Britain’s medicines watchdog has been urged to tighten its conflicts of interest policy after it emerged that six of its board members were 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 pharmaceutical giants and companies with ambitions to break into the UK healthcare market. health. Some offer advisory services while others help manage or own shares in drug and medical device companies, according to official transparency records.
There are no suggestions of wrongdoing, but the findings have raised concerns about perceived conflicts of interest among senior officials at the Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the Ministry of Health and Social Care responsible for regulating medicines and medical devices and ensuring that they are safe.
The MHRA said that “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 were being held in public and that the non-executive members of the board – to whom the potential conflicts relate – are not involved in “any work or decision regarding the regulation of any product”.
But critics raised concerns about the potential for bias – or its perception – and called for stricter rules on conflicts of interest for those working in drug regulation.
The board is responsible for helping to set strategic priorities and advising on policy implementation, potentially giving members access to information that could be useful in their roles with outside organizations.
David Rowland, director of the Center for Health and the Public Interest think tank, said regulators need to be “whiter than white” in order to maintain “absolute public trust” – especially when they are responsible for “the ‘new and potentially innovative licensing’. products and devices.
“We have 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 had, it’s very difficult to win that trust back.”
Of 16 board members, six have declared financial interests in pharmaceutical or medical device companies, or companies working on their behalf, according to Observer analysis of official transparency records published in February.
All but one of the six joined the council in September and each of the appointments was signed 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 newspapers. He also owns shares in the pharmaceutical company Merck Sharp and Dohme and is a paid adviser to the Swiss company Novartis.
Dr. Paul Goldsmith is a shareholder and director of Closed Loop Medicine, which develops products for hypertension and insomnia, 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 the future.
Raj Long offers fee-based “access consulting” services to Huya Bio, a Chinese company that aims to enable “faster, more cost-effective and lower-risk drug development in 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 board since 2019, is the director of Quince Consultancy, whose clients include pharmaceutical companies.
Haider Husain, appointed to the MHRA board as a “non-voting associate non-executive director”, is the chief operating officer of Healthinnova, which provides consultancy services on “how to get the most out of investments in digital health”.
Meanwhile Professor Graham Cooke, Deputy Chairman of the MHRA Board, is a paid adviser to two medical device companies and an unpaid adviser to a third – DnaNudge, which offers diet products suitable for DNA in addition to being a provider of Covid-19 tests.
The MHRA has a strict conflict of interest policy for staff and is currently revising its rules for advisers to its expert committees, such as the Human Medicines Commission and the Herbal and Herbal Medicines Advisory Councils. homeopathic, to ensure that “the experts who provide us with advice are independent and impartial”.
But he said last week he had no plans to review policies for non-executive board members, who are currently allowed to have industry ties provided they are declared.
Other regulators, such as the Gambling Commission, prevent board members from accepting payments or holding shares of companies in the gambling industry.
And last week a non-executive director of the Civil Aviation Authority board, whose appointment was approved by the Department for Transport, resigned over a potential conflict of interest because he owns shares in the parent company of British Airways.
Harry Cayton, former chief executive of the Professional Standards Authority, said it was valuable to have industry figures as board members and was “compulsory [be] a crossover level. “The point is not, ‘Are you on the MHRA board?’ but do you make decisions that relate to your interests?” he said.
But Professor John Abraham, a medical regulation expert and former policy adviser, has called for those involved in health regulation to be required to waive “all direct and personal financial conflicts of interest” in order to maintain public trust.
“The response from regulators for many years has been that they couldn’t get the expertise they needed to advise. It’s just not very plausible because there are so many scientists and experts out there,” he said.
In 2020, the Independent Review of the Safety of Medicines and Medical Devices, led by life peer Julia Cumberlege, raised concerns about conflicts of interest in medical regulation and called for an “overhaul of the culture from the MHRA. “Steps must be taken to ensure that the patient perspective and public interest always take precedence over industry interests,” the review says.
The MHRA said non-executive members of the board had been appointed to provide “constructive challenge and advice on the strategic direction of the MHRA” through an “open and transparent process” managed by the Board. Ministry of Health.
“Conflicts of interest are reviewed on a case-by-case basis upon appointment and at the start of each board meeting,” he added.