The EFPIA Disclosure: Where are we for the 7th publication?
For the seventh year, EFPIA Member Companies and companies that are members of EFPIA Member Associations will disclose payments made, directly or indirectly, to HealthCare Professionals (HCPs)[1] and Healthcare Organisations (HCOs)[2] on their company websites or, where available, on a national platform for disclosure.
By introducing the self-regulated disclosure requirements, EFPIA and its members have demonstrated their commitment to bring greater transparency to the relationship with HCPs and HCOs. The disclosure of transfers of value to Patient Organisations (POs)[3] is also a provision of the EFPIA Code (since 2012).
This commitment helps to bring greater understanding of the value of these collaborations between the industry and POs, HCPs/HCOs. In the context of increasing societal expectations on transparency, the disclosure requirements seek to address any public concerns about these interactions by making them open and transparent.
Nevertheless, the disclosure landscape is complicated by the existence of diverse factors such as data protection, local legislation and resistance from some stakeholders. EFPIA and its members continue to work tirelessly to build understanding about, and reduce barriers to a greater disclosure.
Inconsistencies in the scope and approach of disclosure requirements are occasionally highlighted by the media community. Some recent media articles[4] have highlighted several structural problems within the existing industry framework and raised concerns about the access to data and criticized the level of details disclosed.
EFPIA and its members shared the same goals for evolving disclosure via the self-regulation framework, which has led to several actions are being implemented[5]. However, EFPIA and its members would like to focus on the following three key issues:
- Increasing the level of individual data disclosed
Since disclosure started in 2016, there has been an increase in positive consent given by HCPs (and HCOs where applicable) to disclose payment information across most member countries. However, some countries still have a low consent rate Therefore, more needs to be done to promote and improve disclosure at an individual level.
The disclosure includes personal data e.g. the names, the address of the HCPs and the amounts of transfers of value provided to them.
The General Data Protection Regulation 679/2016 considers that companies can legally process the personal data (that do not contain sensitive personal data) if they rely on the following legal bases:
- Legal duty: there is a legislation in place allowing the personal data treatment
- Consent: the individuals agree with the treatment of their personal data.
- Legitimate interest ground: the data processor considers that there is a public interest higher than the private interests of the individuals.
The appropriateness of these legal bases for disclosure may differ between Member States.
Several best practices to improve transparency come from country’ individual initiatives, for example in Spain where the Spanish Data Protection Authority[6] granted a consent waiver (meaning that companies do not have to seek the HCPs’ consent before publication).
Recently, Norway opened discussions with its national DPA and obtained to base the disclosure on the legitimate interest.
The UK member association, ABPI recently publicly championed the use of Legitimate Interests for individual disclosure, and produced guidance to support those companies. The position in the UK is supported by the medical communities and government bodies.
Additionally, the Dutch self-regulation regime and the national transparency laws have also acknowledged that there is a clear societal interest for the disclosure of individual information.
EFPIA and its members work with stakeholders to increase the disclosure of individual data.
- Explaining the R&D category
Research and Development (R&D) transfers of value are disclosed on an aggregate basis.
The EFPIA Code defines as “Research and Development Transfers of Value” the following:
- non-clinical studies (as defined in OECD Principles on Good Laboratory Practice);
- clinical trials (as defined in Regulation N° 536/201412); or
- non-interventional studies that are prospective in nature and that involve the collection of patient data from or on behalf of individual, or groups of, HCPs specifically for the study (Article 18 of the EFPIA Code)
Nevertheless, it is worth noting that R&D, and in particular clinical trials, are subject to transparency legislation under the EU Clinical Trial Regulation (2001/20) and the European Medicines Agency Transparency Policy (Policy 0070). As of October 2021, 40.948 clinical trials are available on the EU Clinical Trials Register. The names of investigators working on industry-sponsored trials will be publicly disclosed in the Clinical Study Reports published by the EMA. In addition, Innovative Medicines Initiative publicly disclosed investment in research and innovation. Moreover, EFPIA developed together with PhRMA data sharing commitments regarding clinical trial data. Even though this data does not contain financial information, it does provide information regarding studies run by companies.
In addition to the information already published by the EFPIA members (e.g., in the companies’ methodological note explaining the disclosure), EFPIA is looking into ways to improve awareness and greater understanding of the types of R&D activities disclosed in aggregate.
Some recent media articles[7] have highlighted several structural problems within the existing industry framework regarding data access, including differences in disclosure practices such as pdf vs read-only online methods of publication, and inconsistently formatted reports dispersed across multiple websites and raised concerns about the access to data because of the format of the template and scattered information.
Regarding the disclosure accessibility, EFPIA and its members are working to make the data easier for patients and others to access and help them understand the disclosure.
Providing clearer guidance on how to implement a unified format and publication standard (in the absence of a governmental or national platform), on how to implement national platforms with a consistent format and structure that is also searchable and downloadable and how to publish all the disclosure (HCPs, HCOs and POs) in a central more accessible location are currently being explored by EFPIA and its members.
Conclusion
In order to continue to be successful, transparency requirements need to respond to the evolving demands of society and to solve the disparities emerging during their application. Self-regulation is ideally suited to address the continuous challenge and proactive adaptation.
The EFPIA Disclosure initiative can be enhanced, further promoted and valued. Few patients know that Member Companies disclose the data related to their interactions with HCPs, HCOs and POs, and they are not aware that this self-regulation initiative comes from the pharmaceutical industry itself. EFPIA remains committed to improving and evolving transparency in ways that directly address current challenges and growing societal expectations.
>> Learn more on EFPIA disclosure here <<
[1] such as contribution to costs to attend meetings, speaker fees, consultancy and advisory boards
[2] such as donations and grants, sponsorship for meetings or fees for services
[3] In 2012, EFPIA introduced disclosure provisions in the Patient Organisations Code. Member Companies must disclose a list of POs to which they provide financial support and/or significant indirect/non-financial support or with whom it has engaged to provide contracted services for that Member Company.
[4] Euros for Docs studies + Shai Mulinari, Luc Martinon, Pierre-Alain Jachiet, Piotr Ozieranski. Pharmaceutical industry self-regulation and non-transparency: country and company level analysis of payments to healthcare professionals in seven European countries; 2020 + Accessibility and quality of drug company disclosures of payments to healthcare professionals and organisations in 37 countries: a European policy review | BMJ Open.
[5] Board guidance on indirect ToVs through PCOs - Board guidance related to non-interventional studies’ disclosure - Board recommendation related to national gateways on association’s websites including links to companies’ disclosure reports and the CodCom additional recommendation to include a link to governmental platforms and add the PO’s disclosure data
[6] The Spanish DPA considered that the individual disclosure of the transfers of value is justified on the legitimate interest ground because it is essential (i) to decrease the perception risk on the influence that the HCP might have received to carry out a specific prescription, dispensing and administration of medicines; (ii) to promote a culture of integrity in transactions with HCPs and (iii) to promote the confidence of the general public in the integrity and independence of the HCPs.
[7] Euros for Docs studies + Shai Mulinari, Luc Martinon, Pierre-Alain Jachiet, Piotr Ozieranski. Pharmaceutical industry self-regulation and non-transparency: country and company level analysis of payments to healthcare professionals in seven European countries; 2020 + Accessibility and quality of drug company disclosures of payments to healthcare professionals and organisations in 37 countries: a European policy review | BMJ Open.
