15 Amendments of Eleonora EVI related to 2020/0102(COD)
Amendment 182 #
Proposal for a regulation
Recital 11
Recital 11
(11) As in the time of health crisis emergency health technology assessment as well as clinical trials can contribute to the rapid development of medical countermeasures the Programme should provide support to facilitate such actions. The Commission has adopted a proposal11 on Health Technology Assessment (HTA) to support cooperation on health technology assessment at Union level. On 14 February 2019, the European Parliament also adopted its legislative resolution at first reading. __________________ 11Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU, COM(2018) 51 final of 31.01. 2018.
Amendment 274 #
Proposal for a regulation
Recital 18
Recital 18
Amendment 353 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitoraddress the root causes of the shortages of medicines, medical devices and other healthcare products, to monitor shortages in Member States and at Union's level and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines.
Amendment 382 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) The Union environmental legislation has an indirect, albeit important impact on public health and the resilience of national health systems. A strong and well-functioning EU environmental regulatory framework is essential to health protection. The Programme therefore should support the development, implementation and enforcement of Union environmental legislation towards a non-toxic environment.
Amendment 489 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3a) contribute to disease prevention by addressing key environmental risk factors;
Amendment 555 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5 a (new)
Article 4 – paragraph 1 – point 5 a (new)
(5a) support actions aimed at primary prevention through the control of exposure to environmental risk factors;
Amendment 641 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases on the work plans established for the Programme and its priorities and strategic orientations and its implementation. The involvement of civil society representatives, including patient representatives, shall also be ensured.
Amendment 700 #
Proposal for a regulation
Annex I – point d – introductory part
Annex I – point d – introductory part
(d) Development and implementation of Union health legislation and action, and of Union environmental legislation and its impact on public health, in particular through support to:
Amendment 710 #
Proposal for a regulation
Annex I – point d – point i
Annex I – point d – point i
(i) Implementation, enforcement, monitoring of Union health legislation and action, and of Union environmental legislation and its impact on public health; and technical support to the implementation of legal requirements;
Amendment 813 #
Proposal for a regulation
Annex I – point g – point ix
Annex I – point g – point ix
(ix) Support the establishment and implementation of programmes assisting Member States and their action to improve health promotion and disease prevention (for communicable and non-communicable diseases), including by reducing the burden of diseases caused or impacted by modifiable environmental factors;
Amendment 865 #
Proposal for a regulation
Annex I – point h – point iii
Annex I – point h – point iii
(iii) Support prevention programmes on the main cancer risk factors, including the environmental ones;
Amendment 881 #
Proposal for a regulation
Annex I – point h – point v
Annex I – point h – point v
(v) Actions supporting access to cancer services and to innovative medicines for cancer, including actions to improve the affordability of oncology medications and treatments;
Amendment 927 #
Proposal for a regulation
Annex I – point i – point ii
Annex I – point i – point ii
(ii) Support actions to fight vaccine hesitancy through ongoing community engagement, addressing of individual and group concerns, trust-building activities;
Amendment 935 #
Proposal for a regulation
Annex I – point i – point iii
Annex I – point i – point iii
(iii) Support clinical trials, in particular support to their transparency and to the full implementation of the EU database with publicly accessible data, to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines;
Amendment 962 #
Proposal for a regulation
Annex I – point i – point vi
Annex I – point i – point vi
(vi) Support action to monitor shortages of medicines and medical devices occurring in hospitals and community pharmacies, to address such shortages at their roots, and to increase security of supplies;