Petition Review how to turn MHRA into a fully transparent, patient first regulator

There are no plans to initiate a review the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA plays a pivotal role in ensuring the safety, efficacy, and quality of medicines and healthcare products available to patients in the United Kingdom.

The Government position reflects MHRA’s continuing priority to deliver for patients, establish and maintain consistent performance in all areas, and increase transparency with robust management of conflicts of interest.

The petitioners raise concerns regarding MHRA’s focus on enabling innovation and supporting patient access to new products. Patient safety remains the MHRA’s highest priority. The Agency works to ensure that patients have access to safe products, whether this be through assessment of new and innovative or existing products.

The MHRA has invested extensively in proactive monitoring of the safety of medicines and medical devices. The Agency takes every opportunity to encourage reporting of any safety concerns to the Yellow Card scheme. A major investment programme to upgrade MHRA safety reporting systems is well underway and this will further improve the ability to proactively detect and assess signals on the safety of products. Improvements to the reporting systems have made it easier for patients to raise their concerns and will increase transparency of actions taken in relation to reports received.

The MHRA has robust conflict of interest mechanisms covering MHRA staff, board members and those who give independent, expert advice on MHRA committees. These mitigate any potential conflicts of interest effectively.

Staff members cannot hold direct financial interests in the pharmaceutical and healthcare (medical devices) industries. Any other potential interests, or those of close members of family, must be declared by staff upon appointment or as soon as they become aware. Failure to do so could constitute a disciplinary matter. Action to manage the potential or actual conflict of interest of a member of staff would depend on the nature of the conflict but would ensure no risk of bias in regulatory action.

Board members’ interests are declared in the MHRA Annual Report and Accounts. In addition, a register of interests is available to view on GOV.UK and is updated frequently to reflect any changes from members. Furthermore, the Board is not involved in licensing decisions on specific medicines or medical devices.

Finally, the MHRA recognises the importance of providing access to information about regulatory decisions and processes.

The MHRA’s responses to requests made under the Freedom of Information (FOI) Act are issued within the provisions of the legislation and considering the Information Commissioner’s guidance. The MHRA carefully considers instances where it may be necessary to apply an exemption to withhold information. Exemptions such as Section 43 (commercial interests) of the FOI Act may be applied to requests when it is identified that a prejudice would or would be likely to arise because of disclosure, and after considering the public interest in all the circumstances of the case. Often decisions are taken in accordance with HMA/EMA Transparency guidelines (https://www.ema.europa.eu/en/documents/other/heads-medicines-agencies-european-medicines-agency-guidance-document-identification-commercially-confidential-information-and-personal-data-within-structure-marketing-authorisation-application_en.pdf) which also sets out the types of information deemed commercially sensitive following the approval of a marketing authorisation. In making these decisions the MHRA must weigh the potential impact of disclosing the information against the need for transparency and accountability, ensuring a balanced approach to handling FOI requests.

The MHRA has implemented several initiatives that involve them proactively publishing regulatory decisions, safety assessments and adverse event reports, while safeguarding confidential information. The Agency is currently working to expand this further.

With regards to MHRA funding sources, as an Executive Agency of the Department of Health and Social Care, the Agency is funded mostly by income from fee-charging activities and sales from the products and services provided. The remainder of funds come from the Department of Health and Social Care as grant-in-aid for specific activities mainly related to medical devices regulation and scientific research. This is an appropriate model that replicates funding for other regulatory bodies in the UK and internationally. This also ensures public spending is not supporting activities that should be borne by those accessing and using these services.

The MHRA champions patient safety over any other priorities including commercial interests. The Government is confident that regulatory decisions are grounded in robust scientific data, ethical conduct, and a commitment to public health, and that transparency on how this is being delivered is reflected in the MHRA’s future focus.

Department of Health and Social Care