16 Amendments of Daniel BUDA related to 2018/0161(COD)
Amendment 29 #
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 countries outside the EU (‘third countries’) where protection does not exist or has expired. Assuming a sustained growth in global demand for medical products, by 2020 generics and biosimilars will represent 80 % of all medicines by volume, and about 28 % by value.
Amendment 39 #
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 countrywith a view to enter 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 fmmediately after expiry of the certificate and/or export those manufacturers to enter the Union market immediately after expiry of the certificateo countries in which such protection does not exist or has expired, 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 5
Recital 5
(5) This puts manufacturers of generics and biosimilars established in the Union at a significant competitive disadvantage compared with manufacturers based in third countries that offer less or no protection. or where protection has expired. The European Union must therefore strike a balance between, on the one hand, ensuring a level playing field between production activities on its territory and in third countries and, on the other, ensuring that the exclusive rights of the certificate holders are guaranteed in relation to the Union market.
Amendment 47 #
Proposal for a regulation
Recital 6
Recital 6
(6) Without any intervention, the viability of the manufacture of generics and biosimilars in the Union could be under threat, with consequences for the Union’s pharmaceutical industrial base as a whole, which may affect the very functioning of the internal market through the loss of potential new business opportunities as well as diminishing investment at EU level, possibly hampering the creation of new jobs.
Amendment 56 #
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, namely the Day-1 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 62 #
Proposal for a regulation
Recital 8
Recital 8
(8) In those 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 third country manufacturers, it is appropriate to restrict the protection conferred by a supplem. This would enable manufacturing exclusively for: (i) export to third countries and (ii) entary protection certificate so as to allow making for the exclusive purpose of export to third countries andonto the Union market immediately after expiry of the relevant supplementary protection certificate, as well as any related acts strictly necessary for that making or for the actual export itself or entry onto the Union market.
Amendment 72 #
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 protected by a supplementary protection certificate, including the making of the corresponding medicinal product, in the territory of a Member State, for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for Day-1 entry on the Union’s market after patent expiration, as well as any upstream or downstream acts, 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 Day-1 Entry. For instance, such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product to which the product covered by the certificate corresponds, or, temporary storage of the product or medicinal product, advertising for othe exclusivr activities necessary for the purpose of actual export to third country destinations or Day-1 Entry.
Amendment 80 #
Proposal for a regulation
Recital 10
Recital 10
(10) The exception should not cover placing thea medicinal product made for the exclusive purpose of export on the marketr for the entry on the Union's market on the first day after patent expiration in the Member State where a supplementary protection certificate is in force, either directly or indirectly after export, nor should it cover re-importation of the medicinal product to the market of a Member State in which a certificate is in force. Moreover, it should not cover any act or activity for the purpose of import of medicinal products, or parts of medicinal products, into the Union merely for the purposes of repackaging and re-exporting.
Amendment 89 #
Proposal for a regulation
Recital 11
Recital 11
(11) By limiting the scope of the exception to making for the purposes of Day-1 entry and 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 or medicinal 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 125 #
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 of the Council42. Furthermore, this Regulation does not affect the rules on the unique identifier provided for in Commission Delegated Regulation (EU) 2016/1611a. . _________________ 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). 1a Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).
Amendment 136 #
Proposal for a regulation
Recital 19
Recital 19
(19) In order to ensure the uniform implementation of this Regulation in the Member States and in order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights equally applied, the exception provided for in this Regulation should only 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 lodgedafter the entry into force from 2023. 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 148 #
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 condand by imposing certain conditions on the application of the exception, This Regulation also ensures respect for the freedom to conduct a business for manufacturers of generics and biosimilars established in the EU (Article 16 of the Charter) and facilitates access by Union citiozens on the application of the exceptionto more accessible healthcare and medicines (Article 35 of the Charter).
Amendment 164 #
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 particular acts against which the basic patent conferred protection if, with respect to thatose particular acts, the following conditions are met: (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 174 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1 Regulation (EC) No 469/2009
Article 1 – paragraph 1 – point 1 Regulation (EC) No 469/2009
(i) making for the exclusive purpose of export to third countries; and/or entry onto the market of Member States immediately after expiry of the certificate in those Member States; and/or
Amendment 187 #
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 or for the actual export itself;, for the export, and/or for effectively entering the market of Member States immediately after expiry of the certificate in those Member States. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 258 #
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)(b) shall be published by that authority within 15 days of receipt of the notification.’; The same provisions shall apply, where appropriate, to the updated notification in accordance with the provisions of Article 4(2)(b). The published notification or, where applicable, updated notification shall not contain any confidential or commercially sensitive information. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)