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

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.

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