Activities of Christofer FJELLNER 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 (34)
Amendment 27 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2 a) The established and elaborate system of protection of intellectual property rights in the Union should not be impinged upon and needs to be strengthened as it is the cornerstone of innovation, competitiveness and growth in the Member States.
Amendment 32 #
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 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 34 #
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 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 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.
Amendment 42 #
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 other patent or 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 46 #
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 52 #
Proposal for a regulation
Recital 12
Recital 12
(12) SEfficient and effective 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 54 #
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 other patent or 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 56 #
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 theeach making is to take place, and to the certificate holder in the relevant Member State, no later than three months before the start date of making in that Member State. The information should be provided before the making is intended to starto start at the earliest for the first time 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 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. The 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 the holder of the certificate of the maker’s intention.
Amendment 59 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13 a) The maker should also inform the certificate holder, in writing, of the intention to make a product pursuant to the exception. A notification form should be provided for this purpose, which will differ from the one used to notify the authority in that it will not contain confidential or commercially sensitive information. This information should be updated when appropriate.
Amendment 63 #
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 68 #
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. The making and related acts should only fall outside the protection conferred by a supplementary protection certificate if the product is labelled in this manner. This labelling obligation would be without prejudice to labelling requirements of third countries. Furthermore, 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. Therefore, this regulation should prohibit a product exclusively intended for the purpose of export to third countries from bearing such Unique Identifier.
Amendment 77 #
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 85 #
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 88 #
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) making for the exclusive purpose of export to third countries where no protection for the medicinal product exists or has expired; or
Amendment 93 #
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 theeach making is to take place, and to the certificate holder in the relevant Member State, no later than three months before the start date of making in that Member State. The information should be provided before the making is intended to starto start at the earliest for the first time 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 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. The 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 the holder of the certificate of the maker’s intention.
Amendment 97 #
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 28 daythree months before the intended 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;
Amendment 100 #
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, of the information listed in points [(a), (c), (e) and (f)] of paragraph 3 no later than three months 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;
Amendment 101 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) The maker should also inform the certificate holder, in writing, of the intention to make a product pursuant to the exception. A notification form should be provided for this purpose, which will differ from the one used to notify the authority in that it will not contain confidential or commercially sensitive information. This information should be updated when appropriate.
Amendment 102 #
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 b (new)
Article 4 – paragraph 2 – point b b (new)
(b b) the notification to the certificate holder shall not contain any confidential or commercially sensitive information.
Amendment 105 #
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)
Amendment 109 #
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 114 #
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 list of the intended third country or third countries to which the product is to be exported. If the maker, after the list is provided, intends to export to further countries, it shall provide a notification within the time period specified in Art 4(2)(b).
Amendment 115 #
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. The making and related acts should only fall outside the protection conferred by a supplementary protection certificate if the product is labelled in this manner. This labelling obligation would be without prejudice to labelling requirements of third countries. Furthermore, 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. Therefore, this regulation should prohibit a product exclusively intended for the purpose of export to third countries from bearing such Unique Identifier.
Amendment 120 #
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 127 #
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 141 #
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 156 #
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 of export to third countries where no protection for the medicinal product exists or has expired; or
Amendment 172 #
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 28 daythree months before the intended 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;;
Amendment 178 #
(ba) the certificate holder is informed, in writing, by the maker, of the information listed in points [(a), (c), (e) and (f)] of paragraph 3 no later than three months 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;
Amendment 179 #
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 b (new)
Article 4 – paragraph 2 – point b b (new)
(bb) the notification to the certificate holder shall not contain any confidential or commercially sensitive information.
Amendment 183 #
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)
Amendment 204 #
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
(f) an indicative list of the intended third country or third countries to which the product is to be exported. If the maker, after the list is provided, intends to export to further countries, it shall provide a notification within the time period specified in Art 4(2)(b).
Amendment 218 #
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 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)].;