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EU's API anti-counterfeiting measures insufficient

By Nick Taylor , 16-Jun-2008

DSM and the European Chemical Industry Council (CEFIC) have criticised the European Commission's proposals for tackling counterfeit active pharmaceutical ingredients (APIs).

The responses were published following the EU's public consultation, which drew 100 responses from industry, civil society and health centres. CEFIC wrote that the measures "fall short" of what needs to be done and has issued numerous recommendations for how the document can be improved with regard to APIs. The response from DSM said: "Though we regard the rough outline of proposals, as included in the public consultation document, as an important step forward we find the proposed framework insufficient, too vague and containing on balance too few really new concrete elements with regards to APIs." Both parties voice concerns over the substantial proportion of API's originating from countries whose health authorities they regard as having "much lower standards", in particular India and China. Ensuring that all APIs in medicines destined for the EU market comply with good manufacturing practices (GMP) is a central tenet of the responses. Although APIs manufactured in facilities with low standards may not automatically register with people as being counterfeit the respondents call on the Commission to adopt a broader definition of "rogue APIs". This would cover counterfeit APIs and those that are regarded as "severely, deliberately non-compliant". An API would fall into the latter category if one or more parties that should have been aware of regulatory standards played a role in bringing non-compliant APIs into the EU supply chain. DSM and CEFIC are dismissive of the Commission's proposals for ensuring GMP compliance, which at best they regard as "very meagre" measures to improve the "highly inadequate API inspectional approach".


The Commission's proposals do not overturn the current EU guidance which states the need for suspicion of non-compliance with good distribution practice (GDP) or GMP before an inspection is instigated, much to the chagrin of the respondents. DSM and CEFIC believe that inspections must form the backbone of any anti-counterfeiting programme, urging the EU to launch unannounced inspections on plants, based on "risk-based priority". This is intended to discourage the EU from inspecting a disproportionate amount of plants from within its borders, which CEFIC believes has "reduced their competitiveness and innovation capacity, and it has led to a loss of jobs and the closure of many efficient EU plants".


The responses were drafted prior to confirmation of the joint inspections between the FDA and EMEA. However, it seems that at best this would only partially alleviate the concerns raised in the two responses.

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