Germany debates adding APIs to counterfeit legislation

An amendment to Germany’s Medicines Act could make it illegal not only to counterfeit finished pharmaceutical products but also active pharmaceutical ingredients (APIs).

The so-called 15th amendment, which is scheduled to be debated in an overnight session of the German parliament in Berlin this evening, will make it illegal to transport, distribute and trade in falsified APIs.

Prior to this amendment the law only made reference to finished pharmaceutical products.

The issue of API quality and supply chain security came to prominence last year with the contaminated heparin scandal, and the widespread attention to this case is thought to have been a factor behind the decision by the European Commission to include tighter requirements for the manufacture and marketing of APIs in its proposed ‘pharmaceutical package.’

The EC is proposing to require a mandatory notification procedure for manufacturers and importers of APIs, enhance audit and enforceability of GMP and improve GMP inspections for actives.

Thomas Brueckner, head of pharmaceutical affairs at the German Pharmaceutical Industry Association, said the German amendment shows the country is ahead the field in tackling the issue of substandard and falsified APIs, but some significant problems remain, not least the difficulty in actually defining API counterfeiting.

“It’s comparatively easy to define what is meant by a counterfeit medicine, but much harder for an API,” he told the Anti-Counterfeiting Pharma conference in Wiesbaden yesterday.

For APIs the intellectual property level is much lower, because the ways of manufacturing them are often common knowledge, in that they are written down in national and international pharmacopoeias, he said.

“That means that anyone can make them, and it is thus harder to establish what is in fact a falsified API,” said Brueckner.

Conversely, if a pharmaceutical manufacturer buys an API and realise that it consists not only of the desired material but also foreign matter, is that already a falsification? he asked.

“At the moment this situation is not clear, he said. “Everyone is talking about falsified APIs, but no-one knows exactly what that means as there is no definition.”