Sunshine Consultation – why you should care

10 September 2023

Following years of lobbying by Sling The Mesh followed by the First Do No Harm review, the government is running a six-week consultation on the potential for a Sunshine Payment Act in the UK. This would force industry to openly publish all payments and benefits in kind they give to the healthcare sector.

It’s important that everyone who cares about patient safety gets involved. Carry on reading to find out more and complete the consultation. Deadline: 11:59pm on 16 October 2023.

How would you feel if your Doctor or a health charity promoted a perfect treatment for your health condition with great results and virtually no risk?

You’d snap it up.

But what if you subsequently found out that the doctor or charity took thousands of pounds from the treatment makers to write a scientific paper promoting it, attend an all-expenses paid conference to talk about it, spent time working as their expert consultant or had donated funds to projects, research, conferences or charitable funds.

You might question their opinion.

As campaigners, we saw that American doctors who were heavily promoting mesh or publishing studies into mesh success, were taking large sums of money from companies making the product.

Money had biased their opinion.

We were able to obtain this information thanks to the American CMS Database which lists money given to the healthcare sector by industry, in easy to search categories. For example, by searching a doctor’s name. It is free to use.

This database was set up following the American Sunshine Payment Act (2013).

And while there were strong indications that industry money was also affecting doctors’ opinion in the UK, we had no way of proving it.

A Sunshine Payment Act to create one government-held database independent of industry would provide up-to-date, ongoing evidence by shining a light on industry money exchanging hands.

Accurate information helps patients decide whether their doctor is making independent, sound judgments about their care. It will help campaigners and journalists decide if scientific evidence can be trusted. Accurate information will improve patient safety.

Why you should care

Industry payments are legal. We’re not campaigning for industry payments to stop. However, just as with MPs’ conflicts of interest, such money must be publicly declared so their effects can be recognised.

Time and again it has been shown that industry payments:

Affect treatment choices that doctors make for patients.
Affect the results of scientific studies – those sponsored by companies are more likely to find positive results.

What will change if we have a Sunshine Act?

The effects of industry payments on medicine and science can be addressed.
Journalists, campaigners and policy makers can access this information.

Industry gives millions of pounds every year to doctors, researchers, teaching hospitals, surgeon societies, healthcare charities, parliamentary interest groups and lobby groups.

Not because industry is a generous benefactor. It’s because industry recognises the value of key opinion leaders who can raise awareness of their products across various different platforms.

Whether that’s in a Drs consulting room, a health charity’s social media posts, Parliamentary meetings or within the pages of scientific research.

The mesh scandal – £100K secret money

As campaigners, we saw industry payments at play when the BBC covered the story of a Scottish surgeon who secretly took £100,000 from makers of a mesh sling, he was trialling.

Surgeon Professor Mohammed Abdel-fattah failed to declare a £100,000 research grant from the makers of a vaginal mesh sling he was studying. As lead clinician on a 2012 study he concluded no patients were suffering thigh pain three years after surgery. However, this type of TVTO mesh has caused some of the most harrowing injuries to women leaving many in wheelchairs or needing sticks to walk.

A complaint was made about the study to the GMC in 2018 with allegations of research misconduct and Prof Abdel-fattah published a correction admitting funding from the manufacturer, but denied any link to “any aspect of the study at any time”.

He said the research grant from Coloplast was “inadvertently omitted” from the original disclosure. The correction contains a link to Prof Abdel-fattah’s personal declaration of interests, including money from mesh manufacturers and being a consultant and trainer for mesh making giants Ethicon and Coloplast.

Overseeing support group Sling The Mesh and watching hundreds of women globally suffer the life-changing, irreversible and devastating effects of the TVTO mesh slings which Abdel-fatteh studied is appalling.

Patients deserve better. we deserve to know about industry payments.

Do other countries have a Sunshine Payment Act?

Time and again, systems for voluntary reporting by clinicians have been shown not to work. For this reason, some countries have realised that legislation is the only way to ensure industry money to doctors is logged.

Examples of countries that have set up systems where drug and device companies are required by law to declare their payments to the healthcare sector. Information is held on a central public register. These countries are changing. It’s time for the UK to change too:

🇺🇸 United States
🇩🇰 Denmark
🇨🇵 France – transparency also applies to social media influencers and patient groups
🇵🇹 Portugal
🇰🇷 Japan
🇧🇪 Belgium

Industry influence

In his recent blog on the Sunshine Payments consultation, Professor Carl Heneghan writes that the Royal Colleges have received more than £9m from drug and medical devices companies since 2015. Recently, the Observer reported a sharp rise in spending by drug firms in the UK health sector: “In 2022, the total value of such payments was more than £200m – up 26% compared with the previous year, and almost double the amount spent by industry in 2015.” From 2012 to 2016, the industry donated over £57m to UK patient organisations – the yearly sum more than doubled.

Sling The Mesh has campaigned for a Sunshine Payment Act since 2015 and succeeded in getting Section 92 added into the Health and Care Act 2022, which lays the foundations for such a system. It’s time for the law to now be enacted to shine a light on the secret millions.

Get involved

We are calling for a system like the American CMS Open Payments model, where, in a matter of a few clicks, you can find out if a healthcare professional, local hospital or researcher has taken industry funding – we want this extending to health charities who exert considerable influence over health policy and public opinion.

We want one central government-held register. We want a law enacting so industry MUST log all payments made to the healthcare sector.

Anyone can complete the UK’s consultation. It is important that the government hears from a diverse range of healthcare professionals and patients.

Complete the consultation here: Deadline is 11:59pm on 16 October 2023.

PS Our three concerns

We have three concerns with the Sunshine consultation wording which feels deliberately vague:

Can commercially sensitive information be omitted? If so what classes as commercially sensitive?
Will the Association of British Pharmaceutical Industry run the database? We hope not! We need a database that’s independent of industry. Plus, the ABPI doesn’t cover medical devices like mesh.
We want information on payments from industry to be held on one central, government registry to act like a one-stop-shop for industry payment information.

Background

The Sunshine Payment Act was passed in America in 2013. A year later a 2014 article in Health Affairs noted that: “Financial relationships between physicians and medical product manufacturers are common and can include everything from free meals to consulting or speaker fees to direct research funding. These relationships can have many positive outcomes and–particularly in the context of consulting and research funding–are often a key component in the development of new drugs and devices. However, they can also create conflicts of interest and in some cases can blur the line between promotional activities and the conduct of medical research, training, and practice” https://www.healthaffairs.org/do/10.1377/hpb20141002.272302/full/

In the United States it is the responsibility of the companies to declare payments to the Centers for Medicare & Medicaid Services (CMS). It is easy and free for the public to navigate.

In the UK there is only a voluntary reporting database, which was set up in 2016 by the Association of the British Pharmaceutical Industry (ABPI). Disclosure of payments to this database is not mandatory and it only covers drugs. NOT devices like surgical mesh. [RM1]

In our evidence to the First Do No Harm review, we called for a Sunshine Payment Act as a matter of urgency.

This was backed by chair of the Surgical Mesh APPG, MP Emma Hardy, who spoke about it in a debate in the Houses of Parliament in April 2018