EGA Press Release

Tuesday, 10 November 2009

STOP FAKE MEDICINES: FOCUS ON SUPPLY CHAIN INTEGRITY AND CRIMINALISATION SAY MEPS AND EXPERTS

Policy makers must shift the focus away from technological measures to stop counterfeiting of medicines and look at real and effective solutions such as implementing and increasing criminal sanctions while ensuring that all parties do business only with certified and reliable partners.

This was the key message at the event hosted by the ALDE MEP Antonyia Parvanova at the European Parliament and organised by the European Generic medicines Association on 10 November 2009.

MEP Antonyia Parvanova stressed that "costly technology should only be considered as a secondary line of defence if all the other measures are proven to fail. Moreover, it is tough criminal sanctioning and not bar coding that is going to stop counterfeiters."

Mr Greg Perry, EGA director general, stressed that patient safety must be put first. Patients must not be alarmed since, to date, the number of counterfeit medicines reaching the patient in the legal supply chain remains extremely limited, thanks to current actions at Member State level and customs control at borders. No cases of generic medicine have been involved, since counterfeiters focus their criminal activities on well-known brands of medicines. However, no one must be complacent as counterfeiting is on the increase and one of the key solutions to ensure zero tolerance to counterfeiting is to make sure that operators in the supply chain act fully in accordance with the law and work only with legally recognised and transparent operators.

Mr Perry’s views and clear warnings were echoed by Dr. Di Giorgio, AIFA Anti-counterfeiting activities manager and secretariat of the Italian Anti-Counterfeiting Force, key speaker at the conference. He stated that "strong initiatives towards the criminalisation of the counterfeiting of medical products and similar crimes, involving the drafting of an international convention, have been initiated in the Council of Europe".

Mr. Deats, Head of Enforcement of the UK Medicines and Healthcare products Regulatory Agency (MHRA) speaking at the event said "the MHRA is committed to improving the security of the supply chain. Technology is one of a number of measures which will make the environment more difficult for the counterfeiters to operate. However we are focused on ensuring the exercise of due diligence and the reporting of suspicious transactions by those engaged in the import, wholesale and retail distribution of medicines to improve the integrity of the supply chain and adopt a risk based approach to the protection of products".

The EGA has been highly supportive of a risk assessment with the right criteria, such as price and past incidents, for all medicines that would be considered high risk medicines. If any costly technological systems are to be implemented they should guarantee to effectively stop counterfeiting, be cost-effective, cost proportional and commercial and patients’ confidential data should be secured by an independent party.

Also in line with other parties in the pharmaceutical supply chain Mr. Perry reiterated the importance of tackling the main source of counterfeit medicines, which is the internet.
Ms Antonyia Parvanova MEP introductory speech
Greg Perry's presentation

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For further information contact Hugo Carradinha
Tel: +32 (0)2 736 84 11