MHRA still working to understand Brexit ramifications

28 June 2016

The UK’s drug and medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said Monday it is still working to understand the full ramifications of the country’s departure from the EU.

“Following the result of the referendum on the UK’s membership of the European Union, the focus of the Medicines and Healthcare products Regulatory Agency continues to be on our public health role,” the agency said on Monday. “We will continue to work to the highest levels of excellence and quality, working with and supporting our customers, partners and stakeholders to protect health and improve lives.”

At stake is a whole host of issues linked to the UK referendum, including but not limited to: How the UK will authorize new drugs and medical devices outside of the EU’s centralized authorization process, which it’s relied on for decades; how quickly and where the European Medicines Agency (EMA) and its hundreds of employees will relocate during the two-year period, when these negotiations have to be drawn up, or after (current headquarters are in London); how EMA and MHRA officials will interact on foreign and domestic manufacturing and clinical trial site inspections; and how the UK will restructure its import/export process from and to countries outside the EU to ensure a safe drug and device supply chain.

“Working closely with government we will consider the implications for the work of the Agency. We will continue to make a major contribution globally to improving public health through the effective regulation of medicines and medical devices, underpinned by science and research,” MHRA said.

UK Notified Bodies

Another potential sticking point for UK medical devices and their future is whether UK notified bodies, the third-parties that authorize the use of devices across the EU, will be able to continue to work within the confines of EU law.

The UK’s National Standards Body, known as the British Standards Institutions (BSI), said late Sunday that it will continue and its role “as an EU Notified Body will not change while UK Government sets out the arrangements for its withdrawal from the EU. We anticipate that products already certified and those certified while the negotiations progress, will continue to be accepted by the EU authorities and member states of the EU.”

Part of those negotiations will hinge on the vagueness of Article 50, which EU countries have to trigger (and which UK Parliament would need to authorize the use of) in order to leave the EU.

“There are recognized existing mechanisms in place for non-EU countries to participate [in the EU], these include the Mutual Recognition Agreements between the EU and America, Canada, Australia, Switzerland and Japan,” BSI said. “Regulatory authorities in these countries designate Notified Bodies to carry out these activities in the same way as member states of the EU.”

And for now, as the UK and EU politicians hammer out the details of how the UK will actually make its Brexit, lots of commentators are offering various opinions on the options the UK has, which includes remaining in the European Economic Area (EEA) to hold onto the progress made at the EU level for medicine and device regulation, or functioning more like Switzerland.

“My best guess is that the situation between the EU and UK will come to look very much like that between Switzerland and the EU, because I do not expect the UK to settle for EEA membership (as sort of EU light, which allows for example Norway to have notified bodies and have mutual recognition),” Netherlands-based medical device lawyer Erik Vollebregt wrote on Sunday. “EEA membership means automatic implementation of most EU law with none of the influence of a member state in its legislative process.”

Whatever happens moving forward, what remains clear is that MHRA will need to continue to work closely with its EMA counterparts to ensure public health is not impacted by Brexit.

As Sir Kent Woods, UK's former chairman of the EMA board, warned in May: "The UK on its own, representing 2.5% of the world pharmaceutical market, could not build an equivalent regulatory structure for an industry which is now truly global."

Source: RAPS