Activities of Kateřina KONEČNÁ related to 2020/2071(INI)
Shadow reports (1)
REPORT on the shortage of medicines – how to address an emerging problem
Amendments (24)
Amendment 22 #
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 riskshortages of medicines have worsened exponentially in recent years in the EU, undermining health services in the Member States entailing considerable risks for the health and safety of patients, including disease progression and/or worsening of symptoms, increased exposure to falsified medicines, medication errors or adverse events occurring when the missing medicine is substituted by another one, avoidable transmission of infectious diseases, significant psychological distress; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 48 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas drug shortages are sometimes artificially created by pharmaceutical companies that choose to produce more profitable drugs while neglecting less profitable ones;
Amendment 116 #
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 143 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas parallel trade can lead to a severe lack of access to medicines in some Member States while benefitting others;
Amendment 155 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authoritycoordination at European level, stockpiling in some Member States is leading to a market imbalance;
Amendment 182 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas a lack of information around medicine shortages remains one of the most problematic issues for patients, as they are often the last group to be informed about a medicine shortage, if they are told at all; whereas this issue is also experienced in in-patient hospital settings, where patients are not told when they are not receiving the preferred treatment and are instead being given an alternative;
Amendment 290 #
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 medicines; calls on the Commission to map out potential production sites in the EU; calls the EU to enable the creation of a European public pharmaceutical hub which will have the responsibility to ensure the production of essential drugs and vaccines and make them available at cost price to the health departments of Member States;
Amendment 319 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy with, among others, a mechanism to oblige the companies owning the patents to produce the needed medicines even if they are less profitable, and the possibility to impose compulsory licences in order to facilitate, without constraint, the increase of the production of the most needed drugs or vaccines;
Amendment 336 #
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 producersmeasures that would encourage producers to diversify their sources of supply, in particular raw materials, and 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; all public funding being conditioned to the full transparency and traceability of investments, as well as to supply obligations on the European market and to accessible prices of medicine;
Amendment 358 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on Member States to ensure that pharmaceutical companies and whole sale distributors comply with the requirement in Directive 2001/83/EC to ensure appropriate and continued supplies of medicines; highlights the need to ensure that pharmaceutical companies report about all medicines shortages within the established timeframes; stresses the need to apply dissuasive sanctions for non-compliance with these legal obligations; calls on the Commission to explore how the requirement to ensure continued supplies could be strengthened;
Amendment 369 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Calls on the Commission and the Member States to review existing legislation to ensure effective early notification requirements to marketing authorisation holders regarding supply interruptions in order to prevent shortages;
Amendment 400 #
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 410 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls on the Commission and Member States to develop better procurement systems and guidance to ensure continued availability of old, generic and inexpensive medicines that are still needed in patient care;
Amendment 417 #
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 441 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Urges the Commission and the Member States to ensure that algorithm- based technologies used to address medicines shortages are effective and compliant with the European Data Protection framework;
Amendment 464 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Commission to ensure that, when EU public money is spent on research, the results of that research are not protected by intellectual property rights and price accessibility to patients is guaranteed for the products developed; stresses the importance of public research and development activities and institutions and of cooperation at international level, while expressing concerns over the dominant role of multinationals in the pharmaceutical sector; urges all pharmaceutical companies to pool their data and knowledge in a collective effort to identify, test, develop and manufacture vaccines and treatments to curb COVID-19;
Amendment 515 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Recommends the creation of a permanent system for monitoring of medicine shortages in the EU, coordinated by the EMA, with additional resources;
Amendment 534 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections, infections, rare diseases and other areas particularly affected by shortages, whose prices are harmonised, in a bid to counter recurrent shortages and ensure that patients have access to treatment;
Amendment 557 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on the Commission and Member States to adopt a common definition of medicines shortages in the EU, and a common minimum set of data requirements for reporting and cataloguing shortages;
Amendment 630 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to do a careful assessment about the impact of parallel trade on patients’ and consumers’ access to medicines in the different Member States; calls for such a study to inform the need for better guidance to Member States on parallel trade; in this regard calls on the Commission to assess the possibility of withdrawal of the movement of medicine from the restrictions applied under Articles 34 and 35 TFEU;
Amendment 656 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised and publicly accessible digital 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 663 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls on the Commission to launch a multi-stakeholder consultation platform to identify root causes, including but not limited to supply chain issues, that increase the risk of medicine shortages; considers that such a platform should include all stakeholders, including patients, health professionals and other relevant civil society organisations and focus particularly on assessing in detail the experience of patients and the impact of shortages on their health, treatment and care across the EU and across diseases;
Amendment 686 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Calls on the Commission and Member States to ensure effective use of the Joint Procurement Agreement (JPA) for medical countermeasures; calls on expanding the scope of the JPA so it can be used beyond situations of cross-border health threat;
Amendment 690 #
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Underlines the importance of patient empowerment and a patient- centred approach, urges the Commission and Member States to improve patients representation and input into the decision-making process around addressing potential supply issues affecting their medicines;