16 Amendments of Răzvan POPA related to 2018/0161(COD)
Amendment 31 #
Proposal for a regulation
Recital 3
Recital 3
(3) Since the adoption in 1992 of the predecessor to Regulation (EC) No 469/2009, markets have evolved significantly and there has been huge growth in the manufacture of generics and especially of biosimilars, in particular in third countries outside the Union where protection does not exist or has expired.
Amendment 42 #
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 countrycountries outside 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 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 50 #
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, and to ensure Day-1 Entry of generic and biosimilar medicines onto the Union market after the expiry of the relevant supplementary protection certificate and this fostering access to medicines. 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 EU-Day1 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 51 #
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 and to ensure that generic and biosimilar products can enter the Union market from the first day after the supplementary protection certificate 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 63 #
Proposal for a regulation
Recital 8
Recital 8
(8) In thoese specific and limited circumstances, and in order to creatit is appropriate to eliminate the aforementioned, unintended side effects of the supplementary protection certificate so as to enable a level -playing field between Union-based manufacturers and those in 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. ies. This would enable manufacturing exclusively for (i) export to country markets where the supplementary protection has expired, as well as for any other acts that are strictly necessary for this manufacturing and (ii) entry onto the Union market as soon as the supplementary protection certificate expires.
Amendment 73 #
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 countriescountry markets where no supplementary protection certificate is in place and to prepare for EU-Day1 Entry, 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 and for EU-Day1 Entry. 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 84 #
Proposal for a regulation
Recital 11
Recital 11
(11) By limiting the scope of the exception to makingThe scope of the exception is limited to making for the entry onto the Union market from the first day of the expiration of the supplementary protection certificate 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 willshould 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 86 #
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 UnionEU-Day1 Entry and for the purpose of export to country markets where no supplementary protection certificate is in place or has expired 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 96 #
Proposal for a regulation
Recital 12
Recital 12
(12) SReasonable and proportionate 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.
Amendment 106 #
Proposal for a regulation
Recital 13
Recital 13
(13) To this end, this Regulation should impose a once-off duty on the 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 theeach making is to take place. The information should be provided before the making isor before other acts that are related for that making are intended to start for the 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 duty to provide information to the authority 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 116 #
Proposal for a regulation
Recital 14
Recital 14
(14) In addition, this Regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate. The maker should be required to inform persons within its supply chain, through appropriate means, in particular contractual means, that the product is covered by the exception introduced by this Regulation and is intended for the exclusive purpose of export and/or Day-1 entry. A maker who failed to comply with these due diligence requirements would not benefit from the exception, nor would any third party performing a related act in the same or a different Member State where a certificate conferring protection for the product was in force, and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate.
Amendment 119 #
Proposal for a regulation
Recital 14
Recital 14
(14) In addition, this Regulation should impose certain due diligence requirements on thea maker as a condition for the exception to operate. TheEach maker should be required to inform persons within its supply chain, through appropriate means, in particular contractual means, that the product is covered by the exception introduced by this Regulation and is intended for the exclusive purpose of export. A maker who failed to comply with these due diligence requirements would not benefit from the exception, nor would any third party performing a related act in the same or a different Member State where a certificate conferring protection for the product was in force, and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate.
Amendment 124 #
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 purposes of Day-1 entry onto the Union market after the expiry of the supplementary protection certificate or of export to third countries. The making and, storing 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 163 #
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
Article 4 – paragraph 2
2. The certificate referred to in paragraph 1 shall not confer protection against a particularcertain act against which the basic patent conferred protection if, with respect to that particular act, the following conditions are met:
Amendment 221 #
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 – point b
Article 4 – paragraph 3 – point b
(b) the address, or addresses, of the premises where the making isand other related acts for that making are to take place in the relevant Member State;
Amendment 243 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 4
Article 4 – paragraph 4
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: