A key objective of ISPOR Spain Chapter is to act as a training and informative resource at national level for professionals interested in pharmacoeconomics and health outcomes research. As part of this, it will periodically organize training on Wednesdays, under the name of “Los miercoles del Capítulo” ("ISPOR Wednesdays" in English), consisting of training sessions on relevant topics in the field, taught by experts in this field, with a duration of two hours.
The first presentation in 2023 was delivered by Iñaki Gutiérrez Ibarluzea, director of Organizational Innovation and Management of the BIOEF (Basque Foundation for Health Innovation and Research). The focus was the HTA regulation story, highlighting the ‘highs and ‘low, as well as reflecting on the adequacy or not of the (so-called) European HTA regulation and its consequences at the Spanish national level, on EUnetHTA21’s task going forward and how it will impact individual countries and on medical device and diagnostic testing regulations. As a final reflection, the audience discussed who should benefit and how from these activities, initiatives, and policies in health.
Below is a brief summary of the presentation:
The role that Health Technology Assessment (HTA) should play in decision-making at European level and in the formation of a pan-European health system has been subject to discussions since the 1990s, when the first experiences of evaluation units were implemented in countries such as Spain, the United Kingdom and Scandinavian countries. In fact, the Spanish National Health System and its service providers were among the first to include HTA as a decision-making tool.
More recently, a joint effort by the International HTA Society (HTAi) and the International Network of Public HTA Agencies (INAHTA) has developed a new definition of Health Technology Assessment as: A multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its life cycle. The purpose is to inform decision-making to promote an equitable, efficient and high-quality health system. This new definition, which slightly qualifies the previous ones, is aligned with the universal coverage objectives of the World Health Organization, which define that access to safe, effective, quality and affordable essential medicines and vaccines must be ensured for all. And that, to ensure that goal, the design of the essential benefits package must be based on data and evidence.
On this basis, and in systems that generally ensure universal or near-universal coverage in Europe, why is the role of HTA in this regard still being discussed? The first reason that can explain it would be to assess in which EU countries HTA is deployed, and for what purpose. In fact, although it seems impossible at this point in the game, there are still countries in the EU that do not have HTA or similar mechanisms implemented to support the processes of defining and updating their portfolio of services. This is especially relevant in the case of Eastern European countries, but also occurs at the national level in other countries with previous experiences in HTA. The second reason relates to the difference in service delivery and provision systems and the lack of a common idea of health in Europe. Since the beginning of the twenty first century, the European Commission and the EU have asked different experts and committees to advise on how to do this and from there several reports and initiatives emerged, such as EUR-ASSESS, ECHTA-ECAHI, the EUnetHTA project and the subsequent JA1, JA2 and JA3 joint actions. More recently, an extension called EUnetHTA21 has been proposed. In this state of affairs, several actions have taken place and one of them that has changed the landscape has been the decision of the EU, whether appropriate or not, to promote a regulation; on the other hand, the promoters of an HTA network in Europe have generated in parallel an organization called Head of Agencies Group (HAG) that has emerged as the successor of the initial EUnetHTA project.