53 Amendments of Marc BOTENGA related to 2021/2013(INI)
Amendment 9 #
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas the COVID-19 pandemic has revealed the limits of the current set- up as regards the anticipation, coordination and strategic management of production, value and supply chains and the accessibility of key pharmaceuticals, including vaccines against COVID-19;
Amendment 31 #
Draft opinion
Recital B a (new)
Recital B a (new)
B a. whereas the Commission’s final evaluation of the public-private IMI Joint Undertaking concluded that “no socio- economic benefits from IMI Joint Undertaking activities could be identified”, nor did it find any examples of it “bringing new, safer and more effective therapies or products to patients” or shortening development time; and that research topics “closer to the public interest than those identified by the industry” may be better identified under the wider research programme, and “at a lower cost for the public budget”;
Amendment 38 #
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. whereas universal access to high- quality, effective and safe medicines is a fundamental right; whereas the full enjoyment of this right is incompatible with a pharmaceutical production system geared primarily to commercial interests and the pursuit of profit;
Amendment 45 #
Draft opinion
Recital B b (new)
Recital B b (new)
B b. whereas the practice of parallel exports to countries where medicine is more expensive can create disruptions in supply across Member States, whereas in its resolution of 2March 2017 Parliament called on the Commission and the Council to assess the impact of the parallel trade and supply quotas;
Amendment 49 #
Draft opinion
Recital B b (new)
Recital B b (new)
Bb. whereas an effective pharmaceutical strategy should include measures designed to mitigate the impact of medicine shortages, but also to prevent them, by looking at their many root causes;
Amendment 53 #
Draft opinion
Recital B c (new)
Recital B c (new)
B c. whereas US Defense Advanced Research Projects Agency (DARPA)and the US Biomedical Advanced Research and Development Authority (BARDA) have pushed, supported and directed new technological trajectories in notably mRNA vaccine technologies; whereas certain Member States have experimented with similar programmes;
Amendment 54 #
Draft opinion
Recital B c (new)
Recital B c (new)
Bc. whereas public pharmaceutical research and innovation should be guided by, and intended solely to achieve, public health objectives, including unmet medical needs; whereas the effectiveness of the current innovation system has steadily declined;
Amendment 57 #
B d. whereas the Declaration on the TRIPS Agreement and Public Health, adopted in Doha on14November 2001, states that the TRIPS agreement should be implemented and interpreted in a way that is good for public health – encouraging both access to existing medicines and the development of new ones; whereas the WTO TRIPS Council decided on 6 November 2015 to extend the drug patent exemption for the least developed countries (LDCs) until January 2033;
Amendment 58 #
Draft opinion
Recital B d (new)
Recital B d (new)
Bd. whereas the problems of the lack of diversity in pharmaceutical supply chains and supply bottlenecks are being exacerbated by the emergence of monopolistic groupings, in particular in the biosurgery supplies industry; whereas this lack of diversity is being made worse by significant intellectual property barriers which are preventing actors from manufacturing the products needed;
Amendment 77 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Recalls the need of constant and sufficient availability of affordable medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to guarantee full transparency in production and supply chains, notably in its new industrial strategy; invites the Commission to develop synergies with horizon scanning and mapping processes already inexistence via EMA or existing voluntary inter-country cooperation schemes;
Amendment 78 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Calls on the Commission and the Member States to establish a 'European public medicines hub' with a view to launching a genuinely public programme covering the whole of the value chain and life cycle of medicines, including research and development, production and distribution; calls, in that connection, for the development of European public biomedical infrastructure to foster public- public partnerships; emphasises the contribution which the European Medicines Agency, the European Centre for Disease Prevention and Control and the future European Health Emergency Preparedness and Response Authority (HERA) could make to this project;
Amendment 80 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Emphasises that health is a fundamental, inalienable and universal human right; regards medicines, therefore, as a shared resource for humankind which should not be treated marketable goods whose use is geared solely to the pursuit of profit;
Amendment 82 #
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
Amendment 85 #
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Takes the view that the 'European public medecines hub' will be able to meet the Commission's calls for open strategic autonomy;
Amendment 87 #
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1 c. Considers that uncompetitive and monopolistic markets, as well as a lack of standardization, have contributed to supply chain shortages, notably for single use bioprocessing equipment, limiting the rapid scale-up of Covid-19 vaccine production; calls on the Commission to support intellectual property waivers and compulsory licensing of monopoly patents throughout the supply chain to address these bottlenecks;
Amendment 88 #
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Insists, with a view to mitigating the shortcomings and short-termism of private pharmaceutical laboratories, that a genuine industrial strategy be implemented to restore conditions conducive to local pharmaceutical production; considers that this European pharmaceutical industrial strategy should contribute to a genuine public health strategy focused on patients' interests;
Amendment 89 #
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1 d. Is concerned about the continuous decline in efficiency of the current innovation system due in part to data silos and the fragmentation of knowledge; calls on the Commission to promote and support open science partnerships as a mechanism to reverse declining efficiency and promote innovation, avoiding restrictive forms of intellectual property to facilitate use and sharing;
Amendment 91 #
Draft opinion
Paragraph 1 e (new)
Paragraph 1 e (new)
1 e. Recognizes the shortcomings and limited returns of the usual economic models used by the industry to develop new antibiotics; calls on the Commission to urgently present its analysis and thorough review of the current R&I incentive models in this area and address antimicrobial resistance;
Amendment 92 #
Draft opinion
Paragraph 1 f (new)
Paragraph 1 f (new)
1 f. Recognizes that further analysis to examine the limits of the current pharmaceutical system in the EU and its Member States is needed, in particular in relation to the impact of certain incentives in EU pharmaceutical legislation, the use thereof by economic operators and the consequences for the innovation, availability, accessibility and affordability of medicinal products for the benefit of patients including as regards innovative treatment solutions to common diseases that cause a heavy burden for individuals and health systems;
Amendment 93 #
Draft opinion
Paragraph 1 f (new)
Paragraph 1 f (new)
1f. Urges the Commission and the Member States to carry out a survey of all the most recent manufacturing locations of medicinal products of major therapeutic interest (MPMTIs) in the EU;
Amendment 94 #
Draft opinion
Paragraph 1 g (new)
Paragraph 1 g (new)
1 g. Welcomes the Commission's initiative to create a European Health Emergency Preparedness and Response Authority (HERA); Invites the Commission to set up an inclusive public health and public interest driven governance for HERA, ensuring transparent public control and a balanced representation of public health civil society organisations, patients, and consumers, while excluding industrial lobbies from its decision-making; Highlights the need for the new public agency to be financially sustainable in order to permit long-term planning;
Amendment 96 #
Draft opinion
Paragraph 1 h (new)
Paragraph 1 h (new)
1 h. Invites the Commission to base HERA’s decisions on evidence-based and global health driven priorities defined in close collaboration with the World Health Organization; favours a broad mandate to address bottlenecks from the discovery phase all the way to production and distribution in order to guarantee public oversight and control and ensure equitable distribution and affordable access to end products; calls on the Commission to promote, through HERA, strategic public investment in research, development, manufacture, deployment, distribution and use of critical medicines and medical devices;
Amendment 98 #
Draft opinion
Paragraph 1 i (new)
Paragraph 1 i (new)
1 i. Highlights the importance of public R&D efforts in discovering new treatments; stresses that research priorities must address public health needs, and stresses that the regulatory framework must facilitate the best possible outcome for patients and public health; calls on the Commission and the Member States to foster R&D driven by public health and unmet medical needs, including by researching new antimicrobials;
Amendment 100 #
Draft opinion
Paragraph 1 j (new)
Paragraph 1 j (new)
1 j. Considers that future medicines and vaccine development needs to be steered towards delivering optimal health technologies for public health and global access, including through the design and use of mission-oriented innovation programmes; highlights the necessity of enhanced EU leadership in prioritising public health needs and steering future R&D of health technologies by selecting and pursuing promising potential products based solely on public health considerations;
Amendment 102 #
Draft opinion
Paragraph 1 k (new)
Paragraph 1 k (new)
1 k. Calls on the Commission and the Member States to examine the possibility of creating one or more European public or non-profit pharmaceutical undertakings which operate in the public interest to manufacture medicinal products of health and strategic importance for healthcare, as part of its Industrial and Pharmaceutical Strategies, in order to complete and guarantee security of supply and prevent possible shortages of medicines in cases of emergency; recalls the essential role that new technologies, digitalisation and artificial intelligence can play in enabling researchers from European laboratories to work in a network and share their objectives and their results, while fully respecting the European Data Protection Framework;
Amendment 103 #
Draft opinion
Paragraph 1 k (new)
Paragraph 1 k (new)
1k. Calls on the Commission and the Member States to work together with health professionals, patients’ associations and manufacturers to draw up an evolving list of MPMTIs for which there are serious risks of shortages, using monitoring indicators such as previous shortages and indicators relating to the fragility of the production chain;
Amendment 104 #
Draft opinion
Paragraph 1 l (new)
Paragraph 1 l (new)
1l. Calls for public medicinal product hubs to be set up in all the Member States, and also at EU level; takes the view that these public hubs should be run democratically and transparently by management boards which bring together representatives of national health authorities and social security institutions, representatives of industry trade unions, associations of public health system users, scientists and parliamentarians;
Amendment 115 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
Amendment 120 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Condemns the practice employed by pharmaceutical laboratories of abandoning all medicines no longer considered profitable enough, even if they are essential, and only seeking to maximise profits by filing patents;
Amendment 121 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the Commission to ensure that the results of research fully or partly financed by Union programmes or other public funds, including HERA, remain in the public domain and are subject to non- exclusive licences;
Amendment 145 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Is concerned, particularly in regard to the Innovative Health Initiative, that the Industry exercises exclusive control on the priorities of the Innovative Medicines Initiative (IMI2) Joint Undertaking, that the Industry alone draws up the strategic agendas and annual work plans and privatises the results and data of projects financed by public money;
Amendment 147 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls for the introduction of a new incentive model, based on a study of decoupling mechanisms as an alternative to exclusive protection arrangements and subject to strict conditions governing the accessibility and availability of public funds for research and innovation;
Amendment 148 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3 b. Calls on the Commission to correct structural flaws in the design of Joint Undertakings, which give Industry a monopoly on strategic decision-making, allowing it to block the 2018 Commission proposal to integrate epidemiological preparation into the scope of the work of the IMI2 Joint Undertaking;
Amendment 152 #
Draft opinion
Paragraph 3 c (new)
Paragraph 3 c (new)
3 c. Notes that the Industry refuses to disclose crucial documents related to Joint Undertakings and public-private partnerships, such as project proposals, grants or project agreements; recalls, in that regard, that those documents concern projects funded by public money; regrets that these problems are partly a consequence of the structure and mechanisms of this public-private partnership; calls therefore on the Commission to introduce stringent transparency obligations in all current and future partnerships;
Amendment 159 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
Amendment 161 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Emphasises that patent protection and enforcement should have due regard for the interests of society, namely the safeguarding of human rights and public health priorities; points out that patent protection should not interfere with the right to health, undermine the accessibility and availability of medicines or serve to widen social divides;
Amendment 167 #
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Calls on the Commission to consider introducing compulsory European licences for medicines and vaccines, as a means of making responses to future public health crises in Europe quicker and more effective; calls for the applicable data protection and market exclusivity periods provided for in Regulation (EC) No 816/20061 to be waived every time a Member State issues a compulsory licence or in case of need;
Amendment 169 #
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Recalls that IP rights allow an extensive period of exclusivity that needs carefully and effectively to be regulated, monitored and implemented by the competent authorities so that IP rights do not limit accessibility and availability of medicines nor conflict with the fundamental human right to health;
Amendment 171 #
Draft opinion
Paragraph 4 c (new)
Paragraph 4 c (new)
4 c. Calls on the Commission to build on, extend and generalize the additional exploitation obligations, including an obligation to license on a non-exclusive basis and at fair and reasonable conditions included in the special Coronavirus calls under the Horizon 2020 Framework Programme;
Amendment 193 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Stresses that the high level of public funds used for R&D is not reflected in the pricing due to a lack of traceability of the public funds in the patenting and licensing conditions, impeding a fair return on public investment;
Amendment 195 #
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Considers that “value-based” and “willingness-to-pay” pricing models are at odds with the right to access to medicines, medical products and technologies as part of the right to health, as well as with sound fiscal policy, notably for new highly effective treatments for chronic diseases, life-saving medicines, orphan drug sand cures offering no proven benefit to research and development; therefore invites the Commission to support pricing models based on real production costs,including favouring grants, subsidies, and cash rewards to ensure robust funding for R&D, delinking the cost of R&D from the price of the products;
Amendment 198 #
Draft opinion
Paragraph 6 c (new)
Paragraph 6 c (new)
6 c. Notes that repurposing off-patent drugs has long been presented as a cost- effective and efficient way to develop new treatments; regrets however that a lack of publicly available data has limited its potential; insists that the repurposing of off-patent medicines not lead in any case to a decline in accessibility and that price increases would defeat the low cost of off- patent medications, a main point of interest of repurposing; highlights therefore the importance of public investment, coordination and initiative;
Amendment 199 #
Draft opinion
Paragraph 6 d (new)
Paragraph 6 d (new)
6 d. Calls on the Commission to urgently assess the impact of parallel trade on shortage of medicines in the Member States and to tackle problems adequately by taking all necessary action to ensure that medicines reach all patients in the EU in a timely manner; Calls to prioritize the right of access to healthcare to patients over the free movement of goods;
Amendment 205 #
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to promofacilitate joint procurement and make it standard practice and apply most economically advantageous tender (MEAT) criteria more stringently, in order to help push the price of medicines down; draws attention, in that connection, to the New Zealand Pharmac experiment or the Kiwi model;
Amendment 211 #
7 a. Calls for EU joint procurement to be used more systematically to avoid Member States competing against each other and to ensure equal and affordable access to important medicines and medical devices, in particular for new innovative antibiotics, new vaccines and curative medicines, and medicines for rare diseases;
Amendment 222 #
Draft opinion
Paragraph 8
Paragraph 8
8. Regrets the excessive influence of industry interest groups, which is detrimental to public-health, patient and consumer associations and to trade unions.Calls on the Commission to guarantee total transparency and democratic scrutiny of decisions, procedures and choices in this area; condemns the excessive influence of industry interest groups, which is exerted to the detriment of associations representing patients, consumers and health professionals, experts in clinical trials, public-health associations and trade unions representing workers in the industry; calls for transparent governance arrangements and decision-making procedures independent of the pharmaceutical industry to be established for all authorities, public agencies and joint undertakings in the health sector;
Amendment 230 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Stresses the importance of safe- guarding and creating quality jobs along the entire pharmaceutical value chain; calls on the Commission to promote equality employment in the pharmaceutical sector; considers that public funding, notably under Next Generation EU, requires employment safeguards; calls for a ban on collective redundancies in companies distributing shareholder dividends;
Amendment 237 #
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8 b. Recalls the critical need both for global health and global supply chains to develop local capacities, including in developing countries, notably in terms of pharmaceutical research, development and production, in order to bridge the persisting gap in research and medicines production through product-development partnerships and the creation of open centres of research and production; Calls on the Commission to use the Industrial, IP and Pharmaceutical Strategies to facilitate this;
Amendment 248 #
Draft opinion
Paragraph 8 c (new)
Paragraph 8 c (new)
8 c. Highlights that increasing manufacturing and ‘fill and finish’ capacities requires sharing the technological know-how and intellectual property and corresponding technology; invites the Commission to encourage the transfer of crucial health technologies to developing countries by granting open licenses for such technologies in line with obligations under Article 66.2 of the TRIPS Agreement;
Amendment 254 #
Draft opinion
Paragraph 8 d (new)
Paragraph 8 d (new)
8 d. Calls on the Commission to propose a strategy addressing the concentration of capacity production and support decentralisation with partners in multiple countries in order to distribute systemic risks, build systematic resilience in the manufacturing and supply of essential medicines and vaccines, and strengthen global health commons;
Amendment 259 #
Draft opinion
Paragraph 8 e (new)
Paragraph 8 e (new)
8 e. Recalls that the Human Genome Project governed by the Bermuda Principles illustrated the potential of publicly funded initiatives committed to data sharing; calls for a coordinated, collaborative and open approach in the field of research and innovation, with a stronger role for the Commission and Member States in coordinating health and epidemiological research so as to avoid duplication and drive research towards outcomes including needed medicines, vaccines, medical devices and equipment;
Amendment 264 #
Draft opinion
Paragraph 8 f (new)
Paragraph 8 f (new)
8 f. Notes that opacity of contracts and private-public partnerships generates information asymmetries that unduly benefit certain companies and limit public accountability of Commission and Member States; calls on the Commission and Member States to fully comply with WHO transparency resolution (WHA 72.8), and the specific transparency norms in the resolution, including in regard to transparency of net prices, patent landscapes, units sold, sales revenues, subsidies and incentives, registration status in countries, the costs of human subject clinical trials and the outcomes from trials;
Amendment 269 #
Draft opinion
Paragraph 8 g (new)
Paragraph 8 g (new)