The latest addition to Kwasi Kwarteng's reading list

“Regulatory reform in medical devices is urgently needed.”

With these words, Sir Bruce Keogh (the former Medical Director of the NHS) begins the foreword to last week’s Report on Medical Devices (the Report) by the Regulatory Horizons Council (the RHC).

The RHC presents the Report as a "timely call to action" to address how the UK can encourage investment and innovation in medical devices, whilst also improving safety and charting a future for the UK after Brexit.

The Report is set against a backdrop of events that the RHC says pose particular questions for the life sciences industry to grapple with, including:

• Brexit and the fact the EU has adopted new medical device regulations, whereas UK regulations are two decades old;
• The Independent Medicines and Medical Devices Safety Review, published last year by Baroness Cumberlege that contained significant criticism of the existing regulatory regime; and
• The power at the government’s disposal to introduce secondary legislation under the Medicines and Medical Devices Act 2021. 

The RHC is an independent body and its recommendations are not UK government policy. However, the Secretary of State for Business, Energy and Industrial Strategy (BEIS), Kwasi Kwarteng, has warmly welcomed the Report, calling it “highly relevant and timely.” The Report will influence the government's plans for reform of medical device regulations.  Anyone whose work in medical devices encompasses risk management or insurance is encouraged to study the Report.

Based on our experience in advising companies on regulatory risks and defending product liability claims, these are three recommendations that caught our eye:

Recommendation: Centre the regulation of medical devices on the needs of patients

Implications

The RHC is pushing for patient representation on expert groups before devices are placed on the market. It also recommends that existing patient consultation initiatives should be expanded. Manufacturers would need to review how they explain to patients the balance of risks and benefits when seeking regulatory approval. They would also need to obtain better patient feedback from clinical trials.

Whilst these steps may increase costs, it could make products more immune to product liability litigation where patients suffer side-effects. The difficult question of how much risk is acceptable will have had patient input before a product is put into circulation. That will inform the court when it considers allegations that a product is defective. In addition, patient groups might demand better explanations of risks, or additional safety measures – which in turn may make products safer and less likely to attract litigation. 

Recommendation: Build international partnerships through mutual recognition of other jurisdictions’ regulations

Implications

The one aspect of medical devices regulation that is most likely to become a political hot potato is this: what was Brexit for? In the run up to concluding the “Brexit Deal” (the Trade and Cooperation Agreement of December 2020), the Prime Minister emphasised that Brexit was about sovereignty and the UK taking back control of its laws.

The life sciences industry has generally been sceptical that there can be much of a 'sovereignty dividend' from Brexit because UK manufacturers will need to comply with EU requirements to sell products there. Equally, European manufacturers will be keener on investing in the UK if the UK adopts broadly similar standards to their own. The RHC recognises this and refers to the need for “international efforts to increase regulatory cooperation, and reduce potential barriers to trade.” By acknowledging this issue, the Report chimes with points made by industry and regulators that are adding up to a clear warning to the government not to diverge too far from international standards.

Patient safety comes into this too. Baroness Cumberlege, in her report, suggested that the government should consider adopting the patient safety measures in the EU's new Medical Device Regulation 2017/745.

The Report supports our view that we expect that future UK regulations, for all but the most innovative products, will be broadly similar to EU standards.

Recommendation: Develop a UK patient safety database 

Implications

The RHC notes data programmes that are currently maintained by the Medicines and Healthcare products Regulatory Agency (MHRA) and the NHS. It calls for a combined reporting system for adverse incidents that should be held on a MHRA database. If this comes to fruition then it could mitigate the problem, identified by Baroness Cumberlege, that it has taken too long for regulators and manufacturers to spot trends when a product is underperforming.

Manufacturers and their insurers will welcome this initiative. Better data could lead to better systems, allowing manufacturers to issue more timely guidance to clinicians or even recall products from the market at an earlier stage.

What next?