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

We believe the MHRA should be reviewed. This should include its approval processes, its monitoring of safety of existing products, its transparency and accountability, and its mechanisms to ensure patient safety is prioritised over commercial interests.

The review should also cover how conflict of interests can be eradicated, improving the yellow card process, and limiting its funding sources. A wide range of medicines & devices approved by MHRA have caused patient harm. We believe the MHRA focuses too much on clinical trials of new medicines, rather than safety of existing ones.

Information sought through FOIs has sometimes not been provided due to commercial interests.

There is a 'revolving door' between industry & the regulator, board members have declared financial interests in the pharmaceutical industry.

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.