Wednesday, 16th February 2011
Speech on fake medicines at Strasbourg plenary
Falsified Medicinal Products
(Amendment of Directive 2001/83/EC)
Speeech to Plenary, Strasbourg, 16 Feb.2011
Struan Stevenson MEP
There is no doubt that counterfeit medicines are a problem – customs officials stopped 32 million medicinal products in 2008 largely as a result of the MedFake campaign carried out by EU border control agencies in the Autumn of 2008. The WHO estimates that 50% of drugs supplied over the internet are falsified and there are even cases where the legitimate supply chain has been infiltrated. For example between 2005 and 2007 in the UK there were a number of cases reported by the MHRA of fake life saving products such as AstraZeneca’s prostate cancer drug Casodex and the anti-platelet drug Plavix, reaching wholesalers and even pharmacy shelves.
I therefore support the broad aims of this directive but am concerned that the costs of setting up an all inclusive product identification system might be prohibitive to smaller manufacturers of generic medicines. An EC impact assessment in 2008 estimated the cost at between €7 and €11 billion depending on the level of implementation. Today generic medicines represent nearly 50% of all medicines dispensed in the EU. Thanks to their affordable price and the broad use of the International Nonproprietary Name (INN) (rather than brand names) generic medicines are at a very low risk of being counterfeited. To date, there have been no reported cases of counterfeited generic medicines in the EU.
They also provide a source of affordable medicine to the third world. I share the concerns of both the industry and NGO’s such as Oxfam that we must be careful that any safety measures introduced are proportionate and do no adversely impact on the legitimate and much needed generic medicines industry that supply affordable, safe and readily available medicines to both the EU and developing world. I therefore hope that we can go forward with detailed discussions with all parties concerned – not just the major multinationals – on how best to implement a workable and affordable protection system.
