Global Co-Operation Needed to Stem Counterfeit Medicines

16 November 2007

Increasing co-operation between international medicines regulatory agencies on monitoring licensed medicines and preventing illegal and counterfeit medicines will provide enhanced consumer protection going forward, the Chief Executive of the Irish Medicines Board (IMB), Pat O’Mahony stated today at a conference for the pharmaceutical industry. He stated that the abundance of and ceaseless attempts to market illegal and counterfeit medicines was a growing issue for regulatory authorities worldwide and that improved systems of rapid communication between countries would assist in restricting potential harmful medicines reaching consumers.  

Speaking at the Irish Healthcare Pharmaceutical Association (IPHA) annual conference, Mr. O’Mahony said that the IMB is committed to working with its counterparts at EU and international level to ensure that medicinal products placed on the Irish market are of the highest standard. He stated that already Ireland has agreements in place with the US Food & Drug Administration (FDA) as well as the MRHA in the UK for the early exchange of information – this is in addition to Ireland’s highly active role as a member of the European Medicines Agency, which promotes pan European liaison.  

Mr O’Mahony announced that Ireland will host the second International Summit of Regulatory Agencies on the 5th December in Dublin to discuss common global issues including the threat of counterfeit medicines, the operation of clinical trials and the development of efficient systems of information sharing and reporting.  

“The increasing incidence worldwide of illegal and counterfeit medicines is an international issue with consumers being mislead into thinking they may be purchasing an effective medicine. At best, they are purchasing a product that won’t work while, at worst, they are purchasing a product containing a substance other than the specified active ingredient which could damage their health.  The IMB is fully committed to working with its counterparts at EU and international level to seeking ways to restrict the supply of illegal medicines but consumers too must be vigilant.“  

The IMB states that there is no evidence that counterfeit medicinal products have been placed on the Irish market place within the legitimate supply channels. It is consistently monitoring and spot sampling in this regard. However, it has identified counterfeit medicinal products in unauthorised supply lines, such as through mail order and Internet sites. Thus, the public can expect that medicinal products it receives from authorised sources are genuine, safe, effective and of good quality.  

“We are concerned at the public health risk posed by the supply of medicinal products via the internet and our inspectorate’s actions have led to the closure of a dozen websites selling prescription-only medicines in Ireland last year; however, the IMB can only regulate and close sites registered in Ireland. As such, close cooperation with our counterparts in other jurisdictions is paramount to ensure they are notified when we identify illegal supply into Ireland from international sites and thus play a role in international website closures. The WHO estimates that some 50% of medicines sold over the Internet are counterfeit, not of good quality or not safe. We have long called for people not to purchase medicines over the internet and we again state that people should not do so they are wasting their money most times but more importantly could be endangering their health,” says Pat O’Mahony.      

At the conference, Mr. O’Mahony also highlighted a number of new regulatory processes which are in the pipeline including proposed amendments to Variations Regulations at EU level. The proposed amendments would make the assessment of variations of medicines licences more efficient, ultimately leading to more rapid availability of medicines on the market for those who need them.   

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Siobhan Molloy /Angie Grant - Weber Shandwick              
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