The UK medicines watchdog has been urged to strengthen its conflict of interest policy after it emerged that six of its board members are receiving payments from the pharmaceutical industry.
Board members involved in overseeing the regulator’s “strategic direction” also have financial interests in companies including US and Saudi drug giants and firms with ambitions to break into the UK’s healthcare market. Some offer consultancy services while others help run or own shares in drug and medical device firms, according to official transparency records.
There is no suggestion of wrongdoing, but the findings have led to concerns about perceived conflicts of interest among senior figures at the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care responsible for regulating drugs and medical devices and ensuring they are safe.
The MHRA said that “in order to be an effective regulator” it needed to “bring together the right expertise from across industry, academia, the public and beyond”, adding that board meetings are held in public and non-executive board members – to whom the potential conflicts relate – are not involved in “any work or decisions relating to the regulation of any products”.
But critics raised concerns about the potential for bias – or the perception of it – and called for stricter rules on conflicts of interest for those working in pharmaceutical regulation.
The board is responsible for helping set strategic priorities and advising on the delivery of policies, potentially giving members access to information that could be useful in their positions at outside organisations.
David Rowland, director of the Centre for Health and the Public Interest thinktank, said regulators needed to be “whiter than white” in order to maintain “the absolute trust of the public” – particularly when they are responsible for “licensing new and potentially innovative products and devices”.
“We’ve seen during the pandemic a lot of people questioning the reliability and safety of vaccines and other treatments,” he said. “Once people start thinking there are potential financial gains to be made it’s very difficult to get that trust back.”
Of 16 board members, six have declared financial interests in drug or medical device companies, or firms working on their behalf, according to Observer analysis of official transparency records published in February.
All but one of the six joined the board in September and each of the appointments was signed off by the Department of Health.
Dr Junaid Bajwa, chief medical scientist at Microsoft, is also a non-executive director of Ondine Biomedical, a Canadian life sciences company, and Nahdi Medical, a Saudi pharmaceutical retailer, according to the logs. He also owns shares in the pharmaceutical company Merck Sharp and Dohme and is a paid adviser to the Swiss firm Novartis.
Dr Paul Goldsmith is a shareholder and director of Closed Loop Medicine, which is developing hypertension and insomnia products, according to its website. He owns shares in Summit Inc, a drug discovery and development company, and Ieso, which intends to seek approval for its autonomous digital tools – AI therapy – in future.
Raj Long offers paid “access advisory” services to Huya Bio, a Chinese company that aims to enable “faster, more cost-effective and lower-risk drug development in the global markets”, and is a shareholder in Bristol Myers Squibb and Novartis, while Amanda Calvert, who has been a non-executive director of the MHRA’s board since 2019, is the director of Quince Consultancy, whose clients include drug companies.
Haider Husain, appointed to the MHRA board as a “non-voting associate non-executive director”, is chief operating officer of Healthinnova, which provides consultancy services on “how to derive the most value from digital health investments”.
Meanwhile, Prof Graham Cooke, deputy chair of the MHRA’s board, is a paid adviser to two medical device companies, and an unpaid adviser to a third – DnaNudge, which offers DNA-tailored diet products as well as being a provider of rapid Covid-19 tests.
The MHRA has a strict conflict of interest policy for staff and is currently reviewing its rules for advisers on its expert committees, such as the Commission on Human Medicines and the advisory boards for herbal and homeopathic medicines, to ensure “experts providing us with advice are independent and impartial”.
But it said last week that it had no plans to review the policies for non-executive board members, who currently are permitted to have industry links provided they are declared.
Other regulators, such as the Gambling Commission, bar board members from accepting payments from, or owning shares in, companies in the gambling industry.
And last week, a non-executive director of the Civil Aviation Authority’s board, whose appointment was signed off by the Department for Transport, resigned due to a potential conflict of interest because he owns shares in British Airways’ parent company.
Harry Cayton, former chief executive of the Professional Standards Authority, said it was valuable to have industry figures as board members and that there was “bound to [be] a level of crossover”. “The point is not, ‘Are you on the board of the MHRA?’ but are you making decisions that relate to your interests?” he said.
But Prof John Abraham, an expert in medical regulation and former policy adviser, called for those involved in health regulation to be required to relinquish “all direct and personal financial conflicts of interest” in order to uphold public trust.
“The response by regulators over many years is that they couldn’t get the expertise that they need to advise. That’s just not very plausible because there are so many scientists and experts out there,” he said.
In 2020, the Independent Medicines and Medical Devices Safety Review, led by life peer Julia Cumberlege, raised concerns about conflicts of interest in medical regulation and called for an “overhaul of the culture” of the MHRA. “Steps should be taken to ensure that the patient perspective and the public interest always takes precedence over the interests of industry,” the review said.
The MHRA said non-executive board members were appointed to provide “constructive challenge and advice on the strategic direction of the MHRA” through an “open and transparent process” operated by the Department of Health.
“Conflicts of interest are considered on a case-by-case basis on appointment and at the start of every board meeting,” it added.
