The clock is ticking and the spreadsheets are being populated as industry gears up to meet the new EFPIA Disclosure Code which comes to life, and public view, in July 2016.
The pan-Europe regulation requires all EFPIA members to reveal any ‘transfers of value’ made in 2015 by summer next year.
It will reveal expenditure such as congress and consultancy fees, travel payments along with details of the relationship involved between company and healthcare professional (HCP). Time will tell if it is a turning point or a tourniquet.
The surge for greater transparency is irresistible and EFPIA believes the code is an opportunity for industry to enhance its positive impact on patient health rather than it being some form of punitive administrative task for miscreant behaviour.
The gigabytes of data that will land in 2016 will provide a fascinating – and potentially skewed – view of healthcare relationships and EFPIA is concerned that the figures are not taken in isolation.
It has, it freely admits, a job to do explaining to a wider world the importance of the synergy between pharmaceutical companies, their products and the people that prescribe them. The image of a sharp suited drugs salesman sprinkling largesse on a greedy flock has been banished but old stereotypes could be reignited if the process is not fully explained, EFPIA concedes.
I see this as a major step in an evolutionary process for the industry
Explaining relationships
“What we should avoid is a large data set arriving which describes relationships which are not fully understood,” says Andy Powrie-Smith, communications director for the trade body, which has 40 member firms and influence over the majority of the European industry as national organisations are aligned to its codes.
“Those relationships have evolved over a number of decades and have not been particularly well communicated. The first element is how industry and HCPs can come together and shape the research agenda with a unique perspective. HCPs and patients have an unparalleled experience of how a medicine fits into a particular treatment pathway and this helps industry shape what medicines to make, how to make them and how they can be used.
“The second important consideration is the opportunity for peer-to-peer learning, sharing best clinical practice based on thought leadership, inspirational new service design, innovative treatments and devices that get shared around the community to advance patient care.”
The concern is that these benefits to the patient and healthcare could get submerged in a similar deluge of headlines that greeted the arrival of the Physician Payment Sunshine Act, as part of the 2010 Affordable Care Act, which laid bare payments in the US system. It sent dollar sign shockwaves across the US and caused a dip in faith in the medical profession and pharmaceutical companies. The UK health minister Jeremy Hunt has just announced that his government is following suit with ‘Sunshine’ legislation as a means of promoting transparency and monitoring spending.
Transparency is like a Messerschmitt bubble car – it has no reverse gear
Strong governance
Europe already has muscular regulation – the Association of the British Pharmaceutical Industry (ABPI) code in the UK has been publishing aggregate payments publicly since 2012; other strong governance systems and legislation exist in Holland, France, Denmark and Slovakia – so the new disclosure code is seen as another constructive layer rather than a fresh foundation of control.
And, amid all the scare figures in the US were some that underpinned a more solid story of healthcare and industry. A report from Harvard Medical School found that 88% of $76.7m paid by the pharmaceutical industry to Massachusetts physicians over a 30-month period went on joint research projects, clinical trials and advising on disease treatments.
Teething problems may be inevitable and reputations may be bruised but transparency is part of a compelling societal script, making its delivery inevitable.
“Transparency is like a Messerschmitt bubble car; it has no reverse gear. It is also highly unlikely that anyone will stand up and say: ‘We tried it, didn’t like it and we’ll pull back’. We have a data-based society which has a real appetite for transparency and I see this as a major step in an evolutionary process for industry and, although it may be difficult to see where it goes from here, there will be no going back.”
Powrie-Smith, who took up his post in January this year, arriving from the ABPI, adds: “I don’t see the disclosure code as a reputation builder. It is part of our licence to operate, making sure a vital relationship for industry runs smoothly so that we develop and make the best medicines for patients and help health professionals learn and share best practice. It is about strengthening that relationship and being transparent helps us address any concerns, be they real or myth. But I don’t think people will wake up in July 2016 with a particularly different view of health professionals or industry.”
The ABPI, one of the national bodies committed to transparency, says 56 full member companies and 60 non-member companies have agreed to comply with the code and independent polling shows a willingness to embrace disclosure on both sides of the relationship.
GSK has decided to use in-house scientists and medics for presentations and other companies may introduce corporate tweaks after assessing the impact but the code is no surprise to those in Powrie-Smith’s old stomping group of the UK, where companies have been disclosing aggregate payments to healthcare professionals since 2012.
UK industry aggregate figures for payments to healthcare professionals were approximately £41m, covering just over 28,500 relationships with healthcare professionals. The ABPI told PME it expects 2015 levels – which will be reported on the new platform – to be fairly similar to those seen in 2014.
There is also a suggestion from the ABPI that the use of a central platform, rather than individual company websites, could in the future allow it to be used to centrally disclose other payments from the pharmaceutical industry. Potentially, this could include those made to patient organisations, which are currently disclosed on individual company websites, or payments made to HCPs from other agencies and organisations.
For his part, Powrie-Smith believes the code fits neatly into the collaboration strand of industry’s modern DNA. “Gone are the days when a scientist took their small molecule down into an underground research lab and emerged a decade later with a medicine, it just doesn’t happen like that,” he says. “Collaboration is a feature across the board, be it HCPs, academic institutions, industry, or the small company – big company dynamic.
“But this is a massive undertaking, involving an enormous investment of time and resources. There are companies with multiple interactions across multiple countries, often through affiliates, which takes complex tracking and investment in new business systems. New legal, contract and compliance procedures have to be established and relationships with customers have to be managed. Doing it signifies a commitment across the pharma community.
“When this data lands there will undoubtedly be more focus on these relationships but also a better understanding of how it works and companies across the board are very sensibly looking at making sure their interactions are benefiting patients. If the code helps strengthen collaboration then it is a good thing for patients. If they are an active group of patients online and want to understand and have confidence in the relationships, then they have the opportunity to do that. It is really important that patients have confidence in the company that invents the medicine that can extend, save and improve quality of life along with the clinician that prescribes that medicine.
“I hope it will be taken as a real signal of how important industry takes transparency and about how it looks to strengthen relationship with HCPs in the future.”
