ESIP (European Social Insurance Platform)

The European Social Insurance Platform (ESIP) acknowledges the objectives of revising the EU regulatory framework for medical devices and in-vitro diagnostics, reducing unnecessary administrative burdens and supporting timely access to medical technologies.

The European Social Insurance Platform (ESIP), representing social and health insurers in the EU including those responsible for the assessment and/or reimbursement of medical devices, notes the European Commissions initiative to present a targeted revision of Regulations (EU) 2017/745 (Medical Devices Regulation, MDR) and (EU) 2017/746 (In Vitro Diagnostics Regulation, IVDR).

The European Social Insurance Platform (ESIP) and the Medicine Evaluation Committee (MEDEV) welcome the initiative to revise the EU pharmaceutical legislation ('the revision'). Today, high pharmaceutical prices often coupled with incomplete evidence affect national pricing and reimbursement (P&R) decisions and consequently access to treatment.

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 European Social Insurance Platform (ESIP) and the Medicine Evaluation Committee (MEDEV) support the objective of strengthening Europe's biotechnology and biomanufacturing ecosystem through the EU Biotech Act. Importantly, industrial policy measures must remain compatible with timely patient access, affordable medicines, robust clinical evidence and the long-term sustainability of healthcare systems.

The European Social Insurance Platform (ESIP), representing national social security and health insurance institutions across Europe, views positively the European Commissions initiatives to boost the EU life sciences sector, particularly the upcoming European Biotech Act.

The European Social Insurance Platform (ESIP), representing statutory social security institutions, welcomes the intention to establish the European Health Data Space (EHDS). We endorse two separate infrastructures for primary and secondary use as well as a twofold governance mechanism, where access is granted by national competent bodies, networked at EU level.

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…

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.

The European Social Insurance Platform (ESIP), representing statutory social security institutions and healthcare payers in Europe, welcomes the Commissions initiative for a Council Recommendation to support Member States improving early detection of cardiovascular diseases (CVD). CVD remains a major public health, social and economic burden.

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, 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.

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 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.

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.