EGA calls for improved regulatory environment for generics and biosimilars in Europe

Greg Perry, director general of the European Generic medicines Association (EGA) opened the 9th edition of the EGA Scientific and Regulatory Affairs Conference held recently in London, UK, by reiterating the association's vision to create an improved European regulatory framework for generic and biosimilar medicines. Entitled Vision 2015, the plan aims to meet three main objectives: create a globally competitive generic industry, increase patient access to affordable quality medicines and ensure sustainable healthcare in Europe.

He emphasized that significant successes had been achieved in the regulatory system since its reform in 2003 but there is clearly room for improvement. 'Generic medicines are one of the most competitive sectors in Europe, accounting for almost 50% of all the medicines dispensed, bringing combined savings of between 25 and 30 billion euros ($35.3 billion-$42.39 billion) yearly. And yet numerous hurdles crop up as a result of anti-competitive activities that create unnecessary delays in the development and introduction of new generic medicines. Our vision will create a clear, open market that will benefit patients everywhere, spur innovation and generate considerable savings. Some reforms will require new law others can be achieved by better application of the current law." Mr Perry said.

Five steps to achieving objective