Activities of Nathalie COLIN-OESTERLÉ related to 2020/2071(INI)
Reports (1)
REPORT on the shortage of medicines – how to address an emerging problem
Amendments (23)
Amendment 1 #
Motion for a resolution
Citation 7
Citation 7
— having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and Article 81 thereof concerning an adequate and uninterrupted supply of medicinal products, and Article 23a thereof on notifying the competent authority if a product ceases to be placed on the market on a temporary or permanent basis,
Amendment 31 #
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demand hasin particular has very sharply aggravated shortages of medicines in the EU over the last few years, undermining health services in the Member States and exposing patients to considerable health and other risks; whereas the Member States have a duty to find swift and, effective and coordinated solutions through closer European integration;
Amendment 43 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas there are no definitions harmonised between Member States of ‘shortages’, ‘tensions’, ‘supply disruptions’ and ‘overstocking’; whereas a distinction should be made between ‘medicinal products of major therapeutic interest’ (MITMs) and ‘medicines of health and strategic interest’(MISS);
Amendment 45 #
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 88 #
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 % the volume of medicinal end products marketed in the EU now originating in third countries; whereas the onlyone 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 chemical ingredients are manufactured outside the EU, mainly in China and India;
Amendment 122 #
Motion for a resolution
Recital E
Recital E
E. whereas stocks of ‘strategic’ medicines are inadequate, with chemicalactive pharmaceutical ingredients that are cheap and easy to produce and mature medicines which are however essential for public health being in particularly short supply; whereas pharmaceutical firms operate on a just-in-time basis;
Amendment 187 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas a strong, innovative and competitive pharmaceutical industry in Europe is in the vital interest of the EU and its Member States;
Amendment 190 #
Motion for a resolution
Recital J b (new)
Recital J b (new)
Jb. whereas the pharmaceutical industry needs the right legal framework to do research, development and production of pharmaceuticals within the EU;
Amendment 245 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for health policies to focus on patients' interests and safety for closer cooperation between Member States;
Amendment 249 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Insists on the importance of a definition harmonised between Member States of ‘shortages’, ‘tensions’, ‘supply disruptions’ and ‘overstocking’; calls on the Commission to work on harmonising these concepts in conjunction with all the players concerned; calls for a distinction to be made between ‘medicinal products of major therapeutic interest’ (MITMs) and ‘medicines of health and strategic interest’(MISS);
Amendment 272 #
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 outensure the conditions for security of supply of health products and local pharmaceutical manufacturing, giving priority to ‘medicinal products of major therapeutic interest’; calls on the Commission and the Member States, with the help of producers, to draw up an evolving map of current and potential production sites within the EUnion with the aim of maintaining them in the long term and modernising and strengthening them where necessary, possible and viable;
Amendment 304 #
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 and manufacturers', the collaboration of national regulatory authorities and the EU’s dependence on third countries;
Amendment 335 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce measures to support competitiveness and tax and financial incentives in return for appropriate commitments and to authorise, with due respect for international and EU legislation, 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, with any public incentive having as a counterpart the transparency and traceability of investments, as well as the obligation to supply the European market;
Amendment 389 #
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; proposes that investments in the manufacture of active ingredients and medicinal end products in the EU should also be a criterion as well as the number, location of production sites, and the application of social, environmental, ethical and quality standards;
Amendment 428 #
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, on the model of army or hospital pharmacies, to manufacture priority medicines of strategic importance for health care in the absence of an existing industrial production facility and ensuring security of supply; 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; calls on the Commission to make proposals on the establishment within the Union of public-private partnerships along the lines of the US Biomedical Advanced Research and Development Authority;
Amendment 488 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management to bring about greater transparency in the medicine production and distribution chain and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supplyunit for preventing and managing shortages;
Amendment 512 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Calls on the Commission and the Member States to reflect on the establishment of harmonised shortage management plans obliging producers to identify medicines of major therapeutic interest requiring the introduction of preventive and corrective measures in order to avoid or alleviate any disruption in supplies;
Amendment 523 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Ccalls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treestablish a financial programme to build up a stock of medicines of strategic importance for health care to ensure that patmient of cancer and infections whose prices are harmonised, in a bid to counter recurrent shortages and ensure that patients have access to treatments have access to treatment; calls on the Commission to examine the possibility of a harmonised price for these essential medicines in order to make up for the shortages;
Amendment 553 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission 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 and to make it an emergency European pharmacy;
Amendment 595 #
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) could be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff; calls on the Commission to amend existing legislation in order to strengthen the Agency's capacities;
Amendment 611 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for further invitations to tender to be issued at European level, following a reasoned opinion and under the control of the Commission, in an effort to counter shortages, as has been done following the onset ofinitiated for the COVID-19 virus, simplifying procedures in the interests ofto ensure improved response times;
Amendment 645 #
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 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 difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling; calls on the Commission and the Member States to set up an early warning system both at national and European level in order to reinforce the obligation to notify pharmaceutical companies of any interruption or tension in the supply of medicines;
Amendment 698 #
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 in order to facilitate sales of medicines between Member States; recommends the provision of more comprehensivcalls on the Commission to review the regulations to obtain more precise information on the origin of medicines;