Highlights - Codes and Regulations
Julie Bonhomme, representing the European Federation of Pharmaceutical Industries and Associations (EFPIA) and George Fife from Ernst & Young focused on the topic of transparency and consent, with a particular spotlight on the EFPIA Disclosure Initiative. Since the first disclosure in 2016, EFPIA has mandated Ernst & Young to assess the transfers of value disclosed by EFPIA members companies and analyse the evolution of amounts and consent levels. The results showed that, while pharmaceutical companies may be driving transparency from an industry perspective, healthcare professionals are not necessarily aligned. The question remains how to bring HCPs along effectively when making these decisions and how to increase consent for individual data, improve access to information via national platforms, and ensure a clearer understanding about what the data means.
Michael Gleave and Mette Jacobsen addressed Lundbeck’s transparency journey, and how the company moved from the traditional step-by-step overview to today’s assessment of fit for purpose, a labour-intensive process. In the end, it comes down to asking the right questions in all situations: are they still fit for purpose? Are they fulfilling our transparency obligations as a company and an industry? Are they driving the right dialogue and demystifying the relationship between Pharma and HCPs? Not satisfied with where they are today, Lundbeck continues to look at what the future holds, and how they can potentially leverage technology and automation to help focus efforts on the high-risk priority areas.
Holger Diener, representing IFPMA (International Federation of Pharmaceutical Manufacturers and Associations), walked attendees through the latest changes to their code of practice, which is based on an ethical framework that puts trust at the very core. Some key changes described include the complete ban on gifts with no exceptions, and no more promotional aids for Rx-based medicines.
Aoife Delmas from the European Society of Cardiology provided the perspective on compliancefrom medical societies. In fact, medical societies have fundamentally questioned whether there is still a role for them in the changing world – and found that, when talking to membership, there was an extremely positive responsive in terms of the value societies provide especially with regard to expertise, excellence and peer-to-peer exchange. But Aoife Delmas noted that medical societies need to evolve as the environment they operate in changes. There is real societal value in the relationship between the healthcare industry and physicians, but regulations have changed the dynamic of that relationship and resulted in confusion, poor understanding and a breakdown in trust. Now is the time to build collaboration with the pharmaceutical industry on new foundations that could include digital as a more powerful channel and new ideas for collaborative models for independent medical education.
Julie Bonhomme, EFPIA, and Arthur Muratyan, representing MedTech Europe, provided an in-depth look at changes to their respective compliance codes and then joint the other speakers for a panel discussion.