Interview: Security of supply is a priority for EMA

Published: 6-Feb-2013

Drug shortages caused by quality problems leave the EU open to an increased risk of counterfeit supplies. Guido Rasi, executive director of the EMA, shares his concerns with Manufacturing Chemist

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Many countries in Europe are experiencing serious shortages of vital drugs used to treat cancer and other major diseases. The European Association of Hospital Pharmacists (EAHP) said recently that it was ‘deeply concerned at reports from hospital pharmacists across Europe of increasing experience of medicines shortages’.

Professor Guido Rasi, executive director of the European Medicines Agency (EMA), based in London, described this as ‘an exploding problem’ and said that the EMA wanted ‘to see what role we can play and what counsel we can give in respect of the problem of the (drug) shortages’.

Although the situation has ‘a number of causes, very different causes’, he said the shortages that had been seen thus far were mostly due to quality problems, including those emanating from manufacturing facilities in the US. ‘We can see that these problems are often related to relocation of companies’ manufacturing plants to places outside their home territories,’ he suggested.

Paradoxically, however, the problems often did not occur in the manufacturing plants in the new location, ‘but instead in the manufacturing plants in their home countries, which they no longer invest in appropriately’.

‘Of course, we don’t have any direct powers or influence in that, but we expect that we will be involved in this discussion, at least on the inspection side, and we might have a role there,’ he said.

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