It has been 50 years since the idea of authorising pharmaceuticals at European Union (EU) level first took shape and while the present system has its critics, few would say that public health in Europe is not significantly better off as a result. The process was triggered by the thalidomide tragedy of the late 1950s and early 1960s, an experience which, says the European Commission, ‘shook public health authorities and the general public (and) made it clear that to safeguard public health, no medicinal product must ever again be marketed without prior authorisation’.
Manufacturing Chemist asked public health organisations, industry and the academic community what they felt had been achieved 50 years on. ‘The founding legislation is Directive 65/65/EEC, which is what we’re really celebrating,’ said Melanie Carr, Head of the Corporate Stakeholder Department at the London-based European Medicines Agency (EMA). ‘After the thalidomide disaster it became very clear there was a need to have an evidence-based review and authorisation of medicines going onto the market and that really set the scene to have this EU review of quality, safety and efficacy. The level of harmonisation was built up progressively,’ she said. Thalidomide was first sold in what was then West Germany in 1957, and was henceforth sold around the world, creating thousands of birth defects as a side-effect.
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