Moves to boost transparency in the relationships between healthcare professionals and pharmaceutical companies come to fruition this year, but what challenges and opportunities will disclosure create?

In 2014, pharma companies paid healthcare professionals (HCPs) a total of £41 million for mainly consultancy services and for sponsorship to attend meetings. Beyond this, though, there is little public information about what these relationships entail or who these payments were made to.

However, in these days of greater transparency there is a growing expectation among the general public and the healthcare professions that such payments be brought out into the open, and that each payment should be individually detailed. Whether this is achieved by self-disclosure or through government legislation has sparked a heated debate.

“If an HCP works with a company it is right and proper that they be remunerated,” says Karen Borrer, head of reputation at the Association of the British Pharmaceutical Industry (ABPI). “It’s important that we keep working with HCPs to develop medicines because pharma companies don’t necessarily have their frontline experience. However, we need to be clear and open.”

Bribery or legitimate payments?

Action on this issue was first spurred by the development of a new Disclosure Code by the European Federation of Pharmaceutical Industry Associations (EFPIA) which requires member companies to be transparent about HCP payments.

However, the issue was thrust into the popular spotlight in mid-2015 when The Telegraph published an article revealing how some NHS staff were being paid thousands of pounds to work as consultants for pharmaceutical companies. The article made the point that the same companies were also lobbying the same ‘NHS bosses’ to get their products taken up by the health service.

Soon after, Health Secretary Jeremy Hunt announced plans to tighten expectations for disclosure via a so-called ‘sunshine rule’, which could lead to HCPs being prosecuted under the Bribery Act if they are found guilty of wrongdoing. It remains unclear whether this will lead to legally mandated disclosure in the UK, but this is an increasingly common approach across Europe, for example in France, Denmark and Greece.

While the ABPI welcomes the opportunity to work with the Department of Health on the issue, it remains convinced that self-disclosure rather than legislation is the best first step.

“There’s little appetite for legislation in the UK,” says Borrer. “The industry and all the professional bodies are self-regulated, and we would all prefer to do it that way. No bodies intend to change their own code of conducts to mandate it but everyone we’ve spoken to is very supportive of transparency.”

Michael Littlechild, chief executive of business ethics assessor GoodCorporation, agrees. “Over recent years, people have become more focused on transparency because businesses are subject to more ethics questions generally,” he says. “It behoves the industry to take this forward rather than waiting to be forced and seeming to drag its feet. It would give a much better impression of their desire to instil trust among the public.”

To coordinate the first wave of disclosures in the UK, the ABPI is setting up a searchable database for companies to post the details of their ‘transfers of value’ to HCPs, who will be individually named.

“Our goal is make the database as easy to use and transparent as possible for the end user,” says Borrer. Users could be anyone from the public to journalists and HCPs themselves.

The first UK disclosures will be available by the end of June.

What do doctors think?

The new approach has been well received by nurse and pharmacist professional bodies, however, the ABPI has found doctors to be more wary about disclosing every payment.

“The feeling we’re getting is that doctors don’t have a problem with transparency and being open about payments – they’re happy to register for the database – but there are concerns around public disclosure.” The ABPI is working to help them to better understand what information will be shown – for example R&D isn’t included at the moment – and “dispelling some fears” about what people are going to be able to see. “This is uncharted territory for everyone,” she says.

At this point, power rests in the hands of the HCPs because the UK Data Protection Act supersedes the ABPI code and allows HCPs to opt out of disclosure at any time. This includes withdrawing their consent after the data has been published, which could be problematic for the ABPI’s database.

“Consent rates could go either way,” says Borrer, “but I think with the increasing push towards transparency across society – which the sunshine rule is part of – it’s becoming more of an expectation.” The ABPI expects around 69 percent of HCPs to disclose, based on a 2015 poll, and Borrer is optimistic that this could rise over time. “Peer pressure might also encourage HCPs to sign up, but then it may only take one piece of dramatic media coverage to make a difference the other way.”

Although there is little the ABPI can do to stop doctors opting out, it is encouraging companies to engage with HCPs on the issue, says Borrer. “We are encouraging companies to have a conversation at the point where someone says ‘I’m not comfortable with this, I would like to remove my consent’.” Her hope is that companies could persuade HCPs to change their minds.

Whether HCPs opt out or not, aggregate totals will be available for each pharma company, as well as the number of HCPs included.

Reputational risk?

Potential threats of disclosure include worries that it could lead to the naming and shaming of doctors who often work with pharma companies in the media, and the uphill struggle against negative stereotypes in the media regarding the relationship between doctors and pharma.

However, GoodCorporation’s Littlechild says pharma should take steps to avoid such situations in the first place. “Those who don’t take the right measures and aren’t cautious enough are running the risk of getting dumped with bad headlines. The companies that are more cautious and don’t get into that position will be glad that it’s not them, but will also be aware that it besmirches the industry itself.”

He adds that while there are some potential disadvantages of self-regulation, they are unlikely to be a problem. “If companies think that the level of public demand for transparency will never get too loud then some might think they can get away with it. And if a company felt it would be shown in a poor light because it operates in a traditional way, they might have reason to oppose such moves. It would be a losing battle though; the more reluctant they seem, the more scrutiny they’ll get."

Tough stance

Under the self-regulation approach advocated by the ABPI, companies are free to manage their own contracts with HCPs and decide their approach to consent. While some are asking HCPs to disclose every time they do a new piece of work, others are doing it on a rolling basis and asking at intervals. Some are even refusing to work with HCPs who will not give consent to full disclosure.

GSK is one company taking a blanket “no consent, no contract” approach, says UK and Ireland medical director, Stephen McDonough, who adds that it is part of a wider push for transparency across the company. “We think there’s a need for a new standard across the industry,” he says. “People want to know we can do everything as openly as we can. If there isn’t consent to disclose then we won’t continue to work on a contractual basis with those doctors. Of course consent can be given at the time then withdrawn later, but once that’s done then we wouldn’t engage with that HCP in the future.”

GSK’s more open approach goes beyond payments to HCPs and includes being transparent about clinical trial data and moving to independent medical education. The company has even completely stopped paying HCPs to speak on their behalf at events.

Although the company's new payment policy is still in its early stages, no HCP has refused to disclose so far and McDonough believes the company is already seeing the benefits. “Before we went live we interacted with a broad range of healthcare professionals and institutions to get a flavour of how this would be received,” he says. “There were some mixed opinions but most of it was very positive. They liked that GSK is taking action in an area that needed to be addressed. In fact, commissioners have come to talk to us now simply because we’re doing this, and these are the sort of people who would not necessarily have interacted with industry.”

This approach is the logical conclusion for transparency, says Littlechild. “It seems that this is where transparency is going in the long run, but more disclosure could lead to [the industry] not going as far as it could do if people are comfortable that these matters are monitored.”

Although the exact nature of the ‘sunshine rule’ is not yet clear, it is natural that companies will want to avoid too much government intervention, and there may be benefits to doing so. At least for the time being, the power to improve transparency lies in pharma’s hands – if the industry does not seize the opportunity now it may be some time before it gets another chance to prove it can be trusted.

There’s little appetite for legislation. the industry and all the professional bodies are self-regulated, and we would prefer to do it that wayKaren Borrer, ABPI
Those who don’t take the right measures and aren’t cautious enough are running the risk of getting dumped with bad headlinesMichael Littlechild, Goodcorporation