24-26 - ABPI: We can see clearly now

The 7th annual publication of Disclosure UK data by the Association of the British Pharmaceutical Industry (ABPI) was an important event overlooked, ignored and missed by many.

This, in itself, serves as a reminder that, while disclosure and transparency around financial arrangements between pharma companies, HCPs and healthcare organisations is a good thing, the disclosure process is still not good enough to be properly meaningful for its stakeholders – the industry, HCP peers, HCOs or the general public. But it could be.

Within Government, it is a legal requirement for MPs to disclose financial benefits made to them outside their salaries. Similarly, under the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code, the pharmaceutical industry has a requirement to disclose payments and transfers of value (ToVs) made to healthcare professionals and organisations.

With disclosure in the UK being a voluntary act, however, and not a legislative requirement, data protection rules must be applied, which means that, while all HCO data is disclosed, pharma companies must still gain consent from the HCPs they pay in order to disclose their data and name them. The annual Disclosure, therefore, contains some named HCPs – but, if an HCP doesn’t consent, the data goes into an aggregated number.

About 29% of the payments to HCPs is aggregated and, for me, this has always been somewhat at odds with the principles and philosophy of a transparency initiative. The aggregated amount tells you how many HCPs have been paid but nothing more than that.

Disclosure reporting within the European Union first began in 2015 as an initiative around improving the industry’s reputation and as a direct response to the US healthcare law, the 2010 [Physician Payments] Sunshine Act. This made it a legal requirement for US pharmaceutical and medical device manufacturers to publicly disclose any payments or ToVs made to healthcare professionals and providers.

The Act itself came into force as a result of the industry wanting to address criticisms made against it following well-publicised bad practice and a resulting scepticism around the pharma/healthcare industry.

Five years later, the EFPIA implemented a voluntary disclosure programme into its guidelines and framework for any country where there was no legislative requirement, and the individual European member states applied these to their own markets.

Countries such as Belgium, Denmark, France, Portugal and Slovakia have made varied forms of disclosure of payments to HCPs mandatory through legislation – whilst, in the UK, this is still a voluntary requirement, although there are increasing calls for this to become a blanket legal requirement.

Collaboration between industry and HCPs is a relationship that has delivered many improvements in the provision of care and equality of knowledge across the health profession, changing the way diseases can impact on our lives.

Full transparency, therefore, must be required. However, it is vital that we first improve the rules and requirements for disclosure reporting – to allow greater detail to be recorded for each payment or ToV. This would provide much-needed context for such vast amounts of money changing hands and enable us to properly understand both the nature of the relationship and the transaction without guesswork or artistic licence.

There are, after all, several ways that HCPs can be paid.

They can be paid directly as is often the case with speaker fees, consultancy work and advisory boards. But they can also be paid indirectly, as in ToVs, which are like a benefit in kind, and where a company may pay, for example, the registration fees directly to the congress or cover travel and accommodation expenses in relation to such an event, and where the HCP would be a recipient.

Currently, there is no scope for providing such context such as a description of the services or even allowing HCPs to record if they have declined payment or what they have done with the payment e.g., donated it to charity or research fund. And so, a consultant recorded as receiving £100,000 from a pharmaceutical company could be easily misconstrued.

The pharma industry’s total Disclosure for 2021 was revealed to be £557.1m, up £70.6m (14.5%) on 2020. Of that, some £405.1m was categorised as Research & Development (R&D), up £57.4 (16.5%) on last year. And the remainder, £152m, was categorised as non-R&D spend – split between HCOs (77%) and HCPs (23%).

As a further breakdown, £35.4m was spent on Cost of Events (up £7.6m / 27.4%); £44m on Donations & Grants (down £8.8m / 16.6%); £65.5m on Fees & Service (up £11.3m / 20.8%); and £7.1m on Collaborative Working (up 3.2m / 80.8%).

There is a lot of the information within Disclosure UK that could be of enormous value to the industry in helping it to understand itself and its competitors better, and how the individual companies relate to their peers and different promotional strategies. And, of course, there’s the relativity to where they were last year, who else engages with our key opinion leaders and how much are they paying them.

For an HCP, Disclosure UK is a bit like The Times Rich List. There’s a measure of ‘who gets more than me’? Who else is considered by industry to be a thought leader in my therapy area, and which companies are they working with? Of course, such assessments are limited to the value received and number of companies engaged with, which are primarily geared towards validation and ego-driven rankings.

Even so, the data set could provide even greater value by digging deeper to deliver a richer assessment of what is being shared. Then it has the potential to provide real insight and greater understanding, with a platform for individuals to advance their knowledge even further – and this approach could be a game changer.

From the general public’s understanding and perspective, these are astonishing figures in terms of the sheer size of the transactions and it is clear that more detail and context is necessary.

If you were to run the information as a headline: ‘UK pharma industry paid £543million to UK HCPs and HCOs in 2021’ – providing the facts but not the context (way beyond the definitions and typical practices) leaves this open to interpretation based on the personal bias of the person receiving the information.

And, while I could look up my consultant and see how much he/she has received, without any context, so what? What’s the value? OK, it’s there and it’s publicly available – but it’s nothing more than a big data dump and, in the spirit of transparency, it’s not really shining a light on anything.

On the one hand, someone who has been paid £113k, mostly by a single company (and the previous year, and the year before that), you could ask: Is this someone in the industry’s pocket, and do I really value his opinion? But, without an explanation, there is no way of knowing if this is indeed the case or if, conversely, this person has been paid for giving an invaluable talk to share leading clinical practices in regard to a killer or debilitating disease and has donated the money he or she received to a research fund to advance treatment options for rare diseases. Both highly commendable actions.

You could also think that, because an HCP has been transparent and disclosed payments, that’s a good thing because, effectively, it looks like he or she has got nothing to hide. But an HCP can agree to disclose that he or she made £1k with one company and decline consent to disclose that he or she made £50k with another. The data is open to manipulation and can create smoke and mirrors. So there needs to be caution when trying to interpret the data.

Best of all, I would like to see HCPs taking control of their own data. The industry might gather, collate and publish the data – but there must be scope for HCPs to provide the context and add information around these payments. Otherwise, there’s a danger of these disclosures taking on the dark angle of people solely looking at who’s being paid the most amount of money - interpreting the figures through a negative lens.

The real and most important focus should be this very important relationship between the HCP/HCO and the pharma company, which is at the heart of enabling healthcare to grow, evolve and be innovative.

The industry has taken some action to increase the visibility of payments, with an increasing number of companies using ‘legitimate interest’ as a legal basis for disclosure, where all ToVs made are publicly disclosed on a named basis without consent. Or, alternatively, ‘legitimate interest with the right to object’, where all ToVs made are publicly disclosed on a named basis unless an HCP explicitly requests to opt out.

It is great that more and more HCPs are choosing to disclose the payments made to them but more needs to be done to provide context and explanation – and to include the missing 29% of HCP payments to bring them in line with HCO disclosures. In the final analysis, it’s time for HCPs to take some control.