Transparency in Europe

05.16.14 | By Marc Eigner

A key issue faced by the European life sciences compliance community that clearly came to the fore at this year’s CBI Global Transparency Congress held in London was the battle of the transparency vs. the data privacy directives and how meeting one mandate could mean violating the other as the situation currently stands. It was the question of the day throughout the two-day conference, in the session presentations and in the side conversations that many of us had while there. If there is one issue that’s keeping European life sciences executives up at night, it’s definitely this one and it’s one that their compliance counterparts in the U.S. have never had to face.

Companies in Europe are getting ready for a January 2015 deadline for various European variations of the U.S. Sunshine Act and to meet the requirements, just like in the U.S., they need to report much of their HCP/O spend data. Unlike in the U.S. though, they may need to ask the consent of every HCP/O they’ve made payments to, to report that information publicly as mandated by data privacy laws governing Europe. If doctors say no, that could red light the entire process in Europe. Complicating the issue even further is the fact that another data privacy law is expected to be enacted in Europe before the end of the year. Only in countries that take EFPIA voluntary guidance and turn it into actual law and not guidelines or codes, can life sciences companies possibly wiggle out of this conundrum. It was mentioned that some companies in Europe may not do business with physicians who don’t consent to making payment information public. It will be interesting to see if that’s a trend that takes off, but in any case, this is a very sticky issue that will surely impact European compliance efforts to some degree. Whatever happens, we think it will be in the best interests of life sciences companies and the HCP community in Europe to work together to voluntarily report this data to regulatory officials.

While this was a vexing concern expressed by many European life sciences compliance people at the conference, overall attitudes about transparency mandate deadlines at this year’s conference weren’t much different from last year’s. Even though the first deadline date of January 2015 has been established this year, the general sentiment at the conference seemed to be that companies still have a lot of uncertainty and they won’t do much until final guidances and transpositions are issued around the EFPIA codes. In fact, almost completely absent from this year’s conference was any discussion or perspectives presented about progress that’s been made thus far in preparation for the initial deadline. The one notable exception was a presentation given by Chugai Pharmaceutical’s U.K. compliance officer, David Eaves, on how they’ve successfully created and managed an aggregate spend, transparency and disclosure program on a small budget.

Our perspective on this lack of industry anecdotal experiences is that it can largely be traced to the fact that compliance mandates in Europe are nearly universally voluntary in nature, so European companies may be feeling they will have some leeway from authorities in reporting first year deadline payment spend. The fact that 10 EU countries still need to transpose into either a code or law the EFPIA guidelines may also be contributing to a less intense focus on the January 2015 deadline at the moment. We believe things will shift into higher gear as the year goes on, however, and European life sciences companies, whether they are headquartered in countries with a code or a law in place, will accelerate their compliance preparedness activity as no company would want to stick out like a sore thumb by not disclosing their payment spend reports. Also, for many companies who have U.S. operations, they are wrapped up in Sunshine Act work, so compliance for them is multidimensional and they will want to be prepared earlier rather than later. One big ray of light for Europe is that they are focused on defining and clarifying the big stake issues and it’s a collaborative effort between industry and government, whereas U.S. Sunshine Act compliance is being debated around minutiae like whether to value article reprints at a dollar or a dollar, fifty.

Suffice it to say that with 33 countries, cultures, codes and laws involved, implementing compliance and transparency in Europe has been and will continue to be a very challenging undertaking.