By Ruth MacLeod and Kath Sansom of Sling The Mesh

Sling The Mesh has expressed deep disappointment following a lack of response from Baroness Gillian Merron, Parliamentary Under-Secretary of State for Patient Safety, Women’s Health and Mental Health, to a letter calling for Sunshine legislation for the UK.

If given the go ahead, this would shine a light of transparency on the millions given from industry to the UK’s health sector every year – including NHS hospitals.

Industry money can bias doctors in their prescribing choices and affect the quality of research into new and existing treatments – both a huge patient safety concern.

Our letter, signed by a coalition of prominent academics, patient safety advocates and politicians, called for the implementation of Sunshine legislation so that such monies are logged on one central public database, independent of industry.

In September, we wrote to Baroness Merron to express our concerns on how financial ties between healthcare professionals and organisations, with drug and medical device companies can lead to conflicts of interest which, if not addressed adequately, can harm patients.

Six weeks later we have still not received a response.

Is she processing our request? Has it been forgotten about? Is there work going on behind the scenes to address conflicts of interests? Will a meeting be arranged to discuss patient safety with patient safety advocates like ourselves who see first hand the devastation of avoidable harm?

We look forward to a response. Our letter can be found below:

Dear Baroness Merron,

We are writing to you as a group concerned with the issue of transparency on financial conflicts of interest in the healthcare sector – members of the Sling the Mesh campaign group, an international group of academics specialising in systems for transparency on financial interactions in the healthcare sector, medical doctors with an interest in this topic, patient safety campaigners, and concerned MPs.

We thank you for your words in the recent House of Lords debate on vaginal mesh implants, on the new Government’s plans for the recommendations of the seminal Independent Medicines and Medical Devices Safety (IMMDS) review.

We noted in particular you comment that the Department of Health and Social Care will shortly be responding to the October 2023 public consultation on the disclosure of industry payments to the healthcare sector. As you will know, this consultation followed on from the IMMDS review’s recommendation that transparency of payments to the healthcare sector needs to improve – specifically, its recommendation that there should be mandatory, statutory reporting for pharmaceutical and medical device industries of payments made.

We write to request an urgent meeting with you and the health select committee chair on the imminent Government response to this consultation. We are concerned that the proposals put forward in the consultation released by the last Government were impractical and will bring no transparency gains.

Financial ties between healthcare professionals and organisations, and drug and medical device companies can lead to conflicts of interest which, if not addressed adequately, can harm patients, undermine the integrity of medical research, result in wasteful spending of taxpayers’ money, and weaken trust in the health service. Without transparency, the effects of these financial ties on healthcare decisions cannot be controlled and managed.

Full transparency is therefore the necessary first step to ensure that any collaborations between the NHS, its staff and industry can stand the test of public scrutiny and benefit patients.

Whilst the existence of a payment from industry does not carry an automatic assumption of bias, or wrongdoing, international research evidence shows unequivocally industry payments to doctors affects their choice of treatment for patients, and that studies sponsored by drug or device companies are more likely to find results that favour the company, even if this means the prescription of unnecessary, more expensive, or even harmful products to patients.

One key case in point is the disastrous opioid crisis in the US, which was demonstrably fuelled by unmitigated payments the manufacturers made to doctors. It is against this background that the decades-overdue need for proper transparency is clear.

The recommendation of the IMMDS review to improve transparency in the healthcare sector was, therefore, very welcome- as was the consequent primary legislation in the Health and Care Act 2022, which gave the Secretary of State the powers to make regulations that would make it mandatory for the pharmaceutical and device companies to publish details of the payments they make to the healthcare sector.

By contrast, expert opinion has confirmed that the subsequent proposals put forward in the October 2023 consultation on the disclosure of industry payments to the healthcare sector were confused and unworkable.

In October 2023, a number of us wrote to the then Health Secretary to set out the serious concerns with the consultation- yet received no proper reply from the Department.

Essentially, the proposals in the consultation set out plans to give manufacturers the choice between publishing information about their payments to the healthcare sector on their individual websites, and publishing them on a third-party scheme like the Association of the British Pharmaceutical Industry (ABPI)’s Disclosure UK database. This would fragment the available data, and make the consultation’s stated intent that patients should be able to identify and track the payments to an individual clinician impossible. In addition, there is no database scheme equivalent to Disclosure UK for the medical device industry.

These proposals also disregard well-documented shortcomings of Disclosure UK. Ambiguities in how payment information is identified on this database by different companies means the value of payments received by key healthcare providers like NHS trusts and general practices is often unclear. This payment information is then of no use to policymakers and regulators in managing potential conflicts of interest, making healthcare less accountable to patients and taxpayers.

We would also like to alert you to a recent scandal involving Novo Nordisk, the largest player in the obesity care market in the UK, which failed to report approximately 500 payments worth £7.8m to the Disclosure UK database. The more than 150 recipients of these payments included NHS staff, healthcare organisations, and journalists. The inadequacy of Disclosure UK is shown not only by the scale of the missing disclosures but also that, even now the scandal has been uncovered, the company’s declarations still have not been updated on Disclosure UK.

In addition to this, studies of different systems for declaration of interest in the healthcare sector in countries around the world show that “mixed” disclosure systems (as set out in this Government consultation), which involve both legislative provisions and expansions of industry-run databases, do not work well. They tend to leave a significant portion of industry payments outside of the public’s scrutiny such as payments related to companies’ research activities, which make up a majority of all payments made in the pharmaceutical industry. Industry self-regulation does not work well.

As a result, any regulations based on the proposals in the consultation are likely to be impractical, and present no improvement to transparency in this area.

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 the GMC should hold the register, nor are the GMC willing to do so. The best and simplest solution is for regulations, following on from the clause in the Health and Care Act 2022, which set out a statutory requirement for companies to report their payments to healthcare professionals and organisations to a single, central, searchable, publicly accessible, and user-friendly government-held register. Other countries who have legislated to mandate the declaration of payments from industry, such as the USA and France, have also chosen to hold the information on central, government run registers.

We understand the previous Government had looked at a separate piece of work, piloting a local system for doctors to voluntarily declare their interests to local NHS employers, and you made reference to this work in your recent speech.

However, there is ample evidence that systems of voluntary self-declaration of financial interests in medicine also do not work well, with consistent and significantunder-reporting. Again-this is why other countries have moved to place a statutory obligation on manufacturers to declare these payments to a central, government-held register. NHS Trusts already have guidance encouraging employees to disclose relevant conflicts of interest, but evidence suggests recording and disclosure is poor.

The Sling the Mesh signatories of this letter are grateful for the Hughes report. However, it not acceptable to take the advice of the Patient Safety Commissioner on the IMMDS’s recommendations in place of meeting with patient groups. As the IMMDS report authors said, “listen to the patients”. We, and the expert signatories of this letter, do not agree that a new system to address transparency around conflict of interest in the UK should be led by industry nor that we can rely on local NHS systems of voluntary reporting, because the evidence is clear that neither solution brings transparency gains.

With the support of patient and professional groups, public, scientific and media interest in this issue will not dissipate. For Labour to begin a strong and credible record on patient safety, it is vital that evidence-based action is taken to address the issue of transparency on conflicts of interest in medicine.

We would be grateful if you could indicate some suitable times to meet with members of Sling the Mesh and academics specialising in this area to discuss the issue.

Please contact slingthemesh@gmail.com.

We have also circulated this letter to Layla Moran, as new Chair of the Health and Social Care Committee and would be grateful if Ms Moran were also willing to attend this meeting.