Why were further changes to the ABPI Code’s 2014 recommendations on transparency and disclosure required?
In 2010 ABPI members voted to introduce the disclosure of aggregate totals paid to health professionals, and the number of individuals with whom they work – figures for which were first published in 2013. This aggregate disclosure has paved the way for the next step in 2016, when we will be releasing more detailed figures for the year 2015, including showing certain payments made to named individuals.
This is now a Europe-wide initiative and is being introduced in the 33 European countries covered by the EFPIA Disclosure Code in a bid to recognise and respond to increasing societal expectations for openness and transparency in industry-HCP relationships.
How can we ensure payments are not concealed under shell arrangements or via third parties?
In a 2013 survey of more than 1,000 individual healthcare professionals and healthcare organisations, including professional bodies, there was widespread agreement (89%) that payments to named healthcare professionals should be transparent.
Although individual disclosure is entirely voluntary on the part of health professionals, for these people, as for industry, the move from aggregate disclosure of payments to individual named disclosure is a next step. Where the payment is made indirectly via a healthcare organisation, the payment should preferably be disclosed against the individual’s name.
Why is it necessary for doctors to declare their fees when this is not required of other healthcare professionals?
Pharmaceutical companies will be required to disclose certain payments to all healthcare professionals – not only doctors – and payments to other relevant decision-makers as well. Payments made to healthcare organisations will also be declared.
Aren’t these stricter regulations likely to have a detrimental effect on industry by putting off some doctors?
In a 2013 survey, 76% of HCPs already participating in paid activities with pharmaceutical companies stated that disclosure of payments would either make them ‘more likely’, or ‘have no effect’, on their willingness to collaborate in paid activities. A similar response (75%) was seen among those who had never participated in paid activities with pharma. So there is no reason to believe public disclosure of payments will have a significant impact on the important relationship between healthcare professionals and industry.
How will the data be made publicly available?
From 1 January, and throughout 2015, details of payments made to individual healthcare professionals and healthcare organisations will be collected by companies and details of these payments will be published on a central platform, accessible via the ABPI website, from July 2016. The platform will provide a single, searchable database that will allow anyone to search for payment data by individual HCP, healthcare organisation, practice address (such as a hospital or local GP surgery), town or pharmaceutical company, and the whole dataset will be downloadable.
What lessons can we learn from the results of the Sunshine Act to date?
It is very difficult to draw comparisons between the UK and other initiatives because of the different nature of healthcare systems, different culture and expectations about transparency between countries – and importantly, the difference between a legislative approach in the USA compared with a voluntary, self-regulatory one in the UK. The US initiative has shown that good communication with the public and healthcare professionals is extremely important, particularly to explain what the data can – and can’t – show about the industry/health professional relationship.
Shouldn’t the regulators have more faith in the probity and integrity of the medical profession?
As an industry we rely on public and patient trust as part of our licence to operate. The disclosure of payments to healthcare professionals is a Europe-wide initiative concerned with bringing greater transparency to pharma relationships. This is critical to the future of medical innovation. Transparency is no longer a ‘nice to have’: it is a societal expectation.
Reaction of the GMC
“Our guidance for doctors is clear that they have a duty to be open and honest about their financial and commercial dealings and we welcome efforts to promote transparency. It is vital for doctors to recognise conflicts of interest and to inform their patients if this may affect – or be seen to affect – their decision-making. We are looking at the future of our register including whether it would be appropriate to include doctors’ interests as part of their entry on the medical register.” Niall Dickson, chief executive of the General Medical Council
This article was published in the January/February issue of PharmaTimes Magazine. To read the full issue, click here.