Counterfeiting of medicines
Counterfeiting of medicines is a criminal act that puts peoples’ lives at risk. It is often part of organised crime. We welcome and support the MHRA’s decision to treat it as such and to develop a professional enforcement team with experts in law enforcement and intelligence gathering. This is an appropriate response by the regulator.
A counterfeit medicine can only reach a patient through community pharmacies if someone in the legitimate supply chain has done business with a criminal. So the most effective way of preventing counterfeiting of medicines is to ensure the integrity of the medicines supply chain through all parties “doing business with certified partners only”. We therefore welcome the approach taken by the MHRA to consult on changes to the regulation of the medicines supply chain which would allow this principle to be applied.
Technical features as being proposed by the European Commission (such as mass serialisation, seals, or other similar features) do not stop criminal behaviour such as counterfeiting. They can only be seen as secondary lines of defence potentially helping to trace identified counterfeit medicines, and may give a false sense of security. They should therefore only be applied compulsorily to products at high risk of counterfeiting and where they could be cost-effective.
Unsurprisingly, counterfeiters focus their efforts on high priced branded products and not generics. Though we are not complacent, we note that no counterfeit generic medicine has been discovered in the European Union. We welcome the European Commission’s proposal that the technical measures that it is proposing should only be applied to specific products or product categories after a risk assessment and its acknowledgement that generic medicines have specific characteristics in this regard.
