23 Amendments of Frédérique RIES related to 2018/0161(COD)
Amendment 33 #
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 within the Union, even for the exclusive purpose of exporting to third country 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 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 53 #
Proposal for a regulation
Recital 12
Recital 12
(12) SAppropriate 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 58 #
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 60 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13 a) The maker should be required to inform the competent authority as well as the certificate holder of any changes to the information provided in the notifications.
Amendment 65 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14 a) The warning letter to the SPC Holder should not include commercially sensitive information and/or 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 June2016 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 69 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15 a) 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 71 #
Proposal for a regulation
Recital 17
Recital 17
(17) This Regulation does not affect the application of Union measures that aim to prevent infringements and facilitate enforcement of intellectual property rights, including Directive 2004/48/EC of the European Parliament and of the Council41 and, Regulation (EU) No 608/2013 of the European Parliament and of the Council42 , and Delegated Regulation (EU) No 2016/161 of the European Commission42a. __________________ 41 Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L157, 30.4.2004, p. 45). 42 Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights (OJ L 181, 29.6.2013, p. 15). 42a Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).
Amendment 75 #
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 applied for, granted 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 86 #
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 applied for, granted 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 98 #
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 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 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 99 #
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 a (new)
Article 4 – paragraph 2 – point b a (new)
(b a) 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 106 #
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 a (new)
Article 4 – paragraph 2 – point c a (new)
(c a) 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 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 115 #
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 indicativthe list of the intended third country or third countries to which the product is intended to be exported.
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 122 #
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 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 124 #
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 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;
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;