News
More proposals on managing & preventing shortages 26-02-2021
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.
