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RPS: Brexit poses counterfeit medicines risk as FMD benefits lost

The government must put “robust plans” in place to ensure counterfeit medicines don’t enter the supply chain as FMD ceases to apply across the UK post Brexit, the RPS has said.

The Royal Pharmaceutical Society (RPS) is “concerned” that removal of EU anti-counterfeit drugs legislation known as the Falsified Medicines Directive (FMD) could leave the UK “vulnerable to an influx of counterfeit medicines,” it warned yesterday (October 13).

FMD came into force in February 2019, but “under current plans”, the UK will “cease to benefit” from it once the Brexit transition period ends on December 31, the RPS said in a statement.

The RPS has therefore written to health secretary Matt Hancock emphasising the “need for robust plans to be put in place urgently to maintain formal links with the EU to help authenticate the legitimacy of medicines that move between the EU and the UK”, it explained

RPS president Sandra Gidley 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”.

In its letter to Mr Hancock, the RPS has “emphasised that establishing technical agreements with the EU is now more critical than ever in our fight against counterfeit medicines,” she said.

Ms Gidley highlighted the “significant investment made by the NHS, pharmacy organisations and individual pharmacy owners in the infrastructure for FMD”, and stressed that the RPS is advocating for the FMD provisions to continue to apply in the UK.

A spokesperson for the Department of Health and Social Care (DH) told C+D yesterday that it is “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”.

“Protect the supply of medicines into Northern Ireland”

Last week (October 6), the UK FMD Working Group for Community Pharmacy - whose members include the National Pharmacy Association, the Company Chemists’ Association and the Pharmaceutical Services Negotiating Committee (PSNC) – called on the government to “protect the supply of medicines into Northern Ireland” after the end of the transition period.

Under the terms of the Northern Ireland protocol of the EU Withdrawal Agreement pharmacies in Northern Ireland will still be required to comply with FMD after December 31 as the directive will continue to apply in the country, unlike in England, Scotland and Wales

Raj Patel, chair of the UK FMD Working Group, warned that “pharmacies in Northern Ireland might quickly find themselves short of supplies and unable to service patients’ needs”, if it becomes “unviable for manufacturers and wholesalers to put stock into Northern Ireland”.

“Since medicines regulation is not a devolved responsibility, we are asking the Westminster government to clarify what arrangements it has for medicine verification in Northern Ireland after December 31,” Mr Patel said.

Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies (AIMp), told C+D last week (October 8) that the “potential for shortages to become worse in Northern Ireland post-Brexit is clear”. AIMp expects the UK government to “have risk-assessed this and to take proactive action to prevent it”, she added.

The PSNC announced yesterday that it has reconvened the Community Pharmacy Brexit Forum – a group that “brings together more than 20 organisations across the pharmacy, wholesale and wider primary care sectors to discuss Brexit matters”.

Forum members said were also concerned about the “lack of clarity around supplies of medicines from Great Britain to Northern Ireland after 31 December 2020, and the potential for prescribing periods to be extended ahead of the Brexit deadline”

Do you think FMD should be kept after the transition period ends?

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