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.

New ESIP Paper on shortages of Medical Devices and PPE

In light of the lessons learned from COVID-19, ESIP welcomes and supports the reinforced European commitment to secure continuous supply of medicines, medical devices (MD) and personal protective equipment (PPE). In our recently adopted position paper we outline proposals for securing supply of MD and PPE, building upon our position on medicines shortages and taking stock of the measures specific to MD in the legislative proposals on Building an EU Health Union.

ESIP first insights on the Inception Impact Assessment

On 23 December the European Commission opened consultations on a European Health Data Space (EHDS). The evaluation roadmap/inception impact assessment remained open for feedback until 3 February. This initiative would complement the proposal for a Data Governance Act and promote access to and exchange of health data for primary use (healthcare delivery) and secondary use (research and development, policy-making).

ESIP feedbacks to the legislative proposals on strengthening crisis preparedness

On 11 November the European Commission released a package of three legislative proposals for a European Health Union. ESIP commented on two of the proposed Regulations: on a reinforced role for the EMA and on serious cross-border threats to health.