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Proposal of Law No 206/XII

Exhibition of Motifs

This law transposes into the internal legal order of the Directive

No 2011/24/EU, of the European Parliament and of the Council of 9 March 2011, relative

to exercise patient rights in cross-border health care.

Following the caselaw of the Court of Justice of the European Union on

issues related to cross-border health care, in particular,

reimbursement of the costs of these care, in which it is confirmed that neither the special nature

nor the way they are organized or funded may exclude care

the scope of the fundamental principle of freedom to provide services, the said Directive

The aim is to ensure more general and effective application of the principles laid down by the Court

of justice in an affluent way.

Directive 2011/24/EU, European Parliament and Council of 9 March

2011, thus came to establish rules aimed at facilitating access to health care

high quality and safe crossborders in the European Union and to promote

cooperation between Member States with regard to health care,

the responsibilities of the Member States with regard to the definition

in the field of health and the organization and provision of health care.

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Thus, this law sets standards for access to cross-border health care

by the beneficiaries of the National Health Service and Regional Health Services,

to ensure patient mobility, respect for national skills and

the definition of their health policy and management,

organization and provision of health services and medical care in accordance with paragraph 7 of

Article 168 of the Treaty on the Functioning of the European Union. In this sense, the

rules for access to cross-border health care provided for in this law

the implementation of the national and regional provisions in force with regard to

organization and funding of health care in non-related situations

cross-border health care. At national level, it complies with the Portuguese State, in

constitutionally consecrated terms, guarantee the right to health protection through

a universal and general National Health Service and taking into account economic conditions

and social of citizens, often free.

The National Health Service has long had its own rules in the Regions

Autonomous, through the Regional Legislative Decrees establishing their respective

Regional Health Services, which has been adopted, throughout this law, clarification

on which services, in particular, must assume the management responsibilities

administrative and financial repayments.

On the other hand, health care access rules may be subject to restrictions,

when this is justified for imperious reasons of general interest, which can legitimize

the freedom to provide services. In this sense, it is planned

the possibility of restricting access to cross-border health care and

the right to reimburse expenses directly related to them,

on the basis of imperious reasons of general interest in accordance with the Treaty on

Functioning of the European Union and the caselaw of the Court of Justice of the Union

European Union, as well as the application of a prior authorization system in certain

situations and for some type of health care.

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The adoption of measures relating to access to restrictive treatment for reasons

of general interest, it is only legitimate and effective, if in concrete and in

function of existing casuistics, if it confirms that the planning and investment carried out

in highly specialized and costly medical infrastructure or equipment

aim of ensuring access to certain high quality treatment, are not the

be profitable and do not contribute to the sustainability of the National Health Service.

It is not possible, nor is it justified that, a priori, an exercise of typifying and listing

Any situations that may determine restrictions on access to health care

crossborders and regulations, without knowing the assumptions and the

concrete circumstances under which such restrictions are based. In this sense, the present law

the possibility of the competent departments of the Public Administration to propose

Member of the Government responsible for the area of health or members of the Governments of

Regions Self-employed persons responsible for the health area, where appropriate, the adoption of

such measures.

It also stresses that Directive No 2011/24/EU of the European Parliament and of the European Parliament

Council of 9 March 2011 provides for the possibility of applying the same

conditions, eligibility criteria and legal and administrative formalities for reimbursement

of the health care costs that would impose if such care had been provided in

national territory. In this sense, according to this law, an assessment is required

previous by a general and family doctor of the National Health Service or of the

Regional Health Services, which determines the need for health care.

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It is thus intended, through this legal framework, to ensure the need to forward and

orient the beneficiary of the National Health Service in order to assess the need and to ensure

the quality and safety of health care provided, as well as the need for

to safeguard planning in the National Health Service. It is underlined that, solutions

profiled in this law, seek to ensure that patient mobility does not place in

causes sufficient and permanent access to a balanced and quality range of care

health in the National Health Service, or strengthening capacity in the medium and long

deadlines and the profitability of investments made in the National Health Service. By

On the other hand, it allows the National Health Service to control costs and, avoid, both

as possible, a waste of financial, technical and human resources within

Legal framework of Directive 2011/24/EU, the European Parliament and the Council of 9

March 2011.

In particular, as regards the application of the prior authorization system, this law is

Supplementary application to Regulation (EC) No 883/2004, the European Parliament and the

Council of 29 April 2004 when the conditions laid down are met

the same, except if the patient asks otherwise.

The importance of encouraging cooperation in the field of recognition

of medical recipes, European reference networks, rare diseases, health in

line, assessment of health technologies. In this context, this law proceeds,

also transposition into the internal legal order of the Executive Directive

No 2012/52/EU of the Commission of 20 December 2012 laying down measures for

To facilitate the recognition of medical receipts issued in another Member State.

The self-government bodies of the Autonomous Regions and the Commission

National Data Protection.

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So:

Pursuant to the d) Article 197(1) of the Constitution, the Government shall submit to the

Assembly of the Republic the following bill:

Article 1

Object

This law lays down rules for access to cross-border and

promotes cross-border health care cooperation, transposing to

the internal legal order to Directive 2011/24/EU, the European Parliament and the

Council of 9 March 2011 on the exercise of patient rights in the field

of cross-border health care and implementing Directive No 2012/52/EU of the

Commission of 20 December 2012 laying down measures to facilitate the

recognition of medical receipts issued in another Member State.

Article 2

Scope

1 - This law does not apply:

a) To integrated continuing care, in accordance with Decree-Law No 101/2006,

of 6 June, and of the Regional Legislative Decree no. 30/2012/M, of 8 August;

(b) To the gift or harvest of organs, after death, their allocation and access to

for therapeutic or transplant purposes;

(c) To the National and Regional Vaccination Plan under the legislation in force.

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2 - The provisions of this law shall not affect the application:

a) Regulation (EC) No 883/2004 of the European Parliament and of the Council of

29 April 2004 on the coordination of social security systems and

Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16

September 2009 laying down detailed rules for the application of the Regulation

(EC) No 883/2004 on the coordination of social security systems;

(b) The current legislation on the organization and financing of care

health, in situations not related to cross-border health care;

(c) From legislation applicable to health subsystems.

3 - No provision of this law requires reimbursement of the beneficiaries of expenditure

resulting from the provision of health care by care providers

health established in the national territory, which are not integrated or

contracted with the National Health Service or with the Regional Health Services.

Article 3

Definitions

For the purposes of this law, it is understood by:

a) 'Beneficiary', the beneficiary of the National Health Service or the beneficiary of

Regional Health Services, in accordance with the law, in particular:

(i) Portuguese nationals;

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ii) People, including members of your family and their survivors,

covered in the chapter Title III of Regulation (EC) No 883/2004,

of the European Parliament and of the Council of 29 April 2004 and

for which the Portuguese State is held as a State

in accordance with the applicable Community regulations and the law,

iii) Nationals of third countries residing in Portugal covered by

Council Regulation (EC) No 859/2003 of 14 May 2003 or

by Regulation (EU) No 1231/2010, the European Parliament and the

Council of 24 November 2010 or under the law;

(b) 'Health care', care provided by health professionals to

patients aiming to evaluate, maintain or rehabilitate their health status,

including prescription, dispensing and supplying medicines and

medical devices;

(c) ‘cross-border health care’, health care provided or prescribed

in another Member State of the European Union when the Member State of

affiliation is the Portuguese State, as well as health care provided or

prescribed by the Portuguese State when the Member State of affiliation is

others Member State;

d) «Medical device», a medical device as such considered by

Decree-Law No 145/2009, of 17 June;

e) « Patient», a natural person seeking to receive or receive health care

in Portugal or elsewhere Member State;

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f) 'Affiliation Member State'

(i) For the people referred to in the subalíneas I) and I) of the a), the

Member State competent to grant prior authorization to

appropriate treatment outside the Member State of residence in accordance with the

Regulation (EC) No 883/2004 of the European Parliament and of the Council,

of 29 April 2004, and of Regulation (EC) No 987/2009 of the

European Parliament and the Council of 16 September 2009;

ii) For the people referred to in the subalínea iii) of the a), the

Member State competent to grant prior authorization to

appropriate treatment in another Member State under the Regulation

(EC) No 859/2003 of the Council of 14 May 2003 or by

Regulation (EU) No 1231/2010, of the European Parliament and of the Council,

of 24 November 2010, being that, if none Member State

in accordance with the said Regulations, the Member State

affiliation is the Member State in which people are insured or have

the right to sickness benefits under the legislation of that State

member;

g) 'Member State of treatment', the Member State in whose territory

health care is effectively provided to the patient, considering, in

in the case of telemedicine, which health care is provided in the Member State

in which the health care provider is established;

h) ‘Measuring’, any medicinal product under Decree-Law No 176/2006,

of August 30;

(i) «Health care provider», a natural or legal person who supplies

health care under the law;

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j) 'clinical process', any record, computerized or not, containing

health information about patients or their relatives, in accordance with the Law

no. 12/2005, of January 26;

k) 'Health professional', a health professional providing health care

under Directive 2005/36/EC, the European Parliament and the Council,

of 7 September 2005 on recognition of qualifications

professional, or other professional whose activity in the health care sector

constitutes a regulated profession under Law No 9/2009 of 4

March, or a person considered a health professional under the law

of the Member State of treatment;

(1) «Medical recipe», a prescription of medicines or medical devices

prescribed by a person who exercises a regulated health profession in

terms of the aArticle 3(1) of Directive No 2005/36/EC of the

European Parliament and the Council of 7 September 2005

legally authorized to do so in the Member State in which the revenue is prescribed;

m) «Health technology», a medicine, a medical device or

medical or surgical procedures, as well as prevention measures,

diagnosis or treatment of diseases used in the provision of care

health.

Article 4

General principles of cross-border health care provision

1 - Crossborder health care is provided in accordance with the principles of

universality, access to quality, equity and health care

solidarity, in accordance with:

a) The legislation of the Member State of treatment;

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(b) The quality and safety standards and guidelines established by the

Member State of treatment; and

(c) European Union legislation on safety standards.

2 - Crossborder health care is provided in respect of the right to

the privacy of patients, in accordance with Law No 67/98, of October 26, and the Law

n.o 46/2012, of 29 August.

3 - Cross-border health care is reimbursed to beneficiaries under the terms of

of this law.

Article 5

National contact point

1 - For the purposes of this law, the national contact point for health care

crossborder is designated by dispatch of the member of the Government responsible for

health, between the services and bodies of the Ministry of Health, and the points of

National contact for autonomous health care regions

crossborders are designated by dispatches of the members of the Governments of the

Regions Self-employed persons responsible for the health area, their contacts

communicated to the European Commission.

2 - National contact point and national contact points for regions

self-employed persons must ensure that health care information

crossborder, care provided in national territory and providers

established in national territory is easily accessible, is disclosed by means

electronic, and is suitable for people with special needs.

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3 - The national contact point and the national contact points of the autonomous regions

should also provide information when requested by the patient about:

a) The clinical standards in force in the health system, applicable to all

health professionals who exercise their professional activity;

(b) The legislation in force on licensing of entities providing services

health care;

(c) The supervisory mechanisms and the assessment of compliance with

rules and legislation referred to in the preceding paragraphs;

d) The right of a specific provider to exercise legally certain activity or

any restrictions on their practice in the national territory;

e) The rights of patients in cross-border health care,

including conditions for reimbursement of costs and conditions

the applicability of EU regulations on coordination

of social security systems;

f) The mechanisms of administrative or judicial impugnation;

g) Access to health units for people with disabilities;

h) Data from the national contact points of the other Member States;

(i) The items to be included in the receipts issued in a Member State other than

the one in which they are dismissed.

4 - National contact point and national contact points for regions

autonomous establish a close articulation with the other entities with

health care at national and European Union level and

consultation, where necessary, patient organisations and care providers

health.

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5 - The services and entities that integrate the structure of the Ministry of Health under the terms

of their organic law, private health care providers and the Orders

Professionals linked to the health sector provide national contact and

national contact points for the autonomous regions, the information necessary for the

compliance with paragraphs 2 and 3.

6 - The national contact point and the national contact points of the autonomous regions

other national contact points of the other Member States

European Union the information needed in the field of health care

crossborder, as well as requesting their collaboration, in particular in

quality and safety in health, supervision and evaluation of providers

health care and clarification of the contents of expenditure documents.

7 - For the purposes of paragraph 7 D) of paragraph 3 shall be made available to the authorities of others

Member States, where requested, through the Information System

Internal market, created under the European Commission Decision 2008/49/EC,

of 12 December 2007, information on the right to exercise the profession by

part of health professionals in national or local registers established

in the national territory.

8 - The national contact point can propose, in conjunction with the other entities

the conclusion of agreements with other Member States, in particular in

areas such as quality, safety and billing.

Article 6

Health care providers duties

1 - Health care providers provide patient information about:

a) The treatment options and availability of them;

(b) Quality control mechanisms and health care safety

provide;

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(c) Prices;

d) Your position in terms of authorization or registration;

e) The insurance of professional liability or the equivalent scheme applicable to

terms of the legislation in force on liability for damages

resulting from the provision of health care.

2 - Information must be provided directly to patients and published by means

electronic, in easy formats and also adapted to people with needs

special as well as posted in the health care provider's facilities.

3 - Health care providers ensure that the information provided in the

Health care invoices provided are discriminated under the law.

4 - The patient has the right to know the information recorded in his clinical process,

access to the distance or at least a copy of your clinical process,

terms of the law.

5 - Patients must be treated on the basis of the principle of non-discrimination for reasons

nationality.

Article 7

Organization measures for health care

1 - Without prejudice to paragraph 5 of the previous Article, they may be adopted in situations

in accordance with the principle of proportionality, measures

restriction of access to certain treatment under this law in accordance with the

Articles 52 and 62 of the Treaty on the Functioning of the European Union for reasons

imperious of general interest, when justified by the need to maintain access

sufficient, permanent, balanced and planned for all beneficiaries to a range

balanced treatment of high quality at national level or at a medical service

and hospital.

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2 - The Central Administration of the Health System, I.P. (ACSS, I.P.), approves and discloses

integrated establishments and services in the National Health Service or Services

Regional Health guidelines exemplifying the situations in which it can be

proposed the adoption of restriction measures under the previous number.

3 - The establishments and services integrated in the National Health Service or in the

Regional Health Services, regardless of their legal nature, propose

ACSS, I.P., the adoption of measures under paragraph 1.

Article 8

Right to refund

1 - Without prejudice to Article 11, the beneficiaries are entitled to reimbursement of the

expenses directly related to cross-border health care provided

in another Member State, provided that the care in question is taken as care

the Portuguese State would guarantee through the National Health Service

or of the Regional Health Services and the Portuguese State is considered State-

membership.

2 - Health benefits eligible for reimbursement under the preceding paragraph are the

provided in the price table of the National Health Service or Regional Services

Health, as well as in the legal systems of State or State participations

Regional Health Services at the price of medicines.

3 - Cross-border health care should be suitable for the health status of

scientifically proven beneficiary and effectiveness recognized by the best

International evidence.

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4 - The right to reimburse expenses which are not subject to prior authorization

under Article 11 presupposes the existence of a prior evaluation by a doctor

general and family medicine of the National Health Service or Regional Health Services

Health, which determines the need for health care.

5 - Cross-border health care costs are reimbursed only until the

limit that would have been assumed by the Portuguese State as responsibility

financial of the National Health Service or Regional Health Services, if these

care had been provided in the national territory under the price table

of the National Health Service or Regional Health Services and the general scheme

State or Regional Health Services participations in the price of

medicines, however, do not exceed the actual costs of health care received.

6 - Do not give the right to reimburse cross-border health care carried out

by health providers who are not legally recognized in the State-

Member of treatment or not complying with the respective standards and guidelines in

quality of health care and safety of the patient established by

same state.

7 - They are not entitled to reimbursement, the beneficiaries who, in accordance with the provisions

in Regulations (EC) No 883/2004, the European Parliament and the

Council of 29 April 2004 and No 987/2009 of the European Parliament and of the

Council of 16 September 2009

Social Security of another Member State.

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8 - Without prejudice to the preceding paragraphs, they may be adopted in situations

in accordance with the principle of proportionality, measures

restriction on reimbursement of expenses directly related to certain

health care provided in another Member State under this law

in accordance with the Treaty on the Functioning of the European Union, for urgent reasons of

general interest, where justified by the need to ensure sufficient access

permanent, balanced and planned for all beneficiaries in a balanced range

high-quality treatments at national level or at a medical service and

hospital or the need to control costs and avoid as much as possible the

waste of financial, technical and human resources in the National Health Service

or in the Regional Health Services.

9 - ACSS, I.P., and the Directorate-General for Health (DGS) propose to the member of the Government

responsible for the health area, and the competent services of the Autonomous Regions,

propose to the members of the Governments of the Autonomous Regions responsible for the area

the adoption of the measures referred to in the previous paragraph.

10 - The adoption of any refund restriction measures referred to in paragraph 8 is

notified to the European Commission within 30 days of its entry

in force, as well as any change.

Article 9

Request for refund

1 - The refund request depends on the request to be submitted, through the portal of the

or at the competent service of each Autonomous Region,

beneficiary or at the request of it to the functional units of the

Health Centres in the area of residence of the beneficiary or in the competent units of

each Autonomous Region, within 30 days of payment of expenditure.

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2 - The application for reimbursement shall be accompanied, inter alia, by the

following elements:

a) Proof of payment of expenses incurred from where the

in particular: the name of the beneficiary, the Member State of treatment and the

respective service, diagnostic procedures and treatment;

(b) The identification number of citizens, the number of users, the number of

Tax identification, tax residence, security identification number

social, age, sex and, where applicable, the beneficiary number, the respective

subsystem, policy number and insurance identification;

(c) The reason for the move;

d) The clinical evaluation proves the need for diagnosis or treatment,

issued by a general and family doctor of the National Health Service

or of the Regional Health Services or the proof of the application

prior authorization, where applicable;

e) The clinical information related to health benefits performed, with

express reference to the codes and designation of the main diagnosis, additional,

comorbidities, complications, procedures, according to Classification

International Diseases, 9th Review, Clinical Modification (CID-9-MC) or

equivalent coding in force in the Member State of treatment, date of

admission, date of high and destination after high.

3 - The original documents referred to in paragraphs a) and and) of the previous number, when

written in foreign language, must be accompanied by duly translated

certified under the law.

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4 - Repayment of health care costs is made by ACSS, I.P., or by

competent service of each Autonomous Region, depending on whether they are at issue

National Health Service or Regional Health Services within 90 days

account of the submission of the respective request, in accordance with the number

previous.

5 - If the request for reimbursement and the accompanying documentation raises doubts, you may

additional information to the beneficiary applicant and to

national contact points, by ACSS, I.P., or by the competent service of each

Autonomous Region, the period referred to in the preceding paragraph until the reception

the documents or the information concerned.

6 - In case of doubt, from a clinical point of view, the ACSS, I.P., or the competent service of

each Autonomous Region may request the opinion of the DGS, which shall issue it in

five working days.

7 - ACSS, I.P., and DGS ensure access to the patient's clinical information is

limited to health professionals subject to secrecy under the law.

8 - The models of the request for refund are approved by ACSS, I.P., and

by the respective services of the Autonomous Regions, and are subject to prior opinion of the

National Data Protection Commission under the law.

Article 10

Refund

1 - Repayment of costs of cross-border health care to beneficiaries is

made according to the price tables applied to the National Health Service or to the

Regional Health Services and with the general arrangements for State or

of the Regional Health Services at the price of medicines.

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2 - To the amounts to be reimbursed under the preceding paragraph, the value shall be deducted

in the case of health benefits

be carried out under the National Health Service or the Regional Health Service

Health, where applicable, in accordance with the legislation in force, and the amount

due to third contractually responsible.

Article 11

Prior authorization system

1 - Repayment of crossborder health care is subject to prior authorization

surgery that require hospitalization for at least one night, as well as, the

repayment of cross-border health care requiring infrastructure resources

or highly expensive medical equipment and high specialization.

2 - Repayment of health care is also subject to prior authorization

crossborders involving treatments that present a special risk for

or for the population or reimbursement of cross-border health care which

are provided by a health care provider who, by a casuistic decision of the

competent authority for the examination of the application for prior authorization, may raise

serious and specific concerns about the quality or safety of care.

3 - Health care referred to in paragraph 1 shall be defined by the body of the member of the

Government responsible for health, which is communicated to the European Commission in

within 30 days of its entry into force, as well as any

change anyway.

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4 - Failure to submit the application for prior authorization for the provision of care

crossborder health referred to in previous numbers or the refusal of the application

authorization, pursuant to this law, determines that the refund is not due by the

Portuguese State.

Article 12

Request for prior authorization

1 - The application for prior authorization depends on the application to be submitted through the portal

of the user, to the hospital unit of the area of residence of the beneficiary or of the

competent unit of each Autonomous Region.

2 - The application for prior authorization shall include, in particular, the

the name of the beneficiary, the identification number of citizens, the number of users, the

tax identification number, social security identification number,

Tax residence, age and gender, Member State of treatment and their unit

providing, as well as, clinical information with the indication of the need for

the provision of health care.

3 - The models of the application for prior authorization are approved by the

ACSS, I.P., and the competent services of the Autonomous Regions, are subject to

prior opinion of the National Data Protection Commission under the law.

Article 13

Evaluation of the beneficiary's clinical condition

1 - The clinical information contained in the application for prior authorization is

subject to a hospital clinical assessment of the need for diagnosis or treatment

and surgical suitability, to be carried out within 20 working days from the date of

the application for prior authorization, taking into account situations

Proven of greater clinical urgency.

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2 - From the clinical evaluation referred to in the previous paragraph, the proposed deferment must be included

or refusal of the application for prior authorization.

Article 14

Prior authorization procedure

1 - The application for prior authorization and the respective evaluation report

clinics are referred to by the hospital unit which issued the report, ACSS, I.P., or the

competent departments of the Autonomous Regions for assessment.

2 - ACSS, I.P., or the competent services of the Autonomous Regions

application for prior authorization within 15 working days of receipt of the report

of clinical evaluation, unless the clinical condition of the patient requires response within a period of time

Shorter.

3 - The application for prior authorization must be rejected in the following cases:

a) If the clinical evaluation indicates, with reasonable certainty, that the patient is

exposed to a security risk that cannot be considered acceptable, having

in account the potential benefit for the health care patient

intended crossborders;

(b) If there is a reasonable degree of certainty to conclude that the population is exposed to

a considerable risk of safety in health care outcomes

intended crossborders;

(c) If the health care concerned is provided by a care provider

of health that raises serious and specific concerns about respect for

standards and guidelines on health and health care quality

patient safety;

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d) If the health care in question can be provided in Portugal within a period of time

reasoned clinically useful, taking into account the state of health and

probable evolution of the disease of the patient.

4 - In case of doubt, from a clinical point of view, the ACSS, I.P., or the competent services

of the Autonomous Regions may request the opinion of the DGS, which must be issued in the

five working days.

5 - ACSS, I.P., and DGS ensure access to the patient's clinical information is

limited to health professionals subject to secrecy under the law.

6 - ACSS, I.P., or the competent services of the Autonomous Regions inform the patient

when your situation fulfils the conditions of application of Regulations (EC)

No 883/2004 of the European Parliament and of the Council of 29 April 2004 and

No 987/2009 of the European Parliament and of the Council of 16 September 2009

the coordination of social security systems in the European Union.

Article 15

Recognition of medical receipts issued in another Member State

1 - Medical receipts issued in a Member State of the European Union are recognised

in Portugal, in accordance with the legislation in force, if the medicinal product is authorised

or registration of market introduction pursuant to Decree-Law No 176/2006 of 30

August, and the recipe includes the following elements:

a) In the identification of the patient, the full name, written extensively and without

abbreviations, and the date of birth;

(b) In revenue authentication, issue date and digital or handwritten signature,

whether it is electronic or manual revenue;

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(c) In the identification of the health professional responsible for the prescription, the name

complete, written extensively and without abbreviations, professional qualifications,

elements for direct contact, in particular the electronic address, the number

telephone or fax, with indication of the international indicative and the address

the name of the Member State;

d) In the identification of the prescribed drug, where applicable:

(i) Common denomination, defined in Article 1 of Directive 2001/83/EC,

of the European Parliament and of the Council of 6 November 2001

establishes a Community code on medicinal products for use

human;

ii) The trademark, if the prescribed product is a biological medicinal product,

as defined in paragraph 3.2.1.1 bAnnex I (part I)

Directive 2001/83/EC, of the European Parliament and of the Council, of 6 June 2001/83/EC, of the European Parliament and of the Council, of the European Parliament

November 2001, the health professional responsible for the prescription

consider it necessary from the medical point of view, and should in this case be

indicated in the recipe, briefly, the reasons that justify the use of

trade mark;

e) The pharmaceutical form;

f) The quantity;

g) The dosage;

h) Possession.

2 - Medical recipes prescribed in Portugal, which the patient wishes to be

Dismissed in another Member State, include the following:

a) In the identification of the patient, the full name, written extensively and without

abbreviations, and the date of birth;

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(b) In revenue authentication, issue date and digital or handwritten signature,

whether it is electronic or manual revenue;

(c) In the identification of the health professional responsible for the prescription, the name

complete, written extensively and without abbreviations, professional qualifications,

elements for direct contact, in particular the electronic address, the number

telephone or fax, with indication of the international indicative and the address

the name of the Member State;

d) The prescription of the drug complies with the requirements set out in the

Articles 120 and 120a of Decree-Law No 176/2006 of August 30, and

regulation.

3 - Paragraph 1 shall not apply to medicinal products for which a

special medical prescription, in accordance with the bArticle 113(2) and Article 117. the

of Decree-Law No 176/2006 of 30 August.

4 - Medical income from medical devices issued in a Member State of the Union

Europeans are recognised in Portugal under the legislation in force if the

medical device is legally placed in the national market, and the recipe

include:

a) The elements provided for in paragraphs a) a c) and f) of paragraph 1;

(b) Other elements to be defined by order of the member of the responsible government

by the health area.

5 - The pharmacist may refuse the dispensing of medical prescriptions issued in a State--

Member of the European Union who raise legitimate and justified doubts about their

authenticity, content or intelligibility, as well as those in force

allows them to be refused for ethical reasons.

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Article 16

National reference centres

1 - For the purposes of applying this law, the Ministry of Health, identify,

to approve and officially recognize national reference centres, in particular for

diagnosis and treatment of rare diseases.

2 - The Ministry of Health promotes the participation and integration of reference centres

nationals who voluntarily wish to integrate the European Reference Networks.

Article 17

Online health cooperation

1 - The national authority responsible for online health cooperation

effect of this law is defined by order of the member of the responsible government

by the area of health, among the services, organisms and entities of the Ministry of Health.

2 - The national authority participates in the European network of responsible national authorities

by cooperation in the field of online health, whose standards of creation, management and

the Commission's implementing decision of 22

December 2011, laying down the rules for creation, management and

operation of the network of national authorities responsible for online health.

Article 18

Cooperation on the assessment of health technologies

1 - The national authority responsible for evaluating health technologies is defined by

order of the member of the Government responsible for the area of health, between services,

bodies and entities of the Ministry of Health.

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2 - The competent authority participates in the European network of national authorities

responsible for evaluating health technologies whose standards of creation, management and

The Commission's decision to implement the

26 June 2013, laying down the rules for creation, management and

transparent operation of the network of national authorities or bodies

responsible for the evaluation of health technologies.

Article 19. the

Reports

ACSS, I.P., and DGS present to the member of the Government responsible for the area of

health, and the competent services of the Autonomous Regions

Governments of the Autonomous Regions responsible for the health area, annual reports of

monitoring of the application of this law for disclosure purposes during the first

semester of the following year they respect.

Article 20

Autonomous regions

The provisions of this law apply to the Autonomous Regions of Madeira and the Azores, with

the necessary adaptations.

Article 21

Regulation

The regulation provided for in this law shall be approved within 30 days from its

entry into force.

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Article 22

Entry into force

This law shall enter into force on the first working day of the month following that of its publication.

Visa and approved in Council of Ministers of 30 January 2013

The Prime Minister

The Minister for the Presidency and Parliamentary Affairs