80 Amendments of Bernard GUETTA related to 2020/2071(INI)
Amendment 3 #
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
- having regard to the assessment report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of 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,
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 5 #
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
- having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC,
Amendment 9 #
Motion for a resolution
Citation 14 a (new)
Citation 14 a (new)
- having regard to Commission communication of 27 May 2020 on "Europe's moment: Repair and Prepare for the Next Generation",
Amendment 10 #
Motion for a resolution
Citation 14 b (new)
Citation 14 b (new)
- having regard to Commission communication of 27 May 2020 on "The EU budget powering the recovery plan for Europe",
Amendment 14 #
Motion for a resolution
Citation 23
Citation 23
— having regard to Report No 737 of 27 September 2018 entitled ‘Shortages of medicines and vaccines: focusing more closely on public health issues in the medicine supply chain’, drawn up by Jean- Pierre Decool on behalf of the French Senate fact-finding mission on the shortage of medicines and vaccines, which is inspired by the report of the French Academy of Pharmacy of 20 June 2018 on the unavailability of medicines,
Amendment 18 #
Motion for a resolution
Citation 24 a (new)
Citation 24 a (new)
- having regard to the Commission communication of 11 December 2019 on ‘The European Green Deal’,
Amendment 19 #
Motion for a resolution
Citation 24 b (new)
Citation 24 b (new)
- having regard to its resolution of 15 January 2020 on the European Green Deal,
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 51 #
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas ensuring patient access to essential medicines is one of the core objectives of the EU and the WHO, and of Sustainable Development Goal 3; whereas universal access to medicines depends on their timely availability and their affordability for everyone, without any geographical discrimination;
Amendment 55 #
Motion for a resolution
Recital A c (new)
Recital A c (new)
Ac. whereas patients should have access to the healthcare and treatment options of their choice and preference;
Amendment 57 #
Motion for a resolution
Recital A d (new)
Recital A d (new)
Ad. whereas pharmaceuticals are one of the pillars of healthcare, and whereas insufficient access to essential medicinal products and high prices of innovative medicines pose a serious threat to population health and to the sustainability of national health care systems;
Amendment 58 #
Motion for a resolution
Recital A e (new)
Recital A e (new)
Ae. whereas, in many cases, the prices of new medicines, notably cancer treatments, have increased during the past few decades to the point of being unaffordable to many EU citizens
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 73 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas shortage of medicines destabilizes the organization of care and generates high human and financial costs;
Amendment 76 #
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas access to suitable and affordable diagnostic tests and vaccines is as vital as access to safe, effective and affordable medicines;
Amendment 124 #
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 mature 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 173 #
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 combination with globalisation and increased travel; whereas European surveillance has been strengthened on vector-borne diseases such as Malaria, Dengue, Chikungunya, Zika and West Nile viruses;
Amendment 198 #
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, diagnostic tools, vaccines, medical devices and medical equipment;
Amendment 211 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Recalls that shortage of medicines is a global challenge; stresses that developing countries, such as a number of African countries, are the most affected by these shortages; urges that access to medicines in developing countries be tackled in a wider context in the WHO framework ; calls on the Commission and the Member States to increase their support to developing countries, in particular through the rescUE strategic reserve;
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 256 #
Motion for a resolution
Subheading 1
Subheading 1
Securing supplies in the interests of patients and restoring health sovereignty
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 262 #
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Underlines that a higher price of the substitute medicine proposed to the patient, a lower reimbursement rate or the lack of reimbursement constitute in several Member States major obstacles to access to medicines for populations with low incomes or suffering from chronic conditions ; calls on the Member States to guarantee access to a substitute medicine at an equivalent price or subject to a similar reimbursement in the event of a supply shortage;
Amendment 263 #
Motion for a resolution
Paragraph 3 d (new)
Paragraph 3 d (new)
3d. Welcomes the publication of the call for tenders launched by DG SANTE for a study on the causes of shortage of medicines in the Union; calls, however, for another study to be carried out on the impacts of drug shortages on patient care, treatment and health;
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 265 #
Motion for a resolution
Paragraph 3 f (new)
Paragraph 3 f (new)
3f. Stresses that patient associations should be more involved in defining research strategies for public and private clinical trials, in order to ensure that they meet the unmet needs of European patients;
Amendment 266 #
Motion for a resolution
Subheading 1 a (new)
Subheading 1 a (new)
Restoring health sovereignty
Amendment 267 #
Motion for a resolution
Paragraph 3 k (new)
Paragraph 3 k (new)
3 k. Recalls that no Member State is self-sufficient with regard to raw materials, intermediates, active pharmaceutical ingredients (APIs) and finished medicines necessary to guarantee the proper functioning of the health system;
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 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 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 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 368 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Recalls that Articles 81 and 23a of Directive 2001/83/EC establishing a Community Code relating to medicinal products for human use have laid down general obligations for the supply of medicinal products to be borne by marketing authorization holders (MAHs) and distributors, as well as a notification obligation for MAHs in the event of a temporary or permanent supply interruption;
Amendment 375 #
Motion for a resolution
Paragraph 6 c (new)
Paragraph 6 c (new)
6c. Regrets, however, the disparities observed by the EMA in the transposition of these obligations into national legislations;
Amendment 379 #
Motion for a resolution
Paragraph 6 d (new)
Paragraph 6 d (new)
6d. Considers that the European Green Deal constitutes a major opportunity to encourage pharmaceutical manufacturers to participate to the green recovery plan by producing in compliance with environmental and ecological standards;
Amendment 380 #
Motion for a resolution
Paragraph 6 e (new)
Paragraph 6 e (new)
6e. Calls for the revision of Directive 2001/83/EC establishing a Community code relating to medicinal products for human use in order to ensure the notification of shortages, to strengthen the obligations incumbent on marketing authorization holders (MAHs) and to be able to ensure compliance with all of the obligations of actors in the drug supply chain;
Amendment 381 #
Motion for a resolution
Paragraph 6 f (new)
Paragraph 6 f (new)
6f. Calls on the Commission and the Member States to encourage marketing authorisation holders (MAHs) to build up and manage rolling stocks of medicines of major therapeutic interest in the form of finished products; considers that several months of rolling stocks would make it possible to absorb the supply shortfalls and avoid the losses linked to the expiry of the medicines;
Amendment 382 #
Motion for a resolution
Paragraph 6 g (new)
Paragraph 6 g (new)
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 455 #
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; highlights the role of European projects and SMEs in improving access to medicines in the Union; underlines the crucial role of the Horizon Europe program in this respect;
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 484 #
Motion for a resolution
Paragraph 11 e (new)
Paragraph 11 e (new)
11e. Calls on the Member States to adopt a common position and start negotiations on the proposal for a Regulation of the Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU;
Amendment 485 #
Motion for a resolution
Paragraph 11 f (new)
Paragraph 11 f (new)
11f. Calls on the Commission to present a revision of Directive 89/105 /EEC on the transparency of measures regulating the prices of medicinal products in order to ensure effective controls and full transparency of the procedures used to determine the prices and reimbursement of medicines in the Member States;
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 517 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Calls for the establishment of European lists of 'medicinal products of major therapeutic interest' along the lines of the 'WHO model list of essential medicines'; suggests that the EMA shortage risk indicators (manufacturing and quality) be used to identify high risk products,
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 541 #
Motion for a resolution
Paragraph 14
Paragraph 14
Amendment 561 #
Motion for a resolution
Paragraph 15
Paragraph 15
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 582 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission and Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; 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 613 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for further invitations to tender to be issuedjoint procurements at European level in an effort to counter shortages, as has been done following the onset of the COVID-19 virus, with simplified and transparent procedures in the interests of improved response times;
Amendment 621 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls for the full and rapid application of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials for medicinal products for human use; considers that this Regulation would facilitate the launch of large clinical trials carried out in a harmonised and coordinated manner at EU level;
Amendment 633 #
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Notes that the differences in the price of a medicine from one Member State to another have led to the development of parallel exports, which can increase the risk of supply stress and cause of shortages; recalls that the free movement of goods within the Union allows certain wholesaler-distributors called "short-liners" to buy medicines in one Member State and to resell them more expensive in neighbouring countries; calls for the adoption of preventive measures to limit the parallel trade of medicines within the Union;
Amendment 658 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital monitoring platform for sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; 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 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 701 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic information notice to be drawn up in all the Union languages for every medicine on the EU market via bar or matrix codes, in order to facilitate sales of medicines between Member States and to fight against parallel trade; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 708 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Condemns the exploitation of shortages for criminal purposes; recalls that counterfeiting or falsification of medicines and medical products worsens supply tensions; calls for the strengthening of measures to combat these practices: the control of online platforms offering drugs, the strengthening of cooperation between relevant EU and national agencies and the respect of the victims’ rights;
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 729 #
Motion for a resolution
Paragraph 21 d (new)
Paragraph 21 d (new)
21d. Recalls that a company that markets a medicine can enjoy data exclusivity for a period of eight years as of the first marketing authorization according to Article 14(11) of the Commission Regulation No. 726/2004; calls on the Commission to propose a revision of this regulation to temporarily authorize the granting of compulsory licenses in the event of a health crisis in order to allow a producer to market a generic medicine;
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;