21 Amendments of Jutta PAULUS related to 2021/2013(INI)
Amendment 1 #
Draft opinion
Recital -A (new)
Recital -A (new)
-A. whereas the problem of shortages of medicines in the EU is long-standing and the number of incidents relating to shortages of medicines has been growing in the EU Member States in recent years;
Amendment 7 #
Draft opinion
Recital A
Recital A
A. whereas the pandemic has revealaffirmed the limitations of the current set-up for managing value chains and accessibility to medicines and vaccines;
Amendment 21 #
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; whereas innovation and development and allocation of essential pharmaceuticals should be driven by medical and social needs, and governed by public mechanisms, particularly during health emergencies;
Amendment 37 #
Draft opinion
Recital B a (new)
Recital B a (new)
B a. whereas the current R&D system is biased towards high revenue generating diseases, leading to an increasing gap between real unmet medical needs and investment; whereas transparency on R&D cost is urgently needed in order to ensure fair pricing for patients and social security systems;
Amendment 44 #
Draft opinion
Recital B b (new)
Recital B b (new)
B b. whereas residues of several pharmaceuticals found in surface and ground waters, soils and animal tissues across the Union pose risks because of their toxicity or other adverse properties and affect ecosystems; whereas growing antimicrobial resistance (AMR) through uncontrolled release of antibiotics in the environment poses a serious danger;
Amendment 72 #
Draft opinion
Paragraph 1
Paragraph 1
1. Calls on the Commission toStates that the current COVID-19 crisis shows the need for more European cooperation in the health sector, calls for more EU competences in the sector; calls on the Commission to take greater responsibility for investing in and shaping pharmaceutical innovation and work towards a European public biomedical infrastructure covering the entire medicines value chain and to develop the prospective European Health Emergency Response Authority (HERA) along those lines; calls on the Commission to ensure that beneficiaries of funding disbursed through the HERA Incubator commit to sharing intellectual property and know- how to scale-up the production and availability of vaccines against new COVID-19 variants;
Amendment 106 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to pursue a public-driven model of R&D that ensures health innovations responding to real public health needs, 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 health; calls on the Commission to promote the use of TRIPS flexibilities to improve access to medicines;
Amendment 119 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of end products; calls on the Commission to adopt and implement a general policy on such conditionality under Horizon Europe;
Amendment 124 #
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2 b. Urges the Commission to propose measures to promote green manufacturing of pharmaceutical products, to include assessment of environmental properties of the active substance and environmental standards in production in the marketing authorisation process and to review tendering systems in order to reward sustainable, ethical and quality manufacturing;
Amendment 138 #
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Commission to develop a new incentive model, look into decoupling mechanisms as an alternative to exclusive protections, and attach strict conditions to public funds, attach strict conditions, including on pricing, transparency and availability, to public funds, incentives and rewards, in accordance with the principle of fair return on investment;
Amendment 158 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Calls on the Commission to consider proposing changes in the marketing authorisation framework that require the pharmaceutical industry to ensure that its supply chain is diversified, identifying alternatives for each component of the supply chain akin to the principle of N-1 redundancy in electrical grid operation and put in place a mandatory medicine shortage risk mitigation plan to manage any vulnerabilities in and risks to the supply chain; stresses the need to ensure that solid evidence, based on well-designed, well-powered comparative randomised clinical trials with meaningful endpoints are required for marketing authorisations;
Amendment 166 #
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Calls for increased funding for research on the potential negative impact of pharmaceuticals on the environment and the links between the presence of antimicrobials in the environment and the development and spread of AMR; stresses that the EU has a global responsibility in containing AMR; urges the Commission to propose the inclusion of environmental standards, especially on waste and wastewater management, in the Good Manufacturing Practice guidelines at the international level, also in order to create a level playing field;
Amendment 173 #
Draft opinion
Paragraph 5
Paragraph 5
5. CStresses that public trust relies on full transparency; calls on the Commission to ensure that EMA has sufficient public funding and human capacity to sustainably cope with its transparency policy and obligations, both in normal times and in crisis situations; calls for public investment in R&D to be made transparent and for it to be reflected in product availability and pricing;
Amendment 183 #
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to implement transparency obligations on research and development and production cost and to support pricing models based on real productionthese costs;
Amendment 206 #
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to draw conclusions from the experience of joint negotiations gained during the pandemic, to promote joint procurement and apply most economically advantageous tender (MEAT) criteria more stringently;
Amendment 212 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Calls for additional safeguards to ensure that pharmaceutical materials and ingredients entering the EU market are produced in accordance with adequate social and environmental standards;
Amendment 223 #
Draft opinion
Paragraph 8
Paragraph 8
8. Regrets the excessive influence to public authorities of industry interest groups, which is detrimental to public- health, patient and consumer associations and to trade unions. ; calls the Commission and Member States for a wide, comprehensive and genuine involvement of all relevant stakeholders, including patient and consumer groups to ensure balance between the public and commercial interests;
Amendment 234 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Stresses the importance of ensuring the protection on personal data while harnessing the benefits of digital technologies in the pharmaceutical and health sector, stresses that electronic product information should complement, but not replace, the package information leaflet;
Amendment 238 #
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8 b. Calls on the Commission to introduce a legal basis for a EU-wide early warning system for anticipated and verified shortages, involving all supply chain stakeholders, from manufacturers, full-service healthcare distributors, online and community pharmacists to prescribers, the national competent authorities and EMA for coordination at EU level; stresses that timely communication on shortages to affected stakeholders is crucial to ensure that patients’ needs are met;
Amendment 249 #
Draft opinion
Paragraph 8 c (new)
Paragraph 8 c (new)
8 c. Urges the Commission to ensure the free flow of medicines within the EU Single Market and to implement a framework which only allows temporary restrictions to the free movement of medicines if they are in conformity with Treaty of the European Union;
Amendment 258 #
Draft opinion
Paragraph 8 d (new)
Paragraph 8 d (new)
8 d. Calls for the need to reflect the diversity of society and gender-specific issues in physiology when conducting research on medicines, and stresses that legislation must ensure that these issues are properly reflected and taken into account when granting market authorisation;