BHA calls for ‘critical’ regulatory arrangements be made in Brexit negotiations

The Brexit Health Alliance (BHA), which brings together the NHS, medical research, industry, patients and public health organisations, has urged for regulatory arrangements to be made as a matter of urgency to prevent any potential risk to public health as a result of Brexit.

In its briefing, released today (29 January), the BHA has summarised the potential impact Brexit may have on patient access to medicines and medical devices and released what it would like to see happen to ensure patients are not negatively affected.

As Brexit is progressing into the second phase of Article 50 negotiations and the relocation of the European Medicines Agency to Amsterdam has been confirmed, it is critical in the view of the BHA to address regulatory changes that may affect access for patients to medicines and medical devices.

Currently, regulatory arrangements are very complex in nature and are managed by an EU-wide system. If there are changes to these arrangements, then the supply of medicines and devices may be affected across Europe.

In the briefing, the alliance goes into detail about how access could be affected, particularly noting that in a ‘no-deal’ or a deal that does not address future cooperation situation patients may experience a delay in access to medicines and medical devices. It highlights the case of non-EMA member country Switzerland, which, despite having several bilateral trade agreements with the EU, tends to gain access to medicines about five months later than the EU on average.

However, it also states that going the other way there could be implications for the EMA and the EU as a result of the UK’s exit and as such its regulatory authority the Medicines and Healthcare Products Regulatory Agency (MHRA). Last year, it has been reported that the MHRA led a fifth of scientific evaluations of mew medicines for the EMA, therefore, the EMA’s relocation and loss of the MHRA could have an impact on the approval of medicines for the EU.

This impact is specified as being even higher within the medical devices space, where, the briefing reports, about half of assessment work needed to attain approval for products currently takes place in the UK.

The supply of medicines will also be affected if arrangements are not put in place as after March 2019, the marketing authorisations that are held by a UK company for medicines will not be valid for legal supply into the EU and vice versa. With a vast amount of licences (accounting for 36% of products) that are currently applicable under the central marketing authorisation procedure, a ‘no-deal’ or one that does not mutually recognise these licences will seriously impact supply to patients.

Another area, highlighted in the briefing that will be affected by the outcome of Brexit negotiations is that of clinical trials. With many currently registered that will still be ongoing when March 2019 arrives, their continuation may be jeopardised due to regulatory framework issues or a lack of access to the new EU infrastructure.

“It’s 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,” said Aisling Burnand, chief executive of the Association of Medical Research Charities when speaking to The Guardian.

In the same report from The Guardian the Department of Health and Social Care rejected the BHA’s concerns, with a spokesman stating: “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 cooperation and a strong regulatory framework.”

What the Brexit Health Alliance is calling for:

• No negative impact on patients. Future cooperation on medical devices and medicines to be prioritised in the negotiations, so that patients and the wider public are not negatively impacted from disruptions in the supply of medicines and other health technologies, or from a reduction in standards or safety.
• Patient safety and public health to be guaranteed post Brexit through aligning the UK as much as possible with the EU’s regulation of medicines and medical devices, and by close regulatory cooperation between the EU and UK, as proposed by the UK government.
• Pragmatic solutions allowing patients and the public to bene t from the UK’s participation in EU systems such as data sharing networks, pharmacovigilance and the new clinical trials infrastructures post Brexit.
• An implementation period beyond the two years of Article 50 negotiations (which end in March 2019). This period should adequately reflect the time needed to ensure relevant customs, trade and regulatory procedures are in place.