NEWSLETTER I HEALTH LAW
CONTENTS HEALTH LAW NEWSLETTER I JULY, 2017 I CREATION AND IMPLEMENTATION OF THE NATIONAL CANCER REGISTRY II REGULATION OF SURROGACY: "WOMBS FOR HIRE" III NATIONAL LEGISLATION
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HEALTH LAW NEWSLETTER
I CREATION AND IMPLEMENTATION OF THE NATIONAL CANCER REGISTRY
On the last 14th of July, it was published the Law no. 53/2017, which created the National Cancer Registry ("RON"), a system whose implementation and entry into force shall be suspended until the first day of next year, January 1, 2018.
This initiative, which has been under the attention of the legislative bodies for more than a year, was subject to an extensive debate until the decision to implement it. At the heart of the discussion was the risk, raised by the National Data Protection Commission (CNPD), regarding discriminatory and privacy-invading impacts on users whose personal data should be collected and processed by the RON system.
Despite the negative opinion issued by the CNPD during the legislative process, the benefits of implementing the RON system for the National Health Service (NHS) and the treatment of cancer disease were considered to be prevailing, leading to the approval of this law.
The main objective of the RON system is to centralize and register on a single platform all the information regarding cancer patients diagnosed and/or treated in Portugal by all public, social and private health establishments and services, regardless their legal nature.
In this regard, all existing information will be centralized and processed by the Regional Cancer Registries, which will be terminated once RON system has been created.
The centralization of national information, covering Portugal, Azores and Madeira Islands, will be processed by the Regional Cancer Registry of the South ("ROR-Sul"), which currently only comprises public health institutions located in Lisbon and Vale do Tejo, Alentejo, Algarve and the Autonomous Region of Madeira.
Moreover, private entities that have not yet implemented a cancer registration practice in their services shall submit an application for authorization to SPMS - Shared Services of the Ministry of Health for access to the Health Informatics Network "RIS", which will in turn create the computerized mechanisms for access of the requesting health institution to the RON system.
The entity responsible for the administration of RON will be the board of directors of Grupo Hospitalar Instituto Portugus de Oncologia Francisco Gentil (GHIPOFG), with the specific task of accompanying the process of implementing the RON system.
The two main objectives of the new law are essentially to ensure:
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(i) the monitoring of the activity carried out by all health institutions (public and private), as well as the effectiveness of the organized screenings and the therapeutics of the treatments used;
(ii) the monitoring of the effectiveness of the medicines and medical devices used in association with INFARMED - National Authority for Medication and Health Products, I.P.,
In addition, monitoring and control through quality testing of data entered into RON will be assigned to a committee composed by the following actors: Director of the National Cancer Program, coordinator appointed by GHIPOFG, a representative of each regional health administration, one representative of each of the regional health services of the autonomous regions and one representative of the Portuguese Medical Association.
II REGULATION OF SURROGACY: "WOMBS FOR HIRE"
As of August 1, 2017, it became possible to initiate, alongside the Portuguese National Council for Medically Assisted Procreation ("CNPMA"), a process of surrogacy, a medically assisted procreation technique more commonly known as "wombs for hire".
This method of medically assisted procreation was already provided for in Law 25/2016, of August 22, nonetheless, the implementation and approval of the necessary administrative mechanisms so that Portuguese citizens could have access to it was still lacking.
In this sense, the Regulatory Decree no. 6/2017, published in the Portuguese Official Gazette on July 31, 2017, complemented the legal document that provided for the mechanism of surrogacy, defining the following:
Prior authorization to conclude the surrogacy contract:
The surrogacy relationship must be preceded of an application for authorization issued by the beneficiary couple and the surrogate mother to the CNPMA, through the form already approved and available on the website of this entity.
The request for prior authorization must be accompanied by the following documentation:
(i) Documents identifying the applicants; (ii) Declarations of acceptance by the applicants of the mandatory conditions provided
for in the standard surrogacy contract; (iii) Statement by a psychiatrist or psychologist favorable to the conclusion of the
surrogacy contract; (iv) Medical statement issued by the Center in which the surrogacy process will be
carried out to certify that the wife of the beneficiary couple is in any of the legally
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prescribed conditions (severity, injury or serious disease of the uterus , in such terms as to make pregnancy absolutely and definitively impossible); (v) Declaration of acceptance issued by the Director of the Center in which it is intended to carry out the surrogacy process
It was through this form that the first request to conclude the surrogacy contract was submitted to the CNPMA on the last August 7.
Standard contract of surrogacy:
The standard contract of surrogacy has not yet been approved and published by the CNPMA and its elaboration process is still in progress.
However, the Regulatory Decree already develops the main aspects to be regulated in the agreement between the beneficiary couple and surrogate mother, being the autonomy of the CNPMA in this matter very limited to the regulatory parameters already in force.
As elements to be included in the standard contract, we highlight the following:
(iii) (iv) (v) (vi) (vii)
List of the obligations of the surrogate mother, with respect to compliance with all medical guidelines of the obstetrician who follows her pregnancy; List of the surrogate mother rights, such as the right to psychological counseling (before and after childbirth), the right to choose the obstetrician, the type of birth and the place where it will take place, the possibility of refusing certain types of examinations, or the possibility of traveling under certain conditions and until the third trimester of gestation; Providing information to applicants on the meaning and consequences of the influence of the surrogate mother lifestyle on embryo and fetal development; The terms of revocation of the consent or contract and its consequences; The provisions to be observed in the eventual voluntary termination of pregnancy, as well as the provisions to be observed for any intercurrences of health occurring during pregnancy, either at the fetal level or at the level of the surrogate mother The possibility of termination of the contract by either party in the event of a number of failed attempts at pregnancy and in what terms such termination may occur; The gratuitousness of the legal transaction and the absence of any type of imposition, payment or donation by the beneficiary couple in favor of the surrogate mother.
In addition, the way in which these elements will be realized and reflected in the standard contract still has to be specified
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In fact, the majority of the issues identified by the Portuguese National Council of Ethics for the Life Sciences ("CNECV"), in the scope of the opinion issued in January this year, do not appear to have been densified by the regulatory decree. What are the consequences of revoking consent for the child and the other parties involved? What kind of health intercurrences should they reveal for the purpose of voluntary termination of pregnancy? Moreover, in case of disagreement between the parties, what are the decision parameters to be observed? These are just some of the many issues raised by the sensitivity and ethical nature of the subject.
It is now a matter of waiting for the approval and publication of the standard contract by the CNPMA, a process that should be completed soon, since the requests for authorization for access to surrogacy are already being accepted.
III NATIONAL LEGISLATION
Law no. 53/2017 D.R. 135/2017, Series I of 2017-07-14
Creates and regulates the National Cancer Registry.
Order no. 212/2017 D.R. 138/2017, Series I of 2017-07-19
Regulates the criteria and the conditions for the granting of institutional incentives to the family health units (FHU) models A and B and to the personalized health care units and financial incentives to the professionals that integrate the FHU model B.
Council of Ministers of 20 July 2017
The Council of Ministers approved two decrees-laws for the establishment of the legal regime of the pharmaceutical career in Public Administration, the requirements of professional qualification for integration in that career, as well as the pharmaceutical career regime in public business entities and in health partnerships, which operate under private management and financing, integrated in the National Health Service.
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Decree-Law no. 86/2017 D.R. no. 144/2017, Series I of 2017-07-27 Amends the standards and specifications of the quality system for blood services by transposing the Directive (EU) no. 2016/1214.
Hospital Referral Network
Dispatch no. 6542/2017 D.R. no. 145/2017, Series II of 2017-07-28 Establishes the provisions on the hospital referral network of the National Health Service in the context of human immunodeficiency virus (HIV) infection and viral hepatitis, for the prison population.
Dispatch no. 6669/2017 D.R. no. 148/2017, Series II of 2017-08-02 Determines the Reference Centres, officially recognized by the Ministry of Health, for the areas of cystic fibrosis, interventional neuroradiology, cerebrovascular disease, coagulopathies, cochlear implants and ECMO - extracorporeal membrane oxygenation.
Regulatory Decree no. 6/2017 D.R. no. 146/2017, Series I of 2017-07-31 Regulates the access to surrogacy.
Surgical treatment in minors
Dispatch no. 6668/2017 D.R. no. 148/2017, Series II of 2017-08-02 Establishes the provisions on the right to accompany the child under the age of 18 years in a surgical intervention, also applicable to persons with disabilities or dependent persons, at the time of induction of anesthesia and during surgical recovery
National Vaccination Program
Order no. 248/2017 D.R. no. 150/2017, Series I of 2017-08-04 Establishes the governance model for the national vaccination program as well as other vaccine strategies for the protection of public health and groups at risk or under special circumstances.
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