For new medical devices entering the UK market, they will only need to comply with the old, and for some, less stringent, device standard (MDR, 2002). The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will become the gatekeeper of all new medical device registrations.
Listed below are the industry trends impacting the Brexit theme, as identified by GlobalData.
From a Covid-19 testing perspective, the UK has been continually under pressure. Technological developments have eased the burden on testing laboratories by extending testing into the point of need setting. However, laboratories have been rapidly overwhelmed by demands for tests, increasing result reporting delays. Delayed test results have impacted track and trace efforts and have contributed to exacerbating the crisis.
While the establishment of ‘mega labs’ such as Lighthouse Laboratories helped, increasing quality control issues due to a lack of trained staff devalued their impact. The government turned to population-level testing to ease restrictions and the demand for increased point-of-care tests, such as antigen tests.
On 28 July 2021, the government made it a legal requirement that all Covid-19 tests sold in the UK undergo a mandatory approval process, to ensure they meet quality standards. GlobalData estimates the market for Covid-19 diagnostic tests in the UK was worth $1.9bn in 2021, which was the highest in Europe.
New medical device regulations
Medical device regulation is an area where the UK had scope to make different policy choices than the European Union (EU). But the MHRA recognised that the situation post-Brexit left the UK out of step with international best practice and technological developments. It published a consultation focusing on patient safety and innovation, recognising that gaining and maintaining competitiveness in a global market will be best supported by alignment with internationally recognised best practice and standards, including new EU regulations.
Although the new proposed policies closely align with EU regulations, manufacturers will still have to conform to the UK Conformity Assessed (UKCA). Investing in the US, EU, and UK each comes with a different return on capital for manufacturers. If any country tries to create additional hurdles to approval, the industry responds to those incentives. Many companies are already struggling with the demands of the Medical Device Regulation and In Vitro Diagnostics Regulation (MDR/IVDR). Coupled with the additional authorisation process required to reach the UK market, this may lead to delays or deter companies from selling their products in the UK altogether.
The National Health Service (NHS)
Covid-19 demonstrated the importance of resilient international supply chains for medicines and medical goods, such as personal protective equipment (PPE). Normal market dynamics ceased to exist, and typical NHS procurement procedures were affected. It was essential that the government adapted its approach to sourcing critical equipment and, as a result, protocols for the rapid procurement of critical equipment and PPE were implemented.
The procurement process was not a traditional competition, but continually assessed multiple options against changing requirements. In the short term, Brexit had no major impact on the NHS, but GlobalData expects disruptions in the long term.
Workforce uncertainty and migration policies
Strict controls on migration may make gaps in the health and social care workforce harder to fill. The NHS is the biggest employer in the UK, with over 1.3 million staff. Staff shortages in the UK’s healthcare sector are an ongoing problem, and Brexit may worsen the issue. According to The Department of Health data from 2017, more than 5% of nurses, 9% of doctors, 16% of dentists, and 5% of allied health professionals in England came from EU countries. London is particularly dependent on the EU healthcare workforce, with one-third of all EU.
Migration policies could affect UK citizens living across Europe. Private health insurance may have an increased role to play for these citizens and many may have to return to the UK to seek healthcare, which will increase treatment demand in the near- to medium-term.
This is an edited extract from the Brexit Impact on Medical Devices – Thematic Research report produced by GlobalData Thematic Research.