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June 18, 2012 6:07 pm
European patients face the prospect of medicine shortages if legislation designed to ensure the high quality of ingredients goes ahead as planned next year, top drug company executives have warned.
An EU law set to be implemented by July 2013 would impose higher standards of proof of the purity of any “active pharmaceutical ingredients” – the contents of medicines – which come from outside the EU.
The action reflects intensifying concerns over quality at a time of growing globalisation of drug manufacturing, but drug companies say the new rules are both unnecessary and unrealistic, imposing regulations that both suppliers and manufacturers will struggle to meet in the months ahead.
Addressing the annual meeting of the European Generics Association, the trade body, in Malta, last week Gudbjorg Edda Eggertsdottir, a senior executive at Actavis, one of the EU’s larger medicine suppliers, said: “Twenty five per cent of our medicines in Europe are in danger of becoming unavailable after July 2013.”
Responding to pricing pressures, pharmaceutical companies are increasingly reliant on low-cost suppliers from India and China for the ingredients of their medicines. A handful of cases – including infected Chinese-made Heparin, a blood thinner, discovered in the US in 2007 – have stoked a debate on the scant scrutiny by western regulators of international suppliers.
The new European rules call for regulators in countries outside the EU providing raw materials for drugs sold within Europe to certify all their own domestic suppliers; or to approve the quality of each individual batch sent to manufacturers into Europe.
John Dalli, the EU health commissioner, insisted the law would go ahead as planned and played down the impact on industry. “All these controls are seen by the industry as an additional cost,” he told the Financial Times. “But they are an insurance against anything going wrong, which if it did would have astronomical costs in human suffering and economically.”
Ms Eggertsdottir’s concerns are shared across the EU pharmaceutical industry. “It really does create a huge risk,” said Nick Haggar, head of commercial operations for western Europe at Sandoz, the world’s second-largest generic drugmaker. Anish Mehta, vice-president of European generics at Watson, said adapting to the new rules would take time: “The entire market infrastructure has to be changed.”
Some observers suggest EU officials and parliamentarians have overreacted to concerns about counterfeit medicines sold illegally via the internet. While these products are often substandard, there have been few examples of poor quality raw materials or finished drugs sold within Europe by regulated, legitimate manufacturers.
Two instances identified by regulators in Italy in recent years showed a failure by the manufacturers to meet all documented requirements on paper, but laboratory analysis of the drugs themselves showed that the ingredients met the required standards.
Generic drug companies are already concerned that sharp price cuts and the introduction of aggressive competitive tenders introduced in recent months by European countries seeking to reduce healthcare expenditures are undermining the health of the industry and could spark shortages.
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