EGA Press Release

Wednesday, 3 March 2010

MEPS LAUNCHED DISCUSSION ON NEW CONTROLS
OF ACTIVE PHARMACEUTICAL INGREDIENTS (APIS)

"New controls of Active Pharmaceutical Ingredients (APIs) must be workable, effective and ensure continuous supply of all medicines". This was the key message of Greg Perry director general of the European Generic medicines Association (EGA) at the round table hosted by MEP Judith Merkies and MEP Marisa Matias on "Effective Controls against Falsification in Active Pharmaceutical Ingredients and Excipients" in the European Parliament on 2 March.

Greg Perry reiterated his industry support for enhancing the current audit systems proposed by the European Commission and for the written declaration by the exporting country attesting the ‘equivalence of standards’ to those of the EU.
A common agreement was reached among various speakers on the fact that an EU certification and mandatory inspections systems would unavoidably lead to limitation of ready access to affordable and innovative treatments for EU patients. Participants welcomed that these aspects were not part of the European Commission’s proposal.

Echoing views of other parties in the round table, Judith Merkies said that much has already been done in the EU and that the European Parliament should not overburden operators and authorities in the legal supply chain. "The European Commission proposal builds effectively on current practices. The main focus now must be on how to tackle the illegal supply chain and criminals as they are the main sources of the problem" Merkies said.

The European Commission, represented by Martin Terberger, Head of the Pharmaceuticals Unit at the Health and Consumers DG, expressed its concerns on putting unrealistic requirements on API controls mainly because resources are, to date, insufficient to conduct mandatory inspections. The same remark applies to excipients used in the manufacturing of medicines. Adding to this, Greg Perry declared "Excipients are widely used by other sectors in the EU and most excipients suppliers already operate according to official international quality standards". These observations were also supported by representatives of other sectors of the pharmaceutical industry.

Concluding the event, Judith Merkies and Marisa Matias called for building on existing international cooperation of inspections as the way forward to rationalise resources and avoid duplications of inspections.

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For further information contact Julie Chauvet
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