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malgosia janicka

With the UK government focusing its efforts on controlling the renewed, and much sharper, COVID-19 threat in 2021, the true impact of Brexit on the local medtech and life sciences sectors will not be known for some time.

For the present, wish lists and expert insight are helping give shape to the post-EU UK medtech sector. They refer to the global potential of a free-standing, agile regulatory system, the promise to better prioritize patient safety, and of a globally competitive, digitally-enabled ecosystem that will serve to support innovation and encourage overseas investment.

The impact that Brexit might have on UK life sciences trade and regulation was the focus of the third annual report of the UK All-Party Parliamentary Group (APPG) on Access to Medicines and Medical Devices (December 2020). Summing up the views of 37 stakeholders (22 from industry), it proposed a series of recommendations designed to maximize the future chances for UK medtech and pharma.

In turn ambitious, cautionary and realistic, the report’s recommendations offered a sober appraisal of both the opportunities and potential pitfalls in the immediate and mid- to longer term for the UK in the post-EU era.

The report stressed that post-Brexit supply chain disruption due to additional checks at borders is a central concern of patients and industry. In particular, the Northern Ireland protocol is seen by many APPG members as an immediate threat to the continuity of medicines and medical devices access in Northern Ireland.

Simplified Trade Channels Urged By Industry

This Brexit bureaucracy is viewed dimly by German medtech companies, however, they appear relieved that “no deal” was avoided, and harmonized medtech market access will be perpetuated.

Industries relying on just-in-time delivery must in future adopt warehouse-based operations in the UK, given the added bureaucracy of processes including new customs clearances, said Wolfgang Weber, chair of the German electromedical industry association ZVEI.

Partial solutions might be risk-based customs inspections and “pre-arrival processing” of goods either side of the English Channel.

But speaking to the doctor’s daily news portal Ärztezeitung, he claimed that EU-UK trade would undergo long term damage. Major business sectors including medtech are already reducing their investment in the UK, he said.

UKCA Mark Global Recognition Vital

Enhancing the UK medtech’s global reputation and ensuring recognition of the new UKCA mark for devices are therefore seen as essential. The UK’s trade negotiations should focus on ensuring an international standing for the UKCA mark, said the APPG report, both in markets where the CE mark is recognized and in those where it is not. The APPG called on the Medicines and Healthcare products Regulatory Agency (MHRA) to develop an implementation plan for how the UKCA mark will be recognized outside the UK.

The UK medtech sector has called for future UKCA marking to be carried out electronically, rather than physically printed on product labels. Moreover, artificial intelligence and digital technology should be employed more widely by the MHRA “to develop a more reliable system.”

Digital technology should similarly be applied in future medtech data registries and also to develop a more robust market surveillance system, in line with the recommendations of the Cumberlege Review, the report added. (Also see "UK MHRA In The Spotlight As Cumberlege Review Puts Medtech Safety At The Top Of Health Agenda" - Medtech Insight, 9 Jul, 2020.)

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