2 Amendments of Mireille D'ORNANO related to 2018/0161(COD)
Amendment 36 #
Proposal for a regulation
Recital 6
Recital 6
(6) Without any intervention, the viability of the manufacture of generics and biosimilars in the Union could be under threat, with consequences for the Union’s pharmaceutical industrial base as a whole, against the backdrop of serious problems affecting industrial activities in many Member States.
Amendment 39 #
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 and thereby help to prevent shortages of certain medicines, like those which have occurred recently, by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate.