United Kingdom

Medical regulator faces questions about board members’ relationships with pharmaceutical companies NHS

The British Medicines Authority has been called upon to step up its conflict 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. Some offer consulting services, while others help manage or own shares in drug and medical device companies, according to official transparency records.

There is no suspicion of wrongdoing, but the findings have raised concerns about alleged conflicts of interest among senior officials in the Medicines and Health Products Regulatory Agency (MHRA), the executive agency of the Ministry of Health and Social Welfare responsible for regulating medicines and medical devices. and ensure they are safe.

The MHRA said that “in order to be an effective regulator” it must “gather the right experience from the whole industry, academia, the public and beyond”, adding that board meetings are held in public and non-executive board members – for which are related to potential conflicts – do not participate in “any work or decisions related to the regulation of any products”.

But critics have expressed concern about the potential for bias – or its perception – and called for stricter rules on conflicts of interest for pharmaceutical workers.

The Board is responsible for assisting in setting strategic priorities and advising on policy implementation, potentially providing members with access to information that may be useful in their positions in external organizations.

David Rowland, director of the Center for Health and the Brain Trust of the Public Interest, said regulators need to be “whiter than white” to maintain “absolute public trust” – especially when they are responsible for licensing new and potentially innovative products and devices ”.

“We saw many people during the pandemic who doubted the reliability and safety of vaccines and other treatments,” he said. “Once people start thinking there are potential financial gains, it’s very difficult to regain that trust.”

Of the 16 board members, six have declared financial interests in drug or medical device companies or companies working on their behalf, according to an Observer analysis of official transparency records released in February.

All but one of the six joined the board in September, and each of the appointments was signed by the Ministry of Health.

Dr. Junaid Bajua, chief medical scientist at Microsoft, is also the non-executive director of Ondine Biomedical, a Canadian life sciences company, and Nahdi Medical, a Saudi pharmaceutical company, according to the registries. He also owns shares in the pharmaceutical company Merck Sharp and Dohme and is a paid advisor 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 stand-alone digital tools – AI therapy – in the future.

Raj Long offers paid “access consulting services” to Huya Bio, a Chinese company that aims to enable “faster, more efficient and lower-risk drug development in global markets” and is a shareholder in Bristol Myers Squibb and Novartis, while Amanda Calvert, who has been the non-executive board of the MHRA since 2019, is the director of Quince Consultancy, whose clients include pharmaceutical companies.

Haider Hussein, appointed to the MHRA as an “associate non-voting non-executive director”, is the chief operating officer of Healthinnova, which provides consulting services on “how to get the most out of digital healthcare investments”.

Meanwhile, Prof. Graham Cook, vice chairman of the MHRA, is a paid advisor to two medical device companies and an unpaid advisor to a third, DnaNudge, which offers DNA-compliant diets and 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 in its expert committees, such as the Committee for Human Medicines and the Advisory Councils for Herbal and Homeopathic Medicines, to ensure that “experts who advise us are independent and impartial. “

Last week, however, he said he had no plans to review policies for non-executive board members who are currently allowed to have links with industry, provided they have been declared.

Other regulators, such as the Gambling Commission, prohibit board members from accepting payments from or holding stakes in companies in the gambling industry.

And last week, a non-executive director on the board of the Civil Aviation Authority, whose appointment was signed by the Ministry of Transport, resigned due to a potential conflict of interest as he owns shares in the parent company of British Airways.

Harry Keaton, former chief executive of the Professional Standards Body, said it was valuable to have industry figures as board members and that it was “a duty to [be] crossover level ”. “The question is not, ‘Are you on board the MHRA?’ But are you making decisions that are in your best interests?” He said.

But Professor John Abraham, a medical regulation expert and former political adviser, called on those involved in health regulation to be required to give up “all direct and personal financial conflicts of interest” in order to maintain public confidence.

“The answer of the regulators for many years is that they could not get the expertise they need to advise. “It’s just not very plausible because there are so many scientists and experts,” he said.

In 2020, the Independent Review of the Safety of Medicines and Medical Devices, led by peer Julia Cumberlegi, expressed concerns about conflicts of interest in medical regulation and called for a “culture renewal” of the MHRA. “Steps must be taken to ensure that the patient’s perspective and the public interest always take precedence over the interests of industry,” the review said.

MHRA said non-executive board members have been appointed to provide “constructive challenge and advice on MHRA’s strategic direction” through an “open and transparent process” managed by the Ministry of Health.

“Conflicts of interest are considered on a case-by-case basis at the time of appointment and at the beginning of each board meeting,” he added.