Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential impact of proposed reforms to the Medicines and Healthcare products Regulatory Agency's statutory fees structures on (a) the Agency, (b) industry, (c) the NHS and (d) patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the United Kingdom.

Most of the MHRA’s income comes from charging fees for its services. Its fees are set to recover the full cost of delivering the respective services. This is in compliance with the HM Treasury guidance, Managing Public Money.

The MHRA aims to update its fees every two years, so that it can continue to recover its costs. This ensures the agency’s continued financial sustainability, and the ongoing delivery of its services.

The MHRA has recently consulted on its current fee uplift. The consultation has now closed, and they are analysing the responses. The Government response to the consultation should be published in the new year. With regards to the expected impacts:

• the fees uplift will ensure the MHRA’s continued financial sustainability and the ongoing delivery of its services;
• the MHRA’s fees will increase for industry, as by ensuring that the MHRA is fully recovering costs, it will be in a better position to deliver the level of service that the industry wants and expects;
• the MHRA’s fees will increase for everyone, including the National Health Service, however, the impact on the NHS is expected to be small as it represents a small proportion of the MHRA’s total income, and the increase in its costs is also expected to be small; and
• the fees uplift it will ensure the MHRA is sufficiently resourced to deliver its public health duties for patients, and additionally, the charging fees mean that the regulated bear the cost of regulation, rather than the taxpayer and patients themselves.