09:30 – 11:00 Healthcare Financing and Health Technology Assessment – Bridging Medical Needs With Scientific Progress
HTA – related European landscape appears to be constantly changing as a consequence of the increasing pressure exerted by still adverse economic conditions and the need to find improved therapeutic solution for patients. Just recently, the Romanian Ministry of Health passed into legislation HTA-based regulatory framework for extending reimbursement of medicines, build on criteria such as improved therapeutic benefit as certified by the French National Authority for Health (Haute Authorite de Sante, HAS), cost-efficacy as certified by the UK’s National Institute for Health and Care Excellence (NICE), reimbursement status in other EU Member States, relative efficacy and safety. Nevertheless, Romania is just one of the increasing number of countries seeking to optimize public expenditure by implementing hybrid policy instruments, relying on both technological (therapeutic) and financial criteria.
ADVANCE – HTA aims to broaden the spectrum, complement and address areas of intense methodological debate in the application, use and implementation of HTA. It also aims to improve HTA methods, which can be taken further by competent authorities nationally whilst supplementing the work of supra-national bodies (e.g. EUnetHTA) towards a common understanding of choices in health care decision-making.
Under the circumstances, it becomes clear that understanding HTA models as well as their likely development direction is a critical factor for successful performance of operations, for both payers and the industry (be it pharma, medical devices or medical services). The debate we invite you to attend will focus on key strategic elements of these models, weighting both the policy value and operational impact.
• The HTA induced paradigm shift – which are the benefits and limitations brought forward by the transition to HTA, from the perspective of the main stakeholders: patients, public payer and the industry.
• In the long run, what are the perspectives? The more the countries adopting HTA based reimbursement systems the more varied the models and hence the more fragmented the outlook of EU and non – EU HTA landscape. Consequently, finding an answer to the questions ‘which model may be suitable for EU wide adoption’ and ‘how large is the gap between the national and EU wide model’ would provide the stakeholders with a critically needed understanding of the future challenges, taking into consideration that this model may spread to non EU countries.
• In the short run, is HTA creating challenges or competitive advantages? The obvious answer appears to be the former; yet, experience gained in other markets may indicate that HTA also provides significant benefits for the companies prepared to harvest them.
Moderator: Nic Voiculescu, MD, EMBA - Managing Partener, Link Resource
Vasile Cepoi, MD – Former Minister of Health, Healthcare Counselor to the Prime Minister
Cristian Busoi, MD, Ph. D – President of the National Health Insurance House
Makis Papataxiarchis – Managing Director, Johnson & Johnson Romania, ARPIM President
Ciprian Ciobanu – Board Member, Medlife
George Sofianos – CEO, IHS Romania
Nela Pavaloiu – President, European Development Platform
11:00 – 11:15 Coffee Break
11:15 – 12:45 Medical Research & Development – Is Romania Competitive In The Global Market?
While in peer European Member States and in developed partner countries clinical research & development has been the engine for progress in medical field, newest EU countries need to incentivize development of infrastructure and establishment of new business models in order to both align to proven successful trends and benefit of the advantages provided by new therapeutic solution while also supplying Romanian patients with an alternative that is hardly available today. Currently, clinical research still struggles to match its way into the overall healthcare system in order to be recognized as a viable healthcare option available for well defined categories of patients and a balanced state is yet to be seen at horizon.
The situation looks even more challenging further East, in countries outside the overarching framework of European Directives, where implementation of Good Clinical Practices, the regulatory foundation on which the entire clinical studies industry rests, is still seen as variable between first-tier investigational sites and second- and third-tier ones with direct susceptibility over the quality of clinical data but providing one major advantage over the consecrated clinical research geographical areas: immense naïve-to-treatment recruitment pools. The debates will aim to approach critical questions pertaining to clinical trials:
• Will the experience acquired by the recent EU Member States in implementing regulatory frameworks and clinical trial infrastructure generate an “oil spot” effect over towards the East?
• Will these emerging eastern countries develop their unique regulatory and facility infrastructure that will impose them as harsh competitors of EU on the clinical research market?
Moderator: Nic Voiculescu, MD, EMBA - Managing Partner, Link Resource
Prof. Dr. Dragoş Vinereanu, MD, PhD, EC, FESC - Professor of Cardiology, Vice Rector, University of Medicine and Pharmacy "Carol Davila" Bucharest
Acad. Prof. Dr. Victor Voicu, MD, PhD – Member of the Romanian Academy, Professor of Clinical Toxicology and Pharmacology, University of Medicine and Pharmacy "Carol Davila" Bucharest
Marius Savu, MD - President, National Agency for Medicines and Medical Devices
Mihaela Geoana – President, Red Cross Romania
Oana Cuzino, MD – Healthcare Media Expert, TV Producer, MediaPro Group
12:45 – 13.30 Session 3 – “Consumer Confidence Survey On Quality Of Healthcare Services – a Romanian Perspective”
Prior to Bucharest Forum, Link Resource and Exact CC initiated, for the first time on the Romanian Market, a large market survey aiming to quantify the level of confidence of and satisfaction among beneficiaries of healthcare system, both public and private. The results of the study will be presented in a brief, closing session of the Healthcare Session, open to participants and media as well.
Lacramioara Loghin, Managing Director, Exact CC
Andrei Tarnea, Executive Director, Aspen Institute, Romania
Nora Marcovici, CEO, Grafitti BBDO
Nic Voiculescu, MD, EMBA - Managing Partner, Link Resource