The UK could become a dumping ground for counterfeit medicines after Brexit if it fails to continue to sign up to the European Union (EU) falsified medicines directive, Scottish community pharmacy owners have warned members of the Scottish parliament.
Matt Barclay, director of operations at Community Pharmacy Scotland (CPS) — which represents pharmacy owners — said he was hopeful that the new EU regulation, due to be introduced next February to tighten control over the medicines supply chain against counterfeit medicines, would still be applied across the UK after Brexit.
He told members of the Scottish parliament’s health and sport committee: “If we have reversal of the Falsified Medicines Directive, and it is fair to say that there is no indication that it will not be part of the system [post Brexit], … but if it were to fall, it would mean the UK could become the dumping ground for counterfeit medicines, because we would not have the same safeguards that the other EU states have. The whole system then becomes a patient safety issue.”
His warning came during his evidence to the committee that is looking at the impact of leaving the EU on health and social care in Scotland.
The CPS is also concerned about the impact on access to new drugs post-Brexit— even if, as Prime Minister Theresa May hopes, the UK successfully negotiates associate membership of the European Medicines Agency (EMA), the drug’s safety watchdog.
Barclay said he hoped that, post-Brexit, access to drugs would remain as “seamless” as it is under the present system.
He told the committee that at the moment, 90% of drugs used in the UK are imported and 50% come from the EU.
Negotiating a mutual recognition agreement between the UK and the EU around the import and export of medicines – which would avoid the need to double-test drugs and batches of drugs — is crucial if that seamless supply is to continue.
He said: “There are potential increased costs if that mutual recognition isn’t there. For the current system to be maintained and supported, it [post Brexit] has to be as aligned or as mutually reciprocal as possible.”
Michael Clancy, director of law reform at Law Society of Scotland, spelt out the scale of the problem if there was no mutual recognition agreement post-Brexit.
He told the committee that 82 million packs of drugs cross the EU into the UK every month. And without a mutually recognised system post Brexit, these drugs and batches of drugs will all have to be double-tested, slowing down access of drugs to patients, with a potential impact on patient safety.
John Brown, director of policy at the Scottish Lifesciences Association, agreed about the potential impact and revealed what its members were seeking.
He said: “The UK government position is that it will ask for associate membership of the EMA but the industry view is that the UK should have a mutual recognition agreement of health regulation…that avoids the need for double-testing. That issue is vitally important and we are pressing the government on that.
“The industry is alive to the threat of double-testing and double everything. It would be foolish to say what will happen, but there is still a degree of optimism.”
However, he revealed that the introduction of double-testing could actually have a silver lining and bring business opportunities for Scotland.
He said: “If double-testing and double-batch testing were imposed, there would be an impact on the costs of medicines but it may not be as large as some people might fear.
“We have also seen inward investment by a drug-testing company’s move to Scotland. I can’t say why they have, but it’s interesting that it has moved in at the moment.”