The development of HTA collaboration at European level and the challenge of the EU regulation

Abstract Issue The establishment of HTA has been an important topic in Europe for many years. The engagement of HTA agencies, scientists, politicians and many other stakeholders throughout more than 20 years lead to the EU-HTA regulation, which came into force beginning of 2022. Now it is time to prepare for a sustainable European Network for HTA. Description The implementation of HTA in Europe is of high importance of the EU-commission for more than 20 years. Started with the first projects in 1994 (EUR-ASSESS) it needed quite a bunch of different projects and, in the end, three joint actions for finally providing legal ground for HTA with the EU-HTA regulation. This journey seemed a long one. However, referring to the need of addressing the requirements of Health Care of 27 Member States combined with the demand of reliable high methodological quality and applicability, investing all the time and effort for a sustainable European Network of HTA was definitely worthwhile. Joint Scientific Consultation (JSC) and Joint Clinical Assessments (JCA) will play a central role for national HTA and decision making in health care. But for understanding role, content, national uptake and further development of means, products and results of a European Network for HTA it is quite important to get a perception of the development of HTA collaboration in Europe. Based on this the challenge of the EU-HTA regulation and its implementation will be tackled easier. Effects Through provision of the main pillars of the previous EU-HTA collaboration the appreciation and understanding of the differences and complexities behind the HTA processes in the EU-healthcare systems will made aware. Based on this understanding the challenges of the implementation of the EU-HTA regulation will be discussed.


Iñ aki Gutié rrez-Ibarluzea
I Gutié rrez-Ibarluzea 1 , N Ibargoyen-Roteta 1 , G Benguria-Arrate 1 , L Galnares-Cordero 1 1 Basque Office for Health Technology Assessment, La Fundació n Vasca de Innovació n e Investigació n Sanitarias, Barakaldo, Spain Contact: ebaluatek@gmail.com Issue: Health care systems actors are in need to take decisions every day. The basis for a good decision is to consider all the factors, the value of the action, the values that support a ''go'' or ''not go'' decision and the intended and unintended consequences that those decisions could entail. Furthermore, understanding decisions implies knowing which the context and the circumstances that surround decisions are. Description of the issue: HTA should cover all those aforementioned aspects and make it along the life cycle of health technologies. Thus, it should be the pivotal element that health systems should look at when making decisions. Nevertheless, this is not the case in all the countries/regions or health systems. Empirical research (facts) and normative inquiry (values) are not consistently considered and holistic approaches to the determination of value are lacking.

Results:
Policymakers, health care systems and HTA bodies are differentially approaching to value determination, and, in most cases, this is not explicitly shared with the stakeholders concerned. The consideration of the implication of life cycle concept is not well addressed and decisions are mainly focused on introduction and implementation, meanwhile decisions on deletion or modification of use are lacking, although relevant for health systems sustainability. Mostly systems failed by individual determination of technologies' value without considering that they are used on systems in combination to other technologies, by different professionals, applied to different patients and within different contexts.

Lessons:
There is a need for a holistic approach of value determination. Likewise, the life cycle concept offers a unique opportunity to promote proactive actions in improving added value generation for technologies under development. Similarly, the assessment of value once solutions are introduced is substantially a way to improve systems' outcomes and their efficiency.

Issue:
The establishment of HTA has been an important topic in Europe for many years. The engagement of HTA agencies, scientists, politicians and many other stakeholders throughout more than 20 years lead to the EU-HTA regulation, which 15th European Public Health Conference 2022 came into force beginning of 2022. Now it is time to prepare for a sustainable European Network for HTA.

Description:
The implementation of HTA in Europe is of high importance of the EU-commission for more than 20 years. Started with the first projects in 1994 (EUR-ASSESS) it needed quite a bunch of different projects and, in the end, three joint actions for finally providing legal ground for HTA with the EU-HTA regulation. This journey seemed a long one. However, referring to the need of addressing the requirements of Health Care of 27 Member States combined with the demand of reliable high methodological quality and applicability, investing all the time and effort for a sustainable European Network of HTA was definitely worthwhile. Joint Scientific Consultation (JSC) and Joint Clinical Assessments (JCA) will play a central role for national HTA and decision making in health care. But for understanding role, content, national uptake and further development of means, products and results of a European Network for HTA it is quite important to get a perception of the development of HTA collaboration in Europe. Based on this the challenge of the EU-HTA regulation and its implementation will be tackled easier.

Effects:
Through provision of the main pillars of the previous EU-HTA collaboration the appreciation and understanding of the differences and complexities behind the HTA processes in the EU-healthcare systems will made aware. Based on this understanding the challenges of the implementation of the EU-HTA regulation will be discussed. Growing research around the globe shows that for-profit corporations incur increasingly adverse impacts on health and well-being of people, the planet and the global economy. Their health damaging products and practices fuel non-communicable disease epidemics, damage the earth's natural environment and interfere in health policy making. Such corporate interference in social and public health policy, research and practice is well documented for the pharmaceutical, tobacco, food and beverage, alcohol and arms industries. A commercial determinant lens allows a better understanding of heath inequalities by drawing attention to corporate actors and their tactics as drivers of ill-health rather than people's behaviors. This framework also makes it possible to present interventions to counter these influences. This workshop panel of 5 scholars and activists from around the world who are members of the Governance, Ethics and Conflict of Interest in Public Health Network serves to confirm the detrimental reach of industry practices and the global responses to this interference in public health. It aims to add to the emerging body of knowledge on commercial determinants of health using innovative research approaches and findings. The format is a series of 5 short sequential presentations, followed by an interactive discussion with the audience, moderated by the panel organizer. The presentations will showcase the research methods used including multi-stakeholder interviews, policy analyses, systems mapping and analyses of policy debates. The presentations will also document examples and cases of corporate capture of food industry in Europe, a global mapping of corporate systems, industry interference in health-protecting laws in Columbia, exploitation of humanitarian emergencies in Lebanon, and suggestions of ways forward to protect adults and children from industry vested interests with a Public Health Playbook.

Key messages:
Corporate interference in public health is a growing concern globally for its health harming influence on health systems and future generations.
Continued concerted research revealing overt and covert health harming industry practices is needed to counter their impact on PH in a world fraught with global challenges and uncertainty.
Background: Unhealthy commodities are major drivers of the global burden of noncommunicable diseases. Commercial actors attempt to influence policy to undermine regulation and existing literature draws attention to the underlying macro-level factors that enable this influence. Public health literature also suggests that industry adapts to regulation and such influence may thus be considered a complex adaptive system. Therefore, this study aimed to build a qualitative systems map to help communicate the complexity of industry influence and develop a tool to facilitate the identification of interventions in follow up research.

Methods:
In-person group model grouping workshops were adapted for the online environment. A preliminary qualitative systems map was developed by synthesising two recent studies to facilitate workshop discussions and expedite the mapping process.
Twenty-three small group system mapping workshops were conducted with a total of 52 stakeholders, representing researchers, civil society, and public officials from various geographical regions.

Results:
The qualitative systems map identifies five pathways through which industry influences policy: a) direct access to public sector decisionmakers; b) creation of confusion and doubt about policy decisions; c) prioritisation of commercial growth; d) industry leveraging the legal and dispute settlement