On 23 November 2021, the Regulatory Science Network Netherlands (RSNN) organized its annual workshop in a hybrid format at the Jaarbeurs Utrecht. Many relevant stakeholders were represented at the event, including patients, academia, industry, health technology assessors, and regulators.
The presentation files from the speakers at the RSNN workshop and the recording of the livestream are available at the RSNN website.
The topic of the workshop was: ‘upstream regulatory convergence and downstream divergence’. During the meeting scientific perspectives and the different views of stakeholders on this topic were discussed, including their drivers and consequences for patient access.
The meeting was chaired by Sjaak Bot (Janssen, RSNN) who opened the meeting and provided a general problem analysis. Two speakers then set the scene by introducing illustrative examples in which challenges relating to upstream regulatory convergence and downstream divergence are highly visible. Hans Schikan (Special Envoy vaccines Netherlands, VWS) focused on differences between nations in COVID-19 vaccination strategies, while Delphi Coppens (KWF) presented insights on the implementation of the ATMP hospital exemption in various EU member states.
Following these illustrative examples, three speakers shared their view on the main topic from the perspective of health technology assessment (Wim Goettsch, ZIN), patients (Wim Altena and Carine Besselink) and regulators (Anthony Humphreys, EMA), respectively. This was followed by a presentation by Bernard Steunenberg (Leiden University) who introduced a framework to better understand drivers of and explanations for downstream divergence using insights from the field of public administration.
The workshop’s final session was a lively plenary discussion chaired by Peter Mol (University Medical Center Groningen). The perspectives of patients, academia, industry, and the regulator were represented in the person of Sini Eskola (EFPIA), Anthony Humphreys, Bert Leufkens (RSNN chair), Larissa de Lannoy (PCS Patients Europe) and Hans Schikan. This was followed by closing words from Bert Leufkens. Bert concluded that there is a need for more interdisciplinary studies to better understand the factors driving variation between EU member states. He made a plea to learn from observed dynamics across fields and make them measurable in the context of pharmaceutical policy and regulation. He then closed the meeting after thanking the participants and speakers for their contributions.