By Richard Bergström

The US Open Payments database got off to a less than happy start. EFPIA will tap into this experience to inform implementation of the code on disclosure in Europe, says Richard Bergström, Director General of EFPIA

richard_BergstromThere are two big differences between the US and Europe in moves to disclose transfers of value from pharma companies to healthcare professionals. The first is that the US created a legal requirement to disclose under the Sunshine Act, whereas for the most part, disclosure will be voluntary in Europe.

The second difference is that of scale, with the Centers for Medicare and Medicaid Services (CMS) setting up a single, centralised database for all US records, a technical feat that has not gone smoothly.

Despite these significant differences, Richard Bergström, Director General of EFPIA believes Europe should look to the US experience, as it moves towards the implementation of the voluntary code on disclosure of transfers of value at the start of 2015. “After talking to colleagues in the US, I am clear there are important lessons for us,” he says.

There were a number of published reports in the run-up to the Open Payments database going live, of difficulties physicians had accessing and registering on the system, and of mis-attributions of transfers of value.

This culminated in around one third of the data submitted by companies being withheld by CMS when the database went live. A total of 199,000 records of payments worth $1.1 billion that were submitted to the CMS were not published in the first release of the database.

The promised transparency was further obscured by the fact that much of the data was de-identified. While names of the recipients of 2.7 million payments worth $1.3 billion were given, the recipients of a further 1.7 million payments, valued at $2.2 billion are not named.

Engage and inform

However, subsequent reviews by member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) – many of which are of course also EFPIA members – indicate the data were handed over to CMS in a format consistent with the stated requirements.

Putting the technical issue of the scale of the IT challenge aside, problems with getting Open Payments off the ground, “Highlight how important it is that physicians are properly engaged and informed about the disclosure process – and crucially that they are given sufficient time to review their data,” Bergström says.

The voluntary nature of the code in Europe and the fact that healthcare professionals have the right to withhold consent to publication, makes this engagement by companies and national associations more crucial here than in the US, Bergström believes.

Since the voluntary code was agreed by EFPIA members at the end of 2013 significant effort has been devoted to explaining the transparency objectives to healthcare professionals and healthcare organisations. Whether they are in wholehearted agreement or not, physicians in Europe recognise disclosure will go ahead and they are taking a pragmatic approach.

Putting disclosures in context

In the US, one particular concern to have been raised is that the – considerable – financial value of drugs donated for clinical trials could be interpreted as cash flowing into the accounts of individual clinicians. “This underlines how important it is that in Europe we put all information in context, and make sure the general public understands the types of interaction,” says Bergström.

“If I were head of a university hospital, I would not be coy about disclosure of transfers of value, but embracing it as a way to highlight – alongside recording government grants and endowments from medical charities and foundations and so on – the quality of research and the level of engagement of my institution,” Bergström says.

EFPIA plans to give its members a chance to hear first-hand from people who have been involved in the launch of the Open Payments database in a webinar event next year. “It’s clear many physicians in the US had problems with the information and were not given enough time to review it, we must avoid that here,” Bergström concludes.

Richard Bergström is the Director General of the European Federation of Pharmaceutical Industries and Associations. Following positions in Switzerland in regulatory affairs at the pharmaceutical companies Roche and Novartis, he served for nine years as the  Director-General of LIF, the Swedish Association of the Pharmaceutical Industry. He is a pharmacist by training, receiving his MScPharm degree from the University of Uppsala, Sweden in 1988.