27 Amendments of Elisabetta GARDINI related to 2018/0161(COD)
Amendment 25 #
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 28 #
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 38 #
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. 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, 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 51 #
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 those in third country manufacturers, it is appropriate to restrict the protection conferred by aies. This would enable making exclusively for (i) export to third countries and (ii) entry onto the Union market immediately after expiry of the relevant supplementary protection certificate so, as to allow making for the exclusive purpose of export to third countries andwell as any related acts strictly necessary for that making or for the actual export or that entry onto the Union market itself.
Amendment 60 #
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, 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 actually exporting to third country destinations or Day-1 Entry.
Amendment 69 #
Proposal for a regulation
Recital 10
Recital 10
(10) The exception should not cover placing thea medicinal product made for the exclusive purposes of export and Day 1 Entry on the market in thea 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 77 #
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 83 #
Proposal for a regulation
Recital 12
Recital 12
(12) SReasonable and proportionate safeguards should accompany the exception in order to increase transparency, to, for the exclusive purpose of helping the holder of a supplementary protection certificate to enforcheck compliance wits protection in the Union and to reduce the risk of illicit diversion onto the Union market during the termh the conditions set out hereunder. Those safeguards should not negatively affect competition among companies and should allow the exception to work effectively with no disruption on the main objectives of the excerptificateon.
Amendment 88 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) The European Union has already a very strong IP enforcement system, notably through Directive 2004/48 of 29 April 2004 on the enforcement of intellectual property rights and its national implementations. In this respect, National Courts already strongly protect IP holders from infringements of their IP.
Amendment 92 #
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 placeand to the extent it intends to rely on the exception, the person responsible for the making (‘the maker’), or any person acting on its behalf, should provide certain information to the registered holder(s) of the certificate, at its (their) registered address(es) on a confidentiality basis. 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, shwould onlyaltogether 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, provided that the maker has sent this notification to the holder of the certificate of the maker’s intention.
Amendment 99 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) The notification should be without prejudice to any defences otherwise available to the maker and any other persons conducting the related acts referred to in Recital 9 against a claim from the holder of the certificate in relation to an alleged infringement or threat of infringement of the certificate, and should not be construed as an acknowledgment by the maker that the certificate or the basic patent is valid and/or that the making or any of the related acts referred to in Recital 9 would otherwise infringe the certificate and/or the basic patent.
Amendment 103 #
Proposal for a regulation
Recital 13 b (new)
Recital 13 b (new)
(13b) The notification should not include commercially sensitive information and confidential details of a company business plan, to limit any anti- competitive effects. To that end, the information required in the notification should notably comply with existing EU legislation and recommendations, such as Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on trade secrets and the EMA/HMA Guidance Document on the identification of commercially confidential information and personal data. For the same reasons, the notification and the information it contains should be treated as strictly confidential by the holder of the certificate and should not be used by the holder of the certificate for any other purpose than ensuring that the maker has complied with the scope and conditions of the exception.
Amendment 110 #
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 142 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) 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 acts against which the basic patent conferred protection if, with respect to that particular act, the following conditions are met:
Amendment 148 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) 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(s) 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 160 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) 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.
Amendment 169 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 2 – point b
Article 4 – paragraph 2 – point b
(b) tThe authority referred to in Article 9(1) of the Member State where that making is to take placecertificate holder(s) is (are) notified at its (‘the relevant Member State’) is notified by the person doing the making (‘the maker’)ir) registered address(es), by the person responsible for the making (‘the maker’), or any person acting on its behalf, of the information listed in paragraph 3 no later than 28 days before, prior to the intended start date of making in that Member State;
Amendment 190 #
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
Article 4 – paragraph 3
3. The information for the purposes of paragraph 2(b) shall be treated as strictly confidential by the holder of the certificate and be as follows:
Amendment 191 #
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 a
Article 4 – paragraph 3 – point a
Amendment 192 #
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
Amendment 196 #
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 c
Article 4 – paragraph 3 – point c
(c) the number of the certificate granted in the relevant Member Staterelevant certificate(s), and identification of the product, by reference to the proprietary name used by the holder(s) of thate certificate(s);
Amendment 198 #
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 d
Article 4 – paragraph 3 – point d
Amendment 199 #
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 e
Article 4 – paragraph 3 – point e
Amendment 201 #
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 f
Article 4 – paragraph 3 – point f
Amendment 211 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 4 – introductory part
Article 4 – paragraph 4 – introductory part
4. The maker shall ensure, through appropriate 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:
Amendment 221 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 469/2009
Article 11 – paragraph 4
Article 11 – paragraph 4
Amendment 230 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) No 469/2009
Article 21a – paragraph 4
Article 21a – paragraph 4