Consultation outcome

Annex C - Legal basis and assessment of the matters set out in sections 2 and 15 of the Medicines and Medical Devices Act 2021

Updated 31 January 2023

The Medicines and Medical Devices Act 2021 (the Act) received Royal Assent on 11 February 2021. We propose to make the legislative changes for fees relating to medicines and medical devices under consultation in this document using powers in Part 2 of the Act, which provides powers to make regulations about human medicines and Part 4 in relation to medical devices.

This consultation is conducted pursuant to the consultation requirement in section 45(1) of the Act.

Sections 2 (in relation to medicines) and 15 (in relation to medical devices) of the Act state that safeguarding public health must be the overarching objective of the appropriate authority when making regulations. These sections require that when assessing whether regulations would contribute to that objective, the appropriate authority must have regard to three factors:

(a) The safety of human medicines and medical devices, and that the benefits of doing so outweigh any risks

(b) The availability of human medicines and medical devices

(c) The likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to –

(i) Carry out research relating to human medicines and medical devices

(ii) Conduct clinical trials of medicines,

(iii) Develop medical devices, or

(iii) Manufacture or supply human medicines and medical devices

For medicines, the appropriate authority is the Secretary of State in relation to Great Britain and the Department of Health in Northern Ireland in relation to Northern Ireland. For medical devices, the appropriate authority is the Secretary of State.

Below we have assessed the proposals against each of the factors set out in the Act.

Safety

While all decisions relating to the safety of human medicines and medical devices are made objectively and independently of the price paid for the service, in ensuring that the MHRA statutory fees reflect the cost of the activity and work involved in delivering them, the aim is to ensure the MHRA is sufficiently funded and resourced to carry out the necessary and required work relating to safety in a timely manner.

Availability

There is a risk that increasing fees may deter companies from submitting applications to the MHRA, which would have an impact on the availability of medicines and medical devices. However, the MHRA believe this risk to be low given that annual fee increases across regulators is a standard approach and we would expect this to be built into company budgeting as a standard practice. As set out earlier in this consultation, it is important that the MHRA is properly resourced to deliver the service that industry wants and expects, and therefore, on balance, the MHRA has made the decision to put forward these proposals

Favourability

The purpose of adjusting MHRA statutory fees is intended to have a positive effect on the UK Life Sciences industry. By ensuring the MHRA is accurately recovering the costs involved in delivering services for industry, the MHRA will be in a better position to deliver the level of service that industry wants and expects. Through informal consultation industry have told us that MHRA performance and ability to deliver is paramount, and by adjusting the fees to ensure the Agency is accurately recovering costs, rather than under recovering, the Agency will be able to provide a greater service for industry.

Additionally, these fee proposals are not expected to impact the MHRA’s favourability in the market globally. It is standard practice for regulator fees to be reviewed annually. As an example, the EMA have consistently increased their fees year on year, and in April 2022 the EMA announced an inflationary increase to fees, compounded across 2020 and 2021. The proposed adjustments to MHRA statutory fees are akin to the year-on-year increases by the EMA and other regulators.

Conclusion

Based on our assessment of the statutory fee proposals against each of the factors set out in the Act, we consider the requirements of the Act to be fulfilled as the proposals will ensure the MHRA is sufficiently funded and resourced to deliver a responsive and efficient regulatory service that safeguards and improves public health by facilitating access to high-quality, safe, effective and innovative medical products.