55 Amendments of Frédérique RIES related to 2020/2071(INI)
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 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 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 93 #
Motion for a resolution
Recital C
Recital C
C. whereas the loss of European sovereignty and independence in the health sector is linked to the relocation of production, with 40 % of medicinal end products marketed in the EU now originating in third countries; whereas the only way to save money is to rely heavily on subcontractors to produce pharmaceutical raw materials in Asia, where labour costs and environmental standards are lower, with the result that 80% of active ingredients are manufactured outside the EU, mainly in China and India; whereas India has itself become very dependent on China, despite its status as the largest producer of generic medicines in the world;
Amendment 94 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas this European dependence in the production chain for active pharmaceutical ingredients (APIs) is not irreversible - it is above all a question of the industrial and political choices to be made in order to approach the situation of 30 years ago, when only 20% of the raw materials for medicines came from third countries, and whereas it is satisfied to note that the complex active ingredients forming part of the composition of the most innovative medicines are still overwhelmingly manufactured in the EU;
Amendment 106 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas the price to be paid to secure the EU’s supply of medicines and meet basic needs of the population is far from insurmountable, since active ingredients account for around 10% of the price of a medicine protected by a patent and 40% of that of a generic;
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 134 #
Motion for a resolution
Recital F
Recital F
F. whereas there are no price harmo coexistence of the free movement of goods and the right of States to fix an administration arrangements to facilitate ‘parallel exports’ tove price for reimbursable medicines favours 'parallel importations' from Member States where medicines are cheap to other countries where the medicine in question is more expensive;
Amendment 144 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas in its resolution of 2 March 2017 (2016/2057 (INI) the European Parliament called on the Commission and the Council to better define the concept of a shortage of medicines - and to analyse its causes - and, in this regard, to assess the impact of the parallel trade and supply quotas;
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 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 225 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, that while public health policies are primarily a Member State matter, it is incumbent upon the EU to coordinate and complement national measures to guarantee affordable and high- quality health services for European citizens;
Amendment 244 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for health policies to focus on patients' interests and for closer cooperation and coordination between Member States;
Amendment 247 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the Commission to set up a platform bringing together health ministers and policy makers at European level, paying agencies, patient associations, industry and other relevant stakeholders in the healthcare supply chain, with the aim of establishing a pan- European political framework to prevent shortages, improve sustainable access to medicines for patients and boost the competitiveness of the European pharmaceutical industry; recommends that this platform be one of the practical proposals for the Commission's forthcoming pharmaceutical strategy;
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 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 349 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce, as a priority, tax and financial incentives in return for appropriate commitments and to authorise, on an exceptional and temporary basis, 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 352 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
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 394 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Urges the Commission, in the context of the EU public procurement Directive 2014/24/EU, to promptly propose ad-hoc guidance for Member States to support sustainable tenders practices for pharmaceuticals, where tender practices are used, notably on how to best implement the Most Economically Advantageous Tender (MEAT) criteria, looking beyond the lowest price criteria only, such as rewarding quality and security of supply investments;
Amendment 418 #
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; stresses the key contribution that can be made by new technologies and artificial intelligence in enabling European laboratory researchers to form networks and share their objectives and findings;
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 438 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Underlines the growing success of public/private partnerships, in particular the European Innovative Medicines Initiative (IMI) within the framework of the research programme, whose aim is precisely to meet the challenge of ensuring safe and effective medicines, and believes that the scope of the IMI could be broadened, from pure research to the production of medicines;
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 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 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 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 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 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 618 #
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, as has been done following the onset of the COVID-19 virus, simplifying procedures in the interests of better preparations and 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 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 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 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;