in accordance with section 6 without prejudice to

Public Health (Human Tissues, Cells and Organs)

2009-53

any Gibraltar law concerning the disposal of donated tissues or cells,

according to the consent pertaining to them.

(10) Tissue establishments shall ensure that personnel directly involved in

activities relating to the procurement, processing, preservation, storage and

distribution of tissues and cells shall be qualified to perform such tasks and

shall be provided with the training referred to in Article 28(c) of the

principal Directive.

(11) Tissue establishments shall ensure–

(a) the quality and safety of tissues and cells during distribution;

and

(b) that distribution conditions comply with the requirements

referred to in Article 28(h) of the principal Directive.

Principles governing tissue and cell donation and voluntary unpaid

donation.

15.(1) The Government shall draw up guidelines setting out the conditions

under which promotion and publicity activities in support of the donation of

human tissues and cells may be carried out. Such guidelines shall include

appropriate restrictions or prohibitions on advertising the need for, or

availability of, human tissues and cells, with a view to offering or seeking

financial gain or comparable advantage.

(2) The guidelines referred to in subsection (1) shall endeavour to ensure

that the procurement of tissues and cells is carried out on a non-profit basis.

(3) Tissue establishments shall

(a) comply with guidelines laid down for the promotion and

publicity activities in support of the donation of human tissues

and cells; and

(b) make every effort to ensure voluntary and unpaid donations of

tissues and cells.

(4) Without prejudice to subsection (3), the tissue establishments may

make good the expenses and inconveniences related to the donation in

accordance with the guidelines.

Traceability and labelling of tissues and cells.

16.(1) Every tissue establishment shall ensure that it has in place an

effective and accurate system to uniquely identify, trace and label all tissues

and cells, which it procures, processes, stores or distributes, from donor to

Public Health (Human Tissues, Cells and Organs)

2009-53

end user, or disposal, and vice versa, and this traceability will also apply to

all relevant data relating to products and materials coming into contact with

these tissues and cells.

(2) Every tissue establishment shall implement a donor identification

system which assigns a unique code to each tissue or cell donation and to

each of the products associated with it.

(3) A single European identifying code shall be allocated to all donated

material at the tissue establishment to

(a) ensure proper identification of the donor and the traceability of

all donated material; and

(b) provide information on the main characteristics and properties

of tissues and cells,

and the code shall incorporate at least the information set out in Schedule

11.

(4) Subsection (3) shall not apply to partner donation of reproductive

cells.

(5) Every tissue establishment must use a labelling system that contains

the information or references allowing a link to the information referred to

in Schedule 4 and Article 28(h) of the principal Directive.

(6) Every tissue establishment shall keep such records of the information

referred to in Schedule 4 and such additional records as are necessary–

(a) for the identification and traceability of each single tissue or

cell donation and each single tissue or cell unit and its

components (including tissues and cells which are imported

into the European Union), and products coming into contact

with these tissues and cells; and

(b) to ensure full traceability from donation and procurement,

processing or storage to the point of delivery to a hospital or

site, and at all stages, for a period of not less than 30 years after

clinical use, and data storage may also be in electronic form.

(7) Every tissue establishment shall ensure that the labelling,

documentation and packaging on each tissue or cell supplied by it, shall

conform to the requirements of this Part.

(8) Tissue establishments and organisations responsible for human

application shall retain the data set out in Schedule 10 for at least 30 years,

in an appropriate and readable storage medium.

Public Health (Human Tissues, Cells and Organs)

2009-53

Import and export of human tissues and cells.

17.(1) The competent authority shall ensure that–

(a) all imports of tissues and cells from third countries; and

(b) all exports of tissues and cells to third countries,

are undertaken by authorised tissue establishments.

(2) Tissue establishments shall ensure that imported tissues and cells–

(a) can be traced from donor to the recipient and vice versa in

accordance with the procedures and requirements laid down by

section 16; and

(b) meet standards of quality and safety equivalent to those laid

down in this Part.

(3) Tissue establishments shall ensure that all exports to third countries

comply with the requirements of this Part.

(4) The competent authority may directly authorise the import or export

of–

(a) tissues and cells referred to in section 6(12)(b); and

(b) certain tissues and cells, in case of emergency.

(5) The competent authority shall take all necessary measures to ensure

that imports and exports of tissues and cells referred to in subsection (4)

meet the quality and safety standards equivalent to those laid down in this

Part.

Relations between tissue establishments and third parties.

18.(1) Tissue establishments shall establish written agreements with a third

party each time an external activity takes place which influences the quality

and safety of tissues and cells processed in cooperation with a third party,

and in particular in the following circumstances

(a) where a tissue establishment entrusts one of the stages of tissue

or cell processing to a third party;

(b) where a third party provides goods and services that affect

tissue or cell quality and safety assurance, including their

distribution;

Public Health (Human Tissues, Cells and Organs)

2009-53

establishment which is not authorised; and

(d) where a tissue establishment distributes tissue or cells

processed by third parties.

(2) Agreements between tissue establishments and third parties shall be

examined by the competent authority within the authorisation framework of

section 6.

(3) Tissue establishments shall evaluate and select third parties on the

basis of their ability to meet the standards laid down in this Part.

(4) Tissue establishments shall keep a complete list of the agreements

referred to in subsection (1) that they have established with third parties.

(5) Agreements between tissue establishments and third parties shall

specify the responsibilities of third parties and detailed procedures.

(6) Tissue establishments shall provide copies of agreements with third

parties at the request of the competent authority.

Objections to refusals of authorisation or suspension or revocation of

authorisation.

19.(1) A tissue establishment which objects to–

(a) the refusal of authorisation, or the imposition of any condition

under section 6(5); or

(b) any suspension or revocation of authorisation, or any notice

served, under section 6(8) or (7),

may notify the competent authority of its desire to make written

representations to, or to appear before and be heard by, a person appointed

by the competent authority for that purpose pursuant to subsection (3).

(2) Any notification of an objection under subsection (1) shall be made

within 14 days of service on the tissue establishment of the notice to which

the notification under subsection (1) relates.

(3) Where the competent authority receives a notification under subsection

(1), competent authority shall appoint a person to consider the matter.

(4) The person appointed under subsection (3) shall determine the

procedure to be followed with respect to the consideration of any objection.

Public Health (Human Tissues, Cells and Organs)

2009-53

(5) The person appointed under subsection (3) shall consider any written

or oral objections made by the tissue establishment in support of its

objection, and shall make a recommendation to the competent authority.

(6) A recommendation made under subsection (5) shall be made in writing

to the competent authority, and a copy of it shall be sent to the tissue

establishment concerned, or to its nominated representative.

(7) The competent authority shall take into account any recommendation

made under subsection (5).

(8) Within 14 days of receipt of any recommendation made under

subsection (5), the competent authority shall inform the tissue establishment

whether it (the competent authority) accepts the recommendation and, if it

does not accept it, of the reasons for its decision.

(9) Subject to subsection (11), where the competent authority is notified of

an objection under subsection (1)(b) before the date upon which the

suspension or revocation or the notice is due to take effect, the suspension

or revocation or notice in respect of which the objection is made shall not

take effect until–

(a) the person appointed under subsection (3) has considered the

matter in accordance with the provisions of this section and

made a recommendation; and

(b) the competent authority has informed the tissue establishment

concerned of its decision with regard to the recommendation

under subsection (8).

(10) Subject to subsection (11), where the competent authority is notified

of an objection under subsection (1)(b), within the period specified in

subsection (2), to a suspension, revocation or other notice which has already

taken effect on the date the notification was made, the suspension,

revocation or notice in respect of which the objection is made shall cease to

have effect until–

(a) the person appointed under subsection (3) has considered the

matter in accordance with this section and made a

recommendation; and

(b) the competent authority has informed the tissue establishment

concerned of its decision with regard to the recommendation

under subsection (8).

(11) Subsections (9) and (10) shall not apply–

Public Health (Human Tissues, Cells and Organs)

2009-53

(a) in relation to a suspension or revocation, which takes

immediate effect in accordance with section 7(3); or

(b) in any other case, where the competent authority determines

that it is necessary in the interests of public safety for the

suspension, revocation or notice to take effect on the date

originally specified, and serves a notice in writing to that effect

on the tissue establishment concerned.

Disclosure of information by tissue establishments and data protection.

20.(1) A tissue establishment shall ensure that all information, including

genetic information which is collected for the purposes of this Part is held

securely so that it is–

(a) available for the purpose of tracing donations;

(b) not disclosed except–

(i) in accordance with one or more of the requirements of

subsection (2); or

(ii) where it has been rendered anonymous so that donors

and recipients are no longer identifiable; and

or modifications to donor files or deferral records and transfer

of information.

(2) The requirements of this section are–

(a) the disclosure is made in accordance with an order of a court or

is otherwise required by law;

(b) the disclosure is to an authorised person; or

donor to recipient or recipient to donor.

(3) Where a disclosure is made to an authorised person under subsection

(2)(b), the authorised person shall not further disclose the information

received unless

(a) the disclosure is made in accordance with an order of a court or

is otherwise required by law;

Public Health (Human Tissues, Cells and Organs)

2009-53

(b) the disclosure is to another authorised person or an officer of

the Gibraltar Health Authority where this is necessary for the

proper performance of any function of any such officer; or

donors are no longer identifiable.

(4) Where a disclosure is made under subsection (3), the person to whom

the disclosure is made shall not further disclose the information he receives

other than in accordance with the requirements of that subsection.

(5) The responsible person shall ensure that he puts in place procedures to

resolve data discrepancies.

(6) The responsible person shall ensure that the identity of the recipient is

not disclosed to the donor or his family and vice versa, without prejudice to

any provision of law on the conditions for disclosure, notably in the case of

gametes donation.

Inspections.

21.(1) The competent authority shall conduct a regular inspection of each

site of a tissue establishment, not less than once every 2 years, for the

purpose of ensuring that–

(a) the procedures and activities carried out by tissue

establishments comply with the requirements of this Part;

(b) documents or other records relating to the requirements of the

this Part are examined;

identified; and

(d) the site complies with the requirements of this Part.

(2) The competent authority may conduct such additional inspections of

tissue establishment sites or facilities of third parties, as the competent

authority considers necessary for the purpose of ensuring compliance with

the requirements of this Part.

(3) The competent authority may also serve a notice on a tissue

establishment requiring that it furnish the competent authority with such

information concerning its compliance with this Part and as shall be

specified in the notice within such period as shall be specified in the notice.

Public Health (Human Tissues, Cells and Organs)

2009-53

(4) Any tissue establishment which receives a request for information in

accordance with subsection (3) shall provide the information requested

within the period specified in the notice.

(5) In the event of any serious adverse event or any serious adverse

reaction or suspicion thereof, the competent authority shall request such

information, conduct such inspections, or carry out control measures, in

accordance with this section, as it shall consider appropriate.

(6) Any reference to an inspection of a site which the competent authority

is required or empowered to conduct by virtue of this section, shall be

construed so as to include an inspection of premises within a Member State

at which any of the prescribed activities are carried out by any person on

behalf of, and pursuant to a contractual arrangement with, a tissue

establishment.

(7) The competent authority’s functions under this section in relation to a

tissue establishment are also applicable in the case of a tissue establishment

seeking authorisation under section 6.

(8) The competent authority, on receipt of a duly justified request from the

competent authority in a Member State, shall organise such inspection or

carry out control measures.

(9) The competent authority shall, upon the request of a Member State, or

the Commission, provide information on the results of inspections and

control measures carried out, in relation to the requirements of this Part.

Authorised persons.

22.(1) The competent authority–

(a) may appoint such and so many persons as it (the competent

authority) thinks fit to be authorised persons for the purposes

of this Part; and

(b) shall furnish each such authorised person with a warrant of the

authorised person’s appointment.

(2) An authorised person shall, when performing a function imposed

under this Part on an authorised person, produce his warrant for inspection

if requested to do so by a person affected by the performance of that

function.

(3) For the purposes of enforcing compliance with this Part or conducting

inspections under section 19, an authorised person may–

Public Health (Human Tissues, Cells and Organs)

2009-53

(a) subject to subsection (5), enter (if necessary by the use of

reasonable force), at all reasonable times, any premises at

which he has reasonable grounds to believe that it is necessary

to visit, including–

(i) any premises owned or managed by a tissue

establishment, or at which the tissue establishment

carries out any prescribed activities,

(ii) any premises of any person who carries out any

prescribed activities on behalf of, and pursuant to a

contractual arrangement with a tissue establishment,

(iii) where any facilities for donor evaluation and testing are

in the premises of any person other than a tissue

establishment, those facilities in that person’s premises,

and

(iv) any premises at which books, records or other documents

(including documents stored in non-legible form)

relating to any prescribed activities are stored or kept,

(b) at such premises inspect and take copies of, any books, records,

other documents (including documents stored in non-legible

form) or extracts therefrom, which he finds in the course of his

inspection;

premises and detain them for such period as he reasonably

considers to be necessary for the purposes of his functions

under this Part;

(d) carry out, or have carried out, such tests, examinations,

analyses, inspections and checks of–

(i) the premises,

(ii) any relevant thing at the premises, or

(iii) any equipment, machinery or plant at the premises, as he

reasonably considers to be necessary for the purposes of

his functions under this Part;

(e) require any person at the premises or the owner or person in

charge of the premises and any person employed there to give

to him such assistance and information and to produce to him

such books, records or other documents (and in the case of

documents stored in non-legible form, produce to him a legible

Public Health (Human Tissues, Cells and Organs)

2009-53

reproduction thereof) that are in that person’s power or

procurement, as he may reasonably require for the purposes of

his functions under this Part;

(f) without payment, take samples of any relevant thing found at

the premises for the purposes of any test, examination or

analysis;

(g) direct that such relevant thing found at the premises as he,

upon reasonable grounds, believes does not comply with the

requirements of this Part not be sold or distributed or moved

from the premises, without his consent;

(h) secure for later inspection any premises or part of any premises

in which a relevant thing is found or ordinarily kept, or books,

records or other documents are found or ordinarily kept, for

such period as may reasonably be necessary for the purposes of

his functions under this Part;

(i) without payment, take possession of and remove from the

premises for any test, examination or analysis any relevant

thing found there, and detain it for such period as he considers

reasonably necessary for the purposes of performing his

functions under this Part;

(j) without payment, take samples of any relevant thing, detained

under paragraph (i), for the purposes of any test, examination,

or analysis; or

(k) where the taking of samples of any relevant thing under

paragraph (f) or (j) is, for whatever reason, not practicable,

without payment take the relevant thing concerned for the

purposes of any test, examination or analysis.

(4) In performing a function under this Part, an authorised person may,

subject to any warrant under subsection (6), be accompanied by any–

(a) other authorised person; or

(b) persons with expertise relating to any relevant thing, as he

considers appropriate in the circumstances of the case.

(5) An authorised person shall not enter a dwelling, other than–

(a) with the consent of the occupier; or

(b) in accordance with a warrant issued under subsection (6).

Public Health (Human Tissues, Cells and Organs)

2009-53

(6) Upon the application of an authorised person, the Stipendiary

Magistrate, if satisfied that there are reasonable grounds for believing that–

(a) a relevant thing is to be found in any dwelling, or is being or

has been subjected to any process or stored in any dwelling;

(b) books, records or other documents (including documents stored

in non-legible form) referred to in subsection (3)(a)(iv) are

being stored or kept in any dwelling; or

carrying out any prescribed activity,

may issue a warrant authorising a police officer accompanied by the

applicant and such other authorised persons or persons with expertise

relating to any relevant thing, as may be necessary, at any time or times,

within one month of the date of issue of the warrant, to enter the dwelling

and perform any of the functions of an authorised person under paragraphs

(b) to (k) of subsection (3).

(7) Where a police officer or an authorised person, upon reasonable

grounds, believes that a person has committed an offence under this Part, he

may require that person to provide him with his name and the address at

which he ordinarily resides.

(8) A statement or admission made by a person pursuant to a requirement

under subsection (3)(e) shall not be admissible as evidence in proceedings

brought against that person for an offence (other than an offence under

section 26(6)).

(9) Nothing in this section shall be taken to compel the production by any

person of a document of which he would be exempt from production in

proceedings in a court on the ground of legal professional privilege.

Taking of samples by authorised persons.

23.(1) Subject to subsection (3), where an authorised person takes a sample

of a relevant thing, he shall–

(a) divide the sample into 3 approximately equal parts;

(b) place each part into separate containers; and

as to identify it as part of the sample taken by that authorised

person.

Public Health (Human Tissues, Cells and Organs)

2009-53

(2) Where an authorised person has complied with subsection (1), he

shall–

(a) offer one of the sealed containers to the owner or person for the

time being in charge or possession of the relevant thing from

which the sample concerned was taken;

(b) retain one of the sealed containers; and

for test, examination or analysis of the sample.

(3) Where a relevant thing is contained in a container and its division into

parts under subsection (1) is, for whatever reason, not practicable, an

authorised person, who wishes to take samples of such relevant things for

the purposes of any test, examination or analysis, shall take possession of 3

such containers belonging to the same batch, and each such container shall

be deemed to be part of a sample for the purposes of subsection (1), and

subsections (1) and (2) shall apply to it accordingly.

(4) Where an authorised person takes a relevant thing under section

22(3)(k), he shall–

(a) place the relevant thing in a container; and

(b) forthwith seal and mark the container in such a manner as to

identify it as a relevant thing taken pursuant to that section.

Records to be kept by the competent authority.

24.(1) The competent authority shall keep such records of information

which the competent authority receives from, or relating to, tissue

establishments as are considered appropriate in accordance with section 14

and shall, in particular, keep records relating to–

(a) authorisations under section 6;

(b) the designation of responsible persons under section 8; and

reactions by tissue establishments under section 10(3); and

(d) inspections or requests for information under section 19.

(2) The competent authority shall maintain a publicly accessible register

of tissue establishments, specifying the activities for which the

establishments have been authorised.

Public Health (Human Tissues, Cells and Organs)

2009-53

(3) The competent authority shall provide the assistance necessary to

enable the Commission to establish a network linking all the tissue

establishment registers in the Union.

Communication of information between competent authorities and to

the Commission.

25. The competent authority shall ensure that such information as is

appropriate with regard to serious adverse reactions and events is

communicated to the competent authorities of Member States and to the

Commission in order to guarantee that adequate actions are taken.

Offences and penalties.

26.(1) A person who contravenes any of the provisions of section 5(1),

6(9), 8 (other than subsection (3)), 9, 10, 11, 12, 15(3), 16 (other than

subsection (3)), 17(3) or 19 (4) shall be guilty of an offence and liable on

summary conviction to a fine not exceeding level 4 on the standard scale, or

to imprisonment for a term not exceeding 6 months, or to both.

(2) Any person who fails to comply with a notice of suspension or

revocation of the person’s authorisation served under section 7, except

where the operation of that notice has been suspended under section 19 or

has been withdrawn or revoked by the competent authority, shall be guilty

of an offence and liable on summary conviction to a fine not exceeding level

3 on the standard scale, or to a term of imprisonment not exceeding 6

months, or to both.

(3) Any person who knowingly supplies tissue or cells which are not

labelled in accordance with the requirements of section 16(3) shall be guilty

of an offence and liable on summary conviction to a fine not exceeding level

2 on the standard scale, or to a term of imprisonment not exceeding 3

months, or to both.

(4) Any person who–

(a) contravenes section 20; or

(b) discloses any information referred to in section 20(1) to which

he has access by virtue of this Part, otherwise than in

accordance with the provision of section 20(2) and (3),

shall be guilty of an offence and liable on summary conviction to a fine not

exceeding level 2 on the standard scale, or to a term of imprisonment not

exceeding 3 months, or to both.

(5) Any person who–

Public Health (Human Tissues, Cells and Organs)

2009-53

(a) obstructs or interferes with an authorised person or a person

with expertise relating to any relevant thing (within the

meaning of section 2), in the course of performing a function

conferred on him by this Part or a warrant under section 22(6);

(b) impedes the performance by the authorised person or person

with expertise, of such function or fails or refuses to comply

with a request or requirement of, or to answer a question asked

by, the authorised person or person with expertise, under

section 22;

answer to such question gives information to the authorised

person or person with expertise, that he knows to be false or

misleading in any material respect,

shall be guilty of an offence and liable on summary conviction to a fine not

exceeding level 2 on the standard scale, or to imprisonment for a term not

exceeding 3 months, or to both.

(6) A person who falsely represents himself to be an authorised person

shall be guilty of an offence and liable on summary conviction to a fine not

exceeding level 2 on the standard scale, or to imprisonment for a term not

exceeding 3 months, or to both.

(7) Nothing in subsection (5)(b) shall be construed as requiring any person

to answer any question or to give any information if to do so might

incriminate him or, in the case of a person who is married, his or her spouse.

(8) On conviction for an offence under this Part (including an offence

under section 27), the court may, in addition to any other penalty–

(a) order any relevant thing (within the meaning of section 2) to

which the offence relates to be forfeited to the competent

authority for destruction or other disposal as the competent

authority thinks fit;

(b) upon application made to it by or on behalf of the competent

authority, order the person convicted of the offence to pay to

the relevant person all or part of the costs of such destruction

or other disposal subject to such conditions, if any, as are

specified in the order.

Offence to import below standard tissues and cells into Gibraltar.

27. Any person who imports into Gibraltar any tissues or cells (including

tissues or cells intended for use as a starting material or raw material in

Public Health (Human Tissues, Cells and Organs)

2009-53

manufactured products) from a country or territory outside the European

Union which do not meet standards of quality and safety equivalent to those

laid down in this Part is guilty of an offence and liable on summary

conviction to a fine not exceeding level 4 on the standard scale, or to

imprisonment for a term not exceeding 6 months, or to both.

Reports by the competent authority.

28.(1) The competent authority shall ensure that, as soon as practicably

possible after the coming into operation of this Part, a report is sent to the

Commission on the activities undertaken in relation to the provisions of this

Part, including an account of the measures taken in relation to inspection

and control. A further such report shall be sent to the Commission on 7

April 2012 and thereafter at regular intervals of three years.

(2) The competent authority shall–

(a) ensure that each year, and by 30 June of the following year, a

report is submitted to the Commission on the notification of

serious adverse reactions and events received by the competent

authority; and

(b) make this report available to tissue establishments.

(3) Any data transmission under this Part shall–

(a) comply with the data exchange format specifications as set out

in Schedule 9, Part A and B; and

(b) provide all the information necessary to identify the sender and

maintain its reference data.

PART 2

HUMAN ORGANS

Subject matter and application of this Part.

28A.(1) This Part sets the standards of quality and safety for human organs

intended for transplantation to the human body, in order to ensure a high

level of human health protection.

(2) This Part applies to the donation, testing, characterisation,

procurement, preservation, transport and transplantation of human organs

intended for transplantation.

(3) Where human organs are used for research purposes, this Part only

applies where they are intended for transplantation into the human body.

Public Health (Human Tissues, Cells and Organs)

2009-53

Interpretation of Part 2.

28B. In this Part, unless the context otherwise requires−

“Authority” means the competent authority within the meaning of section

1B;

“designated individual”, in relation to a licence under section 28E, means

the individual designated in the licence as the person under whose

supervision the licensed activity is authorised to be carried on;

“disposal” means the final placement of an organ where it is not used for

transplantation;

“donation” means donating organs for the purposes of transplantation;

“donor” means a person who donates one or several organs, whether

donation occurs during lifetime or after death;

“donor characterisation” means the collection of relevant information on

the characteristics of the donor needed to evaluate the donor’s

suitability for organ donation, in order to undertake a proper risk

assessment and to minimise the risks for the recipient, and optimise

organ allocation;

“duly authorised person”, in the context of any provision, means a person

authorised by the Authority to act for the purposes of that

provision;

“European organ exchange organisation” means a non-profit

organisation, whether public or private, dedicated to national and

cross-border organ exchange, in which the majority of its member

countries are Member States;

“licence holder” means a person who holds a licence granted under

section 28E;

“licensed activity”, in relation to a licence, means an activity which the

licence authorises under section 28E;

“organ” means a differentiated part of the human body, formed by

different tissues, that maintains its structure, vascularisation, and

capacity to develop physiological functions with a significant level

of autonomy and a part of an organ is also considered to be an

organ if its function is to be used for the same purpose as the entire

organ in the human body, maintaining the requirements of structure

and vascularisation;

Public Health (Human Tissues, Cells and Organs)

2009-53

“organ characterisation” means the collection of the relevant information

on the characteristics of the organ needed to evaluate its suitability

for transplantation, in order to undertake a proper risk assessment

and minimise the risks for the recipient, and optimise organ

allocation;

“Organ Directive” means Directive 2010/53/EU of the European

Parliament and of the Council of 7 July 2010 on standards of

quality and safety of human organs intended for transplantation as

amended from time to time;

“operating procedures” means written instructions describing the steps in

a specific process, including the materials and methods to be used

and the expected end outcome;

“preservation” means the use of chemical agents, alterations in

environmental conditions or other means to prevent or retard

biological or physical deterioration of organs from procurement to

transplantation;

“procurement” means a process by which a donated organ becomes

available for transplantation;

“procurement activity” means any of the following activities, undertaken

for the purposes of procurement−

(a) donor characterisation;

(b) organ characterisation;

(d) making arrangements to transport an organ; or

(e) retrieval of an organ;

“procurement organisation” means a healthcare establishment, a team or

a unit of a hospital, a person, or any other body which undertakes

or coordinates the procurement of organs, and is authorised to do

so by the Authority;

“recipient” means a person who receives a transplant of an organ;

“serious adverse event” means any undesired and unexpected occurrence

associated with any stage of the chain from donation to

transplantation that might lead to the transmission of a

communicable disease, to death or life-threatening, disabling or

Public Health (Human Tissues, Cells and Organs)

2009-53

incapacitating conditions for patients or which results in, or

prolongs, hospitalisation or morbidity;

“serious adverse reaction” means an unintended response, including a

communicable disease, in the living donor or in the recipient that

might be associated with any stage of the chain from donation to

transplantation that is fatal, life-threatening, disabling,

incapacitating, or which results in, or prolongs, hospitalisation or

morbidity;

“traceability” means the ability to locate and identify the organ at each

stage in the chain from donation to transplantation or disposal,

including the ability to−

(a) identify the donor and the licence holder who retrieved the

organ from the donor;

(b) identify the licence holder who implanted the organ in the

recipient;

implanted into the recipient; and

(d) locate and identify all relevant non-personal information

relating to products and materials coming into contact with that

organ;

“transplantation” means a process which is intended to restore certain

functions of the human body by transferring an organ from a donor

to a recipient; and

“transplantation activity” means any of the following activities,

undertaken for the purposes of transplantation−

(a) donor characterisation;

(b) organ characterisation;

(d) making arrangements to transport an organ; or

(e) implantation of an organ;

“transplantation centre” means a healthcare establishment, a team or a

unit of a hospital or any other body which undertakes the

transplantation of organs and is authorised to do so by the

Authority.

Public Health (Human Tissues, Cells and Organs)

2009-53

Framework and compliance with licensing conditions and directions.

28C.(1) The Authority shall establish and keep updated a Framework which

shall specify how the requirements for the quality and safety of organs for

transplantation shall be ensured to secure compliance with the Organ

Directive.

(2) The Framework shall–

(a) cover all stages of the chain from donation to transplantation or

disposal; and

(b) include information about the−

(i) procurement activities and transplantation activities that

are required to be carried on under the authority of a

licence granted under section 28E,

(ii) licensing application process,

(iii) requirements that licensees must comply with, including

the licensing conditions and any directions that the

Authority has given under section 28H(4) to (7), and

(iv) guidance that the Authority has given under section

28H(1) to (3).

(3) The Framework shall provide for the adoption and implementation of

operating procedures for−

(a) the verification of donor identity;

(b) the verification of the details of the donor's or the donor's

family's consent, authorisation or absence of any objection;

characterisation;

(d) the procurement, preservation, packaging and labelling of

organs;

(e) the transportation of organs;

(f) ensuring traceability, guaranteeing compliance with the

European Union and Gibraltar provisions on the protection of

personal data and confidentiality;

Public Health (Human Tissues, Cells and Organs)

2009-53

(g) the accurate, rapid and verifiable reporting of serious adverse

events and reactions; and

(h) the management of serious adverse events and reactions,

in accordance with the provisions in this Part.

(4) The operating procedures referred to in paragraphs (f), (g) and (h) shall

specify, inter alia, the responsibilities of procurement organisations,

European organ exchange organisations and transplantation centres.

(5) The Authority shall–

(a) ensure that the healthcare personnel involved at all stages of

the chain from donation to transplantation or disposal are

suitably qualified or trained and competent; and

(b) develop specific training programmes for such personnel.

Public Health (Human Tissues, Cells and Organs)

2009-53

Licensing requirement for procurement and transplantation activity.

28D.(1) No person shall carry out a procurement activity or a

transplantation activity otherwise than under the authority of a licence

granted under section 28E.

(2) A person who contravenes subsection (1) commits an offence unless

that person reasonably believes that−

(a) the activity being undertaken is not an activity to which

subsection (1) applies; or

(b) he is acting under the authority of a licence granted under

section 28E.

Granting of licences.

28E.(1) The Authority may, on the application of any person, grant a

licence for the purposes of section 28D.

(2) A licence granted under subsection (1) must−

(a) designate an individual as the designated individual; and

(b) not authorise a procurement activity or a transplantation

activity to be carried on under the supervision of more than one

such individual.

(3) A licence granted under this section must include at least the following

conditions−

(a) that the licensed activities shall be carried on only under the

supervision of the designated individual;

(b) that the procurement activity or the transplantation activity−

(i) shall have in place operating procedures for the

management of a serious adverse event or a serious

adverse reaction,

(ii) shall ensure to rapidly report to the Authority−

(A) any serious adverse event that may influence

the quality and safety of an organ, or any

serious adverse reaction observed during or

after transplantation, which may be attributed

to the testing, characterisation, procurement,

preservation and transport of an organ, and

Public Health (Human Tissues, Cells and Organs)

2009-53

(B) the management measures taken with regard to

such a serious adverse event or reaction;

from donation to the transplantation or disposal of an organ are

suitably qualified or trained and competent to perform their

tasks and are provided with relevant training;

(d) that training programmes are developed for the personnel

referred to in subparagraph (c);

(e) that the data required to ensure the traceability of organs is kept

for 30 years from the date of the retrieval of the organ;

(f) to comply with the Data Protection Act 2004; and

(g) to have in place operating procedures demonstrating how the

requirements in paragraphs (b), (e) and (f) shall be complied

with.

(4) A licence granted under this section must require for a procurement

activity−

(a) that medical activities are performed under the advice and

guidance of a registered medical practitioner;

(b) that procurement material and equipment which could affect

the quality and safety of an organ are managed in accordance

with relevant European Union or other international obligations

and Gibraltar legislation, standards and guidelines on the

sterilisation of medical devices; and

requirements in paragraphs (a) and (b) shall be complied with.

(5) It shall be a condition of a licence for the procurement activity of

retrieval of an organ−

(a) that the retrieval take place in an operating theatre which is

designed, constructed, maintained and operated in accordance

with adequate standards and best medical practices so as to

ensure the quality and safety of the organs procured;

(b) to make endeavours to follow-up a living donor for the

purposes of identifying and managing any event potentially

relating to the quality and safety of the donated organ and any

Public Health (Human Tissues, Cells and Organs)

2009-53

serious adverse reaction in the living donor that may result

from the donation;

reaction referred to in paragraph (b); and

(d) to have in place operating procedures demonstrating how the

requirement in paragraph (a) shall be complied with.

(6) A licence granted under this section must require for a procurement

activity or transplantation activity of donor characterisation or organ

characterisation to ensure−

(a) that a registered medical practitioner, or a person acting under

the supervision of a registered medical practitioner, has

endeavoured to obtain−

(i) all necessary information from the living person and for

that purpose has provided that person with the

information that person needs to understand the

consequences of donation, or

(ii) where possible and appropriate in the case of a deceased

donor, such information from relatives of the deceased

donor or other persons and has explained to such persons

the importance of swift transmission of that information;

(b) subject to subsection (8), that donors and organs are

characterised before implantation by−

(i) the collection of at least the information specified in Part

A of Schedule 12, and

(ii) where considered appropriate by a registered medical

practitioner, or a person acting under the supervision of a

registered medical practitioner, the collection of the

information specified in Part B of Schedule 12;

carried out by laboratories with suitably qualified or trained

and competent personnel and adequate facilities and

equipment; and

(d) that any organisation, body or laboratory involved in organ and

donor characterisation has appropriate operating procedures in

place to ensure that information on organ and donor

characterisation reaches the person who will be implanting an

Public Health (Human Tissues, Cells and Organs)

2009-53

organ in a recipient within a time period that would not

compromise the quality and safety of the organ.

(7) It shall be a condition of a licence for the transplantation activity of

implantation−

(a) that, subject to subsection (8), the following are verified before

proceeding to implant an organ in a recipient−

(i) identification and consent of the donor,

(ii) the collection of information prescribed in subsection

(6)(b), and

(iii) compliance with the conditions in subsection (9) about

the preservation and transportation of shipped organs;

and

(b) to have in place operating procedures demonstrating how the

requirements in paragraph (a)(i) and (ii) shall be complied

with.

(8) Where any of the information specified in Part A of Schedule 12 is not

available, it shall be a licensing condition for the transplantation activity of

implantation to be permissible following the conduct of a risk-benefit

analysis to determine whether the expected benefits for the recipient of the

organ outweigh the risks posed by the lack of any information and the

particular circumstances of the case.

(9) It shall be a condition of a licence for a procurement activity or a

transplantation activity making arrangements to transport an organ−

(a) that appropriate procedures are in place to ensure the integrity

of the organ during transport and that the transport time is

suitable to ensure the quality and safety of the organ;

(b) that, subject to subsection (10), the shipping containers used

for transporting organs are labelled with the following

information−

(i) identification of the licence holder who retrieved the

organ and the place where the retrieval took place,

including their addresses and telephone numbers,

(ii) identification of the place that an organ will be implanted

in a recipient, including its address and telephone

number,

Public Health (Human Tissues, Cells and Organs)

2009-53

(iii) a statement that the package contains an organ,

specifying the type of organ and, where applicable, its

left or right location and marked “HANDLE WITH

CARE”, and

(iv) recommended transport conditions, including

instructions for keeping the container at an appropriate

temperature and position;

organ and donor characterisation; and

(d) to have in place operating procedures demonstrating how the

requirements in subparagraphs (a) to (c) shall be complied

with.

(10) The conditions in subsection (9)(b) do not apply where transportation

is carried out in the same establishment.

(11) The Authority shall specify in the licence granted under this section

as to which procurement activity or transplantation activity a licence holder

may undertake.

(12) The Authority shall permit a person making an application for two or

more−

(a) procurement activities;

(b) transplantation activities; or

to make a single application in respect of the activities.

Preconditions to grant of a licence.

28F.(1) The Authority may not grant a licence under section 28E unless the

requirements set out in this section are met.

(2) In the application for a licence, an individual must be designated who

shall−

(a) be the applicant for the licence; or

(b) consent to an application for a licence.

(3) The Authority must be satisfied that the proposed designated

individual−

Public Health (Human Tissues, Cells and Organs)

2009-53

(a) is a suitable person to supervise the activity to be authorised by

the licence;

(b) will perform the duty imposed by section 28E;

(i) has a diploma, certificate or other evidence of formal

qualification in the fields of medical or biological

sciences awarded on completion of a university course of

study, or other courses of study recognised in Gibraltar

as equivalent, or

(ii) is otherwise considered by the Authority to be suitably

qualified on the basis of academic qualification and

practical experience; and

(d) has at least two years’ practical experience which is directly

relevant to the activity to be authorised by the licence.

(4) Where the applicant for the licence is not the proposed designated

individual, the Authority must be satisfied that the applicant is a suitable

person to be the holder of the licence.

(5) The Authority must be satisfied that the premises in which an

applicant seeks to carry out the procurement activity of retrieval or the

transplantation activity of implantation are suitable for the carrying out of

that activity and it complies with the provisions of this Part and the Organ

Directive.

(6) The Authority must be satisfied that the applicant meets−

(a) the relevant conditions in section 28E and will continue to do

so; and

(b) any other conditions or requirements that the Authority has

imposed.

(7) A copy of the conditions to be imposed by the licence must have been

shown to, and acknowledged in writing by−

(a) the applicant for the licence; and

(b) where different, the proposed designated individual.

(8) In this section, references to the proposed designated individual are to

the individual whom the application proposes that the licence should

Public Health (Human Tissues, Cells and Organs)

2009-53

designate as the person under whose supervision the activity to be

authorised is to be carried on.

(9) It shall be the duty of a designated individual to secure that−

(a) the other persons to whom the licence applies are suitable

persons to participate in the carrying-on of the licensed

activity;

(b) suitable practices are used in the course of carrying on that

activity; and

(10) The designated individual and licence holder shall take all necessary

measures to ensure the highest possible protection of living donors in order

to fully guarantee the quality and safety of organs for transplantation.

Consequences of failure, etc.

28G.(1) Where an inspection under this Part demonstrates that the

designated person or the licence holder has failed to comply with the

conditions of the licence, the Authority may−

(a) suspend the licence for a period not exceeding 6 months;

(b) withdraw the licence permanently; or

activity until the failures or defects are remedied.

(2) The Authority shall not take any action under subsection (1) unless the

licence holder and the designated individual are given a notice to show

cause within seven days and his explanations are considered.

(3) A person aggrieved by a decision of the Authority under this section

may appeal to the Supreme Court within thirty days and the decision of the

Supreme Court shall be final.

Guidance and directions.

28H.(1) The Authority shall publish such guidance to licence holders,

designated individuals, and healthcare personnel referred to in section

28E(3)(c) as it considers necessary to ensure compliance with the Organ

Directive.

(2) The Authority shall keep the guidance published under subsection (1)

under review and prepare revised guidance when it considers necessary.

Public Health (Human Tissues, Cells and Organs)

2009-53

(3) The Authority shall publish the guidance under this section in such a

way as, in its opinion, is likely to bring it to the attention of licensees.

(4) A guidance published under this section must include guidance for the

collection of relevant post-transplantation information to evaluate the

quality and safety of the organs transplanted.

(5) The Authority may give directions for any purpose for which

directions may be given under this Part.

(6) Any power under this Part to give directions–

(a) includes power to vary or revoke directions given in previous

exercise of the power; and

(b) is exercisable by instrument in writing.

(7) Directions under this Part–

(a) to a particular person, shall be given by serving notice of the

directions on the person; and

(b) in respect of any licence (including one which has ceased to

have effect) may be given−

(i) by serving notice of the directions on the person who is

(or was immediately before the cessation) the designated

individual or holder of the licence, or

(ii) if it appears to the Authority that it is not practicable to

give notice in that way, by publishing the directions in

such way as, in its opinion, is likely to bring them to the

attention of the persons to whom they are applicable.

(8) Directions under this Part which appear to the Authority to be general

directions may be given by publishing them as mentioned in subsection (7)

(b)(ii).

Records, reports and information.

28I.(1) The Authority shall−

(a) in accordance with the provisions of the Data Protection Act

2004 and any applicable European Union measure, keep a

record of activities that licence holders are carrying on, which

shall include−

(i) the aggregate number of living and deceased donors, and

Public Health (Human Tissues, Cells and Organs)

2009-53

(ii) the types and quantities of organs procured and

transplanted, or otherwise disposed of;

(b) publish an annual report on the activities referred to in

paragraph (a); and

procurement activity or a transplantation activity.

(2) The Authority shall, upon the request of the Commission or any

Member State provide information on–

(a) the requirements in Gibraltar for the authorisation of–

(i) procurement organisations;

(ii) transplantation centres; and

(b) the record of procurement organisations and transplantation

centres.

The principles of organ donation.

28J.(1) The Authority shall ensure that every donation of organs from a

deceased or a living person must be voluntary and unpaid.

(2) A living donor may be paid compensation to make good the expenses

and loss of income related to the donation which must not be such as to

become financial incentives or benefit for a potential donor.

(3) No person shall advertise the need for, or availability of, organs where

that advertisement is with a view to offering or seeking financial gain or a

comparable advantage.

(4) The Authority shall ensure that the procurement of organs is carried

out on a non-profit basis.

The quality and safety of living donation.

28K.(1) Every living donor must be selected by suitably qualified or trained

and competent professionals on the basis of an assessment of the health and

medical history of that living donor.

(2) An assessment referred to in subsection (1) may provide for the

exclusion of persons whose donation could present unacceptable health

risks.

Public Health (Human Tissues, Cells and Organs)

2009-53

(3) The Authority shall keep a record or register of living donors for the

purposes of ensuring the follow up of living donors, in accordance with the

Data Protection Act 2004 and any applicable European Union measure

relating to the protection of personal data and statistical confidentiality.

(4) The Authority shall make arrangements which−

(a) ensure that reasonable endeavours are made to follow-up all

living donors for the purposes of identifying and managing any

event potentially relating to the quality and safety of the

donated organ and any serious adverse reaction in the living

donor that may result from the donation; and

(b) identify, report and manage any event or reaction identified

under paragraph (a).

(5) In subsection (4), a relevant donor means a living donor from whom

the person who has ceased to be licensed retrieved an organ.

(6) The provisions of this section shall be applied so as to ensure the

highest possible protection of living donors in order to fully guarantee the

quality and safety of organs for transplantation.

Serious adverse events and serious adverse reactions.

28L.(1) The Authority shall ensure that there is a reporting system in place

to report, investigate, register and transmit relevant and necessary

information concerning serious adverse events that may influence the

quality and safety of organs and that may be attributed to the testing,

characterisation, procurement, preservation and transport of organs, as well

as any serious adverse reaction observed during or after transplantation

which may be connected to those activities.

(2) For the purposes of subsection (1), the Authority shall ensure that there

is an operating procedure in place for the management of serious adverse

events and reactions as provided for in the framework for quality and safety.

(3) The operating procedure referred to in subsection (2) must include a

system for the notification, in due time, of−

(a) any serious adverse event and reaction to the Authority and to

the concerned procurement organisation or transplantation

centre; and

(b) the management measures with regard to serious adverse

events and reactions to the Authority.

(4) For the purposes of this section, when a licence holder reports a

serious adverse event or a serious adverse reaction to the Authority, or the

Public Health (Human Tissues, Cells and Organs)

2009-53

Authority is otherwise made aware of such an event or reaction, the

Authority shall−

(a) rapidly notify that information to such persons that the

Authority considers may be affected by that information;

(b) investigate the matter where the Authority considers that an

investigation will promote the quality and safety of organs; and

(5) There shall be an interconnection between the reporting system

established under this section and the notification system established in

accordance with sections 11 and 12.

Traceability.

28M.(1) The Authority shall ensure that a traceability system is established

for the purposes of ensuring−

(a) that all organs procured, allocated and transplanted in Gibraltar

can be traced from the donor to the recipient and vice versa in

order to safeguard the health of donors and recipients; and

(b) notification of serious adverse events or reactions in

accordance with section 28L(1)(a).

(2) The Authority shall ensure–

(a) the implementation of a donor and recipient identification

system in Gibraltar that can identify each donation and each of

the organs and recipients associated with it; and

(b) that confidentiality and data security measures are in place with

regard to such a system n compliance with European Union

law and the Data Protection Act 2004.

(3) The Authority shall ensure that−

(a) any person who is licensed to carry out a procurement activity

or a transplantation activity that is involved in the chain from

donation to transplantation or disposal keeps the data needed to

ensure traceability at all stages of the chain from donation to

transplantation or disposal and the information on organ and

donor characterisation as specified in Schedule 12, in

accordance with the framework for quality and safety;

Public Health (Human Tissues, Cells and Organs)

2009-53

(b) data required for full traceability is kept for a minimum of 30

years after donation and that data may be stored in electronic

form.

(4) Where any person who is licensed to carry out a procurement activity

or a transplantation activity ceases to be licensed, the Authority shall make

arrangements to ensure that the data collected by that person under the

licensing condition pursuant to section 28E (3) (e) is kept for 30 years from

the date of the retrieval of the organ.

Organs sent to another country.

28N.(1) Where an organ is sent to a Member State, the Authority shall

ensure that−

(a) information on organ and donor characterisation that is

specified in Part A of Schedule 12 is transmitted to that State;

(b) such information in Part B of the Schedule 12 that has been

collected by a registered medical practitioner or a person acting

under their supervision; and

transmitted to that State in conformity with procedures

established by the Commission under Article 29 of the Organ

Directive.

(2) Where an organ is sent to, or received from, a Member State, the

Authority shall ensure the reporting of serious adverse events and reactions

in conformity with procedures established by the Commission under Article

29 of the Organ Directive.

(3) The Authority shall ensure that any organs sent to, or received from,

countries which are not in the European Union can−

(a) be traced from the donor to the recipient; and

(b) meet quality and safety standards that are equivalent to those

required by this Part.

(4) For the purposes of subsection (3), the Authority may enter into

agreements with countries that are not in the European Union.

The Authority and European organ exchange organisations.

28O.(1) The Authority as defined in section 28B(1) is designated the

competent authority for the purposes of Article 17 of the Organ Directive.

Public Health (Human Tissues, Cells and Organs)

2009-53

(2) The Authority shall, whenever reasonably practicable−

(a) participate in the network of competent authorities established

by the European Commission; and

(b) co-ordinate Gibraltar’s input into the activities of that network.

(3) The Authority may conclude agreements with European organ

exchange organisations, if such organisations ensure compliance with the

requirements of this Part, delegating to those organisations−

(a) the performance of activities provided for under the framework

for quality and safety;

(b) specific tasks in relation to the exchanges of organs to and

from Gibraltar and third countries.

(4) The Authority shall supervise each organ exchange with third

countries.

(5) For the purpose of subsection (4), the Authority and the European

organ exchange organisations may conclude agreements with counterparts

in third countries.

(6) The Authority may delegate the supervision of organ exchange with

third countries to European organ exchange organisations.

(7) Organ exchange with third countries shall be allowed only where the

organs−

(a) can be traced from the donor to the recipient and vice versa;

and

(b) meet quality and safety requirements equivalent to those laid

down in the Organ Directive.

Control and audit by way of inspections.

28P.(1) The Authority shall put in place an inspection regime for the

regular inspection of procurement organisations and transplantation centres

in order to ascertain compliance with the requirements of this Part.

(2) For the purposes of subsection (1), a duly authorised person may

require a person to produce for inspection any documents relevant for

compliance with this Part.

(3) Where records or documents to which subsection (2) applies are stored

in electronic form, the power under this section includes power to require

Public Health (Human Tissues, Cells and Organs)

2009-53

the records or documents to be made available for inspection in a visible

and legible form or in a form from which they can readily be produced in a

visible and legible form.

(4) A duly authorised person may inspect and take copies of any

documents produced for inspection in pursuance of a requirement under

subsection (2).

(5) For the purposes of subsection (1), the Authority may arrange for any

premises in which a licensed activity is being carried out to be inspected on

its behalf, and for a report of the inspection to be made to it, for the purpose

of ensuring compliance−

(a) with this Part;

(b) with the conditions of the licence; and

28F(9).

(6) If a justice of the peace is satisfied on sworn information that there are

reasonable grounds for believing that−

(a) an offence under this Part is being, or has been, committed on

any premises; and

(b) any of the conditions in subsection (7) is met in relation to the

premises,

he may, by a signed warrant, authorise a duly authorised person to enter the

premises, if need be by force, and search them.

(7) The conditions referred to in subsection (6) are that−

(a) entry to the premises has been, or is likely to be, refused and

notice of the intention to apply for a warrant under this section

has been given to the occupier;

(b) the premises are unoccupied;

(d) an application for admission to the premises or the giving of

notice of the intention to apply for a warrant under this

subsection would defeat the object of entry.

(8) A warrant under this section shall continue in force until the end of the

period of 31 days beginning with the day on which it is issued.

Public Health (Human Tissues, Cells and Organs)

2009-53

(9) Entry and search under a warrant under this section is unlawful if any

of subsections (10) to (12) and (14) is not complied with.

(10) Entry and search shall be at a reasonable time unless the person

exercising the warrant thinks that the purpose of the search may be

frustrated on an entry at a reasonable time.

(11) If the occupier of the premises to which the warrant relates is present

when the person executing the warrant seeks to enter them, the person

executing the warrant shall−

(a) produce the warrant to the occupier; and

(b) give the occupier−

(i) a copy of the warrant, and

(ii) an appropriate statement.

(12) If the occupier of the premises to which the warrant relates is not

present when the person executing the warrant seeks to enter them, but

some other person is present who appears to the person executing the

warrant to be in charge of the premises, the person executing the warrant

shall−

(a) produce the warrant to that other person;

(b) give that other person−

(i) a copy of the warrant,

(ii) an appropriate statement, and

premises.

(13) In subsections (11)(b)(ii) and (12)(b)(ii) the references to an

appropriate statement are to a statement in writing containing the

information set out section 28Q.

(14) If premises to which the warrant relates are unoccupied, the person

executing the warrant shall leave a copy of it in a prominent place on the

premises.

(15) Where the premises in relation to which a warrant under this section

is executed are unoccupied, or the occupier is temporarily absent and no

other person is present who appears to the person executing the warrant to

Public Health (Human Tissues, Cells and Organs)

2009-53

be in charge of the premises, the person executing the warrant shall, when

leaving the premises, leave them as effectively secured as the person

executing the warrant found them.

Appropriate statements.

28Q. An appropriate statement for the purposes of section 28P must contain

the following information−

(a) a statement that the duly authorised person has been authorised

by the Authority for the purposes of section 28P;

(b) a statement that the duly authorised person’s rights of entry and

search are subject to that person producing evidence of

entitlement to exercise them, if required;

be, to enter premises by force;

(d) a description of the duly authorised person’s powers under

section 28R(2) to (4) of inspection and seizure of property;

(e) a description of the requirement under section 28R(5) for the

duly authorised person to leave a statement giving particulars

of what the duly authorised person has seized and a statement

of what has been seized;

(f) a description of the powers of the duly authorised person−

(i) under section 28R(6), to bring with the duly authorised

person such other persons and equipment as is

considered by the duly authorised person necessary, and

(ii) under section 28R(7), to inspect equipment and inspect

and take copies of records, and in the case of premises in

respect of which a licence under this Part is in force, to

observe the carrying-on of licensed activity;

(g) a description of the duly authorised person’s obligations under

section 28S(2) to prepare a written report of the search and, if

requested to do so by the appropriate person, give the

appropriate person a copy of the report; and

(h) a statement that a person commits an offence under section

28U if that person fails without reasonable excuse to comply

with requirements under section 28R(8).

Seizure in the course of inspection or search.

Public Health (Human Tissues, Cells and Organs)

2009-53

28R.(1) A duly authorised person entering and inspecting premises under

this Part may seize anything on the premises which the duly authorised

person has reasonable grounds to believe may be required for purposes of

the Authority’s functions relating to the grant, revocation, variation and

suspension of licences under this Part and to the investigation of serious

adverse events and serious adverse reactions.

(2) A duly authorised person entering and searching premises under a

warrant under section 28P may seize anything on the premises which he has

reasonable grounds to believe may be required for the purpose of being used

in evidence in any proceedings for an offence under this Part.

(3) Where a person has power under subsection (1) or (2) to seize

anything, that person may take such steps as appear to be necessary for

preserving the thing or preventing interference with it.

(4) The power under subsection (1) or (2) includes a power to retain

anything seized in the exercise of the power for so long as it may be

required for the purpose for which it was seized.

(5) Where by virtue of subsection (1) or (2) a person seizes anything, that

person shall leave on the premises from which the thing was seized a

statement giving particulars of what has been seized and stating the name of

the person who has seized it.

(6) Any power under this Part to enter and inspect or search any premises

includes a power to take such other persons and equipment as the person

exercising the power reasonably considers necessary.

(7) Any power under section 28P or 28Q to inspect or search any premises

includes, in particular−

(a) power to inspect any equipment found on the premises;

(b) power to inspect and take copies of any records found on the

premises; and

section 28E is in force, power to observe the carrying-on on the

premises of the licensed activity.

(8) Any power under this Part to enter, inspect or search premises includes

power to require any person to afford such facilities and assistance with

respect to matters under that person’s control as are necessary to enable the

power of entry, inspection or search to be exercised.

Requirements when exercising power of inspection or search.

Public Health (Human Tissues, Cells and Organs)

2009-53

28S.(1) A person’s right to exercise a power under this Part is subject to

that person producing evidence of their entitlement to exercise it, if

required.

(2) As soon as reasonably practicable after having exercised a power

under this Part to inspect or search premises, the duly authorised person

shall−

(a) prepare a written report of the inspection or search; and

(b) if requested to do so by the appropriate person, give the

appropriate person a copy of the report.

(3) In subsection (2), the “appropriate person”, in relation to premises

where a licensed activity is being carried out, means the designated

individual or the licence holder.

Protection of personal data, confidentiality and security of processing.

28T.(1) The holder of a licence issued under this Part shall ensure that the

fundamental right to protection of personal data is fully and effectively

protected in all organ donation and transplantation activities, in accordance

with sections 8(2)(h), 11 and 12 of the Data Protection Act 2004.

(2) The holder of a licence issued under this Part shall take all necessary

measures to ensure that-

(a) the data processed are kept confidential and secure in

accordance with sections 11 and 12 of the Data Protection Act

2004;

(b) donors and recipients whose data are processed within the

scope of this Part are not identifiable, except as permitted by

section 8(2) of the Data Protection Act 2004; and

the Data Protection Act 2004 are met.

Offences and penalties.

28U.(1) A person who contravenes section 28D, commits an offence and is

liable−

(a) on summary conviction to a fine not exceeding level 5 on the

standard scale; or

(b) on conviction on indictment−

Public Health (Human Tissues, Cells and Organs)

2009-53

(i) to imprisonment for a term not exceeding 2 years,

(ii) to a fine, or

(iii) to both.

(2) A person commits an offence if that person-

(a) fails without reasonable excuse to comply with a requirement

under section 28P(2); or

(b) intentionally obstructs the exercise of any right or powers

under sections 28P or 28R.

(3) A person guilty of an offence under subsection (2) is liable on

summary conviction to a fine not exceeding level 4 on the standard scale.

(4) A person commits an offence if that person in contravention of section

28T−

(a) accesses any data or systems that makes identification of donor

or recipients possible; or

(b) uses any system or data that makes the identification of donors

or recipients possible with a view to tracing donors or

recipients other than for the purposes permitted by section 8(2)

of the Data Protection Act 2004.

(5) A person who commits an offence under subsection (4) is liable–

(a) on summary conviction, to a fine not exceeding level 4 on the

standard scale; or

(b) on conviction on indictment to a fine not exceeding level 5 on

the standard scale.

(6) Where a person is convicted of an offence under subsection (4), the

court may order any data material which appears to the court to be

connected with the commission of the offence to be forfeited or destroyed

and any relevant data to be erased.

(7) The court shall not make an order under subsection (6) in relation to

data material or data where it considers that some person other than the

person convicted of the offence may be the owner of, or otherwise interested

in, the data unless such steps as are reasonably practicable have been taken

for notifying that person and giving him an opportunity to show cause why

the order should not be made.

Public Health (Human Tissues, Cells and Organs)

2009-53

Offences by bodies corporate.

28V.(1) Where an offence under this Part is committed by a body corporate

and is proved to have been committed with the consent or connivance of or

to be attributable to any neglect on the part of−

(a) any director, manager, secretary or other similar officer of the

body corporate; or

(b) any person who was purporting to act in any such capacity,

that person (as well as the body corporate) commits the offence and shall

be liable to be proceeded against and punished accordingly.

(2) Where the affairs of a body corporate are managed by its members,

subsection (1) applies in relation to the acts and defaults of a member in

connection with that member’s functions of management as if that member

were a director of the body corporate.

Reports to the Commission.

28W. The Authority shall ensure that a report is sent to the Commission

before 27 August 2013 and every three years thereafter on the activities

undertaken in relation to the provisions of the Organ Directive, and on

experience gained in implementing it.

Regulations.

29.(1) The Minister may make Regulations–

(a) prescribing fees to be paid under this Part;

(b) giving effect to or implementing any International Convention,

Protocol or Agreement or any European Union Directive or

Regulation that relate to the subject-matter of this Part; or

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 1

Section 13(2) (a) and 13 (7)

SELECTION CRITERIA FOR DONORS OF TISSUES OR CELLS

OR BOTH (EXCEPT DONORS OF REPRODUCTIVE CELLS).

Selection criteria for donors are based on an analysis of risks related to the

application of the specific cells/tissues. Indicators of these risks must be

identified by physical examination, review of the medical and behavioural

history, biological testing, post-mortem examination (for deceased donors)

and any other appropriate investigation. Unless justified on the basis of a

documented risk assessment approved by the responsible person as defined

in section 2(1), donors must be excluded from donation if any of the

following criteria applies:

1. Deceased Donors.

1.1. General criteria for exclusion

1.1.1. Cause of death unknown, unless autopsy provides information on the

cause of death after procurement and none of the general criteria for

exclusion set out in the present section applies.

1.1.2. History of a disease of unknown aetiology.

1.1.3. Presence, or previous history, of malignant disease, except for

primary basal cell carcinoma, carcinoma in situ of the uterine cervix, and

some primary tumours of the central nervous system that have to be

evaluated according to scientific evidence. Donors with malignant diseases

can be evaluated and considered for cornea donation, except for those with

retinoblastoma, haematological neoplasm, and malignant tumours of the

anterior segment of the eye.

1.1.4. Risk of transmission of diseases caused by prions. This risk applies,

for example, to

(a) people diagnosed with Creutzfeldt-Jakob Disease, or variant

Creutzfeld-Jakob Disease, or having a family history of non-

iatrogenic Creutzfeldt-Jakob disease.

(b) People with a history of rapid progressive dementia or

degenerative neurological disease, including those of unknown

origin;

Public Health (Human Tissues, Cells and Organs)

2009-53

gland (such as growth hormones) and recipients of grafts of

cornea, sclera and dura mater, and persons that have undergone

undocumented neurosurgery (where dura mater may have been

used).

For variant Creutzfeld-Jakob Disease, further precautionary measures may

be recommended.

1.1.5. Systemic infection which is not controlled at the time of donation,

including bacterial diseases, systemic viral, fungal or parasitic infections, or

significant local infection in the tissue and cells to be donated. Donors with

bacterial septicaemia may be evaluated and considered for eye donation, but

only where the corneas are to be stored by organ culture to allow detection

of any bacterial contamination of the tissue.

1.1.6. History, clinical evidence, or laboratory evidence of HIV, acute or

chronic hepatitis B (except in the case of persons with a proven immune

status) hepatitis C and HTLV I/II, transmission risk or evidence of risk

factors for these infections.

1.1.7. History of chronic, systemic autoimmune disease that could have a

detrimental effect on the quality of the tissue to be retrieved.

1.1.8. Indications that test results of donor blood samples will be invalid

due to: (a) the occurrence of haemodilution, according to the specifications

in section 2 of Schedule 2, where a pre-transfusion sample is not available;

or (b) treatment with immunosuppressive agents.

1.1.9. Evidence of any other risk factors for transmissible diseases on the

basis of a risk assessment, taking into consideration donor travel and

exposure history and local infectious disease prevalence.

1.1.10. Presence on the donor’s body of physical signs implying a risk of

transmissible disease(s) as described in point 1.2.3 of Schedule 4.

1.1.11. Ingestion of, or exposure to, a substance (such as cyanide, lead,

mercury, gold) that may be transmitted to recipients in a dose that could

endanger their health.

1.1.1 Recent history of vaccination with a live attenuated virus where a

risk of transmission is considered to exist.

1.1.13. Transplantation with xenografts.

1.2. Additional exclusion criteria for deceased child donors.

Public Health (Human Tissues, Cells and Organs)

2009-53

1.2.1. Any children born from mothers with HIV infection or that meet any

of the exclusion criteria described in section 1.1 must be excluded as donors

until the risk of transmission of infection can be definitely ruled out.

(a) Children aged less than 18 months born from mothers with

HIV, hepatitis B, hepatitis C or HTLV infection or at risk of

such infection, and who have been breastfed by their mothers

during the previous 12 months, cannot be considered as donors

regardless of the results of the analytical tests;

(b) Children of mothers with HIV, hepatitis B, hepatitis C or

HTLV infection or at risk of such infection, and who have not

been breastfed by their mothers during the previous 12 months

and for whom analytical tests, physical examinations and

reviews of medical records do not provide evidence of HIV,

hepatitis B, hepatitis C or HTLV infection, can be accepted as

donors.

2. Living Donors.

2.1. Autologous Living Donor

2.1.1. If the removed tissues and cells are to be stored or cultured, the same

minimum set of biological testing requirements must apply as for an

allogeneic living donor. Positive test results will not necessarily prevent the

tissues or cells or any product derived from them being stored, processed

and re-implanted, if appropriate isolated storage facilities are available to

ensure no risk of cross-contamination with other grafts or no risk of

contamination with adventitious agents or mix-ups or both.

2.2. Allogeneic Living Donor

2.2.1. Allogeneic living donors must be selected on the basis of their health

and medical history, provided on a questionnaire and through an interview

performed by a qualified and trained healthcare professional with the donor,

in compliance with point 2.2.2. This assessment must include relevant

factors that may assist in identifying and screening our persons whose

donation could present a health risk to others, such as the possibility of

transmitting diseases or health risks to themselves. For any donation, the

collection process must not interfere with or compromise the health or care

of the donor. In the case of cord blood or amniotic membrane donation, this

applies to both mother and baby.

2.2.2. Selection criteria for allogeneic living donors must be established

and documented by the tissue establishment (and the transplanting clinician

in the case of direct distribution to the recipient) based on the specific tissue

or cells to be donated, together with the donor’s physical status and medical

Public Health (Human Tissues, Cells and Organs)

2009-53

and behavioural history and the results of clinical investigations and

laboratory tests establishing the donor’s state of health.

2.2.3. The same exclusion criteria must be applied as for deceased donors

with the exception of point 1.1.1 Depending on the tissue or cell to be

donated, other specific exclusion criteria may need to be added, such as:

(a) pregnancy (except for donors of umbilical cord blood cells and

amniotic membrane and sibling donors of haematopoietic

progenitors);

(b) breastfeeding;

transmission of inherited conditions.

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 2

Section 13(1)(a) and (b)

LABORATORY TESTS REQUIRED FOR DONORS (EXCEPT

DONORS OF REPRODUCTIVE CELLS).

1. Biological tests required for donors.

1.1. The following biological tests must be performed for all donors as a

minimum requirement;

HIV 1 and 2 Anti-HIV-1,2

Hepatitis B HbsAg

Anti HBc

Hepatitis C Anti- HCV- Ab

Syphilis See 1.4 (below)

1.2. HTLV-I antibody testing must be performed for donors living in, or

originating from, high-prevalence areas or with sexual partners originating

from those areas or where the donor’s parents originate from those areas.

1.3. When anti-HBc is positive and HbsAg is negative, further

investigations are necessary with a risk assessment to determine eligibility

for clinical use.

1.4. A validated testing algorithm must be applied to exclude the

presence of active infection with Treponema pallidum. A non-reactive test,

specific or non-specific, can allow tissues and cells to be released. When a

non-specific test is performed, a reactive result will not prevent procurement

or release if a specific Treponema confirmatory test is non-reactive. A donor

whose specimen tests reactive on a Treponema-specific test will require a

thorough risk assessment to determine eligibility for clinical use.

1.5. In certain circumstances, additional testing may be required

depending on the donor’s history and the characteristics of the tissue or cells

donated (e.g. RhD, HLA, malaria, CMV, toxoplasma, EBV, Trypanosoma

cruzi).

1.6. For autologous donors, point 2.1.1. in Schedule 1 applies.

2. General requirements to be met for determining biological markers.

2.1. The tests must be carried out by a qualified laboratory, authorised as

a testing centre by the competent authority, using CE marked testing kits

where appropriate. The type of test used must be validated for the purpose

in accordance with current scientific knowledge.

Public Health (Human Tissues, Cells and Organs)

2009-53

2.2. The biological tests will be carried out on the donor’s serum or

plasma; they must not be performed on other fluids or secretions such as the

aqueous or vitreous humour unless specifically justified clinically using a

validated test for such a fluid.

2.3. When potential donors have lost blood and have recently received

donated blood, blood components, colloids or crystalloids, blood testing

may not be valid due to haemodilution of the sample. An algorithm must be

applied to assess the degree of haemodilution in the following

circumstances

(a) ante-mortem blood sampling: if blood, blood components or

colloids were infused in the 48 hours preceding blood sampling

or if crystalloids were infused in the hour preceding blood

sampling;

(b) post-mortem blood sampling: if blood, blood components or

colloids were infused in the 48 hours preceding death or if

crystalloids were infused in the hour preceding death.

Tissue establishments may accept tissues and cells from donors with plasma

dilution of more than 50% only if the testing procedures used are validated

for such plasma or if a pre-transfusion sample is available.

2.4. In the case of a deceased donor, blood samples must have been

obtained just prior to death, or if not possible, the time of sampling must be

as soon as possible after death and in any case within 24 hours after death.

2.5.

(a) In the case of living donors (except allogeneic bone marrow

stem-cell and peripheral blood stem-cell donors, for practical

reasons), blood samples must be obtained at the time of

donation or if not possible, within 7 days post donation (this is

the ‘donation sample’).

(b) Where tissues and cells of allogeneic living donors can be

stored for long periods, repeat sampling and testing is required

after an interval of 180 days. In these circumstances of repeat

testing, the donation sample can be taken up to 30 days prior to

and 7 days post donation.

stored for long periods and repeat sampling is therefore not

possible, paragraph 2.5(a) above applies.

2.6. If, in a living donor (except bone marrow stem-cell and peripheral

blood stem-cell donors) the ‘donation sample’ as defined in paragraph

2.5(a) above, is additionally tested by the nucleic acid amplification

Public Health (Human Tissues, Cells and Organs)

2009-53

technique (NAT) for HIV, HBV and HCV, testing of a repeat blood sample

is not required. Retesting is also not required if the processing includes an

inactivation step that has been validated for the viruses concerned.

2.7. In the case of bone marrow and peripheral blood stem-cell

collection, blood samples must be taken for testing within 30 days prior to

donation.

2.8. In the case of neonatal donors, the biological tests may be carried

out on the donor’s mother to avoid medically unnecessary procedures upon

the infant.

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 3

Section 13(1)(c) and (d) and 13(2)(b)

SELECTION CRITERIA AND LABORATORY TESTS REQUIRED

FOR DONORS OF REPRODUCTIVE CELLS

1. Partner donation for direct use.

Donor selection criteria and laboratory testing do not need to be applied in

the case of partner donation of reproductive cells for direct use.

2. Partner donation (not direct use).

Reproductive cells that are processed or stored or both and reproductive

cells that will result in the cryopreservation of embryos must meet the

following criteria

2.1. The clinician responsible for the donor must determine and

document, based on the patient’s medical history and

therapeutic indications, the justification for the donation and its

safety for the recipient and any child(ren) that might result.

2.2. The following biological tests must be carried out to assess the

risk of cross contamination

HIV 1 and 2 Anti-HIV-1,2

Hepatitis B HbsAg

Anti HBc

Hepatitis C Anti- HCV- Ab

In case of sperm processed for intrauterine insemination, not to be stored

and if the tissue establishment can demonstrate that the risk of cross

contamination and staff exposure has been addressed through the use of

validated processes, the biological testing may not be required.

2.3. Where HIV 1 and 2, hepatitis B or hepatitis C test results are

positive or unavailable, or where the donor is known to be a source of

infection risk, a system of separate storage must be devised.

2.4. HTLV-I antibody testing must be performed for donors living in, or

originating from, high-prevalence areas or with sexual partners originating

from those areas or where the donor’s parents originate from those areas;

2.5. In certain circumstances, additional testing may be required

depending on the donor’s travel and exposure history and the characteristics

of the tissue or cells donated (e.g. RhD, malaria, CMV, T cruzi).

Public Health (Human Tissues, Cells and Organs)

2009-53

2.6. Positive results will not necessarily prevent partner donation in

accordance with national rules.

3. Donations other than by partners.

The use of reproductive cells other than for partner donation must meet the

following criteria

3.1. Donors must be selected on the basis of their age, health and medical

history, provided on a questionnaire and through a personal interview

performed by a qualified and trained healthcare professional. This

assessment must include relevant factors that may assist in identifying and

screening out persons whose donation could present a health risk to others,

such as the possibility of transmitting diseases (such as sexually transmitted

infections), or health risks to themselves (e.g; superovulation, sedation or

the risks associated with the egg collection procedure or the psychological

consequences of being a donor).

3.2. The donors must be negative for HIV 1 and 2, HCV, HBV and

syphilis on a serum or plasma sample, tested in accordance with point 1.1 of

Schedule 2 and sperm donors must additionally be negative for Chlamydia

on a urine sample tested by the nucleic acid amplification technique (NAT).

3.3. HTLV-I antibody testing must be performed for donors living in, or

originating from, high-prevalence areas or with sexual partners originating

from those areas or where the donor’s parents originate from those areas;

3.4. In certain circumstances, additional testing may be required

depending on the donor’s history and the characteristics of the tissue or cells

donated (e.g. RhD, malaria, CamV, T.cruzi).

3.5. For autologous donors, point 2.1.1 in Schedule 1 applies.

3.6. Genetic screening for autosomal recessive genes known to be

prevalent, according to international scientific evidence, in the donor’s

ethnic background and an assessment of the risk of transmission of inherited

conditions known to be present in the family must be carried out, after

consent is obtained. Complete information must be provided, in accordance

with the requirements in this Act. Complete information on the associated

risk and on the measures undertaken for its mitigation must be

communicated and clearly explained to the recipient.

4. General requirements to be met for determining biological markers.

4.1. The tests must be carried out in accordance with points 2.1 and 2.2

of Schedule 2.

Public Health (Human Tissues, Cells and Organs)

2009-53

4.2. For donations other than by partners, blood samples must be obtained at

the time of each donation.

For donation by partners (not for direct use), blood samples must be

obtained within three months before the first donation. For further partner

donations by the same donor, further blood samples must be obtained

according to national legislation, but no later than 24 months from the

previous sampling.

4.3. Sperm donations other than by partners will be quarantined for a

minimum of 180 days, after which repeat testing is required. If the blood

donation sample is additionally tested by the nucleic acid amplification

technique (NAT) for HIV, HBV and HCV, testing of a repeat blood sample

is not required. Retesting is also not required if the processing includes an

inactivation step that has been validated for the viruses concerned.

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 4

Sections 9, 10 and 14

CELL OR TISSUE OR BOTH DONATION AND PROCUREMENT

PROCEDURES AND RECEPTION AT THE TISSUE

ESTABLISHMENT

1. Donation and procurement procedures.

1.1. Consent and donor identification

1.1.1. Before the procurement of tissues and cells proceeds, an authorised

person must confirm and record

(a) that consent for the procurement has been obtained in

accordance with section 13; and

(b) how and by whom the donor has been reliably identified.

1.1.2. In the case of living donors, the health professional responsible for

obtaining the health history must ensure that the donor has

(a) understood the information provide,

(b) had an opportunity to ask questions and been provided with

satisfactory responses;

of his/her knowledge.

1.2. Donor evaluation (this paragraph does not apply to partner

donation of reproductive cells or to autologous donors)

1.2.1. An authorised person must collect and record the donor’s relevant

medical and behavioural information according to the requirements

described in point 1.4

1.2.2. In order to acquire the appropriate information, different relevant

sources must be used, including at least an interview with the donor, for

living donors, and the following when appropriate:

(a) the medical records of the donor;

(b) an interview with a person who knew the donor well, for

deceased donors;

Public Health (Human Tissues, Cells and Organs)

2009-53

(d) an interview with the general practitioner;

(e) the autopsy report.

1.2.3. In addition, in the case of a deceased donor, and in the case of a

living donor when justified, a physical examination of the body must be

performed to detect any signs that may be sufficient in themselves to

exclude the donor or which must be assessed in the light of the donor’s

medical and personal history.

1.2.4. The complete donor records must be reviewed and assessed for

suitability and signed by a qualified health professional.

1.3. Procurement procedures for tissues and cells

1.3.1. The procurement procedures must be appropriate for the type of

donor and the type of tissue/cells donated. There must be procedures in

place to protect the safety of the living donor.

1.3.2. The procurement procedures must protect those properties of the

tissues/cells that are required for their ultimate clinical use, and at the same

time minimise the risk of microbiological contamination during the process,

particularly when tissues and cells cannot subsequently be sterilised.

1.3.3. For deceased donation, the area of access must be restricted. A local

sterile field using sterile drapes must be used. Staff conducting procurement

must be clothed appropriately for the type of procurement. Usually, this will

extend to being scrubbed, gowned in sterile clothing and wearing sterile

gloves, face shields and protective masks.

1.3.4. In the case of a deceased donor, the place of procurement must be

recorded and the time interval from death to procurement must be specified

so as to ensure that the required biological or physical properties of the

tissues/cells are retained.

1.3.5. Once the tissues and cells have been retrieved from a deceased donor

body, it must be reconstructed so that it is as similar as possible to its

original anatomical appearance.

1.3.6. Any adverse event occurring during procurement that has or may

have resulted in harm to a living donor and the outcome of any investigation

to determine the cause must be recorded and reviewed.

1.3.7. Policies and procedures must be in place to minimise the risk of

tissue or cell contamination by staff who might be infected with

transmissible diseases.

Public Health (Human Tissues, Cells and Organs)

2009-53

1.3.8. Sterile instruments and devices must be used for tissue and cell

procurement. Instruments or devices must be of good quality, validated or

specifically certified and regularly maintained for the procurement of tissues

and cells.

1.3.9. When reusable instruments must be used, a validated cleaning and

sterilisation procedure for removal of infectious agents has to be in place.

1.3.10. Wherever possible, only CE marked medical devices must be used

and all concerned staff must have received appropriate training on the use of

such devices.

1.4. Donor documentation

1.4.1. For each donor, there must be a record containing

(a) the donor identification (first name, family name and date of

birth – if a mother and child are involved in the donation, both

the name and date of birth of the mother and the name, if

known, and date of birth of the child);

(b) age, sex, medical and behavioural history (the information

collected must be sufficient to allow application of the

exclusion criteria, where required);

(d) haemodilution formula, where applicable;

(e) the consent/authorisation form, where applicable;

(f) clinical data, laboratory test results, and the results of other

tests carried out;

(g) if an autopsy was performed, the results must be included in

the record (for tissues and cells that cannot be stored for

extended periods, a preliminary verbal report of the autopsy

must be recorded);

(h) for haematopoietic progenitor cell donors, the donor’s

suitability for the chosen recipient must be documented. For

unrelated donations, when the organisation responsible for

procurement has limited access to recipient data, the

transplanting organisation must be provided with donor data

relevant for confirming suitability.

Public Health (Human Tissues, Cells and Organs)

2009-53

1.4.2. The organisation performing the procurement must produce a

procurement report, which is passed on to the tissue establishment. This

report must contain at least:

(a) the identification, name and address of the tissue establishment

to receive the cells/tissues;

(b) donor identification data (including how and by whom the

donor was identified);

(including samples for testing);

(d) identification of the person who is responsible for the

procurement session, including signing;

(e) date, time(where relevant, start and end) and location of

procurement and procedure (SOP) used, including any

incidents that occurred; where relevant, environmental

conditions at the procurement facility (description of the

physical area where procurement took place);

(f) for deceased donors, conditions under which the cadaver is

kept: refrigerated (or not), time of start and end of

refrigeration;

(g) ID/batch numbers of reagents and transport solutions used.

The report must also contain the date and time of death where possible.

Where sperm is procured at home, the procurement report must state this

and must contain only

(a) the name and address of the tissue establishment to receive the

cells/tissues;

(b) the donor identification. The date and time of procurement may

be included, where possible.

1.4.3. All the records must be clear and readable, protected from

unauthorised amendment and retained and readily retrieved in this condition

throughout their specified retention period in compliance with data

protection legislation.

1.4.4. Donor records, required for full traceability must be kept for a

minimum of 30 years after clinical use, or the expiry date, in an appropriate

archive acceptable to the competent authority.

Public Health (Human Tissues, Cells and Organs)

2009-53

1.5. Packaging

1.5.1. Following procurement, all recovered tissues and cells must be

packaged in a manner which minimises the risk of contamination and must

be stored at temperature that preserve the required characteristics and

biological function of the cells/tissues. The packaging must also prevent

contamination of those responsible for packaging and transportation of the

tissues or cells.

1.5.2. The packaged cells/tissues must be shipped in a container which is

suitable for the transport of biological materials and which maintains the

safety and quality of the contained tissue or cells.

1.5.3. Any accompanying tissue or blood samples for testing must be

accurately labelled to ensure identification with the donor, and must include

a record of the time and place the specimen was taken.

1.6. Labelling of the procured tissues or cells or both

At the time of procurement, every package containing tissues and cells must

be labelled. The primary tissue/cell container must indicate the donation

identification or code and the type of tissues and cells. Where the size of the

package permits, the following information must also be provided

(a) date (and time where possible) of donation;

(b) hazard warnings;

(d) in the case of autologous donations, the label must state ‘for

autologous use only’;

(e) in the case of directed donations, the label must identify the

intended recipient.

If any of the information under points (a) to (e) above cannot be included on

the primary package label, it must be provided on a separate sheet

accompanying the primary package.

1.7. Labelling of the shipping container

When tissues/cells are shipped by an intermediary, every shipping container

must be labelled at least with

(a) TISSUES AND CELLS and HANDLE WITH CARE;

Public Health (Human Tissues, Cells and Organs)

2009-53

(b) The identification of the establishment from which the package

is being transported (address and phone number) and the

contact person in the event of problems;

(address and phone number) and the person to be contacted to

take delivery of the container;

(d) the date and time of the start of transportation;

(e) specifications concerning conditions of transport relevant to the

quality and safety of the tissues and cells;

(f) in the case of all cellular products, the following indication:

DO NOT IRRADIATE;

(g) when a product is known to be positive for relevant infectious

disease marker, the following indication: BIOLOGICAL

HAZARD;

(h) in the case of autologous donors, the following indication:

FOR AUTOLOGOUS USE ONLY.

(i) specifications concerning storage conditions (such as DO NOT

FREEZE).

2. Receipt of the tissue/cells at the tissue establishment.

2.1. When the retrieved tissues/cells arrive at the tissue establishment,

there must be documented verification that the consignment, including the

transport conditions, packaging, labelling and associated documentation and

samples, meet the requirements of this Schedule and the specifications of

the receiving establishment.

2.2. Each establishment must ensure that the tissue and cells received are

quarantined until they, along with the associated documentation, have been

inspected or otherwise verified as conforming to requirements. The review

of relevant donor/procurement information and thus acceptance of the

donation needs to be carried out by specified/authorised persons.

2.3. Each tissue establishment must have a documented policy and

specifications against which each consignment of tissues and cells,

including samples, are verified. These must include the technical

requirements and other criteria considered by the tissue establishment to be

essential for the maintenance of acceptable quality. The tissue establishment

must have documented procedures for the management and segregation of

non-conforming consignments, or those with incomplete test results, to

Public Health (Human Tissues, Cells and Organs)

2009-53

ensure that there is no risk of contamination of other tissues and cells being

processed, preserved or stored.

2.4. The data that must be registered at the tissue establishment (except

for donors of reproductive cells intended for partner donation) include

(a) consent/authorisation; including the purpose(s) for which the

tissues and cells may be used (i.e. therapeutic or research, or

both therapeutic use and research) and any specific instructions

for disposal if the tissue or cells are not used for the purpose

for which consent was obtained;

(b) all required records relating to the procurement and the taking

of the donor history, as described in the donor documentation

section;

tests (such as the autopsy report, if used in accordance with

point 1.2.2.);

(d) for allogeneic donors, a properly documented review of the

complete donor evaluation against the selection criteria by an

authorised and trained person;

(e) in the case of cell cultures intended for autologous use,

documentation of the possibility of medicinal allergies (such as

to antibiotics) of the recipient.

2.5. In the case of reproductive cells intended for partner donation, the

data to be registered at the tissue establishment include

(a) consent; including the purpose(s) for which the tissues and

cells may be used (such as reproductive only or for research or

both) and any specific instructions for disposal if the tissue or

cells are not used for the purpose for which consent was

obtained;

(b) donor identification and characteristics: type of donor, age, sex

and presence of risk factors and, in the case of a deceased

donor, the cause of death;

(d) place of procurement;

(e) tissues and cells obtained and relevant characteristics.

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 5

Section 5(2)

Requirements for authorisation of tissue establishments

A. ORGANISATION AND MANAGEMENT

1. A responsible person must be appointed having qualifications and

responsibilities as provided in section 8 of this Part.

2. A tissue establishment must have an organisational structure and

operational procedures appropriate to the activities for which authorisation

is sought; there must be an organisational chart which clearly defines

accountability and reporting relationships.

3. Every tissue establishment must have access to a nominated medical

registered practitioner to advise on and oversee the establishment’s medical

activities such as donor selection, review of clinical outcomes of applied

tissues and cells or interaction as appropriate with clinical users.

4. There must be a documented quality management system applied to

the activities for which authorisation is sought, in accordance with the

standards laid down in this Part

5. It must be ensured that the risks inherent in the use and handling of

biological material are identified and minimised, consistent with

maintaining adequate quality and safety for the intended purpose of the

tissues and cells. The risks include those relating in particular to the

procedures, environment, and staff health status specific to the tissue

establishment.

6. Agreements between tissue establishments and third parties must

comply with section 18 of this Part. Third party agreements must specify the

terms of the relationship and responsibilities as well as the protocols to be

followed to meet the required performance specification.

7. There must be a documented system in place, supervised by the

responsible person, for ratifying that tissues or cells or both meet

appropriate specifications for safety and quality for release and for their

distribution.

8. In the event of termination of activities the agreements concluded

and the procedures adopted in accordance with section 14(9) of this Part

shall include traceability data and material concerning the quality and safety

of tissues and cells.

Public Health (Human Tissues, Cells and Organs)

2009-53

9. There must be a documented system in place that ensures the

identification of every unit of tissue or cells at all stages of the activities for

which authorisation is sought.

B. PERSONNEL

1. The personnel in tissue establishments must be available in

sufficient number and be qualified for the tasks they perform. The

competency of the personnel must be evaluated at appropriate intervals

specified in the quality system.

2. All personnel should have clear, documented and up-to-date job

descriptions. Their tasks, responsibilities and accountability must be clearly

documented and understood.

3. Personnel must be provided with initial or basic training, updated

training as required when procedures change or scientific knowledge

develops and adequate opportunities for relevant professional development.

The training programme must ensure and document that each individual

(a) has demonstrated competence in the performance of their

designated tasks;

(b) has an adequate knowledge and understanding of the scientific

or technical processes and principles relevant to their

designated tasks;

health and safety rules of the establishment in which they

work; and

(d) is adequately informed of the broader ethical, legal and

regulatory context of their work.

C. EQUIPMENT AND MATERIALS

1. All equipment and material must be designed and maintained to suit

its intended purpose and must minimise any hazard to recipients or staff or

to both.

2. All critical equipment and technical devices must be identified and

validated, regularly inspected and preventively maintained in accordance

with the manufacturers' instructions. Where equipment or materials affect

critical processing or storage parameters (e.g. temperature, pressure, particle

counts, microbial contamination levels), they must be identified and must be

the subject of appropriate monitoring, alerts, alarms and corrective action, as

required, to detect malfunctions and defects and to ensure that the critical

parameters are maintained within acceptable limits at all times. All

Public Health (Human Tissues, Cells and Organs)

2009-53

equipment with a critical measuring function must be calibrated against a

traceable standard if available.

3. New and repaired equipment must be tested when installed and must

be validated before use. Test results must be documented.

4. Maintenance, servicing, cleaning, disinfection and sanitation of all

critical equipment must be performed regularly and recorded accordingly.

5. Procedures for the operation of each piece of critical equipment,

detailing the action to be taken in the event of malfunctions or failure, must

be available.

6. The procedures for the activities for which authorisation is sought,

must detail the specifications for all critical materials and reagents. In

particular, specifications for additives (e.g. solutions) and packaging

materials must be defined. Critical reagents and materials must meet

documented requirements and specifications.

D. FACILITIES OR PREMISES

1. A tissue establishment must have suitable facilities to carry out the

activities for which authorisation is sought, in accordance with the standards

laid down in this Part.

2. When these activities include processing of tissues and cells while

exposed to the environment, this must take place in an environment with

specified air quality and cleanliness in order to minimise the risk of

contamination, including cross-contamination between donations. The

effectiveness of these measures must be validated and monitored.

3.Unless otherwise specified in point 4, where tissues and cells are exposed

to the environment during processing, without a subsequent microbial

inactivation process, an air quality with particle counts and microbial colony

counts equivalent to those of Grade A as defined in the current European

Guide to Good Manufacturing Practice (GMP), Annex 1 and Directive

2003/94/EC is required with a background environment appropriate for the

processing of the tissue/cell concerned but at least equivalent to GMP Grade

D in terms of particles and microbial counts.

4. A less stringent environment than specified in point 3 may be

acceptable where

(a) a validated microbial inactivation or validated terminal

sterilisation process is applied;

Public Health (Human Tissues, Cells and Organs)

2009-53

(b) or, where it is demonstrated that exposure in a Grade A

environment has a detrimental effect on the required properties

of the tissue or cell concerned;

application of the tissue or cell to the recipient implies a

significantly lower risk of transmitting bacterial or fungal

infection to the recipient than with cell and tissue

transplantation;

(d) or, where it is not technically possible to carry out the required

process in a Grade A environment (for example, due to

requirements for specific equipment in the processing area that

is not fully compatible with Grade A).

5. In point 4(a), (b), (c) and (d), an environment must be specified. It

must be demonstrated and documented that the chosen environment

achieves the quality and safety required, at least taking into account the

intended purpose, mode of application and immune status of the recipient.

Appropriate garments and equipment for personal protection and hygiene

must be provided in each relevant department of the tissue establishment

along with written hygiene and gowning instructions.

6. When the activities for which authorisation is sought involve storage

of tissues and cells, the storage conditions necessary to maintain the

required tissue and cell properties, including relevant parameters such as

temperature, humidity or air quality must be defined.

7. Critical parameters (e.g. temperature, humidity, air quality) must be

controlled, monitored, and recorded to demonstrate compliance with the

specified storage conditions.

8. Storage facilities must be provided that clearly separate and

distinguish tissues and cells prior to release in quarantine from those that are

released and from those that are rejected, in order to prevent mix-up and

cross-contamination between them. Physically separate areas or storage

devices or secured segregation within the device must be allocated in both

quarantine and released storage locations for holding certain tissue and cells

collected in compliance with special criteria.

9. The tissue establishment must have written policies and procedures

for controlled access, cleaning and maintenance, waste disposal and for the

re-provision of services in an emergency situation.

E. DOCUMENTATION AND RECORDS

1. There must be a system in place that results in clearly defined and

effective documentation, correct records and registers and authorised

Public Health (Human Tissues, Cells and Organs)

2009-53

Standard Operating Procedures (SOPs), for the activities for which

authorisation is sought. Documents must be regularly reviewed and must

conform to the standards laid down in this Part. The system must ensure that

work performed is standardised, and that all steps are traceable; i.e. coding,

donor eligibility, procurement, processing, preservation, storage, transport,

distribution or disposal, including aspects relating to quality control and

quality assurance.

2. For every critical activity, the materials, equipment and personnel

involved must be identified and documented.

3. In the tissue establishments all changes to documents must be

reviewed, dated, approved, documented and implemented promptly by

authorised personnel.

4. A document control procedure must be established to provide for the

history of document reviews and changes and to ensure that only current

versions of documents are in use.

5. Records must be shown to be reliable and a true representation of the

results.

6. Records must be legible and indelible and may be handwritten or

transferred to another validated system, such as a computer or microfilm.

7. Without prejudice to section 16(8) of this Part, all records, including

raw data, which are critical to the safety and quality of the tissues and cells

shall be kept so as to ensure access to these data for at least 10 years after

expiry date, clinical use or disposal.

8. Records must meet the confidentiality requirements laid down in

section 20. Access to registers and data must be restricted to persons

authorised by the responsible person, and to the competent authority for the

purpose of inspection and control measures.

F. QUALITY REVIEW

1. An audit system must be in place for the activities for which

authorisation is sought. Trained and competent persons must conduct the

audit in an independent way, at least every two years, in order to verify

compliance with the approved protocols and the regulatory requirements.

Findings and corrective actions must be documented.

2. Deviations from the required standards of quality and safety must

lead to documented investigations, which include a decision on possible

corrective and preventive actions. The fate of non-conforming tissues and

cells must be decided in accordance with written procedures supervised by

Public Health (Human Tissues, Cells and Organs)

2009-53

the responsible person and recorded. All affected tissues and cells must be

identified and accounted for.

3. Corrective actions must be documented, initiated and completed in a

timely and effective manner. Preventive and corrective actions should be

assessed for effectiveness after implementation.

4. The tissue establishment should have processes in place for review

of the performance of the quality management system to ensure continuous

and systematic improvement.

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 6

Section 9(1)(c)

Requirements for the authorisation of tissue and cell preparation

processes at the tissue establishments

The competent authority shall authorise each tissue and cell preparation

process after evaluation of the donor selection criteria and procurement

procedures, the protocols for each step of the process, the quality

management criteria, and the final quantitative and qualitative criteria for

tissues and cells. This evaluation must comply at least with the requirements

set out in this Schedule.

A. RECEPTION AT THE TISSUE ESTABLISHMENT

Upon reception of procured tissues and cells at the tissue establishment, the

tissues and cells must comply with the requirements defined in this Part.

B. PROCESSING

When the activities for which the authorisation is sought include processing

of tissues and cells, the tissue establishment procedures must comply with

the following criteria

1. The critical processing procedures must be validated and must

not render the tissues or cells clinically ineffective or harmful

to the recipient. This validation may be based on studies

performed by the establishment itself, or on data from

published studies or, for well-established processing

procedures, by retrospective evaluation of the clinical results

for tissues supplied by the establishment.

2. It has to be demonstrated that the validated process can be

carried out consistently and effectively in the tissue

establishment environment by the staff.

3. The procedures must be documented in SOPs which must

conform to the validated method and to the standards laid

down in this Part accordingly with Schedule 1 (E), points 1 to

4. It must be ensured that all processes are conducted in

accordance with the approved SOPs.

5. Where a microbial inactivation procedure is applied to the

tissue or cells it must be specified, documented, and validated.

Public Health (Human Tissues, Cells and Organs)

2009-53

6. Before implementing any significant change in processing, the

modified process must be validated and documented.

7. The processing procedures must undergo regular critical

evaluation to ensure that they continue to achieve the intended

results.

8. Procedures for discarding tissues and cells must prevent the

contamination of other donations and products, the processing

environment or personnel. These procedures must comply with

national regulations.

C. STORAGE AND RELEASE OF PRODUCTS

When the activities for which the authorisation is sought include storage and

release of tissues and cells, the authorised tissue establishment procedures

must comply with the following criteria

1. Maximum storage time must be specified for each type of

storage condition. The selected period must reflect among

others possible deterioration of the required tissue and cell

properties.

2. There must be a system of inventory hold for tissues and cells

to ensure that they cannot be released until all requirements

laid down in this Part have been satisfied. There must be a

standard operating procedure that details the circumstances,

responsibilities and procedures for the release of tissues and

cells for distribution.

3. A system for identification of tissues and cells throughout any

phase of processing in the tissue establishment must clearly

distinguish released from non-released (quarantined) and

discarded products.

4. Records must demonstrate that before tissues and cells are

released all appropriate specifications are met, in particular all

current declaration forms, relevant medical records, processing

records and test results have been verified according to a

written procedure by a person authorised for this task by the

responsible person as specified in section 8 of this Part. If a

computer is used to release results from the laboratory, an audit

trail should indicate who was responsible for their release.

5. A documented risk assessment approved by the responsible

person as defined in section 8 of this Part must be undertaken

to determine the fate of all stored tissues and cells following

the introduction of any new donor selection or testing criterion

Public Health (Human Tissues, Cells and Organs)

2009-53

or any significantly modified processing step that enhances

safety or quality.

D. DISTRIBUTION AND RECALL

When the activities for which the authorisation is sought include distribution

of tissues and cells, the authorised tissue establishment procedures must

comply with the following criteria

1. Critical transport conditions, such as temperature and time

limit must be defined to maintain the required tissue and cell

properties.

2. The container and the package must be secure and ensure that

the tissue and tissues and cells are maintained in the specified

conditions. All containers and packages need to be validated as

fit for purpose.

3. Where a contracted third party carries out distribution, a

documented agreement must be in place to ensure that the

required conditions are maintained.

4. There must be personnel authorised within the tissue

establishment to assess the need for recall and to initiate and

coordinate the necessary actions.

5. An effective recall procedure must be in place, including a

description of the responsibilities and actions to be taken. This

must include notification to the competent authority.

6. Actions must be taken within pre-defined periods of time and

must include tracing all relevant tissues and cells and, where

applicable, must include trace-back. The purpose of the

investigation is to identify any donor who might have

contributed to causing the reaction in the recipient and to

retrieve available tissues and cells from that donor, as well as

to notify consignees and recipients of tissues and cells procured

from the same donor in the event that they might have been put

at risk.

7. Procedures must be in place for the handling of requests for

tissues and cells. The rules for allocation of tissues and cells to

certain patients or health care institutions must be documented

and made available to these parties upon request.

8. A documented system must be in place for the handling of

returned products including criteria for their acceptance into

the inventory, if applicable.

Public Health (Human Tissues, Cells and Organs)

2009-53

E. FINAL LABELLING FOR DISTRIBUTION

The primary tissue or cell container must provide

(a) type of tissues and cells, identification number or code of the

tissue or cells, and lot or batch number where applicable;

(b) identification of the tissue establishment;

(d) in the case of autologous donation, this has to be specified (for

autologous use only) and the donor/recipient has to be

identified;

(e) in the case of directed donations - the label must identify the

intended recipient;

(f) when tissues and cells are known to be positive for a relevant

infectious disease marker, it must be marked as:

BIOLOGICAL HAZARD.

If any of the information under points (d) and (e) above cannot be included

on the primary container label, it must be provided on a separate sheet

accompanying the primary container. This sheet must be packaged with the

primary container in a manner that ensures that they remain together.

2. The following information must be provided either on the label or in

accompanying documentation

(a) description (definition) and, if relevant, dimensions of the

tissue or cell product;

(b) morphology and functional data where relevant;

(d) biological determinations carried out on the donor and results;

(e) storage recommendations;

(f) instructions for opening the container, package, and any

required manipulation or reconstitution;

(g) expiry dates after opening or manipulation;

Public Health (Human Tissues, Cells and Organs)

2009-53

(h) instructions for reporting serious adverse reactions or events or

both as set out in sections 11 and 12 of this Part;

(i) presence of potential harmful residues (e.g. antibiotics,

ethylene oxide etc).

F. EXTERNAL LABELLING OF THE SHIPPING CONTAINER

For transport, the primary container must be placed in a shipping container

that must be labelled with at least the following information

(a) identification of the originating tissue establishment, including

an address and phone number;

(b) identification of the organisation responsible for human

application of destination, including address and phone

number;

and HANDLE WITH CARE;

(d) where living cells are required for the function of the graft,

such as stem cells gametes and embryos, the following must be

added: ‘DO NOT IRRADIATE’;

(e) recommended transport conditions (e.g. keep cool, in upright

position, etc.);

(f) safety instructions or method of cooling (when applicable).

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 7

Section 11(3)

NOTIFICATION OF SERIOUS ADVERSE REACTIONS

PART A

Rapid notification for suspected serious adverse reactions

Tissue establishment

Report identification

Reporting date (year/month/day)

Individual affected (recipient or donor)

Date and place of procurement or human application

(year/month/day)

Unique Donation identification number

Date of suspected serious adverse reaction (year/month/day)

Type of tissues and cells involved in the suspected serious

adverse reaction

Type of suspected serious adverse reaction(s)

Public Health (Human Tissues, Cells and Organs)

2009-53

PART B

Conclusions of serious adverse reactions investigation

Tissue establishment

Report identification

Confirmation date (year/month/day)

Date of serious adverse reaction (year/month/day)

Unique donation identification number

Confirmation of serious adverse reaction (Yes/No)

Change of type of serious adverse reaction (Yes/No)

If Yes, Specify

Critical outcome (if known)

-Complete recovery

-Minor sequelae

-Death

Outcome of the investigation and final conclusions

Recommendations for preventive and corrective actions

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 8

Section 12(4)

NOTIFICATION OF SERIOUS ADVERSE EVENTS

PART A

Rapid notification for suspected serious adverse events

Tissue establishment

Report identification

Reporting date (year/month/day)

Date of serious adverse event (year/month/day)

Serious adverse event, which

may affect quality and safety

of tissues and cells due to a

deviation in:

Specification

Tissues

and cells

defect

Equipment

failure

Human

error

Other

(specify)

Procurement

Testing

Transport

Processing

Storage

Distribution

Materials

Others (specify)

Public Health (Human Tissues, Cells and Organs)

2009-53

PART B

Conclusions of Serious Adverse Events investigation

Tissue establishment

Report identification

Confirmation date (year/month/day)

Date of serious adverse event (year/month/day)

Root cause analysis (details)

Corrective measures taken (details)

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 9

Section 28(3)

ANNUAL NOTIFICATION FORMAT

PART A

Annual notification format for serious adverse reactions

Reporting country

Reporting date 1 January-31

December (year)

Number of serious adverse reaction(s) per type of tissue and cell

(or product in contact with the tissues and cells)

Type of tissue/cell

(or product in

contact with the

tissues and cells)

Number of serious

adverse

reaction(s)

Total number of

tissues/cells of

this type

distributed (if

available)

…

Total

Total number of tissues and cells distributed (including type of

tissue and cell for which no serious adverse reactions were

reported):

Number of recipients affected (total number of recipients):

Number of serious adverse

reactions reported

Total number of serious

adverse reaction(s)

Transmitted bacterial infection

Transmitted

viral

Infection

HBV

HCV

HIV-1/2

Other

(Specify)

Public Health (Human Tissues, Cells and Organs)

2009-53

Transmitted

parasitical

Malaria

Other

(Specify)

Transmitted malignant diseases

Other disease transmissions

Other serious reactions

(Specify)

PART B

Annual notification format for serious adverse events

Reporting country

Reporting date 1 January-31 December (year)

Total number of tissues and cells processed

Total number of serious

adverse events, which may

have affected quality and

safety of tissues and cells due

to a deviation in:

Specification

Tissues

and

cells

defect

(specify)

Equipment

failure

(Specify)

Human

error

Other

(specify)

Procurement

Testing

Processing

Storage

Distribution

Materials

Others (specify)

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 10

Section 16(8)

Information on the minimum donor or recipient or both data set to be

kept

A. BY TISSUE ESTABLISHMENTS

Donor identification

Donation identification that will include at least

— Identification of the procurement organisation or Tissue

establishment

— Unique Donation ID number

— Date of procurement

— Place of procurement

— Type of donation (e.g. single v multi-tissue; autologous v

allogenic; living v deceased)

Product identification that will include at least

— Identification of the tissue establishment

— Type of tissue and cell or product (basic nomenclature)

— Pool number (if applicable)

— Split number (if applicable)

— Expiry date

— Tissue/cell status (i.e. quarantined, suitable for use etc.)

— Description and origin of the products, processing steps

applied, materials and additives coming into contact with

tissues and cells and having an effect on their quality or safety

or both.

— Identification of the facility issuing the final label

Human application identification that will include at least:

— Date of distribution or disposal

Public Health (Human Tissues, Cells and Organs)

2009-53

— Identification of the clinician or end user or facility

B. BY ORGANISATIONS RESPONSIBLE FOR HUMAN

APPLICATION

(a) Identification of the supplier tissue establishment

(b) Identification of the clinician or end user or facility

(d) Product identification

(e) Identification of the recipient

(f) Date of application

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 11

Section 16(3)

Information contained in the European Coding System

(a) Donation identification

— Unique ID number

— Identification of the tissue establishment

(b) Product identification

— Product code (basic nomenclature)

— Split number (if applicable)

— Expiry date.

Public Health (Human Tissues, Cells and Organs)

2009-53

SCHEDULE 12

Sections 28E and 28M

ORGAN AND DONOR CHARACTERISATION

PART A

Minimum data set

Minimum data – information for the characterisation of organs and donors

which has to be collected for each donation in accordance with the second

subparagraph of Article 7(1) of the Organ Directive and without prejudice

to Article 7(2) of the Organ Directive.

Minimum data set

The establishment where the procurement takes place and other general data

Type of donor

Blood group

Gender

Cause of death

Date of death

Date of birth or estimated age

Weight

Height

Past or present history of IV drug abuse

Past or present history of malignant neoplasia

Present history of other transmissible disease

HIV; HCV; HBV tests

Basic information to evaluate the function of the donated organ

PART B

Complementary data set

Public Health (Human Tissues, Cells and Organs)

2009-53

Complementary data – information for the characterisation of organs and

donors to be collected in addition to minimum data specified in Part A,

based on the decision of the medical team, taking into account the

availability of such information and the particular circumstances of the case,

in accordance with the second subparagraph of Article 7(1) of the Organ

Directive .

Complementary data set

General data

Contact details of the procurement organisation/the establishment where the

procurement takes place necessary for coordination, allocation and

traceability of the organs from donors to recipients and vice versa.

Donor data

Demographic and anthropometrical data required in order to guarantee an

appropriate matching between the donor/organ and the recipient.

Public Health (Human Tissues, Cells and Organs)

2009-53

Donor medical history

Medical history of the donor, in particular the conditions which might affect

the suitability of the organs for transplantation and imply the risk of disease

transmission.

Physical and clinical data

Data from clinical examination which are necessary for the evaluation of the

physiological maintenance of the potential donor as well as any finding

revealing conditions which remained undetected during the examination of

the donor’s medical history and which might affect the suitability of organs

for transplantation or might imply the risk of disease transmission.

Laboratory parameters

Data needed for the assessment of the functional characterisation of the

organs and for the detection of potentially transmissible diseases and of

possible contraindications with respect to organ donation.

Image tests

Image explorations necessary for the assessment of the anatomical status of

the organs for transplantation.

Therapy

Treatments administered to the donor and relevant for the assessment of the

functional status of the organs and the suitability for organ donation, in

particular the use of antibiotics, inotropic support or transfusion therapy.