Also calls on EU to agree to set up quality testing, pharmacovigilance systems and regulatory agency in Africa
The European Generic Medicines Association (EGA) has outlined its priorities for EU Trade Policy to EU Commissioner Karl de Gucht.
In the Transatlantic Trade and Investment Partnership (TTIP) between the European Union and the US, the EGA wants to see a single development for specialist generic and biosimilar medicines to promote the highest Transatlantic approval standards while substantially lowering development costs and avoiding the duplication of clinical trials.
In the EU-Africa relationship, the EGA is working with local industry and governments and the EU to improve pharmaceutical regulation and markets to increase access to high-quality generic and biosimilar medicines for patients.
At the 5th EU-Africa Business Forum held in Brussels this week, EGA President Nick Haggar called for an immediate political commitment to agree on setting up rigorous product quality testing, pharmacovigilance systems and regional bioequivalence centres, implementation of the African Medicines Regulatory Harmonisation programme (AMRH) and setting up the African Medicines Regulatory Agency (AMA).
The Forum emphasised the importance of increased bilateral trade and investment, and market integration for a mutually beneficial relationship between the EU and Africa. It also highlighted the common challenge of consolidating sustainable economic growth while creating jobs and improving public-private partnerships.
The EGA is also calling on the EU to introduce an export regulation to enable the European generic and biosimilar industries to produce for export during the market exclusivity extension granted to originator industries for marketing delays (the Supplementary Protection Certificate – SPC). This measure could create up to 50,000 new jobs for Europe, the EGA said.