The Bucharest Forum / Healthcare symposium will take place in Bucharest, on March 27th, 2015. The event is the fourth healthcare sector specific conversation in the framework of Bucharest Forum and takes place at Institutul National de Statistica, Bulevardul Libertății 16, Bucharest.

The Aspen Institute Romania and Link Resource, under the auspices of the Romanian Government and with special support of Romanian Ministry of Healthcare, National Health Insurance House and National Agency for Medicines and Medical Devices, are developing a long term dialogue platform designed for decision-makers in the healthcare sector. Focusing on public policies and best practices in healthcare the series (comprised of public and closed door meetings), the event is part of the Aspen Institute Romania’s Healthcare and Quality of Life Program. Building on a body of European and regional expertise, we set to further deepen the conversation on managed entry agreements for pharmaceuticals, EMA guidelines for patients’ associations, medical research and social health insurance vs private health insurance. The organizers aim for lively, non-partisan and inclusive debates with a view of supporting, streamlining and assisting efficient policy making in the field. This is built to serve both public sector and private sector decision makers and administrators.

Based on the outcomes of its previous editions, the organizers would like to further progress in finding sustainable solutions to the perennial and evolving problems of healthcare systems by bringing together key stakeholders and their views on available alternatives. The event on March 27th will gather healthcare sector specialists, national and European regulatory experts, medical technology and pharmaceutical sector researchers and decision makers, as well as healthcare sector business leaders, with significant role in shaping healthcare policies.



08:30 – 09:00 Registration of Participants & Welcome Coffee

09:00 – 09:10 Opening Remarks
Mircea Geoană, President, Aspen Institute Romania

09:10 – 09:30 Keynote Speech
Nicolae Bănicioiu, Romanian Minister of Health

09:30 – 11:00 Market Access Mechanism for Pharmaceuticals

In a macro environment seeking to attain stabilization, both in Romania and in the European Union, diverging economic interests of the public authorities and the industry give rise to novel types of partnerships and expense containment solutions, which on one hand aim to satisfy the need to improve patients’ access to new therapeutic alternatives while observing the limitations of the payers and in the same time provide opportunity for business development within these recurring constraints.
Following the debates initiated and hosted by Aspen Institute Romania, the local healthcare authorities took under consideration a new approach in their search for sustainable solutions and implemented some of the solutions discussed during the Bucharest Forum / Healthcare.
It is in this context that the organizers would like to further progress and deepen the debate on the outcomes of its previous editions, putting forward topics related to the ‘must have’ as well as ‘need to have’ refinements to the presently applicable market access regulatory framework and how these may assist in the pursue of seemingly opposing objectives of the patients, the public payers and the industry.
The debate will focus on the steps that have been taken so far as well as on needs to be done so that the market access mechanism currently in place overcomes the implementation challenges.

Moderator: Nic Voiculescu, MD, EMBA, Managing Partner, Link Resource
● Nicolae Bănicioiu, MD, Romanian Minister of Health
● Marius Savu, MD, President, National Agency for Medicines and Medical Devices
● Cristian Bușoi, Member of the European Parliament
● Andrew Stainthorpe, Executive Director, PASLU, NICE
● Driss Berdaï, MD, MSc, Member of Transparency Committee, Haute Authorité de Santé
● Finn Børlum Kristensen, MD, PhD, Executive Committee Chair, EUnetHTA
● Jaime Espín, Professor, Andalusian School of Public Health
● Radu Rășinar, Country President, AstraZeneca Romania and South Eastern Europe

11:00 – 11:15 Coffee Break
11:15 – 12:45 Personalized Medicine – The Long Road ahead for Medical Research and Development

Clinical research that can bring a real impact in the health sector should contribute to accommodate the challenge of sustainability in the context of demographic changes in the Romanian and other European societies alike. Scientific advancements outline a path towards ‘personalized medicine, a targeted approach to the prevention, diagnosis and treatment of disease based on an individual’s specific genetic profile. In fact, in recent years therapeutic alternatives based on genetic profile have been developed, but use of genetic data to inform medical decisions is unfortunately lagging.
Meanwhile, EU-wide medical research community is faced with challenges that can only be overcome by patient involvement in the medicines R&D process, building knowledge and competences for patients’ involvement in medicines R&D as well as increasing public awareness about the development of new medicines. Also to be considered is that healthcare budgets, both public and private, are coming under increasing pressure while the medical needs are growing and diversifying.
Consequently it becomes critical that all stakeholders collaborate, especially in an environment that is recently characterized by significant genetic knowledge advancements, which need to be quickly absorbed and transformed into viable solutions and treatments.
Hence, Aspen Institute Romania aims to further deepen the dialogue on supporting and acknowledging the role of clinical research in the health sector and the assistance it may receive from all stakeholders, including patients associations and public bodies in achieving its ultimate objective – shaping the personalized approach to medicine.

Moderator: Alexandra Petrilă, Senior Partner, Link Resource
● Vasile Ciurchea, MD, President, National Health Insurance House
● Prof. Stephen Smye, Hon FRCP, Director, NIHR Comprehensive Clinical Research Networks
● Florina Mihaela Nedelea, MD, Consultant in Genetics, Filantropia Clinical University Hospital, Bucharest
● Cătălin Costovici, MD, Diagnosis, Ambulatory Treatment and Preventive Medicine Medical Center of the Romanian Academy
● Jaime Espín, Professor, Andalusian School of Public Health
● Colin R.W. Hayward, FFPM, European Medical Director, Myriad Genetics
● Oana Cuzino, MD, Healthcare Media Expert, TV Producer, MediaPro Group

12:45 – 13:30 Lunch

13:30 – 15:00 Patients’ Associations: Present & Future

Patients and consumers have been involved with several regulatory bodies for many years and are already well integrated into numerous areas of its work. Overall interactions with patients groups have proved useful; they bring a crucial patient perspective to the discussions on medicinal products and can help to provide valuable insights such as acceptable levels of associated risks as well as other relevant topics. Over the time, it became clear that, in order to reach meaningful results, some standards are required, which, whilst not legally enforced should be observed.
Proof of this need are the initiatives of EU relevant regulatory bodies, which, in their pursue of operational transparency and high quality activities, deemed necessary to require their partners to observe similar standards.
It is in this context that Aspen Institute Romania intends to initiate a meaningful debate on the role played by patients associations in the shaping of significantly important healthcare policy and strategic decisions as well as on which organizational criteria should be observed by such bodies so that the dialogue with the regulatory institutions efficiently results in constructive outcomes for both parties.

Moderator: Andrei Țărnea, Executive Director, Aspen Institute Romania
● Marius Savu, MD, President, National Agency for Medicines and Medical Devices
● Francesco de Lorenzo, MD, President, European Cancer Patient Coalition, fmr. Italian Minister of Health
● Margaret Walker, CEO, European Liver Patients Association
● Vlad Voiculescu, VP MedAlert, VP&Treasurer European Cancer Patient Coalition
● Vlad Mixich, Senior Editor, Hotnews
● Dorica Dan, President, National Alliance for Rare Diseases Romania, Member of EURODIS Board of Directors

15:00 – 15:10 Closing Remarks