UK pharma disclosure of payments: lessons from the US Sunshine Act

In the second article on pharma's disclosure of payments in the UK, Andrew McConaghie talks to the PMCPA's Heather Simmonds about potential complaints, and lessons from the US.

The pharma industry is opening up its business to external scrutiny like never before, spurred on by the need to prove that it is indeed an ethical sector.

The biggest shift is in declaring certain transfers of value made to individual doctors and other health professionals as well as healthcare organisations – which are now being revealed for all to see.

The US was the first country to introduce transparency of payments via the Physician Payments Sunshine Act, a mandatory measure which went live for the first time in September 2014.

The UK and Europe are gearing up to follow suit with the first disclosures due by 1 July 2016.

So what can Europe learn from the US experience? The answer is a lot – and much of it being things to avoid, rather than emulate. This is because the US regulations have proven unpopular with many doctors, and got off to a bad start last year. The American Medical Association, which represents the 200,000 doctors affected by the new law, said the project had been 'plagued' by problems of accuracy, and protested that physicians had not been given enough time to review the data published on payments they had received.

"One of the problems with the US Sunshine Act is that it is seen as too burdensome in places"

One of the problems with the US Sunshine Act is that it is seen as too burdensome in places. The rules compel companies to itemise declarations for any 'transfer of value' worth more than $10; this could be light refreshments, honoraria, travel expenses or gifts and grants.

The good news is that the pharma and regulatory leaders who drew up European pharma's new self-regulatory code (EFPIA's HCP/HCO Disclosure Code) have tried to learn from the US system.

Heather Simmonds

Heather Simmonds, director of the Prescription Medicines Code of Practice Authority (PMCPA), the UK pharmaceutical industry's self-regulatory body, was a member of the EFPIA Compliance Committee that helped draft the EFPIA requirements. As part of this work, the committee considered the US model, and tried to avoid the US problems.

"One of the learnings related to 'appropriate hospitality'," she explained. "EFPIA decided that it wasn't necessary or practical to disclose every cup of coffee for every interaction – so instead settled for every country having an appropriate limit on the cost of hospitality, in addition to other limitations on hospitality. Not disclosing down to that level means that companies can make better use of their resources, and focus on the payments that are perhaps of more interest."

Key differences between EFPIA, UK and other European Code requirements for disclosure

EFPIA developed a template for disclosure as part of its HCP/HCO Disclosure Code which has been adopted by the majority of countries. However some have adapted the template to reflect the needs of their market. The EFPIA Code requires the data to be disclosed via either an individual company's website or via a central platform; in the UK the ABPI has decided that companies must use a central platform.

This decision was taken to make the data as useful and accessible as possible, and drew on positive experiences in the Netherlands, where the industry body Nefarma has successfully pioneered this model. UK companies are currently disclosing their aggregated data for health professionals and individual data for healthcare organisations on their own websites, so the transition to a central platform will be another technical challenge.

Overall, Heather Simmonds says the UK is following the EFPIA template wherever possible, but has had to add in a few further elements. One of these concerns 'joint working' – a well-established method of collaboration between pharma and the National Health Service (NHS) that is currently not replicated in the rest of Europe.

Changing relationships

While pharma is often blamed for undue influence on doctors, there is also recognition that health care professionals (HCPs) must take responsibility for their relationships, and any benefits received.

"There are fears that the disclosure of certain transfers of value, including payments, could damage relations between pharma and health professionals"

As witnessed in the US, there are fears that the disclosure of certain transfers of value, including payments, could damage relations between pharma and health professionals, which is in no-one's interests.

Pharma companies need to ensure that HCPs are informed in advance of the publication, to make sure there are no nasty surprises for anyone. The PMCPA and the ABPI are both advising companies to update their contracts with HCPs to include clear references to the new disclosure rules.

However, as in the US, giving doctors time to verify or query the proposed data before it is published could be vital to minimising any backlash from HCPs, some of whom may instinctively oppose the new transparency requirements.

Complaints likely

So will complaints about disclosure become a regular addition to the PMCPA reports on breaches of its Code?

Heather Simmonds says it is likely that there will be challenges made against companies, but can't predict what form they will take.

"I am sure there will be complaints made – but I don't know if they will be along the lines of 'there hasn't been disclosure' or 'the disclosure isn't accurate', or a HCP saying they didn't perform that particular service."

She adds: "Of course the 2015 data being collected now won't be disclosed until mid-2016, so we are some way off receiving complaints."

Advice and training for pharma

Whilst the PMCPA will rule on any complaints received in relation to the new requirements, it is working to give pharma companies informal guidance on the Code. The PMCPA also provides training on the Code.

"People can always email or phone us for informal guidance. We are happy to advise in that way," says Heather.

However this informal advice does not represent a guarantee of any sort, as the responsibility always rests with the pharma company.

Heather Simmonds states: "The responsibility is clearly on the pharmaceutical companies, so if there is a complaint it will be taken up with the relevant company."

Could pharma finally crack its reputation problems?

The million dollar question (to coin a phrase) is this: can these latest changes help address problems of industry practices, relations and reputations, once and for all?

While it would be nice to believe this is possible, it is unlikely – pharma must remain vigilant, and must keep adapting to changing expectations about corporate conduct and transparency.

It would be naïve to believe the new requirements alone can stop unethical practices – as inevitably there are usually ways to conceal bad behaviour in any industry as seen in GlaxoSmithKline's damaging bribery scandal in China. A number of experts in the field of disclosure across all industries say there is little evidence that it works as intended, and even some suggestion that it allows complacent attitudes to creep in. (Read ProPublica's The Trouble With Disclosure: It Doesn't Work.)

But, despite these doubts about the long-term effectiveness of disclosure regimes, European pharma must press ahead, and demonstrate its commitment to increased transparency to everyone; stakeholders, patients, partners and critics, many of whom will be watching closely come 1 July 2016.

References

The EFPIA Disclosure Code

The newly updated 2015 edition of the ABPI Code of Practice

About the author:

Andrew McConaghie is pharmaphorum's managing editor, feature media.

Contact Andrew at andrew@pharmaphorum.com and follow him on Twitter

Read the first article in this series:

A new era of transparency: UK pharma prepares to publish doctor payments