Activities of Nicola CAPUTO related to 2018/0161(COD)
Plenary speeches (1)
Supplementary protection certificate for medicinal products (A8-0039/2019 - Luis de Grandes Pascual) IT
Amendments (11)
Amendment 30 #
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 markets outside the Union ("third country marketsies") 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.
Amendment 45 #
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. 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 55 #
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, but not any patent or other intellectual property right existing in a Member State, 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.
Amendment 146 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 2 – point a
Article 4 – paragraph 2 – point a
(a) the act compriseis:
Amendment 151 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 2 – point a – point i
Article 4 – paragraph 2 – point a – point i
(i) an act of making for the exclusive purpose of export to third countries where protection for the product or medicinal product does not exist or has expired; or
Amendment 162 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) 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; and would otherwise require the consent of the certificate-holder; and
Amendment 164 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 2 – point a – point ii a (new)
Article 4 – paragraph 2 – point a – point ii a (new)
(iia) not an act or activity for the purpose of import of medicinal products, or parts thereof, into the Union merely for the purposes of repackaging and re- exporting.
Amendment 168 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 2 – point b
Article 4 – paragraph 2 – point b
(b) the authority referred to in Article 9(1) of the Member State where thateach making is to take place (‘'the relevant Member State’') isand the certificate-holder at its address for service in the relevant Member State are notified by theeach person doing the making (‘'the maker’') of the information listed in paragraph 3 no later than 28 day3 months before the intendedearliest start date of making or any related act that is strictly necessary for that making in that Member State;
Amendment 205 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point f
Article 4 – paragraph 3 – point f
(f) an indicative list of the intenlist of the third countries to which the product is to be exported. If, after this list is provided, third country e maker intends to export thirdo further countries to which the product is to be exported, it shall provide a further notification within the time period specified in Art 4(2)(b).
Amendment 207 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point f a (new)
Article 4 – paragraph 3 – point f a (new)
(fa) an undertaking not to put the product on the market in the Union or to otherwise infringe the certificate while it is inforce.
Amendment 210 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 4 – introductory part
Article 4 – paragraph 4 – introductory part
4. The maker shall ensure, through appropriate and documented means, that persons in a contractual relationship with the maker who perform acts falling within paragraph 2(a)(ii) are fully informed and aware of the following: