Activities of Felix REDA related to 2018/0161(COD)
Plenary speeches (1)
Supplementary protection certificate for medicinal products (debate)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products PDF (350 KB) DOC (162 KB)
Amendments (18)
Amendment 32 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) The Council, in its conclusions on strengthening the balance in the pharmaceutical systems in the Union and its Member States1a, and the European Parliament in its Resolution 2016/2057(INI) on Access to medicines, have underlined the importance of timely availability of generics and biosimilars in order to increase competition, to reduce prices, to facilitate patients' access to pharmaceutical therapies and to improve the sustainability of national health systems; _________________ 1a Council conclusions adopted in June 2016: https://www.consilium.europa.eu/en/press /press-releases/2016/06/17/epsco- conclusions-balance-pharmaceutical- system.
Amendment 35 #
Proposal for a regulation
Recital 3 b (new)
Recital 3 b (new)
(3b) Supplementary Protection Certificates in the EU grant prolonged market exclusivity status upon the expiry of the patent term, the extension of exclusive rights beyond the patent terms, including Supplementary Protection Certificates, go beyond the mandatory requirements of the TRIPS agreement (‘TRIPS Plus’);
Amendment 36 #
Proposal for a regulation
Recital 3 c (new)
Recital 3 c (new)
(3c) None of the studies commissioned by the European Commission and by Member States on the SPC system in 2018 found evidence that without SPCs, pharmaceutical companies lacked adequate protection to recoup Research and Development investments. Whereas the lack of such data calls for a more thorough evaluation and debate about the relevance of the SPC system, beyond the scope of the SPC manufacturing waiver subject of the present Regulation;
Amendment 52 #
Proposal for a regulation
Recital 7
Recital 7
(7) The aim of this Regulation is to ensure that manufacturers established in the Union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired, as well as on the internal market from the day that the supplementary protection has expired. It is intended to complement the efforts of the Union’s trade policy to ensure open markets for Union-based manufacturers of medicinal products. Indirectly, it is also intended to put those manufacturers in a better position to enter the Union market immediately after expiry of the relevant supplementary protection certificate. It would also help to serve the aim of fostering access to medicines in the Union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate.
Amendment 67 #
Proposal for a regulation
Recital 8
Recital 8
(8) In those specific and limited circumstances, and in order to create a level playing field between Union-based manufacturers and third country manufacturers, it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries , entering markets in the Union immediately upon expiry of the supplementary protection certificate and any related acts strictly necessary for making or for the actual export itselfose purposes.
Amendment 77 #
Proposal for a regulation
Recital 9
Recital 9
(9) That exception should cover the making of the product, including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a Member State, for the exclusive purpose of export to third countries, as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker, where such acts would otherwise require the consent of the certificate-holder, and are strictly necessary for making for the purpose of export or for the actual export itself, storing, the preparation of market entry or for export. For instance, such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds, or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations.
Amendment 79 #
Proposal for a regulation
Recital 10
Recital 10
Amendment 92 #
Proposal for a regulation
Recital 11
Recital 11
(11) By limiting the scope of the exception to making for the purpose of export outside the Union and acts strictly necessary for such making or for the actual export itselfapplying strictly to acts necessary in order to allow the bringing to market of medicinal products in situations where no supplementary protection applies, the exception introduced by this Regulation will not unreasonably conflict with normal exploitation of the product in the Member State where the certificate is in force, nor unreasonably prejudice the legitimate interests of the certificate- holder, taking account of the legitimate interests of third parties.
Amendment 99 #
Proposal for a regulation
Recital 13
Recital 13
Amendment 113 #
Proposal for a regulation
Recital 14
Recital 14
Amendment 120 #
Amendment 139 #
Proposal for a regulation
Recital 20
Recital 20
(20) The Commission should carry out an evaluation of this Regulation. The merits of the present regulation deserve a thorough debate; the impact of the patent system, and of the SPC protection in particular, on generic competition, on healthcare budgets and on the access to medicines in Europe should be carefully assessed through a continuous evaluation of the SPC system. Given the paramount importance of access to and affordability of medicinal products for public health and public expenditure, a frequent evaluation cycle is justified. Pursuant to paragraph 22 of the Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making of 13 April 201643, that evaluation should be based on the five criteria of effectiveness, efficiency, relevance, coherence and added value and should provide the basis for impact assessments of possible further measures. The evaluation should take into account exports to outside the Union and the ability of generics and especially biosimilars to enter markets in the Union as soon as possible after a certificate lapses. In particular, this evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for generic and biosimilar firms in the Union and a swifter entry of generic and especially biosimilar medicines onto the market after a certificate lapses. It should also study the impact of the exception on research and production of innovative medicines by holders of certificates in the Union and consider the balance between the different interests at stake, including those of public health. _________________ 43 OJ L 123, 12.5.2016, p. 1. OJ L 123, 12.5.2016, p. 1.
Amendment 180 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point a – point i
Article 4 – paragraph 2 – point a – point i
(i) making for the exclusive purpose of export to third countries; or
Amendment 182 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point a – point i a (new)
Article 4 – paragraph 2 – point a – point i a (new)
(ia) making for the purpose of entering markets in the Union on Day-1 after the expiry of the supplementary protection certificate; or
Amendment 190 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point ii
Article 4 – paragraph 2 – point ii
(ii) any related act that is strictly necessary for that making or for the actual export itself, storing, the preparation of market entry in the Union or export;
Amendment 216 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 3
Article 4 – paragraph 3
Amendment 245 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 5
Article 4 – paragraph 5
5. Paragraph 2 shall apply in the case only of certificates granted on or after [OP: please insert the date of the first day of the third month that follows the month in which this amending Regulation is published in the Official Journal)].to existing certificates;
Amendment 264 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 469/2009
Article 21
Article 21