12 Amendments of Francisco de Paula GAMBUS MILLET related to 2018/0161(COD)
Amendment 42 #
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, namely the Day-1 entry. 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 49 #
Proposal for a regulation
Recital 8
Recital 8
(8) In those specific and limited circumstances, and in order to creatit 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 countries andwell as any related acts strictly necessary for that making or for the actual export or that entry onto the Union market itself.
Amendment 61 #
Proposal for a regulation
Recital 9
Recital 9
(9) That exception should cover the making of the product, including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a Member State, for the exclusive purpose of export to third countries, as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the makerprotected by a supplementary protection certificate, including the making of the corresponding medicinal product, in the territory of a Member State, for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for Day-1 entry on the Union's market, as well as any upstream or downstream acts, where such acts would otherwise require the consent of the certificate-holder, and are strictly necessary for making for the purpose of export or for the actual export itself and for Day-1 Entry. For instance, such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product to which the product covered by the certificate corresponds, or, temporary storage of the product or medicinal product, advertising for othe exclusivr activities necessary for the purpose of actually exporting to third country destinations or Day-1 Entry.
Amendment 70 #
Proposal for a regulation
Recital 10
Recital 10
(10) The exception should not cover placing thea medicinal product made for the exclusive purpose of export and Day-1 entry on the market in thea Member State where a supplementary protection certificate is in force, either directly or indirectly after export, nor should it cover re-importation of the medicinal product to the market of a Member State in which a certificate is in force. Moreover, it should not cover any act or activity for the purpose of import of medicinal products, or parts of medicinal products, into the Union merely for the purposes of repackaging and re-exporting.
Amendment 76 #
Proposal for a regulation
Recital 11
Recital 11
(11) By limiting the scope of the exception to making for the purposes of Day-1 entry and of export outside the Union and acts strictly necessary for such making or for the actual export itself, the exception introduced by this Regulation will not unreasonably conflict with normal exploitation of the product or medicinal product in the Member State where the certificate is in force, nor unreasonably prejudice the legitimate interests of the certificate-holder, taking account of the legitimate interests of third parties.
Amendment 81 #
Amendment 89 #
Proposal for a regulation
Recital 13
Recital 13
Amendment 106 #
Proposal for a regulation
Recital 14
Recital 14
Amendment 112 #
Proposal for a regulation
Recital 15
Recital 15
Amendment 121 #
Proposal for a regulation
Recital 19
Recital 19
Amendment 131 #
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 137 #
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 date after entry into force of this Regulation and by imposing certain conditions on the application of the exception,the right to healthcare 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 the Article 6 TFEU on the right to health protection for European citizens.