Four Challenges For Pharma Disclosure In Europe

Introduction

In the first of this two-part guide, we mentioned five common challenges stakeholders in Europe face towards pharmaceutical disclosure. In this one, we approach disclosure challenges from the other side—highlighting how seemingly positive gestures from pharmaceutical and industry organizations can backfire.

Issue # I—Voluntary Disclosure

Emphasizing voluntary disclosure has the overt purpose of encouraging openness in how pharmaceuticals report spend figures. It is assumed that pharmaceuticals will not willingly publish spend TOVs (Transfers of Value), they know to be erroneous or misleading.

It may also be assumed that for organizations lacking the necessary resources or infrastructure, non-voluntary disclosure could impose undue pressure, forcing them to submit spend reports that may not only be inaccurate, but also at odds with what was actually expected of the disclosure exercise.

The cost of disclosure is raised. What about its value?

This is our point of contention. A brief study suggests disclosure rates drop when the requirement is voluntary, and public attitude appears to support that.

In the case of Germany, for instance, there are four major pharmaceutical associations. Only two of these associations have made it mandatory for its members to disclose. I.e. the code is not universally applicable. This directly hits the physician publication consent rate.

Spain is another case in point. Up until disclosure was voluntary, consent rates at 20%.

Pharmaceutical companies are the real losers in an environment of non-mandatory disclosure. Although it may appear that they have been saved from a consuming and stressful assignment, the truth is that voluntary disclosure (if translated into a decision of non-disclosure), will:

  • Stop pharmaceuticals from gaining the fullest possible insights into their spend data
  • Impede strategy development/implementation, especially for pharmaceuticals with a cross-market presence
  • Present an incomplete—or shortsighted view—of the pharmaceutical company’s competitive space. Decisions are based on assumptions about competitor activity, instead of a quantifiably sound, and well-validated analysis of market activity.

Issue # II— A Sensational Story

Media interest can have a downside. In markets where the fourth estate has taken the lead in analyzing pharmaceutical spend, interpretations may reflect a strong variance from the truth. They might, in some cases, focus on spend volume or value for one HCP, while understating the category or detail which justified spend. KOLs are particularly susceptible, as their technical expertise may be of little interest (or understanding) to the media’s mainstream audience. Making scandal fodder out of spend volumes will have the adverse effect of discouraging physicians from providing consent in the future.

The core essence of pharmaceutical disclosure—to give patients truthful information and evidence to make the right decisions about their treatment—- is missing here. Media updates are far more easily consumed, and last longer in public memory than a static report listing physician spend history.

Thus, the need to include detail, and to make platforms responsive and user-friendly is a priority pharmaceutical companies must address in their own interests.

Issue # III—Problematic Privacy

In some markets, the decision not to disclose has nothing to do with transparency. Physicians have a legal right to withhold publishing consent, and they exercise this consent vigorously. The refusal to provide consent spirals into a series of problems for pharmaceutical companies and their compliance/transparency teams:

 

 

 

 

 

 

 

 

 

 

 

Issue # IV—Incomplete Disclosure

In some markets, mandatory publication of pharmaceutical spend data has been a revolutionary step forward. But is it does it give the correct ‘big picture’? Does it provide enough information for stakeholders to take the right action?

 

 

 

Member Vs Non-Member

ABPI has 150 members. But data of only 104 members is published. How will insights change if input from the remaining 46 members, and non-members are included? As the case of all research goes, the larger your (valid) sample size, the more generalizable your findings will be towards the population.  The problem is not that we know that the current picture is different from the complete picture. The problem is that we do not know how significant the difference is.

Thresholds

Incomplete disclosure also takes place when threshold amounts impose spend ceilings or floors. There is a threshold of €500 in the Netherlands, for instance. This means that ToVs (Transfers of Value) less than €500 per transaction do not form part of the published data. Is there public insight on how many physicians currently fall in this threshold? Is it possible that heftier spend arrangements are being rearranged to fit below this threshold and thereby evade reporting? Again, we see the challenge with incomplete disclosure is that the black space for compliance professionals extends from ‘known unknowns’ to ‘unknown unknowns.’

Contract Vs Amount

In France, physician speaker contracts are published under the transparency directive, excluding their spend amounts. Again, a large black hole as far as transparency is concerned. The good news is that a new law is revising this practice.

HCP Vs HCO

Also, if one were to visit Base Transparence Santé, the disclosure site for France, one would find a healthy volume of HCP information, but ‘virtually none’ for HCOs. Despite being regulated by the Ministry of Social Affairs, one may say the site is far from comprehensive.

A related challenge exists in Open Payments, USA’s disclosure database. While at 11.91 million records, it is a very comprehensive database for HCPs and HCOs, its definition of HCOs includes only teaching hospitals, leaving out medical societies and associations.

Why is this a problem? While the latter may not be marketing products, they do conduct R&D (the second largest spend item for the entire industry); and do have other categories of spend.

Transparency, Disclosure And Privacy: Related?

Does privacy hurt disclosure?

Yes.

Germany is a case in point. Despite a comprehensive system of codes, at least four national pharmaceutical associations and a strong national record of transparency, physician consent rates in Germany were less than 40% in 2016.

After the promulgation of GDPR, things will get worse from a disclosure viewpoint before they get better. The example here is Spain. At 20%, its initial consent rates were the lowest in the region. But forward-looking legislation, consumer buy-in and a wide outlook decided that transparency is in the public’s interest. In less than five years, low consent rates have been replaced by ‘no need for consent’. (I.e. mandatory publishing).

The Road Ahead

In this environment, who can do what to improve disclosure across the EU? We believe all disclosure so far is good news, because it creates a demand for an industry that is ‘cleaner’ and more service oriented than its predecessor.

The responsibility for better disclosure—and so, better compliance—still largely lies with pharmaceutical companies. They can encourage a more cooperative vibe across stakeholders, by:

  • Educating physicians and HCOs on the consent process; its benefits, and their rights. Quite possibly, the apprehensions of physicians are misplaced and borne out of popular practice.
  • Simplifying consent management for themselves, HCPs and HCOs by increasing the role of technology.
  • Treat compliance—and physician engagement—as necessary and welcome responsibilities, rather than necessary but undesirable additions to their work. Findings by a firm last year suggested that pharmaceutical sales reps are ‘less willing’ to engage with physicians in the future if they refuse to provide consent the first time round. This is just one of many internal approaches that needs to change for a more transparent industry
  • Strengthen company reputation inside-out: Substantial compliance improves employee ownership of the compliance process. They become participants instead of executors of compliance policies. Understanding their role in good corporate governance practices, and seeing their compliance contribution bear fruit will go a long way in ensuring policies and practices—are in full compliance with a robust transparency program.

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