MEP questions figure used to justify not having mandatory inspections of API plants
After analysing industry responses to its initial anti-counterfeiting proposals the European Commission (EC) published a draft directive, accompanied by a working document, in December 2008.
The document stated that there are an estimated 20,000 third-country active pharmaceutical ingredient (API) plants supplying the European Union (EU). Mandatory inspections of all these sites were regarded as too expensive and consequently excluded from the draft directive.
However, a priority question to the EC from Amalia Sartori, a member of the European Parliament (MEP), has raised doubts about whether 20,000 is the appropriate figure when considering mandatory inspections.
Sartori expects to receive a response this week but evidence supporting her doubt has already been provided by Guy Villax, CEO of Hovione, and Chris Oldenhof, president of the Active Pharmaceutical Ingredients Committee (APIC).
Oldenhof, who is also manager of external regulatory affairs at DSM and a board member of the European Fine Chemicals Group (EFCG), told Outsourcing-Pharma that the 20,000 figure is “entirely absurd”.
He explained that the estimate of 20,000 API plants came from the European Chemical Industry Council (CEFIC), Oldenhof himself to be precise, but was not intended to represent the number of sites that should be inspected.
CEFIC gave the figure in response to the question: "How many API manufacturers may be supplying to Europe in the situation that there is a lack of authority oversight?".
Consequently the figure is a rough estimate, and given the complexity it is very difficult to be certain of the true number, of the total number of API plants outside of the EU. However, only a very small proportion of these sites are allowed, legally speaking, to supply the EU.
Oldenhof said that “it is very obvious that only a small part of that grand total should be inspected” but it is difficult to give an exact figure of how many API plants the EU should be looking at.
Based on different methods of estimation and on various data sources Oldenhof gave 500 as a rough figure for the number of sites that are allowed to supply the EU but emphasised that this is “an educated guess that makes clear that 20,000 is madness”.
Taking EU anti-counterfeiting forward
The original timeline for the EU draft directive aimed for a political agreement to have been reached by 30 November 2009 but this has been delayed because of the complexity of discussions, according to Oldenhof.
He now expects the European Parliament to vote on the directive in April or May 2010 and before this point it can still be “drastically amended”. This creates the possibility that mandatory inspections could be implemented and there appears to be some political desire for this change.
Sartori, the MEP who filed the question with the EC, told Outsourcing-Pharma that she is convinced mandatory inspections are “the only effective way to protect our citizens and to guarantee the quality of medical products available in the European market”.
