Activities of Alessia Maria MOSCA related to 2018/0161(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products
Amendments (20)
Amendment 36 #
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 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 43 #
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 ofnufacturing exclusively for (i) exporting to third countries and any related acts strictly necessary for making or for the actual export itselfthis manufacturing and (ii) entering the Union's market as soon as the supplementary protection certificate expires.
Amendment 44 #
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 and to prepare for Day-1 entry in the Union's market, 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 and for Day-1 entry. 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 or Day- 1 entry in the Union's market.
Amendment 48 #
Proposal for a regulation
Recital 11
Recital 11
(11) By limiting the scope of the exception to making for Day-1 entry in the Union's market and 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 51 #
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 enforce its protection in the Union and to reduce the risk of illicit diversion onto the Union market during the term of the certificate. Those safeguards should not negatively affect competition among companies and should allow the exception to work effectively with no disruption to the main objectives of the exception. At the same time the safeguards should also ensure the necessary confidentiality and protection of commercially sensitive information of the applicant, in compliance 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.
Amendment 55 #
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 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 requikeep the notification and the information it contains confidential and take appropriate measureds to publish that information, in the interests of transparency and for the purpose of informingrotect such confidentiality. The authority may disclose the information to the holder of the certificate only if disclosure is ordered by a court (i) upon request from the holder of the certificate (and other persons entitled under national law to start an infringement action on the basis of the certificate), (ii) after the maker was given the opportunity to attend and to be heard, (iii) if the holder of the certificate has provided evidence rendering plausible that the maker did not comply with the conditions for the exception to apply, and (iv) if the holder of the certificate of thand the court have mtaker’s intentionn appropriate measures to keep the notification and the information it contains confidential and avoid their disclosure to third parties.
Amendment 62 #
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, 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 67 #
Proposal for a regulation
Recital 15
Recital 15
Amendment 74 #
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 granted on or after a specified date afterfollowing a transition period of 1 year after the Regulation's entry into force, irrespective of when the application for the certificate was first lodged. The date specifietransition period 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 80 #
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 90 #
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 a (new)
Article 4 – paragraph 2 – point a – point i a (new)
(i a) making for the purpose of entering the Union's market on Day-1 entry after the expiry of the supplementary protection certificate;
Amendment 92 #
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, storing or for the actual export itself;
Amendment 104 #
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
Amendment 109 #
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
Article 4 – paragraph 3
3. The information for the purposes of paragraph 2(b) shall be treated as strictly confidential and be as follows:
Amendment 110 #
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 premisesrelevant Member State where the making is to take place in the relevant Member State;
Amendment 111 #
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 113 #
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 119 #
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 ofollowing a transition period of 1 year 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 125 #
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.; authority as referred to in Article 9(1) shall keep the notification referred to in Article 4(2)(b) and the information listed in paragraph 3 confidential, and shall take appropriate measures to preserve such confidentiality; The authority shall only disclose the notification and the information it contains to the holder of the certificate, and if such disclosure is ordered by a court having competence under national law to hear an infringement action based on the certificate. A court shall only order such disclosure if at least the following conditions are met: (a) the person requesting the disclosure is the holder of the certificate (or a person entitled under national law to start an infringement action on the basis of the certificate; (b) the maker is given the opportunity to attend the proceedings and to be heard before the court; (c) the holder of the certificate has provided evidence rendering plausible that the maker did not comply with the conditions set out in paragraph 2; (d) the holder of the certificate and the court have taken appropriate measures to keep the notification and the information it contains confidential and avoid their disclosure to third parties.
Amendment 127 #
Proposal for a regulation
Annex I
Annex I