Welcome to the spring quarterly roundup of regulatory developments in the life sciences sector affecting healthcare institutions - providing bite-size updates from around the industry.
The Medicines and Medical Devices Act becomes law
The Medicines and Medical Devices Act 2021 (the MMDA) received Royal Assent on 11 February 2021 and passed into law.
The MMDA is primarily a piece of Brexit related legislation. It grants the UK government powers to update the existing life sciences regulatory framework in the post Brexit era. However, it also sets the tone for how regulations will be amended in future.
Healthcare institutions should note:
- As a result of amendments made to the Bill as it passed through Parliament, the MMDA requires future changes to the regulatory framework to take account of patient safety. This provision should be welcomed by hospitals as it mitigates the risk that future governments could 'loosen red tape' to boost industry at the expense of patient safety.
- The MMDA provides for the appointment of a "Commissioner for Patient Safety" (which was a key recommendation of the Independent Medicines & Medical Devices Safety Review (the Review)). The MMDA is light on detail regarding the role of the Commissioner but the Review, chaired by Baroness Cumberlege, recommended that the Commissioner should act as an advocate for patients in raising concerns over potentially defective healthcare products, including within the private sector. As and when the government appoints the first Commissioner, healthcare institutions can expect to receive demands for information from the Commissioner where products and surgical techniques come under scrutiny.
- The MMDA allows the government to establish information systems to require the retention of medical device information. Hospitals may in future have to adhere to similar requirements over tracking medical devices that exist in EU law under the Unique Device Identification system - brought in by the Medical Devices Regulation 2017.
Artificial Intelligence: UK Parliamentary Office of Science and Technology (POST) paper
POST has published a note on the application of Artificial Intelligence (AI) in healthcare. The note is the result of interviews with a significant number of organisations. Whilst the note (and an earlier report it refers to) focuses on using AI in the NHS, the private sector will find that the paper surfaces risk factors to be guarded against where AI is used in hospitals generally. Significant issues include the following:
- AI can perform worse than expected, due to differences between development conditions in the R&D phase and the real world
- Few studies have examined the performance of AI systems in real clinical settings
- Risks are heightened where healthcare staff lack new skills and the technical knowledge needed to operate and understand AI systems
- Sharing large datasets increases the risks of data breaches
- In the event of harm to a patient where AI may be to blame, it can be complicated to unpick liability that may be shared between healthcare providers, clinicians and AI developers
MHRA publishes decision on classification of baby monitors
A number of baby monitors are available for sale on the UK market. The Medicines and Regulatory products Healthcare Agency (MHRA) has investigated these products. In February 2021, the MHRA published its finding that products that have been marketed as general consumer goods in fact meet the legal definition of a medical device. Accordingly, such products are required to undergo conformity assessment before they can be placed on the market in accordance with medical devices law.
For hospitals, the implications of this investigation may include:
- The prospect of a wider range of monitors, certified as medical devices, appearing on the market in future
- Greater demand, by parents, for monitoring babies at home as opposed to in hospital
- The possibility of the private hospital sector partnering with manufacturers over research and marketing of baby monitors
The MHRA issues guidance on placing medical devices on the market
The government has used secondary legislation to cater for how medical devices are placed on the market in Great Britain following the end of the Brexit transition period. Healthcare institutions that use medical devices will note changes in how products are placed on the market in the coming months and years, including:
- CE marking will continue to be recognised in Great Britain until 30 June 2023
- The UKCA (UK Conformity Assessed) mark will be a requirement from 1 July 2023 and replace CE marking, although manufacturers may already use a UKCA mark in place of a CE mark
- Certificates of conformity issued by EU Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- Newly designated UK Approved Bodies will conduct assessments for the purposes of UKCA marking (where previously EU Notified Bodies had carried out assessments for the purposes of CE marking)
- Since 1 January 2021, all medical devices placed on the Great Britain market have needed to be registered with the MHRA (subject to grace periods for higher risk products)
- Manufacturers based outside the UK will need to have appointed a UK Responsible Person to take responsibility for the product in Great Britain
Under the terms of the Northern Ireland Protocol on Brexit, EU rules continue to apply in Northern Ireland, including regarding CE marking.
Imperial College research into the Nocebo Effect
The Nocebo Effect is a phenomenon where a patient, who is warned of a possible adverse side effect from a drug or medical device, or reads about it in the media, is more likely to suffer an adverse reaction from the product than a patient who did not know about the issue. It is the flip side of the Placebo Effect: where a patient believes a treatment (even a "sugar pill") will be effective and so benefits from it.
A recent study by Imperial College into statins concluded that up to 90% of reported side effects were experienced largely because of a "negative association" with statin use and not because of a pharmacological effect of the drugs themselves.
The Nocebo Effect could be on the rise due to a tendency for some products to be targeted in the media; causing the "worried well" to experience physical symptoms triggered by what they read.
There are implications for hospitals and clinicians:
- Litigation could occur where claimants allege that a particular product is defective, or a treatment negligent, due to an adverse reaction which is subjective and not clinically measurable
- Healthcare statistics relating to the safety of medical products may be unreliable due to the Nocebo Effect (this issue was considered in a 2018 judgment (Gee v DePuy) concerning the metal-on-metal hip litigation)
- The Imperial College study is a reminder that clinicians, healthcare providers, regulators and the media share in responsibility for ensuring that the reporting of side-effects is measured and focussed on evidence
- The study serves to emphasise the important role clinicians have in providing patients with accurate information, particularly to counter scare stories that circulate on social media
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.