How effective is the MHRA?
Jim Thomson, EAASM Chair, asks whether UK patients are safe from counterfeit medicines, when the Medicines and Healthcare products Regulatory Agency (MHRA) randomly sampled only 0.000357% of medicine packs in the supply chain in the ten years leading up to 2005. Read the whole article, which critically examines the MHRA’s distinction between ‘parallel trade’ and ‘parallel distribution’, and calls for an immediate end to both. (29 October 2007, Pharma Marketletter)
Seven different types of counterfeit three-pack condoms have been found in retail outlets (e.g. corner shops and newsagents) in Hakney, London, UK. Counterfeit condoms may not be manufactured to the appropriate European standards, and therefore may not provide adequate protection against sexually transmitted infection or pregnancy. The Medicines and Healthcare products Regulatory Agency will be sending out a Medical Device Alert to those involved in condom distribution including pharmacies, contraception services and sexual health clinics. (26 October 2007, MHRA)
Anti-counterfeiting trade agreement
The European Union’s Executive Commission has announced that the EU should join an agreement between the world’s biggest economies to fight counterfeiting in countries such as China and Russia. A new Anti-Counterfeiting Trade Agreement, first proposed by the United States and Japan, would safeguard people from counterfeit products, including the growing problem of fake medicines, the Commission said, as well as helping efforts to protect intellectual property around the world. Fake drugs are estimated to account for almost 10 percent of world trade in medicines. (23 October 2007, Reuters)
Pact against counterfeit medicines
The European Alliance for Safe Medicines today welcomed the announcement of the European Generic Medicines Industry’s ‚Pact Against Counterfeit Medicines‘. Commending the industry on taking this initiative, Jim Thomson, EAASM Chair said, “There is little doubt that, as investigative attention is more focussed on branded medicines, counterfeiters will turn their attention to generics. However, it remains unclear what the Pact will consist of in real terms, as it does not include the implementation of any technological measures – even the most basic 2D bar-coding.”
The EAASM acknowledges that technology can be expensive and that the reimbursement price for generics is often lower than for branded medicines.That said, they are often used in far higher volumes and it is perhaps misleading to suggest that they are not counterfeited.Counterfeits are often uncovered by the security teams of the major manufacturers and generics manufacturers do not employ the same level of security personnel.Therefore, although it is to be expected that the level of counterfeit generic ‚finds‘ will be much lower, it does not necessarily follow that they are not out there.
While any progress in anti-counterfeiting is to be welcomed, the Pact must be based on action. As Thomson points out, “To mean anything at all, this Pact must focus on patient safety. Yes, some technological solutions can be expensive but others are not and, in any event, what is the price of patient safety?The EAASM looks forward to seeing some real patient safety outcomes as a result of the Pact.We also look forward to seeing the generics industry take real action to protect its ultimate customer, the patient, much as the innovative sector of the industry is doing.” (4 October 2007, Jim Thomson, EAASM Chair)
Dangers of internet health research
At least one per cent of patients now order medicines over the internet for reasons including speed and refusal of certain drugs by a GP. The risks associated with bypassing traditional methods of obtaining medicines should not be underestimated. Drugs prescribed via the internet could interfere with current medication or, at worst, be counterfeit. There are important reasons why drugs are tightly controlled and should only be prescribed by a medical professional. Life-threatening problems also occur because not all websites are regulated and information could be being supplied by somebody with a vested interest. (1 October 2007, Western Mail, Wales, UK)