Could a 'Hard' Brexit Disrupt Drug Supply?

Peter Russell

January 31, 2018

Patients could face delays accessing medicines they need when the UK leaves the EU, a coalition of health professionals, NHS employers and pharmaceutical companies is warning.

A briefing paper from the Brexit Health Alliance says a shared regulatory framework across the EU has provided patients with faster access to treatments. But it cautions that no deal, or one between the UK and the EU that does not address future cooperation on medicines and medical technologies could put public health at risk.

A Complex Regulatory Framework

It says current regulations for medicines and medical devices are complex and warns that changes to the current regime may have an impact on supplies across Europe, as well as to the UK.

"It is critical that UK and EU patients do not lose out on the best treatments and medical devices as the UK leaves the EU," says Niall Dickson, the Alliance's co-chair in a statement. "We want to make sure that patients continue to benefit from early access to new health technologies and cutting-edge medicines, and that includes being able to take part in international clinical trials."

According to the Brexit Health Alliance, a report by the Office of Health Economics found that depending on the final outcome of the negotiations to leave the bloc, the potential impact on the UK means:

  • The average lag of new marketing submissions for drugs and medical technologies could be 2 to 3 months

  • 5% to 15% of applications could be submitted more than a year later

  • Some products may never be marketed in the UK

Despite bilateral trade agreements with the EU, it is estimated that Switzerland gains access to new medicines on average 157 days later than the EU, the paper says.

Drugs for Prostate Cancer

In a case study, supplies of a prostate cancer medicine, made in a sophisticated process in the UK and used in 80 countries including all of Europe, could be disrupted in the event of a 'no deal' Brexit.

The paper says a possible need for duplication of quality testing and release facilities by the manufacturer to another EU country could seriously affect the supply of this cancer medication to patients, including up to 120,000 in Europe each year, as well as jeopardising skilled UK jobs.

It also warns that the future of research into new medicines and medical technologies could also be affected with many UK-led clinical trials hanging in the balance.

The Alliance says disruption has already begun while leave talks are still in progress. As a result of the relocation of the European Medicines Agency (EMA) from London to Amsterdam, the agency has already had to slow down some of its work on child and public health issues, including in the fields of anti-microbial resistance and flu pandemics.

Future Cooperation Between the UK and the EU

The Alliance makes a number of recommendations including establishing close regulatory cooperation between the EU and the UK and an extension of the 2 year implementation period for Brexit.

"What patients need is maximum co-operation and alignment between the EU and the UK on the regulation of medicines and medical devices and we very much welcome the UK Government's commitment to close collaboration with our European partners," says Niall Dickson. "Let's put patients first. Both the UK Government and European Commission must make this cooperation [a] priority in the interests of UK and EU patients."

Aisling Burnand, chief executive of the Association of Medical Research Charities, adds: "It is vital that the health of patients is prioritised in the second phase of negotiations. If not, patients in the UK and the EU could face delays in accessing potentially life-saving treatments.

"Officials on both sides of the negotiating table must have patients' best interests at heart and ensure safety considerations are paramount."

A spokesperson for the Department of Health and Social Care says in an emailed statement: "We are committed to ensuring patients in the UK continue to access the best and most innovative medicines.

"Patient safety is our priority, and we will protect it through ongoing co-operation and a strong regulatory framework."

SOURCES:

Brexit and the impact on patient access to medicines and medical technologies, Brexit Health Alliance

Department of Health and Social Care

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