> ## Excerpt > A group of MPs and patient safety experts has warned that the drug and device regulatory system spearheaded by the MHRA is putting patient safety at risk. --- The All-Party Parliamentary Group (APPG) on pandemic response and recovery has raised "serious patient safety concerns" about the Medicines and Healthcare products Regulatory Agency (MHRA), along with other aspects of a system that, "far from protecting patients, continues to put them at serious risk". In a [letter to Health Secretary Steve Brine](https://appgpandemic.org/news/mhra-letter-health-select-committee), APPG co-chairs Esther McVey and Graham Stringer, with 26 cosignatories, highlighted the Independent Medicines and Medical Devices Safety (IMMDS) [investigation of Primodos, sodium valproate, and pelvic mesh scandals](https://www.medscape.co.uk/viewarticle/more-support-needed-women-and-children-affected-medical-2023a10001a3), which [found](https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf) the response of the healthcare system was not sufficiently robust, speedy, or appropriate, causing some patients to suffer life-changing or fatal, avoidable harm. ## MHRA at "the Tip of a Sizeable Iceberg of Failure" Subsequent evidence "leads us to believe that serious patient safety concerns persist beyond even the findings of the IMMDS review", the APPG signatories wrote. "The MHRA is at the heart of these far wider endemic failings," and "those cited in this letter merely represent the tip of a sizeable iceberg of failure." _Medscape News UK_ has reported increasing concern worldwide about the degree to which [medicines regulators are captured by the drug industry](https://www.medscape.co.uk/viewarticle/institutional-corruption-permeates-drug-regulators-globally-2022a1001obx). A 2022 BMJ investigation found [serious conflicts of interest](https://www.bmj.com/content/377/bmj.o1538) potentially influencing health policy and approval decisions. Regulatory agency members and expert advisers had financial interests in products being licensed, including several experts on COVID-19 vaccine advisory committees with [financial ties to vaccine manufacturers](https://www.bmj.com/content/373/bmj.n1283) that regulators did not always disclose.  Notorious "revolving door" arrangements mean many officials move between regulatory agencies and the companies they regulate. For example, a former MHRA chief executive arrived from SmithKline Beecham and left to serve on the board of a biotech company and advise the Gates Foundation, which has major interests in vaccines and partly funds the MHRA.  ## "A Prime Example of Institutional Corruption" One expert [cited in the BMJ](https://www.bmj.com/content/377/bmj.o1538) described the situation as "a prime example of institutional corruption". In 2020-21, 98.5% of applications for new medicines approvals yielded positive decisions.  The APPG drew attention to MHRA chief executive Dame June Raine's statement in March 2022 that the agency had transitioned “[from watchdog to enabler](https://www.youtube.com/watch?v=xUQfzTqPUm4)”. "Enabler of what?" the letter asked, saying the statement "does little to quell suspicions of conflicts, and the implications for patient safety cannot be overlooked".  Drugs passed through expedited approval processes – 36% in the UK in 2020 – [are more likely](https://www.medscape.co.uk/viewarticle/institutional-corruption-permeates-drug-regulators-globally-2022a1001obx) to be withdrawn for safety reasons, carry a subsequent black box warning, or have dosage forms voluntarily discontinued by the manufacturer. Moreover, the APPG said that the yellow card scheme was "failing patients", with "gross under-reporting" of suspected adverse drug reactions: only 1 in 12 patients is aware of it, and up to 98% of reactions go unreported. The MHRA has no effective processes to monitor, investigate, or follow up reports, and complaints systems are "too complex and too diffuse to allow early signal detection".  The MHRA's lack of transparency and conflicts of interest did not fulfill its statutory duty to protect patient safety or maintain public trust, the letter said. The system is "beset by conflicts" and "often too late in detecting and acting to prevent serious harms". Hence the AstraZeneca coronavirus vaccine was suspended in other countries on 11 March 2021, but the MHRA did not publish safety advice until 7 April, after 24 million people had been vaccinated in the UK "without MHRA’s pharmacovigilance system detecting a problem". MHRA withdrew the product for under 40s only on 7 May, "after further needless deaths". ## Prioritise Patient Safety Over Commercial Interests The letter urged the Health and Social Care Select Committee to launch "a thorough, wide-ranging and long-overdue investigation into the MHRA". It advocated mandatory reporting of industry payments, with a dedicated register of conflicts of interest, echoing a [current parliamentary petition](https://petition.parliament.uk/petitions/652008) asking legislators to make the MHRA "fully transparent" to "ensure patient safety is prioritised over commercial interests".  Dr Margaret McCartney, honorary senior lecturer in medicine at the University of St Andrews and senior associate at the Centre for Evidence Based Medicine, University of Oxford, told _Medscape News UK_: "It's clear from decades of research that conflicts of interest, especially financial, are associated with poorer quality and more expensive healthcare. We need transparency. Such conflicts should not be hidden from patients or other professionals where decisions could be affected." However, she cautioned, merely asking people to declare their interests "doesn't take away the conflict. There is a risk that by creating registers of declarations, an assumption is made that the risk has been managed, but that isn't the case. Transparency is only a first step". Asked by _Medscape News UK_ to comment, MHRA chief executive Dr June Raine said: "We have made significant steps to put patients at the heart of all our work. "These include incorporating patient views and lived experience into our safety reviews, involving patients in the early stages of planning medicines development, and building a new responsive reporting system for patients to tell us about any adverse incidents. We have also led on legislative changes to strengthen surveillance for medical devices and medicines, meaning patient safety is embedded firmly into law. "Our progress so far in making changes based on meaningful patient involvement gives us a solid base to build upon as we continue on this important journey. We are committed to enabling innovation that brings transformative medical products safely to patients."