Activities of Marie-Christine BOUTONNET related to 2018/0161(COD)
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 (9)
Amendment 38 #
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 countrywith a view to enter the Union 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 certificatemmediately after expiry of the certificate and/or export to countries in which such protection does not exist or has expired, 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.
Amendment 53 #
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. 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, namely the Day-1 entry. 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 60 #
Proposal for a regulation
Recital 8
Recital 8
(8) In thoese 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 restricteliminate the prounintecntion conferred byal effects of a supplementary protection certificate so as to allow making for the exclusive purpose of (i) export to third countries and any related acts strictly necessary for making or for the actual export itself. (ii) entry onto the Union market immediately after expiry of the relevant supplementary protection certificate, and any related acts strictly necessary for making or for the actual export itself or entry onto the Union market.
Amendment 76 #
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 protected by a supplementary protection certificate, including the making of the corresponding medicinal product, 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 or countries and/or Day-1 entry on the Union’s market, as well as any upstream or downstream acts, 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 or for Day-1 Entry. For instance, such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product to which the product covered by the certificate corresponds, or temporary storage of the product or advertising fmedicinal product or othe exclusivr activities necessary for the purpose of export to third country destinations or Day- 1 Entry.
Amendment 81 #
Proposal for a regulation
Recital 10
Recital 10
(10) The exception should not cover placing the medicinal product made for the exclusive purpose of export and Day 1 entry on the market in thea Member State where a supplementary protection certificate is in force, either directly or indirectly after export, nor should it cover re- importation of the medicinal 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.
Amendment 88 #
Proposal for a regulation
Recital 11
Recital 11
(11) By limiting the scope of the exception to making for Day-1 entry in the Union's market and for the purpose of export outside the Union, and acts strictly necessary for such making or for the actual export itself, 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 160 #
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 – introductory part
Article 4 – paragraph 2 – introductory part
2. The certificate referred to in paragraph 1 shall not confer protection against a particular acts against which the basic patent conferred protection if, with respect to that particular act, the following conditions are met:
Amendment 173 #
Proposal for a regulation
Article premier – paragraph 1 – point 1
Article premier – 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; and/or entry onto the market of Member States immediately after expiry of the certificate in those Member States; and/or
Amendment 184 #
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 ii
Article 4 – paragraph 2 – point a – point ii
(ii) any related act that is strictly necessary for that making or for the actual export itself;, for the export itself and/or entry onto the market of those Member States immediately after expiry of the certificate in those Member States.