Brussels, 05/02/2009 (Agence Europe) - The European Generic Medicines Association (EGA) has made its position public on the investigation DG Competition at the European Commission launched last year on access to generic medicines in Europe. In its preliminary report, the Commission denounced laboratories' practices that impeded the arrival of general onto the European market (EUROPE 9793). Public consultation finished on 31 January 2009.
The EGA is requesting an amendment to European legislation on the Bolar Clause (which authorises tests on molecules covered by a patent to generic marketing as soon as the product, of which it is the copy, is no longer protected) and the Transparency Directive. Administrative and legislative procedures should be simplified in order to ensure rapid and effective decision making and subsequently reveals the need for recruiting judges for specialist patents.
A more robust examination of the demands of obtaining a patent will be needed to avoid weak or non-valid patents. This will increase the need for resources at the European Patent Office (EPO), as well as the need for information to better assess invention patentability. The EGA is proposing to make a distinction between real innovations and medicines that are not very effective so as to prevent second generation products with little or no added value get on the market. A specific ban will also be introduced to combat misleading information and marketing campaigns by innovative laboratories against their generic counterparts.
The EGA concludes that the agreements not postponing the entry of generics onto the market beyond the normal period of patent protection should not be considered as anti-competitive. (E.M./trans/rh)