An update on payment disclosure
Last year was a good year for increased transparency in the pharmaceutical industry. Throughout Europe, there was a general agreement to move payment disclosure to the individual level as the European Federation of Pharmaceutical Industry Associations (EFPIA) required each member association to transpose the EFPIA Disclosure Code, which requires publication of payment data by 2016, into its own national code by the 31st of December 2013.
To be in line with the European Code, transfers of value to healthcare professionals (HCPs) or healthcare organisations (HCOs) are to be disclosed on an individual basis for payments related to donations and grants, contributions to costs related to events and for fees for services and consultancy. EFPIA requires that the code is fully transposed into local codes of practice throughout Europe, except where this might clash with any local laws or regulations: in this case exceptions are allowed but “only to the extent necessary to comply with such national law or regulation”.
The EFPIA Code also stipulates that member companies shall be bound by the relevant Member Association’s Code in each country in Europe in which they operate (whether directly or through a subsidiary). Reporting will occur on an annual basis in what is termed an ‘Annual Disclosure Cycle, with the first reporting period for the calendar year (Jan to December) 2015 for publication in 2016. The consequence of this is that companies must now think about putting in place robust systems to record their payment data.
In the UK, the Prescription Medicines Code of Practice Authority, (PMCPA), administers The Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice. On the 5th of November last year, the PMCPA agreed amendments to the second edition of the ‘Code of Practice for the Pharmaceutical Industry’, which brought the UK up to speed with the European regulations. For the UK, the Code requires that payment disclosure should be on a company’s website but if a central platform for disclosure in the UK is established, the use of that platform is likely to be obligatory: the decision on whether there will be a central platform for disclosure will be made by the PMCPA by the end of 2014. (For reference for pharmaceutical companies, a template for disclosure is available for download from the PMCPA website).
The response of industry and a vision for 2014
In line with the pressures of increased transparency from the industry, GlaxoSmithKline decided at the end of 2013 to end payments to healthcare professionals to speak on its behalf to audiences who can prescribe or influence prescribing and the company will no longer pay doctors directly to attend medical conferences. As an alternative, GSK will fund education for healthcare professionals through what they describe as “unsolicited, independent educational grant routes.”
In addition, GSK will stop linking the bonuses of sales staff to the number of drugs they sell. According to GSK, the changes are “designed to bring greater clarity and confidence that whenever we talk to a doctor, nurse or other prescriber, it is patients’ interests that always come first. We recognise that we have an important role to play in providing doctors with information about our medicines, but this must be done clearly, transparently and without any perception of conflict of interest.”These changes to ‘modernise’ relationships with healthcare professionals will happen globally by the start of 2016.
Despite these changes, however, there will still be a sizeable amount of payment data to be collected as GSK will continue to provide appropriate fees for services to healthcare professionals for sponsored clinical research, advisory activities and market research. According to GSK, these activities are essential to allow “insights on specific diseases; identification of symptoms and diagnosis; application of clinical trial data or medication dosage and administration; and how to effectively and appropriately communicate the benefits and risks of its medicines to help meet patient needs.”
As we have seen above, 2014 is set to be an even better year in terms of transparency in the pharmaceutical industry. Over the next few months it will be interesting to observe the response of other pharmaceutical companies to GSK’s changes to payments and it is believed that many will follow their lead. If these changes do occur, the type of data that needs to be collected on payments may change – but companies will still need to set in place robust systems for accurately recording the remaining transfers of value to ensure they are remaining compliant with EFPIA’s Code of Conduct.
It will be interesting to see how the EFPIA code is transposed throughout the 33 countries of Europe: all will be revealed on the 31st of March this year, as the EFPIA Code Committee produces its report into how Member Associations have managed to transpose the EFPIA code into their own National Codes.