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European Patients' Forum (EPF)

EPF

The European Patients' Forum is a leading umbrella organization advocating for patient interests in EU healthcare policy.

Lobbying Activity

Meeting with Yvan Verougstraete (Member of the European Parliament, Shadow rapporteur) and European Chemical Industry Council and

27 Jan 2026 · European Competitiveness Fund

Meeting with Ariane Vander Stappen (Head of Unit Health and Food Safety)

15 Jan 2026 · Exchange of views on antimicrobial resistance priorities for 2026

Meeting with Flora Giorgio (Head of Unit Health and Food Safety) and Biomedical Alliance in Europe

15 Dec 2025 · Exchange of views on the current state of play of the medical devices Regulations reform proposal and discussion on the organisation of a conference on medical devices on the 16th of March 2026.

Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

28 Nov 2025 · Exchange of views on the state of play and next steps for the medical devices sector.

Meeting with Maya Matthews (Head of Unit Health and Food Safety)

24 Nov 2025 · Discussion on EPF’s current activities and planned actions with respect to the Health Technology Assessment Regulation (HTAR) implementation

Meeting with Victor Negrescu (Member of the European Parliament)

21 Nov 2025 · Operating Grants in EU4Health

Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

17 Nov 2025 · Exchange of views on the current state of play of the medical devices Regulations reform proposal and discussion on the organisation of a conference on medical devices on the 16th of March 2026.

Meeting with Stine Bosse (Member of the European Parliament)

14 Nov 2025 · Pharmaceutical and healthcare policy

Meeting with András Tivadar Kulja (Member of the European Parliament)

5 Nov 2025 · European patients rights

Meeting with Victor Negrescu (Member of the European Parliament) and AstraZeneca PLC and

4 Nov 2025 · EUROPA CONNECT - Health EU Summit

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

15 Oct 2025 · Pharma Package

European Patients' Forum urges stronger safety oversight and patient information in device regulations

6 Oct 2025
Topic — Revision of EU medical device and in vitro diagnostic regulations to reduce burden while maintaining safety.
Message — The organization requests binding guidance for safety investigations with strict deadlines, mandatory post-market data collection for breakthrough devices, and expanded EUDAMED information including recalls and complications. They demand patient involvement in governance through a permanent forum.1234
Why — This would give patients faster access to safety information and ensure their voices shape device regulation.56
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Meeting with Olivér Várhelyi (Commissioner) and

2 Oct 2025 · All pressing portfolio topics

Meeting with Stine Bosse (Member of the European Parliament)

15 Sept 2025 · General Pharmaceutical Legislation - patient representation

European Patients' Forum urges stable funding for health NGOs

5 Sept 2025
Topic — Creating a framework to protect and support civil society actors within the EU.
Message — EPF calls for institutionalized multiannual operating grants to ensure long-term sustainability. They demand meaningful involvement in policy cycles and protection from legal harassment.123
Why — Guaranteed funding and structured dialogue would ensure long-term stability and political influence.45
Impact — Industry representatives would lose their dominant influence over high-level EU policy meetings.67
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Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

1 Sept 2025 · Pharma Regulation

Meeting with Sandra Gallina (Director-General Health and Food Safety) and

16 Jul 2025 · Exchange of views on the state of play and next steps for the medical devices sector.

Response to Health technology assessment - Joint clinical assessments of medical devices and in vitro diagnostic medical devices

25 Jun 2025

The European Patients' Forum (EPF) welcomes the publication of the draft Implementing Act on Joint Clinical Assessments (JCA) of medical devices and in vitro diagnostic medical devices, which sets out the rules for patient involvement in the context of JCA and brings us a step closer to implementing the EU HTA Regulation. We are pleased to add as an attachment our answers to improve the current draft, including in terms of the incorporation of patient perspectives into JCAs, the role of patient organisations, how the summary reports should be published as well as our call for constructive approach to conflict of interest. EPF will continue to work with the European Commission and Member States to ensure that the implementing rules for the joint HTA lead to meaningful patient involvement.
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Meeting with Olivér Várhelyi (Commissioner) and

25 Jun 2025 · Ongoing policy developments

Meeting with Mohammed Chahim (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and

25 Jun 2025 · Roundtable Critical Medicines Act

European Patients' Forum Urges Patient-Centred Focus in Biotech Act

11 Jun 2025
Topic — New legislation to accelerate the transition of biotechnological products and applications to the market.
Message — The Forum demands a patient-centred framework prioritizing equal access and meaningful involvement in innovation. They advocate for rigorous safety safeguards and harmonized assessments to ensure timely treatment availability.12
Why — Patients would gain greater agency over their health data and more affordable, personalized treatments.3
Impact — Biotech companies could face higher costs from mandatory patient involvement and stricter safety monitoring.4
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Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

16 May 2025 · MDR/IVDR state of play and next steps.

Response to EU Strategy on medical countermeasures

9 May 2025

Please find attached the European Patients' Forum (EPF) contribution
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Meeting with András Tivadar Kulja (Member of the European Parliament)

30 Apr 2025 · Workforce shortage, patient participation

Meeting with Marco La Marca (Cabinet of Commissioner Dubravka Šuica) and NOVE and

29 Apr 2025 · Fertility

Response to Implementing regulation for electronic instructions for use for medical devices

20 Mar 2025

The European Patients Forum (EPF) generally supports allowing instructions for use in electronic format for medical devices intended for exclusive use by healthcare professionals in the legislation, however only in combination with the use of paper-based versions to ensure uninterrupted access to instructions by healthcare professionals (HCPs) and, ultimately, patient safety. While digitalisation can ease delivery of information, fully replacing paper instructions with electronic ones risks patients health and safety in case of electricity blackouts and other emergencies or where there is no reliable digital infrastructure. HCPs must be able to access instructions for use at any time and in any situation to ensure that they are able to use medical devices and their accessories safely and as intended on patients. Therefore, we recommend that electronic instructions can be introduced in the legislation as long as paper-based versions remain mandatory. When introducing electronic instructions for use, safeguards must be in place: 1) HCPs must receive instructions in a timely manner and have continuous, easy access at any time through manufacturers websites, any national platforms, or EUDAMED, enabling them to review instructions before they start using devices. Of note, cybersecure platforms for access to eIFUs as well as compliance with strict privacy requirements must be prioritised. 2) QR codes must lead directly to the specific instructions of the device at hand instead of general landing pages of websites to avoid confusion. 3) Both electronic and paper instructions for all devices must be kept up-to-date. 4) National information campaigns and dedicated trainings should target HPCs to ensure they are able to access and navigate electronic instructions, including retraining when significant changes to the systems occur. We also emphasise the importance of consulting with HCP organisations to ensure that these measures meet the needs of HCPs. Regarding (parts of) instructions intended to be provided to patients, EPF supports the Commissions proposal to maintain the obligation for mandatory paper-based access. However, the introduction of electronic instructions, as an additional and complementary format to paper versions, may also be considered. A recent EPF survey with patient communities on the implementation of the EU medical devices regulations has shown that many patients are open to receiving information about devices in digital format. However, lack of digital health literacy and limited internet coverage are key concerns and make continued access to paper-based versions essential to ensure equitable access for patients across the EU. We stress that this approach should apply to all medical devices, not only implantable ones. We also stress that no personal data should be collected from patients through QR codes, links, and the use of electronic instructions through, for instance, the Internet Protocol (IP) address, cookies, or other surveillance tools. When introducing electronic instructions for use for patients, national information campaigns and trainings should target patients to support them in accessing and navigating them, including information on EUDAMED. Electronic instructions should also be systematically available on EUDAMED to enhance transparency. It is essential that all patients can access clear, comprehensive, and transparent information about the medical devices they use. Further, recent trends show that patients have become increasingly informed and are taking active control of their devices, advocating for roles as co-creators of medical devices and related information. To make those (parts of) instructions for use that are intended to be provided to patients more patient-friendly, including adequate lay language and comprehensive content, patients or patient representatives need to be involved in the development of instructions for use before they are placed on the market.
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

20 Mar 2025

The European Patients Forum (EPF) welcomes a thorough review of the Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Commission to assess gaps and benefits of the legislation. As a first step, EPF believes increased coordination, guidance, and targeted support measures within the current framework can smoothen the implementation. Any potential legislative adjustments identified at the end of the review should be driven by public health needs, thorough impact assessments, and close consultation with those the system is supposed to benefit the most patients. Examining the MDR/IVDR implementation, EPF surveyed patient communities on their experiences and results are presented below. 1. PATIENT SAFETY RECOMMENDATIONS: 1) Strengthen oversight and responsiveness to patient safety issues, 2) Establish clear safety incident reporting pathways for patients. 28% of respondents in our survey reported device safety issues, including defective insulin pumps, malfunctioning software, and poor-quality prosthetics. 20% were unsure where to report concerns. As referenced in MDR preamble 78, establishing clear reporting pathways for patients with competent authorities and healthcare professionals is essential, supported by patient information campaigns. Further, the vigilance system must be reinforced, with clear and swift processes for handling safety events and corrective actions. Improved coordination among competent authorities is vital to exchange information, reach all affected patients in case of safety issues, and harmonise evidence requirements for consistent safety standards across device types. 2. DEVICE AVAILABILITY RECOMMENDATIONS: 1) Systematically investigate the root causes of shortages of existing devices, 2) Identify effective support measures to address shortages of devices patients need, 3) Enhance communication of relevant stakeholders with patients in case of device shortages and recalls, 4) Improve equitable access to innovative devices that provide real added value to patients. 44% of respondents faced shortages or market withdrawals across a wide range of devices, some of which lasted months or years, causing patients physical and emotional hardship. We urge the Commission to identify shortage root causes linked to the MDR/IVDR, especially for orphan devices, versus other supply chain issues. Clear, proactive communication between regulators, healthcare providers, and patient communities is essential to mitigating negative impacts of supply chain disruptions on patients health and safety. 3. INFORMATION ACCESS RECOMMENDATIONS: 1) Fully operationalise and promote EUDAMED promptly, 2) Foster equity and inclusion of patients in decision-making processes, 3) Provide comprehensive, easy-to-understand information to patients. While many patients accept device information in digital format, paper-based information must remain for equitable access across the EU. Clear, comprehensive device information is essential, yet many patients do not feel well informed. Hence, a fully functional, user-friendly EUDAMED database is key to transparency and patients informed decision-making. Achieving this vision of EUDAMED requires stronger collaboration among stakeholders, including patient organisations and healthcare professionals. 4. PATIENT INVOLVEMENT RECOMMENDATIONS: 1) Include patient experience data in clinical investigations, 2) Include patients in the MDCG, 3) Include patients in the governance of the medical devices system and regulatory processes. There is a strong need to meaningfully include patients/patient organisations in the processes affecting them, including pre- and post-market research and surveillance, and participation in regulatory decision-making and engagement with authorities, at EU and national level. Creating a dedicated, permanent forum for patient-relevant issues is a crucial first step in enhancing patient involvement in regulatory governance.
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Meeting with Stine Bosse (Member of the European Parliament)

14 Mar 2025 · Setting up event on EU4Health and civil society

Meeting with Cynthia Ní Mhurchú (Member of the European Parliament)

6 Feb 2025 · Introduction meeting

Response to Health technology assessment – Joint scientific consultations on medical devices and in vitro diagnostic medical devic

26 Nov 2024

The European Patients Forum (EPF) welcomes the draft Implementing Act on Joint Scientific Consultations (JSCs) on medical devices and in vitro diagnostic medical devices as a critical step towards securing mandatory, meaningful patient participation in EU health technology assessments. We call for robust, transparent, legitimate and expert participation in joint scientific consultations (JSCs) to guide the development of technologies that truly meet patient needs. Patient involvement is essential at all stages of the technology lifecycle, from initial design to implementation and ongoing evaluation. Patients insights highlight the benefits they value most and the risks they are willing to accept. Their participation challenges assumptions, aligns HTA priorities with patient needs, and addresses critical areas like safety, data governance, and patient education, especially for technologies supporting self-management. Patient contributions promote meaningful innovation, improve transparency, and enhance legitimacy, resulting in better outcomes. In JSCs, patient involvement ensures technologies address specific needs, fostering their successful adoption. EPF stresses the importance of structured and effective measures for patient participation in JSCs for medical devices, building on its recommendations for medicinal products. These include: Guidelines co-drafted with patient organisations. Diverse patient representation and use of experiential data. Compensation for contributions. Onboarding support by the HTA Secretariat. Patient-friendly timelines and accessible documents. Support for digital participation and robust data protection. Please refer to our attached statement for a comprehensive overview of our considerations.
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Response to Health technology assessment – Joint scientific consultations on medicinal products for human use

29 Oct 2024

The European Patients Forum (EPF) welcomes the draft Implementing Act on Joint Scientific Consultations (JSCs) on medicines as a critical step towards securing mandatory, meaningful patient participation in EU health technology assessments. We advocate for robust, transparent and expert patient involvement in joint scientific consultations to help shape the development of medicines that truly meet patient needs. Key Recommendations: 1. Guidelines for patient participation: Expect timely guidelines for patient involvement in JSCs, developed with patient organisations. 2. Diversity of patient representation: Ensure a broad range of patient perspectives, including national and cross-border expertise. 3. Compensation for participation: Include provisions for fair remuneration of patients in all JSC stages. 4. Onboarding process for patients: Require a comprehensive induction for selected patients, with ongoing support from the HTA Secretariat. 5. Support for digital participation: Implement measures to assist patients with digital participation, including training and user-friendly materials. 6. Accessible and patient-friendly documents: Ensure all materials are clear and patient-friendly, with dedicated staff to support patient experts. 7. Protection of patient data: Maintain patient confidentiality during JSC meetings and inform them about data handling practices. 8. Role of patient organisations: Recognise the critical role of patient organisations in representing collective patient views. 9. Clarify selection criteria for JSCs and increase the capacity for JSCs post-2025. 10. Specify the obligations of Member States regarding the implementation of JSC report implementation. Please refer to our attached statement for a comprehensive overview of our considerations.
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Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament) and European Pain Federation EFIC

16 Oct 2024 · EU health policy

Meeting with Oihane Agirregoitia Martínez (Member of the European Parliament)

16 Oct 2024 · Política de saludo

Meeting with Pierre Jouvet (Member of the European Parliament) and France Assos Santé

15 Oct 2024 · Politiques de santé

Meeting with Stine Bosse (Member of the European Parliament, Committee chair)

4 Oct 2024 · European health policy

Meeting with Maria Noichl (Member of the European Parliament)

2 Oct 2024 · SRHR

Meeting with Stine Bosse (Member of the European Parliament, Committee chair) and Confederation of Danish Industry

26 Sept 2024 · European health policy

Meeting with András Tivadar Kulja (Member of the European Parliament)

20 Sept 2024 · European Patients Rights

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

11 Sept 2024 · Preparatory call High-Level Policy Event - EPF

Response to Health technology assessment – Cooperation with the European Medicines Agency

23 Jul 2024

The European Patients' Forum (EPF) welcomes the publication of the draft Implementing Act on Health Technology Assessment (HTA) cooperation with the European Medicines Agency (EMA). We strongly support close interaction between regulators and HTA bodies to enable faster patient access to medicines. Although the EMAs assessment is distinct from the HTA one carried out at EU level, the two processes are closely interlinked and affect the entire medicine lifecycle, including determining whether a medicine provides significant benefit. A key aspect of this interconnection is the involvement of patients. The EMA has a long history of patient engagement, supported by established frameworks such as the Public and Stakeholder Engagement Unit within the Stakeholder and Communications Division. The EMA's good practice on patient involvement should be an integral part of the HTA collaboration with the EMA to build the capacity of the HTA bodies to fully embed patient involvement in the joint work. Efforts should be made to align patient involvement practices, especially regarding the confidentiality of profiles and information. Confidentiality policies need to be clarified and communicated to patients, particularly when the same patient is involved in both the EMA and the JCA, to ensure compliance and prevent any discrepancies. The draft Implementing Act further allows for the same patient to participate in both the EMA and HTA processes. This dual involvement enhances the contribution of patients, as their participation in the EMA's Protocol Assistance and Scientific Advice meetings where they discuss comparators, treatment outcomes and trial design prepares them to contribute effectively to the scoping and Joint Clinical Assessments (JCAs). However, participating in both processes can be burdensome for patients, given the simultaneous demands of preparing for EMA and HTA procedures, such as overlapping meetings and extensive documentation to review. While patient experts will be remunerated at the EMA, no remuneration is planned for patients involved in HTA at EU level, which may exclude individuals from lower socio-economic backgrounds. Having the same patient involved in both assessments runs multiple risks: tokenism; always having the same people involved, and therefore reducing the representativeness of the community and the opportunity for robustness of input. The representativeness issue is even amplified in case only one patient is invited to contribute to the Joint Scientific Consultations (JSCs) or JCAs. To address these potential issues, we suggest diversifying the workforce and ensuring that different patients are involved in the EMA and JCA processes. Widening the pool of patients and diversifying their recruitment sources is essential to: 1) ensure comprehensive and diverse patient input into all assessments, and 2) reduce the risk of generating biases or potential conflicts of interest. Patient organisations are a key resource in widening the pool of patients and identifying the relevant profiles. They can raise awareness within their communities and support the development of the different profiles. With clear and balanced conflict of interest criteria, they can diversify their workforce capabilities to ensure that their communities can engage with regulators and HTA bodies. Through their networks and established governance and transparency mechanisms, patient organisations can also better identify appropriate profiles and coordinate the engagement, in particular providing support to identified patients who are not trained or have no previous experience of participating. Patient organisations should be aware of the planning and forecasting of JCAs and JSCs as early as possible. This will allow them to plan ahead, identify appropriate experts and train them if necessary. Please refer to our attached statement for a comprehensive overview of our considerations.
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

26 Jun 2024

The European Patients' Forum (EPF) welcomes the publication of the draft Implementing Act for assessing and managing conflicts of interest (CoI). This crucial document will determine which patients and clinical experts participate in Health Technology Assessment (HTA) cooperation at the EU level. The experiences and perspectives of patients provide essential evidence and guidance for evaluating the clinical effectiveness and safety of health technologies, ensuring that HTA is conducted in the best interests of those directly impacted. When it comes to HTA, it is essential to maintain the high integrity of the assessment process to secure trust and acceptance from national HTA bodies and involved stakeholders. Integrity implies accountability of those taking part, and transparency and reliability of sources informing the decision-making process. In other words, it is in the interest of all parties to generate soundly based decisions. However, elevating the risk of CoI to an exclusion criterion for patient involvement in HTA risks producing the unwanted effect of missing valuable input generated through interactions with other stakeholders. EPF calls for a constructive approach to CoI, based on transparency, which limits competing interests to the extent that they do not hinder patient involvement in the joint work and access to the best available expertise. Patients should not be penalised for being transparent and compliant with the mandatory disclosure of interests. In particular, we have made four recommendations to ensure optimal patient involvement in EU HTA processes: 1. Establish a scoring system to assess risk of Conflict of Interest among experts 2. Allow the expert witness status for experts in HTA process 3. Develop guidelines to mitigate CoI among patients 4. Offer accessible and patient-friendly onboarding support for EU HTA processes It is important to recognise that patients are not involved in the HTA Coordination Group nor in the decision-making process of the EU joint work on HTA. Relevant subgroups of the HTA Coordination Group will decide whether to consider patient input. This mirrors the approach taken by the National Institute for Health and Care Excellence (NICE) which recognises and weighs the different interests of the patients involved, but - as they are not decision-makers - patients are not prevented from contributing their expertise to NICE's HTAs. We are concerned that some of the criteria defined in the Implementing Act could result in a situation where no patient would be able or willing to participate in the joint EU HTA work. This could significantly limit patient involvement and impair the European Commission and Member States to ensure the best available patient knowledge participation in the assessment. Please refer to our attached statement for a comprehensive overview of our considerations. We urge the European Commission and the HTA Coordination Group to consider these recommendations in order to ensure a balanced approach to the management of conflicts of interest, facilitating meaningful patient involvement while maintaining the transparency and integrity of HTA at EU level. EPF will continue to work with the European Commission and Member States to ensure that the implementing rules for the joint HTA lead to meaningful patient involvement.
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European Patients' Forum urges deeper patient involvement in health assessments

2 Apr 2024
Topic — The consultation establishes rules for joint clinical assessments of medicinal products in Europe.
Message — The group demands that patient input be included from the very beginning to avoid tokenistic involvement. They also call for financial support, translation services, and more time for representatives to review materials.123
Why — This ensures patient expertise is formally embedded and adequately funded throughout the assessment process.4
Impact — Resource-constrained Member States may struggle to meet the proposed high standards for involvement.5
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Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and GARDP Foundation

5 Mar 2024 · Revision of Pharmaceutical Package (staff level)

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

23 Feb 2024 · Directive on Medicinal products for human use

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur) and European Society of Cardiology

23 Feb 2024 · Pharmaceutical legislation

Response to Review of the Health Emergency Preparedness and Response Authority (HERA)

19 Feb 2024

Please find attached the European Patients' Forum (EPF) contribution
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Meeting with Adam Jarubas (Member of the European Parliament) and European Federation of Pharmaceutical Industries and Associations and

31 Jan 2024 · EU pharmaceutical roundtable - the EU institutions’ representatives and the stakeholder's dialogue

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

29 Jan 2024 · Directive on Medicinal products for human use

Response to Interim evaluation of the EU4Health Programme 2021-2027

9 Jan 2024

Please find attached the European Patients' Forum's (EPF) feedback
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

8 Jan 2024 · Directive on Medicinal products for human use

Meeting with Peter Liese (Member of the European Parliament)

15 Nov 2023 · Austausch

European Patients' Forum calls for patient-centred pharmaceutical regulation

6 Nov 2023
Topic — EU revision of pharmaceutical legislation governing medicine authorisation and access.
Message — The organization requests an EU-wide definition of added therapeutic value developed with patients, modulated incentives balancing R&D and access, and embedded patient participation throughout regulatory processes. They call for comprehensive unmet medical need criteria including quality of life impacts.1234
Why — This would ensure medicines development targets patient priorities and improve their access to treatments.567
Impact — Pharmaceutical companies lose extended market exclusivity periods that delay generic competition and maintain higher prices.89
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Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and

23 Oct 2023 · Pharmaceutical Package (Regulation)

Meeting with Tilly Metz (Member of the European Parliament) and European Public Health Alliance and

10 Oct 2023 · Pharma Package

Meeting with Catherine Amalric (Member of the European Parliament, Shadow rapporteur)

25 Sept 2023 · Reform of the EU pharmaceutical legislation

Meeting with Kateřina Konečná (Member of the European Parliament, Shadow rapporteur)

22 Sept 2023 · Pharmaceutical package legislation

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur) and EuropaBio

20 Sept 2023 · Pharmaceutical legislation

Meeting with Margrete Auken (Member of the European Parliament, Shadow rapporteur)

18 Sept 2023 · Pharma legislation

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur)

1 Sept 2023 · EHDS

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

31 Aug 2023 · Directive on Medicinal products for human use

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

19 Jul 2023 · Revision of the Pharmaceutical Legislation (staff level)

Meeting with Margaritis Schinas (Vice-President) and

6 Mar 2023 · Pharma Strategy

Meeting with Stella Kyriakides (Commissioner) and

6 Mar 2023 · Meeting to discuss the reform of EU pharmaceutical legislation

Meeting with Kateřina Konečná (Member of the European Parliament, Shadow rapporteur)

13 Jan 2023 · European Health Data Space

Meeting with Sara Cerdas (Member of the European Parliament, Shadow rapporteur) and GSK

5 Dec 2022 · Espaço Europeu de Dados de Saúde

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and Align Technology, Inc.

1 Dec 2022 · European Health Data Space - EHDS

Response to Proposal for a Directive on cross-border activities of associations

28 Oct 2022

The European Patients Forum (EPF) is an umbrella organisation of patient organisations across Europe and across disease-areas. Our 78 members include disease-specific patient groups active at EU level and national coalitions of patients. EPF welcomes this initiative and supports the creation of a new legal form for associations allowing for recognition in all Member States, to be developed in close consultation with a diverse community of NGOs across the EU to ensure benefits and avoid unforeseen negative impacts. EPF considers that the first challenge for associations operating cross-border within the EU is the increased formalities and administrative burden they face. As there is no automatic recognition between the Member States, bureaucratic procedures need to be repeated across each country in which the organisation aims to operate. These procedures, although often similar, are never the same. Moreover, currently, rules are further tailored at the regional and/or local level, thus adding one more layer of complexity. In addition, associations operating across borders within the EU face a language barrier. The administrative procedures and requisites to be met in each country need to happen in the local language (which in the case of some regions may not even be the national language of the country). Although this situation cannot be fixed with hard law, the mutual recognition of the "association" status between the Member States would alleviate this. Finally, some governments (either at the national, regional and or local level) may introduce measures that are unique and distinct from the place where the organisation has its seat. Meeting these criteria is an added layer of operational complexity for organisations in the field. A recent example is how COVID-19 measures were implemented.
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Meeting with Stella Kyriakides (Commissioner) and

21 Sept 2022 · Rare diseases

European Patients' Forum calls for patient control over health data

20 Jul 2022
Topic — EU regulation establishing framework for exchange and sharing of electronic health data.
Message — The organization requests that patients control their electronic health data through a standardized format, that safeguards limit data reuse to clearly defined public benefits, and that patient representatives have formal roles in governance bodies. They argue vague innovation purposes erode trust, especially when private companies are involved.123
Why — This would give patient organizations formal influence over data governance and scale up education programs.45
Impact — Private companies lose access to health data for broadly defined innovation purposes without clear public benefit.6
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Meeting with Ralf Kuhne (Cabinet of Commissioner Stella Kyriakides)

25 May 2022 · VTC meeting - European Health Data Space – EPF Congress 2022

Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides) and EUROPEAN ORGANISATION FOR RARE DISEASES and

25 Nov 2021 · Follow up to Cssr Kyriakides’ meeting with CSOs on 25/10/2021 on civil society funding through EU4Health

Meeting with Stella Kyriakides (Commissioner) and EUROPEAN ORGANISATION FOR RARE DISEASES and

25 Oct 2021 · VTC Meeting: EU4Health Work Programme 2022 and operating grants.

Response to Requirements for Artificial Intelligence

6 Aug 2021

EPF welcomes the EC’s endeavours to develop a European framework for artificial intelligence (AI) based on excellence, trust, human rights, and fundamental values. In healthcare, it is essential to adopt an approach aimed at ensuring the creation of an ethical, transparent, and trustworthy AI within an environment that fosters innovation bringing concrete added value to patients. EPF calls for particular attention on ensuring that AI in healthcare enhances society and is an enabler of – and not a threat to – patients’ rights and wellbeing, guaranteeing that the value of real human contact is not minimised or entirely replaced by technological alternatives. AI has the potential to transform care delivery methods and can provide great benefits at several levels of the healthcare value chain. However, there may also be unrealistic expectations. AI has risks, limitations and concerns including ethical, technical, and legal, which are often closely connected and should be considered when adopting a new framework on AI. There are risks of limiting human autonomy if AI were to make a calculation on risk or restrict a patient’s right to free, fully informed choice of treatment. Maintaining human oversight of AI-based decisions and the decisions flowing from them is thus particularly important in healthcare. AI must be seen as a support tool to improve care delivered by healthcare professionals (HCPs), not as a replacement. AI also depends on the availability of very large amounts of data. If the data are not enough, not good quality, this limits the potential of AI to be useful. Furthermore, biases in data also introduce issues in terms of the potential for AI-enabled decisions themselves to be biased or discriminatory. AI also has the potential to make wrong decisions, lead to overdiagnosis or overtreatment: reliability and safety are particularly critical in healthcare, where errors can have serious consequences. The EU framework on AI should take this into full consideration: it should clarify accountabilities and liabilities ensuring ample protection and safety. The exercise of rights should be made simple and not overly burdensome. In terms of risks related to AI, EPF calls for particular attention on the definition of high-risk AI in healthcare and a dedicated discussion on this topic inclusive of the views of patients. Furthermore, lack of skills and digital health literacy, for both patients and HCPs can also limit the potential of AI in health and create potential dangers. Empowering people by enhancing skills and literacy is a precondition to make the most out of AI-based innovation. Furthermore, patients must be fully informed about the functionality, consequences, and possible consequences of AI incorporation in their healthcare pathways. The points mentioned above should also apply beyond clinical practice, when AI is used to inform broader delivery of services, public health interventions, and policy making in the field of healthcare. Considering this context and given the ongoing development of the EHDS, which is also covering AI in healthcare, it will be essential to ensure effective alignment and synergies between both these new frameworks and existing Regulations, to avoid unnecessary confusion, complexity and duplication that could potentially impede rather than facilitate progress and positive application of AI for the benefits for patients. Finally, the EU framework on AI should be ‘future-proof’ and able to adapt rapidly in response to technological evolution. EPF’s views on AI, detailing the points shared above, can be found in our AI White Paper response (https://www.eu-patient.eu/globalassets/documents/1.-ai-white-paper_consultation-response_epf_statement-final.pdf) and in our response to the 2021 EHDS Consultation, where we specifically addressed AI (https://www.eu-patient.eu/globalassets/0.-ehds_epf-accompanying-paper---final_06-aug.pdf).
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Meeting with Stella Kyriakides (Commissioner) and EUROPEAN ORGANISATION FOR RARE DISEASES and

30 Jul 2021 · Meeting with civil society representatives regarding the EU4health programme.

Meeting with Margaritis Schinas (Vice-President) and

16 Jun 2021 · Supply chains for medicines

European Patients' Forum seeks patient-led reform of drug laws

27 Apr 2021
Topic — The European Commission is revising pharmaceutical laws to improve medicine accessibility and affordability.
Message — The group advocates for mandatory patient involvement in drug development and clearer definitions for medical needs. They call for medicine incentives to be tied to affordability and availability across Europe.123
Why — Patients would secure more influence over drug approvals and access to cheaper treatments.4
Impact — Pharmaceutical companies could face reduced profits due to mandatory price and research transparency.5
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Meeting with Margaritis Schinas (Vice-President) and

8 Apr 2021 · Health Union

Meeting with Thierry Breton (Commissioner) and

16 Feb 2021 · Pact for Skills roundtable with the representatives of the health sector

Meeting with Nicolas Schmit (Commissioner) and

16 Feb 2021 · Pact for Skills roundtable with the representatives of the health sector.

Response to Evaluation of patient rights in cross-border healthcare

11 Feb 2021

The European Patients’ Forum (EPF) has engaged extensively with Directive 2011/24/EU and welcomes the opportunity to comment. EPF has undertaken extensive measures to raise awareness amongst patient communities across the EU, through information materials for patient organisations and a series of regional and national meetings. We have also published several position statements and recommendations to policymakers and National Contact Points. Our work has identified the following priorities: > Patients’ rights Patients have a right to timely and affordable, high-quality care, information, and empowerment. The original purpose of the directive was to clarify patients’ legal rights. For a right to be meaningful, people need to know they have it, and be able to exercise it in practice. An EU study in 2016 found that frameworks vary across the EU and there are weaknesses in the enforcement of rights. In addition, other factors such as health literacy can affect people’s capacity to exercise their rights. EPF recommends that a framework for monitoring the realisation of patients’ rights should be established at European level, including a clear mechanism to address complaints when patients feel their rights have been violated. > Information for patients Information for patients should be re-evaluated. Particularly, clear information about patients’ entitlements, even within the domestic healthcare system, was a gap identified by our members. EPF compiled a summary of information that patients would need at different stages of the decision-making and healthcare journey, which could be taken as a reference. When it comes to receiving treatment abroad, financial implications of the choices available are quite important to know in advance. > Equity of access All patients should have the right to timely, safe, high-quality healthcare based on need rather than means, regardless of where they live, in accordance with the fundamental EU values of solidarity, equity and universality. Timely treatment reduces the burden on patients and families and can help lower long-term health costs. While the Directive has led to progress in important areas such as eHealth, HTA and ERNs, it has yet to fulfil the main expectation of patients – namely to ensure access to treatment abroad when necessary. There remain unacceptable inequities between patients from poorer and wealthier countries. In EPF’s view, the goal should not be to enable health tourism for wealthy consumers, but to redress fundamental health inequalities. Key issues that present barriers to patients are the requirement for upfront payments and the low level of reimbursements. Member States could thus make more effective use of the Regulation when it is more beneficial for a patient. In addition, direct payments should be implemented to avoid burdening already vulnerable families further. > Patients’ involvement in assessing the Directive EPF calls for the involvement of patient organisations in assessing the Directive. The Commission should engage with patient organisations from several disease-areas, including rare diseases, cancer, but also others where access barriers exist, and patients would benefit from being able to have cross-border treatment. For EPF’s full recommendations please refer to our position statement, attached and available here (https://www.eu-patient.eu/globalassets/policy/cross-borderhealthcare/epf_position_statement_cbhc_220416.pdf), or visit our website at https://www.eu-patient.eu/policy/Policy/Patients-Mobility/.
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Response to Legislative framework for the governance of common European data spaces

2 Feb 2021

Given the upcoming proposal for a European Health Data Space (EHDS), EPF welcomes the request for a regulation on European data governance (Data Governance Act), which will serve as a horizontal framework for data governance across the different sectoral data spaces. A solid governance framework, built on trust, data protection, ethical standards, transparency, and clear definitions will be fundamental to ensure the safe and efficient establishment of the health data space while increasing citizens’ and patients’ trust in data sharing. Focusing on the contents of the Data Governance Act, EPF would like to address a set of elements included in the current version of the proposal that we believe require further attention, especially considering their potential impact on the field of health data. While we are aware that several of these aspects will be tackled and better defined within the framework of the health data spaces, it is important to highlight them now in the context of the Data Governance Act proposal discussion. Within the context of this feedback response, EPF calls for particular attention on: 1. Clear definition and concepts to improve understanding and trust in data sharing 2. Increasing trust through labelling, clarity, and transparency 3. The European data altruism consent form 4. Re-Use and data sharing to third countries 5. An inclusive European Data Innovation Board Our full response is available in the attached document and online here: https://www.eu-patient.eu/globalassets/epf-consultation-response---data-governance-act.pdf EPF look forward to participating in the upcoming consultation efforts on the European Health Data Space to provide further inputs and help shaping a patient-centred EHDS.
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European Patients' Forum calls for patient-centred Health Data Space

2 Feb 2021
Topic — EU regulation on health data exchange, research use, and digital health services.
Message — The organization requests improved data access and control for patients, a clear framework for data use and re-use, better investments in infrastructure, and meaningful patient involvement in governance. They emphasize patients should have barrier-free access to their health records and control over how data is used.123
Why — This would give patients greater control over their health information and stronger participation in healthcare decisions.45
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Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

The European Patients’ Forum welcomes the opportunity to comment on the proposal. Our response focuses on two main aspects. > Tackling infectious and chronic diseases at European level EPF supports the extension of the ECDC’s mandate to improve preparedness, surveillance, risk assessment, early warning and response to future cross-border health threats, as well as smooth cooperation between ECDC and other agencies, bearing in mind the likely future creation of centres of excellence and EU disease-specific platforms for exchange and benchmarking of best practices foreseen by the EU4Health programme. We also welcome the proposals to give the ECDC more autonomy to formulate recommendations and actions. However, in recognition of the important and growing health impact of chronic diseases, EPF recommends that the mandate of the ECDC is further extended to encompass chronic diseases. Timely availability of cross-EU incidence and prevalence data, diagnoses and health outcomes is vital to inform appropriate policy at EU and member state levels. The 2019 evaluation of the ECDC identified the need to strengthen EU collaboration on infectious diseases and suggested the ECDC could respond to the need for comprehensive, evidence-based coverage of population health and burden of disease by providing information on differences between Member States and related policy needs to improve health, quality of life and well-being. Without EU-level comparable data, the vision of the European Health Union cannot be effectively implemented. There are already several synergies. Activities that already come into the remit of the ECDC – health education, health literacy, behaviour change – are highly relevant to the prevention of infectious and chronic diseases and health promotion. These activities could be enlarged to address disease prevention, guidelines, recommendations, and programmes addressing health determinants. The ECDC should be also resourced to monitor health systems’ capacity with regard to chronic diseases. It has become clear during the COVID-19 pandemic that when a system’s capacity is overwhelmed by a communicable disease, it creates a far-reaching detrimental impact on other diseases and can severely harm patients. > Engagement with stakeholders and the public One of the roles of the ECDC is to communicate with the public on communicable diseases, health threats, prevention and control measures among other things. The communication and information capabilities of public institutions are of a growing importance in a society characterised by the instant availability of overwhelming amounts of online information on one hand, and the segmentation of people into like-minded “bubbles” on the other. This includes unreliable information, misinformation and deliberate disinformation campaigns. The need for readily accessible, evidence-based, trustworthy information based on science and tailored to the needs of lay people is greater than ever, as has been witnessed during the COVID-19 pandemic. The EMA has had active engagement with patients and consumers since its creation in 1995 – now with a working party for patients and consumers and for healthcare professionals. The ECDC does not have a similar mechanism. The EMA’s experience of early engagement with such stakeholders has been proven to add significant value to its activities, support transparency and improve regulatory processes. Patient and consumer organisations also help to shape information, communication and public messaging to ensure it is optimal, function as effective interlocutors on patient concerns, and as dissemination hubs to their communities. We believe the addition of a permanent, sustainable stakeholder engagement platform similar to that of the EMA, and other agencies like EFSA and ECHA, would enhance the ECDC’s public engagement, add to its credibility and help raise public awareness of ECDC as an expert body and a reference point for trustworthy information.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

EPF welcomes the proposal to extend the EMA’s mandate and resources. The EMA plays an important role in protecting public health in the EU. We believe it does not go far enough and can be improved. > Addressing medicines shortages Shortages are a systemic problem that predates COVID-19, though it was brought into relief by the pandemic. Tackling shortages is a key priority of the European Commission and its pharmaceutical strategy. The proposal focuses on increasing EMA’s capacity to manage and mitigate shortages of medicines, and certain medical devices, in crisis situations. We welcome these measures. However, it misses an opportunity to put a comprehensive system in place for monitoring, mitigating and preventing shortages on a continual basis. This backbone would provide a basis to implement crisis measures more easily. EPF therefore calls for an increase in the mandate and resourcing of EMA to ensure its capacity to undertake shortages activities even outside crisis situations. Shortages are a critical public health problem that can seriously harm patients’ health and safety, quality of care, professionals’ ability to deliver care, and health system functioning. Monitoring of shortages of all kinds of products should be ongoing, including medicines with important off-label uses. Lists of potentially critical products should be defined in advance, even if specific products may need to be added to these lists in an actual crisis. In line with the recommendations of ESMO, which EPF supports, we call for the development of catalogues of shortages based on a common EU definition and the enablement of a common minimum data set of requirements. In line with the common position of EMA working parties of patients, consumers and healthcare professionals (PCWP and HCPWP), national systems for reporting should be harmonised and linked to a user-friendly database hosted by EMA, accessible to all stakeholders. The EMA should therefore be given a stronger coordinating role at EU level and resources to implement necessary activities, e.g. the recommendations emerging from the EMA/HMA Task Force on Availability of Authorised Medicines such as the EU-SPOC network after its pilot phase. > Support for patient and civil society engagement Understanding patients’ experiences of shortages and their impact is key. Patient organisations’ involvement in communicating updated information on shortages, not only from regulators to the patient communities but also from the patient communities to the regulators, can add significant value; appropriate channels and mechanisms should be set up in EMA for such exchange of information. The expansion of EMA’s mandate will increase the range of issues where it needs to engage with patients and the public. Patients’ representatives are already members of most EMA working parties and groups; they should logically be allocated a dedicated seat on any future EMA working group or expert group. Moreover, EMA should be given sufficient additional resources dedicated to further enhancing and constructing its civil society engagement mechanisms. Building public trust and ensuring stakeholder support for the EU’s regulatory system is more important than ever in the wake of COVID-19. EMA already recognises the added value of patient involvement in regulation, based on over 10 years’ experience; this includes but goes far beyond provision of information. However, organisations that regularly participate in EMA’s activities currently receive no compensation for their efforts. Patient representatives are in a particularly important yet vulnerable position: they are often volunteers and spend considerable time contributing to EMA. By actively participating in such platforms as the PCWP, patient organisations perform a vital public health function. Their contribution should reasonably be compensated from the EU budget, based on best practices of those national regulators that already compensate patient representatives.
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European Patients' Forum Demands Affordable Medicines and Patient Involvement

7 Jul 2020
Topic — EU consultation on ensuring safe, affordable medicines and supporting pharmaceutical innovation.
Message — The group demands that patients are involved in defining medical needs and assessing value. They want increased transparency in drug pricing and stronger EU cooperation on joint procurement.12
Why — Systematic involvement would ensure that medical research produces treatments that address patients' actual priorities.3
Impact — Pharmaceutical companies would face lower profits if the EU mandates transparency and joint price negotiations.4
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Meeting with Stella Kyriakides (Commissioner)

26 Jun 2020 · VC meeting: Exchange of views on the forthcoming Pharmaceutical Strategy

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

29 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner)

7 May 2020 · VC meeting on EU's Cancer Plan and challenges of patients with chronic diseases during COVID-19

Meeting with Stella Kyriakides (Commissioner) and

7 Jan 2020 · Discussion on cancer

Meeting with Vytenis Andriukaitis (Commissioner) and

13 Nov 2019 · Patient involvement as a path towards more effective health systems

Meeting with Anne Bucher (Director-General Health and Food Safety)

12 Nov 2019 · participation in high level forum

Meeting with Anne Bucher (Director-General Health and Food Safety)

11 Nov 2019 · To give a speech at the give to contribute to the opening Plenary Session of EPF Congress “Advancing Meaningful Patient Involvement – A path to effective health systems”.

Meeting with Vytenis Andriukaitis (Commissioner) and

9 Oct 2019 · Discussion on the future of the EPF cooperation with the Commission

Response to European Partnership for innovative health

27 Aug 2019

The European Patients’ Forum (EPF) welcomes the European Commission’s roadmap on proposal for a Council Regulation for a European Partnership on Innovative Health under Horizon Europe. EPF fully agrees with the key drivers behind the initiative (outlined in the section “problem the initiative aims to tackle”), but calls for Research & Innovation (R&I) funding to be streamlined with upscaling and implementation funding to ensure that findings of successful projects are translated into good practices. In Section B (“objectives and mapping of policy options”) it should be ensured that patient-defined priorities are taken into account under point (a). Furthermore, in points (b) and (c) when using data for better research, it is essential that patients’ rights are complied with and that patients have the possibility to control their data when it comes to (re-)use. In this context, all relevant legislations, including the GDPR, should be followed. Lastly, point (d) needs to consider patient-defined models and methodologies for assessment. It is important those patient-centred principles are an integral part of both the proposed Regulation as well as the implementing proposal calls. When it comes to the choice between calls for proposals or partnerships, EPF is supportive of the latter, as it creates better opportunities for long-term collaboration and allows to develop good working methods with the involved stakeholders. Next to the relevant work on the topic that can be found on our website: www.eu-patient.eu, EPF will shortly publish the results of a survey of patients’ perceptions on the use of data from their electronic health records. About EPF: The European Patient’s Forum (EPF) is an umbrella organisation working with patients’ groups in public health and health advocacy across Europe. Our members represent specific chronic disease groups at EU level or are national coalitions of patients. Our vision is that all patients with chronic conditions in Europe have access to high-quality, patient-centred health and related care. Our mission is to be the collective influential patient voice in European health and related policies and a driving force to advance patient empowerment and equitable patient access to care in Europe.
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Meeting with Anne Bucher (Director-General Health and Food Safety)

28 Mar 2019 · discussion on EMA’s strong commitment to patient engagement

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

23 May 2018 · Discussion about collaboration with Sante

Meeting with Vytenis Andriukaitis (Commissioner) and

15 May 2018 · HTA

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

17 Jan 2018 · Discussion on the future cooperation with DG SANTE

Meeting with Vytenis Andriukaitis (Commissioner) and

12 May 2017 · Sustainable Development Goals, EPF ‘s campaign on this issue and the Social Pillar

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

27 Sept 2016 · To discuss different issues: public health programme, chronic diseases

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis) and European Critical Care Foundation

25 Apr 2016 · Cooperation in the area of acute care

Meeting with Vytenis Andriukaitis (Commissioner) and

28 Jan 2015 · Health system performance assesment