The Queen’s Speech: the Medicines and Medical Devices Bill

Update: The Medicines and Medical Devices Bill received Royal Assent and became law on 11 February 2021. We report further on this legislation in Chambers and Partners Practice Guide: Medical Devices & Consumer Health Products 2021.

Queen’s Speech December 2019

When the General Election was called in October, any Bills which had not received Royal Assent fell away upon the dissolution of parliament, their fate to be determined by the successful party on 13 December. As the Conservatives returned to power, today’s Queen's Speech held few surprises as many of the fallen Bills were reintroduced – including the Medicines and Medical Devices Bill.

As before, the Brexit deadline looms large and we wait with interest to see the progress of this Bill through parliament.

The original article, published 16 October 2019, can be found below:

Queen's Speech October 2019

Boris Johnson’s first Queen’s Speech delivered on Monday 14 October 2019 - dominated by Brexit-related legislation - included the Medicines and Medical Devices Bill (the Bill). 

The Bill is a continuation of the government’s strategy of promoting the growth of the UK’s life sciences sector, ensuring that the UK “remains at the forefront of the global life sciences industry after Brexit” and takes a “lead role in global research to find cures for rare diseases and improve treatments for patients around the world”.  

Speedy access to innovative medicines and patient safety are at the heart of the Bill and it is envisaged that these aims will be achieved by:

1. Simplifying processes to make it easier for NHS hospitals to manufacture and trial new medicines and devices.
2. Removing red tape in respect of low risk clinical trials with a view to making the UK an attractive place for companies to trial their products.
3. Implementing a scheme to combat counterfeit medicines entering supply chains and a registration scheme for online sellers.
4. Increasing the range of professions able to prescribe low-risk medicines ensuring effective use of the NHS workforce as well as developing new ways to dispense medicines in accordance with expert recommendations.
5. Encouraging the UK to become a global lead in personalised medicine and Artificial Intelligence by developing new regulations to enable early access to cutting-edge technologies and break new ground in complex clinical trials.

Comment

With the government insisting that the UK will be leaving the EU on 31 October 2019 come what may, the Bill may be viewed by the life sciences sector as a grand declaration of independence by the UK in anticipation of a possible no-deal Brexit. Given the uncertainties surrounding Brexit, stakeholders will undoubtedly welcome the UK Government’s continued commitment to the UK’s life sciences sector. 

If the proposals in the Bill are realised, we can expect to see:

• Less reliance by the UK on global manufacturers and suppliers
• An increase in the development of home grown products
• Faster trialling and production of innovative medicines and treatments as well as improved access for patients
• Other health professionals, such as nurses and pharmacists prescribing and administering “low risk” medicines that would ordinarily be performed by a qualified doctor.

After years of compliance with European regimes, the proposed changes will take time to implement and, as is recognised by the MHRA in their published ‘no deal’ guidance, it is likely that the UK will need to remain aligned with EU safety standards so that UK products can continue to be developed and sold across Europe. Insurers and manufacturers will need to carefully evaluate the risks any changes will bring.

Click here for our further analysis of what Brexit could mean to the Life Sciences sector.

Related items:

• Brexit White Paper: protecting the UK life sciences industry
• House of Commons publishes report on the impact of Brexit on the pharmaceutical sector
• House of Commons considers the impact of Brexit on the life sciences sector
• Implications of ‘No Deal’ for the medical devices industry post-Brexit
• Brexit page