Key Benefits:
CHAIR OF THE COUNCIL OF MINISTERS
1
Proposal for Law No 206 /XII
Exhibition of Motives
This Law proceeds to the transposition into the internal legal order of the Directive
n. 2011 /24/UE, of the European Parliament and of the Council of March 9, 2011, concerning
to the exercise of the rights of patients in cross-border health care.
Following the case-law of the Court of Justice of the European Union concerning
issues related to cross-border health care, in particular, the
reimbursement of the costs of these care, in which it is confirmed that neither the special nature
neither the way they are organized or are financed can exclude the care from
health of the scope of the fundamental principle of the free provision of services, the said directive
aims to ensure a more general and effective application of the principles established by the Court
of Justice in an avulable way.
The Directive No 2011 /24/UE, of the European Parliament and of the Council of March 9 of
2011, came, thus, to establish rules aimed at facilitating access to health care
secure and high quality cross-border business in the European Union and to promote
cooperation between the Member States on health care, respecting
simultaneously the responsibilities of the Member States with regard to the definition
of benefits in the field of health and the organisation and provision of health care.
CHAIR OF THE COUNCIL OF MINISTERS
2
Thus, the present law sets up standards for access to cross-border health care
by the beneficiaries of the National Health Service and the Regional Health Services, from
how to ensure patient mobility, in respect of national skills and
regional with regard to the definition of the respective health policy as well as the management,
organization and provision of health and medical care services under the terms of paragraph 7 of the
article 168 of the Treaty on the Functioning of the European Union. In this sense, the
rules for access to cross-border health care stipulated in this Law no
undermine the implementation of the national and regional provisions in force with regard to the
organization and financing of health care in unrelated situations with
the cross-border health care. At the national level, it complies with the Portuguese State, in
constitutionally enshrined terms, guaranteeing the right to protection of health through
a universal and general National Health Service and taking into account economic conditions
and social of citizens, tendentially free.
The National Health Service has, for a long time, been rules in the Regions
Autonomous, by way of the Regional Legislative Decrees instituting the respects
Regional Health Services, by what has been adopted, along the present law, the clarification
on which services that, in concrete, should take over management responsibilities
administrative and financial by the reimbursements.
On the other hand, the rules of access to health care can be the subject of restrictions,
when this is warranted for compelling reasons of general interest, which they can legitimize
barriers to freedom to provide services. In this sense, it is planned in the
present law the possibility of restricting access to cross-border health care and in
concrete the right to reimbursement of the expenses directly related to the same,
on the basis of compelling reasons of general interest pursuant to the Treaty of
Operation of the European Union and of the case-law of the Court of Justice of the Union
European, as well as the application of a prior authorization system, in certain
situations and for certain typology of health care.
CHAIR OF THE COUNCIL OF MINISTERS
3
The adoption of measures regarding access to treatment of a restrictive nature, for reasons
imperious of general interest, it is only legitimate and enforcing effective, if in concrete and in
function of the existing casualty, if it confirms that the planning and investment realized
in highly specialized and onerous infrastructure or medical equipment with the
objective to ensure 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 , be done an exercise in typifying and listing
possible situations that may determine restrictions on access to health care
cross-border and to carry out its regulations, without getting to know the assumptions and the
concrete circumstances in which such restrictions are based. In that sense, the present law
devotes the possibility of the competent services of the Public Administration to propose to the
member of the Government responsible for the area of health or the members of the Governments of the
Autonomous Regions responsible for the area of health, when justifying, the adoption of
such measures.
Let's also emphasize that, the Directive No 2011 /24/UE, of the European Parliament and of the
Council, of March 9, 2011, provides for the possibility of being applied the same
conditions, eligibility criteria and legal and administrative formalities for reimbursement
of the costs of health care that mattered if such care had been provided in
national territory. In that sense, pursuant to this law, an assessment is required
prior to a general and family medical practitioner from the National Health Service or the
Regional Health Services, which determines the need for health care.
CHAIR OF THE COUNCIL OF MINISTERS
4
It is thus intended, through this legal framework, to ensure the necessity of forwarding and
guide the recipient of the National Health Service in order to afer the need and ensure
for the quality and safety of the health care provided, as well as, the need for
safeguard planning in the National Health Service. It is stressed that, the solutions
pervades in the present law, seek to ensure that patient mobility does not put in place
causes sufficient and permanent access to a balanced range and quality of care
of health in the National Health Service, or the capacity building in the medium and long
deadlines and the profitability of investments made in the National Health Service. By
other side, allows the National Health Service to control costs and, avoid, both
how much possible, a waste of financial, technical and human resources, within the
legal framework of Directive No 2011 /24/UE, of the European Parliament and of the Council, of 9 of
march: March 2011.
In particular, with respect to the application of the prior authorization system, the present law is
of supplementation application to Regulation (EC) No 883/2004, of the European Parliament and of the
Council, of April 29, 2004, whenever the defined conditions are fulfilled
same, except if the patient requests otherwise.
It is recognized the importance of encouraging cooperation in the field of recognition
of medical prescriptions, of European reference networks, of rare diseases, health in
line, from the assessment of health technologies. In this framework, the present law proceeds,
likewise, to the transposition into the internal legal order of the Enforcement Directive
n 2012 /52/UE of the Commission of December 20, 2012 laying down measures for
facilitate the recognition of medical prescriptions issued in another Member State.
The self-governing bodies of the Autonomous Regions and the Commission were heard
National of Data Protection.
CHAIR OF THE COUNCIL OF MINISTERS
5
Thus:
Under the terms of the paragraph d) of Article 197 (1) of the Constitution, the Government presents to the
Assembly of the Republic the following proposal for a law:
Article 1.
Object
This Law sets out standards for access to cross-border health care and
promotes cooperation on cross-border health care, by transposing to
the internal legal order to Directive No 2011 /24/UE, of the European Parliament and of the
Council of March 9, 2011 on the exercise of the rights of patients in matter
of cross-border health care and the Enforcement Directive No 2012 /52/UE, da
Commission, of December 20, 2012, laying down measures to facilitate the
recognition of medical prescriptions issued in another Member State.
Article 2.
Scope
1-A This Law shall not apply:
a) To the integrated continuum care, pursuant to the Decree-Law No. 101/2006,
of June 6, and of the Regional Legislative Decree no. 30 /2012/M of August 8;
b) To the donation or harvesting of organs, after death, respect allocation and access to the
same for therapeutic or transplant purposes;
c) To the National and Regional Plan of Vaccination under the current legislation.
CHAIR OF THE COUNCIL OF MINISTERS
6
2-The provisions of this Law shall be without prejudice to the application:
a) From Regulation (EC) No 883/2004, of the European Parliament and of the Council, of
April 29, 2004, concerning the coordination of social security systems and the
Regulation (EC) No 987/2009, of the European Parliament and of the Council, of 16
of September 2009, which sets out the modalities of the application of the Regulation
(EC) No 883/2004 on the coordination of social security systems;
b) From the legislation in force concerning the organization and financing of the care of
health, in situations unrelated to cross-border health care;
c) Of the legislation applicable to health subsystems.
3-No provision of this Law obliges to reimburse the beneficiaries of the expenses
arising from the provision of health care by providers of care of
health established in the national territory, which do not find themselves integrated or
contracted with the National Health Service or with the Regional Health Services.
Article 3.
Definitions
For the purposes of this Act, it shall be understood by:
a) "Beneficiary", the beneficiary of the National Health Service or the beneficiary of the
Regional Health Services, in accordance with the law, namely:
i) The citizens of Portuguese nationality;
CHAIR OF THE COUNCIL OF MINISTERS
7
ii) The people, including the members of their family and their survivors,
covered in Chapter I of Title III of Regulation (EC) No 883/2004,
of the European Parliament and of the Council of April 29, 2004 and
for which the Portuguese State is held as a State
competent, pursuant to the applicable community regulations and the law,
iii) The nationals of third countries resident in Portugal covered by the
Regulation (EC) No 859/2003, of the Council of May 14, 2003, or
by Regulation (EU) No 1231/2010, of the European Parliament and of the
Council, of November 24, 2010, or in the terms of the law;
b) 'Health Care', the care provided by health professionals to the
patients with the aim of assessing, maintaining or rehabilitating their state of health,
including the prescription, dispensation and supply of medicines and
medical devices;
c) "Cross-border health care", the 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 the health care provided or
prescribed by the Portuguese State when the state-member of affiliation is
other Member State;
d) "Medical device", a medical device as such considered by the
Decree-Law No 145/2009 of June 17;
e) "Sick", a natural person who seeks to receive or receive health care
in Portugal or in another member state;
CHAIR OF THE COUNCIL OF MINISTERS
8
f) "State-member of affiliation",
i) For the persons referred to in subparagraphs i ) and ii ) of the paragraph a ), the
Member state competent to grant a prior authorization for
appropriate treatment outside the state-member of residence pursuant to the
Regulation (EC) No 883/2004 of the European Parliament and of the Council,
of April 29, 2004, and of Regulation (EC) No 987/2009, of the
European Parliament and of the Council of September 16, 2009;
ii) For the persons referred to in sub-paragraph iii ) of the paragraph a ), the
Member State competent to grant a prior authorization for
appropriate treatment in another Member State under the Regulation
(EC) No 859/2003, of the Council, of May 14, 2003, or by the
Regulation (EU) No 1231/2010, of the European Parliament and of the Council,
of November 24, 2010, being that, if no Member State is
competent in the terms of the said regulations, the Member State of
affiliation is the member state in which people are insured or have
right to sickness benefits under the law of that State-
member;
g) "State-member of treatment", the Member State in whose territory the
health care is effectively provided to the patient, considering, in the
case of telemedicine, which health care is provided in the member state
where the provider of the health care is established;
h) "Medicinal", any medicinal product under the Decree-Law No 176/2006,
of August 30;
i) 'Health Care provider' means a natural or legal person who is to pay
health care in the terms of the law;
CHAIR OF THE COUNCIL OF MINISTERS
9
j) "clinical process" means any registration, computerized or not, that contains
health information about patients or their relatives, under the Act
n. 12/2005 of January 26;
k) "Health professional", a health care professional who provides health care
pursuant to Directive No 2005 /36/CE, of the European Parliament and of the Council,
of September 7, 2005, concerning the recognition of qualifications
professionals, or another professional whose activity in the health care sector
constitutes a regulated profession pursuant to Law No. 9/2009, 4 of
march, or still a person deemed to be a health professional under the law
of the Member State of treatment;
l) "Medical prescription", a prescription of medicines or medical devices
prescribed by a person who pursues a regulated health profession in the
terms of the point a ) of Article 3 (1) of the Directive No 2005 /36/CE, of the
European Parliament and of the Council of September 7, 2005 and which is
legally entitled 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 measures for prevention,
diagnosis or treatment of diseases used in the provision of care of
health.
Article 4.
General principles of the provision of cross-border health care
1-Transboundary health care is provided in accordance with the principles of
universality, access to quality health care, equity and the
solidarity, in accordance with:
a) The legislation of the Member State of treatment;
CHAIR OF THE COUNCIL OF MINISTERS
10
b) The standards and guidelines on quality and safety established by the
State-member of treatment; and
c) The European Union's legislation on safety standards.
2-Transboundary health care is provided in respect of the right to
privacy of patients, pursuant to Law No. 67/98, of October 26, and of the Law
n. 46/2012, of August 29.
3-Transboundary health care is reimbursed to the beneficiaries, on the terms
of this Law.
Article 5.
Point of national contact
1-For the purposes of this Law, the national point of contact for health care
cross-border is designated by dispatch of the member of the Government responsible for the
area of health, from among the services and bodies of the Ministry of Health, and the points of
national contact for autonomous regions for health care
Cross-border, are designated by dispatches from the members of the Governments of the
Autonomous Regions responsible for the area of health, with respect being the contacts
reported to the European Commission.
2-At the point of national contact and national contact points for the regions
autonomous competes to safeguard that information concerning health care
cross-border, to the care provided on national territory and to providers
established in national territory is easily accessible, it is disclosed by means
electronic, and is suitable for people with special needs.
CHAIR OF THE COUNCIL OF MINISTERS
11
3-The national point of contact and the national contact points of the autonomous regions
must still provide information, when requested by the patient, about:
a) The clinical standards in place in the health system, applicable to all
health professionals who exercise their professional activity;
b) The legislation in force in licensing of the licensing bodies of
health care;
c) The supervisory mechanisms and evaluation in respect of compliance with
standards and legislation referred to in the previous paragraphs;
d) The right of a specific provider to exercise legally certain activity or
on possible restrictions on their practice, on the national territory;
e) The rights of patients in cross-border health care,
including the conditions for the reimbursement of costs and the conditions of
applicability of regulations of the European Union on coordination
of social security systems;
f) The mechanisms of administrative or judicial impeding;
g) Access to health units for persons with disabilities;
h) The data of the national contact points of the other Member States;
i) The elements to be included in the revenue issued in a Member State other than
the one in which they are waived.
4-The national point of contact and national contact points for the regions
autonomous establish a close articulation with the remaining entities with
assignments in the field of health care at national and European Union level and
consult, when necessary, patient organisations and carers
of health.
CHAIR OF THE COUNCIL OF MINISTERS
12
5-The services and entities that integrate the structure of the Ministry of Health in the terms
of their organic law, private health care providers and Orders
Professionals connected to the health sector provide, at the point of national contact and the
national contact points for the autonomous regions, the information required by
compliance with the provisions of paragraphs 2 and 3.
6-The national point of contact and the national contact points of the autonomous regions
they provide to the other national contact points of the remaining Member States of the
European Union the necessary information in the field of health care
cross-border as well as ask for the collaboration of them, particularly in
quality and safety issue in health, supervision and evaluation of providers of
health care and clarification of the content of the expense documents.
7-For the purposes of the provisions of the d ) of paragraph 3 is made available to the authorities of others
Member States, whenever requested, through the Information System of the
Domestic Market, created pursuant to the European Commission Decision 2008 /49/CE,
of December 12, 2007, information on the right to exercise the profession by
part of the health professionals constant of national or local records established
in the national territory.
8-The point of national contact may propose, in articulation with the remaining entities
involved, the conclusion of agreements with other Member States, in particular in
areas such as quality, safety and invoicing.
Article 6.
Duties of providers of health care
1-Health care providers provide information to the patient about:
a) The options for treatment and availability of them;
b) The mechanisms for monitoring the quality and safety of health care that
provide;
CHAIR OF THE COUNCIL OF MINISTERS
13
c) The prices;
d) Your situation in terms of authorisation or registration;
e) The insurance of professional liability or the equivalent scheme applicable in the
terms of the legislation in force on liability for damages
resulting from the provision of health care.
2-A information should be provided directly to patients and advertised by means
electronics, in easy formats and also tailored to people with needs
special as well as affixed to the facilities of the health care provider.
3-Health care providers ensure that the information made available in the
invoices of the health care provided is discriminated against under the law.
4-The patient is entitled to know the information recorded in his / her clinical process, the
to accept you in the distance or to have at least one copy of your clinical process, in the
terms of the law.
5-Patipatients should be treated on the basis of the principle of non-discrimination for reasons
of the nationality.
Article 7.
Measures to organize the provision of health care
1-Without prejudice to the provisions of paragraph 5 of the preceding Article, they may be adopted, in situations
exceptional and in observance of the principle of proportionality, measures of
restriction on access to a particular treatment under this Act pursuant to the
articles 52 and 62 of the Treaty of Functioning of the European Union, for reasons
imperious of general interest, when justified by the need to maintain an access
sufficient, permanent, balanced and planned to all beneficiaries to a range
balanced of high quality treatments at the national level or a medical service
and hospitalar.
CHAIR OF THE COUNCIL OF MINISTERS
14
2-A Central Administration of the Health System, I.P. (ACSS, I.P.), approves and disseminates by the
integrated establishments and services in the National Health Service or the Services
Regional Health guidelines exemplificative advisors of the situations in which it may be
proposed the adoption of restriction measures in the terms of the previous number.
3-The integrated establishments and services in the National Health Service or in the
Regional Health Services, regardless of their legal nature, propose to
ACSS, I.P., the adoption of measures under the terms of paragraph 1.
Article 8.
Right to reimbursement
1-Without prejudice to the provisions of Article 11, the beneficiaries are entitled to the reimbursement of the
expenses directly related to the cross-border health care provided
in another Member State, provided that the care in question is taken as care
of health that would fit the Portuguese State to ensure through the National Health Service
or of the Regional Health Services and the Portuguese State be considered State-
member of affiliation.
2-Health benefits eligible for reimbursement under the previous number are the
provided for in the National Health Service or Regional Services Price Table
of Health, as well as in the legal regimes of the state's or the
Regional Health Services in the price of medicines.
3-Transboundary health care should be appropriate to the state of health of the
beneficiary and scientifically proven efficacy, recognized by the best
international evidence.
CHAIR OF THE COUNCIL OF MINISTERS
15
4-The right to reimbursement of expenses that do not meet subject to prior authorization
pursuant to Rule 11 presupposes the existence of a prior assessment by a physician
of general and family medicine from the National Health Service or the Regional Services of
Health, which determines the need for health care.
5-The costs of cross-border health care are reimbursed only up to the
limit that would have been assumed by the Portuguese State as a responsibility
Financial from the National Health Service or the Regional Health Services, should these
care had been provided in the national territory pursuant to the price table
of the National Health Service or the Regional Health Services and of the general scheme of the
comprised of the State or the Regional Health Services at the price of the
medications, without exceeding, however, the actual costs of the health care received.
6-Do not confer right to reimbursement for cross-border health care carried out
by health providers who do not find themselves legally recognized in the state-
treatment member or who do not comply with their respective standards and guidelines in
quality matter of the patient's health and safety care established by the
same state.
7-Do not have a right to reimbursement, the beneficiaries who, under the provisions of the provisions
constants of the Regulations (EC) No 883/2004, of the European Parliament and of the
Council, of April 29, 2004, and paragraph 987/2009, of the European Parliament and of the
Council, of September 16, 2009, to be covered by the System of
Social Security of another Member State.
CHAIR OF THE COUNCIL OF MINISTERS
16
8-Without prejudice to the provisions of the preceding paragraphs, they may be adopted, in situations
exceptional and in observance of the principle of proportionality, measures of
restriction on reimbursement of expenses directly related to determined
health care provided in another Member State within the framework of this Law in the
terms of the Treaty of Functioning of the European Union, for compelling reasons of
general interest, when justified by the need to ensure sufficient access
permanent, balanced and planned to all beneficiaries in a balanced range
of high quality treatments at the national level or a medical service and
hospital or by 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-A ACSS, I.P., and the Directorate General of Health (DGS) propose to the member of the Government
responsible for the area of health, and the competent services of the Autonomous Regions,
propose to the members of the Governments of the Autonomous Regions responsible for the area
of health, when this is warranted, the adoption of the measures referred to in the preceding paragraph.
10-A The adoption of any refund restriction measures, referred to in paragraph 8, is
notified to the European Commission within a maximum of 30 days of its entry
in force, as well as any change to the same.
Article 9.
Request for a refund
1-The request for a refund depends on an application to be submitted, through the portal of the
utent, to the ACSS, I.P., or to the competent service of each Autonomous Region, by the
beneficiary or at the request of this from the functional units of the Groupings of
Health centres of the area of the beneficiary's residence or in the competent units of
each Autonomous Region, within 30 days of the payment of the expenditure.
CHAIR OF THE COUNCIL OF MINISTERS
17
2-The application for the refund application is accompanied, in particular, of the
following elements:
a) The voucher for the payment of the expenses incurred from where it is conscrit
specifically: the name of the beneficiary, the State-member of treatment and the
respects the prescarving unit, the diagnostic procedures and the treatment;
b) The citizen identification number, the number of utente, the number of
tax identification, the tax residence, the number of security identification
social, age, sex and, where applicable, the number of beneficiary, the respect
subsystem, the number of policy and the identification of the insurer;
c) The reason for the displacement;
d) The clinical evaluation proving the need for diagnosis or treatment,
issued by a general and family medicine physician from the National Health Service
or of the Regional Health Services or the voucher of deferrals of the application
of prior authorization, in the applicable cases;
e) The clinical information related to the health benefits carried out, with
express reference to the codes and designation of the main diagnostic, additional,
comorbilities, complications, procedures, according to the Classification
International of Diseases, 9. Revision, Clinical Modification (CID-9-MC) or
equivalent coding in force in the State-member of treatment, date of
admission, date of the high and destination after high.
3-The original documents to which the points are referred a ) and and ) from the previous number, when
drafted in foreign language, must be accompanied by translation properly
certified, in the terms of the law.
CHAIR OF THE COUNCIL OF MINISTERS
18
4-The reimbursement of the costs of health care is effected by the ACSS, I.P., or by the
competent service of each Region Autonomous, depending on whether they are in cause users of the
National Health Service or the Regional Health Services, within 90 days of
count of the presentation of the respectable application, pursuant to the provisions of the figures
previous.
5-If the request for reimbursement and the documentation that accompanies it raises doubts, it may
be requested supplementary information to the applicant beneficiary as well as, to the
national contact points, by the ACSS, I.P., or by the competent department of each
Autonomous Region, suspending the period referred to in the preceding paragraph up to the reception
of the documents or the information in question.
6-In case of doubt, from the clinical point of view, the ACSS, I.P., or the competent service of
each Autonomous Region may request the opinion of the DGS, to which it shall issue it in the
term of five working days.
7-A ACSS, I.P., and DGS ensure that access to the clinical information of the patient is
limited to health professionals subject to secrecy, under the law.
8-The models of the application for the refund application are approved by the ACSS, I.P., and
by the respected services of the Autonomous Regions, and are subject to the prior opinion of the
National Data Protection Commission, pursuant to the law.
Article 10.
Refund
1-The reimbursement of costs of cross-border health care to the beneficiaries is
done in accordance with the price tables applied to the National Health Service or the
Regional Health Services and with the general regime of state compositions or
of the Regional Health Services in the price of medications.
CHAIR OF THE COUNCIL OF MINISTERS
19
2-To the amounts to be reimbursed in the terms of the preceding paragraph, the value is deducted
corresponding to the moderating rates that would be due, in case health benefits
were carried out within the framework of the National Health Service or the Regional Office of
Health, where applicable, under the current legislation, as well as the amount
due by third contractually responsible.
Article 11.
Prior authorization system
1-It is subject to prior authorization the reimbursement of cross-border health care
surgical that require the internment for at least one night, as well as, the
reimbursement of cross-border health care that requires resources to infrastructure
or highly onerous medical equipment and high specialization.
2-It is still subject to prior authorization the reimbursement of health care
cross-border that involve treatments that present a special risk to the
sick or to the population or the reimbursement of cross-border health care that
are provided by a health care provider who, by casualty decision of the
competent entity for consideration of the application for prior authorization, may raise
serious and specific concerns about the quality or safety of care.
3-The health care referred to in paragraph 1 shall be defined by the holder of the member of the
Government responsible for the area of health, to which it is communicated to the European Commission in the
maximum term of 30 days from its entry into force, as well as any
change to the same.
CHAIR OF THE COUNCIL OF MINISTERS
20
4-A lack of submission of the application for prior authorization for the provision of the care of
cross-border health referred to in the preceding paragraphs or the rejection of the application for
authorization, pursuant to this Law, determines that the refund is not due by the
Portuguese State.
Article 12.
Application for the application for prior authorization
1-The application for prior authorization depends on an application to be submitted through the portal
of the utent, together with the hospital unit of the residence area of the beneficiary or of the
competent unit of each Autonomous Region.
2-Of the application for the application for prior permission shall appear, in particular, the
name of the beneficiary, the citizen identification number, the number of utente, the
number of tax identification, the number of social security identification, the
tax residence, age and sex, the State-member of treatment and the respect unit
presas, as well as, clinical information with the indication of the need for
realization of the provision of health care.
3-The models of the application for the application for prior authorization are approved by the
ACSS, I.P., and by the competent departments of the Autonomous Regions, and are subject to
opinion of the National Data Protection Commission, pursuant to the law.
Article 13.
Assessment of the clinical condition of the beneficiary
1-A The constant clinical information of the application for the application for prior permission is
subject to a hospital clinical assessment of the need for diagnosis or treatment
and of surgical suitability, to be carried out within 20 working days from the date of
formulation of the application for prior authorization, taking into account situations
proven of greater clinical urgency.
CHAIR OF THE COUNCIL OF MINISTERS
21
2-From the clinical assessment referred to in the preceding paragraph shall appear on the proposal of dewound
or improper of the application for prior authorization.
Article 14.
Prior authorization process
1-The application for the application for prior authorization and the respect report of the assessment
clinica are remitted by the hospital unit that issued the report, to the ACSS, I.P., or to the
competent services of the Autonomous Regions, for consideration.
2-A ACSS, I.P., or the competent departments of the Autonomous Regions issue reply to the
application for prior authorization within 15 working days of the receiving of the report
of the clinical assessment, unless the clinical condition of the patient requires response within a time limit
shorter.
3-The application for prior authorization shall be dismissed, in the following cases:
a) If the clinical assessment indicates, with a reasonable degree of certainty, that the patient is
exposed to a safety hazard that cannot be considered acceptable, having
into account the potential benefit for the patient of health care
cross-border intended;
b) If there is a reasonable degree of certainty in order to conclude that the population is exposed to
a considerable security risk in health care outcomes
cross-border intended;
c) If the health care in question is provided by a care provider
of health that raises serious and specific concerns as to respect for the
standards and guidelines on the quality of health care and
safety of patients;
CHAIR OF THE COUNCIL OF MINISTERS
22
d) If the health care in question can be provided in Portugal within a time limit
Reasoned useful from the clinical point of view, taking into account the state of health and the
probable evolution of the disease of the patient.
4-In case of doubt, from the clinical point of view, the ACSS, I.P., or the relevant departments
Autonomous Regions may request the opinion of the DGS, which shall be issued in the
term of five working days.
5-A ACSS, I.P., and DGS ensure that access to the clinical information of the patient is
limited to health professionals subject to secrecy, under the law.
6-A ACSS, I.P., or the competent services of the Autonomous Regions inform the patient
when your situation meets the conditions of application of the Regulations (EC)
n 883/2004, of the European Parliament and of the Council of April 29, 2004, and
n 987/2009, of the European Parliament and of the Council of September 16, 2009, at para.
the coordination matter of social security systems in the European Union.
Article 15.
Recognition of medical prescriptions issued in another member state
1-Medical prescriptions issued in a member state of the European Union are recognized
in Portugal, under the current legislation, should the medicinal product have permission
or registration of introduction on the market pursuant to the Decree-Law No. 176/2006, 30 of
august, and the recipe includes the following elements:
a) In the identification of the patient, the full name, written by extensive and without
abbreviations, and the date of birth;
b) In the authentication of the recipe, the date of issue and the digital signature or manuscript,
depending on whether it deals with electronic or manual revenue;
CHAIR OF THE COUNCIL OF MINISTERS
23
c) In the identification of the health professional responsible for the prescription, the name
complete, written by extensive and without abbreviations, the professional qualifications, the
elements for direct contact, specifically, the electro address, the number
by telephone or fax, with indication of the international indicative and the address
professional, including the name of the Member State;
d) In the identification of the prescribed medicinal product, where applicable:
i) Common denomination, defined in Article 1 of the Directive No 2001 /83/CE,
of the European Parliament and of the Council of November 6, 2001, which
establishes a community code regarding medicinal products for use
human;
ii) The trade mark, if the product prescribed is a biological medicinal product,
as defined in paragraph 3.2.1.1 of the point b ) of Annex I (Part I) of the
Directive No 2001 /83/CE, of the European Parliament and of the Council, of 6 of
november 2001, the health professional responsible for prescribing the
consider necessary from the medical point of view, owing in this case to be
indicated in the recipe, briefly, the reasons justifying the use of the
trade mark;
e) The pharmaceutical form;
f) The quantity;
g) The dosage;
h) The posology.
2-Medical prescriptions prescribed in Portugal, which the patient intends to be
dispensed in another Member State, include the following elements:
a) In the identification of the patient, the full name, written by extensive and without
abbreviations, and the date of birth;
CHAIR OF THE COUNCIL OF MINISTERS
24
b) In the authentication of the recipe, the date of issue and the digital signature or manuscript,
depending on whether it deals with electronic or manual revenue;
c) In the identification of the health professional responsible for the prescription, the name
complete, written by extensive and without abbreviations, the professional qualifications, the
elements for direct contact, specifically, the electro address, the number
by telephone or fax, with indication of the international indicative and the address
professional, including the name of the Member State;
d) The prescription of the medicinal product obeys the requirements set out in the
articles 120 and 120-A of the Decree-Law No. 176/2006 of August 30, and respect
regulation.
3-The provisions of paragraph 1 shall not apply to medicinal products for which a
special medical prescription, under the terms of the ( b ) of Article 113 (2) and in Article 117.
of Decree-Law No. 176/2006 of August 30.
4-Medical prescriptions of medical devices issued in a Member State of the Union
European are recognized in Portugal under the current legislation, if the
medical device find itself legally placed on the national market, and the recipe
include:
a) Compulsorily, the elements set out in the points a ) a c ) and f ) of paragraph 1;
b) Other elements to be defined by dispatch of the member of the Government responsible
by the area of health.
5-The pharmacist may refuse the dispensation of medical prescriptions issued in a State-
member of the European Union who suss out legitimate and justified doubts about his
authenticity, content or intelligibility, as well as those that the legislation in force
allows them to be refused on ethical grounds.
CHAIR OF THE COUNCIL OF MINISTERS
25
Article 16.
National reference centres
1-For the purposes of applying this Act, it is incumbent on the Ministry of Health, to identify,
approve and officially recognize national reference centres, specifically for
diagnosis and treatment of rare diseases.
2-The Ministry of Health promotes the participation and integration of reference centers
national who voluntarily wish to integrate the European Reference Networks.
Article 17.
Cooperation on online health
1-A national authority responsible for cooperation on online health for
effects of this Law is defined by dispatch of the member of the Government responsible
by the area of health, from among the services, bodies and entities of the Ministry of Health.
2-A The national authority participates in the European network of responsible national authorities
by cooperation on online health, whose standards of creation, management and
operating are set out in the Commission Implementing Decision, 22
of December 2011, which sets the standards for the creation, management and the
operation of the network of national authorities responsible for online health.
Article 18.
Cooperation in the assessment of health technologies
1-A national authority responsible for the assessment of health technologies is defined by
dispatch of the member of the Government responsible for the area of health, from among the services,
bodies and entities of the Ministry of Health.
CHAIR OF THE COUNCIL OF MINISTERS
26
2-A competent authority participates in the European network of national authorities
responsible for the assessment of health technologies whose standards of creation, management and
operating are set out in the Commission Implementing Decision, of
June 26, 2013, which sets the standards for the creation, management and the
transparent operation of the network of national authorities or bodies
responsible for the evaluation of health technologies.
Article 19.
Reports
The ACSS, I.P., and the DGS present to the member of the Government responsible for the area of
Health, and the competent services of the Autonomous Regions present to the members of the
Governments of the Autonomous Regions responsible for the area of health, annual reports of
monitoring of the application of this Law, for the purpose of disclosure during the first
semester of the following year to which they respect.
Article 20.
Autonomous Regions
The provisions of this Law shall apply to the Autonomous Regions of Madeira and the Azores, with
the necessary adaptations.
Article 21.
Regulation
The regulation provided for in this Act is approved within 30 days of its
entry into force.
CHAIR OF THE COUNCIL OF MINISTERS
27
Article 22.
Entry into force
This Law shall come into force on the 1's working day of the month following that of its publication.
Seen and approved in Council of Ministers of January 30, 2013
The Prime Minister
The Minister of the Presidency and Parliamentary Affairs
