Warning of 'influx' of fake medicines post Brexit

14 October 2020

A UK pharmaceutical trade body is calling for government measures to protect against “an influx of counterfeit medicines” as the UK leaves the EU.

The Royal Pharmaceutical Society (RPS) has written to the government warning that “robust plans” need to be implemented to ensure the legitimacy of medicines entering the UK healthcare supply chain.

After December 2020, the end of the Brexit transition period, the UK will no longer benefit from EU regulations which authenticate medicines.

In a letter to the health secretary Matt Hancock the RPS said “technical agreements” needed to be made with the EU. It recommended a continuation of the EU’s Falsified Medicines Directive (FMD), which enforces authentication requirements for “legitimate, safe and high quality” medicines. 

“We are concerned that removal of these safeguards could leave the UK vulnerable to an influx of counterfeit medicines, impacting on patient care in the UK and across the EU,” said RPS.

Sandra Gidley, RPS president, said: “It is unacceptable that in the final months of the Brexit transition period, robust plans have not been put in place to prevent falsified or counterfeit medicines entering the UK. With 45 million packs of medicines moving between the UK and the EU every month, this is a critical issue for patient safety in the UK and every European country.

“In our letter to the government we have emphasised that establishing technical agreements with the EU is now more critical than ever in our fight against counterfeit medicines. We have made it clear that the ideal way forward is for continuity of the provisions of the Falsified Medicines Directive, enabling ongoing connectivity between the UK and Europe.

“Not only will this help to provide assurances to patients about the safety of their medicines but it will also ensure the UK can continue to benefit from the significant investment made by the NHS, pharmacy organisations and individual pharmacy owners in the infrastructure for FMD.”

A spokesperson from The Department of Health and Social Care (DHSC) commented: “The Government has committed to explore all options for a national system to ensure that UK patients will continue to be protected from the public health threat posed by falsified medicines.

“We are committed to fully consulting with stakeholders on the future development of a national falsified medicines scheme that is the best fit for our national supply chain.”

The DHSC said that some of the protections introduced while the EU FMD scheme applied to the UK, including maintaining security of supply around the active pharmaceutical ingredient, will remain in place.

It added that there are provisions in the Medicines and Medical Devices Bill that will give the flexibility to develop options around any potential successor to the measures under the EU FMD, with full stakeholder input.

The UK government is currently in discussion with the European Commission on the details of delivery of the protocol, and government will publish full guidance for businesses and third parties, and will share information as soon as possible.

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