EFPIA and its Members remain committed to improving transparency and evolving disclosure in an effort to reinforce the legitimacy and value of the relationships between the industry and healthcare stakeholders and the role they play in helping to advance innovative medicines and patient care.

Against a backdrop of technology-fueled disruption, growing societal expectations and interest in areas such as privacy, conflicts of interest, and calls for increased access to data related to transfers of value between the medical community and the pharmaceutical industry, transparency remains an essential component in helping to establish and retain trust between the industry and society and is also an ethical obligation of EFPIA and its Members.

Consistency and standardisation in an evolving landscape

Since its inception, the self-regulated disclosure requirements outlined in the EFPIA Code (section 23.04) have encouraged and strived for standardisation in its implementation, including consistency in the publication, accessibility, and structure of reports, at both the national and company level.

However, due to the nature of requirements, diverse legislation, precautionary interpretations of data privacy regulations, and varying national attitudes and practices towards transparency, the current ecosystem threatens to undermine transparency efforts.

This growing concern has been highlighted in recent media articles[1],[2], in which current disclosure practices are criticised, specifically those related to data access. The key concerns focus on the varying formats of disclosure templates and reports, inconsistencies in practices such as publication and disparate locations of reports and data on company and national platforms.

Examples of industry established national platforms, such as the platform created by the ABPI in the UK (Disclosure UK), are being used to illustrate the “perceived” ease and efficiency of moving to a centralised, online, and searchable database to address the problem of data accessibility and have resulted in calls for the implementation of a European wide disclosure platform - a single centralised repository of all transfers of value across the European pharmaceutical industry.

While these platforms help to drive consistency and greater accessibility to data, especially at the national level, the implementation of such a platform at a European level would require significant change across Europe as well as significant investment and time to implement. There is also an argument to be made that a European-wide platform could potentially impact transparency overall (lowering individual consent rates) and ultimately impact relationships between healthcare stakeholders and the industry, creating additional barriers to medical research and advancement of patient care. The idea of moving to a European platform, therefore, remains an aspirational long-term ambition.

Evolving Disclosure requirements

Nevertheless, in an effort to continue to evolve disclosure practices and a proactive approach to address concerns and structural problems within the industry self-regulated framework, EFPIA will issue new disclosure recommendations (for the format) and closely monitor pre-existing recommendations (for national gateways), to drive greater access and consistency in the publishing of data related to transfers of value between its member companies and healthcare stakeholders.

Proposed improvements include the following:

1. Clearer guidance and stronger enforcement for member companies to implement a unified format and publication standard (in the absence of a governmental or national platform).
2. Implementation of the recommendation (Annex 1 of the EFPIA Code) for a national platform which implements a consistent format and structure that is also searchable and downloadable.

An aspirational step forward: European gateway

EFPIA and its members took the first steps towards the aspirational ambition of a European platform by implementing a single European gateway, intended to provide any interested stakeholders with a single point of access to transparency data through a centralised and easy-to-navigate portal, which connects all EFPIA member countries, whether data is hosted on individual company websites or centralised on national platforms.

Launched today, the European gateway represents a proactive and pragmatic approach to implementing a European-wide platform, while still being flexible enough to accommodate complex and diverse data privacy regulations and national laws.

Conclusion

Self-regulation is the industry framework by which EFPIA and its members continue to hold ourselves accountable to our ethical obligations and commitment towards improving and evolving transparency in ways that directly address challenges and growing societal expectations.

While proactive evolution and adaptation of disclosure processes and data access solutions help to reinforce the legitimacy and value of the relationships between the industry and healthcare stakeholders, data access remains closely linked to the topic of data completeness (via positive consent or legal basis such as legitimate interest), and advancement in both is required to improve transparency overall.

In the spirit of the EFPIA Code, we encourage all countries and companies across the industry to join us in improving transparency as one of the ways we can advance the interests of patients and public healthcare.

[1] Le Monde "Euros for Docs", an unprecedented database on the links between the pharmaceutical industry and health professionals By Stephane Horel Published on June 01, 2021: https://www.lemonde.fr/planete/article/2021/06/01/euros-for-docs-une-epopee-informatique-pour-rendre-visibles-les-liens-entre-industrie-pharmaceutique-et-monde-medical_6082282_3244.html

[2]  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; 2021;125:915-922: https://www.sciencedirect.com/science/article/pii/S0168851021001135?via%3Dihub