Activities of Dominique RIQUET related to 2021/2013(INI)
Shadow opinions (1)
OPINION on a pharmaceutical strategy for Europe
Amendments (41)
Amendment 4 #
Draft opinion
Recital A
Recital A
A. whereas the pandemic has revealed the limitations of the current set-up for managing value chains and accessibility to medicines and vaccines; whereas access to medicines can be improved in particular by means of closer cooperation with third countries on regulatory standards;
Amendment 13 #
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. having regard to the announcement made by the Commission on 11 November 2020 on the setting-up of the Health Emergency Preparedness and Response Authority (HERA);
Amendment 18 #
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. whereas the pharmaceutical sector is essential to the EU's strategic autonomy, in particular by virtue of its capacity to address health crises and provide biodefence;
Amendment 19 #
Draft opinion
Recital A c (new)
Recital A c (new)
Ac. whereas the COVID-19 pandemic has made the EU even more dependent on third countries for supplies of certain active ingredients, raw materials and other substances used in manufacturing medicines;
Amendment 24 #
Draft opinion
Recital B
Recital B
B. whereas universal access to medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit;
Amendment 41 #
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. whereas the EU pharmaceutical industry employs 800 000 people directly and in 2019 generated profits of EUR 109.4 billion;
Amendment 43 #
Draft opinion
Recital B b (new)
Recital B b (new)
Bb. whereas research into and the development, production and distribution of medicines depends on an ecosystem of public and private actors which includes large pharmaceutical companies, SMEs, start-ups and other innovative newcomers, along with universities, public research centres, national paying agencies, wholesalers and pharmacies;
Amendment 51 #
Draft opinion
Recital B c (new)
Recital B c (new)
Bc. whereas significant advances in treatments have been achieved in the last 20 years by European pharmaceutical companies, in particular in the areas of biotechnological products for chronic diseases such as diabetes, anti-viral medicines, personalised treatments for cancer patients or cell or genetic therapy products; whereas Europe also recently scored a success by developing and producing the RNA messenger vaccine against COVID-19;
Amendment 60 #
Draft opinion
Recital B d (new)
Recital B d (new)
Bd. whereas actors in the medicines industry have to reconcile incentives and rewards for innovation, guarantees regarding patient access to medicines and the viability of health systems;
Amendment 61 #
Draft opinion
Recital B e (new)
Recital B e (new)
Be. whereas a European pharmaceutical industry which specialises in research into and the development and production of innovative medicines in areas where large population groups have glaring needs which are not being met is essential for public health and for the competitiveness of the industry itself;
Amendment 64 #
Draft opinion
Recital B f (new)
Recital B f (new)
Amendment 65 #
Draft opinion
Recital B g (new)
Recital B g (new)
Bg. whereas a competitive pharmaceutical industry needs a skilled, specialist workforce;
Amendment 66 #
Draft opinion
Recital B h (new)
Recital B h (new)
Bh. whereas too often pharmaceutical research is based on studies of male physiology, with most clinical trials still being conducted on men; whereas the result is a dangerous degree of ignorance about the effects of medicines on women;
Amendment 67 #
Draft opinion
Recital B i (new)
Recital B i (new)
Amendment 68 #
Draft opinion
Recital B j (new)
Recital B j (new)
Bj. whereas veterinary medicines are present in the food chain, and whereas animals are likely to ingest residues of medicines intended for human consumption which are present in water and the soil;
Amendment 69 #
Draft opinion
Recital B k (new)
Recital B k (new)
Bk. whereas the excessive and inappropriate use of antimicrobials in veterinary and human medicine is giving rise to antimicrobial resistance which in turn is making it more difficult to treat infectious diseases and perform surgical operations;
Amendment 70 #
Draft opinion
Recital B l (new)
Recital B l (new)
Bl. whereas radiological and nuclear technologies can contribute to the fight against cancer;
Amendment 76 #
Draft opinion
Paragraph 1
Paragraph 1
1. Calls on the Commission to work towards a European public biomedical infrastructure covering the entire medicines value chain and to develop the prospective European Health Emergency Preparedness and Response Authority (HERA) along those lines;
Amendment 81 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Welcomes the launch on 17 February 2021 of the HERA incubator focusing on the fight against the variants of the COVID-19 virus;
Amendment 83 #
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Calls on the Commission and the Member States, under the seven-year Multiannual Financial Framework, to endow HERA with an ambitious and predictable budget intended to support research and development and gear it towards addressing significant public health problems for which private funding is insufficient and, in the event of a health crisis, providing operational support to pharmaceutical companies;
Amendment 113 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to keep the results of Union-funded R&D in the public domain; points out that the protection of patents must not run counter to the right to healthmaintain a stable and predictable legislative framework for intellectual property in order to encourage pharmaceutical innovation in the EU;
Amendment 116 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Notes that the implementation of Regulation (EC) No 141/2000 on orphan medicinal products and Regulation (EC) No 1901/2006 on medicinal products for paediatric use has led to an increase in the number of clinical trials and the number of treatments available for rare diseases; draws the Commission's attention to the fact that any proposal to revise these two regulations must maintain a stable and predictable incentive framework, with a particular focus on the prevalence threshold;
Amendment 125 #
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Takes the view that constant dialogue between pharmaceutical companies, health authorities and paying agencies is essential in order to match research and development priorities with those of health systems;
Amendment 128 #
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Calls on the health authorities and pharmaceutical companies to make determined efforts to address the persistent gender bias in this area and guarantee an equal focus on male and female physiology in research and development;
Amendment 132 #
Draft opinion
Paragraph 3
Paragraph 3
Amendment 146 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Points out that a range of EU programmes can be used to fund pharmaceutical research projects, such as Horizon Europe, InvestEU, EU4Health, cohesion policy and the Digital Europe programme for projects focusing on the deployment of artificial intelligence;
Amendment 149 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Calls for due consideration to be given to the further training and retraining of workers involved at all stages in the value chain and to broadening the range of training opportunities for STEM specialists;
Amendment 154 #
Draft opinion
Paragraph 4
Paragraph 4
Amendment 185 #
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to support pricing models based onwhich take account of real production costs;
Amendment 187 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission, in the context of Directive 2014/24/EU on public procurement, to draw up guidelines designed to support sustainable public procurement practices in the area of pharmaceuticals and bring about the inclusion in most economically advantageous tender (MEAT) criteria, in addition to price, of criteria concerning security and continuity of supply and environmentally sound production;
Amendment 207 #
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to promote joint procurement and applyDraws attention to the possibility for the Member States to engage in joint procurement whilst guaranteeing that most economically advantageous tender (MEAT) criteria moare stringentlyapplied;
Amendment 218 #
Draft opinion
Paragraph 8
Paragraph 8
Amendment 236 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls for long-term monitoring of medicines placed on the market in order to identify any harmful side effects and assess their cost-effectiveness as treatments;
Amendment 241 #
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Welcomes the Commission's intention, as part of the European Data Strategy, to establish a European health data area and to introduce interoperable tools for health data access in order to facilitate the secure and anonymous cross-border analysis of these data, which will be essential to the deployment of artificial intelligence;
Amendment 245 #
Draft opinion
Paragraph 8 c (new)
Paragraph 8 c (new)
Amendment 253 #
Draft opinion
Paragraph 8 d (new)
Paragraph 8 d (new)
8d. Welcomes the publication by the Commission on 5 February 2021 of the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA Action Plan); calls on the Commission, when revising pharmaceutical legislation, to draw up a regulatory framework geared to the deployment of radiological and nuclear technologies for therapeutic, and not solely diagnostic, purposes;
Amendment 263 #
Draft opinion
Paragraph 8 e (new)
Paragraph 8 e (new)
8e. Emphasises the strategic role played by the European pharmaceutical industry in guaranteeing the EU's autonomy in the event of a health crisis or a bioterrorist attack;
Amendment 266 #
Draft opinion
Paragraph 8 f (new)
Paragraph 8 f (new)
8f. Welcomes the revised industrial strategy published by the Commission on 5 May 2021, which analyses the EU's strategic dependencies, including the production of active pharmaceutical ingredients, which is concentrated in a small number of factories in China and India;
Amendment 270 #
Draft opinion
Paragraph 8 g (new)
Paragraph 8 g (new)
8g. Calls for the introduction of reporting requirements vis-à-vis the competent public authorities for pharmaceutical undertakings, involving the drafting of a plan which guarantees continuity of supply so that they can cushion the impact of any event which disrupts the supply chain;
Amendment 277 #
Draft opinion
Paragraph 8 h (new)
Paragraph 8 h (new)
8h. Calls for an Important Project of Common European Interest (IPCEI) to be launched in the pharmaceutical sector with a view to identifying targeted diseases or technologies in advance;
Amendment 279 #
Draft opinion
Paragraph 8 i (new)
Paragraph 8 i (new)
8i. Calls on the Commission to include in the future Single Market Emergency Instrument on the free movement of goods and persons in the event of a crisis measures which ensure that borders are kept open for pharmaceutical undertakings and their workers, in particular through the establishment of green corridors, in order to guarantee the continuity of activities involving research into and the development, production and distribution of medicines;