I  THE CONFLICT RESOLUTION OF THE PORTUGUESE HEALTH REGULATION AUTHORITY

Following the amendment of the Portuguese Health Regulation Authority’s (“ERS”) by-laws in 2014, through the Decree -Law 126/2014, of August 22, ERS is able to act as a mediator on mediation and conciliation proc edures regarding the conflict of NHS establishments, between them and private and social providers, under concession agreements, public -private partnership agreement or similar contractual relations in the health sector, and also betw een health care providers and users. Until now, ERS could only act as mediator in the conflicts between health care providers.

As a result of that amendment, Regulation 628/2015, from Portuguese Health Regulation Authority, was published on September 17. This Regulation governs the conditions and the operation requirements of the conflict mediation and conciliation.

The Regulation starts defining the two procedures: mediation and conciliation. Both procedures are alternative means, from the courts, of co nflict resolution, where the parties, assisted by an independent third party, a mediator, try to reach an agreement that solves the conflict. The difference between the procedures is that on the conciliation, the mediator proposes solutions for the conflic t.

As mentioned, conciliation procedures cover the conflicts between the establishments of the NHS, providers of private and social sector, as well as conflicts between health care providers and users. However, conflicts regarding quality administrative issues and waiting time in the administrative service do not qualify as conflicts for this purpose .

The procedure begins with a joint request from the mediated addressed to ERS, or just by one of the mediated, and in this situation the other party should adhere to the request made. After a preliminary assessment of the application by ERS, and its acceptance, the four key stages of the procedure are: a session of pre -mediation, the mediation session, private session and the total agreement, partial or no agreement. The term of the procedure should not exceed 90 days. However, and if properly justified this deadline may be extended.

One of the advantages of adopting this procedure is that the agreement is enforceable. Indeed, provided that the agreement is executed or authenticated by a notary or lawyer, and provides the constitution or recognition of an obligation, and without requiring the approval of a court, it is enforceable. Also the fact that the procedure is free of charges, since the intervention of the ERS as a mediator entity is free, is named as another advantage.

Finally, just a note to highlight that, under the previous by-laws of ERS, this entity could act as a mediator only in mediation or conciliation of disputes between establishments of the NHS or between them and private and social establishments.

In this context, and according to information posted on ERS website w ere conducted 6 mediation proceedings, 5 of which resulted in agreement.

The introduction of this new mechanism for resolving disputes is clearly intended to reinforce  the safeguarding  of the  legitimate interests and  rights of users to protect health, and facilitated access to a defense mechanism of their rights which envisions be faster and carries no cost.

II  LEGISLATION

Health Care Professionals

Law 104/2015 - Official Gazette 164/2015, Series I of 08-24-2015

Creates the National Inventory of Health Care Professionals.

National Health Service ("NHS")

Order 246/2015 - Official Gazette 158/2015, Series I of 08-14-2015

Establishes the State reimbursement system in the price of spacer devices, intended to NHS members.

Order 289-B/2015 - Official Gazette 182/2015, Supplement 1, Series I of 09-17- 2015

First amendment to Order 311-D/2011 of 27 December, establishing the criteria to verify the economic condition of users for the purpose of exemption from user fees and other charges that depend the access to benefit from the NHS and Order 297-A/2012 of 28 September, approving the model Declaration 43 and respective filing instructions for use by agencies of the Ministry of Solidarity and Social Security, for communication the values paid by social benefits.

Order 10314-B/2015 - Official Gazette 181/2015, 3rd Supplement, Series II of 09- 16-2015

Determines the increase in cash, of the share capital of state-owned entities of the NHS.

Shared Services of the Ministry of Health ("SPMS")

Order 10296/2015 - Official Gazette 181/2015, Series II of 09-16-2015

Sets out the provisions, under SPMS, relating to public supply contracts that establish the conditions for the supply of syringes, needles and containers.

Order 10342/2015 - Official Gazette 182/2015, Series II of 09-17-2015

Sets out the provisions, under SPMS, relating to public supply contracts that establish the conditions for the supply of oral contraceptives, prophylactic and mechanics.

Order 10343/2015 - Official Gazette 182/2015, Series II of 09-17-2015

Sets out the provisions, under SPMS, relating to public supply contracts that establish the conditions of supply of hormones and other medicinal products used in the treatment of endocrine disorders.

Nurses Association

Law 156/2015 - Official Gazette 181/2015, Series I of 09-16-2015

Second amendment to the By-laws of the Nurses Association, conforming it with Law 2/2013 of 10 January, establishing the legal framework for the creation, organization and operation of professional public associations.

National Network of Continuing Care

Order 289-A/2015 - Official Gazette 182/2015, Supplement 1, Series I of 09-17- 2015

First amendment to Decree 174/2014 of 10 September, which defines the installation and operating conditions to be met by the inpatient units and outpatient and operating conditions of the high management teams and teams integrated continuous care of the National Network of Integrated Continuous Care, and third amendment to Order 1087-A/2007 of September 5, fixing the prices of health care and social support provided in inpatient units and ambulatory National Network of Integrated Continuous Care, provided for in article 12 of Decree-Law 101/2006 of 6 June and the general conditions for hiring within the RNCCI.

Donors

Decree-Law 168/2015 - Official Gazette 163/2015, Series I of 08-21-2015

Establishes  the  live  organ  donor  protection  legal  framework  in  relation  to  possible complications of the donation and procurement process.

Decree-Law 185/2015 - Official Gazette 171/2015, Series I of 02-09-2015

Transposing Directive 2014/110/EU of the Commission of 17 December 2014 amending Directive 2004/33/EC, of the Commission, on 22 March, with regard to the criteria of temporary suspension of blood donors in respect of allogeneic donations, and proceeds to the second amendment to Decree-Law 267/2007 of 24 July.

Ionizing Radiation

Decree-Law 184/2015 - Official Gazette 169/2015, Series I of 08-31-2015

Proceeds to the second amendment to Decree-Law 167/2002 of 18 July, which approved the licensing of the legal system and the functioning of the entities to provide services in the field of protection against ionizing radiation, updating licensing procedures and the technical requirements to be met by entities and setting new rules for the distribution of fees in the context of licensing.

Central Administration of the Health System (ACSS)

Decree-Law 206/2015 - Official Gazette 186/2015, Series I of 09-23-2015

Proceeds to the second amendment to Decree-Law 35/2012 of 15 February, approving the organizational structure of the Central Administration of the Health System, IP, redefining their respective assignments.

Infarmed

Order 306/2015 - Official Gazette 186/2015, Series I of 09-23-2015

First amendment to INFARMED’s by-laws, approved in annex to Decree 267/2012 of 31 August.

Palliative care

Order 340/2015 - Official Gazette 197/2015, Series I of 08-10-2015

Regulates under the National Network of Palliative Care, the characterization of services and admission to local teams and conditions and construction requirements and safety of palliative care facilities.

III  NATIONAL CASE LAW

Constitutional Court decison of July 7, 2015, Case Number 763/13

The decision at stake concerns the constitutionality of arts. 2 and 3 of Law 62/2011, of 12 December, when interpreted as meaning that the owner of industrial property rights can only resort to mandatory arbitration, resigning definitely the direct appeal to the Judicial Court, even referring to an injunction, and also when interpreted as meaning that the holder of the industrial property right can not sue the Marketing Authorization Holder (MA) or an application for an MA, beyond the term of thirty days of the publication by INFARMED, referred to in Article 9, paragraph 3 of Law 62/2011, of 12 December.

The Constitutional Court decides not to judge unconstitutional the normative dimension of art. 2, according to which the holder of the right can only resort to mandatory arbitration, by waiving to the access to Judicial Court with regard to interim measures.

The Constitutional Court decides, however, to find unconstitutional the normative dimension of art. 3, paragraph 1, when read in conjunction with art. 2, with the meaning mentioned above. The unconstitutionality decision is based essentially on the fact that 30 days is insufficient due to the limited information and the complexity of the subject, consolidating a special burden imposed on the holder of the patent right.