UK and EU’s future relationship must protect patients from fake meds

Representatives of the UK health sector have issued a plea that the political declaration being drawn up by the UK and EU27 countries includes clear commitments on public health, including the fight against falsified medicines.

News is just emerging from the European Council that a draft of the details of the future shape of EU-UK relations has been “agreed in principle”, but details are not yet available.

Earlier this week, the coalition of health sector players – including the NHS and figures from the pharmaceutical and biotech industries – have warned that the negotiators “have a responsibility to protect 500 million patients on both sides of the Channel.”

They want much firmer commitments than are expressed in an initial, slim document published in the wake of the Brexit withdrawal agreement agreed last week. That included references to “cooperation on matters of health security” but lacks detail and “does not make it clear how it will guarantee that patients are protected as they are today on issues including medicines safety, public health disasters and infectious disease control.”

It’s notable that preventing falsified or fraudulent medicines from entering the legal supply chain is top of the list of concerns, along with sharing data on potential medicine problems, preventing and controlling infectious diseases, and ensuring the smooth supply of drugs between the UK and Europe.

The organisations are calling for the following to be included in the text of the final Political Declaration on the future UK-EU relationship:

• To make specific reference to the importance of cooperating on the regulation of medicines;
• To make clear that the UK and EU will cooperate on protecting citizens from infectious disease and counterfeit medicines; and
• To make clear that the UK and EU will agree closer collaboration on science and innovation.

“Brexit negotiators have an opportunity to take decisions today which will protect patients in the future,” commented  Mike Thompson, chief executive of the Association of the British Pharmaceutical industry. “We are asking government to give explicit commitments on issues of public health and medicines safety which we think is the minimum that patients across Europe should expect.”

Meanwhile, the CEO of the NHS Confederation, Niall Dickson, said it should be possible to specific but non-controversial commitments” in the Declaration to make sure collaboration on areas like pharmaceutical supply and falsified medicines are retained in future.

“We need assurances from the UK and the EU authorities that they will put patients first as they negotiate details of the long-term relationship,” he added.

Earlier this year, the European Industrial Pharmacists Group’s (EIPG) warned that the combination of Brexit and the implementation of the safety features provisions of Falsified Medicines Directive – which occur within weeks of each other – could lead to medicine shortages and weaken the security of the European supply chain.

And last month, the UK Medicines and Healthcare products Regulatory Agency (MHRA) said regulations coming into force as part of the FMD – including the use of unique serialised codes on medicine packs to allow verification at the point of dispensing – would not apply to UK pharmacies if the country leaves the EU without a deal, and it would expect the UK would not have access to the EU central data hub in that scenario.

The FMD comes into effect on February 9, just before the UK is due to leave the EU on March 29.