Medicines and Medical Devices Act 2021 and what it means for the UK regulatory landscape

18.02.2021

On 11 February the Medicines and Medical Devices Bill received royal assent, becoming law as the Medicines and Medical Devices Act 2021 (the MMD Act).

The MMD Act provides the Secretary of State (SoS) for Health with a jaw-dropping range of powers to amend the existing regulatory framework regarding human and veterinary medicines, and medical devices in the UK. The Act also establishes a new Commissioner for Patient Safety.

The Bill was first introduced in February 2020 by the current SoS for Health, Matt Hancock. In introducing the proposed legislation to the House of Commons, he set out four keys aims:

  1. to provide the UK with means to depart from the EU rules regulating these products,
  2. to allow easy amendment of existing laws through statutory instruments,
  3. to strengthen patient safety, and
  4. to ensure the balance between capturing the benefits of innovation without compromising patient safety.

The MMD Act has not gone unchallenged in its journey through both Houses of Parliament. The most controversial aspect of the legislation is the breadth and extent of the powers granted directly to the SoS to amend the existing regulatory framework.

During the second reading in the House of Lords the powers under the bill were described as “absolutely atrocious and an affront to parliamentary democracy”. At one stage, it appeared as though the period during which these powers would be exercisable would be limited to three years, although this amendment did not make its way into the final MMD Act.

The MMD Act does require a public consultation before making regulations under the Act[1]. Further, for the vast majority of regulations, a draft regulation must be approved by both Houses of Parliament in the “light touch” affirmative procedure[2]. As we have seen over the past year of the pandemic, many statutory instruments have been laid before parliament with little notice and have gained approval from the House slightly with very little parliamentary scrutiny.

The Government asserts that the MMD Act provides a crucial step towards the UK forging its own regulatory landscape. The breadth of the scope of the powers under this Act could allow the SoS to diverge rapidly from the EU or conversely change with the EU moving forward.

In conclusion, we look forward (with only slight trepidation) to secondary legislation to follow hot on the heels of the MMD Act.

[1] Section 45
[2] Section 47

 

Alex Denoon

Author

Hugo Kent-Egan - Trainee Solicitor

Hugo Kent-Egan

Author