Industry payments to the healthcare sector: UK government plans under fire
The UK government’s plans for mandatory reporting of industry payments made to research institutions, teaching hospitals and clinicians “will be of little practical use, and must be amended”, a coalition of 13 experts, members of parliament and health groups including TranspariMED has warned.
Writing to Steve Barclay, the Secretary of State for Health, and Steve Brine, Chair of the House of Commons Health Committee, the coalition noted that under the existing plans payment data would be so fragmented as to be useless:
“It would be entirely impossible for a patient to check whether any payments from industry had been made to an individual healthcare professional, as they would not know which company websites to check…”
“The best and simplest solution is for there to be a statutory requirement for companies to report their payments to healthcare professionals and organisations to a single, central, searchable, publicly accessible, government-held register.”
“Poorly thought out, ineffectual proposals around transparency of payments in medicine are likely to further damage patient trust.”
The coalition notes that other countries, including France and the United States, compile data on such payments on a central, government-held register.
The letter was coordinated by the Sling the Mesh campaign. The full letter is reproduced verbatim below.
Dear Mr Barclay and Mr Brine,
We welcome publication of the Government’s consultation on the disclosure of industry payments to the healthcare sector, following their acceptance in principle of the Independent Medicines and Medical Devices Safety (IMMDS) Review's recommendation of mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and clinicians.
Evidence shows that such payments do affect decisions about the treatment given to patients, and even the outcomes of scientific research. Whilst arguments may be made for the benefit of these collaborations, it is widely accepted that transparency round their existence is the first step in assessing their overall impact on healthcare.
However, there are a number of concerns which make the consultation’s proposals unworkable in their current form.
Whilst we agree that the Government should introduce the necessary secondary legislation to compel manufacturers of drugs, devices, and borderline substances to report details of the payments they provide, the options proposed to enact this will be of little practical use, and must be amended.
The main proposal set out in the consultation is for a regulatory requirement, underpinned by Section 92 of the Health and Care Bill, for these manufacturers to publish information about their payments to healthcare professionals and organisations on their individual websites.
The stated intent is that patients should be able to identify and track the payments received by, e.g., a known healthcare professional involved in their care.
However, it would be entirely impossible for a patient to check whether any payments from industry had been made to an individual healthcare professional, as they would not know which company websites to check. Even a well-informed academic would not know, for example, the names of every device manufacturer who may have paid an individual clinician, in order to trace payments.
The Government also propose that, as an alternative to declaring on their websites, companies may comply by exception with any legislative reporting requirements through a designated third-party scheme. The implication is that, for pharmaceutical companies, this third-party scheme will be ABPI’s Disclosure UK database.
However, this proposed use of third-party schemes does not present a practical solution. The proposal would give pharmaceutical companies the choice of declaring payment information on their websites or via Disclosure UK, which would fragment the available data. In addition, the Disclosure UK database does not cover payments from manufacturers of medical devices or borderline substances, and there are no equivalent schemes for these industries in the UK.
The report of the IMMDS specified that declarations of interests should be held together in one central register. The Government have stated they do not think a GMC should hold the register, nor are the GMC willing to do so.
The best and simplest solution is for there to be a statutory requirement for companies to report their payments to healthcare professionals and organisations to a single, central, searchable, publicly accessible, government-held register.
Other countries who have legislated to mandate the declaration of payments from industry have also chosen to hold the information on a central, government run register.
In the USA, the Sunshine Act of 2010 required manufacturers of drug and medical devices to track all financial relationships with clinicians and teaching hospitals and to report all payments over $10 to the Centers for Medicare and Medicaid Services (CMS), a branch of the US Department of Health.
In France, the Bertrand Law of 2014 means that these payments are recorded on a register held by the Ministry of Social Affairs and Health and searchable by the public, the “Transparence Santé”.
Finally, the consultation does not make clear what the Government intend with their proposal that they “exempt businesses from disclosing commercially sensitive information” that could affect “the legitimate business interests of the undertaking to which it relates”.
This appears to miss the point of legislation mandating the disclosure of payments from industry; transparency, in order to allow the effects of these payments on science and medicine to be examined. In addition, the likelihood that a declaration would threaten a company's legitimate commercial interests is remote.
We understand the Government are currently undertaking a separate piece of work, piloting a local system for doctors to voluntarily declare their interests to local NHS employers. However, there is ample evidence that voluntary declaration of financial interests in medicine does not work well, which is why other countries have moved to place a statutory obligation on manufacturers to declare these payments to a central, government-held register.
In the consultation, the Government acknowledge the limitations to, and gaps in, the existing systems for disclosing payment information, stating that comprehensive and consistent transparency may be required. They state that the potential mandating of sponsorship reporting could achieve 2 key objectives: improving patient trust in healthcare professionals and organisations, and helping to ensure that healthcare professionals continue to make impartial, evidenced-based decisions about patient care.
The COVID-19 pandemic has shown vital importance of these two aims. Poorly thought out, ineffectual proposals around transparency of payments in medicine are likely to further damage patient trust.
We request that the Government work to modify these consultation proposals, and move to set up a central register.
Yours sincerely,
Kath Sansom and Ruth MacLeod, Sling the Mesh
Alec Shelbrook MP, Co Chair of the Surgical Mesh APPG
Sharon Hodgson MP, Vice Chair of the Surgical Mesh All Party Parliamentary Group
Dr Julian Lewis, MP, Vice Chair of the Surgical Mesh All Party Parliamentary Group
Professor Carl Heneghan, University of Oxford
Roger Fisken, Chair, HealthSense
Marie Lyon, Association for Children Damaged by Hormone Pregnancy Tests
Till Bruckner, Transparimed
Dr Peter J Gordon, Retired NHS Consultant
Helen Hughes, Chief Executive of Patient Safety Learning
Miles Sibley, Patient Experience Library
Ken Lownds, Zero Harm Healthcare
Tommy Sheppard MP for Edinburgh East