Activities of Michèle RIVASI related to 2020/2071(INI)
Shadow reports (1)
REPORT on the shortage of medicines – how to address an emerging problem
Shadow opinions (1)
OPINION on Shortage of medicines – how to address an emerging problem
Amendments (41)
Amendment 29 #
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demandmedicine shortages are a growing public health threat with a serious impact on our national health care systems; the increase in global demand during the COVID-19 pandemic has aggravated shortages of medicines in the EU, undermining health services in the Member States and exposing patients to considerable risks; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 61 #
Motion for a resolution
Recital B
Recital B
B. whereas medicine shortages can lead to possible delays in treatment or the need to switch to alternative therapies that could be less effective and increase risk of adverse side effect and a danger to life when concerning essential medicines; whereas medicines to treat cancer, infections and disorders of the nervous system account for more than half of those in short supply;
Amendment 86 #
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 relyEU pharmaceuticals supply chain relies too heavily on subcontractors to produce pharmaceutical raw materials in Asiacountries, 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 EU citizens reply on equitable, fair, timely access and supply of medicines based on a sustainable, healthy, competitive multi-source single market;
Amendment 108 #
Motion for a resolution
Recital D
Recital D
D. whereas theshortages of medicines are a consequence of growing demand coupled with pricthe suppression of production costs is the concentration of supply, and a reduction in the number of chemicals manufacturers and a lack of altwho are based and opernative solutions should problems arise in Europe;
Amendment 141 #
Motion for a resolution
Recital F
Recital F
F. whereas there are no price harmonisation arrangements to facilitate ‘parallel exports’ to countries where the medicine in question is more expensive; whereas parallel trade of pharmaceuticals is related to the free movement of goods in the internal market, fostering competition and lowering the cost of patented pharmaceuticals and therapeutics; whereas agreements to restrict parallel trade are prohibited under Article 101 (1) TFEU;
Amendment 145 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas profit-oriented decision making by the pharmaceutical industry and Market Authorisation Holders MAHs such as the discontinuation and withdrawal of medicines supplies solely on what is profitable;
Amendment 152 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authoritycoordination at EU level, stockpiling in some Member States is leading to a market imbalance and exacerbating medicines shortages;
Amendment 175 #
Motion for a resolution
Recital I a (new)
Recital I a (new)
Ia. whereas generic and biosimilar medicines industry supply the majority of medicines to EU patients (almost 70% of dispensed pharmaceuticals);
Amendment 223 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, while public health policies arecurrently are mainly a Member State mattercompetence, it is incumbent upon the EU to coordinate and complement national measures to guarantee affordable and high- quality health services for European citizens;
Amendment 237 #
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; calls on the Commission and Member States to closely coordinate to protect the resilience and sustainability of the healthcare supply chain and ensure the continuous availability of medicines as well as their safe distribution and fair allocation to all dispensing points throughout Member States;
Amendment 279 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is neededrapid action to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out existing and potential production sites in the EU and promote European health sovereignty through the establishment of an EU-wide network of pharmaceutical suppliers and manufacturers;
Amendment 296 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission to come forward with clear traceability rules on medicines both in regard to the final product and also any other pharmaceutical components used in medicines, including active and inactive ingredients; considers that transparent traceability of pharmaceutical components to be of the upmost importance in regard to a prevention framework; suggests that the traceability of pharmaceuticals should be similar in concept to the general tracing requirements found in Articles 18,19 and 20 of the Regulation (EC) No 178/2002 laying down the general principles and requirements of food law (General Food Law Regulation);
Amendment 302 #
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Considers that the Commission should proactively disclose all documents related to the pharmaceutical supply network, including the work and meetings of the European Medicines Agency (EMA);
Amendment 331 #
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 produput in place restrictions for medicines produced under bad labour circumstancers to locate their operations in Europeand environmental standards, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and theand importance of heavily investing in European based companies, in the interests of resource diversification; return for binding commitments regarding issues such as transparency, traceability, accessibility and affordability of manufacture and distribution across the entire medical supply chain to ensure medicines are equally available across all regions at a fair price;
Amendment 351 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission and Member States to ensure that, if incentives are offered to the medicines industry, these do not affect medicine affordability; stresses the need to make incentives conditional on medicines being available and affordable;
Amendment 367 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Calls on the Commission and Member States to reflect on the need for manufacturers to diversify their sources of supply for raw materials and the manufacture of health products, including the relocation of production in Europe;
Amendment 374 #
Motion for a resolution
Paragraph 6 c (new)
Paragraph 6 c (new)
6c. Calls on the Commission and Member States to strengthen their work on the responsibilities of Market Authorisation Holders (MAHs) in relation to the continuous supply obligations set out in Directive 2001/83/EC (Article 81); calls on the Commission and the European Medicines Agency (EMA) to clarify these obligations into enforceable guidelines and encourage Member States ensure compliance, provide sanctions and to explore all options to ensure that continuous supplies are strengthened, particularly in relation to a European network of pharmaceutical suppliers to promote increased competition and security of supply;
Amendment 378 #
Motion for a resolution
Paragraph 6 d (new)
Paragraph 6 d (new)
6d. Calls on the Commission and Member States to establish requirements to oblige pharmaceutical companies to submit medicine shortage prevention plans for risk mitigation; stresses the need to make such prevention plans mandatory in EU law; calls for the proactive monitoring at national and EU level of medicines that are at risk of shortage;
Amendment 390 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Notes that security of supply is an essential factor in combating shortages and must be used as a qualitative criterion in connection with the award of public pharmacy contracts and calls for tender for the supply of medicines, as recommended in Article 67 of Directive 2014/24/EU; other essential factors are the reinvestment of profits into R&D and promotion of affordability and accessibility; proposes that investments in the manufacture of active ingredients and medicinal end products and to increase resilience in the EU should also be a criterion;
Amendment 403 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Notes that procurement practices focusing solely on prices have resulted in manufacturers pulling out from national markets leading to a lack of competition, market consolidation and an increased risk of medicines shortages; calls on the Commission and Member States to engage in a structured exchange to apply alternative criteria to the tendering process such as reliability of supply and the number of location and product sites;
Amendment 412 #
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Calls on the Commission to issue targeted and binding EU guidelines on the procurement of medicines, recommends that the public procurement Directive should recommend to Member States how to implement multi-winner framework agreements, applying Most Economically Advantageous Tender (MEAT) criteria and strengthen the security of medicines supply for Europe;
Amendment 424 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to create one or moreestablish a network of European non-profit pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importance for health care; stressurges 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 findingsCommission and Member States to ensure that algorithm based technologies used to address medicines shortages are effective and compliant with the European data protection framework;
Amendment 437 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls for full transparency at EU and Member State level through a Europe-wide medicines shortages database and an early warning system involving the main supply-chain stakeholders, including manufacturers, healthcare distributors, pharmaceutical wholesalers, pharmacists to prescribers and the competent national authorities, about existing and anticipated shortages, providing their root causes in a harmonised, comparable format;
Amendment 446 #
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 of manufacturers and suppliers;
Amendment 469 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Commission and the Member States to consider implementing an EU wide formulary (list) of approved medicines, indicating which products are interchangeable and key information on the composition, description, prescribing and timely administration of medicines;
Amendment 478 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Calls for European wide tracking of public financial resources used for R&D for each medicinal product as well as final net price charged;
Amendment 480 #
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Calls for EU legislative action to ensure that reinvestment of profits, affordability and accessibility become standard requirements on contracts related to public funding for R&D of medicinal products between public institutions and pharmaceutical companies;
Amendment 482 #
Motion for a resolution
Paragraph 11 d (new)
Paragraph 11 d (new)
11d. Calls for additional funding into Horizon 2020 to be specifically dedicated to clinical trials and new medicinal products that have a clear societal value with public sharing of research results;
Amendment 483 #
Motion for a resolution
Paragraph 11 e (new)
Paragraph 11 e (new)
11e. Calls for a revision of EU Regulation (EC) No 141/2000 on orphan medicinal products to reverse the ‘burden of proof’ for the ten-year market exclusivity clause in order that the holder of the market authorisation has to prove that the product is not sufficiently profitable to cover R&D costs;
Amendment 498 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management to bring about greater transparency inunder the leadership of the European Medicines Agency (EMA) to bring about greater transparency in the price-setting of medicinal products and the distribution chain; also recommends the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supply;
Amendment 537 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to develop European health strategies on the basised ofn 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 548 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to assess the option 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; stresses the importance of ensuring adequate consultation of patients and consumer groups in this process;
Amendment 555 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on the Commission to ensure transparency around the functioning of RescEU and the criteria to distribute stocks; urges the Commission to develop guidance and a monitoring system to ensure that national initiatives on stockpiling are proportionate to the needs and do not create unintended consequences in other Member States;
Amendment 559 #
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Calls on the Commission to revise the European rules on data and market exclusivity and include an exception clause to ensure that Member States can make use of compulsory licensing for medicinal products for rare diseases and to accelerate the generic production and supply of lifesaving medicines in times of shortages;
Amendment 578 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition of 'medicines shortages' relevant for all stakeholders, ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain; calls for a European regulatory authority to be designated to carry out the task of setting quotas for the allocation of medicines from that reserve to the Member States;
Amendment 584 #
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;to prevent shortages, 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 staffcoordinating and monitoring medicines shortages at EU level during emergencies and beyond to prevent and manage shortages of medicines, with a correspondingly stronger mandate and better infrastructure; reiterates that the EMA should be entirely publicly funded as a prerequisite to its independence;
Amendment 627 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Considers it essential that more focus is given to the possible illegality of supply quota systems and to whether they are used as means of pressure to introduce legislation to ban parallel exports; calls on the Commission to introduce minimum requirements for Market Authorisation Holders (MAHs) to initiate investigations to identify the true root causes of the shortages and to impose sanctions upon those manufacturers who cause shortages by failing to manufacture enough without justified reason;
Amendment 643 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform for sharingthe reporting and notifying harmonised information provided by national agencies and all stakeholders regardingthat enables those agencies and stakeholders to share information on actual or expected shortages of medicines and medical equipment as well as available stocks; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; which should be integrated in the EU telematics strategy and should be interconnected with the National Medicines Verification Organisation (NMVO) system; calls for existing information systems to be improved so as to provide a clear overview of problems, shortages and requirementavailable stocks in each Member State, with a view to preventing stockpiling;
Amendment 670 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls on the Commission to place an obligation on all MAHs to make a formal notification of expected and potential shortages to be enshrined in EU law as well as an obligation to maintain safety stock surplus of 2-3 months for medicines of significant therapeutic interest;
Amendment 679 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. CHighlights that doctors must have access to up-to-date information to be able to adequately respond to arising and existing shortages; early awareness of a supply problem and early identification of therapeutic alternatives may mitigate the possibility of adverse reactions endangering patient safety; considers it essential to improve 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;
Amendment 707 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Considers regulatory flexibility should be given to parallel traders, not least in relation to language requirements; in that regard recommend that the packaging of medicines should be harmonised at EU level; calls on Commission and regulatory authorities to enable and promote the use of electronic package information leaflets (ePIs); highlights the need to ensure that ePIs should complement but not replace paper leaflets;