Activities of Joëlle MÉLIN related to 2020/2071(INI)
Opinions (1)
OPINION on shortage of medicines - how to address an emerging problem
Amendments (45)
Amendment 13 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas 60 % to 80 % of the active ingredients of medicinal products, i.e. the substance which gives the therapeutic effect, are manufactured outside Europe, mainly in China and India; whereas this proportion was 20 % 30 years ago;
Amendment 21 #
Draft opinion
Recital A b (new)
Recital A b (new)
A b. whereas the Commission has issued guidelines for an optimal and rational supply of medicines in order to avoid shortages during the COVID-19 pandemic; whereas, in these guidelines, the Commission recognises that no country is self-sufficient in either raw materials or Active Pharmaceutical Ingredient (APIs), intermediate products or finished medicines needed for the proper functioning of the health system;
Amendment 26 #
Draft opinion
Recital A c (new)
Recital A c (new)
A c. whereas, according to the Commission, the COVID-19 pandemic crisis has justified and still justifies a significant increase in the production of both active ingredients and medicinal products in the EU, and whereas this situation requires a reorganisation of supply chains and production lines;
Amendment 26 #
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 risks; whereas these include the progression of the disease and/or worsening of symptoms, increased exposure to falsified medicines, medication errors or adverse events which occur when the missing medicine is replaced by another, avoidable transmission of infectious diseases and significant psychological distress; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 32 #
Draft opinion
Recital A d (new)
Recital A d (new)
A d. whereas the Commission has announced its intention to publish, by the end of 2020, recommendations for a future EU pharmaceutical strategy;
Amendment 34 #
Draft opinion
Recital A e (new)
Recital A e (new)
A e. whereas, in her statements made during a meeting with the members of the European Parliament’s Environment, Public Health and Food safety (ENVI) committee, on April 22, Commissioner Stella Kyriakides highlighted the need to increase the production of medicines and the level of innovation within the UE;
Amendment 38 #
Draft opinion
Recital A f (new)
Recital A f (new)
A f. whereas, to date, no compulsory label or labelling - visible by patients/customers - is required for medicinal products and active ingredients concerning their origin and country of manufacture;
Amendment 41 #
Draft opinion
Recital A g (new)
Recital A g (new)
A g. whereas existing tax mechanisms and incentives can be implemented at European and Member States level for strategic industrial sectors;
Amendment 43 #
Draft opinion
Recital A h (new)
Recital A h (new)
A h. whereas there is a high level of control in force in the EU over the quality of drug production;
Amendment 44 #
Draft opinion
Recital A i (new)
Recital A i (new)
A i. whereas all small and medium- sized pharmaceutical laboratories constitute a wealth to be preserved and a breeding ground for research and discoveries to be supported, as they can participate in the prevention of drug shortages;
Amendment 46 #
Draft opinion
Recital A j (new)
Recital A j (new)
A j. whereas the relocation of production units for medicinal products is likely to be accompanied by an increase in the cost of manufacturing said products; whereas purchasers, in particular hospital pharmacies, are subject to budgetary restrictions which very often require them to consider only financial criteria and not quality or origin;
Amendment 58 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Calls on the Commission, in cooperation with the stakeholders of the sector, to finally develop a shortage alert mechanism that will be both responsive and easily activated, so that in the future countries facing this problem can react and turn to other markets if necessary; insists that this mechanism be extended, as far as possible, to the entire supply chain, so that distributors can also trigger the alert;
Amendment 70 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas medicine shortages may lead to delays in the treatment of patients, the need to use alternative therapies that could be less effective and, accordingly, to adverse effects and even a danger to life where a shortage concerns vital medicines;
Amendment 71 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Calls on the Commission to reflect, together with stakeholders from the pharmaceutical industry, on the volumes of stock of medicines available; recalls in this respect that the quotas of stock volumes put in place by distributors are often tight and cause slowdowns and shortages, and that at all levels there is a lack of stock transparency;
Amendment 78 #
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2 b. Calls on the Commission to organise the revision of the European legislative framework through the future pharmaceutical strategy to enable the Member States to put transparency measures into practice;
Amendment 89 #
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 onlya way tof saveing money and maximising profit 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 ingredients are manufactured outside the EU, mainly in China and India;
Amendment 113 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Urges the Commission to enable the Member States to make every necessary effort to ensure that small and medium-sized pharmaceutical companies continue or resume their research activities and help ensure the diversity of our production and the maintenance of the jobs that go with it;
Amendment 126 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Considers that the relocation of the activities of the European pharmaceutical industries, on the one hand, and their willingness to continue to invest in their European units on the other, will depend in part on our ability to develop advanced authentication and traceability technologies that will ensure the reliability of the entire chain of manufacture, packaging and distribution of their products; this could possibly be achieved by making more appropriate use of the data from the EMVS (European Medicines Verification System) directory to obtain complete serialisation of each box of medicines;
Amendment 135 #
Motion for a resolution
Recital F
Recital F
F. whereas there are no price harmonisation arrangements tocurrent internal market rules facilitate ‘parallel exports’ to countriMember States where the medicine in question is more expensive; whereas, however, in a market economy, price planning is inconceivable;
Amendment 142 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Invites the Commission, therefore, to introduce incentives for manufacturers or a system of labelling - visible and identifiable by patients/customers - concerning the origin and place of production of medicinal products and active ingredients;
Amendment 146 #
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5 c. Calls on the Commission to promote and include in the future pharmaceutical strategy for the EU the paradigm of sovereignty in the production of medicines and active ingredients; calls, in this regard, for a coordinated and concerted plan with the Member States to provide for the urgent relocation within the EU of production lines for all essential and strategic medicines and active ingredients;
Amendment 150 #
Draft opinion
Paragraph 5 d (new)
Paragraph 5 d (new)
5 d. Calls on the Commission to strengthen border controls on the conformity of imported medicinal products or active ingredients, particularly where such imports drive down internal market prices, distort competition, and lead to the relocation of production lines outside the EU;
Amendment 153 #
Draft opinion
Paragraph 5 e (new)
Paragraph 5 e (new)
5 e. Calls on the Commission and the Member States to carry out stress tests on the availability and production capacity of medicines and active ingredients in order to protect against future pandemic health crises;
Amendment 154 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority, stockpiling in some Member States is leading to a market imbalancesome Member States, stockpiling can further contribute to actual medicine shortages;
Amendment 155 #
Draft opinion
Paragraph 5 f (new)
Paragraph 5 f (new)
5 f. Calls on the Commission to plan investment measures for innovative research projects and for the development of cutting-edge pharmaceutical technologies; encourages, in this respect, the Commission to direct these investments as a matter of priority towards laboratories of excellence and European small and medium-sized enterprises in the pharmaceutical sector, in order to restore a form of capacity equity in the face of the giants of the pharmaceutical industry.
Amendment 166 #
Motion for a resolution
Recital H
Recital H
Amendment 172 #
Motion for a resolution
Recital I
Recital I
I. whereas the greater number, geographical spread and impact of epidemics is partly attributable to climate change, in combination with globalisation and increased travelglobalisation is a decisive factor as regards the increased geographical spread and impact of epidemics, not to mention the speed at which the infection spreads;
Amendment 181 #
Motion for a resolution
Recital J
Recital J
J. whereas the destruction of biodiversity, the proliferation of man-made habitats and damage to natural areas densely populated by humans are potentially facilitating the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens;
Amendment 185 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas health is not a commodity, and making it subject to internal market rules as if it were, has done nothing but discourage research and the production of new medicines, as well as promote the establishment of a parallel market in medicines and an oligopoly of multinationals;
Amendment 204 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the UnionMember States regain itstheir sovereignty and independence with regard to health care and secure itstheir supply of medicines and medical equipment;
Amendment 285 #
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 sovereigntythe medical and pharmaceutical self-sufficiency of the Union and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU;
Amendment 399 #
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 447 #
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; calls for medical research to be encouraged in Europe, to support the relocation and renewed competitiveness of the sector;
Amendment 505 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised managementmanagement coordinated by the ECDC or 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 530 #
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 whose prices are harmonisedtailored to the purchasing power of each Member State, in a bid to counter recurrent shortages and ensure that patients have access to treatment;
Amendment 544 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to create, as part of the ‘RescEU’ mechanism, a European contingencystrategic 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 permajor therapeutic importance and at high risk of shortage, to act as a contingency stock for Member States in critical situatiodns;
Amendment 566 #
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 for health carmajor therapeutic importance’ 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 590 #
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 staffat no additional cost to the Union budget;
Amendment 597 #
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 Centre for Disease Prevention and Control (ECDC) or 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;
Amendment 601 #
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 regulatoryalert authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff;
Amendment 622 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to encourage producers, on a voluntary basis, to introduce a labelling system - visible to and identifiable by patients / consumers - concerning the place of origin and production of medical products and active ingredients, in order to avoid the risks of falsified medicines and to meet consumers' expectations;
Amendment 655 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform, which can be consulted by the public, 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;
Amendment 696 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for the paper information notice to be supplemented by an electronic information notice to be drawn up in all the official Union languages for every medicine on the EU marketsold in the Union itself, in order to facilitate sales of medicines between Member States; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 709 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Stresses the need to use state-of- the-art track-and-trace systems and technologies for medicines, from when the active ingredients are produced, in order to improve the reliability of the entire production, packaging and distribution chain and ensure a high quality of medicines;
Amendment 734 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Takes the view that the introduction of stress tests by the Member States to assess the resilience of respective health systems in emergencies would provide an effective means of countering shortages in the event of pandemics and of identifying structural risk factors which go to create shortages;