Activities of Sirpa PIETIKÄINEN related to 2020/0102(COD)
Plenary speeches (1)
Programme for the Union's action in the field of health for the period 2021-2027 (“EU4Health Programme”) (debate)
Amendments (17)
Amendment 118 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) While the treaties oblige the EU to improve public health, preventing physical, and mental illness and diseases and obviating sources of danger to physical and mental health, the new and upcoming challenges, like COVID-19, have clearly shown that EU needs to take a stronger role ensuring the needed health policies are in place and health and wellbeing for its citizens because the Member States alone don´t have the adequate skills, capacities and resources to face the increasing and more complex health challenges.
Amendment 124 #
Proposal for a regulation
Recital 5
Recital 5
(5) On 11 March 2020 the World Health Organization (WHO) declared the novel SARS-CoV-2 coronavirus and associated respiratory disease (COVID-19) outbreak a global pandemic. That pandemic has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering, and more specifically the severe acute respiratory disease causing both premature death and chronic lung conditions that it involves, has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering, particularly affecting the most vulnerable, patients, people suffering from chronic diseases, women and carers.
Amendment 128 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) Women have been impacted disproportionately by the pandemic response measures and their long-term effects, must not compound existing inequities. Women across the lifespan remain under-represented in biomedical and health research and data. Consequently, the evidence base is weaker for women as well as for older people, many conditions are underdiagnosed in women, such as cardiovascular disease. Medicinal products are safer and more effective for everyone when clinical research studies include diverse population groups. To reduce inequalities and health disparities, sex and gender should be incorporated throughout the health process from design of clinical trial protocols, data analysis, health technology assessment and access to care.
Amendment 151 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) While the Union´s action in the field of health is limited, the Union should have the capacity to face future worrying realities and health threats, such as pandemics and cross-border threats, antimicrobial resistance, and also to support Member States in addressing the challenges of an ageing population, of chronic diseases, or disease prevention, in promoting a healthy lifestyle, including a sex, gender and age perspective and preparing their health systems for emerging technologies.
Amendment 167 #
Proposal for a regulation
Recital 10
Recital 10
(10) 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. Further developing the common European crisis preparedness, strategically sufficient manufacturing and stockpiling is essential. __________________ 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 178 #
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) To combat serious threats to the health of European citizens we need to establish communicable diseases regulation. Communicable diseases move freely within whole EU. In more complex and globalised world, the ability to respond to the challenges clearly requires a common regulation to face and tackle the border crossing diseases on EU level. Individual Member States cannot face these global challenges alone.
Amendment 201 #
Proposal for a regulation
Recital 13
Recital 13
(13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices, active pharmaceutical ingredients, as well as personal protective equipment needed in the Union during the pandemics. The Programme therefore should provide support to actions which foster the production, procurement and management of crisis relevant products ensuring complementarity with other Union instruments. Upgradable and scalable manufacturing capacity of medicines within European Union should be achieved, to avoid the hindrances in medicine circulation and shortages in supply.
Amendment 223 #
Proposal for a regulation
Recital 15
Recital 15
(15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility and resilience. In the context of such transformation and reforms, the Programme should promote, in synergy with the Digital Europe Programme, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster disease prevention and health promotion, to provide new care models and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs and ensure an efficient public health workforce equipped with the right skills, including digital skills. The development of a European health data space and of a European Electronic Health Record would provide health care systems, researchers and public authorities with means to improve the availability and quality of healthcare. Such European Health Record should be standardised, interoperable with different health data systems and accessible for the patients in all Member States with privacy ensured and information encoded into the European Health Insurance Card, EHIC. Given the fundamental right to access to preventive health care and medical treatment enshrined in Article 35 of the Charter of Fundamental Rights of the European Union and in view to the common values and principles in European Union Health Systems as set out in the Council Conclusions of 2 June 200612 the Programme should support actions ensuring the universality and inclusivity of health care, meaning that no-one is barred access to health care, and those ensuring that patients’ rights, including on the privacy of their data, are duly respected. __________________ 12Council Conclusions on Common values and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1).
Amendment 230 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) A regulation on patient's rights is needed to ensure the right to accessible, affordable and high quality patient- centred health care, including relevant, appropriate and value based medicinal care, right to affordable, effective medication, rehabilitation and support for care. The right to cross-border health care and adequate support services should be guaranteed. Patients' right to second opinions should also be ensured.
Amendment 233 #
Proposal for a regulation
Recital 15 b (new)
Recital 15 b (new)
(15b) It is important to guarantee equal access for patients in different Member States to effective therapeutics, treatments and prevent individual health care units from excessive and unreasonable costs when treating rare diseases. The Commission should therefore explore the possibility to establish a European fund, co-financed by the Member States, for negotiating and purchasing the orphan medicines and other new, personalised and experimental medication.
Amendment 244 #
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) Gender and sex sensitivity and knowledge needs to be improved in the education of health care professionals, the research, diagnosis, treatment and impact of medicines and therapeutics to better understand and treat both sexes.
Amendment 245 #
Proposal for a regulation
Recital 16 b (new)
Recital 16 b (new)
(16b) Training for health care professionals and specialised health care facilities needs to be provided so that the needs of groups such as LGBTIQ, Roma and other groups with special needs can be met.
Amendment 246 #
Proposal for a regulation
Recital 16 c (new)
Recital 16 c (new)
(16c) The programme should provide easy access to basic healthcare to all. Low-threshold guidance, counselling, and access to preventive health care should be available to all citizens. Family doctor system for necessary health checks to provide preventive healthcare should be promoted. Adequacy of this capacity should be monitored in the European Semester.
Amendment 305 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) It is well recognised that cancer is often diagnosed late, which means that fewer treatment options are available for people affected by an advanced stage of the disease. If more patients were diagnosed earlier, it could lead to much more effective treatment outcomes, better quality of life, as well as improved overall survival rates. An earlier diagnosis means also a reduction in the healthcare burden. Compared to early diagnosis, cancer screening is a distinct and more complex public health strategy that mandates additional resources, infrastructure and coordination. When planned effectively, appropriately financed and implemented, screening can reduce deaths from cancer and, in the case of some cancer types, can also reduce the risk of developing cancer. The Programme should therefore contribute to the investment in early diagnosis and screening, and to promotion and awareness raising in relation to the benefits of such early diagnosis and screening. The EU should have extensive cancer screening recommendations and guidelines for all major cancers to be implemented in all Member States.
Amendment 339 #
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, 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 and treatment, promote incentives to develop such medicinal products as antimicrobialsboost the production capacity for antimicrobials, personalized medicines and care, treatment and vaccination, and foster the digitial transformation of health care products and platforms for monitoring and collecting information on medicines. The programme should also strengthen decision-making on medicines by enabling access to and analysis of real- world healthcare data by regulators and HTA bodies. The Programme should also help to ensure best use of research results and facilitate the uptake, scaling-up and deployment of health innovation in health care systems and clinical practice. In 2020, the Commission announced the ‘Pharmaceutical strategy for Europe’ with the overall goal of helping to ensure the Union’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts in the Union and globally. The Programme should support the implementation of the Pharmaceutical strategy for Europe.
Amendment 364 #
Proposal for a regulation
Recital 23
Recital 23
(23) As the optimal use of medicines and antimicrobials in particular yields benefits for individuals and health systems, the Programme should promote their prudent and efficient use. In line with the European One Health Action Plan against Antimicrobial Resistance14 , adopted in June 2017 following the request from Member States, and given the experience with the bacterial secondary infections related to COVID 19, it is essential that the Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops, in the framework of an integrated policy on patient safety and prevention of medical errors. Regulation (EU) 2019/6 on veterinary medicinal products should be reviewed in this regard to use antibiotic medicinal products and other medication only for treatment of disease prescribed by a veterinary for a limited period of time and not to be used for prophylaxis. __________________ 14Communication from the Commission to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017.
Amendment 383 #
Proposal for a regulation
Recital 26
Recital 26
(26) Cross-border cooperation in the provision of healthcare to patients moving between Member States, collaboration on health technology assessments (HTA), and European Reference Networks (ERNs) are examples of areas where integrated work among Member States has shown to have strong added value and great potential to increase the efficiency of health systems and thus health in general. The Programme shouldose are examples of areas where integrated work among Member States has already been shown to have strong added-value and great potential to increase ther efore support activities to enable such integrated and coordinated work, which alsoficiency of health systems and thus of health in general. Nevertheless, those areas are not yet developed, not in terms of Union legislation, nor its implementation or resources. The Programme should therefore aim at ensuring that such integrated and coordinated work is developed and implemented to its full potential in areas such as HTA and ERN. That work would serves to foster the implementation of high-impact practices that are aimed at distributing in the most effective way the available resources to the concernedrelevant sector of the population and areas so as to maximise their impact, reducing inequalities, through the consideration of sex, gender and age and the establishing of a Reference Network for safe use of medicines in pregnancy and lactation.