22 Amendments of József SZÁJER related to 2018/0161(COD)
Amendment 49 #
Proposal for a regulation
Recital 7
Recital 7
(7) TKeeping in mind that the SPC regulation in the EU provides for uniform solution of the protection and for the free movement of medicinal products, 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 supplementarhance further balance between the interests of the originators, generic and biosimilar makers and public health by following the principle of proportionality. The Regulation will promote the competitiveness of makers of generics and biosimilar producers established in the Union, enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions. This will help these makers to compete effectively in markets where intellectual property protection does not exist or has expired. It is intended tshould also complement the efforts of the Union’s trade policy to ensure open markets for Union-based manufacturkers 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 or active ingredients, and it will ensure that neither Member States’ health systems nor the patients are forced to bear excessive pharmacotherapy costs which would be in direct conflict with the public interest.
Amendment 66 #
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 so as to allow making for the exclusive purpose of export to third countriesor placing on the market after the expiry of the certificate and any related acts strictly necessary for making, for the eventual placing on the market or for the actual export itself.
Amendment 71 #
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 countriesor placing the product on the market after the expiry of the certificate, 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 placing the product on the market subsequently to the certificate’s expiry 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 destinationsor stocking the product to prepare for entry to the market after the expiry of the certificate.
Amendment 87 #
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 Unionand of marketing after the certificate has expired and acts strictly necessary for such making or for the actual export itself (including temporary storage and stocking), the exception introduced by this Regulation will not unreasonablyshould not 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 107 #
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, or of placing on the market after the expiry of the certificate 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 115 #
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 that it is being manufactured exclusively to be marketed only after the expiry of the certificate. 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 131 #
Proposal for a regulation
Recital 19
Recital 19
(19) In order to ensure that the rights of holders of supplementary protection certificates already in force are not deprived of their acquired rights not unduly restricted, the exception provided for in this Regulation should only apply to certificates that are granted on or after a specified dateapplied for after the entry into force of this Regulation, as well as to certificates that enter into effect two years after the entry into force of this Regulation, irrespective of when the application for thse certificates was first lodged. The date specified should allow a reasonable time for applicants and other relevanere granted. It is necessary to ensure a timely entry into force of this Regulation, given that, as from 2020, patents will expire in third countries for many high-turnover medicinal products that market players to adjust to the changed legal context and toe protected by certificates in the Union, thus opening up considerable new opportunities in global marke 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 accountts that makers of generics and biosimilars established in the Union should be able to seize. At the same time, these timing arrangements should allow a reasonable time for certificate holders to adjust to the changed legal context and to make appropriate investment decisions in a timely way, while ensuring that the economic benefits of the exception can be effectively reaped by makers of pgending applications for certificateerics and biosimilars.
Amendment 143 #
Proposal for a regulation
Recital 21
Recital 21
(21) It is necessary and appropriate for the achievement of the basic objective, of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired, to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate, and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules. This Regulation complies with the principle of proportionality, and does not go beyond what is necessary in order to achieve the objectives pursued, in accordance with Article 5(4) of the Treaty on European Union.
Amendment 144 #
Proposal for a regulation
Recital 22
Recital 22
(22) This Regulation respects fundamental rights and observes thee CJEU has confirmed on numerous occasions that the objective pursued by Regulation No 469/2009 is not to compensate the holder fully for the delay to the marketing of his invention. Moreover, the protection granted by the SPC relates to exclusivity on the EU market which does not fall within the scope of the waiver introduced by this Regulation in respect of the fundamental rights and principles recogniszed by the Charter of Fundamental Rights of the European Union. In particular, this Regulation seeks toaims at ensureing full respect for the right to property inguaranteed by Article 17(2) 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 conditions on the applic holder. By the introduction of this exception, the Union adopts a solution in the pharmaceutical sector which is essential to promote public interest. The exception should be considered in the light of the principle of proportionality, measuring it up with the protection of values such as health protection, which is a special emanation of the general concept of public interest. Facilitating the wide-ranging availability of medicinal products constitutes an important goal of health policy, including the one pursued at the EU level in accordance with Article 35 of the Charter of Fundamental Rights of the European Union. Any unjustified delay of lawful price competition in the pharmaceutical sector means that both state budgets and patients are forced to bear excessive pharmacotherapy costs, which is in conflict with the public interest. The provisions establishing supplementary protection certificate aim at compensating the holder of the basic patent for the period prior to the granting of a marketing authorization when they cannot enjoy the market exclusivity conferred by the basic patent. This compensation consists of a specific extension of patent protection for the purpose of ensuring market exclusivity lasting 15 years from the first marketing authorization of the medicinal product. Such an extension, however, does not grant an absolute right to the holder of the certificate and therefore may be subject to certain restrictions, as long as the essential compensation function of the extension is safeguarded, notably that adequate market exclusivity is ensured for the duration of the certificate. In order to reap the full benefits of the exception introduced by this Regulation with due regard to the protection of legitimate expectations and without unduly curtailing acquired rights, the exception should be operational in the case of certificates that enter into effect two years after the entry into force of this Regulation, irrespective of when these certificates were granted. This solution ensures an appropriate transitional period but also makes the exception apply across the board from the specified date, allowing for a timely and transparent introduction of the new regime. From the point of view of public interest, it is most beneficial to introduce the waiver as soon as possible. However, postponing its application guarantees predictability to applicants and other stakeholders. In addition, it is ensured that legal continuity is maintained to the extent that it is necessary for the planned systemic change. It needs to be underlined that it is not possible to achieve the desired goal by other means. The legitimate expectations of the exception, holders of certificates granted before the specified date remains fully respected, as the exception does not alter their factual status on the markets on which they enjoy the extension of patent protection in any economically relevant manner. They will continue to enjoy market exclusivity for the same amount of time, as their competitors will only be able to lawfully enter the market in territories where no such exclusivity exists.
Amendment 155 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – introductory part
Article 1 – paragraph 1 – point 1 – introductory part
(1) Article 45 is replaced by the following:
Amendment 156 #
Article 45 – Subject matter of protection and exeffect of the ceprtions to rights conferredficate
Amendment 157 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificateSubject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.
Amendment 158 #
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 act against which the basic patent conferred protection if, with respect to that particular act,By way of derogation from paragraph 1, the certificate shall not confer protection against a particular act which would otherwise require the consent of the holder of the certificate referred to in Article 11 (‘the certificate holder’) if the following conditions are met:
Amendment 170 #
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 countries or to countries where no supplementary protection certificate is in place; or placing on the market after the expiry of the certificate; or
Amendment 201 #
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 points(a) and (c) of paragraph 3 no later than 28 days before the intended start date of making in that Member State;
Amendment 211 #
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
Article 4 – paragraph 2 – point c
(c) in the case of products made for the exclusive purpose of export to third countries, the maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer packaging of the product or, if there is no outer packaging, to its immediate packaging;
Amendment 219 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Amendment 226 #
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 d
Article 4 – paragraph 3 – point d
Amendment 228 #
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 e
Article 4 – paragraph 3 – point e
Amendment 232 #
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
Amendment 249 #
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)]to certificates where the lawful term of the corresponding basic patent expires on or after 1 January 2021.;
Amendment 261 #
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 the information listed in points (a) and (c) of Article 4(3) within 1520 days of receipt of the notificinformation.;