For new medical devices entering the UK market, they will only have to comply with the old standard, and for some, less stringent (MDR, 2002). The UK Medicines and Healthcare Products Regulatory Agency (MHRA) will become the custodian of all new medical device registrations.
Below are industry trends impacting the Brexit theme, as identified by GlobalData.
From a Covid-19 testing perspective, the UK has been under continual pressure. Technological developments have lightened the load on test laboratories by extending testing to the point of determining requirements. However, labs were quickly overwhelmed with requests for testing, increasing delays in reporting results. The delayed test results have impacted track and trace efforts and contributed to aggravating the crisis.
Although the creation of “mega labs” such as Lighthouse Laboratories has helped, increasing quality control issues due to a lack of qualified personnel has devalued their impact. The government has turned to population-level testing to ease restrictions and increased demand for point-of-care tests, such as antigen tests.
On July 28, 2021, the government made it a legal requirement that all Covid-19 tests sold in the UK go through a mandatory approval process, to ensure they meet quality standards. GlobalData estimates that the UK Covid-19 diagnostic testing market was worth $1.9 billion in 2021, which was the highest in Europe.
New regulations on medical devices
The regulation of medical devices is an area where the UK had the opportunity to make policy choices different from those of the European Union (EU). But the MHRA has acknowledged that the post-Brexit situation has left the UK out of step with international best practice and technological developments. It released a consultation focused on patient safety and innovation, recognizing that gaining and maintaining competitiveness in a global marketplace will be best supported by alignment with internationally recognized best practices and standards, including new EU regulations.
Although the proposed new policies are closely aligned with EU regulations, manufacturers will still need to comply with UK Conformity Assessment (UKCA). Investing in the US, EU and UK each comes with a different return on capital for manufacturers. If a country tries to create additional barriers to approval, the industry responds to those incentives. Many companies are already struggling with the requirements of the Medical Device Regulation and the In Vitro Diagnostics Regulation (MDR/IVDR). Coupled with the additional authorization process required to reach the UK market, this can cause delays or deter companies from selling their products in the UK.
The National Health Service (NHS)
Covid-19 has 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 supply procedures were affected. It was essential that the government adapt its approach to procurement of 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 evaluated multiple options against changing requirements. In the short term, Brexit has not had a major impact on the NHS, but GlobalData expects long-term disruption.
Labor insecurity and migration policies
Tight migration controls can make it harder to fill labor shortages in health and social services. The NHS is the UK’s largest employer, with over 1.3 million staff. Staffing shortages in the UK healthcare sector are an ongoing problem, and Brexit could make the problem worse. According to 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 EU health workers, with a third of the whole 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 of them may need to return to the UK for treatment, increasing the demand for treatment in the short to medium term.
This is an edited excerpt from Impact of Brexit on Medical Devices – Thematic Research report produced by GlobalData Thematic Research.