30 Amendments of Soledad CABEZÓN RUIZ related to 2018/0161(COD)
Amendment 19 #
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 medicinal products, and to contribute to Regulation (EC) No 469/2009 provided a uniform solution at Community level to prevent a heterogeneous evolution of national legislation creating new disparities, which could hinder the free movement of medicines within the Community and thus directly affect the functioning of the internal market. However, the medicines system in the EU has evolved in recent decades with the introduction of generic and biosimilar medicines which impreoventing the relocation of pharmaceutical research outside the Union to countries that may offer greater protection competitiveness, the sustainability of health systems and European citizens’ access to medicines, while the exception intended by the proposed amendment of this regulation provides an opportunity to improve the parameters referred to above, which are now under threat.
Amendment 23 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) The proposal to amend the regulation so as to allow the production of generics and biosimilars for export and storage to make it possible for them to enter the European market when the patent expires does not conflict with intellectual property rights, as they do not interfere with the duration of market exclusivity rights during the patent, which is underscored by the fact that immediate import is allowed after expiry, but represents a competitive disadvantage for the European generic medicines industry.
Amendment 27 #
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 medicinal products, and to contribute to preventing the relocation of pharmaceutical research outside the Union to countries that may offer greater protection, while at the same time ensuring access to medicines within the Union.
Amendment 34 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) The timely entry of generics and biosimilars onto the Union market is important for increasing competition, reducing prices and ensuring the sustainability of healthcare systems.
Amendment 43 #
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 (EU-Day1 Entry), 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 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 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 95 #
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 104 #
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 the making is to take place. The information should be provided before the making is 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 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 129 #
Proposal for a regulation
Recital 19
Recital 19
(19) In order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights, tThe exception provided for in this Regulation should only apply to certificates that are granted on or after a specified date after entry into force, for which the basic patent expirrespective of when the application for the certificate was first lodged on or after 1 January 2020. Theat date specified should also allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way. The date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make, and should take due account of pending applications for certificates.
Amendment 136 #
Proposal for a regulation
Recital 22
Recital 22
(22) This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union. In particular, this Regulation seeks to ensure full respect for the right to property in Article 17 of the Charter by maintaining the core rights of the supplementary protection certificate, by confining the exception to certificates granted on or after a specified date after entry into force of this Regulationthe right to health care in Article 35 of the Charter by making medicines more accessible to EU patients, the principle of proportionality in Article 52 of the Charter, point (a) of Article 6 TFEU on the right to health protection for European citizens, confining the exception to all certificates that are already granted and by imposing certain conditions on the application of the exception,.
Amendment 140 #
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, including access to medicines within the Union and those of public health. _________________ 43 OJ L 123, 12.5.2016, p. 1.
Amendment 146 #
Proposal for a regulation
Recital 22
Recital 22
(22) This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union. In particular, this Regulation seeks to ensure full respect for the right to property in Article 17 of the Charter by maintaining the core rights of the supplementary protection certificate, by confining the exception to certificates granted on or after a specified date after entry into force of this Regulation and by imposing certain conditionsfor which the basic patent expired on or after 1 January 2020 and by imposing certain conditions on the application of the exception, as well as the right to health care in Article 35 of the Charter by making medicines more accessible to EU patients and the principle of proportionality in Article 52 onf the application of the exception,Charter, point (a) of Article 6 TFEU on the right to health protection for European citizens.
Amendment 159 #
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 particularcertain acts against which the basic patent conferred protection if, with respect to that particular act, the following conditions are met:
Amendment 178 #
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) making for the exclusive purpose of export to third countriescountry markets where no supplementary protection certificate is in place; or
Amendment 181 #
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 a (new)
Article 4 – paragraph 2 – point a – point i a (new)
(ia) making for the purpose of entering the Union's market on Day-1 after the expiry of the supplementary protection certificate; or
Amendment 191 #
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, storing or for the actual export itself;
Amendment 192 #
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 a (new)
Article 4 – paragraph 2 – point a – point ii a (new)
(iia) and excludes any act or activity for the purpose of import of medicinal products, or parts thereof, onto the Union merely for the purpose of repackaging and re-exporting.
Amendment 203 #
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 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’) is notified by the person doing the making (‘the maker’) of the information listed in paragraph 3 no later than 2814 days before the intended start date of making in that Member State;
Amendment 217 #
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 – introductory wording
Article 4 – paragraph 3 – introductory wording
3. The information for the purposes of paragraph 2(b), which must be treated in a strictly confidential manner by all parties, shall be as follows:
Amendment 222 #
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 is to take place in the relevant Member Statrelevant Member State where the making is taking place;
Amendment 225 #
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 d
Article 4 – paragraph 2 – point d
Amendment 229 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Amendment 235 #
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 f
Article 4 – paragraph 2 – point f
Amendment 247 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 5
Article 4 – paragraph 5
5. Paragraph 2 shall apply in the case only of certificates granted on or after [OP: please insert the date of the first day of the third month that follows the month in which this amending Regulation is published in the Official Journal)].;for which the basic patent expires on or after 1 January 2020.
Amendment 256 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 469/2009
Article 11 – paragraph 4
Article 11 – paragraph 4