Generic drugmakers call to make Europe the 'medicines manufacturer of the world'

The key message delivered at the annual conference of the European Generic medicines Association (EGA) in Cascais, Portugal, last week was that Europe must seize on new opportunities to increase employment and create growth in the generic and biosimilar medicines markets.

With the global biosimilar and generic medicines markets set to expand significantly over the next 10 years, it is imperative that Europe acts swiftly on the global stage. The EGA is therefore calling for the establishment of a European Union export Bolar provision to take advantage of this new situation. This would allow the European generic and biosimilar medicines manufacturers to develop and manufacture within the patent/SPC life, provided these products are intended for export.

Some countries permit the manufacturers of generic pharmaceuticals to use the technology of a patented pharmaceutical to perform work that would assist in the marketing or regulatory approval of the generic product, while the patent is in force. This "Bolar" provision then allows the generic producer to market and manufacture their goods as soon as the patent expires.