15 Amendments of Elena GENTILE related to 2018/0161(COD)
Amendment 29 #
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 outside the Union ("third countries") 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 44 #
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 56 #
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 78 #
Proposal for a regulation
Recital 11
Recital 11
(11) By limiting tThe scope of the exception is limited to making 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 94 #
Proposal for a regulation
Recital 13
Recital 13
(13) To this end, this Regulation should impose a once-off duty on thea person making the product for the exclusive purpose of export, requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the Member State where the making is to take place. The information should be provided before the making is intended and to the certificate-holder at its address for service in the relevant Member State. The information should be provided before the making or any related act that is strictly necessary for that making to start forat the earliest first time in that Member State. The making and related acts, including those performed in Member States other than the one of making in cases where the product is protected by a certificate in those other Member States too, should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority (or other designated authority) of the Member State of making. The once-off and to the certificate-holder at its address for service. The duty to provide information to the authority and to the certificate-holder should apply in each Member State where making is to take place, both as regards the making in that Member State, and as regards related acts, whether performed in that or another Member State, related to that making. The authority should be required to publish that information, in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention.
Amendment 145 #
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 150 #
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, and for a limited storage before the expiry of the SPC finalised to the entry into the EU market; or
Amendment 152 #
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) 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 161 #
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 163 #
(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 171 #
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 that 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 the person doing the making (‘the maker’) of the information listed in paragraph 3 no later than 2860 days before the intendedearliest start date of making or any related act that is strictly necessary for that making in that Member State;
Amendment 185 #
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 c a (new)
Article 4 – paragraph 2 – point c a (new)
(ca) the maker ensures that the medicinal product manufactured under paragraph 2(a) does not bear a Unique Identifier as per Articles 3(d) and 4 of Commission Delegated Regulation 2016/161/EU. Where appropriate, competent authorities shall have access to the data in the repositories mandated by Directive 2011/62/EU and Delegated Regulation 2016/161/EU to ensure that the maker complies with its obligations.
Amendment 194 #
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 b
Article 4 – paragraph 3 – point b
(b) the address, or addresses, of the premises where the making isand any related acts strictly necessary for that making are to take place in the relevant Member State;
Amendment 200 #
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 e
Article 4 – paragraph 3 – point e
(e) the intendedearliest start date of making in the relevant Member State or any related acts strictly necessary for making;
Amendment 203 #
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 intended third country or third countries to which the product is to be exported. If, after this list is provided, the maker intends to export to further countries, it shall provide a further notification within the time period specified in Art 4(2)(b).