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The Proposed European Approach to BOLAR: An Appropriate Adaptation of the Experimental Use Exemption for the European Community?

The Importance of Clinical Trials

The authorisation of medicinal products requires clinical trials without which therapeutic progress would be impossible. Although the safety and efficacy of new medicinal substances are first tested in vitro (the analytical test) and in tests with animals (the pharmacological-toxicological test), the therapeutic efficacy of a drug is only finally established by a trial in humans (the clinical trial).

Clinical trials are usually also conducted for authorisation of well-established medicines - that is, the authorisation of generic medicinal products - for which an abridged authorisation procedure is available if the generic is 'essentially similar' to the well-established reference drug. In a judgement made on 3rd December 1998 (the 'Generics judgement'), the European Court of Justice (ECJ) held, among other things, that a medicinal product is essentially similar to an original medicinal product when (1):


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By Dr Manja Epping, Lawyer at Ashurst and Ina Gerstberger, Lawyer at Taylor Wessing

Dr Manja Epping is a qualified lawyer working in the Munich office of international law firm Ashurst. In 1990 she took a French degree (Maоtrise en droit) in international and European law. After having qualified in Germany in 1995, Manja wrote her doctoral thesis on German and international arbitration law. Since then, she has specialised in German and European intellectual property law including regulatory issues, with a particular focus on the pharmaceutical and nutraceutical industries. She is an experienced litigator and a regular speaker at conferences.

Ina Gerstberger studied Biochemistry and Law and worked as a Research Assistant at the Department of Public Law at the University of Hannover. She is now a qualified lawyer at the Munich office of the international full-service law firm Taylor Wessing. Ina specialises in pharmaceuticals, chemistry and biotechnology patent matters and the protection of plant varieties. She also advises clients on R&D and licensing contracts. Ina has particular expertise in delimitation of pharmaceuticals, foodstuffs, medical devices and the approval of biocides, as well as unfair competition law in relation to medicinal products. She is a regular speaker at conferences.
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Manja Epping
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Ina Gerstberger
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