Thirty-three European countries have been heads down for almost two years setting the scene for what will be one of pharma’s most coming-of-age transformations – releasing the intimate (and potentially uncomfortable) details of exactly which doctors have been paid by which pharma companies, what for and how much. Driven through by the European trade body EFPIA, the move, which came into force on 1 January this year, marks the societal shift and expectation that big pharma has no alternative now but to embrace transparency.
“This is not just about reputation,” explains Andrew Powrie-Smith, communications director at EFPIA. “It’s about our licence to operate. There is an increasing expectation globally that the relationship between industry and healthcare professionals should be transparent. Our relationship with healthcare professionals is critical to advancing patient care. Transparency is part of ensuring this relationship is on the right footing for the next decade.”
The UK has opted for voluntary self-regulation rather than the less flexible legislation that some countries have chosen; notably the USA, France and Slovakia. Under the requirements, EFPIA’s 33 member states are each required to write the rules into their respective codes of practice. These will require companies to: disclose the names of healthcare professionals and healthcare organisations that have received payments or other “transfers of value” from pharma; the total amount paid over a specified period of time; the type of activity (ie speaker, sponsor, advisory board, travel, accommodation, etc) the HCP is being paid for (but not per payment because of anti-competition law); and then publish this information on a public platform, either on company websites or a central platform (nine countries including the UK are looking at this latter option). All payments made in 2015 will be published in 2016.
In the UK this takes transparency a step further following the 2012 introduction of rules to disclose aggregate payment to HCPs (but not individually naming them). The first figures released in 2013 show the industry paid doctors a total of £40 million in the previous year, dropping slightly to £38.5 million the following year. The 2014 stats have yet to be released, but expectations are the figure will have reduced again. And, in 2016, we will see which individual doctors were the high earners although – in the UK at least – doctors will have to consent to the disclosure of payments made to them. For those who don’t, an aggregated total and the number of non-consenting doctors will be listed. In other countries, waivers with data protection authorities are being explored to address privacy laws.
Nevertheless, concerns have been raised that both HCPs and pharma are not sufficiently aware of the implications or how the process will work, despite intense conversations and workshops between industry trade bodies and HCP counterparts. In addition, it is impossible to second-guess media and public reaction. “There is a need to work with the health professional community to build understanding of the clinician/industry relationship and how it benefits patients,” Powrie-Smith says. “The wider society also needs to understand the relationship between doctors and the industry.”
What does seem likely, however, is that there will be a reduction in the number of HCPs willing to work with the industry. After the USA introduced the Sunshine Act legislation in 2010, the first wave of data naming doctors and associated dollar figures went live in September last year (http://cms.gov/OpenPayments). It showed that in the last five months of 2013 doctors and teaching hospitals were handed $3.5 billion from pharma and medical device makers. The result of transparency has been a drop in the number of HCPs working with the industry there, Powrie-Smith says. “Experience in the USA has shown a reduction in the number of HCPs working with industry, however relationships will be more open and transparent.”
US trade body PhRMA says it’s too early to predict the effects of the Sunshine Act but says “we hope the Open Payment database will benefit patients in letting them know about interactions between their physicians and biopharmaceutical companies to help them make accurate and informed healthcare decisions”. While the ABPI insists there is no reason to expect a significant impact on the pharma/doctor relationship.
But Sarah Eglington, healthcare intelligence director at Binley’s, says some companies in the UK have already stopped making payments to HCPs. Indeed, GSK announced at the end of 2013 it would end direct payments to HCPs for speaking slots and attending conferences. Other companies may now take a view that stopping payments altogether will avoid any risk of being found in breach of the legislation. As for the HCP, Eglington adds: “Some healthcare professionals are happy to provide services without payment but others may stop if payment isn’t offered. There are too many uncertainties on all sides to be able to fully assess the potential impact.”
There is no mistaking the new rules will require a change in both mindset and culture, and as Powrie-Smith puts it this is a journey for the industry. “Transparency is like a Messerschmitt bubble car – there is no reverse gear. Societal expectations tend to move forward, and we need to work with our stakeholders to ensure that our relationships continue to meet expectations.”
What do the doctors think?
Dr Mark Freeman, consultant in diabetes and endocrinology
“I give talks on behalf of various pharma companies regarding new drugs. It takes time to prepare a presentation and deliver it, and I would not be prepared to do it without payment.
However, if I’m talking to a group of GPs, for example, I will talk about the class of drug rather than a particular medicine and I will always be clear in declaring my interests at the start of the talk and in any relevant materials by listing the names of the companies for which I am speaking.
I like to think the majority of doctors maintain this level of openness and integrity when receiving payments from pharma and, from that point of view, I do not support the idea of squeezing them further by publishing details of payments to individuals. I declare my earnings from this work to the HMRC. Further detailed disclosure of exact fees is not the case for other professionals.
There is a risk that some doctors will be unfairly lambasted in the press for receiving payments from pharma and that some patients could misinterpret doctor/pharma relationships and think, for example, that they were only prescribed a certain drug because their doctor received a large payment from the manufacturer.
While the new regulations would not stop me from continuing to work with pharma, I think it will put some doctors off and this could be detrimental for the industry. I think regulators should have more faith in the probity and integrity of the medical profession as a whole.’’
Dr Michael Blackmore, retired GP
“Since authors of research papers have declared financial interests for several years now, this is only a modest extension of the principle. It is already obvious to those who attend meetings sponsored by pharmaceutical companies that speakers and chairs will have been paid for their services, so the publication of names and details of payments is hardly a revelation.
Pharmaceutical companies perform a valuable function in developing, refining and manufacturing existing and new treatments as well as supporting many medical publications and providing “soft” funding for research registrar posts, which would otherwise almost certainly not exist in the present situation in the NHS. They also provide research grants to individuals and institutions.
Most of this funding is already pretty transparent and in no way “secret”. When I was doing research into smoking and lung cancer with the late Professor Richard Passey at the Chester Beatty in Fulham in 1964-6,
we had grants from the Tobacco Research Council. These were funded by the tobacco manufacturers and were disclosed in our papers. They were no secret.
Although it is true that the pharmaceutical industry has suffered a fair bit of adverse publicity recently, and there have undoubtedly been cases of disgraceful behaviour, nevertheless much good is also done. If this change in practice helps to improve the image of big pharma and encourages the exposure and eradication of unacceptable practice, it is to be welcomed. Of course, a determined effort to conceal misbehaviour is still likely to evade these provisions fairly easily by concealing payments under ‘shell arrangements’ or via third parties.”
This article was published in the January/February issue of PharmaTimes Magazine. To read the full magazine, click here.