ESIP key messages on the proposal for Regulation on the European Health Data Space

The European Social Insurance Platform (ESIP) welcomes the establishment of the European Health Data Space (EHDS) and puts forward a set of key messages in light of the ongoing institutional negotiations. 

ESIP views in light of the EC proposal amending the Medical Devices Regulation

In May 2017, Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation - 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.

ESIP-MEDEV views on the revision of the EU legislation on orphan medicines

In view of the upcoming revision of the EU pharmaceuticals legislation (expected in Q1 2023), ESIP & MEDEV published a joint position on the EU legislation on medicines for rare diseases (orphan medicinal products - OMPs). The ESIP & MEDEV position includes a compilation of amendments to Regulation (EC) 141/2000 & Regulation (EC) 847/2000 and the accompanying position paper.

ESIP-MEDEV views on the revision of the EU general pharma legislation

The upcoming proposal by the European Commission on the revision of the EU general pharmaceuticals legislation, expected by the end of 2022, intends to address shortcomings in terms of access to and availability of new treatments. Safety, quality and affordability are crucial elements for bringing effective medicines to the market with
significant benefits for patients and healthcare systems’ sustainability.

ESIP responds to the public consultation on the revision of EU rules on pharmaceuticals

Under the Pharmaceutical Strategy for Europe, presented in November 2020, the European Commission announced the future revisions of the EU general pharmaceutical legislation as well as of the Regulations on medicines for rare and paediatric diseases. The related legislative proposals are expected by the end of 2022.

ESIP recently discussed the need to revise the general pharmaceutical legislation, with view to increasing affordability by strengthening fair competition and revising the framework for incentives. 

ESIP responds to the Public Consultation on the Revision of the OMP and paediatrics Regulations

As part of the legislative initiatives under the Pharmaceutical Strategy for Europe, the Commission opened consultations towards the revision of the EU legislation on medicines for children and rare diseases. ESIP provided its feedback building on the 2019 paper on orphan medicinal products and the previous response to the inception impact assessment. 

ESIP responds to the Public Consultation on the upcoming European Health Data Space

In view of the legislative proposal for a European Health Data Space (EHDS), expected by the end of this year, ESIP took part in the public consultation process on access to and exchange of health data for healthcare provision, policy-making and research & innovation purposes, as well as on the use of digital health products & services and development & deployment of AI systems applied to healthcare.

ESIP reflection paper on new approaches for health insurers

On 12 July, ESIP adopted its reflection paper on Cancer comorbidities and complications: proposals for a new approach for health insurers. The paper was prepared in the wake of the EU’s Beating Cancer Plan, published on 3 February, and as a follow up to the POLITICO Working Group on Cancer Comorbidities that ESIP joined on 24 February. 

ESIP responds to the evaluation roadmap-inception impact assessment

On 30 March the Commission launched the first stage of consultations with stakeholders towards the revision of the general pharmaceutical legislation, namely Directive 2001/83/EC1 and Regulation (EC) No 726/2004. ESIP submitted its first response to the evaluation roadmap-inception impact assessment touching upon several elements identified by the Commission to feed into future policy actions.

Payers and EMA discussed evidence generation along the life-cycle of medicines

On 12 March, representatives from the European Social Insurance Platform (ESIP), the payer platform Medicines Evaluation Committee (MEDEV), the International Association of Mutual Benefit Societies (AIM) and the European Medicines Agency (EMA) met for the third time to further explore synergies and foster mutual understanding and cooperation on evidence generation, with the aim of better aligning evidence requirements for the different decision-making processes. On this occasion the focus was on evidence generation along the life-cycle of medicinal products.