The Top Five Challenges For Pharma Disclosure In Europe
Transparency is important. Transparency is inevitable. And Transparency is the future for pharmaceutical companies. These are statements compliance professionals have been exposed to with increasing frequency in the past decade. They have witnessed how the role of Regulatory Intelligence and the complexity of pharmaceutical disclosure have both grown in equal proportion.
Does that mean achieving full transparency in pharmaceuticals will be easy? Evidence is ambiguous. Great inroads have been accompanied by challenges of equal proportion. Pharmaceutical compliance by itself is a strategic commitment, with efforts yielding long-term, rather than short-term rewards. For many pharmaceutical companies, the fear of penalties is far more in evidence than the promise of reward.
At qordata, where we are committed to global transparency, these are merely the surface challenges we see our clients confronting every day.
Through superior products, thought leadership, and customer experience excellence, we have succeeded in making the pharmaceutical disclosure cycle easier for clients in North America and Europe.
In this book, we explain the nature of challenges pharmaceutical companies in Europe can expect in their efforts towards achieving healthy compliance. We also describe how the disclosure landscape is changing, and what such organizations can do to prepare and perform better in this new order of global transparency.
Transparency is one of the newer aims of EFPIA. The fact that it has issued opinion papers on pharmaceutical transparency, asserted voluntary compliance and supported individual associations in their effort to develop custom pharmaceutical compliance codes shows that the priority of this issue is much more than cosmetic.
Why promote transparency? What is to be achieved?
The response comes from EFPIA itself. In a presentation dated April 2013, it described the importance of pharmaceuticals adopting robust transparency practices for:
- Access to information to make independent, informed decisions on own health/treatment
- Access to clinical trial data (raw datasets)
MEDIA AND THE PUBLIC:
- Scrutinize industry behavior following series of high-profile drug safety events
- More clarity on regulators’ decision-making
- Use of competitive information
Where are pharmaceutical disclosure’s greatest challenges coming from? Consumer- or industry-led?
Challenge # I– “Dirty Data”
Analysts define ‘dirty data’ as: “Inaccurate, incomplete or erroneous data. It refers to data that contains errors, including spelling or punctuation errors, incorrect data associated with a field, incomplete or outdated data, or even data that has been duplicated in the database.”
“Inaccurate, incomplete or erroneous data. It refers to data that contains errors, including spelling or punctuation errors, incorrect data associated with a field, incomplete or outdated data, or even data that has been duplicated in the database.”
Dirty data is a routine battle for pharmaceutical associations in Europe. The first, most common problem here is the regularity with which compliance professionals have to sort through erroneous or missing entries, especially where TOV disclosure is required.
Less serious, but equally damaging is data presentation. Following country convention, some databases will list first names before last; add salutations or omit them. In the case of countries like Germany (which has at least four pharmaceutical industry associations), a company’s multiple memberships can overlap across organizations, causing data duplicates. In the case of other countries, the degree of detail required per HCP/HCO can lengthen the reporting process; and discourage too thorough a scrutiny of data. In cases where consent is revoked, the process to re-validate aggregate from listed publication can be an iterative and prolonged exercise. Thus, non-validated data; or data that is not validated often enough, can also be a significant disclosure challenge.
Challenge # II—Static Platforms
By platforms, we refer to more than EFPIA’s website, or those of its member organizations. We mean company websites, reports (and their formats) and the general extent of reachability across each of these channels.
Spend Data Publishing should be central to:
- The audience and its average skillset/capability
- Publishing purpose
Starting with the assumption that the first reader is an ordinary citizen—possibly a patient, the data should be:
- Clearly presented—the more visual data representation, the better.
- Easily accessible—Which means file size, placement and search-ability considerations
- Validated—No duplicates, no data overlaps
Now let’s see how these points bear out in actual European reporting scenarios:
Company Reports: In the case of global companies, particularly those who have entered JVs or acquired subsidiaries, publishing user-friendly reports can be a challenge. It is easier to publish a collective dataset.
The problem with this is that it makes the effort of the user (i.e. potential patient or patient’s caregiver) unnecessarily inconvenient and time-consuming. File size, legibility of published data, file location, and regular updates are factors that weigh. Typically, such a file will be in a PDF format, it may contain non-searchable images instead of text, and may be of a size that consumes a disproportionate amount of download time and storage space.
A language appropriate to the market is another consideration that is not always reflected in the way reports are published. Typically, they are published in standard global languages—four at most. So a report published in Mandarin might make the pharmaceutical company appear socially responsible, but does not assist the French or German speaking patient seeking data for his/her home country in Europe.
Challenge # III—Reputational Risk
Some journalists and media-led organizations in Europe have replaced compliance professionals and government agencies as the most stringent scrutinizers of spend data. They regularly undertake the analysis needed to expose pharmaceutical wrongdoing. Well-respected newspapers and journals have published questionable spend amounts in meals and hospitality for physicians, as well as highlighting how many HCPs and HCOs refused to provide publishing consent.
This practice should be encouraged as far as it furthers the cause of transparency. But sometimes, journalists cross the line which guards physicians’ fundamental right to privacy. In search of the next story they may sensationalize routine payments—for example, seemingly high payments that fall within a company’s normal threshold per physician.
The cost in this case is greater for the HCP than it is for medical drug/device company. It can invite unwelcome (and unnecessary) attention from tax authorities, charity organizations and so on. This in turn, may affect the physician’s subsequent dealings with pharmaceutical companies in general.
Reputational risk works both ways. While companies are mindful of their obligation to appear transparent, they need to respect the rights of the HCPs and HCOs they work with. As things stand, regulation is inclining towards the latter.
GDPR, which will be in effect by May 2018, offers protection to physician privacy, and is expected to have a direct impact vis-à-vis lower disclosure rates.
Challenge # IV—Thresholds
Do all EFPIA member associations have to disclose everything? The answer depends on which country the member represents.
In the Netherlands, there is a minimum threshold of €500. So data for individual amounts less than €500 will simply not be featured. On the surface, this does not appear to be problematic. But creative accounting can find ways around this, leading to greater social ills like tax evasion etc.
It also places an undue burden on HCPs who received spend marginally higher than the threshold amount, or who were less innovative in the way they declared TOVs.
By contrast, in France, a payment as small as €10/ + tax must be declared by law. Seemingly positive, the first challenge associated with this practice is the difficulty complying, despite legal obligation. Immaterial spend amounts clog the data publishing process. They compel the public to work harder to gain the same insights. For pharmaceutical companies, this means more heavy-lifting from their Corporate Finance and Compliance teams—which, as a function of resources available, may discourage thorough and dedicated effort for each TOV instance, and may even detract from higher-spend instances. Compliance professionals have also noted the absence of disclosure by HCOs. And in some cases, HCPs get state-sponsored immunity from declaration. In the case of Speaker Programs, for instance, the Speaker Contracts are published. Their TOV amounts are not.
Where does this take us in the threshold debate?
Thresholds are good. Positive. Constructive. What’s missing is the factoring in of market dynamics. Thresholds should realistically be factored in on the industry as a whole in the country.
Challenge # V— Linguistic Challenges
Achievements of CMS Open Payments—the system in place in USA—reflect many of the objectives prioritized by EFPIA. For instance, thanks to CMS, there have been measurable advancements in:
- Building confidence of stakeholders in the pharmaceutical industry by creating an operating environment of openness and candor
- Improving ordinary citizens’ understanding of the relationships between medical drug and device companies, and HCP/HCOs
- Clarifying the nature of cooperation between pharmaceutical companies and healthcare professionals
- Increasing transparency and improving relationships between the industry and medical professionals for the benefit of patients
It is worth asking why such a system cannot be extrapolated to Europe. In one of qordata’s webinars, this question was posed to the webinar presenter. He responded by pointing out the linguistic challenges such a system would face.
Although the 33 member organizations of EFPIA are encouraged to publish in English, and also their local language (if other than English), the templates and guidelines vary for each country.
How would rules—some overriding the need for physician consent, others protecting physician privacy with legislation—be harmonized under one platform? Linguistic considerations also affect the way data is presented. For instance, in spellings and the way salutations are attached to names etc.
EFPIA does offer a tremendous level of data harmonization. The platform itself makes it easier for transparency investigators to explore the differences and implications of these differences in country-specific disclosure codes. For instance, Austria operates under one Code of Conduct. Germany, its neighbour, has seven. And that excludes the publishing template.
Before the codes can be harmonized, it pays to revisit a basic truth in anti-corruption practices: Sometimes the cost of reducing corruption, outweighs the value.
Unnecessary and non-applicable procedures will dis-incentivize pharmaceuticals from voluntary spend submission. They will position compliance as a ‘necessary’ evil instead of a core function that improves organizational performance inside out.
The team at qordata anticipates greater challenges in the disclosure landscape. With the promulgation of GDPR in May 2018, the challenge to earn and then sustain physician consent will become even more difficult. The process of collecting data will have to be more circumspect, and flexible to account for changes in the consent status and with the inclusion of the ‘Right to forget’ and the ‘right to erasure’.
- Embrace Technology: Digital documentation brings transparency and visibility to the consent collection process. It also enables physicians to retain control over the consent management process, which lowers apprehensions towards giving consent. Good platforms provide consent flexibility—which means general or specific consent, or limiting consent by period, type of TOV etc. The possibility of revoking consent also somewhat lowers the reluctance for HCPs to comply. The benefit of technology-driven consent solutions for pharmaceuticals is the degree of transparency and process acceleration they offer. Pharmaceuticals benefit from the efficient and instant updates such a physician engagement solution provides. It saves them the effort—and resources—needed to monitor/manage publishing consent status.
- Find Cross-Industry Allies: Pharmaceutical companies need to look beyond the drug-and-device manufacturing universe to ensure better disclosure rates. Their allies will be in technology, corporate compliance and business intelligence, to name a few.