26 Amendments of António MARINHO E PINTO related to 2018/0161(COD)
Amendment 30 #
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 and active ingredients, in particular in third countries, outside the European Union, where protection does not exist or has expired.
Amendment 37 #
Proposal for a regulation
Recital 4
Recital 4
Amendment 48 #
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 toshould thereby 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 69 #
Proposal for a regulation
Recital 8
Recital 8
(8) In those specific and limited circumstances, andcases, 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, 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 itselfof generic products, biosimilars and active ingredients for the exclusive purpose of export to third countries.
Amendment 70 #
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 countries, 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. 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 85 #
Proposal for a regulation
Recital 11
Recital 11
(11) By limiting the scope of the exception 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 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 98 #
(12) SAppropriate 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 103 #
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 starts 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 and where the supplementary protection certificate holder has been duly informed about the name and address of the maker, the certificate number and the intended starting date of the making. On the one hand, this limited information should be sufficient for the certificate holder to assess whether there is or will be an infringement of his certificate, and on the other hand, prevents the disclosure of business sensitive information to the certificate holder. The once-off duty to provide information to the authority should apply in each Member State where making is to take place. The authority should be required to publish thate information provided by the maker, in the interests of transparency and foin a timely manner twhe purpose of informing the holder of the certificate of the maker’s intentionreby business sensitive information provided to the competent authority should not be published.
Amendment 110 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) The information contained in the notification to the competent authority should be kept confidential and may only be disclosed upon court order.
Amendment 111 #
Proposal for a regulation
Recital 13 b (new)
Recital 13 b (new)
(13b) The maker should be required to inform the competent authority as well as the certificate holder of any changes to the respectively provided information.
Amendment 114 #
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. 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 126 #
Proposal for a regulation
Recital 17
Recital 17
(17) This Regulation does not affect the application of Union measures that aim to prevent infringements and facilitate enforcement of intellectual property rights, including Directive 2004/48/EC of the European Parliament and of the Council41 and Regulation (EU) No 608/2013 of the European Parliament and, Regulation (EU) No 608/2013 and rules ofn the Council42 . _________________ 41 Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L157, 30.4.2004, p. 45). 42 Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights (OJ L 181, 29.6.2013, p. 15)unique identifier provided for in Commission Delegated Regulation (EU) 2016/161.
Amendment 127 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) However, in order to avoid abuse and illicit distribution of medicinal products manufactured according to this Regulation onto the Union market, even though it was manufactured with the sole purpose of being exported to third countries, thus to help preventing the so called ‘launch-at-risk’, unique identifiers provided for in Commission Delegated Regulation (EU) 2016/161 should not be affixed to the medicinal product.
Amendment 132 #
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, the exception provided for in this Regulation should onlynot apply to certificates that are granted on or after a specified date after entry into force, irrespective of when the application for the certificate was first lodgedpplied for before entry into force of this Regulation. The date specified should 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 137 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) This Regulation should not have any retroactive effect.
Amendment 138 #
Proposal for a regulation
Recital 20
Recital 20
(20) The Commission should carry out an regular 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. To this extent, the evaluation should also address the possible extension of the scope of this Regulation to manufacturing within the Union by Union established makers for reasons of stockpiling with a view to Day-1 entry into the Union market when a certificate lapses. In this context, it would be important to ascertain that as a consequence of such an extended scope of the exception, the manufacturing currently taking place outside of the Union, would be moved to within its territory. 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 those of public health. _________________ 43 OJ L 123, 12.5.2016, p. 1.
Amendment 150 #
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 applied for, granted on or after a specified date after entry into force of this Regulation and by imposing certain conditions on the application of the exception,
Amendment 165 #
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
Article 4 – paragraph 2 – point a
(a) the act comprises: the
Amendment 171 #
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 of a medicinal product for the exclusive purpose of export to third countries; or, including the supply and the import of active ingredients for the purpose of making the medicinal product;
Amendment 183 #
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
Amendment 207 #
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 a (new)
Article 4 – paragraph 2 – point b a (new)
(ba) the maker informs the certificate holder of the information listed in paragraph 3, points (a), (c) and (e) of this Article, including any changes thereof, no later than 90 days before the start date of the making;
Amendment 213 #
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 c a (new)
Article 4 – paragraph 2 – point c a (new)
(ca) the maker ensures that the medicinal product manufactured according to paragraph 2(a) does not bear an active unique identifier laid down in Art. 3(d) and 4 of Commission Delegated Regulation (EU) 2016/161. Where appropriate, the competent authority shall have access to the data in the repositories mandated by Directive 2011/62/EU and Delegated Regulation (EU) 2016/161 in order to verify compliance;
Amendment 239 #
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 f
Article 4 – paragraph 3 – point f
(f) an indicative list of the intendedthe third country or third countries to which the product is intended to be exported.
Amendment 241 #
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 a (new)
Article 4 – paragraph 3 a (new)
3a. The authorities of the Member States referred to in Art. 9(1) shall under no circumstances disclose any business sensitive information provided by the maker of the medicinal product, neither to the certificate holder nor to the public;
Amendment 252 #
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 not apply in the case only of certificates granted on or afterpplied for before [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)].;
Amendment 260 #
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
4. The notification sent to an authority as referred to in Article 4(2)(b9(1) shall be published by that authority within 15 days of receipt of the notification.; the information listed in Article 4, paragraph 3, points (a), (c) and (e) as well as any changes thereof without undue