Transparency in Europe: 2016 and Beyond

By Geert van Gansewinkel

In June 2013, the EFPIA (European Federation of Pharmaceutical Industries and Associations) Statutory General Assembly adopted the “EFPIA code”, a code set by industry self-regulation, requiring its 33 national member associations to publicly report the transfers of value (ToV) made by pharmaceutical companies to physicians (HCPs), and healthcare organizations (HCOs).

The underlying objective was to increase transparency around interactions between industry and HCPs and HCOs, to proactively address potential concerns in society around these interactions.

Three years later, on June 30, 2016, the deadline set for the implementation passed. For the first time, member companies published their ToVs, disclosing their interactions with HCPs and HCOs for 2015. Whilst transparency initiatives in themselves are not new (the US has already had experience reporting ToVs under the US Sunshine Act, and in other countries transparency initiatives where already in place as well, such as in France (Loi Bertrand), the Netherlands (transparentieregister), Portugal (Infarmed) and the UK (ABPI)), this was the first time that transparency reporting happened in so many countries at the same time.

Now, several months after the deadline has passed, is an opportune time to look back and reflect: what were experiences leading up to the deadline, what happened so far, and what can we expect going forward?

The lead-in

In the three years between the first announcement of the EFPIA code in June 2013, and the deadline for first reporting in June 2016, a lot happened. From a regulatory point of view, EFPIA published a general guidance, which included information around the specific format to use for reporting (the reporting template). EFPIA then asked its 33 member associations to transpose the code locally.

In some cases, local associations directly accepted the guidance and made no changes to the reporting format and template (for example in Hungary and Malta). In others, they decided to adopt but with some small changes (for example in Austria and Croatia), adding a field for the title of the physician, or changing the way the address was to be displayed. And yet in others (for example Spain, Belgium, and Poland), changes where significant, such as splitting the report into multiple reports, or changing the way data was to be displayed.

Surprisingly, two countries that are not members of EFPIA, decided to follow the holistic approach proactively (Luxembourg and Iceland). Adding the countries that were already requiring – mostly by existing laws – local transparency, such as France, the Netherlands, Denmark, and Portugal, this led to the existence of in total over 40 different variations of reports. Pharmaceutical companies with reportable activities in all EFPIA countries would therefore need to capture data and generate reports in over 40 different ways.

Apart from the regulatory obligation to report, another relevant factor was the European ruling on data privacy, which stipulates that physicians need to consent to having their data reported, and have the right to revoke their consent later on. Companies therefore had the obligation to report, but at the same time ensure that they were complying with data privacy guidelines.

Up until a few weeks before the deadline, local regulations continued to change. In early May, the Greece national association replaced the requirement of adding the unique country identifier in the report with the requirement to include HCP specialty, and shortly before the reporting deadline, the Netherlands ethics consortium (CGR) issued a press release stating that Dutch companies should disclose R&D expenses (something that had previously been out of scope).

For most, if not all, involved companies, the combination of the need to have processes and systems in place to capture spend data in an accurate way, following laws and regulations that were detailed, diverse, and dynamic, implied a high degree of complexity. They had to install new processes, implement systems, and ensure these new processes and systems would be used in the right way to ultimately ensure accurate reporting of ToV data. For many, this translated into a period of hard work with a lot of time, money and effort spent, all working up to the climactic deadline of June 30, 2016.

What happened so far

As can be expected, the reporting of data proved to be an interesting source of information. In many countries, there was at least some coverage in the national press on what had been reported. In some cases, there was a summary of an analysis done on top of the data. After passing of the deadline in the Netherlands (in March), general press provided a generic summary stating some of the facts that could be found analyzing the data, reporting an overall spend of 516M Eur in 2015 to Dutch HCPs and HCOs, with the highest paid physician receiving 127,000 Eur.

In general, it seems that critical reactions in the press so far have been mostly geared to the frameworks that have been implemented rather than to individual companies or HCPs/HCOs. Following the initial publications, an article in De Volkskrant in the Netherlands of May 14 discussed how much more money would be involved than currently visible, as indirect payments to organizations are not reportable, providing a route to transferring value to HCPs through these organizations that is currently not reportable.

On June 30, Financial Times in the UK published an article providing an analysis of what had been reported (£340M in 2015). In the article, critical notes were put to the fact that whilst 70% of physicians consented to have their data included, this only represented 48% of payments, suggesting that some of the big receivers were opting out. ABPI Chief Mike Thompson commented: “When we analyze the data, it shows that some of those who are paid the most have chosen not to disclose.”

In Germany, an article appeared in der Spiegel on July 14, arguing that whilst the initiative of transparency itself can be seen as positive, it is not meeting its objective for four reasons: spend is only included if HCPs consent, and only 20,000 of the 71,000 reportable physicians consented in Germany; not all pharmaceutical companies are required to report (54 companies are included, representing 75% of the market); R&D spend is aggregated whilst representing a significant amount of the ToV; and there is no central coordination/platform, making it complex to search for information.

What to expect going forward

Based on observations so far, it seems that in general there is wide acceptance for transparency in itself, but that there is room for improvement in the way the current models are achieving the transparency. From a regulatory point of view, we can expect initiatives around further improving transparency.

It can be expected that there will be more initiatives aimed at increasing the scope of transparency (such as in the Netherlands, adding R&D to scope, and in France, where another change in the existing requirements is upcoming, adding the need to report on contract amount), more central platforms to make data searchable (such as in the Netherlands, France, Belgium, UK, Ireland), more initiatives aimed at ensuring consent levels increase (for example by working with doctor organizations) or potentially changing/removing consent requirements making transparency a legal requirement (such as in France).

Additionally, we can expect companies to start using transparency initiatives as a driver for improving their internal processes. The better companies can control the upfront process of HCP/HCO engagements, by going through a structured flow of defining a need, selecting the relevant HCP, defining the payment based on a fair market framework, setting up a standardized contracting, following up, ensuring that the activity was executed as agreed, and ensuring payment was in line with all contractual agreements, the better they will be able to stand by the integrity of their efforts, reduce risk, and increase their internal decision making.

In essence, what can be expected is that after an initial focus on ensuring the deadline would be met, and reporting on actual spend, the focus will now shift to the front, optimizing the process leading into the spend.

Meanwhile, following the pharmaceutical industry, the Medical Device association MedTech Europe is implementing its own transparency code. Additionally, the Medicines for Europe (previously named EGA for European Generic Association) released their code last December for a public disclosure in 2018. Although implemented with a slightly different angle (e.g in the case of MedTech Europe combining the banning of direct HCP sponsorship for professional education and implementing a transparency code focused on educational grants to HCOs), this does show that transparency initiatives are continuing to move forward.