42 Amendments of Danilo Oscar LANCINI related to 2020/0102(COD)
Amendment 141 #
Proposal for a regulation
Recital 6
Recital 6
(6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States, as well as a permanent structured and coordinated dialogue between authorities and relevant stakeholders, in order to improve the prevention and control of the spread of severe human diseases across borders, to combat other serious cross- border threats to health and to safeguard the health and well-being of people in the Union. __________________ 8 Communication to the European Parliament, the European Council, the Council, the European Central Bank, the European Investment Bank and the Eurogroup on coordinated economic response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220.
Amendment 189 #
Proposal for a regulation
Recital 12
Recital 12
(12) With a view to protecting people in vulnerable situations, including those suffering from mental illnesses, non- communicable diseases and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, especially in times of crisis and pandemics, encourage a transition to telemedicine, home administration of medication, and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare services is provided to chronic patients, taking into account the respective levels of digitisation of the Member States and problems of access to digital solutions in remote areas or for certain population groups.
Amendment 197 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) Correlations have been observed between health and/or economic crises and a worrying increase in depressive tendencies resulting from the effects of reduced disposable income, uncertainty about the future and growing unemployment. The Programme should therefore provide support for national actions aimed at integrating mental health into all policies and promoting mental health in all areas, including school and work, and for preventive actions to combat depression and suicide.
Amendment 241 #
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) The Programme should provide for equal access to healthcare. ‘Socioeconomic health inequalities’ cover situations ranging from unequal access to treatment, fragmented access across regions and differences in health status based on economic conditions, to the distribution of health determinants between different population groups. The individual Member States are responsible for developing social and health polices to tackle the national challenges linked to health inequalities.
Amendment 255 #
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, neurological disorders, chronic respiratory diseases, and diabetes, represent major causes of disability, ill- health, health- related retirement, and premature death in the Union, resulting in considerable social and economic impacts. To decrease the impact of non- communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to provide an integrated response focusing on prevention across sectors and policy fields, combined with efforts to strengthen health systems.
Amendment 299 #
Proposal for a regulation
Recital 19
Recital 19
(19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. It is also one of non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer. The actions on cancer should also address its common risk factors and synergies with other major non-communicable diseases, such as neurological diseases, and consider devising a template for other major disease areas based on the ‘Europe’s Beating Cancer Plan’.
Amendment 312 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) Heart attacks and strokes often occur in people previously undiagnosed with cardiovascular diseases. Many of these are due to undetected genetic conditions, such as familial hypercholesterolaemia, arrhythmias, congenital heart disease and cardiomyopathies, and conditions such as hypertension. The Programme should support the development of policies and interventions to identify and manage individuals at high risk of developing cardiovascular disease in order to prevent the onset of the disease and reduce mortality.
Amendment 345 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries, in particular actions, where necessary in synergy with other programmes, to encourage local production of medicinal plants in the Member States, and to encourage and support production of active ingredients and generics within the European Union. 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 349 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitdevelop a single pan- European monitoring, reporting and notification system for shortages of medicines, medical devices and other healthcare products to avoid fragmentation of the single market 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 509 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Article 4 – paragraph 1 – point 1 a (new)
(1a) support actions aimed at modernise and digitalise the EU regulatory Network at European and national level;
Amendment 568 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6
Article 4 – paragraph 1 – point 6
(6)support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer, while addressing its synergies with other major non- communicable diseases, such as neurological disorders;
Amendment 640 #
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. Consideration should be given to promoting synergies between European funds and national funds/resources to ensure long-term effectiveness and sustainability of the actions.
Amendment 666 #
Proposal for a regulation
Annex I – point a – point ii a (new)
Annex I – point a – point ii a (new)
(iia.) Local production of medicinal plants in the Member States;
Amendment 668 #
Proposal for a regulation
Annex I – point a – point ii b (new)
Annex I – point a – point ii b (new)
(iib.) Production of active ingredients and generics within the European Union to reduce the Member States’ dependence on certain third countries.
Amendment 673 #
Proposal for a regulation
Annex I – point c – point i
Annex I – point c – point i
(i) Surveys, studies, centralized and accessible collection of data and statistics, methodologies, classifications, microsimulations, pilots, indicators, knowledge brokering and benchmark exercises;
Amendment 683 #
Proposal for a regulation
Annex I – point c – point iii
Annex I – point c – point iii
(iii) Expert groups and panels, including all relevant stakeholders, providing advice, evaluation, data and information to support health policy development and implementation;
Amendment 689 #
Proposal for a regulation
Annex I – point c – point iii a (new)
Annex I – point c – point iii a (new)
(iii a) Setting up and management of a High Level Pharmaceuticals Forum at political level composed of authorities and relevant healthcare stakeholders to define priorities and concrete measures to be implemented at technical level;
Amendment 694 #
Proposal for a regulation
Annex I – point c – point iv
Annex I – point c – point iv
(iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on "Consumer Safety" and on "Health, Environmental and Emerging Risks" and on "Healthcare systems performance".
Amendment 704 #
Proposal for a regulation
Annex I – point d – introductory part
Annex I – point d – introductory part
(d) DEvaluation, development and implementation of Union health legislation and action, in particular through support to:
Amendment 720 #
Proposal for a regulation
Annex I – point d – point iv
Annex I – point d – point iv
(iv) Development and operation and maintenance of databases and digital tools and their interoperability, including already established project such as creation of a central common repository for all medicines in Europe and SPOR implementation, where appropriate with other sensing technologies, such as space- based;
Amendment 740 #
Proposal for a regulation
Annex I – point d a (new)
Annex I – point d a (new)
(da.)Development of the capacity and resources of patients’ organisations to increase patients’ contribution to health policy planning and implementation.
Amendment 752 #
Proposal for a regulation
Annex I – point e – point iv
Annex I – point e – point iv
(iv) Procurement of goods and services including MEAT criteria, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 761 #
Proposal for a regulation
Annex I – point f – point iii
Annex I – point f – point iii
(iii) Support and/or procure emergency production of medical countermeasures, including essential chemicals and active substances, and the financing of cooperation on emergency health technology assessments and clinical trials; and secure financing of exceptional measures to free capacity of lines that can be utilised to provide ICU medicines;
Amendment 765 #
Proposal for a regulation
Annex I – point f – point v
Annex I – point f – point v
(v) Actions to address the collateral health consequences of a health crisis, in particular those on mental health, onin addition to social exclusion and financial hardship, often experienced by patients suffering from chronic diseases and other vulnerable groups;
Amendment 768 #
Proposal for a regulation
Annex I – point f – point v a (new)
Annex I – point f – point v a (new)
(va.) With patient safety as a top priority, actions to facilitate the availability of accessible and affordable telemedicine services for all patients throughout Europe, and to support digital literacy and a transition to telemedicine, home administration of treatment and medication, and implementation of preventative and self-care plans, while involving patients’ organisations in evaluating, identifying and implementing the best possible solutions in terms of continued access to high-quality care and treatment;
Amendment 773 #
Proposal for a regulation
Annex I – point f – point v a (new)
Annex I – point f – point v a (new)
(va) Actions to support harmonised implementation of electronic product information in all Members States;
Amendment 783 #
Proposal for a regulation
Annex I – point f – point viii a (new)
Annex I – point f – point viii a (new)
(viiia) The creation, development of an EU central portal to monitoring shortages and an effective EU telematics infrastructure to make data on medicine and supply chain data interoperable via the full implementation of SPOR and connection to the FMD system;
Amendment 790 #
Proposal for a regulation
Annex I – point f – point viii b (new)
Annex I – point f – point viii b (new)
(viiib) Actions to secure continuity of care and treatment and in particular of chronic conditions during health crisis;
Amendment 809 #
Proposal for a regulation
Annex I – point g – point vi a (new)
Annex I – point g – point vi a (new)
(via.) Support actions promoting mental health in the workplace and in schools; promote actions to combat depression and suicide; develop socially inclusive forms of mental health care;
Amendment 815 #
Proposal for a regulation
Annex I – point g – point ix
Annex I – point g – point ix
(ix) Support the establishment and implementation of programmes and in particular digital programmes assisting Member States and their action to improve health promotion and disease prevention (for communicable and non-communicable diseases) in hospitals and communities;
Amendment 827 #
Proposal for a regulation
Annex I – point g – point xi a (new)
Annex I – point g – point xi a (new)
(xia) Support the development and implementation of programmes assisting Member States to improve their generic and biosimilar use while guaranteeing the prescribing autonomy of the physician to increase healthcare system efficiency;
Amendment 878 #
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, cost-effective and supportive care medicines for cancer;
Amendment 887 #
Proposal for a regulation
Annex I – point h – point v a (new)
Annex I – point h – point v a (new)
(va) Actions supporting access to the standard of cancer treatment and care;
Amendment 910 #
Proposal for a regulation
Annex I – point h – point x a (new)
Annex I – point h – point x a (new)
(xa.) Support actions to tackle common, shared risk factors and synergies between cancer and other major non- communicable diseases, such as neurological disorders, and to render the European cancer plan a template for other major disease areas;
Amendment 915 #
Proposal for a regulation
Annex I – point h – point x a (new)
Annex I – point h – point x a (new)
(xa) Promote use of MEAT criteria in procurement mechanisms to enhance safe and timely usage of generic and biosimilar medicines in cancer care;
Amendment 918 #
Proposal for a regulation
Annex I – point h – point x b (new)
Annex I – point h – point x b (new)
(xb) Building on Europe’s cancer plan, support the creation of a template for other major disease areas, such as neurological disorders;
Amendment 923 #
Proposal for a regulation
Annex I – point h – point x b (new)
Annex I – point h – point x b (new)
(xb) actions to promote health and safety for healthcare workers involved in cancer treatment;
Amendment 944 #
Proposal for a regulation
Annex I – point i – point iv a (new)
Annex I – point i – point iv a (new)
(iva) Foster a supportive environment for meaningful patient and public involvement in clinical trials, starting with the design phase and ending with dissemination;
Amendment 953 #
Proposal for a regulation
Annex I – point i – point v a (new)
Annex I – point i – point v a (new)
(va) Support actions to foster innovation on in repurposing, reformulation and combinations of off- patent medicines that that deliver relevant improvements for patients, healthcare professionals and/or healthcare systems;
Amendment 963 #
Proposal for a regulation
Annex I – point i – point vii
Annex I – point i – point vii
(vii) Support actions to encourage the development of innovative medicines and medical devices less harmful for the environment and promote greener manufacturing and reward investments in procurement processes;
Amendment 972 #
Proposal for a regulation
Annex I – point i – point ix
Annex I – point i – point ix
(ix) Action to promote the prudent use and disposal of antimicrobialmedicinal products, including antimicrobials; create technology incentives to neutralise waste in manufacturing plants;
Amendment 978 #
Proposal for a regulation
Annex I – point i – point x
Annex I – point i – point x
(x) Support action to foster international development and regulatory convergence and reliance on medicines and medical devices. and to improve regulatory oversight;