The Bolar Exemption - Introduction

In order to market a medicinal product a manufacturer must first obtain regulatory approval by conducting clinical tests and trials to prove that the product is safe and effective. Producers of generic medicines are able to use the original manufacturer's approval if they can demonstrate that the generic version is bioequivalent to the approved medicine. However, the generic producer runs the risk of patent infringement if they conduct clinical trials on a patented product before the patent has expired. The 'Bolar’ exemption means that these necessary studies, tests and trials will not amount to patent infringement.

The Bolar exemption was a small part of a comprehensive reform of the current European Union pharmaceutical legislation proposed by the European Commission in July 2001. This consists of three proposals: a regulation on marketing authorisations and the functioning of European Medicines Evaluation Agency (EMEA); directive on medicinal products for human use; and a directive on veterinary medicinal products.

Within the two directives on medicinal products are proposals to allow the Bolar exemption. These can be found in Article 10, paragraph 5 of the directive on medicinal products for human use and Article 13, paragraph 6 of directive on veterinary medicinal products. The text of these paragraphs is as follows:

"Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 (paragraphs 1 - 5 on the Veterinary Medicinal Products Directive) and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products."

Agreement on the regulation and the directives was reached between the European Council, Commission and Parliament on 18 December 2003, and the Council adopted them in March 2004.