24 Amendments of Stefano MAULLU related to 2018/0161(COD)
Amendment 41 #
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 outside the Union (“third countries”) 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, 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 59 #
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.
Amendment 68 #
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, but not any patent or other intellectual property right existing in a Member State, 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.
Amendment 83 #
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 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 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 97 #
Proposal for a regulation
Recital 12
Recital 12
(12) SEffective 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 102 #
Proposal for a regulation
Recital 13
Recital 13
(13) To this end, this Regulation should impose a once-off duty on thea 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 theeach making is to take place. The information should be provided before the making is intended to star and to the certificate-holder at its address for service in the relevant Member State. The information should be provided before the making or any related act that is strictly necessary for that making is to start at the earliest 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 and to the certificate-holder at its address for service. The duty to provide information to the authority and to the certificate-holder 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 118 #
Proposal for a regulation
Recital 14
Recital 14
(14) In addition, this Regulation should impose certain due diligence requirements on thea maker as a condition for the exception to operate. TheEach maker should be required to inform persons within its supply chain, through appropriate and documented 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 123 #
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 purpose of export to third countries. Conversely, a medicinal product bearing a Unique Identifier as per Articles 3(d) and 4 of Commission Delegated Regulation 2016/161/EU would indicate that the product is not exclusively intended for the purpose of export to third countries. The making and related acts should only fall outside the protection conferred by a supplementary protection certificate if the product is labelled in this manneraccordingly. This labelling obligation would be without prejudice to labelling requirements of third countries.
Amendment 133 #
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 only apply to certificates that are grantedapplied for on or after a specified date after entry into force, irrespective of when the application for the certificate was first lodged. 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 152 #
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 grantedapplied for 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 168 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) the act compriseis:
Amendment 176 #
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) an act of making for the exclusive purpose of export to third countries where protection for the product or medicinal product does not exist or has expired; or
Amendment 188 #
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; and would otherwise require the consent of the certificate-holder; and
Amendment 193 #
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) not an act or activity for the purpose of import of medicinal products, or parts thereof, into the Union merely for the purposes of repackaging and re- exporting.
Amendment 198 #
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 thateach making is to take place (‘'the relevant Member State’') isand the certificate-holder at its address for service in the relevant Member State are notified by theeach person doing the making (‘'the maker’') of the information listed in paragraph 3 no later than 28 day3 months before the intendedearliest start date of making or any related act that is strictly necessary for that making in that Member State;
Amendment 210 #
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) (i) 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;medicinal product and to its immediate packaging; (c) (ii) the maker ensures that the medicinal product manufactured under paragraph 2(a)does not bear a Unique Identifier as per Articles 3(d) and 4 of Commission Delegated Regulation 2016/161/EU. Where appropriate, competent authorities shall have access to the data in the repositories mandated by Directive 2011/62/EU and Delegated Regulation 2016/161/EU to ensure that the maker complies with its obligations.
Amendment 220 #
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 b
Article 4 – paragraph 3 – point b
(b) the address, or addresses, of the premises where the making isand any related acts strictly necessary for that making are to take place in the relevant Member State;
Amendment 230 #
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
(e) the intendedearliest start date of making in the relevant Member State or any related acts strictly necessary for making;
Amendment 238 #
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 lList of the intended third country or third countries to which the product is to be exported. If, after this list is provided, the maker intends to export to further countries, it shall provide a further notification within the time period specified in Art 4(2)(b).
Amendment 240 #
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 a (new)
Article 4 – paragraph 3 – point f a (new)
(fa) an undertaking not to put the product on the market in the Union or to otherwise infringe the certificate while it is inforce.
Amendment 242 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 4
Article 4 – paragraph 4
4. The maker shall ensure, through appropriate and documented 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 244 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 4 a (new)
Article 4 – paragraph 4 a (new)
4a. The maker will bear the burden of proof that the obligations set out under Article4(2) have been complied with.
Amendment 253 #
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 grantedapplied for 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)].’;
Amendment 262 #
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.';