Health News
Proposals to improve EU rules on rare and paediatric diseases 30-07-2021
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.
Promoting access to health data for healthcare, research & policy-making 26-07-2021
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.
First insight into the revision of the EU pharma legislation 27-04-2021
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.
3rd EMA-payer meeting on 12 March 2021 17-03-2021
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.
More proposals on managing & preventing shortages 25-02-2021
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.
Shaping the future Health Data Space 03-02-2021
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).
Further steps towards a EU Health Union 02-02-2021
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.
Towards new OMP and paediatric Regulations 06-01-2021
ESIP feedback to the inception impact assessment on revision of OMP and paediatric legislation
In the framework of the new Pharmaceutical Strategy for Europe – released on 25 November – the European Commission published an Inception Impact Assessment (IIA) on the revision of Regulation No. 141/2000 on orphan and Regulation No. 1901/2006 on paediatric medicinal products.
New Pharmaceutical Strategy for Europe 25-11-2020
Shaping future pharma policies for increased accessibility and affordability of medicines
On November 25 the European Commission released the new Pharmaceutical Strategy for Europe. The Strategy is intended as a roadmap for future action in the pharmaceutical sector, detailing a number of legislative and non-legislative initiatives for the coming years. Such actions should be deployed jointly with Member States.
Paving the way for ambitious EU health budget 13-11-2020
ESIP welcomes the political agreement for a reinforced EU4Health Programme
On November 10 the European Parliament and the German Presidency of the Council reached a political agreement on the next Multiannual Financial Framework (MFF 2021-2027) and recovery package. The new political package includes a budget reinforcement of EUR 15 billion. More precisely the envelope for EU4Health would be tripled compared to the budget set by the Council in July, reaching a final amount of EUR 5.1 billion. This increase was hailed by the European Parliament and Commission as a major victory. Furthermore, on November 13 the European Parliament adopted a resolution on the EU4Health programme, calling to use EU funds to increase disease prevention, foster the digital transformation of health systems, and improve crisis-preparedness with a view to mitigating shortages of medicines and medical devices.
