Intended for healthcare professionals

Feature Competing Interests

Where the mesh inquiry leaves us regarding a register of doctors’ interests

BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.m4839 (Published 06 January 2021) Cite this as: BMJ 2021;372:m4839
  1. Clare Dyer, legal correspondent
  1. The BMJ
  1. claredyer4{at}gmail.com

After years of mounting pressure, the Cumberlege inquiry into drugs and devices has added further weight to calls for the GMC register to record doctors’ conflicts of interest. Will this finally be enough for action, asks Clare Dyer

How did it happen that a product approved with little evidence of long term safety was taken up so enthusiastically by surgeons and implanted in thousands of women, many of whom went on to develop devastating complications? The murky tale of pelvic mesh, laid bare last year in meticulous detail at the Cumberlege inquiry, shines a light on inadequate research, failures in regulation, lack of informed consent, and surgeons keen to take advantage of an apparently quick and easy procedure for stress urinary incontinence and pelvic organ prolapse.1

Evidence to the inquiry, led by the life peer Julia Cumberlege, put common industry practices under the spotlight: aggressive marketing; manufacturers funding research; doctors taking sponsorship for training, travelling fellowships, honoraria, and speaking fees; professional bodies taking money from drug and device makers; and members of professional committees with conflicts of interest. As Carl Heneghan, director of the Centre for Evidence Based Medicine in Oxford, put it in evidence to the inquiry, “Is the whole system commercially conflicted? Yes, it is.” He added, “I think it’s important that, if I’m treating you, you know who’s paying me.”

Taking evidence around the UK as vice chair of the review, the retired paediatric nephrologist and former medical school dean Cyril Chantler recalls a “constant voice across the country of patients telling us they felt the mesh had been very commercially promoted and doctors were receiving benefits from companies prescribing it.”

He and his colleagues on the review—which also looked at two drugs linked to harm to unborn children, the hormone pregnancy test Primodos and the epilepsy treatment sodium valproate—recommended in July that doctors be required to register their financial and non-pecuniary interests in a single place, easily searchable by patients. This, they said, should be the medical register maintained by the General Medical Council, which lists all doctors registered to practise in the UK.

History of pressure

NHS employers and a range of other bodies, including clinical commissioning groups in England, now require doctors to declare interests, but these are not in one place, aren’t comprehensive, and are not easily accessible to the public. The Association of the British Pharmaceutical Industry (ABPI) maintains a database, called Disclosure UK, where drug companies declare payments and benefits in kind to healthcare professionals. But doctors must agree to have their names disclosed, and many refuse.

Patients’ groups told the Cumberlege inquiry that the UK needed an equivalent of the database created by the US Physician Payment Sunshine Act, which records any payments or transfers of value by the industry to a doctor. Searchable online, this was set up after a series of reports identified widespread conflicts of interest.

The idea is not a new one. The GMC came under pressure from politicians to require declarations of interest on the medical register after a scandal in 2012, when it emerged that doctors were offered “incentives” to refer patients to private hospitals. At the GMC’s annual accountability hearings, the regulator assured the House of Commons health select committee, which argued there was a “compelling case” for the GMC to hold a public register of doctors’ interests, that it would look at the issue.

In 2016 it published a consultation on reforms to the medical register, suggesting a two tier register: the first part mandatory, containing all the information required by law, and the second comprising data that a doctor could voluntarily provide for inclusion on the register. Among the possible voluntary items were “competing professional interests.” The consultation produced the largest response ever to a GMC consultation, most of it from doctors. The profession’s verdict was a resounding “no.”2

Since then, pressure has been growing for more scrutiny of doctors’ interests. A report in June 2019 found that a high number of NHS consultants owned shares and equipment in private hospitals and that many had failed to declare them.3 In November 2019 the council of the Royal College of General Practitioners overwhelmingly supported a motion calling on the GMC to develop a publicly available and searchable central registry of doctors’ declarations of interest. The Royal College of Obstetricians and Gynaecologists and the British Society of Urogynaecology told the Cumberlege review that they supported the idea of including doctors’ competing interests on the medical register.

Legislative and practical barriers

The GMC told the review it backed the idea in principle but lacked the support of the profession and the power to impose it without legislation. Anthony Omo, the GMC’s general counsel and director of fitness to practise, told the Cumberlege inquiry, “I think if the review were to say to the department [of health and social care] . . . that this is a priority, then we would be happily backing that.”

Mary O’Rourke QC, who has more than 30 years’ experience defending doctors against GMC charges, agrees that legislation would be needed to make it mandatory for doctors to disclose their interests on the register. “There are more than 250 000 medical practitioners on the GMC’s relevant registers,” she says. “If the proposal is that all of these in practice with licences to practise should disclose their potential conflicts of interest—private jobs or connection to drug companies or medical research, products or licences, or private clinics or consultancies or interests in medical businesses—this could only be achieved by legislation. It would require either amendment of Part IV of the Medical Act 1983 and section 30 (3) by the prescribing of particulars to be provided or under section 34 or by regulations made under Part IV.”

She also raises the possibility of a legal challenge on privacy grounds if an attempt were made to introduce the change. “It would likely be the subject of challenge on the basis of interference with the rights to privacy and family life under Article 8 of the European Convention on Human Rights, which can cover private business interests.”

David Lock QC, an expert in healthcare law, agrees that legislation would “probably” be needed but doubts that a privacy challenge would succeed. “Transparency is an essential building block to creating trust between those who make decisions affecting citizens and those who are affected by those decisions,” he notes. “That’s why full disclosure is required from a wide range of professionals who serve the public, from local councillors to NHS workers.

“Doctors who serve the public are in no different position. The public are entitled to know when a doctor who is providing care to them has relevant pecuniary interests which might affect the doctor’s decision making. Given that mandatory disclosure is required for other people serving the public–such as local councillors, MPs, and members of clinical commissioning group boards and trust boards–the interference with Article 8 rights would be straightforward to justify.”

Shannett Thompson, a partner at the law firm Kingsley Napley, warns that “the keeping of such a register will not be a straightforward task, and the risk of it being inaccurate is quite significant, as interests of this nature are subject to change.”

Chantler, once chairman of the GMC’s standards committee, suggests that the annual appraisal now required for each doctor by the regulator could provide the appropriate occasion for doctors to declare any interests. “As part of that annual appraisal your conflicts of interest ought to be reviewed and brought up to date.”

Possible vehicle for change

The reverberations from hidden conflicts of interest can echo for decades, harming public health and safety. Andrew Wakefield’s fraudulent Lancet study of 1998, used by him to suggest a link between the measles, mumps, and rubella vaccine and autism, fuelled an antivaccination movement that even now threatens the uptake of a vaccine for covid-19. He failed to disclose that the study overlapped with a pilot project funded by the legal aid board through a solicitor who hoped to mount a claim against the manufacturer and that several of the children in the study were prospective litigants. He also failed to disclose that he had filed a patent application for a new measles vaccine.

The UK government has not so far responded to the Cumberlege review. But plans in the pipeline, outlined last July, for sweeping reform to the law governing all the regulators of healthcare professionals could provide an opportunity for parliament to act.4 Officials at the Department of Health and Social Care for England are currently consulting stakeholders, including patients’ groups, with a view to producing a draft bill for consultation, possibly next year.

The Cumberlege review’s recommendation for doctors’ interests to be declared on the medical register is among the reforms under consideration, according to the representative of one stakeholder group who spoke to The BMJ. The draft bill is also expected to allow the regulators, including the GMC, to make more of their own rules without the need for legislation. A spokesperson for the health department said the talks were “general discussions in the context of developing policy” but would not reveal with which stakeholders the department was consulting. Thompson suggests that “the GMC would need to lead the process, as its input for effective drafting would be needed.”

Cumberlege said she was “delighted” that the recommendation was being considered by the health department. “We felt it was important that people who are being treated by doctors should know who’s paying them. I think it should be very clear that this should come about, and it shouldn’t be left to the GMC.”

Footnotes

References