EGA Press Release

Thursday, 25 March 2004

EGA Board of Directors urges early implementation of “Bolar provision” for Generics to ensure the future of European Research & Development.

The Board of Directors of the European Generic medicines Association, meeting today in Dublin, Ireland, called on Member State governments to transpose the so-called “Bolar provision” of the new EU pharmaceutical Directive into national law at the earliest date possible as adopted by the European Council of Ministers on 10 March, 2004.

The provision, which covers both traditional generic medicines and new "bio-similar" products, states that “Conducting the necessary studies and trials […] and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for those medicinal products.” This European legislation effectively allows manufacturers to begin the research and development process in time to ensure that affordable equivalent generic medicines can be brought to market immediately upon the expiry of the originator product’s patent.

But until the provision is implemented by the Member States, generic manufacturers must either wait until the original patent has expired before beginning R&D work, or rely on foreign research and development in countries such as Canada, the United States or India. Waiting until patent expiry delays market entry for generic products, costing European patients and healthcare systems as much as €100 million per medicine per year. Driving R&D out to foreign laboratories denies Europe of much needed jobs for skilled researchers and laboratory technicians.

According to Rory O’Riorden, President of the EGA: “The European Union has a chance with this legislation to place its research and development industry amongst the world's leaders for generic medicines, particularly in the area of bio-similar products. Delayed implementation of these new provisions will only mean missed business opportunities, missed inward investment in R&D, and missed employment.”

Although the newly adopted Directive officially comes into effect in April 2004, transposition into national law is not required until November 2005. Certain portions of the Directive may, however, be transposed into law earlier at the discretion of the individual Member States.

Early implementation of the Bolar provision will set the scene for the European Union to become the world's leading force in Research and Development for generic medicines. This is particularly important with bio-similar products, where EU legislation is more advanced than in any other country, giving Europe a head start over the United States, for example.

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