20 Amendments of Jérôme RIVIÈRE related to 2020/2071(INI)
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 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 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 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 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 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.