Patient safety update

Government to appoint Patient Safety Commissioner for England

The Government has provided an update on its response to the recommendations made by the Independent Medicines and Medical Devices Safety (IMMDS) Review report which was published in July 2020 (see our earlier blogs here and here).

Readers will recall that the IMMDS review looked at three medical interventions -  the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate and implanted pelvic mesh. A total of nine recommendations were made by the review after finding that these treatments had caused avoidable harm to patients. It also found that when patient concerns were raised they were not listened to or acted upon.

We set out below the Government’s actions in response to the recommendations – and its commitment to “hear the voice of the patient” as part of the NHS Patient Safety Strategy.

• Appointment of a Patient Safety Commissioner. The central recommendation in the report was for the establishment of an independent PSC. The Government has tabled an amendment to the Medicines and Medical Devices Bill to provide for a PSC, establishing a statutory office holder ( appointed by the Secretary of State for Health and Social Care) who will act independently on behalf of patients. The PSC will have a number of powers and functions, including the ability to make reports and recommendations to the NHS and independent sector, and to request and share information with these bodies. While the everyday workings of the PSC are to be finalised, and Regulations will be made setting out further details, it is important that the PSC role is complementary to the work of the many existing healthcare services and regulatory bodies already operating in the health and care system. Regulatory and safety bodies such as the Medicines and Healthcare products Regulatory Agency, NHS England and NHS Improvement and the CQC have established areas of work and responsibility for patient safety. The Factsheet: Patient Safety Commissioner describes the PSC as ‘provider neutral’ and, as such, they will be able to exercise their powers across both the NHS and independent sector.
• Creation of an independent Redress Agency for people harmed by medicines and medical devices. This recommendation has been rejected. The Government state that they have previously established redress schemes so there is no need for an additional agency.
• Creation of separate redress schemes for each of the three interventions – hormone pregnancy tests, sodium valproate and pelvic mesh. These schemes remain under consideration.
• Development of a network of specialist centres for implanted mesh and those adversely affected by medication taken during pregnancy. NHS England is working with NHS hospitals to establish specialist mesh services offering multi-disciplinary care and treatment for women who have experienced complications due to mesh procedures. These are currently planned to go live from Spring this year. The aim is to have a centre in every NHS region to share expertise and best practice. The Government is considering specialist centres for those adversely affect by medicines in pregnancy.
• Reform of the Medicines and Healthcare products Regulatory Agency. The MHRA has begun a programme of work to improve systems for adverse incident reporting and to strengthen the evidence base for its regulatory decisions. It has published a report on Optimising Data on Medicines used during Pregnancy and it has also established a Safer Medicines in Pregnancy and Breastfeeding Consortium. In terms of sodium valproate, a Valproate Safety Implementation Group has been established.
• Creation of a central patient-identifiable database of all medical devices. An amendment to the Medicines and Medical Devices Bill has been made to establish a medical device information system.
• Improve the transparency of payments made to clinicians. The Government is considering the publication of declarations of interest of both financial and non-pecuniary interests.
• Appointment of an independent taskforce to implement the review’s recommendations. There are no plans to establish a taskforce.

The Government plan to respond further to the report of the IMMDS Review during 2021.

Paterson inquiry update

Work on the Government response was temporarily paused last spring due to the first wave of Covid-19. However, there are plans to publish the Government’s initial response shortly (see our earlier article on the findings of the Paterson inquiry).