NEWSLETTER I HEALTH LAW
CONTENTS HEALTH LAW NEWSLETTER I OCTOBER, 2017 I NEW REGULATION OF EARLY ACCESS PROGRAM II NATIONAL LEGISLATION
HEALTH LAW NEWSLETTER
I NEW REGULATION OF EARLY ACCESS PROGRAM
Following the publication of Decree-Law 115/2017 ("Decree"), which made the first amendment to the National Health Technology Assessment System (SINATS), approved by Decree-Law 97/2015, of 1 of July, we highlighted as a great novelty the change to the Exceptional Use Authorization scheme ("EAU").
With the amendments introduced by that Decree (which final aim was to supply the medicinal products free of charge), it was established that requests for EAUs for National Health System Hospitals regarding medicinal products that already have a marketing authorization (MA) and are in the process of prior evaluation will have to be carried out under an Early Access Program (EAP) to Medicinal Products and under the terms established in the respective Regulation (Program for Early Access to Medicinal Products, approved by Deliberation 139/CD/2014, of November 6 of Infarmed).
As expected and in the light of the changes implemented, it was approved a new Regulation on Early Access Program of Medicinal Products, through Resolution 80/CD/2017 of 24 October, which published a new version of the Regulation.
The main aspects of the new Regulation are the following:
Scope of Application
Establishes the procedures and conditions of Early Access Program for medicinal products without marketing authorization in Portugal and to medicinal products with marketing authorization in Portugal without prior evaluation procedure in the NHS or for which that evaluation was not requested.
Medicinal Products Free of Charge
The new Regulation prescribes that medicinal products authorized under an EAP's are, as a rule, supplied free of charges to the hospital by the holder of the MA. It should be noted that, to date, this gratuity of the medicinal products was only demanded for medicinal products without a MA. On the other hand, when an application for an EAP was submitted for a medicinal product with a MA without the prior evaluation procedure completed, the holder of the MA was able to charge for the medicinal product.
Based on the deadlines set out in Order 195-A / 2015, of June 30, for the prior evaluation procedure, the new Regulation sets forth that the period of exemption of charges for the acquisition of the medicinal products with MA by the hospital may not exceed the maximum limit of 105 to 210 calendar days, depending on whether they concern to:
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non-generic medicinal products whose international non-proprietary name or therapeutic indication has already been co-participated or authorized for use in the institutions and services supervised by the member of the Government responsible for health, upon prior evaluation;
medicinal products whose international non-proprietary name or therapeutic indication is not yet co-participated or authorized for use in the institutions and services supervised by the member of the Government responsible for the health area, upon prior evaluation.
It should be noted that these deadlines automatically determine the end of the exemption of charges for the acquisition of the medicinal products by the hospital, regardless of the obligation to maintain the EAP until the conclusion of the prior evaluation procedure. Notwithstanding, the future conditions of acquisition and delivery shall be agreed by Infarmed and the applicants.
Deadlines for Approval
In this regard, the Regulation provides that Infarmed has a period of 5 days to approve the EAP or to request a clarification from the applicants. On the other hand, applicants must reply within 5 days, and Infarmed has a period of 5 days to proceed to the decision after the receipt of answers.
In the case of medicinal products with an MA without a prior evaluation procedure and, in case of proven urgency due to imminent risk of life, reasoned by hospital, the deadlines mentioned above are reduced to 24 hours.
In fact and if Infarmed ensures compliance with these deadlines, the purposes of the PAP, which emphasize the non-postponement of the treatment of a certain group of patients, will be safeguarded.
Entry Into Force
Finally, it should be noted that this Regulation takes effect on 6 November 2017. Nevertheless, to the PAPs authorized under the previous regulation, as well as to the medicinal products that, at the date of entry into force of the Decree, have already submitted a request for prior evaluation, the full version of the previous regulation of 2014 will be applied.
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II NATIONAL LEGISLATION
Dispatch 9015/2017 - D.R. 197/2017, Series II of 2017-10-12 Creation of a working group to study and propose measures for the installation in Portugal of a new health unit for the treatment of cancer patients using high energy particle technologies.
Dispatch 9063/2017 - D.R. 198/2017, Series II of 2017-10-13 Determines the extension of the pilot project, aimed at optimizing donation of donor organs in cardiocirculatory arrest, to the Hospital Centers of Lisbon Norte and Central Lisbon, and integrates this type of collection of organs in the Hospital Center of So Joo.
Healthcare Regulation Authority
Dispatch 9102/2017 - D.R. 200/2017, Series II of 2017-10-17 Appoints the members of the salary committee of the Health Regulatory Entity.
Dispatch 9214/2017 - D.R. 202/2017, Series II de 2017-10-19 Determines the extension, until 31 October 2018, of the term of validity of the contracts entered into under the legal regime of the conventions, Decree-Law 139/2013 of 9 October, and establishes a working group with the objective to examine said diploma.
Reimbursement of Medicinal Products
Order 321/2017 - D.R. 206/2017, Srie I de 2017-10-25 It provides that medicinal products intended for the treatment of patients with acromegaly may benefit from an exceptional co-payment scheme. Repeals Order 3837/2005, published on 22 February.
Dispatch 9396/2017 - D.R. 206/2017, Series II, 2017-10-25 Creates and determines the composition of a working group for the evaluation of the model for the application of the fees, in particular for complementary diagnostic and therapeutic means.
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Dispatch 9242/2017 - D.R. 203/2017, Series II of 2017-10-20 Creates the Francisco George Public Health Prize and approves its Regulation.
Dispatch 9553/2017 - D.R. 209/2017, Series II of 2017-10-30 Creates the Prize in Bioethics Joo Lobo Antunes and approves the respective Regulation.
National Health Service
Order 330/2017 - D.R 210/2017, Series I of 2017-10-31 It defines the model of the internal regulation of the services or functional units of the Health Units of the National Health Service, in the nature of public business entities, with legal personality, administrative, financial and patrimonial autonomy. Integrated Responsibility.
Dispatch 9397/2017 - D.R. 206/2017, Series II of 2017-10-25 Determines that the use of a biometric registration system as a form of monitoring the assiduity of workers, regardless of the system of attachment, is mandatory in all services and establishments of the National Health Service.
Dispatch 9496/2017 - D.R. 208/2017, Series II of 2017-10-27 Determines and establishes provisions for the implementation of emergency response in the area of patients burned to 2020.
Director-General of Health
Dispatch 9688/2017 - D.R. 214/2017, Series II of 2017-11-07 Appoints, on a substitution basis, the licensee Maria da Graa Gregrio de Freitas, for the position of Director General of Health.
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