Activities of Gesine MEISSNER 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 (8)
Amendment 98 #
Proposal for a regulation
Recital 13
Recital 13
(13) To this end, this Regulation should impose a once-off duty on the persono the extent it intends to rely on the exception and in the interest of transparency, the person responsible for the making (‘the product for the exclusive purpose of export, requiring that person to provide certain informationmaker’), or any person acting on its behalf should provide, on a confidentiality basis, a warning letter to the registered holder(s) of the certificate, at its (their) registered address(es). The maker should also provide 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, a notification with certain information 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, provided that the maker has sent this notificatione warning letter and the notification respectively to the holder of the certificate and to the competent industrial property authority (or other designated authority) of in the Member State of making. The once-off duty to provide information to the authoritynotification 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 111 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) The warning letter to the SPC Holder 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 warning letter 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 warning letter 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 118 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) The notification to the authority which granted the supplementary protection certificate and the information it contains should be kept confidential. Specific measures should be taken to protect such confidentiality. The authority may only disclose the information if disclosure is ordered by a court under specific circumstances.
Amendment 167 #
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) 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 paragraph 3 no later than 2890 days before the intended start date of making in that Member State; If the information referred to in paragraph 2(b) changes, the maker shall notify the authority referred to in Article 9(1) before these changes take effect. The notification and the information it contains should be kept confidential. The authority may only disclose the information to the SPC holder if disclosure is ordered by a court.
Amendment 177 #
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 a (new)
Article 4 – paragraph 2 – point b a (new)
(ba) the certificate holder is informed, in writing, by the maker, that a notification has been sent pursuant to paragraph 2(b) and is provided with the information listed in of paragraph 3 (c) and (f) of this article no later than 90 days before the start date of making in that Member State and in advance of any related act prior to that making that would otherwise be prohibited by the protection conferred by a certificate; the SPC holder should keep the warning letter and the information it contains strictly confidential and should not use them for any other purpose than ensuring that the maker has complied with the scope and conditions of the exception.
Amendment 184 #
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 c a (new)
Article 4 – paragraph 2 – point c a (new)
(ca) the maker ensures that the medicinal product manufactured under paragraph 2(a) does not bear an active 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 217 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 5
Article 4 – paragraph 5
5. Paragraph 2 shall apply in the case only of certificates applied for, 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)].;
Amendment 225 #
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
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 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 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 disclose 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;