48 Amendments of Ondřej KNOTEK related to 2020/2071(INI)
Amendment 4 #
Motion for a resolution
Citation 7 b (new)
Citation 7 b (new)
- having regard to the Council Conclusions of 8 June 2010 on ‘Equity and Health in All Policies: Solidarity in Health’,
Amendment 27 #
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demand has aggravated shortages of medicines in the EU, undermining health services in the Member States and exposing patients to considerable risks; whereas in France, 1 450 cases of unavailability of medicines were noted in 2019 compared to 44 cases in 2008; whereas in the Netherlands, the number of drug stock-out cases almost doubled in 2019, with 1,492 cases recorded, compared to 769 in 2018; whereas in the Czech Republic, 2,208 products suffered from a supply disruption in 2019, compared to 1,630 in 2018 and 19 in 2008; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 41 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the Charter of Fundamental Rights of the European Union recognises the fundamental right of citizens to health and medical treatment;
Amendment 59 #
Motion for a resolution
Recital A f (new)
Recital A f (new)
Af. whereas the entry of generics and biosimilars into the market is an important mechanism for increasing competition, reducing prices and ensuring the sustainability of healthcare systems; whereas their market entry should not be delayed;
Amendment 60 #
Motion for a resolution
Recital A g (new)
Recital A g (new)
Ag. whereas the COVID-19 crisis has exacerbated the EU’s long-existing structural problems related to the supply of medicines, and the dependency on third-country import for medicines and medical materials;
Amendment 63 #
Motion for a resolution
Recital B
Recital B
B. whereas medicines to treat cancer, infections and disorders of the nervous system account for more than half of those in short supply; whereas injectable specialties appear to be the most vulnerable to the risk of shortage due to the complexity of their manufacturing process;
Amendment 114 #
Motion for a resolution
Recital D
Recital D
D. whereas the consequence of growing demand coupled with price suppression is the concentration of active pharmaceutical ingredients supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 123 #
Motion for a resolution
Recital E
Recital E
E. whereas stocks of ‘strategic’ medicinmedicinal products of major therapeutic interest are inadequatecurrently insufficient, with chemicals that are cheap and easy to produce and matureolder, yet essential medicines being in particularly short supply; whereas pharmaceutical firms operate on a just-in- time basis;
Amendment 160 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority, stockpiling in some Member States is leading to a market imbalance and could, in the event of a health crisis, question the principle of solidarity;
Amendment 209 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the importance of putting the patient at the centre when addressing the problem of medicines shortages and 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;
Amendment 246 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for health policies to focus on patients’ health and interests and for closer cooperation between Member States;
Amendment 259 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Recalls that medicines shortages have a direct impact on patients' health, safety and the continuation of their treatment; stresses that for patients, the consequences of drug shortages include: progression of the disease and / or worsening of symptoms due to delay in treatment, avoidable transmission of infectious diseases, increased risk of exposure to falsified medicines and significant psychological distress for patients and their families;
Amendment 261 #
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Notes that the risks are particularly high amongst vulnerable populations such as children, the elderly, pregnant women, people affected by a disability, patients with chronic diseases or cancer or people in intensive care unit (ICU);
Amendment 264 #
Motion for a resolution
Paragraph 3 e (new)
Paragraph 3 e (new)
3e. Calls for the launch of a Joint Action on the prevention of shortage of medicines which would be funded by the future Health Program; considers that this Joint Action would allow an exchange of good practices between the Member States and the development of common prevention measures;
Amendment 278 #
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 manufacturing, giving priority to essential and strategic medicinesmedicinal products of major therapeutic interest ; calls on the Commission to map out potential production sites in the EU and their production capacity; suggests that the Commission also draw up a map of the production sites established in third countries;
Amendment 284 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needednecessary actions to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicinesmedicines including those which can not be substituted; calls on the Commission to map out potential production sites in the EU;
Amendment 295 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission and the Member States to set up a Task Force responsible for ensuring a constant inventory of the origin and production capacities of manufacturers in terms of active pharmaceuticals ingredients (APIs) and finished medicines,; considers that this independent body could establish and manage a database to prevent and steer European actions to avoid tensions or shortages on medicinal products of major therapeutic interest; stresses that this Task Force could ultimately assess the specific needs of medicinal products of major therapeutic interest of each Member State;
Amendment 307 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating tomake recommendations on ways to improve the availability and accessibility of medicines and to propose solutions to reduce manufacturers’ dependence on third countries in its next pharmaceutical and industrial strategies;
Amendment 315 #
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; shortage mitigation strategies should be included and health economic analysis should be considered;
Amendment 325 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. calls on the Commission to present a specific strategy for managing shortages of medicines and medical products in Europe;
Amendment 339 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversificationorder to diversify resources and encourage the development of innovative production technologies capable of enhancing the responsiveness of production lines, in particular the continuous manufacturing process;
Amendment 341 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce tax and financial incentivesincentives to support the diversification of supply in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversification;
Amendment 365 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Stresses that the pharmaceutical sector remains an important industrial pillar as well as a driving force in terms of job creation;
Amendment 434 #
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 importancemedicinal products of major therapeutic interest for health care; stresses the key contribution that can be made by new technologies, digitalization and artificial intelligence in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 471 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls for strengthening of the European Medicines Market to speed up patient access to medicines, make care more affordable, maximise savings in national health budgets and avoid administrative burdens for generic and biosimilar companies ;
Amendment 475 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Points out that generic and biosimilar medicines enable increased competition, reduced prices and savings for healthcare systems, thus helping to improve access to medicines for patients
Amendment 479 #
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Deplores the litigation cases aiming to delay generic entry; calls on the Commission to ensure that the end of the innovator's period of commercial exclusivity is respected;
Amendment 481 #
Motion for a resolution
Paragraph 11 d (new)
Paragraph 11 d (new)
11d. Stresses that the added value and economic impact of biosimilar medicines on the sustainability of healthcare systems should be analysed, their market entry should not be delayed, and, where necessary, measures to support their introduction to the market should be examined;
Amendment 508 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management to bring about greater transparency in the distribution chain and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supplysupply disruptions;
Amendment 514 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Welcomes the recent creation green lanes, set up to facilitate the transport of all goods, in order to allow the smooth running of the transport not only of medicines but also of raw materials, intermediate products and related materials, including packaging;
Amendment 518 #
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12c. Calls for the introduction of a specific statute for certain mature medicines which would be accompanied by incentives for manufacturers to maintain their marketing on the European market and ensure diversification of European production;
Amendment 519 #
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12d. Encourages the development of shortage prevention and management plans across all Member States; believes that these plans could result from an analysis of manufacturing and distribution risks and include measures on building up stocks, diversifying sources of supply for raw materials and creating other manufacturing sites to ensure resilience from production;
Amendment 520 #
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12e. Underlines that several Member States have already established alert systems which facilitate the anticipation and prevention of shortages; calls for the establishment of alert systems to anticipate shortage of medicines at national and European levels;
Amendment 579 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Calls for the adoption of common definitions of 'supply disruption' and 'stock-out' of medicines as well as a grid of criteria for assessing the risk associated with each of these situations;
Amendment 581 #
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Calls for the adoption of a common definition of 'medicinal products of major therapeutic interest' with reference to their usefulness in public health, the absence of an alternative and the fragility of the production chain;
Amendment 617 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for further invitations to tender to be issued at European level in an effort to counter shortages during time of crisis, as has been done following the onset of the COVID-19 virus, with simplified procedures in the interests of improved response times;
Amendment 640 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital monitoring platform for sharingreporting and notifying harmonised information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipm, including manufacturers, wholesalers and pharmacists regarding shortages of medicines and medical equipment; such a platform should be efficient, user-friendly and transparent; 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 659 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Recommends the development of a catalogue of shortages in all the Member States which would allow the EMA to easily update its public catalogue of shortages assessed by its Committee for Medicinal Products for Human Use (CHMP) and / or its Committee for the pharmacovigilance risk assessment (PRAC);
Amendment 683 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Considers it essential to improve early communication with healthcare professionals and patients on medicine availability through the use of innovative digital tools providing real-time data on the availability, location, quantity and price of a given medicine, in compliance with data protection legislation; recommends the inclusion of information for healthcare professionals on available alternative;
Amendment 688 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Recalls that misinformation can lead to inappropriate use of medicines and the creation of unnecessary stockpiling;
Amendment 697 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic product information noticeleaflet to be drawn up in all the Union languages for everyall the Member States where the medicine on the EUis marketed, in order to facilitate salesthe moving of medicines between Member Statwithin the Single Market to prevent and mitigate shortages; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 710 #
Motion for a resolution
Subheading 3 a (new)
Subheading 3 a (new)
Preventing and responding to shortages in the event of health crises
Amendment 711 #
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
Amendment 722 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission to create a European strategic reserve of medicinal products of major interest, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods; believes that the EMA could be the European regulatory authority responsible of this strategic reserve in order to prevent shortages of these medicines;
Amendment 726 #
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Stresses that its resolution of 17 April 2020 calls for the creation of a European Health Reaction Mechanism (EHRM) to respond to all types of health crises, to ensure operational coordination at European level, to restore European sovereignty over products health and to strengthen European cooperation in research and innovation; considers that this mechanism could monitor the constitution and the triggering of the strategic reserve of medicines and ensure its proper functioning within the Union;
Amendment 728 #
Motion for a resolution
Paragraph 21 c (new)
Paragraph 21 c (new)
21c. Recalls that its resolution also calls for the competences, budget and staffing of EMA to be substantially increased in order to allow it to coordinate medical responses in times of crisis; considers it essential that EMA has solid governance to meet future challenges such as monitoring and responding to shortages in coordination with the Member States; underlines that, in the long term, EMA should be able to make conditional marketing authorizations upon guarantees of supply and accessibility from manufacturers; hopes that the reinforcement of the staff of EMA will enable it to carry out inspections of production sites established in third countries;
Amendment 730 #
Motion for a resolution
Paragraph 21 e (new)
Paragraph 21 e (new)
21e. Considers that in the event of a health crisis the closure of borders and customs controls cannot constitute an obstacle to cross-border movement of medicinal products of major interest within the Union; calls on the Commission and the Member States to set up secure and rapid procedures for checking products at the border during a health crisis in compliance with EU law;
Amendment 736 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Welcomes, 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 on the Commission to monitor strictly the use of these arrangements and to keep them available in the event of problems or shortages;