35 Amendments of Mohammed CHAHIM related to 2020/0102(COD)
Amendment 122 #
Proposal for a regulation
Recital 5
Recital 5
(5) On 11 March 2020 the World Health Organization (WHO) declared, due to an exponential increase of cases, declared COVID-19 (the disease resulting from the novel coronavirus (COVID-19SARS-CoV-2) outbreak a global pandemic. That pandemic hase COVID-19 pandemic and more specifically the moderate to severe cases of the disease that need intermediate and intensive medical care pushed several health systems to breaking point within and outside Union, caused an unprecedented worldwide health crisis with severe socio- economic consequences and human suffering, particularly affecting people with chronic conditions and hitting the most vulnerable, patients, women, carers and the elderly the hardest. The world continues the fight against this unprecedented health crisis, which has led to lock downs and restrictions on the circulation of people, animals, food, medicines and others.
Amendment 135 #
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 in order to improve the prevention andto support rights- and evidence-based approaches that have a high impact in order to improve preparedness for, prevention and a timely and effective control of the spread of severe human infections and diseases across borders, to develop and guarantee the availability and accessibility of products for the prevention and treatment of diseases, to combat other serious cross- border threats to health and to safeguard and improve 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 152 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) The pandemic has revealed the importance of public health policies, and their benefits for citizens, communities and the economy. Such policies are cost- saving and offer returns in the long term of 14:1, meaning that for each euro invested in public health policies, we have economic return of 14 euros.
Amendment 153 #
Proposal for a regulation
Recital 6 b (new)
Recital 6 b (new)
(6b) While the Union´s action in the field of health is limited, the Union should follow a coherent public health strategy in order to flexibly respond to existing epidemics taking into consideration local specificities and having the capacity to face future worrying realities and health threats, such as pandemics and cross- border threats, including antimicrobial resistance and the health impacts of the climate crisis. The Union should support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, of disease prevention, in promoting a healthy lifestyle and preparing their health systems for emerging technologies.
Amendment 159 #
Proposal for a regulation
Recital 9
Recital 9
(9) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented impact of the COVID-19 crisis. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument] and ensure that resilient healthcare and health systems are in place in preparation for future pandemics, improve the health status in societies and to ensure that people are healthier and therefore less susceptible to health threats. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument]. Preparedness is the key to improving resilience to future threats, and Member States, given their responsibility for the provision of healthcare, should carry out stress tests on their healthcare systems to identify weaknesses and verify that they are prepared for a possible future health crisis, through the support of the Commission and its coordination action to establish common acceptable parameters.
Amendment 166 #
Proposal for a regulation
Recital 10
Recital 10
(10) COVID-19 has demonstrated the inter-dependencies between human health and the health of our planet and our vulnerabilities. The emergence of zoonotic diseases which are transmitted from animals to humans is exacerbated by anthropogenic climate change, the destruction of biodiversity and environmental degradation. Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include strategic stockpiling of essential medical supplies or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and preparedness exercises, in keeping with the “One Health” approach. It should facilitate the setting up of an integrated cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 195 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) The right to physical and mental health is a fundamental human right. Every person, without discrimination, has the right to access modern and comprehensive healthcare. The EU4Health programme should guarantee that universal health coverage is provided, in line with the international commitments made through SDGs and with WHO policies, and ensure that everyone can use the health services they need without experiencing financial hardship. To continue being a global leader in health and to provide a high standard healthcare across the Union, the Commission should propose a Directive on minimum standards for quality healthcare with a set of criteria that should be reported by Member States, such as hospital beds per capita, critical care capacities, numbers of doctors and nurses per capita, rate of health expenditure and access and affordability of healthcare for all, including for vulnerable people. This would improve patient safety and result in better conditions in healthcare for patients and professionals.
Amendment 242 #
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) The Programme should provide for equal and fair access to healthcare. “Health inequalities” cover situations ranging from unequal access to treatment, fragmented access across regions, differences in health status origin, and to the distribution of health determinants between different population groups. Health inequalities and inequities are avoidable by reasonable means, and thus preventable, and the Programme should improve the knowledge on health inequalities and inequities to tackle them.
Amendment 267 #
Proposal for a regulation
Recital 17 b (new)
Recital 17 b (new)
(17b) Early detection and screening plays a crucial role in prevention strategies and in timely treatment and health outcomes. Prevention is key in achieving sustainable health systems by ensuring that citizens live disease-free longer and by reducing the pressure of preventable diseases, especially of non- communicable diseases, on health systems. In order to enhance the health status, well-being, and quality of life of Union citizens, primary care healthcare professionals, including community pharmacists, local authorities and citizens should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention, early diagnosis and screening strategies. This includes disease prevention services as part of primary healthcare services.
Amendment 295 #
Proposal for a regulation
Recital 18 c (new)
Recital 18 c (new)
(18c) The International Agency for Research on Cancer (IARC) considered classified diesel engine exhaust as carcinogenic to humans. The Programme should make sure that the health impacts and costs of air pollution are integrated into the Union action against cancer, while ensuring full coherence with the European zero emission strategy.
Amendment 307 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) Under Article 153 TFEU, the Union is to support and complement the activities of Member States concerning improvement of the working environment, and protection of workers' health, safety and working conditions. Considering the large amount of time that the workers spend in their workplaces and the possible risk they could have, such as exposure to health hazard substances and carcinogens and to repeated movements, leading to a high burden of incapacity and number of work days lost, which in turn has consequences for the individual, family and society. The Programme should also reflect the importance of occupational health and its impact on health workers and societies. The Commission should work with Member States to create new legislation to improve workers health conditions, improve their working conditions, the balance between work and life, promote wellbeing and better mental health, prevent early-retirement due to ill health and poor health management.
Amendment 373 #
Proposal for a regulation
Recital 24
Recital 24
(24) Since environmental pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem that can impact on public health, the Programme should foster measures to strengthen the assessment and appropriate management of environmental risks associated with the production, use and disposal of medicinal products, in line with the European Union Strategic Approach to Pharmaceuticals in the Environment15 . The Programme will reinforce the need to have health impact assessments in the EU policies and should promote health promotion and protection in all EU policies, taking into account the European Green Deal, The Farm to Fork Strategy, The Biodiversity Strategy and the Pharmaceutical Strategy for Europe and others. __________________ 15Communication of the Commission to the European Parliament, the Council and the European economic and Social Committee ‘European Union Strategic Approach to Pharmaceuticals in the Environment’, COM(2019)128 final of 11.03.2019.
Amendment 453 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) protect people in the Union from serious cross-border threats to health; implement better preparedness and coordination within and between Member States as regards health emergencies;
Amendment 460 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) support existing and future Union health legislation, improve the availability in the Union of medicines, vaccines, medical devices and other crisismedical relevant products, contribute to their affordability, and support innovation and e-health solutions, contribute to their accessibility, sustainability and affordability, and support research, innovation and development in health and healthcare;
Amendment 486 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3a) support systematic health impact assessment of other EU policies ensuring a comprehensive, Health in All Policies approach;
Amendment 502 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Article 4 – paragraph 1 – point 1
(1) strengthen the capability of the Union for prevention, preparedness and response to serious cross-border threats to health, and the management of health crises, including through coordination, provision and deployment of emergency health care capacity, data gathering and, surveillance and health risk assessment;
Amendment 520 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3
Article 4 – paragraph 1 – point 3
(3) support actions to ensure appropriate availability, accessibility, sustainability and affordability of crisis relevant productmedicines, vaccines, medical devices and other necessary health supplies, stimulate the development of the health production industry within the Union;
Amendment 528 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3 a (new)
Article 4 – paragraph 1 – point 3 a (new)
(3a) support the research and development of new medicines, medical devices and health products, enhance clinical trials and research based on real world data;
Amendment 574 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6 a (new)
Article 4 – paragraph 1 – point 6 a (new)
(6a) strengthen the programmes to fight against communicable diseases and health threats, as AMR, HIV/AIDS, tuberculosis, hepatitis, influenza, sexually transmitted infections among others, promoting healthy lifestyles, premature detection, access to treatment and long- life care;
Amendment 578 #
Proposal for a regulation
Article 4 – paragraph 1 – point 7
Article 4 – paragraph 1 – point 7
(7) foster and support the informed, prudent and efficient use of medicines, and in particular of antimicrobials, and more environmentally friendly production and disposal of medicines and medical devicesinvest in the protection of the environment and sustainability in the whole value chain of all medicines, vaccines, medical devices and other medical products, from the production to the disposal, guaranteeing that an environmental risk assessment for such products is carried out;
Amendment 590 #
Proposal for a regulation
Article 4 – paragraph 1 – point 9
Article 4 – paragraph 1 – point 9
(9) support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, the identification of health technologies meant to benefit from a European assessment, and scaling up networking through the European Reference Networks and other transnational networks aiming to increase the coverage of patients and the response to more diseases and health problems;
Amendment 736 #
Proposal for a regulation
Annex I – point d – point xi a (new)
Annex I – point d – point xi a (new)
(xia) Systematic health impact assessment of other Union policy actions;
Amendment 778 #
Proposal for a regulation
Annex I – point f – point vii a (new)
Annex I – point f – point vii a (new)
(viia) Establishment and operation of a mechanism responsible for procurement and development of countermeasures against biological threats, including bioterrorism, and chemical, nuclear and radiological threats;
Amendment 784 #
Proposal for a regulation
Annex I – point f – point viii a (new)
Annex I – point f – point viii a (new)
(viii a) Support action regarding epidemiological surveillance, focusing on national health entities, thus contributing to assessment of factors that affect or determine the health of citizens;
Amendment 833 #
Proposal for a regulation
Annex I – point g – point xiii a (new)
Annex I – point g – point xiii a (new)
(xiiia) Support actions to combat all types of discrimination concerning patients and to ensure that there is equal access for all to health;
Amendment 838 #
Proposal for a regulation
Annex I – point g – point xiii c (new)
Annex I – point g – point xiii c (new)
(xiiic) Improve the current monitoring system of the Union to measure the extent of healthcare exclusion, collect data and report publicly on access barriers experienced by patients, and develop more accurate indicators where needed to capture these;
Amendment 839 #
Proposal for a regulation
Annex I – point g – point xiii d (new)
Annex I – point g – point xiii d (new)
(xiiid) Support Member States’ actions to boost health education and health literacy, creating well-informed societies, enhancing healthier lifestyles;
Amendment 842 #
Proposal for a regulation
Annex I – point g – point xiii g (new)
Annex I – point g – point xiii g (new)
(xiiig) Support action to reduce health inequalities and inequities and reduce the unmet needs of vulnerable people, people living with chronic diseases, disabilities or incapacities;
Amendment 885 #
Proposal for a regulation
Annex I – point h – point v a (new)
Annex I – point h – point v a (new)
(va) Support equal and timely access to truly innovative medicines and therapies;
Amendment 941 #
Proposal for a regulation
Annex I – point i – point iv
Annex I – point i – point iv
(iv) Support action to ensure greater availability and affordability in the Union of medicines, vaccines, and medical devices and contribute to their affordability for patients and health systems, using the Union mechanism as joint procurement at the same time enhance the transparency of the process;
Amendment 949 #
Proposal for a regulation
Annex I – point i – point v
Annex I – point i – point v
(v) Support action to encourage the development of innovative products andion of less commercially interesting products such as antimicrobial; encourage the development of medicines for rare diseases and making access to them affordable, and investment in the research and development of new antimicrobials and other medicines to fight against communicable diseases;
Amendment 951 #
Proposal for a regulation
Annex I – point i – point v a (new)
Annex I – point i – point v a (new)
(va) Support actions to implement models of R&D and IP ownership and management which prioritise the public interest and ensure that there are societal benefits, for example by including binding safeguards to ensure availability, accessibility and affordability of medical products developed with public funds;
Amendment 1014 #
Proposal for a regulation
Annex I – point k – point iii b (new)
Annex I – point k – point iii b (new)
(iiib) Communication activities aimed at fighting against misinformation and disinformation, such as fake news, regarding medicines, vaccines, health products, causes and treatments of diseases;
Amendment 1026 #
Proposal for a regulation
Annex II – part B – point 1 a (new)
Annex II – part B – point 1 a (new)
1a. Number of strategic reserves of medicines, vaccines, medical devices and other medical products
Amendment 1027 #
Proposal for a regulation
Annex II – part B – point 1 b (new)
Annex II – part B – point 1 b (new)
1b. Number of strategic reserves of health professionals with training and preparedness to respond to health threats and health crises