NEWSLETTER I HEALTH LAW

CONTENTS HEALTH LAW NEWSLETTER I APRIL, 2017 I PORTUGAL APPLICATION TO HOST THE HEADQUARTERS OF THE EUROPEAN MEDICINES AGENCY II THE MANDATORY VACCINATION IN PORTUGAL III NATIONAL LEGISLATION IV EU LEGISLATION V CASE LAW

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HEALTH LAW NEWSLETTER

I PORTUGAL APPLICATION TO HOST THE HEADQUARTERS OF THE EUROPEAN MEDICINES AGENCY

Following several news already envisaged in the media, Portugal's application to host the European Medicines Agency (EMA), in Lisbon, was formally approved by the Council of Ministers on 27 April.

EMA is currently based in London. However, the departure of the United Kingdom from the European Union has led to the relocation of the European agencies based in London, including EMA.

EMA is responsible for the scientific evaluation, supervision and monitoring of the safety of medicinal products developed by pharmaceutical companies and whose use is intended for the European Union. The EMA is managed by an independent Board of Directors. Its day-to-day operations are carried out by EMA workforce, who number about 900 people.

As in other countries, the objective of Portugal to host the agency determines the creation of a National Candidacy Committee (CCN). This will be the institutional support for the organization and promotion of the application, through the establishment of guidelines, definition of strategy, planning and determination of means and actions to be developed. The CCN will also ensure an efficient transition of the Agency to Lisbon so that there are no negative impacts on the Agency's activity, which is essential to European public health.

According to the statement of the Council of Ministers that approved the candidacy of Portugal, the main arguments of our candidacy will be the geographical location, accessibility, including air accessibility, and hotel capacity installed in Lisbon. It also refers to the technical and scientific capacities that Portugal has to host the EMA, with Infarmed, I.P., at a top position in the context of drug evaluation procedures and in the coordination of EMA committees and working groups.

The decision-making process for the new EMA headquarters will be taken by the European Council and the decision should be known by the end of 2017.

II THE MANDATORY VACCINATION IN PORTUGAL

The recent outbreak of measles in Portugal has relaunched the debate on mandatory vaccination in the country. In this regard, the balance between freedom of choice, the right to health and the responsibility to contribute to collective security is discussed.

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Currently, although there is a National Vaccination Program that includes 14 target diseases, the current vaccination regime is non-mandatory. However, there are two mandatory vaccines, namely diphtheria and tetanus vaccines. The obligation of these two vaccines is in force by Decree-Law No. 44,198, published in the Dirio da Repblica of February 20, 1962.

As mentioned in this legal document, in 1955, 206 deaths from diphtheria and 334 from tetanus were registered in Portugal. In 1960, these diseases continued to register 150 and 264 deaths, respectively. In view of the significant mortality they caused and the lack of vaccination, even though their free status had already been established, the Government decided to adopt this measure in order to "improve the health situation in relation to these two diseases", avoidable through Preventive treatment.

Thus, all subjects should receive anti-diphtheria and anti-tetanus vaccination between 3 and 6 months of age, as well as their respective booster doses for the first time between 18 and 24 months and the second between five and seven years. After this age, only those who carried out any of the activities considered at risk should continue to receive the tetanus vaccine every five years.

As a consequence of non-compliance with this legal requirement for diphtheria, no one under the age of 10 could attend or undertake any exam at an educational establishment. As for tetanus, this consequence was extended to any individual, regardless of age, and was also applicable to the exercise of public functions. Those who did not comply voluntarily would be summoned to appear at a place and time scheduled to proceed with the vaccination. Vaccination would be dispensed for individuals who presented a medical certificate proving contraindication or when this contraindication was verified by the medical-sanitary authority, until the moment it has ceased.

It should be noted that, regarding the admission in educational establishments, subject that assumes special relevance, the control carried out tends to treat all vaccines of the National Vaccination Program as non-mandatory. Thus, if there is a failure in the vaccination report, it is only alerted to the child's parents and to the health center of the respective zone, but there is no penalty or impediment to be admitted in an educational establishment.

More than the compliance with this law, it is currently discussed the need to contemplate a greater number of mandatory vaccines.

Time will show whether the current regime is adequate to ensure the right to protection of public health or whether it is unable to prevent the spread of epidemics. Public debate will certainly have an important role to play in this regard, with an apparent conflict between (i) a common good, which requires the need to vaccinate the population as a whole, (ii) an individual good, Which is reflected in the exercise of freedom of choice, especially of parents in relation to their children, and (iii) the problem of the responsibility of those who refuse to vaccinate, knowing that they are protected through the vaccination of others, but at the same time at risk, if the ultimate goal is, immunization.

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III NATIONAL LEGISLATION

Medicinal Products

Dispatch 2777-A/2017 D.R. No. 66/2017, 1st Supplement, Series II of 2017-0403 Appoints the National Coordinator of the National Strategy for Medicinal Products and Healthcare Products, Prof. Henrique Luz Rodrigues, as well as is Support Team, and determines in general their functions and competencies.

Order 141/2017 D.R. No. 76/2017, Series I of 2017-04-18 Determines that the medicinal products for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis and spondylarthritis may benefit from an exceptional regime of 100% reimbursement. Revokes the Dispatch No. 14123/2009.

Primary Health Care

Dispatch 3041/2017 D.R. No. 72/2017, Series II of 2017-04-11 Determines the constitution and composition of a National Technical Group of Clinical Governance and of Health in Primary Healthcare Services.

Parliamentary Resolution 71/2017 D.R. No. 80/2017, Series I of 2017-04-24 Recommends that the Government should acquire vehicles for the provision of home care within context of primary health care services.

Health Information

Dispatch 3156/2017 D.R. No. 74/2017, Series II of 2017-04-13 Establishes provisions and determines the principles of governance and management of the National Strategy for the Health Information Ecosystem' (ENESIS) 2020.

Dispatch 3454/2017 D.R. No. 80/2017, Series II of 2017-04-24 Determines the principal actions to be developed in the year 2017, within context of the National Program for Education in Health, Literacy and Self-Care, coordinated by the Health Ministry Strategic Support Centre (NAE), established by the Dispatch 5372/2016, of the Health Ministry, published in the D.R., 2nd Series, of 20 of April 2016.

Health Services

Decree-Law No. 44/2017 D.R. No. 78/2017, Series I of 2017-04-20 Amends the Integrated System of Access Management for patients of healthcare services.

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Parliamentary Resolution 68/2017 - D.R. No. 80/2017, Series I of 2017-04-24

Recommends that the Government continue the decentralization process in the field of health, education and culture through the conclusion of inter-administrative contracts.

Shared Services of the Ministry of Health

Dispatch 3350/2017 D.R. No. 78/2017, Series II of 2017-04-20

Determines that the Shared Services of the Health Ministry must ensure the execution of the acquisition of 24 "ambulance emergency response vehicles" (VMER), during the year 2017, for the entities envisaged on the Annex enclosed to this dispatch, which forms an integral part thereof.

Dispatch 3456/2017 D.R. No. 80/2017, Series II of 2017-04-24

Determines the creation of a transition team for each Regional Health Administration (ARS) for the purpose of transferring the function TIC of support of primary healthcare from the ARS tom the "SPMS Shared Services of the Health Ministry".

Dispatch 3837/2017 - D.R. No. 88/2017, Series II of 2017-05-08

Determines that the SPMS - Shared Services of the Ministry of Health publishes, through the Public Health Supply Catalog, all the characteristics of the products covered by public supply contracts, which establish the conditions for the supply of various medicinal products.

Dispatch 3838/2017 - D.R. No. 88/2017, Series II of 2017-05-08

Determines that the SPMS - Shared Services of the Ministry of Health publishes, through the Public Health Procurement Catalog, all the characteristics of the products covered by public supply contracts, which establish the conditions for the supply of Vaccines and Tuberculins Part II

Health National Service

Order 147/2017 - D.R. No. 82/2017, Series I of 2017-04-27

Regulates the Integrated System of Management of the Access of the users to the National Health Service (SIGA SNS).

Dispatch 3668-A/2017 - D.R. No. 83/2017, 1 Suplement, Series II of 2017-04-28

Determines that pre-schools, basic and secondary education establishments shall communicate students who do not meet the recommended vaccination updated in accordance with the National Vaccination Program.

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Order 153/2017 - D.R. No. 86/2017, Series I of 2017-05-04

Establishes the Maximum Response Time Guaranteed (MRTG) in the National Health Service for all types of non-emergency health care and approves and publishes the Charter of Rights of Access to Health Care by the NHS Users.

Conventions

Notice 3668-B/2017 - D.R. No. 83/2017, 1 Suplement, Series II of 2017-04-28

Determines that, for the purposes of the standard clauses of the convention for the provision of health care in the area of dialysis, the comprehensive prices of conventional hemodialysis, whether performed in an out-of-hospital center or in the patient's home, are, with effects reported to 1 Of January 2017, reduced by 3%. Suspends the validity of Dispatch no. 10569/2011.

Dispatch 3668-C/2017 - D.R. No. 83/2017, 1 Suplement, Series II of 2017-04-28

Determines the adoption of the procedure for adherence to a standard clause with a view to the conclusion of new national conventions in the area of Nuclear Medicine.

Dispatch 3668-D/2017 - D.R. No. 83/2017, 1 Suplement, Series II de 2017-04-28

In accordance with the New Legal Regime of Conventions, sets the price list to be paid under the new conventions to be celebrated in the area of Nuclear Medicine.

Dispatch 3668-E/2017 - D.R. No. 83/2017, 1 Suplement, Series II of 2017-04-28

Determines that, for the purposes of the standard clauses of the Convention for the provision of health care in the area of clinical analyzes, the prices charged by the contracting entities are, temporarily and with effects reported on January 1, 2017, subject to a discount of 3 % On the total value of each invoice issued, excluding VAT at the legal rate in force.

Dispatch 3668-F/2017 - D.R. No. 83/2017, 1 Suplement, Series II of 2017-04-28

Approves the standard clauses of the convention to be concluded for the provision of health care in the area of Nuclear Medicine.

Dispatch 3668-G/2017 - D.R. No. 83/2017, 1 Suplement, Series II of 2017-04-28

Determines that for the purposes of the convention for the provision of health care in the radiology area, the prices charged by the contracting entities in the categories of Computed Tomography, Ultrasound and Ultrasound are transiently reduced by 3%, with effects reported on January 1, 2017. Osteodensitometry.

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Dispatch 3668-H/2017 - D.R. No. 83/2017, 1 Suplement, Series II of 2017-04-28

Determines the adoption of the procedure of accession to a standard clause with a view to the conclusion of new conventions of national scope of Pathological Anatomy.

Dispatch 3668-I/2017 - D.R. No. 83/2017, 1 Suplement, Series II of 2017-04-28

In accordance with the New Legal Regime of the Conventions, sets the list of prices to be paid in accordance with the new conventions to be celebrated in the field of Pathological Anatomy.

Dispatch 3668-J/2017 - D.R. No. 83/2017, 1 Suplement, Series II of 2017-04-28

Approves the standard clauses of the convention to be celebrated for the provision of health care in the area of Pathological Anatomy.

IV EU LEGISLATION

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83 /EC, Regulation (EC) No. 178/2002 and Regulation (EC) ) No. 1223/2009 and repealing Council Directives 90/385 /EEC and 93/42 /EEC

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, repealing Directive 98/79 /EC and Commission Decision 2010/227/EU.

V CASE LAW

Judgment of the Court of Justice of the European Union of 4-05-2017 Case C-339/15- Vanderborght

In this Judgment, the Court of Justice of the European Union stated that, a general and absolute prohibition of any advertising for the provision of oral and dental care services is incompatible with EU law

Mr Vanderborght, a dentist established in Belgium, advertised his dental care services. Between 2003 and 2004, he installed a sign consisting of three printed faces, stating his name, his designation as a dentist, the address of his website and the telephone number of his practice. In addition, he created a website in order to inform patients of the various types of treatment which he provides at his practice. Finally, he also placed some advertisements in local newspapers.

Following a complaint from the Verbond der Vlaamse tandartsen, a dentists' professional association, criminal proceedings were brought against Mr Vanderborght. Belgian law prohibits

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in absolute terms any advertising relating the provision of oral and dental care services and establishes requirements of discretion with regard to signs of dental practices intended for the public.

In his defence, Mr Vanderborght maintains that the Belgian rules in question are contrary to EU law, in particular, the Directive on electronic commerce and the freedom to provide services laid down in the TFEU. The court hearing the matter, the Nederlandstalige rechtbank van eerste aanleg te Brussel, strafzaken (Dutch-language Court of First Instance, Criminal Section, Brussels) decided to refer the matter to the Court of Justice.

In that regard, the Court identified that a prohibition of advertising for a certain activity is liable to restrict the possibility, for the persons carrying on that activity, of making themselves known to their potential clientele and of promoting the services which they propose to offer to that clientele.

The Court considers that, although the content and form of the commercial communications may legitimately be subject to professional rules, such rules cannot include a general and absolute prohibition of any type of online advertising aimed at promoting the activity of a dentist.

The Court accepts that the objectives of the legislation in question, that is to say, the protection and dignity of the profession of dentistry, are overriding reasons in the public interest capable of justifying a restriction on the freedom to provide services. The extensive use of advertising or the selection of aggressive promotional messages, even such as to mislead patients as to the care being offered, by damaging the image of the profession of dentistry, by distorting the relationship between dentists and their patients, and by promoting the provision of inappropriate and unnecessary care, may undermine the protection of health and compromise the dignity of the profession of dentistry.

In those circumstances, the Court considers that imposing a general and absolute prohibition of any advertising exceeds what is necessary to attain the objectives pursued. Those objectives may be attained through the use of less restrictive measures supervising, closely if necessary, the form and manner which the communication tools used by dentists may legitimately have.

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