Activities of Tadeusz ZWIEFKA related to 2018/0161(COD)
Plenary speeches (1)
Supplementary protection certificate for medicinal products (debate) PL
Amendments (34)
Amendment 27 #
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 countrywith a view to enter the Union 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 certificatemmediately after expiry of the certificate and/or export to countries in which such protection does not exist or has expired, 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 31 #
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 countrywith a view to enter the Union 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 certificatemmediately after expiry of the certificate and/or export to countries in which such protection does not exist or has expired, 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 33 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) The timely entry of generics and biosimilars onto the Union market is important for increasing competition, reducing prices and ensuring the sustainability of healthcare systems.
Amendment 39 #
Proposal for a regulation
Recital 8
Recital 8
(8) In those specific and limited circumstances, and in order to creat it is appropriate to eliminate the aforementioned, unintended side effects of the supplementary protection certificate so as to enable a level -playing field between Union-based manufacturers and those in third country manufacturers, it is appropriate to restrict the protection conferred by aies. This would enable making exclusively for (i) export to third countries and (ii) entry onto the Union market immediately after expiry of the relevant supplementary protection certificate so, as to allow making for the exclusive purpose of export to third countriewell as and any related acts strictly necessary for that making or for the actual export or that entry onto the Union market itself.
Amendment 40 #
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 with a view to enter the Union market immediately after expiry of the certificate and/or export to countries in which such protection does not exist or has expired, 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 50 #
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 enforcheck compliance wits protection in the Union and to reduce the risk of illicit diversion onto the Union market during the termh the conditions set out hereunder. Those safeguards should not negatively affect competition among companies and should allow the exception to work effectively with no disruption on the main objectives of the excerptificateon.
Amendment 50 #
Proposal for a regulation
Recital 8
Recital 8
(8) In those specific and limited circumstances, and in order to creat it is appropriate to eliminate the aforementioned, unintended side effects of the supplementary protection certificate so as to enable a level -playing field between Union-based manufacturers and those in third country manufacturers, it is appropriate to restrict the protection conferred by aies. This would enable making exclusively for (i) export to third countries and (ii) entry onto the Union market immediately after expiry of the relevant supplementary protection certificate so, as to allow making for the exclusive purpose of export to third countriewell as and any related acts strictly necessary for that making or for the actual export or that entry onto the Union market itself.
Amendment 73 #
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, tThe exception provided for in this Regulation should only apply to certificates that are granted on or after a specified date after entry into force, irrespective of when the application for the certificate was first lodgedbecome applicable following period of 1 year after the entry into force of this Regulation. 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 78 #
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 rulesenabling the making of the product in question during the term of the certificate. 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 81 #
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 granted on or after a specified datethe right to health care in Article 35 of the Charter by making medicines more accessible to EU patients, the principle of proportionality in Article 52 of the Charter, point (a) of Article 6 TFEU on the right to health protection for European citizens, while allowing a reasonable predictability for applicants and other relevant market players, by postponing the application of the exception until expiry of a period of 1 year after the entry into force of this Regulation and by imposing certain conditions on the application of the exception,
Amendment 82 #
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 enforcheck compliance wits protection in the Union and to reduce the risk of illicit diversion onto the Union market during the termh the conditions set out hereunder. Those safeguards should not negatively affect competition among companies and should allow the exception to work effectively with no disruption on the main objectives of the excerptificateon.
Amendment 94 #
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 enforcheck compliance wits protection in the Union and to reduce the risk of illicit diversion onto the Union market during the termh the conditions set out hereunder. Those safeguards should not negatively affect competition among companies and should allow the exception to work effectively with no disruption on the main objectives of the excerptificate.on
Amendment 97 #
Proposal for a regulation
Recital 13
Recital 13
(13) To this end, this Regulation should impose a once-off duty and to the extent it intends to rely on the exception, the person responsible for the 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 placemaker’), or any person acting on its behalf, should provide certain information to the registered holder(s) of the certificate, at its (their) registered address(es) on a confidentiality basis. 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, shwould onlyaltogether fall within the scope of the exception where, provided that 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 sholder of the certificate. The notification should be without prejudice to any defences otherwise available to the maker and any other persons conducting the related acts referred to in Recital 9 against a claim from the hould 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 toer of the certificate in relation to an alleged infringement or threat of infringement of the certificate, and should not be construed as an acknowledgment by the maker that the certificate or the basic patent is valid and/or that the 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 in or any of the related acts referred to in Recital 9 would otherwise infringe the certificate and/or the basic patention.
Amendment 105 #
Proposal for a regulation
Recital 13
Recital 13
(13) To this end, and to the extent it intends to rely on the exception, this Regulation should impose a once-off duty on the person makingresponsible for the making, or any person acting on its behalf, 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, shwould onlyaltogether fall within the scope of the exception where, provided that 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 whereOnly the making should be notified, not the related acts. Should making is to take place, both as regards the making in that Member State, and as regards related acts, whether performed in that or ano in more than one Member State where a certificate exists, a notification should be required in each of therse Member State, related to that making. The authority should be required to publishs. Given the confidential and highly sensitive nature of thate information, in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention contained in the notification, the authority should keep the notification and the information it contains confidential and take practical measures to protect such confidentiality.
Amendment 109 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) The maker should also inform the holder of the certificate, in writing, that a notification has been sent to the authority in relation the certificate
Amendment 118 #
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 oThe exception set out in Paragraph 2 shall become applicable following a 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 122 #
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 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 certificatesThe exception provided for in this Regulation should only become applicable following period of 1 year after the entry into force of this Regulation. 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.
Amendment 130 #
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 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.The exception provided for in this Regulation should only become applicable following period of 1 year after the entry into force of this Regulation. 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
Amendment 132 #
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 rulesenabling the making of the product in question during the term of the certificate. 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 135 #
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 granted on or after a specified datethe right to health care in Article 35 of the Charter by making medicines more accessible to EU patients, the principle of proportionality in Article 52 of the Charter, point (a) of Article 6 TFEU on the right to health protection for European citizens, while allowing a reasonable predictability for applicants and other relevant market players, by postponing the application of the exception until expiry of a period of 1 year after the entry into force of this Regulation and by imposing certain conditions on the application of the exception,.
Amendment 141 #
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 rulesenabling the making of the product in question during the term of the certificate. 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 145 #
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 granted on or after a specified datethe right to health care in Article 35 of the Charter by making medicines more accessible to EU patients, the principle of proportionality in Article 52 of the Charter, point (a) of Article 6 TFEU on the right to health protection for European citizens, while allowing a reasonable predictability for applicants and other relevant market players, by postponing the application of the exception until expiry of a period of 1 year after the entry into force of this Regulation and by imposing certain conditions on the application of the exception,.
Amendment 170 #
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) tThe authority referred to in Article 9(1) of the Member State where that making is to take placecertificate holder(s) is (are) notified at its (‘the relevant Member State’) is notified by the person doing the making (‘the maker’)ir) registered address(es), by the person responsible for the making (‘the maker’) ), or any person acting on its behalf, of the information listed in paragraph 3 no later than 28 days before, prior to the intended start date of making in that Member State;.
Amendment 189 #
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
Article 4 – paragraph 3
3. The information for the purposes of paragraph 2(b) shall be treated as strictly confidential by the holder of the certificate and be as follows:
Amendment 200 #
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 doingresponsible for the making (‘the maker’), or any person acting on its behalf, of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that Member State;
Amendment 206 #
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)
(ba) The holder of the certificate is also informed, in writing, by the maker, or any person acting on its behalf ("the letter"), that a notification has been sent pursuant to paragraph 2(b) for a certificate prior to the intended start date of making.
Amendment 216 #
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 granted on oThe exception set out in Paragraph 2 shall become applicable following a 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 218 #
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 – introductory wording
Article 4 – paragraph 3 – introductory wording
3. The information for the purposes of paragraph 2(b) shall be treated as strictly confidential and be as follows:
Amendment 223 #
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 – subparagraph c
Article 4 – paragraph 3 – subparagraph c
(c) the number of the certificate granted in the relevant Member State,relevant certificate(s) and identification of the product, by reference to the proprietary name used by the holder of thate certificate(s);
Amendment 224 #
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 – subparagraph d
Article 4 – paragraph 3 – subparagraph d
Amendment 234 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Amendment 250 #
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 oThe exception set out in Paragraph 2 shall become applicable following a 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 259 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
4. The notification sent to an authority as referred to in Article 4(2)(b9(1) shall be published by that authority within 15 days of receipt of the notification.;keep the notification referred to in paragraph 2(b) and the information listed in paragraph 3 confidential and shall take appropriate measures to preserve such confidentiality
Amendment 263 #
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 a (new)
Article 11 – paragraph 4 a (new)
4a. The letter to the holder of the certificate as referred to in Article 2(b new) shall be treated as strictly confidential and shall not be used by the holder of the certificate for any other purpose than ensuring compliance of the maker with the conditions set out for the exception