Parliamentary Briefing: Medicines and Medical Devices Bill

House of Lords, Second Reading

The UK is currently transitioning from the European Union (EU), which impacts healthcare provision, clinical trials, research, and innovation. A step towards securing the best available healthcare for UK citizens is the Medicines and Medical Devices Bill, which at the time of writing is being presented to the House of Lords for a second reading. We have written a parliamentary briefing to highlight some key challenges and opportunities for the Government in passing the Bill.

The technology market for healthcare is accelerating rapidly, with many new tools and techniques available to healthcare providers and patients alike. The Bill is a welcome addition to regulation and legislation in the healthcare domain. However, in the Bill, a careful balance is needed, which prioritises patient safety, acknowledges the growing complexity of technology being deployed in the field, and a wider appreciation of the impacts of both trade agreements and innovation policy. Alongside these challenges we present the opportunity to lead with a Bill that builds upon existing international legislation in the three areas mentioned above, to ensure the Medicines and Healthcare products Regulatory Authority (MHRA) remains a global leader in regulation.

In our briefing, we pose three key questions for consideration:

Key Questions

1. Does the Government intend to make provisions for ‘decision support tools’ and the use of algorithms in medical devices now or in the future and, if so, when?

2. Does the Government perceive merit in building upon pertinent provisions introduced to safeguard citizens of the European Union and, if not, why?

3. If there is an opportunity to learn from other countries, can the Government highlight which nations the UK is looking toward and outline what it thinks we can usefully learn from them?