28 Amendments of Sirpa PIETIKÄINEN related to 2020/2071(INI)
Amendment 23 #
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 47 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas medicine shortages are a growing public health threat with a serious impact on health care systems and public health;
Amendment 67 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas medicine shortages can lead to possible delays in patients’ treatment, to the need to switch to alternative therapies that could be less effective, to adverse effects and adherence problems or even life threat when a shortage concerns essential medicines;
Amendment 115 #
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 130 #
Motion for a resolution
Recital E
Recital E
E. whereas stocks of ‘strategic’ medicines are inadequate, with chemicals that are cheap and easy to produce and matureolder, yet essential medicines being in particularly short supply; whereas pharmaceutical firms operate on a just-in- time basis;
Amendment 147 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas profit-oriented decision making on the part of the pharmaceutical industry such as products’ discontinuations and withdrawals from particular, less profitable Member States’ markets is often the reason for medicine shortages;
Amendment 193 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the Union regain its sovereigimportance of putting the interest and safety of patientys and independence with regard to health care and secure its supply of medicines and medical equipmentt the centre of European health policy and for closer cooperation between Member States;
Amendment 222 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, while public health policies are a Member State matter, it is incumbent upon the EU to coordinate and complement national measures to guarantee the protection of public health and access to affordable and high-quality health services for European citizens;
Amendment 235 #
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 Statesgeostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines and medical equipment;
Amendment 238 #
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; stresses the need for health policies to focus on patients’ interests and for closer cooperation between Member States; notes that the interest and safety of patients should be at the heart of European health policy;
Amendment 273 #
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 mednecessary actions to ensure security of supply of medicinal products, giving priority to essential medicines and 'medicines of major therapeutic interest; calls on the Commission to map out potential production sites in the EU;
Amendment 277 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needed to restoreensure security of supply of medicines for which European health sovereignty and local pharmaceutical manufacturing are essential tools, giving priority to essential and strategic medicines; calls on the Commission to map outencourage the European pharmaceutical industry not too limit the production to one place and to map out multiple potential production sites in the EU;
Amendment 313 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to take all necessary action to ensure that the adequate manufacturing of active pharmaceutical ingredients is guaranteed in the EU, and to study the possibility of establishing a regulation to create a remunerated obligation for the manufactures to bring the production of these active ingredients to Europe; to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers’ dependence on third countries;
Amendment 337 #
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 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 357 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Notes that the current legislation does not ensure the stable supply of medicines; calls on the Commission to clarify the marketing authorisation holder’s obligations under the Directive 2001/83/EC and develop an enforcement mechanism including sanctions to hold companies accountable;
Amendment 363 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Stresses the need for full transparency and traceability of public investments in research for medicines in order to reflect these public investments in the availability and price setting for the general public;
Amendment 373 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Calls on the Commission and Member States to establish a standardised, early warning system at national and EU level enhancing pharmaceutical companies’ obligations to immediately notify any interruptions of supply of medicines;
Amendment 404 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Notes that procurement practices focusing solely on the price have resulted in manufacturers pulling out of national markets leading to market consolidation and an increasing risk of medicines shortages; calls on the Commission and Member States to engage in a structured exchange to apply other criteria than price in tendering procedures such as reliability of supply and the number and location of production sites;
Amendment 435 #
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 carmajor therapeutic interest at a high risk of shortage; 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 494 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management under the leadership of the European Medicines Agency (EMA) to bring about greater transparency in the production and distribution chains of medicines and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supplysupply disruptions;
Amendment 562 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance fordefine, in collaboration with health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and professionals, patient and consumer associations and manufacturers, an evolving list of medicines of major therapeutic interest at high risk of shortage, by using monitoring indicators such as the history of shortages and indicators reflecting 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 580 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Calls on the Commission and the Member States to adopt the following common definition of ‘medicines of major therapeutic interest’ (MMTI): medicines or classes of medicines for which an interruption of treatment is likely to jeopardise the vital prognosis of patients in the short or medium term, or represents a significant change in patient outcomes with regard to the severity or potential evolution of the disease;
Amendment 583 #
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 managemenby means of a European Joint Action on preventing medicine shortages and to provide for the preparation and publication of European shortage management and prevention plans by marketing authorisation holders for medicines of major therapeutic interest; considers that the European Medicines Agency (EMA) cshould be designated as the regulatory authority tasked with coordinating exchanges between Member States to preventing shortages of essential medicines, with a correspondingly wider remit and more staff;
Amendment 605 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls on the Commission to study and establish a fund for orphan medicines that would be financed by the Member States, to procure collectively on behalf of the Member States the orphan medicines for all the EU;
Amendment 606 #
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Calls on the Commission and the Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; recognises the European Medicines Agency (EMA) the body best suited to take the responsibility of the European response to medicines shortages; considers that the European Medicines Agency (EMA) should be designated as the regulatory authority coordinating and monitoring medicines shortages at EU level during emergencies and beyond with a correspondingly stronger mandate and better infrastructure; notes that EMA should be entirely publicly funded as a prerequisite to its independence;
Amendment 652 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform for sharing information provided by national agencies and all stakeholders regarding, including manufacturers, wholesalers and pharmacists, regarding available stocks and 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 682 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Considers it essential to improve an early 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; recommends the inclusion of information for healthcare professionals on available alternatives
Amendment 685 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Observes 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 potential therapeutic alternatives may mitigate the possibility for adverse reactions endangering patient safety;