About this event
08:30 – 09:00 Registration of participants & welcome coffee
09:00 – 09:10 Opening remarks
Mircea Geoană, President, the Aspen Institute Romania
09:10 – 09:30 Keynote speech
Nicolae Bănicioiu, Romanian Minister of Health
09:30 – 11:30 Health Economics and Market Access Strategies – Translating New EU Trends into the Eastern Europe Context. Is Romania Ready for MEA’s (managed entry agreements)?
In a nutshell, the 2014-20 Healthcare Strategy published by Romanian healthcare authorities puts forward a complete transformation of the healthcare system, shifting its paradigms and re-drafting operational principles. Where pharmaceutical industry is concerned, the document re-states the intention of the Ministry of Health to increase efficiency of spending by reviewing the reimbursed medication on HTA basis.
Meantime, at EU level, the dialogue between the industry and the healthcare systems is focused on transforming the challenges of today’s austerity into the win-win health partnerships of tomorrow by making use of newest market entry tools available and modulating their implementation according to the characteristics of the market, while also keeping an eye on the harmonization of these pathways and sharing best practice across the Member States.
The debates will aim to approach critical questions such as:
· How ready is Romania to face EU regulatory developments in this area while fostering an attractive business environment and observing the macroeconomic constraints?
· Which are the latest MEA and risk sharing developments and how do these reflect on future prospects and policy options?
Moderator: Nic Voiculescu, MD, EMBA Managing Partner, Link Resource
11:30 – 11:45 Coffee Break
11:45 – 13:45 Clinical Research & Real-life data – A Viable Option for Both Patients and the Public Healthcare System in the assessment of new health technologies
The deep transformation of the healthcare system envisaged by the Romanian authorities (and detailed in the Strategy published at the end of 2013) also touches on the role and relevance of clinical research activities. Medical research has been for too long a topic confined to professional communities. Yet, successful examples in other EU Member States, such as the UK and Belgium, show that by creating a seamless interface between medical research activities & regulators, companies and authorities, an entire new assistance infrastructure is created and offered as a viable option for the patients (who thus have access to cutting-edge medical solutions to the health issues they experience). Additionally, such an infrastructure fosters a steep learning curve for the professional community and contributes to relieving the economic burden, thus providing benefits for the entire healthcare system.
Meanwhile, in addition to data provide by the clinical trials, the use of real-life data and their relevance for the reimbursement-related decision-making is increasingly at the focus of attention the competent authorities across EU which rely on such type of information in (re)assessment of health technologies. A similar approach that includes a review of medicines benefits after a certain period of being reimbursed is suggested by the draft reimbursement list recently published by the Romanian Ministry of Health, thus seemingly aligning local processes to the EU best practices.
We hereby invite you to a dedicated debate, focused on possible strategies for disseminating information on clinical research while also examining the usefulness of such information for institutional decision makers and the manner in which real-life data may be used for further refining healthcare policy choices.
Moderator: Andrei Țărnea, Executive Director, Aspen Institute Romania
Speakers all speakers