Activities of Jarosław WAŁĘSA related to 2018/0161(COD)
Plenary speeches (1)
Supplementary protection certificate for medicinal products (debate) PL
Amendments (7)
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 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 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 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 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)].;