Activities of Urszula KRUPA related to 2018/0161(COD)
Shadow opinions (1)
OPINION 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
Amendments (9)
Amendment 20 #
Proposal for a regulation
Recital 2
Recital 2
(2) By providing for a period of supplementary protection of up to five years, Regulation (EC) No 469/2009 seeks to promote, within the Union, the research and innovation that is necessary to develop newer generation medicinal products that support the treatment of new disease entities or offer better therapeutic effects, and to contribute to preventing the relocation of pharmaceutical research outside the Union to countries that may offer greater protection.
Amendment 26 #
Proposal for a regulation
Recital 4
Recital 4
(4) The absence of any exception in Regulation (EC) No 469/2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the Union from manufacturing, even for the exclusive purpose of exporting to third country markets in which such protection does not exist or has expired. A further unintended consequence is that the protection conferred by the certificate makes it more difficult for those manufacturers to enter the Union market immediately after expiry of the certificate, given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed, by contrast with manufacturers located in third countries where protection does not exist or has expired. A significant effect could be the re-export – i.e. the export, repackaging and re-import of medicinal products – both from the Union and, above all, from third countries.
Amendment 34 #
(5) This puts manufacturers of generics and biosimilars established in the Union at a significant competitive disadvantage compared with manufacturers based in third countries that offer less or no protection. It may result in the re-export of generic and biosimilar medicinal products of unknown origin, often at dumping prices.
Amendment 40 #
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, has expired or where there are indications that medicinal products may be re- exported or sold at dumping prices. 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 57 #
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 and any related acts strictly necessary for making or, for the actual export itself and also for re-export or sale of medicinal products at dumping prices.
Amendment 66 #
Proposal for a regulation
Recital 10
Recital 10
(10) The exception should not cover placing the product made for the exclusive purpose of export on the market in the Member State where a supplementary protection certificate is in force, either directly or indirectly after export, nor should it cover re-importation of the product to the market of a Member State in which a certificate is in force. Moreover, it should not cover any act or activity for the purpose of import of medicinal products, or parts of medicinal products, into the Union merely for the purposes of repackaging and re-exporting, i.e. their re-export from third countries to the Union.
Amendment 85 #
Proposal for a regulation
Recital 12
Recital 12
(12) Safeguards should accompany the exception in order to increase transparency, to help the holder of a supplementary protection certificate to enforce its protection in the Union and to reduce the risk of illicit diversion onto the Union market during the term of the certificate for the purpose of obtaining a profit not justified by the market.
Amendment 117 #
Proposal for a regulation
Recital 15
Recital 15
(15) Furthermore, this Regulation should impose labelling requirements on the maker, in order to facilitate, by means of a logo, identification of the product as a product exclusively intended for the purpose of export to third countries. The making and, storage, distribution and sale of medicinal products and other related acts should only fall outside the protection conferred by a supplementary protection certificate if the product is labelled in this manner. This labelling obligation would be without prejudice to labelling requirements of third countries.
Amendment 129 #
Proposal for a regulation
Recital 20
Recital 20
(20) The Commission should carry out an evaluation of this Regulation. 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, includingand above all those of public health. _________________ 43 OJ L 123, 12.5.2016, p. 1. OJ L 123, 12.5.2016, p. 1.