OpenLobby.EU
Explore

European Social Insurance Platform AISBL

ESIP

European Social Insurance Platform represents national statutory social insurance organisations on EU social policy, pension and health issues.

Lobbying Activity

ESIP urges safety safeguards in medical device rule revision

6 Oct 2025
Topic — The consultation seeks to simplify EU rules for medical devices and in vitro diagnostics.
Message — ESIP supports reducing administrative burdens but insists that patient safety and clinical data quality must remain a priority. They call for a dedicated legal framework for orphan and breakthrough devices to improve market access. Revisions should focus on eliminating redundant documentation through digitalization.123
Why — High-quality clinical data enables more precise reimbursement decisions for social insurers.45
Impact — Manufacturers would face increased burdens from mandatory registries and post-market data collection.67
Read full response

Meeting with Olivér Várhelyi (Commissioner) and

2 Oct 2025 · All pressing portfolio topics

Social insurers urge prevention over drugs in EU health plan

15 Sept 2025
Topic — The initiative creates a framework to reduce cardiovascular diseases through prevention and innovation.
Message — ESIP requests that the Plan prioritises prevention and healthy lifestyles over the medicalisation of cardiovascular health through pharmaceutical interventions. They advocate for evidence-based screening for high-risk groups rather than population-wide programs that lead to over-diagnosis. Additionally, they call for support for rehabilitation services to help patients return to work.123
Why — This would reduce the financial pressure on social security systems by avoiding high-cost treatments.4
Impact — The pharmaceutical industry faces reduced revenue if the EU limits high-cost medical interventions.5
Read full response

Response to Critical Medicines Act

3 Jul 2025

The European Social Insurance Platform (ESIP) shares the growing concern over shortages of critical medicines across the EU and welcomes the objective of the proposal for a Critical Medicines Act to address vulnerabilities in the pharmaceutical supply chain. Any intervention to strengthen supply chain resilience must be evidence-based and accompanied by appropriate incentives and conditionalities. In this context, ESIP calls for: (1) A thorough, evidence-based evaluation of current market dynamics, potential supply chain vulnerabilities and their root causes. This should inform the development of a European list of critical vulnerable medicines, identifying products based on both their public health importance and risk of supply disruption. This list should guide the allocation of financial incentives under the Critical Medicines Act. (2) A timely evaluation of the proposals economic effects, particularly regarding the cost implications of the proposed criteria for procurement. (3) Industrial policy measures that demonstrably contribute to higher supply security and the reduction of medicine shortages. Incentives should be granted based on the ability to maintain adequate stock levels and/or ensure flexible and efficient production to meet the European market needs. Penalties for non-compliance with these conditions should also be established. (4) Predictable and appropriate national and EU-level budgets to support industrial policy measures aimed at building, expanding, or modernising the production capacity for critical medicines while ensuring that financial support is provided without further straining the budgets of health insurance funds. (5) Transparency regarding financial and other incentives provided to strategic projects, in order to support well-informed procurement, pricing negotiations and reimbursement decisions by statutory health systems. (6) Guidelines, rather than binding criteria, for public procurement that prioritise security of supply and the resilience of EU-based manufacturing. We underline the importance of maintaining the use of the Most Economically Advantageous Tender (MEAT) criteria as a voluntary tool, as it is currently applied by national contracting authorities in accordance with their specific needs and procurement strategies. Making the inclusion of additional award criteria mandatory would not only lead to unpredictable and potentially substantial cost increases, but would also place a significant administrative and procedural burden on statutory health insurance funds and public procurement bodies. This added complexity risks undermining the efficiency and flexibility of procurement processes and countering the overarching goals of the proposed Regulation, particularly the aim, clearly stated in Article 1, to ensure the affordability, accessibility, and availability of medicines for patients across the Union. (7) Continuous EU-wide monitoring of supply and shortages, in coordination with other legislative files addressing medicine shortages. (8) A European contingency stock mechanism for critical medicines and/or active pharmaceutical ingredients (APIs), complementing but not replacing national stockpiling obligations. (9) Fair and balanced representation in the Critical Medicines Coordination Group, including participation from national authorities responsible for procurement, pricing and reimbursement of both critical and other medicines of common interest. Find more information in the position paper enclosed.
Read full response

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and Sandoz International GmbH

3 Jul 2025 · Health policy

Response to Establishment of an expert panel on orphan and paediatric devices

16 Jun 2025

The European Social Insurance Platform (ESIP), representing social security institutions and healthcare payers across the EU, agrees with the European Commissions proposal to establish an expert panel for small patient populations, such as those with rare diseases or children. ESIP also welcomes the clarification that the European Medicines Agency will provide the Secretariat for all expert panels. Current experiences of manufacturers and Notified Bodies in implementing Regulations (EU) 2017/745 and (EU) 2017/746 suggest that setting up a specialised expert group might simplify certification matters. Beyond that, it might facilitate establishing processes as those suggested by the Medical Device Coordination Group Document 2024-10 on the clinical evaluation of orphan medical devices. Recently, ESIP has proposed a dedicated regulatory framework for orphan medical devices. The position paper is attached and can be accessed following this link: https://esip.eu/publications/health_positions/ESIP-Position_Orphan-Medical-Devices.pdf. One of ESIPs key demands is the establishment of a central authority for orphan medical devices. Implementing an expert panel on paediatric and rare diseases will be a necessary first step towards achieving this goal.
Read full response

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur) and Bureau Européen des Unions de Consommateurs and

13 Jun 2025 · Critical Medicines Act

ESIP urges Biotech Act to prioritize healthcare sustainability

11 Jun 2025
Topic — The Biotech Act aims to accelerate the transition of biotech products to market.
Message — Public investment in research must lead to public benefit and fair product prices. The organization demands that new regulatory pathways do not dilute evidence or safety standards. They also call for early dialogues with payers to align innovation with societal needs.123
Why — This approach would protect the financial viability and long-term sustainability of health systems.4
Impact — Large multinational corporations could lose out if incentives are restricted to smaller firms.5
Read full response

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

6 May 2025 · Demographic Policy

Social insurers urge health focus for life sciences strategy

17 Apr 2025
Topic — This consultation concerns a new strategy to boost competitiveness and innovation in the European life sciences sector.
Message — The strategy should prioritize patient needs and healthcare sustainability over market dynamics. ESIP demands the maintenance of rigorous regulatory standards and insists that industry incentives be tied to affordability conditions.12
Why — These measures would protect the financial stability of national health insurance systems and prevent rising costs for taxpayers.3
Impact — Pharmaceutical companies may face stricter conditions on incentives and more demanding regulatory hurdles for fast-tracking products.4
Read full response

Meeting with Rainer Becker (Director Health and Food Safety)

5 Mar 2025 · Critical Medicines Act

Meeting with Tiemo Wölken (Member of the European Parliament)

5 Mar 2025 · General Exchange on MDR, Pharma and CMA

ESIP urges financial transparency in Critical Medicines Act

26 Feb 2025
Topic — An initiative to address supply chain vulnerabilities and dependencies for critical medicines.
Message — The organization calls for strict conditions on public funding, requiring manufacturers to maintain stocks and prioritize European supply. They demand a full impact assessment to ensure new measures do not increase medicine prices. Furthermore, they advocate for public transparency regarding research and production incentives to aid price negotiations.123
Why — This would help social insurers maintain affordable patient access and healthcare system sustainability.4
Impact — Pharmaceutical manufacturers would face new reporting burdens and financial penalties for supply failures.5
Read full response

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

29 Jan 2025 · EU Policy

Meeting with Francesco Corti (Cabinet of Executive Vice-President Roxana Mînzatu)

8 Jan 2025 · Introduction beginning of the mandate

Meeting with Ana Carla Pereira (Cabinet of Commissioner Nicolas Schmit)

4 Jul 2024 · Future priorities for social protection

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

Social insurers demand tougher drug trials and lower prices

8 Nov 2023
Topic — This consultation evaluates and revises the European Union general pharmaceutical legislation.
Message — The group requests stronger clinical evidence at approval and shorter data protection to boost competition. They also reject using vouchers to incentivize new antibiotics for resistance.12
Why — Earlier competition from generics would lower costs and improve healthcare system sustainability.34
Impact — Pharmaceutical companies would see reduced revenues from shorter market exclusivity and stricter regulations.56
Read full response

Meeting with Catherine Amalric (Member of the European Parliament, Shadow rapporteur) and Médecins Sans Frontières International

9 Oct 2023 · Reform of the EU pharmaceutical legislation

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and RPP Group and Edwards Lifesciences

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

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and Novartis International AG

5 Jun 2023 · Revision of Pharmaceutical Legislation (staff level)

Meeting with Ana Carla Pereira (Cabinet of Commissioner Nicolas Schmit)

19 Apr 2023 · the initiatives of the Commission in 2023

Meeting with Peter Van Kemseke (Cabinet of President Ursula von der Leyen)

13 Apr 2023 · Pharma Package

Meeting with Alexandra Geese (Member of the European Parliament, Shadow rapporteur)

26 Jan 2023 · European Health Data Space

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

26 Jan 2023 · European Health Data Space

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and Merck Sharp Dohme Europe Belgium SRL and European Health Management Association asbl

25 Jan 2023 · European Health Data Space - EHDS

Response to Extension of the transition period for medical devices

18 Jan 2023

In May 2017, the MDR entered into force with the goal to increase the safety of medical devices, raise the requirements for the clinical evaluation of high-risk devices, harmonise assessment by Notified Bodies throughout Europe and increase transparency via a central database on medical devices available on the EU market (EUDAMED). ESIP supports the MDR as an important step towards improving patient safety and the quality of treatment using medical devices. In light of the recent European Commissions proposal amending the MDR and extending the transition period, we acknowledge hurdles concerning the limited capacity of Notified Bodies (NB) and difficulties in accessing those, in conjunction with stricter requirements and timelines. We understand concerns about possible supply disruptions from market withdrawals, leading to shortages and reduced competition. In this context we present our recommendations to ensure availability of medical devices, while preserving the highest safety and quality standards, for the benefit of patients: (1) Further support non-legislative solutions to strengthen the capacity of NB, building on the recommendations of the Medical Devices Coordination Group; (2) Avoid blanket extensions of the transition period and prefer targeted derogations under well-defined conditions e.g. that an application for an MDR conformity assessment is submitted before 26 May 2024, and provided that the respective MD does not present unacceptable health risks; (3) Adopt transparent and harmonised EU measures to address and prevent withdrawals of MD, especially for very rare conditions, avoiding market fragmentation through separate marketing authorisations at national level; (4) Increase overall transparency, about devices at serious risk of withdrawals, reasons for withdrawals, as well as products authorised on the national level. Find more in the attached ESIP statement on the implementation of Regulation (EU) 2017/745 on medical devices.
Read full response

Social insurance bodies urge tighter controls on health data access

28 Jul 2022
Topic — This consultation concerns the creation of a European framework for sharing health data across borders.
Message — ESIP requests that social security institutions be recognized as key data holders. Stricter criteria should be imposed for commercial access to health data. They argue for return on investment provisions and excluding wellness apps.123
Why — These measures safeguard the financial stability and operational control of public social security systems.45
Impact — Commercial firms and wellness app developers face tougher restrictions and potential exclusion from the infrastructure.67
Read full response

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides) and Deutsche Sozialversicherung Europavertretung

19 Jul 2022 · Meeting to discuss pharmaceutical reform.

Response to Unitary Supplementary Protection Certificates (SPC) – creation and granting procedure

5 Apr 2022

The European Social Insurance Platform (ESIP), representing statutory social health insurances in the EU and Switzerland, welcomes the intention to revise and rebalance incentives in the pharmaceutical sector, including supplementary protection certificates (SPCs). Any regulatory revision should aim at promoting fair competition and access to affordable medicines. The existing framework for incentives, based on intellectual property (IP) rights, led to a concentration of investment in markets with higher return on investment and ever-increasing prices, often not justified by R&D costs or cost-effectiveness ratios. Furthermore, long periods of protection delay the entry to market of generics and biosimilars, creating hurdles for competition and pressure on healthcare systems’ financial sustainability. First and foremost, ESIP urges to consider the impact of (extended) IP rights on competition and access to medicines of added therapeutic benefit for patients. At the same time, we acknowledge the results of the recent evaluation of the SPCs legislation and issues of Single Market fragmentation resulting from the granting and enforcing of SPCs applications at national level. We support the introduction of unitary SPCs, complementing unitary patents, provided that this system replaces all other SPCs at national level and applies both to granting and withdrawal processes. Such a simplified EU patent system would help alleviate inconsistencies in terms of coverage and interpretation, increasing legal certainty and reducing the administrative burden for producers and competent authorities. Furthermore, the revision should be used to expand Bolar exemptions to allow for manufacturing and further preparatory steps. Additionally, it would be beneficial to establish a database on patent and SPCs expiries by (new) indication, made accessible to public health authorities, IP competent authorities as well as generics and biosimilars competitors. Consideration should be given to clarify, within the said database, whether the validity of existing patents has been challenged in Court. While the SPC is designed to be an incentive (amongst others) for innovative medicines, there seems to be no direct link to its supporting investment in neglected therapeutic fields nor in areas of proven added value for patients. Criteria for granting (unitary) SPCs should be defined; financial compensation for compulsory and lengthy procedures prior to obtaining marketing approval should not stand as an argument per se. When development costs are recuperated within the standard market protection period, further patent extensions should be excluded, as they would only increase profit on existing innovation. Importantly, the introduction of a unitary patent and SPC regime must not be coupled with extensions of IP protection rights beyond the current limits. This should be clearly embedded in the Regulation and apply not only to SPCs but also to data and market protection times as defined in the EU general pharmaceutical legislation. Instead, shorter protection periods and the earlier introduction of competition in the market would better encourage new investment in further innovation. Finally, ESIP strongly opposes the introduction of transferrable vouchers as an alternative to SPCs extension, unless they remain strictly limited to providing access to regulatory processes.
Read full response

Response to Proposal for a Council Recommendation on long-term care

29 Mar 2022

The European Social Insurance Platform (ESIP), which represents statutory social security institutions from 17 Member States and Switzerland, welcomes the European Commission’s initiative to introduce a European Care Strategy. Overall, ESIP shares the analysis of the challenges highlighted by the Commission, especially as regards the need to ensure the availability and affordability of care while preserving the financial sustainability of social protection systems. We welcome the emphasis on how EU funds and other instruments can support Member States’ action as well as the development of innovative best practices by social security institutions. As regards digitalisation, ESIP members actively support and develop digital technologies for better access to healthcare and long-term care. Availability to and access of digital solutions, especially in rural areas, should be a key priority and combined with community-based services. At the same time, ESIP would like to emphasise the need to account for the digital divide and inequalities due to lower income, lower digital skills, lack of IT infrastructure or simple choice. In order to tackle increasing demand for long-term care brought by the ageing of the population, fostering health promotion, prevention and health literacy across the lifespan is key. The loss of autonomy is an increasingly prevalent risk which is considered within social protection systems, with some countries having a dedicated branch of social security. Social security institutions are also developing best practices to provide formal long-term care at home, to support informal carers, including through rehabilitation programmes, and provide online resources on facilities, costs and reimbursement. Informal carers are especially exposed to psychological and physical stress factors. Health prevention should be provided through targeted information, increased supporting services, and better communication channels with formal carers. The Commission’s action can further support the dissemination of these best practices and policies. ESIP also shares the Commission’s analysis of the need to shift towards further formal care provision, to alleviate the burden of care on informal carers, a vast majority of which are women. EU funding could help support Member States’ action, including investment in a qualified workforce. The Commission should also ensure synergies between the long-term care initiative and other relevant initiatives in the field of health such as the EU’s Beating Cancer plan. ESIP also welcomes the proposal for a Recommendation on the revision of the Barcelona targets on early childhood education and care (ECEC) and emphasise the need for higher EU ambitions in this regard. We would like to emphasise the crucial role of ECEC not only in ensuring the work-life balance and labour market participation of mothers, but also in providing many benefits for children. Access to affordable and high quality ECEC is essential to support the inclusion of all children into society, including the most vulnerable, and foster their future employability and autonomy. It thus helps break the intergenerational cycle of poverty. In addition, it generates additional social contributions and tax revenues from parents’ increased work activity. The Commission could also play a role in this context in supporting the collection of statistics on the effectiveness of investing in ECEC. When designing the Strategy, the impact of COVID-19, increasing the strain on social protection systems should be considered. Social protection systems have acted as economic stabilisers, helping to limit the impact of the crisis on employment, implementing measures such as exceptional sickness benefits as well as solidarity aids for the most deprived, including students and young people in precarious situations, financial support for ECEC services and additional parental leave to compensate the closure of childcare facilities.
Read full response

Meeting with Astrid Dentler (Cabinet of Vice-President Dubravka Šuica) and Deutsche Sozialversicherung Europavertretung

30 Sept 2021 · Green Paper on Ageing, European Care Strategy, long-term care.

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

ESIP, representing statutory social health insurers in the EU, UK and Switzerland, welcomes the Commission’s intention to revise the pharmaceutical legislation. Increasingly high prices of medicines, sometimes coupled with low levels of evidence at time of market authorisation, create pressure on healthcare budgets, consequently hindering access to innovative medicines for patients. The current legislative framework should be revised particularly in the following areas: It is essential to include a common definition of unmet medical needs (UMN) in the EU pharmaceutical legislation targeted to ‘high’ unmet medical/public health/societal needs. The definition must be consistently cross-referenced in the EU legislation. It should build on a common understanding of UMN and agreed quantifiable criteria. Quantification of UMN is possible in terms of burden of disease, the absence or existence of satisfactory treatment options and the possible benefit of a new technology over standard of care. ESIP acknowledges the intention to simplify the EU pharmaceutical legislation particularly to promote the swift market entry of generics and biosimilars. Reducing the regulatory burden on manufacturers needs to fully preserve regulatory standards. Fast-track procedures for new technologies must be limited to specific eligibility criteria and subject to the same high standards of quality, safety and efficacy. The existing framework of incentives, based on intellectual property rights, relies on the economic success of the medicinal product concerned. This leads to a concentration of investment in markets (at territorial and product level) with higher return on investment and to increased prices of patented products, often not justified by R&D costs or by international thresholds for cost-effectiveness ratios. ESIP supports options to link rewards to reinforced obligations to make products available in all EU countries within a restricted timeframe and to ensure transparency of R&D costs. These obligations should be combined and conditionality clauses introduced to ensure public return on public investment when public funds are used for R&D. A revision of the system of incentives – and eligibility criteria – should restore the balance between innovation, affordability and sustainability. Alternative incentives models should be further explored and promoted. Facilitated access to an effective repurposing framework would also encourage companies, in particular generic and biosimilar companies, to apply for the authorisation of new indications/therapies developed under off-label use by public institutions. This would benefit patients and enhance competition. However, care should be taken that indication slicing and possible “orphanisation” is avoided. In addition, to promote competition of generics and biosimilars, the Commission could also consider developing a database of patents and SPC expiries by (new) indication. The database should be accessible to public health authorities and generic and biosimilar manufacturers, promoting faster market entry of competitor products, thus increasing affordability. When adapting the legislation to innovative ways medicines are developed and evidence is generated, randomised controlled trials should remain the gold standard; real-world data should be used primarily as a source of complementary evidence. Evidence requirements for informed pricing & reimbursement decisions should be taken into account from the outset. Finally, to make the pharmaceutical supply chain more resilient, ESIP supports reinforced obligations regarding supply, transparency of stocks and early notification of shortages and withdrawals. Mandatory sanctions, including financial, should be introduced for producers (and wholesalers/suppliers) that fail to comply with their obligations under Articles 81 and 23a of Directive 2001/83/EC. ESIP’s members look forward to expanding on this feedback in the future consultations.
Read full response

Response to European Health Emergency Response Authority

24 Feb 2021

The European Social Insurance Platform (ESIP), representing statutory social security institutions in the EU, Switzerland and the UK, supports EU action to improve the European crisis preparedness and response mechanism to common cross-border health threats and particularly the system of medical countermeasures. As part of the European Health Union project, structural solutions in this field – including the creation of a new permanent Health Emergency Preparedness and Response Authority (HERA) – could complement and support Member States’ crisis preparedness and response plans, in compliance with the subsidiarity principle. A review of the existing EU legal framework and instruments for coordinated actions in times of cross-border health emergencies – including on medical countermeasures – should be integrated in any new policy approach. Advantages and disadvantages of centralising all the tasks included in the Inception Impact Assessment (IIA) into one single body should be assessed and discussed. The interplay between the new proposed authority and existing Agencies, especially in light of their reinforced role and competences, should be examined. Medical countermeasures: We acknowledge the proposal to set up a standalone authority responsible for strengthening EU preparedness and response in terms of medical countermeasures. The new HERA would prioritise medical countermeasures and facilitate their timely development, production, procurement as well as purchase based on a sound assessment and anticipation of threats. Capacity-building in this field should be adaptable to different risk scenarios and be accompanied by a thorough evaluation of effects on the public and private sectors, particularly when public funds are used for the development of medical countermeasures. In this regard we fully support the argument of public return on public investment as pricing and reimbursement decisions should reflect the use of public funds. Common initiatives in the field of medical countermeasures, such as the deployment of rescEU and of the joint procurement mechanism, should uphold the principle of EU solidarity and contribute to the correct functioning of the single market. We welcome a review of the legal basis and mechanism of joint procurement. The existing framework should be further developed and simplified to involve Member States in the decision-making process and maximise their options to participate. As part of the HERA’s remit we support the creation of a decentralised, digitally enabled, European stockpiling system to overcome mismatches in demand and supply and to complement - not replace - Member States’ national supplies. Besides stockpiling the IIA mentions coordinated manufacturing options. The setup of a mechanism for scalable and flexible manufacturing should be coupled with a preliminary EU-wide mapping of production capacities for medicines and medical devices capable of emergency activation. This would allow to scale up production when the health emergency occurs. Action Plan on antimicrobial resistance (AMR): We welcome the preparatory action to be launched in the area of AMR and we acknowledge that it would feed into the new HERA functions. The Commission highlights that the existing framework for incentives and business-model are ill-suited to innovations in the field of antimicrobials, as well as other crisis-relevant and technologically advanced products. In a recent position paper ESIP called for a legal framework for AMR and recommended new and alternative incentive mechanism, along with adequate surveillance, research & data collection on risks related to AMR, continued EU support to the development and use of rapid diagnostic tools, prudent prescription and dispensing, as well as the use of off-patent but still effective antibiotics. ESIP looks forward to expanding on this feedback in the future public consultations.
Read full response

Response to A European Health Data Space

3 Feb 2021

The European Social Insurance Platform (ESIP) welcomes the Commission’s intention to improve access to and exchange of health data, via the establishment of a European Health Data Space (EHDS). We support a reinforcement of the legislative and governance framework to ▪ Increase cooperation among Member States on the exchange of health data for primary use, also as a preventive measure for future cross-border health threats; ▪ Establish an institutionalised infrastructure for data governance and exchange for secondary use, for the common good and in full respect of GDPR. This would benefit access to healthcare especially but not exclusively in cross-border situations. We call for a EHDS that provides real added value for healthcare delivery, need-driven R&D and policymaking. To ensure that sensitive health data are exchanged and used in a responsible way the following preconditions must be met: ▪ Harmonised standards Harmonised standards for data formats – for exchange, quality & anonymisation – should be established to ensure comparability, compatibility and interoperability. The Recommendation on a European Electronic Health Record (EHR) exchange format is a first step in this direction. Security standards should be defined to process sensitive health data. Standardisation of access protocols should also be considered. ▪ Conditions for access and use Building on the eHealth Digital Service Infrastructure, an EU digital space for health data, accessible also to patients, would support the provision of cross-border healthcare and patients’ mobility. Access to the data space should be given upon identification and authentication by authorised actors and service providers, to ensure data safety & confidentiality. Regarding data used for R&D, the new legislative framework should determine which data will be available for secondary use, as well as clarify ownership, access, users’ rights and ensure a uniform interpretation of GDPR. ESIP believes that different technological solutions and separate governance frameworks are needed for primary and secondary use of health data. ▪ A code of conduct In the development and evaluation of digital technologies including AI, attention must be given to ethical issues. A code of conduct should be developed to ensure ethical use of data and promote common understanding of data protection. Access to and use of sensitive health data must comply with GDPR and the proposal for a EHDS should not neglect informed consent and the right to be forgotten. Harmonised legal measures preventing possible unwarranted, opportunistic and malicious use of health data need to be considered. ▪ Solidarity-by-design While seizing the opportunities of data science, consideration should be given to its downstream risks (e.g. algorithmic injustice, ethnic profiling & pervasive data tracking). Machine learning enables the assessment of (health) risks on a case-by-case basis thereby fundamentally changing the principle of solidarity in all domains of social security including healthcare coverage. The EHDS should build on the ethical principle of fairness-by-design, providing an ecosystem of measures that protect end-users, reflecting the central European value of solidarity. ▪ Involving public authorities in the design of EHDS Public authorities – importantly statutory health insurances – should not be considered only as data providers, but as key actors in the establishment of the EHDS, data standards and conditions for use of data. Health insurers could support the development of digital healthcare solutions to ensure real added value for patients and increased health systems’ sustainability. As part of the e-health stakeholders’ group, ESIP’s national experts provide essential insights into the design of appropriate and effective legal, governance and technical frameworks for data exchange. ESIP looks forward to expanding on this feedback in targeted & public consultations.
Read full response

Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

The European Social Insurance Platform (ESIP), representing statutory social security institutions in the EU, in Switzerland and the UK, welcomes the legislative proposals on strengthening crisis preparedness. While Member States are responsible for the definition of national health policies, we believe that situations of common public health concern require coordinated actions and cooperation. We support a European unified approach to tackle cross-border health threats that avoids fragmentation and respects national health competences. In this context an extension of the mandate of the European Medicines Agency (EMA) is timely and crucial. ▪ Monitoring and mitigating shortages of medicines and medical devices With a view to the monitoring and prevention of shortages, we welcome the establishment of the EMA Executive Steering Groups on medicinal products and medical devices, responsible for preparing lists of crisis-relevant products. Such lists should be limited in time and in terms of subject matter to specific incidents and should be established in liaison with the ECDC, responsible for the monitoring of epidemiological data. This would contribute to a timely response to health emergencies and limit the risk of shortages. We also recommend consulting the Medical Devices Steering Group in the same capacity as the Medicines Steering Group with regard to information and advice on the safety and quality of medical devices related to both public health crisis and major events. We support an approach that implies cooperation with national authorities, marketing authorisation holders, device manufacturers and notified bodies for monitoring supply and demand of essential products. We particularly welcome a reinforcement of the obligations on producers to report on issues that could result in supply bottlenecks. Sanctions could also be introduced in the case of non-compliance with such provisions. As national authorities would be requested to provide sensitive health-related information, this mechanism should build on a strong, safe and trustworthy data infrastructure. Participation in a coordinated electronic reporting system should be made mandatory to all relevant actors, to enhance transparency across the supply chain. The European Health Data Space should be swiftly established based on a robust legislative framework, to enable exchange, use and processing of data including in health crisis contexts, in full compliance with the GDPR. ▪ Increased coordination of clinical trials We acknowledge that the EMA would be mandated with the provision of scientific advice and support to clinical trial protocols, as well as with the rolling review of evidence in the context of public health emergencies, as part of the remit of the new Emergency Task Force. This would respond to the urgent need to bring crisis-relevant products on the market. While exceptional measures could be justified to develop and approve urgently needed medicinal products in crisis contexts, quality, safety and efficacy of treatments must remain the key priority. Particularly, the use of real-world data (RWD) should be limited to complementing data generated from randomised controlled trials when the effectiveness of medicinal products is questioned. Overall, a sound impact assessment of EU action during the current crisis is key to evaluating measures aimed at strengthening EU health competences in cross-border health emergencies. We also call for an assessment of the impact of the new legislative package on public health authorities and on health insurance systems. Finally, looking beyond pandemics, other long-term cross-border challenges – such as antimicrobial resistance, cancer and chronic diseases – are posing a threat to the resilience and sustainability of health systems across the EU. They also require a common approach, increased coordination and adequate support instruments, including financial support from relevant EU programmes.
Read full response

Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

The European Social Insurance Platform (ESIP), representing statutory social security institutions in the EU, Switzerland and the UK, welcomes the legislative proposals on strengthening crisis preparedness. While Member States (MS) are responsible for the definition of national health policies, we believe that situations of common public health concern require coordinated actions and cooperation. A reinforcement of the Union’s mechanisms for tackling and preventing cross-border health threats is timely and crucial. We support a European unified approach that avoids fragmentation and fully respects national health competences. ▪ Preparedness and response planning We support the enhanced coordination of national preparedness and response plans, building on the exchange of best practices between MS in the Health Security Committee (HSC). We welcome guidance on prevention and control of cross-border threats, provided that it remains sufficiently flexible and adaptable to national specificities and that MS’s responsibilities in public health are preserved. Furthermore, cooperation and coordination between the HSC and the Integrated Political Crisis Response Mechanism (IPCR) should be improved to avoid duplication of effort. To increase preparedness for cross-border health crises, the joint procurement mechanism should be further developed with the aim of preventing distortions in competition within the Internal Market and maximising the opportunities for MS to participate. Measures included in the proposal are a first step in this direction. ESIP also welcomes measures to improve the monitoring of existing stocks and possible shortages of critical medicinal products and medical devices, as detailed in the Regulation on a reinforced role for the EMA. By way of mandatory participation in a common reporting system, we call for an evidence-based evaluation of supply throughout Europe and within the MS to (digitally) enable a decentralised European stockpiling system, amongst other measures to mitigate shortages. ▪ A robust surveillance and monitoring system The new mechanism for crisis preparedness implies enhancing national surveillance systems. We welcome the use of digital tools to collect and process interoperable data. The swift establishment of the European Health Data Space could enable cross-border exchange of data to identify and monitor health hazards. While welcoming the use of new digital tools for risk assessment, we highlight that protecting data privacy and confidentiality remains key. In this view, particular attention should be given to the use of artificial intelligence for data validation. We also support the proposal to create an EU network of reference laboratories as part of the reinforced responsibilities of the ECDC. The network would offer voluntary guidance on diagnostics/test protocols, material resources, quality assessments, facilitating validation as well as mutual recognition of tests. This would alleviate pressure on healthcare systems and ensure the smooth functioning of the single market, particularly free movement of people across borders. Overall, a sound impact assessment of EU action during the current crisis is key to evaluating measures aimed at strengthening EU health competences in future cross-border health emergencies. We also call for an assessment of the impact of the new legislative package on public health authorities and on health insurance systems. Finally, looking beyond pandemics, other long-term challenges – such as antimicrobial resistance (AMR), cancer and chronic diseases – are posing a threat to the resilience and sustainability of health systems. They also require a common approach, increased coordination and adequate support instruments. Particularly, we welcome the fact that AMR is included in the list of threats of biological origin and would thus be addressed in national response plans as well as by the new European Health Emergency Response Authority.
Read full response

Response to Revision of the EU legislation on medicines for children and rare diseases

6 Jan 2021

ESIP, representing the statutory social health insurances in the EU, UK and Switzerland, welcomes the initiative of the European Commission to revise the existing legislation concerning orphan medicinal products (OMPs) and paediatric medicines with a view to addressing the shortcomings identified in the recent joint evaluation of the two Regulations. In particular, we welcome the focus on the need to revise current incentives to redirect developments to areas of greatest unmet medical need and ensure availability, access and affordability across Europe.  Definition of unmet medical need We welcome the intention to better define the criteria for unmet medical need and identify products that address these needs in the paediatric and orphan medicines legislation. These criteria should reflect patient and societal need. Once defined, existing definitions and references to ‘unmet medical need’ across the EU legislative framework need to be aligned to these (to ensure clarity and implementation across the board).  Including a refined definition of “significant benefit” To foster truly innovative technologies that address this unmet need and ensure legal clarity, the standard definition of “significant benefit” should be revised. Efficacy has to be established based on direct comparative data showing a significant improvement in patient-relevant outcomes. The current stand-alone criterion “major contribution to patient care” should be re-evaluated.  Revising the criteria for orphan designation The current prevalence threshold should be re-assessed to ensure that only areas with real unmet medical need benefit from the incentives set out in the Regulation. A thorough investigation of international definitions should guide this revision. The intention to explore alternative / additional criteria to identify specific rare diseases is welcomed. Furthermore, the prevalence of all indications that a medicinal product is licensed for should be combined. If the combined prevalence of all indications exceeds a certain limit, orphan status could be revoked. The criterion of “expected insufficient return on investment” should not be deleted. On the contrary, this criterion should underpin every orphan designation. As such the profitability of a product alone should be sufficient to revoke orphan status even if the other criteria are still met. The orphan status of every product on the market should be subject to an annual review by EMA.  Including a standard definition of “sufficiently profitable” A standard definition of “sufficiently profitable” is necessary to make this criterion actionable. As with the prevalence criterion (see above), all indications of a product regardless of their orphan status should be taken into account when determining the profit generated. In this context, greater transparency of research and development (R&D) costs would be necessary.  Incentives ESIP welcomes the Commission’s proposals for better targeted incentives linked to specific obligations e.g. ensuring availability throughout the EU. In particular we welcome the shift away from a system based on broad application of market exclusivity and the consideration of alternative incentives. With a view to the introduction of transferrable vouchers as an alternative to SPC extension for development of paediatric medicines, and for unmet need in rare diseases and rare paediatric diseases, these should be limited to providing access to assisted regulatory processes. Further alternative incentives should be explored e.g. incentives that support de-linking R&D from commercialisation aspects, with R&D led by publicly funded institutions, including the development of off-label use and subsequent authorisation via an effective repurposing framework (e.g. that proposed by STAMP in June 2019). ESIP’s members look forward to expanding on this feedback in the future targeted and public consultations.
Read full response

Response to Green Paper on Ageing

14 Dec 2020

ESIP shares the Commission’s opinion that the demographic change Europe faces requires a debate on long-term impact on social protection, especially care and pensions. The EU’s action should foster synergies with other existing strategies and policies, setting priorities and providing financing opportunities. To better evaluate the impact of ageing, the availability and comparability of data in the EU should be enhanced. A declining and ageing workforce means that people must be enabled to work longer, in line with principle 10 of the European Pillar of Social Rights. This includes lifelong healthcare provision, and a culture of health promotion and prevention that enables a long and healthy participation in the working life. A holistic approach supporting people to stay healthy must be introduced at an early stage to guarantee its effectiveness. Special focus should be put on the issue of mental health. In line with the European Skills Agenda, ESIP suggests to the Commission to update the 2012 Action Plan for the EU Health Workforce, to make sure it is adapted to current health needs and demographic context. ESIP also misses a clear indication in the roadmap of the need to maintain the ability to work and any necessary adjustments to the workplace. Reinforcing the focus to rehabilitation and return to work strategies could support individuals to return to work rather than claim long-term disability pensions. The Green Paper should therefore also deal with return-to-work strategies and work reintegration as an integral part of strengthening individuals’ employability. The exchange of best practices among Member States should be supported to further foster the implementation of such strategies. In this respect, a close link to other initiatives will be important, i.e. the EU’s Beating Cancer Plan, putting an emphasis also on prevention and reintegration. Employees exposed to severe physical and/or mental stress during their job should be shown the prospect of changing jobs at an early stage. Workplace and job management should supplement occupational health and safety measures. The support of trained job coaches could help keep people in the working life. ESIP shares the view that untapped potential and opportunities must be better exploited. In our view, this includes making the most of the potential of workers who may not be well represented in the labour market, such as people with disabilities. Supporting people in the work-reintegration process is an economic investment that pays off for employers, social security systems and societies. The Green Paper should support the implementation of the right to work, for those who acquire a disability during the course of employment, as enshrined in the UN CRPD, and build synergies with other EU initiatives. Attention should be also paid to the role of family policies to curb demographic change by enabling families to have the children they wish and achieve a better work-life balance. Investments in early childhood education and care services allow for better participation of parents in the labour market. This generates social contributions and tax revenues and in turn reduces the rising cost of the rising cost of dependent elderly care, which is borne mostly by women. Finally, the increased share of older people is expected to put pressure on statutory pension systems. To support the adequacy and financial sustainability of pension systems, ESIP recommends enhancing the exchange of national best practices on measures to facilitate the extension of healthy working lives. Another challenge is to ensure sufficient pension literacy from an early age. Accruing contributions as early as possible is crucial to build entitlements in view of future retirement and support the sustainability of pension schemes. Thus, awareness-raising events as well as the development of national pension tracking websites should be supported at EU level.
Read full response

Meeting with Astrid Dentler (Cabinet of Vice-President Dubravka Šuica)

25 Nov 2020 · - Green Paper on Ageing - Social protection systems - Healthcare

Response to European Child Guarantee

7 Oct 2020

The European Social Insurance Platform (ESIP) represents statutory social security schemes from 17 Member States, the UK and Switzerland, including institutions responsible for the provision of family and child benefits, as well as services to children, including healthcare and early childhood education and care (ECEC). ESIP would like to take the opportunity provided by the European Commission via this feedback to the Roadmap to offer the expertise gathered within its Family and Social Inclusion Committee (FaSI), in order to support the elaboration of effective tools to fight against child poverty and support inclusion of vulnerable children. We would like to stress the need to ensure that any future European Child Guarantee should be accompanied by earmarked EU funding targeted to its implementation to maximise its impact. ESIP calls on the Commission to include ESIP’s FaSI members as part of the relevant stakeholders to be consulted during the drafting of the Child Guarantee. Indeed, our Members can provide valuable resources in terms of expertise (management and knowledge), data and best practices based on national measures already implemented. For instance, the French national Family Benefits Fund (CNAF) strives to promote access to early childhood education and care (ECEC) for all children and including children with disabilities and children from low income families. ECEC services across France are required to follow the same fee scale which is adjusted accordingly to family income. The funding from the French family branch of social security to ECEC services also increases when the income of parents using the services are low. Specific childcare solutions to help parents go back to work are also provided by CNAF (1). Our members also have extensive expertise in developing or managing programmes dedicated to supporting families and children, especially the most vulnerable ones, managing their financing, and coordinating actions with a wide range of actors and institutions also involved in combating child poverty. An example of the support provided to vulnerable families and children is the Italian “Bonus asilo-nido” (Nursery bonus), provided by the Italian National Social Security Institution (INPS). This benefit is intended to help cover the cost of attending nurseries (and home assistance in case of children with chronic diseases who cannot attend nurseries) for parents with children under 3 years old. The amount (but not the entitlement) depends on the household’s economic situation. One example of a coordinating role that our members play is the “Netzwerk Familienleistungen Mainz”, which was founded in 2018 at the initiative of the German Family Benefits Office (Familienkasse) together with the State Government of Rhineland-Palatinate and the State capital Mainz. The network gathers local partners, such as municipalities and charities, together with federal and regional authorities providing benefits and services to families. It creates a central contact point for families and aims to ensure that families receive the services they are entitled to and needs-based counselling quickly and easily, regardless of which part of the network they turn to. The network also contributes to the development of common operational standards among the network’s partners. As such, ESIP’s FaSI Committee is already set up as a forum for exchange between national experts on those topics. FaSI members and the FaSI itself thus put themselves forward in support of the Commission in designing the best tools to tackle child poverty in the EU. (1) The occupational integration nurseries allow jobseeker parents to benefit from childcare and specific support with a view to their long-term integration into the labour market. This best practice is relevant in view of the child guarantee as removing barriers to parents’ employment is a fundamental tool in fighting structurally against child poverty.
Read full response

Response to Legislative framework for the governance of common European data spaces

31 Jul 2020

The European Social Insurance Platform (ESIP) welcomes the roadmap on a Legislative framework for the governance of common European data spaces, towards the creation of a Single Market for data in crucial sectors such as healthcare. This would particularly benefit people in cross-border situations. We therefore support the European Commission’s initiative to increase accessibility, usability and interoperability of data, while lowering the costs of data transactions. The COVID-19 pandemic revealed the importance of sharing data in a timely, effective manner, namely on health and social-security, across EU Member States. We also welcome the creation of sectoral stakeholders’ groups, namely on e-health – experts can and will provide essential contributions to design legal and technical frameworks for data exchange. ESIP acknowledges that the roadmap focuses amongst others on increasing and improving the use of data held by the public sector e.g. national competent authorities and social security institutions, for research and innovative uses. We advocate for the implementation of a harmonised and legally binding regulatory framework, providing for exchange of publicly accessible data across Member States, in full respect of the principle of Open Science. Transparency and traceability should remain the priority principles; confidentiality should also be respected. Regarding compliance with the GDPR, the legislative framework on common European data spaces should not neglect the right to be forgotten and to withdraw consent from data use to avoid unethical use of data. This is of utmost important especially when it comes to highly sensitive personal data, such as healthcare data. Transparency on the one hand and confidentiality on the other would promote facilitated and responsible access to data, increase acceptance of innovative digital tools amongst EU citizens, and foster cooperation with the scientific community. Exchange of quality and transparent personal data will lower barriers to R&I and offer public sector bodies the essential instruments to ensure cross-border and cross-sectoral data sharing in crucial domains, such as healthcare and social security. Public authorities – importantly statutory health insurance and social security institutions – should not solely be considered as data deliverers, but as key actors in building European data spaces. Data spaces should be designed to benefit all relevant stakeholders who could provide added value for patients, by improving (cross-border) healthcare provision and financial sustainability of healthcare systems. This would ensure a level playing field for all actors involved and purposeful use of public sector data for the benefit of EU citizens. Indeed, there is a need for a shift from an industry perspective to a patient and insured-centered perspective when building data spaces. ESIP also recommends and supports the establishment of European structural enablers for data-sharing. These instruments should serve as coordination bodies to support the exchange of best practices and promote guidelines for common practices. Harmonised standards on data formats are essential to promote data comparability, compatibility and interoperability. Competent authorities in the health sector and social security institutions should be fully involved in exchange of best practices, in setting standards as well as in formulating priorities and conditions for the use of data. (A) European Coordination body/ies should on their side supervise a purposeful processing, transformation and flow of data, while ensuring quality and interpretability, transparency and confidentiality. Finally, we call for a strategic use of investment in digital programmes. In this regard, we express our concerns on the significant cuts made to key programmes, including Digital Europe, despite digitalisation being identified as a strategic priority in the Council 2019-2024 Strategic Agenda and by the Commission.
Read full response

Meeting with Stella Kyriakides (Commissioner)

17 Jul 2020 · Exchange of views on the upcoming Pharmaceutical Strategy

Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

ESIP welcomes the initiative to help ensure Europe’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry remain an innovator and world leader. However, we stress the need for a balanced approach that takes due consideration of access to innovation that addresses real unmet medical need and the financial sustainability of health systems as laid out in the Council Conclusions of 2016. Access and availability ESIP welcomes a broader review of the current regulatory framework governing pharmaceuticals and intellectual property rights, with a view to incentives for innovation and market failures. Incentives need to be targeted to innovative therapies that addresses a high unmet medical need, which should be consistently defined across the legislation. They should also be linked to market launch obligations that ensure equitable access across the EU as well as continuous supply, through stricter enforcement of Directive 2001/83/EC. Abusive behaviour to extent monopoly position that restricts availability should be prevented through stronger enforcement of competition law, as foreseen in the Industry Strategy. We welcome the current discussion on medicine shortages and possible solutions. A European initiative to ensure availability needs to strike a balance between diversification and measures to relocate production back to Europe. Greater transparency and timely information exchange throughout the supply chain is also crucial. Affordability and financial sustainability of health systems While emphasising that pricing and reimbursement decisions are a Member State competence, ESIP welcomes the aim of the future strategy for enhanced cooperation related to cost-effectiveness, pricing and reimbursement decisions and procurement practices, which should build upon existing regional initiatives such as Beneluxa, Finose, and Valetta. This could also include exchange of best practice on innovative and reimbursement models. Such actions go hand in hand with the closer cooperation on health technology assessment as proposed in the draft Regulation. As to affordability of medicinal products, the initiative should equally include a review of how EU investment in its funding programmes e.g. Horizon 2020 has been reflected in the prices set by marketing authorisation holders. Funding through future EU research programmes such as Horizon Europe should be subject to conditionality clauses that guarantee public return on public investment. The EU should also promote developing global market mechanisms for innovative new products to increase their availability to all patients in need, currently underdiagnosed and undertreated in many countries, and lower their cost per patient. Enabling innovation for unmet medical needs EU investment in research and innovation must have a clear orientation to the needs of European health systems by explicitly involving downstream stakeholders - healthcare professionals, patients and payers - in setting the research priorities. The use of real-world data in market authorisation procedures should be applied only in exceptional, well-described cases complementing clinical trial data. Quality standards for this kind of data need to be developed according to their intended use and the regulator should provide a clear statement why these data have been considered fit for purpose. Strict adherence to post-authorisation evidence requirements by the market authorisation holder needs to be ensured. Competitiveness In the context of competitiveness, high social and occupational health standards need to be considered along with quality, safety and environmental standards for medicines marketed in the EU. As a key stakeholder, representing the European social healthcare payers, we urge the Commission to closely involve ESIP at every future stage of the development of the strategy.
Read full response

Response to Europe’s Beating Cancer Plan

3 Mar 2020

The European Social Insurance Platform (ESIP), representing the statutory social and health insurances in 18 EU Member States and Switzerland, welcomes the Commission’s initiative to raise the profile of health at EU level, in its Europe’s Beating Cancer Plan. There is potential for true EU added value by taking a holistic approach and tackling the challenge via a wide range of policies and instruments. The ‘Health in all policies’ approach needs to be fully implemented across all policy fields including agriculture, environment, industry, employment and education. The Roadmap outlines five domains of action: the social insurances have a direct role to play in each of them. We therefore call on the Commission to ensure that social and health insurers are consulted as part of the future targeted stakeholder consultations foreseen. The Commission recognises that prevention is the easiest and most effective way of reducing cancer and we welcome the broad approach to prevention outlined in the Roadmap. We highlight the importance of education and access to information to empower individuals to make healthy lifestyle choices, as well as actions aimed at improving health and safety in the workplace. The EU’s action to reduce exposure to carcinogenic substances in the workplace is of major importance. In addition, while digital tools may help citizens manage their own health, the digital divide needs to be addressed to avoid creating inequalities. Social health insurances propose a number of concrete solutions to improve digital health literacy. We recognise the importance of early detection and diagnosis. In previous years, the EU has supported Member States in developing high quality cancer screening programmes. We believe that these should be extended to other cancers only if there is sufficient evidence to support their effectiveness. It is important that screening and diagnosis are accompanied by adequate information and support for the individual patient as part of an integrated care system. Also, considering that some work-related cancers e.g. due to exposure to asbestos, have a long latency period, continued screening and diagnosis needs to ensured even after changing jobs or retiring. With a view to ‘Treatment and Care’ the Commission lists one of the objectives as ‘to improve the quality, availability and access to cancer treatment’. ESIP believes that ‘affordability’ is fundamental to achieving this goal. We therefore call on the Commission to ensure that this objective refers specifically to improvement of ‘the quality, availability and access to affordable cancer treatment’ and that affordability is specifically addressed in the planned pharmaceutical and chemical strategies, particularly in the design of incentives, as well as Horizon Europe and the allocation of public funds to ensure public return on public investment. Regarding patient access, the plan must address inequalities that exist due to socio-economic and geographical factors. In the context of ensuring the quality of life of cancer patients and informal carers, we stress the importance of rehabilitation and return to work strategies. Early intervention and the active involvement of employers are necessary to implement effective return to work strategies. In addition, as social insurers, we must not forget the quality of life and work-life balance of informal carers, especially from a gender equality perspective, as this remains overwhelmingly a role undertaken by women. Finally, concerning the use of health data, we recall the need to respect data privacy rules and stress the need to ensure public return on the use of public data. We encourage the development and adoption of EU standards to facilitate the cross-border exchange of health records and e-prescriptions, and support for the interoperability of national e-health infrastructures. Last but not least, we emphasise the continued importance of exchange of best practice between health systems.
Read full response

Response to European Partnership for innovative health

27 Aug 2019

The European Social Insurance Platform (ESIP) generally welcomes the aim of the European Partnerships as described in Article 8 of the draft legislation on Horizon Europe. With view to the previous Innovative Medicines Initiatives, we support the Commission’s intention to continue the work already done but more importantly to revise its scope to make sure that the public interest is sufficiently promoted. A lack of transparency around funding, beneficiaries, governance, data and results, as well as a lack of alignment between industry’s research priorities and the public interest, has previously resulted in questionable output for public healthcare systems. The current roadmap for a Council Regulation for a European Partnership on Innovative Health aims to address some of the challenges facing health care systems by facilitating and accelerating the development of safe, effective, patient-centred and cost-effective healthcare innovations. However, bringing health interventions faster to the market does not automatically contribute to addressing these challenges. On the contrary, increasingly, new products are entering the market with a very high price-tag and only limited evidence of their therapeutic- / cost-effectiveness, further challenging the sustainability of healthcare systems. Marketing products faster and with less evidence should not be the main aim of this initiative. We call for closer involvement of a broader group of stakeholders, especially healthcare payers, to ensure adequate uptake of the results and therefore deliver on the problem the initiative aims to tackle, namely increasing financial and organisational pressure on healthcare systems. In establishing the future Partnership, ESIP calls upon the European Commission to take the following into account: - To ensure public return, public investment has to be met with complete transparency regarding the costs of research, development and production. - Public funding should be linked with open access and open data requirements for publicly funded research to ensure that knowledge gained with the support of public funding is openly available to researchers and the wider public. Attaching equitable access conditions is essential in order to guarantee affordable access to new health technologies. - National statutory health insurance institutions must be involved and consulted when setting the priorities within the new Innovative Health Initiative. - In order to bring safe, effective, patient-centred and cost-effective healthcare products to the market, it should be guaranteed that robust evidence on the therapeutic and also the economic value is proven at time of marketing authorisation. - Concrete patient-centred end points should be defined in the framework of the initiative in order to tackle real unmet public health needs. Finally, we stress the importance of a timely publication of the consultation as announced in the roadmap, as well as a minimum time-frame of twelve weeks, to ensure well considered, high quality contributions from stakeholders. The involvement of healthcare payers and regulators should be guaranteed.
Read full response

Meeting with Vytenis Andriukaitis (Commissioner) and

12 Apr 2018 · HTA; 9th EU Framework Programme for Research and Innovation; Digitalisation of health and care; Incentives for pharmaceuticals

Response to Evaluation of the legislation on medicines for children and rare diseases (medicines for special populations)

8 Jan 2018

The European Social Insurance Platform, ESIP, strongly welcomes the initiative of the European Commission to evaluate the legal framework concerning paediatric and orphan medicines and the interaction between the two pieces of legislation. In particular, we welcome the intention to carry out a more detailed analysis of the impact of the orphan medicinal products Regulation as regards fulfilling patients’ needs and the financial and societal consequences. As already stated in our press release* following the Council conclusions adopted in June 2016 on the balance within the pharmaceutical systems, we believe “the focus on assessing the relevance of the EU framework in encouraging real innovation in accordance with patients’ needs is critical to achieve the double goal of ensuring equal access to medicines delivering patient relevant benefits and the sustainability of healthcare systems”. While the Commission report would indicate that since its introduction in 2006 the Paediatric Regulation has had some positive impact on the development of paediatric medicines, there is room for further improvement. However, any review of incentives should not lead to possible exploitation in the same way as has already been experienced to date with some orphan medicines. We are very much looking forward to the findings of the Commission regarding the evaluation of the two pieces of legislation, as a complement to their broader investigation launched in 2017 on general incentives for innovation (the so called “Copenhagen Economics Study”). As representative of the European statutory social health insurers and therefore the payers, ESIP calls on the Commission to specifically include ESIP as a key stakeholder in the targeted consultation mentioned in the roadmap. *Joint ESIP-AIM press release: "Healthcare payers welcome the Council conclusions on strengthening the balance in the pharmaceutical system in the EU", 17 June 2016 (https://esip.eu/publications-intranet?idf=148&preview=288)
Read full response

Meeting with Vytenis Andriukaitis (Commissioner) and

2 Mar 2017 · Towards a renewed EU Alcohol and Health Forum