Evidentiary requirements and the medicines regulatory framework in Europe are integral parts of the access to medicines debate and deserve much more attention. Our session builds on last year’s agenda-setting session and will outline actionable recommendations for medicines regulatory reform in order to achieve meaningful public health needs-driven innovation for the benefit of all patients.

Furthermore, the conference comes at a critical juncture when Europe is debating the role of Health Technology Assessment (HTA), and how to ensure that public investment in medical R&D translates to the medicines we need being developed and made available at prices that patients and governments can afford. The session will draw the link between HTA and the regulatory environment and provide answers to the conundrum of weak evidence-high prices faced by policy-makers across Europe.

The session will be highly interactive and no presentations will be allowed in order to guarantee a lively and comprehensive conversation amongst panelists and with the audience.

Welcome

Kiti Kajana Phillips, Open Society Foundations

PANEL 1

Assessing the Quality of Innovation

– Wolf-Dieter Ludwig, Chairman, Drug Commission, German Medical Association and EMA Management Board member
– Ameet Sarpatwari, PhD.J.D, Instructor in Medicine, Harvard Medical School, Associate Epidemiologist at Brigham and Women’s Hospital, Assistant Director of the Program On Regulation, Therapeutics And Law (PORTAL), Harvard University
– Natasha Azzopardi-Muscat, President, European Public Health Association (EUPHA)
– Bart Vermeulen, Deputy Director Healthcare, Office of the Minister of Social Affairs and Public Health, Belgium

Moderated by Yannis Natsis, Policy Manager for Universal Access and Affordable Medicines, EPHA, Board Member, EHFG

PANEL 2

Case Studies & Tools for Change

– Caroline Izambert, Citizen advocacy and campaigns coordinator, AIDES, France
– Representative of Altroconsumo
– Adrian van den Hoven, Director General, Medicines for Europe
– Vanessa Lopez, Executive Director of Salud por Derecho (Spain)

Moderated by Daniel Wolfe, Open Society Foundations

European Health Forum Gastein 2017

Medicines: new game, new rules

Organised by Open Society Foundations in collaboration with EPHA and EUPHA