28 Amendments of Patrizia TOIA related to 2021/2013(INI)
Amendment 8 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas it is necessary to guarantee the resilience of the European health system by ensuring that the production of medicines and active ingredients on the European territory is maintained through support for productive investments that respond in particular to the objectives of the ecological, energy and digital transition;
Amendment 22 #
Draft opinion
Recital B
Recital B
B. whereas universal access to medicines is a fundamental right, the full realiszation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profitcan be achieved through policy ecosystem that fosters medical innovation, to the benefit of patients and society as a whole;
Amendment 29 #
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 profitthat uses intellectual property rights in a monopolistic way;
Amendment 34 #
Draft opinion
Recital B a (new)
Recital B a (new)
B a. whereas the pharmaceutical strategy recognizes the fundamental role of expired patent medicines (including generics, biosimilars and value-added medicines) in ensuring that access for patients to drug therapies is equitable as well as in ensuring sustainability of health systems, recognizes that their entry into the market must not be delayed in anyway once the industrial property rights have expired;
Amendment 42 #
Draft opinion
Recital B b (new)
Recital B b (new)
B b. whereas the Covid-19 pandemic left the other existing pathologies on standby for more than a year and therefore there was a lack of prevention and treatments for patients. It is necessary to ensure adequate financial tools for Research and production of oncological and non-oncological drugs as well as drugs for the treatment of all diseases of which the pandemic has slow down and reduced treatment, so as to be able to cope with the increase in diseases and the needs of patients;
Amendment 55 #
Draft opinion
Recital B c (new)
Recital B c (new)
B c. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs, and of strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;
Amendment 75 #
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 Response Authority (HERA) along those lines; recognises the importance of involving all stakeholders in the development and activities of HERA as the positive public- private partnerships throughout the COVID-19 pandemic;
Amendment 117 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Welcomes the intention of the European Commission to assess and review the existing incentives framework; calls on the Commission to stimulate competition by adapting a regulatory framework and stimulating investments in off-patent orphan and paediatric medicines, including for oncology, paediatric cancers, rare diseases and neurological diseases;
Amendment 136 #
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 in accordance with the principle of fair return on investmenttargeted incentives in areas where the development of products would otherwise not be sustainable for companies such as transferable market exclusivities to stimulate the development of new antimicrobials, based on decoupling mechanisms;
Amendment 163 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Calls on the Commission, in order to be able to react quickly to health crises, to develop mechanisms that promote and support the voluntary transfer of licenses and technological know-how to countries with scarce resources, up to a compulsory European license or to possible centralized emergential authorization
Amendment 175 #
Draft opinion
Paragraph 5
Paragraph 5
5. Calls for the inclusion of public investment in R&D to be made transparentdrug R&D, and for it to be reflected in product availability and pricing;
Amendment 186 #
Draft opinion
Paragraph 6 – subparagraph 1 (new)
Paragraph 6 – subparagraph 1 (new)
Calls on the Commission to promote the development of Research in the field of pain therapy drugs;
Amendment 191 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Calls on the Commission and the Member States to develop new pricing and reimbursement models for patent expired drugs, including generics, aimed at ensuring full competition at the end of industrial property rights as well as to continue to ensure the marketing of even more consolidated drugs in clinical practice, essential for patients;
Amendment 197 #
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Calls on the Commission to support innovative pharmaceutical pricing models, including based on real R&D costs, production costs, public sector participation and their value to the patient and society;
Amendment 202 #
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to promote joint procurement and apply most economically advantageous tender (MEAT) criteria more stringently with the same clinical value; it must be ensured that joint procurements comply with the conditions laid down by Directive 2014/24 / EU, in order to ensure long term sustainability, competition, security of supply and stimulating investments in manufacturing;
Amendment 225 #
Draft opinion
Paragraph 8
Paragraph 8
8. Regrets the excessive influence of industry interest groups, which is detrimental to public-healthEncourages the active involvement of public health organizations and societies, patient and consumer associations, and tos well as trade unions.;
Amendment 226 #
Draft opinion
Paragraph 8 – subparagraph 1 (new)
Paragraph 8 – subparagraph 1 (new)
Calls the Commission, with regard to the structured dialogue on drug production and the implementation of the industrial strategy, to propose incentives and reforms - both market and regulatory - that stimulate investments in drug production to strengthen the production chain and to ensure a better adequate supply for cancer, rare disease needs;
Amendment 229 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Welcomes the recognition in the pharmaceutical strategy of the need to ensure fair access to medicines and to increase competition; therefore, urgently calls the Commission to ensure that competition, at the end of the protection of intellectual property, is timely and certain by removing all the barriers that limit it, such as the practices of IP evergreening and patent linkage that unjustifiably delay the access to medicines for patients;
Amendment 242 #
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8 b. Underlines the importance for a rapid implementation of the digital transformation in the regulatory system which, while maintaining the same safety standards for patients, reduces administrative burdens and improves the European response to health crises and drug shortages;
Amendment 247 #
Draft opinion
Paragraph 8 c (new)
Paragraph 8 c (new)
8 c. Underlines that ensuring a fit for purpose regulatory environment is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages. The adequate use of Information Technology systems will improve regulatory efficiency across Europe; therefore, the Commission should optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency;
Amendment 252 #
Draft opinion
Paragraph 8 d (new)
Paragraph 8 d (new)
8 d. Urges to promote reforms and investments in drug production technologies (environmental, digital, technological process and automation) necessary to ensure safety, innovation and respect for the environment and also stimulate investments in manufacturing technology (greening, digital, process technology, automation) that are important to enable EU industries to innovate their technology to compete and to meet society needs for security, value added innovation and sustainability;
Amendment 261 #
Draft opinion
Paragraph 8 e (new)
Paragraph 8 e (new)
8 e. Urges the Commission to also propose measures to incentivise the greater inclusion of EU small and medium-sized enterprises in the medicine supply chain given their key role in research and innovation and inherent ability to quickly adapt their production focus, with a view to coping better with unexpected shocks;
Amendment 267 #
Draft opinion
Paragraph 8 f (new)
Paragraph 8 f (new)
8 f. Underlines the importance to developed, adopted and implemented artificial intelligence (AI) technologies in healthcare systems ensuring inclusivity, capacity, trust and ethical principles.
Amendment 271 #
Draft opinion
Paragraph 8 g (new)
Paragraph 8 g (new)
8 g. Calls on the Commission and relevant authorities, to provide regulatory flexibility by allowing targeted measures such as more flexibility for multi- language packs, different pack size and e- leaflet, to ensure that patients are able to access high-quality and safe medicines faster;
Amendment 275 #
Draft opinion
Paragraph 8 h (new)
Paragraph 8 h (new)
8 h. Calls on the Commission to implement a targeted dialogue between regulators, the industry and stakeholders to design an EU Roadmap aimed to define timelines and harmonised EU standards as well as educational campaigns for patients and healthcare stakeholders;
Amendment 278 #
Draft opinion
Paragraph 8 i (new)
Paragraph 8 i (new)
8 i. Believes that in addition to the structured dialogue on manufacturing and supply chain, a wider political high level pharmaceutical forum is also needed, bringing together policymakers, regulators, patient organizations, industry representatives and other relevant stakeholders in the healthcare supply chain in order to tackle other policy areas, such as prevent shortages, address pharmaceutical sustainability issues and ensure the competitiveness of the European pharmaceutical industry overall;
Amendment 282 #
Draft opinion
Paragraph 8 j (new)
Paragraph 8 j (new)
8 j. Welcomes the Strategy's objective to support the competitiveness of the pharmaceutical industry; acknowledges that the pharmaceutical industry is a strategic sector in Europe, which must be supported with adequate, strong industrial policies to ensure that Europe stays a globally leading hub for healthcare innovation, production and services;
Amendment 285 #
Draft opinion
Paragraph 8 k (new)
Paragraph 8 k (new)
8 k. Underlines that the Pharmaceutical Strategy has to provide deeper and greater attention to all aspects of gender medicine and has to support specific Research in this regard;