UK medicines regulator wants active EU partnership post-Brexit
An “active regulatory partnership” between the UK and the EU is necessary to ensure patients have “timely access” to medicines post-Brexit, according to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
The agency unveiled its five-year plan on Tuesday, April 24.
In preparation for Brexit the MHRA said it is considering all possible outcomes, including the “very unlikely scenario in which no mutually satisfactory agreement can be reached and the UK exits without a deal”.
However, the agency recommends that the EU and the UK should continue working together post-Brexit in an “ongoing active regulatory partnership with the rest of Europe” in order to ensure patients continue to have “timely access to safe medicines and medical innovations”.
The MHRA suggested that “clear precedents” for regulatory work are already in place through the collaborations which occur between EU and non-EU territories, such as Switzerland.
Due to the “growing importance of global standards” the regulation of pharmaceuticals and devices is now “globally-driven”, the MHRA added, and the UK voice must remain “active and influential” at this global level.
Under the previous 2013-2018 plan, the MHRA focused on the role of regulation; bringing innovation to market; strengthening surveillance; securing supply in globalised industries; and achieving excellence in the running of the organisation.
The MHRA said “significant progress” has been made in these areas, which are also at the centre of the new 2018-2023 plan. The agency now plans to address them in the “circumstances of substantially increased uncertainty” surrounding Brexit.
Overall, the UK must “proactively offer accelerated routes to market to benefit public health and be a magnet for life sciences”, the MHRA said.
Aside from managing Brexit, a major part of the MHRA’s new plan involves the greater use of data.
For example, the MHRA said it intends to expand its use of real-world data to support regulatory decision-making around pharmaceuticals and devices, and will also explore the use of the Clinical Practice Research Datalink (CPRD) research service to improve surveillance activities.
Optimising the use of CPRD data will allow the agency to be “proactively monitoring medicine and medical devices safety in real time,” according to the plan.
Other challenges identified in the new plan include keeping pace with technological advancements such as artificial intelligence, regulating new and innovative products, and investing in staff recruitment and retention.
The five-year plan will first be reviewed in April 2020.
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