Contribution
My Lords, I am grateful for the opportunity to debate these regulations, which I think can fairly be described as routine. The Medicines and Healthcare products Regulatory Agency charges fees for most of its services and, to ensure continued cost recovery, updates its fees every two years. This regularity provides certainty to customers and enables better financial planning. This statutory instrument helps to achieve this by doing three things.
First, it updates the fees that the MHRA charges in relation to its activities in regulating medical devices and blood components for transfusion. These fees were last updated in April 2023. The implementation date for the proposed changes is July 2025 and they will ensure cost recovery until 2027. This will apply UK-wide, with the fees being the same across the United Kingdom. The total cost to those who pay the MHRA’s fees from this instrument is estimated to be £0.7 million per year after inflation.
Secondly, the instrument introduces a fee for a new, optional service: a regulatory advice meeting for medical devices. In addition to publishing guidance and addressing written inquiries, this new service will further support manufacturers in their understanding of the application of the UK’s regulatory framework to their products. I am glad to say that this service was well received in the consultation. It will be mainly for those developing novel and/or complex products where the application of legislation is not as straightforward or easily understood as it might be. We have had many discussions on removing obstacles to getting products to market which support better care for patients. I hope that this will make a contribution in this regard.
Thirdly, the instrument will introduce a new payment easement for small and medium-sized enterprises for the MHRA’s medical device clinical investigation fees. While this easement will not reduce the overall fee, which would require cross-subsidisation, it will enable the fee to be paid in two instalments, providing flexibility and, I hope, supporting the businesses concerned.
It might be helpful if I highlight the important role that the MHRA plays in safeguarding public health and the importance of the agency continuing to be properly funded to deliver its role. The MHRA is a world-leading regulator of medicines, medical devices and blood components for transfusion in the UK. It plays a vital role in protecting and improving public health. It is, I suggest, an engine for UK growth and innovation; it is certainly an indispensable part of the UK health system and plays a major role globally, working with international partners.
The principles for how the MHRA charges fees are set by HM Treasury in its guidance, Managing Public Money. The basic principle is to set statutory fees to recover full costs. This means that the regulated bear the cost of regulation and that the MHRA does not profit from fees or make a loss that would then have to be subsidised by government departments or the UK taxpayer. It is, of course, standard practice for government bodies that operate on a cost-recovery basis to update their fees. It is also standard practice for other regulators, which is the reason why I described this statutory instrument as “routine”.
All fees are set by taking into account various factors that reflect the cost of the activity—for example, the activities involved in delivering a service, the time taken and the number and grade of staff involved. This process is informed by the recording of staff activity, which is the practice of monitoring and recording certain activities performed by the MHRA’s staff to establish how long they take and, so, how much they cost. In addition, also in line with the HM Treasury guidance, the MHRA includes the costs of necessary corporate overheads and system investments. Regular fee uplifts ensure financial sustainability and enable the MHRA to deliver the responsive, efficient service that its customers rightly expect.
It is worth noting that this instrument does not change the MHRA’s fees in relation to medicines regulations. Given the different legal positions in relation to the powers to make regulations about fees relating to medicines, medical devices and blood components for transfusion, two statutory instruments have been used for the MHRA’s fee uplift. A second instrument for human medicines fees has, therefore, already been laid before the UK Parliament and the Northern Ireland Assembly and has already come into force.
In summary, ensuring that the MHRA is sufficiently resourced will help it to deliver its services more reliably and to provide patients, the public and industry with the service that they expect. I beg to move.