34 Amendments of Eleonora EVI related to 2020/2071(INI)
Amendment 14 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. A. Whereas causes underlying medicines shortages are complex and multi-dimensional and are linked to manufacturing problems, industry quotas, legal parallel trade, but also to economic aspects, such as pricing;
Amendment 20 #
Motion for a resolution
Recital -A (new)
Recital -A (new)
-A. whereas a shortage of a medicinal product occurs when supply of an already marketed medicine does not meet demand at a national level from healthcare professionals or patients in response to clinical needs; whereas shortages of medicines are part of the wider problem of ensuring equitable access, affordability and availability of medicines in all EU;
Amendment 28 #
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demand has aggravated shortagesthe existing problem of medicines shortages in the EU, undermining health services in the Member States and exposing patients to considerable risks due for example to increased delays in care or therapy, suboptimal treatment, cancellation of care, longer hospitalisations, possible adverse reactions from alternative therapies, medication errors; whereas the Member States have a duty to find swift and effective solutions through closer European integration; whereas an effective solution to the problem cannot be found without coordination at EU level;
Amendment 33 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the causes underlying medicines shortages are complex and multi-dimensional, including industrial factors, such as manufacturing difficulties and supply-chain disruptions, industry quotas, quality defects, parallel trade by distributors, logistical inefficiencies, economic factors, such as pricing and reimbursement policies, unsustainable tenders, commercial withdrawals, regulatory time lag and national requirements, geopolitical factors, such as the dependency on active pharmaceutical ingredients (APIs) and chemical raw materials from third countries and the possible implications from the withdrawal agreement with the UK, unexpected pandemics, accidents, natural disasters or other force majeure issues;
Amendment 52 #
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas shortages may concern essential medicines for which an interruption of treatment can be life- threatening; whereas the increase in demand for medicines to treat COVID-19 could also threaten their availability for patients who use them to manage their chronic and/or rare diseases;
Amendment 64 #
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 shortages are more and more frequent for widely used essential products that have been on the market for years;
Amendment 69 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to consider proposinge requirements for the pharmaceutical industry to ensure that its supply chain is diversified and to put in place a medicine shortage risk mitigation plan to manage and overcome any vulnerabilities in and risks toy, disruption or bottleneck in the supply chain;
Amendment 87 #
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses the urgent need for the EU to reduce its over-reliance on a small number of third countries for medicine manufacturing and as sources of key starting materials, intermediate materials and active pharmaceutical ingredients;
Amendment 87 #
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 tocompanies 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 80 % of the APIs in medicines and 40 % of finished medicines sold in Europe come from China (two-thirds) and India (one-third); whereas these two countries reportedly produce 60 % of the world's paracetamol, 90 % of its penicillin and 50 % of its ibuprofen;
Amendment 104 #
Draft opinion
Paragraph 4
Paragraph 4
4. Encourages the Commission to propose measures, including financial incentives, to promote green manufacturing, within the EU, of medicines and of strategically important chemicals used in medicine production; urges the Commission to also propose measures to incentivise the greater inclusion of EU small and medium-sized enterprises in the medicine supply chain given their key role in research and innovation and inherent ability to quickly adapt their production focus, with a view to coping better with unexpected shocks;
Amendment 110 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Acknowledges that parallel trade may cause medicines shortages; calls on the Commission and Member States to adequately tackle problems related to parallel trade in medicines in the EU adopting measures based on the highest human rights standards in order to guarantee full availability and accessibility for all medicines, with particular attention to those needed for serious diseases;
Amendment 131 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Recalls the detrimentally high level of public dependency on the will of private companies to develop life-saving products; calls for a review of the incentives put in place to encourage research on ‘orphan medicines’ in order to determine whether they are successful, and calls for new incentives should this not be the case;
Amendment 136 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Calls on the Commission, in close cooperation with the Member States, to promote andf acilitate greater public transparency, information and best practice sharing and cooperation in regard to pricing, reimbursement and procurement of medicines; calls for a new Transparency Directive to replace Directive 89/105/EEC with the aim of ensuring effective controls and full transparency on the procedures used to determine the prices and the reimbursement of medicinal products in the Member States;
Amendment 219 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, while public health policies are a responsibility of Member State matters, it is incumbent upon the EU to coordinate and complement national measures to guarantee affordable and high- quality health services forto all European citizens, avoiding that policies of risk management in one Member State may cause spill-over effects in other Member States;
Amendment 242 #
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; with a view to finally finding the right solutions to each one of the different causes of medicines shortages;
Amendment 252 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Underlines that exclusively relying on profit-oriented decision-making is never going to solve the problem of medicines shortages, that market failures should be addressed and alternative drug manufacturing models should be explored;
Amendment 282 #
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 andthe necessary actions to ensure the security of supply and encourage local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU;
Amendment 316 #
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, including unmet needs, and manufacturers’ dependence on third countries;
Amendment 332 #
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 produmeasures encouraging producers to diversify their sourcers tof supply and locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises thewhile considering the authorisation of strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversification aid to finance public independent healthcare research establishments;
Amendment 359 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission to work together with Member States’ national authorities and the relevant stakeholders with a view to reinforcing the obligation for continuous supply to tackle the problem of shortages of medicines, including through a revision of Directive 2001/83/EC addressing earlier notification by companies in all Member States, consumer reporting and effective public communication;
Amendment 401 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that procurement procedures with only one successful tenderer may exacerbate vulnerability should supplies be disrupted; calls on the Commission and the Member States to introduce procurement procedures under which contracts may be awarded to a number of successful tenderers, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality and affordable treatment for patients;
Amendment 426 #
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 whicha publicly-funded independent European pharmaceutical company, operateing in the public interest toby researching and manufactureing priority medicines of strategic importance but not profitable for thealth care pharmaceutical industry, starting from rare diseases and the development of new antimicrobials; 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 473 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Stresses the importance of promoting independent, peer-reviewed scientific research on the medical use of cannabis, including through the study of the effects of standardised and magistral preparations;
Amendment 477 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Stresses the importance of encouraging clinical trials for medicines used off-label to ensure their safe and optimal use;
Amendment 506 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management under the EMA 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 supply;
Amendment 575 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition ofjointly adopt a consistent and workable definition of ‘medicine shortages’, ‘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 587 #
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) cshould be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staffcoordinating pan-European activity aiming at tackling medicines shortages at EU level, with a correspondingly enhanced mandate;
Amendment 628 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission and the Council to assess the impact of intra-EU parallel trade and supply quotas on medicines unavailability and consumer access, in particular by addressing the issue of essential medicines disappearing from a Member States and then re- appearing at higher prices;
Amendment 636 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative cestablish a transparent mechanism to monitor, assess and anticipate EU level and Member States existing and potentrialised digital platform for sharing shortages, including by providing real data on patients’ needs and hospital capacity; all the information provided by national agenc, regional and local authorities, and all stakeholders regarding shortages of medics well as doctors, pharmacists and stakeholders, should be uploaded onto a common centralised digital platform, publicly available, ensuring an alignment across the data provided from different sources, as well as a streamlinesd and medical equipmenteffective early warning system at both national and EU levels; welcomes the introduction by the EMA of the SPOC and i-SPOC systemenhanced monitoring system for availability of medicines during the COVID-19 pandemic and calls for its elaboration into a permanent standardised structure for intensifying shortage surveillance after the crisis; calls for all 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 stockpilingthe need for stockpiling or for export restrictions measures, which further exacerbate the problem;
Amendment 671 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls on the Commission and the Council to establish and update together with the Member States, EMA and relevant stakeholders an evolving list of essential medicines which are short of supply;
Amendment 716 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. 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; further calls on the Commission and the Member States to avoid as much as possible short- term requirements and to focus on finding a long-term solution to shortages;
Amendment 741 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission to address shortages in the context of the evaluation of orphan and paediatrics legislation, with the objective of ensuring access and affordability while also dealing with unmet medical needs;
Amendment 743 #
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22b. Calls on the Commission to put the issue of the shortages of oncology medicines at the centre of the treatment part of the forthcoming Europe's Beating Cancer Plan;
Amendment 745 #
Motion for a resolution
Paragraph 22 c (new)
Paragraph 22 c (new)
22c. Calls on the Commission to use the EU4Health Programme to address the root causes of medicines shortages in the EU;