Regulation 2019/933 - Amendment of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products - Main contents

EN

Official Journal of the European Union

L 153/1

Regulation (EC) No 469/2009 of the European Parliament and of the Council (3) provides that any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure, as laid down in Directive 2001/82/EC (4) or 2001/83/EC (5) of the European Parliament and of the Council, may, under the terms and conditions provided for in that Regulation, be the subject of a supplementary protection certificate (‘certificate’).

By providing for a period of supplementary protection, Regulation (EC) No 469/2009 seeks to promote, within the Union, the research and innovation that is necessary to develop medicinal products, and to contribute to preventing the relocation of pharmaceutical research outside the Union to countries that might offer greater protection.

Since the adoption in 1992 of the predecessor to Regulation (EC) No 469/2009, markets have evolved significantly and there has been huge growth in the making of generics and especially of biosimilars, and in the making of their active ingredients, in particular in countries outside the Union (‘third countries’) in which protection does not exist or has expired.

The absence in Regulation (EC) No 469/2009 of any exception to the protection conferred by the certificate has had the unintended consequence of preventing makers of generics and biosimilars established in the Union from making generics and biosimilars in the Union, even for the purpose of export to third-country markets in which protection does not exist or has expired. Likewise, makers are prevented from making generics and biosimilars for the purpose of storing them for a limited period before the expiry of the certificate. Those circumstances make it more difficult for those makers, in contrast to makers located in third countries where protection does not exist or has expired, to enter the Union market immediately after expiry of the certificate, given that they are not in a position to build up production capacity for the purpose of export or for the purpose of entering the market of a Member State until the protection provided by that certificate has expired.

Those circumstances put makers of generics and biosimilars established in the Union at a significant competitive disadvantage in comparison with makers based in third countries that offer less or no protection. The Union should strike a balance between restoring a level playing field between those makers and ensuring that the essence of the exclusive rights of holders of certificates (‘certificate holders’) is guaranteed in relation to the Union market.

Without intervention, the viability of makers of generics and biosimilars established in the Union could be threatened, with consequences for the Union's pharmaceutical industrial base as a whole. That situation could affect the fully effective functioning of the internal market through the loss of potential new business opportunities for makers of generics and...