The CEE Patient Engagement Annual Forum is an annual platform that brings together patient organizations, institutions, industry and health policy experts from the region. Created as a venue for the exchange of experiences and good practices, the forum aims to support the implementation of the common roadmap for patient engagement in CEE, as well as to put health high on the political agenda.Ц
In 2025, the forum was held for the fourth time in Bucharest (25-26 September), with the programme focusing on key challenges: access to innovation, assessment of health technologies, resilience of systems and strengthening the role of patients in decision-making processes. The event also included TEDx-style presentations of successful regional initiatives.
Previous editions of the forum (2022-2024) outlined the framework for action in the region, and in 2024 the Stroke and Aphasia Association (AIA) joined the forum in 2024 and was invited again in 2025 – an expression of recognition for its patient role at national level and progress.
This document offers a synthesized overview of the thematic areas of CEE Forum 2025, with a focus on key messages, documents and resources that are relevant to both patient organizations and political and professional communities in Bulgaria and the region.
Key EU initiatives in health
Focus: legislative and policy developments, access to innovation, role of patient organizations.
Overview of key EU decisions and their impact on Member States and patient organisations
Within the framework of the forum, a detailed overview of the latest solutions at European level was presented, with a focus on their relevance for Member States and for the activities of patient organizations. Particular attention was paid to the current changes in EU pharmaceutical legislation, which aim to improve the availability, availability and environmental responsibility of medicines, while providing incentives for innovation and increasing security of supply.
Update on legislation and strategic initiatives
Specific measures aimed at unmet medical needs and addressing shortages of critical medicines through initiatives such as the Critical Medicines Act were also considered. This act provides for the mapping of supply chains, strategic stocks and production incentives within the EU, thus contributing to greater resilience and security of health systems.
In addition, the forum highlighted the importance of the European Life Sciences Strategy, which brings together the pharmaceutical sector, biotechnology, medical technology and diagnostics in order to strengthen Europe's competitiveness and leadership position in the field of healthcare. In this regard, the role of the Biotechnology Act, which aims to facilitate the regulation, financing and implementation of bioproduction and artificial intelligence in medicine, is also emphasized.
Influence on national policies and patient organisations
These initiatives have a direct impact on national health policies by facilitating access to modern therapies and innovations. An important role in the process of implementation and advocacy for patients' interests is played by patient organizations, which establish themselves as key partners in the development and sustainability of health systems.
Documents and resources:
· Revision of EU pharmaceutical legislation – affordable, available and environmentally responsible medicines, incentives for innovation and greater security of supply.
· Critical Medicines Act – measures against shortages by mapping chains, strategic stocks, incentives for production in the EU.
· Strategy for European Life Sciences – bringing together pharmaceuticals, biotechnology, medtech and diagnostics for competitiveness and leadership.
· EU Biotechnology Act – future legislation to facilitate the regulation, financing and deployment of biomanufacturing and AI.
Health in conditions of uncertainty
Focus: political and economic priorities, national security, role of patient organizations.
How health is being shifted from the EU and national governments' agendas due to priorities such as defence, economy and security. In Central and Eastern Europe, this leads to limited budgets and risks to systems. The need for health to be established as an investment in sustainability and security, and patient organizations as support points in crisis situations, is emphasized.
Health in conditions of uncertainty
Political and economic priorities and their impact
In recent years, health has gradually receded from the top positions on the agenda of both the European Union and national governments. The reason for this is the shift in focus to topics such as defense, economy and national security. In the context of Central and Eastern Europe, this process is particularly acute – limited budgets and growing risks create additional challenges to the resilience of health systems.
Health as an investment in sustainability and security
The need for health to be perceived not just as an expense, but as a strategic investment in the sustainability and security of society is affirmed. Only by systematically integrating health priorities into national policies can adequate crisis preparedness and response be ensured.
Role of patient organizations
In the face of uncertainty, patient organizations stand out as key partners and points of support. Their active role in advocating and supporting patients makes them an indispensable resource in overcoming crises and in shaping policies aimed at the resilience of health systems.
Documents and resources:
· GLOBSEC Healthcare Readiness Index 2023 – nine of the ten least prepared countries are from CEE (including Bulgaria, Poland and Latvia).
· The report "At a turning point: Healthcare Systems in CEE" – an analysis of 13 countries, shows disparities and common challenges after COVID-19.
· Health outcomes and expenditures in CEE – EFPIA – balance between future shocks and increased demand due to ageing and chronic diseases.
Access to innovation through the eyes of patients
Barriers to timely access to innovative therapies
Patients in Central and Eastern Europe often face significant obstacles throughout the life cycle of medicines, from obtaining European approval to the national reimbursement process. These barriers translate into both administrative delays and differences in health systems, leading to inequalities in the accessibility of innovation between countries.
Challenges facing small markets
Small markets in the region are particularly vulnerable, as limited resources and less market appeal often delay the entry of new therapies. This further reinforces the differences in timely access to modern medical solutions between countries.
Importance of Advocacy
Patient organisations play a key role in advocating for patients' rights and promoting systemic change. Through active advocacy, they address systemic weaknesses and draw attention to the need for faster and more equitable access to innovation. Their work contributes to identifying practical challenges and puts pressure on institutions to improve processes.
Impact on health systems
The ability of health systems to innovate directly determines timely access to new therapies for patients. The systemic weaknesses that are observed and the significant differences between countries underline the need to integrate the patient voice and for coordinated efforts to overcome barriers in the region.
Documents and resources:
· W.A.I.T. Indicator (EFPIA, 2024) – an average of 578 days to a new drug, with large differences (Germany – 128; Portugal – 840).
· Root Causes of Unavailability Report (2025) – reasons: slow regulations, late assessments, duplication, delay in reimbursement.
· European Access Hurdles Report (2024) – 69% of delays are after submitting applications to countries.
· Smaller Markets Report (2025) – analysis of 9 markets under 4 million people GUIDE. MRD Healthcare Pathway – an infographic on a real and ideal oncology pathway with personalized therapies.
· FT3 Access & Advocacy Roadmap – a tool for advocates of personalized medicine.
Patient Voice in Health Technology Assessment (HTA)
Focus on patient participation and experience data
The introduction of the new EU Health Technology Assessment (HTA) regulation, which comes into force in January 2025, significantly changes the approach to assessing innovation in healthcare. The Regulation focuses on European coordination and joint assessments, which require the active participation of patients, especially from the Central and Eastern European region.
Incorporating patient voices and patient experience data becomes key to building policies that truly reflect people's needs. CEE patients should have the opportunity to participate in joint assessments, providing valuable information about their experiences, which will contribute to the creation of more patient-centered solutions and policies.
Documents and resources:
· EU Health Technology Assessment Regulation – pan-European assessments for oncology and ATMPs from 2025, for all products by 2030
· EUCAPA – patient training on HTA processes and key principles.
· HTA4Patients (EUPATI) – online courses for participation in joint assessments, available in 6 languages.
· Patient Engagement & Patient Experience Data Overview – An overview of the role of data in experiences.
· Real Voices, Real Value Project – integration of patient data into HTA.
· Global Patient Experience Data Navigator – a tool for collecting and applying PEDs.
· PFMD – Global Coalition for Collaborative Design of Health Solutions.
Inspiring initiatives from the CEE region
Good practices and transformation of patient organizations
The CEE region has seen significant progress in the development and transformation of patient organisations. They move from small, local groups to active actors who influence legislation and health policies.
· Poland: Patient organizations have evolved from limited groups to strong advocacy, which contributes to changes in legislation and better representation of patients' interests.
· Czech Republic: The Pacienti IBD organization stands out for its professionalization and volunteer engagement, managing to reach a community of 90,000 patients, supporting them with information and support.
Mobile services for vulnerable groups
· Croatia: The MOBHOPE initiative provides mobile units for the diagnosis and treatment of hepatitis among vulnerable groups, thereby increasing access to health services and prevention.
Elimination of viral hepatitis through campaigns and partnerships
· Romania: Campaigns are being implemented in the country aimed at eliminating viral hepatitis through screening, information activities and building partnerships that support early diagnosis and treatment.
Additional examples
More successful practices can be found through the Patient Focused Medicine initiative, which puts the patient at the center of health decisions and encourages the exchange of good practices between countries in the region.
Strengthening networks and the role of patients
In the CEE region, patient communities are increasingly involved in healthcare decision-making processes. Patient participation in social activities is established as a key tool for overcoming barriers and increasing organizational capacity. By strengthening their networks and strengthening their role, these communities are able to influence policies and promote change that reflects the real needs of patients.
There are internationally recognised frameworks that facilitate this process, including the European Patients' Forum (EPF) Participation Index, the Patient Catalyst Movement and the World Health Organisation (WHO) resolution on social participation. These tools enable patient organizations to be more fully involved in processes, share experiences and develop sustainable mechanisms to protect patients' interests.
Documents and resources:
· WHO Resolution on Social Participation (2024) – engaging citizens in health decisions.
· BMJ Editorial – the need for sustainable participation mechanisms.
· Voice, Agency, Empowerment Handbook – a practical guide to implementing social participation.
· Global Patient Movement Catalyst – a global vision for empowering patient organizations.
Public-Private Partnerships and the Health Innovation Initiative (IHI)
Public-private partnerships in the healthcare sector are establishing themselves as a key mechanism for introducing sustainable innovation, where the involvement of patient organisations is essential. By actively engaging in such partnerships, patient communities are given the opportunity to contribute to the formulation of priorities, the definition of real needs and the creation of sustainable solutions in the healthcare system. This model not only improves the quality and applicability of innovations, but also ensures that the products and services developed reflect the interests of end-users – patients.
In this context, the European Union Health Innovation Initiative (IHI) serves as a unifying platform where industry, academia and patients work together in search of accelerated and effective solutions to key health challenges. This approach highlights the added value of working together to innovate that is sustainable over time and meets the real needs of society. Examples from ongoing projects clearly show that integrating patient voices into processes allows for faster and more adequate addressing of emerging health problems, creating a basis for long-term positive change.
Documents and resources:
· Innovative Health Initiative – European Commission – Joint Innovation and Patient Participation Programme.
· Example: Guide.MRD – coordination for personalized oncology care.
· IHI Readi – a project to prepare health systems for innovation.