The government responds to Cumberlege - What now for product liability risks in the life sciences sector?
The government has accepted many of the recommendations made by the Independent Medicines and Medical Devices Safety Review chaired by Baroness Cumberlege (the Review). Whilst bold recommendations to bring in a new compensation regime for patients will not be taken forward, the government's response signals significant changes to the healthcare system that will affect the litigation risk associated with medicines and medical devices.
The Review published its report last July (the Report). Baroness Cumberlege and her team examined the healthcare system through the prism of litigation concerning pelvic mesh, sodium valproate and hormone pregnancy tests. The Report made nine strategic recommendations and suggested 50 actions for improvement. After a year considering the Report, the government published its response last week.
Two recommendations the government has rejected
The government has rejected two of the key recommendations that had caught the eye of insurers and manufacturers with experience of defending product liability litigation:
1. A compensation agency
The Report proposed establishing a "redress agency": a non-adversarial process, intended to supplement existing rights, to compensate patients injured by medicines and medical devices. However, the government has rejected this proposal, concluding that a new agency would not, in itself, make products safer or drive the right incentives for industry.
2. A payment scheme
The Report also recommend a "cost of care" scheme to provide payments for the costs incurred by patients where products have failed. The government does not think that this is necessary and has instead highlighted that patients can obtain compensation by suing healthcare providers for clinical negligence, or manufacturers for product liability.
Four recommendations the government has accepted
Whilst a redress agency and payment scheme will not make it onto the statute book, the government intends to take up other recommendations made by Baroness Cumberlege. Amongst the recommendations the government has accepted are four that could have a significant impact on the litigation risk associated with life sciences products:
1. A Patient Safety Commissioner
The government has already legislated for a Patient Safety Commissioner through the Medicines and Medical Devices Act 2021. The government hopes that the Commissioner will "act as a champion for patients in relation to medicines and medical devices." The first Commissioner is expected to be appointed next year. Industry will be interested to see whether the Commissioner will work with manufacturers to improve safety standards - or become a high-profile advocate for patients seeking compensation from companies. A public consultation on the role of the Commissioner is open until 5 August 2021.
2. A change of focus for the Medicines and Healthcare products Regulatory Agency (the MHRA)
Baroness Cumberlege criticised how the MHRA responds to adverse event reporting and its approach towards regulating medical devices. The government has accepted this criticism and put its weight behind the MHRA's initiative to better equip itself to make timely and robust interventions to promote patient safety. This change of focus, aimed at spotting problems with products and removing them from the market sooner rather than later, could work for both manufacturers and the public in improving vigilance.
3. Guidance on consent
The Report found that there needed to be improvement over patients giving informed consent and that more should be done to ensure that information given to patients is clear and meaningful. The government has accepted this recommendation and supports the General Medical Council's (the GMC) revised guidance on consent, which came into effect last year. All other professional regulators will now consider this issue when they next review their guidance. A more uniform approach towards consent could drive up standards and limit the scope for arguments over whether hospitals and manufacturers have a defence based on consent.
4. Information for patients
Baroness Cumberlege recommended that a single patient aid (i.e. set of information) should be produced for every surgical procedure or medical intervention. The materials should be co-designed by patients and clinicians. The government has accepted this and has tasked the National Institute for Health and Care Excellence (NICE) with taking a lead in designing "Patient Decision Aids". As with the above initiative led by the GMC, industry will hope that these changes will speed up the resolution of disputes by providing more certainty over the information given to patients. The quality of instructions and warnings that accompany products can make or break a defence to a product liability claim.
Managing litigation risk in the post Cumberlege era
The Review was commissioned in response to failings concerning healthcare products that go back decades. The government's response to the review ushers in reforms that are likely to have an impact on the litigation landscape for years to come. There is a lot more in the government's response than its rejection of the proposals to limit the role of the courts in compensating patients. Steps to give patients greater representation in the system, a change of focus for the MHRA, and a more uniform approach towards how patients provide consent and receive information may all have an impact on the litigation risk associated with life sciences products. The life sciences industry will want to make sure its perspective is taken into account. Manufacturers should engage with the government, MHRA, professional regulators and NICE as these changes take effect.