24 Amendments of César LUENA related to 2020/2071(INI)
Amendment 2 #
Motion for a resolution
Citation 7
Citation 7
— having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and the obligations set out in Article 81 thereof concerning an adequppropriate and uninterrupted supply of medicinal products,
Amendment 7 #
Motion for a resolution
Citation 13
Citation 13
— having regard to the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (COM(2018) 0051), and to the European Parliament legislative resolution of 14 February 2019 on said proposal;
Amendment 39 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas medicine shortages may be due to manufacturing problems, such as standards regarding good manufacturing practice, insufficient stocks available for a given market or economic reasons; whereas in certain cases medicine shortages can occur either because of illegitimate business strategies, such as ‘pay for delay’ in the pharmaceutical sector, or political, manufacturing or distribution issues, or parallel trade;
Amendment 171 #
Motion for a resolution
Recital I
Recital I
I. whereas the greater number, geographical spread and impact of epidemics is partly attributable to climate change, in combinapproximately two-thirds of human active infectious diseases are zoonotic, i.e. transmitted by animals and that these diseases have increased globally in the past 60 years; whereas human activity and its environmental footprint are at the origin of the multiplication of epidemics owing, inter alia, to deforestation and changes in land use, anthropogenic climate change, the management of the systems of food production and agriculture, the trafficking in wild species, the adoption of wild animals as pets and urbanisation; withhereas globalisation and increased travel exacerbate the incidence of these pathogens and contribute to their geographic spread;
Amendment 177 #
Motion for a resolution
Recital J
Recital J
J. whereas the destruction of biodiversity, the proliferation of man-made habitats and damage to natural areas densely populated by humans are facilitating the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens; whereas human and animal health are interdependent and both depend on environmental health and the good condition of the ecosystems in which they interact; whereas in order to minimise future risks there is a need for a collaborative approach to tackle anthropogenic changes to ecosystems and the link to the increased risk of infectious diseases emerging and of their dissemination;
Amendment 206 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines and medical equipment; stresses the need to boost European manufacture of key products such as health products, medicines and active ingredients;
Amendment 220 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, that while public health policies are a Member State matter, it is the incumbent upon the EU to coordinate and complement national measures to guarantee affordable and high- quality health services for European citizens; underlines that the current crisis has highlighted the divergences in matters of health between Member States in areas such as minimum health standards and the provision of medical devices and medicines; considers it necessary to increase the competence of the European Union in health matters through the creation of an EU Health Union which would address subjects such as joint procurement or minimum standards for the quality of health systems;
Amendment 240 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for health policies to focus on patients' interests and for closer cooperation between Member States and for promoting greater dialogue between the main stakeholders in order to facilitate the exchange of best practices;
Amendment 270 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturingadopt the necessary legislative measures and policies to promote manufacturing in Europe so as to ensure a secure supply and reduce dependency on third countries, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU;
Amendment 314 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers’ dependence on third countries; calls on the Commission to pay special attention to the possibility of a no- deal Brexit and the ramifications it can cause in medical trade and supply; calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy;
Amendment 330 #
Motion for a resolution
Paragraph 6
Paragraph 6
Amendment 355 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Recalls that Article 81 of Directive 2001/83/EC stipulates measures to prevent pharmaceutical shortages by means of a so-called public service obligation (PSO), which obligates manufacturers and distributors to safeguard supplies to national markets; recalls further that, in many cases, the PSO is not applied to manufacturers supplying the distributors, as indicated in a study commissioned by the Commission; stresses that Article 23a requires a holder of the marketing authorisation who ceases production to report all data relating to the volume of sales and prescriptions of the medicinal product to the competent authorities so that they may notify any potential shortages in advance; calls, in this regard, for the effective implementation of the existing regulatory requirements by all actors in the supply chain at national and European level, along with measures to increase transparency in the supply chain;
Amendment 372 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Calls on the Commission to monitor compliance with Article 81 of Directive 2001/83/EC on supply shortages and to take action to remedy the shortcomings resulting from failure to comply with legislative obligations such as, for example, the imposition of financial penalties for failure to report on the interruption of supply or failure to comply with the public service obligation;
Amendment 376 #
Motion for a resolution
Paragraph 6 c (new)
Paragraph 6 c (new)
6c. Calls on the Commission to develop a clear definition of medicine shortages or scarcities and to address all the causes of shortages together with the Member States; calls on the Commission, in this regard, to submit a report on the impact of parallel trade and supply quotas, to explore mechanisms to address the withdrawal of effective medicines from the market for purely commercial reasons and to establish a mechanism for reporting annually on shortages of medicines across the EU;
Amendment 377 #
Motion for a resolution
Paragraph 6 d (new)
Paragraph 6 d (new)
6d. Urges the Commission to establish and update together with the Member States, the EMA and the relevant stakeholders a list of essential/critical medicines in line with the WHO list, for which there should be a mandatory supply reserve to meet the needs of patients and which it should not be possible to export (e.g. vaccines) provided that the export restriction is necessary in the interest of public health and to mitigate the risk of medicine shortages; calls in this regard for the establishment of procedures for prior notification/export authorisation by wholesalers on a pre-defined list;
Amendment 430 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to create one or more European non-profit pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importance for health care in all Union countries irrespective of economic or spatial differences; stresses the key contribution that can be made by new technologies and artificial intelligence with proper data protection safeguards in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 452 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the importance of research and innovation, and calls for the establishment of a genuine European network, given that the price of relocation must not be a deterioration in the quality of medical research; calls on the Commission to provide increased financial resources under Horizon Europe and other EU programmes to strengthen support for rare diseases through increased research, clinical trials, best practices sharing, and medication development; insists that best practices, clinical trials, and medication pertaining to rare diseases be available to all citizens regardless of their Member State;
Amendment 533 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections whose prices are harmonised, in a bid to counter recurrent shortages and ensure that patients have access to treatment;
Amendment 549 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to create a European contingency reserve of medicines of strategic importance for health care, supplies of which are critical, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods; insists that the use of such a reserve be transparent, accountable, and fair for all Member States;
Amendment 592 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission and Member States to ensure the setting up of common, European medical stocks; calls on the Commission and the Member States to develop innovative and coordinated joint strategies and to step up exchanges of good practice in the area of stock management; stresses that ensuring all Member States have fair and transparent access to these stocks through joint European coordination is crucial to managing vulnerabilities and risks to the supply chain; considers that the European Medicines Agency (EMA) could be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff;
Amendment 651 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform for sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; insists that such a digital platform be in strict compliance with the most recent data protection legislation; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be improved so as to provide a clear overview of problems, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 713 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. WelcomNotes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, longer expiry periods, use of veterinary medicinal products, etc.; calls onasks the Commission to monitor strictly the use of these arrangements and to keep ensure that these solutions do not become the norm and are used only on grounds of health em available in the event of difficulties or shortageergencies and are not motivated by commercial considerations;
Amendment 731 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Takes the viewRecalls that this crisis has tested the resilience of public health systems and that the pressures experienced currently pose an unprecedented challenge; takes the view, in this connection, that it is necessary to conduct a thorough examination of national health systems, specifically assessing the capacity of health care institutions to cope with high pressure situations, and that the introduction of stress tests to assess the resilience of public health systems in emergencies would provide an effective means of countering shortages in the event of pandemics and of identifying structural risk factors which go to create shortages;
Amendment 735 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Emphasises that the health systems of the Member States differ in nature depending on (i) the relationship between the public and private systems; (ii) the centralised/decentralised management and administration systems; (iii) whether there is co-payment or fully public funding; or (iv) health coverage; calls, therefore, on the Commission and the Member States to agree on the criteria based on which these stress tests should be carried out; calls on the Commission and the Council, on the basis of the results of these tests, to draw up recommendations addressed to the Member States (and, in certain cases, to their regions), in order to strengthen their health systems and to cover any essential needs that could arise in the event of a health emergency;