NEWSLETTER I HEALTH LAW
CONTENTS HEALTH LAW NEWSLETTER I AUGUST, 2017 I SINATS: NEW LEGAL REGIME II NEW RULES APPLICABLE TO THE ACTIVITY OF CRYOPRESERVATION OF STEM CELLS III INFARMED: SAFETY DEVICES IN MEDICINES IV NATIONAL LEGISLATION
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HEALTH LAW NEWSLETTER
I SINATS: NEW LEGAL REGIME
On the last 7th September, was published on the Official Portuguese Gazette the Decree Law no. 115/2017, which amends the legal regime applicable to the the National System of Health Technology Assessment ("SINAT) i.e. the system that evaluates medicinal products and medical devices to decide whether they can be used in the National Health Service ("SNS"), as well as the possibility of being reimbursed by t he State.
The new legal diploma establishes several changes to the legal regime of SINATS as approved by Decree-Law 97/2015.
The main legislative novelties implemented by Decree-Law 115/2017, in effect since 8th September, are the following:
Homogeneous Groups and Financing of biosimilar medicinal products:
The new legal diploma distinguishes two different groups:
the homogeneous group of generic medicines; the homogeneous group of biosimilars.
This distinction aims to create the possibility of establishing a system for biosimilar medicinal products based on a Reference Price System ("SPR") for biological and biosimilars (i.e. reference medicinal products for biological) which are included in the same homogeneous group of medicinal products.
Under the rules governing the financing of biosimilar medicinal products, the legislator states that whenever a similar biological medicinal product has a market share of the active substance of 5% or more, it may be financed by the State, provided that its price is equal or less than 70% of the price of the reference biological medicinal product.
Change of the AUEs scheme for use in NHS establishments:
In order to discipline applications for Exceptional Use Authorization ("AUE"), in particular regarding its use in National Health System ("NHS") establishments, the new legal diploma establishes that from the date of the granting of a marketing authorization ("MA") and during the period legally provided for the prior evaluation procedure, the granting of the medicinal products subject to the exceptional authorization of use must be carried out under the Early Access Program (PAP), under the terms of the Regulation approved by the board of Directors of INFARMED, IP.
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As provided for under PAP Regulation, this program is specific to the provision of AUEs free of charge, which depend on the request of the pharmaceutical company.
In truth, the current wording of the PAP Regulation only imposes non-chargeable requests for AUEs submitted without MA, leaving the applicant company the choice between free/onerous supplies whenever the AUEs application is submitted without the prior evaluation is concluded, but when there already exists a MA for the medicinal product. However, it is true that the aim of the legislature, when it concerns the amendment of the Regulation, is to extend free of charge to both cases. However, it is certain that the aim of the new legislative measure, when it refers to the amendment of the Regulation, is to impose non-chargeable regime for both cases.
This measure has seriously constrained the appeal by NHS hospital entities to the AUE's system, as far as it imposes the simultaneous association with a PAP program.
II NEW RULES APPLICABLE TO THE ACTIVITY OF CRYOPRESERVATION OF STEM CELLS
On the last 25th August, was published on the Official Portuguese Gazette the Law no. 99/2017, which changed the legal regime applicable to the donation, collection, analysis, processing, preservation, storage, distribution and application of tissues and cells of human origin, as approved by Law no. 12/2009, of 26 March.
The legislative amendment is the result of the effort to transpose the Directives 2015/565/EU and 2015/566/EU, which aimed to implement the following initiatives to modernize the legal framework applicable to the activity of cryopreservation of stem cells:
European Coding System Directive 2015/565/EU
This legal document resulted from the effort to transpose Directive no. 2015/565/EU, in the part relating to the "European Coding System".
The aim of the Community legislature with the adoption of this Directive was to ensure the traceability of tissues and cells of human origin at an European level, by means of a coding system across all Member States.
Thereby, a unique identifier for tissues and cells distributed throughout the European Union, including those imported from third countries, is created - the Single European Code ("CUE").
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The new Law no. 99/2017 develops and explains all types of requirements and elements that must be included in the CUE, imposing on the universe of Portuguese companies related to the cryopreservation of stem cellss activity the obligation to adopt the European Coding System.
However, the new law establishes that tissues and cells stored at the time of its entry into force, i.e. 24th September, may be exempted from the obligations relating to the CUE, provided that they are put into circulation within a maximum of five years as from that date, and that it is ensured a full traceability through alternative means.
Importation of tissues and stem cells - Directive 2015/565/EU
The Directive 2015/566/EU, also transposed by this new legal diploma, has imposed the compliance with additional rules regarding the import of European tissues and cells.
The new law does not change the substance of the authorization procedure as established in the previous regime, clarifying only the competence of IPST, I.P. in this matter.
In this matter, we highlight the following novelties:
Obligation of the importing banks to notify IPST of any substantial changes that may occur in the context of import activities;
Obligation to enter into written contracts between importing banks and suppliers from third countries, whenever the activities related to the treatment of cells or tissues are carried out outside the European Union;
Guarantee of inspections every two years by IPST, in coordination with the DGS;
III INFARMED: SAFETY DEVICES IN MEDICINES
Among many of the measures approved by Directive no. 2011/62/EU ("Fake Medicines Directive") is the obligation of Community pharmaceutical companies to place on the packaging of certain types of medicinal products the so-called "safety devices" in order to allow the detection of counterfeit medicines in the legal circuit of the medicinal product s.
The Counterfeit Medicines Directive was subsequently supplemented by EU Delegated Regulation 2016/161 of 2th October, which is responsible for clarifying and implementing many of the measures necessary for the proper implementation of the obligation to implement "safety devices".
In this regard, in harmony with the scope of the Regulation, and aiming to anticipate some issues of pharmaceutical companies in view of this new obligation, INFARMED issued Circular 1/September/CD/100.20.200.
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This Informative Circular has defined some still open questions, such as: (i) what type of medicinal products are covered by the obligation to adopt the safety devices; (ii) the characteristics and technical specifications of the unique identifier; (iii) what are the modalities of verification and deactivation of unique identifier and (iv) what are the characteristics of the system of repositories.
IV NATIONAL LEGISLATION
National System for the Evaluation of Health Technologies
Decree-Law no. 115/2017 - D.R. no. 173/2017, Series I de 2017-09-07 Changes the National System of Health Technology Assessment.
Cryopreservation of Stem Cell Samples
Law no. 99/2017 D.R. no. 164/2017, Series I of 2017-08-25 Amends Law no. 12/2009, of 26 March, which establishes the legal regime of quality and safety related to the donation, collection and analysis, processing, preservation, storage, distribution and application of tissues and cells of origin, transposing Commission Directives no. 2015/565/EU and 2015/566/EU of 8 April 2015.
Decree-Law no. 108/2017 - D.R. no. 167/2017, Series I of 2017-08-30 Establishes the pharmaceutical career regime in public business entities and in health partnerships, under private management and financing, integrated in the National Health Service ("NHS").
Decree-Law no. 109/2017 D.R. no. 167/2017, Series I of 2017-08-30 Defines the legal regime for the special pharmaceutical career, as well as the professional qualification requirements for integration.
Career of senior technicians in the areas of diagnosis and therapy
Decree-Law no. 110/2017 D.R. no. 168/2017, Series I of 2017-08-31 Defines the legal career regime applicable to senior technicians in the areas of diagnosis and therapy with an employment contract entered with public business entities and health partnerships, under a private management and financing system, integrated in the National Health Service.
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Decree-Law no. 111/2017 D.R. no. 168/2017, Series I of 2017-08-31 Establishes the regime of the special career of superior technician of the areas of diagnosis and therapeutics.
Dispatch no. 75392017 D.R. no. 164/2017, Series I of 2017-08-25 Creates a working group for the development of the care units in the Community.
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