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ReAct - Action on Antibiotic Resistance

Founded in 2005 as an international network, ReAct works to increase policymaker awareness of antibiotic resistance and its drivers.

Lobbying Activity

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Pharma Deutschland e.V

8 Dec 2023 · Directive on Medicinal products for human use

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

7 Dec 2023 · Revision of Pharmaceutical Package - AMR (staff level)

Meeting with Tilly Metz (Member of the European Parliament) and European Patients' Forum (EPF) and

10 Oct 2023 · Pharma Package

Meeting with Sara Cerdas (Member of the European Parliament) and European Public Health Alliance

14 Apr 2023 · Resistência a antimicrobianos

Response to European Health Emergency Response Authority

24 Feb 2021

ReAct – Action on Antibiotic Resistance is pleased to see the proposed ambition for HERA to have a mandate that allows it to act and intervene throughout the entire life-cycle of a drug from early-stage discovery, to production, distribution and patient access. Such an end-to-end approach is positive overall, but will be particularly important in addressing the crisis in antibiotic development caused by a number of challenges across the whole life cycle. Option 3 (and to some extent 2.2) outlined in the Roadmap is the only option that would provide a strong enough mandate and sufficient sustainable funding to fully operationalize an end-to-end mandate. The principle of ensuring a public return in the form of affordable, equitable and sustainable access to emerging end products on public investment must be the basis of developing HERA’s structure and its legal framework. It should be established as a fully public agency, functioning in a transparent, inclusive and accountable manner. The pharmaceutical sector, private foundations and other private sector actors, should be consulted as stakeholders, but should not be part of HERA’s governance structure. HERA should have a mission to act as a driver for increasing overall transparency in the pharmaceutical innovation space including costs of R&D, clinical trial data and end-product pricing to inform and improve the quality of the public discussion on pharmaceutical policy, incentives, pricing and public return on investment. HERA should be a fork in the road for the European Union whereby new approaches that depart from the traditional drug development pathway and traditional condition-free public-private partnerships with the pharmaceutical industry, are tested and implemented. HERA’s level of ambition for the Preparatory Action on AMR should go far beyond the “business as usual” approach taken so far, which has focused on re-engaging the multinational pharmaceutical industry.Going forward the EU must instead be willing to design solutions that are public health driven, have a global perspective and are not dependent upon the participation of multinational pharmaceutical companies in order to succeed. In short, HERA must be able to act as a “Public option”. For the antibiotics field, this is particularly important given the soon-to-be-operational ‘AMR Action Fund’ funded primarily by industry. Unless an alternative public funding pathway is established, the AMR Action Fund will, as the main source of funding for clinical R&D, de facto have the power to decide which compounds to bring to market, and which projects will be terminated. It will also control the shaping (or not) of global access and stewardship policies for the antibiotics it chooses to invest in. The planned Preparatory Action on antibiotic R&D should therefore in our mind be designed to do two things: 1) Target the early discovery phases with large sums of investment to reinvigorate the pre-clinical pipeline. This opportunity should be used to develop the legal language needed for financing contracts, that gives HERA the necessary leverage over compounds throughout their lifecycle to enable HERA to ensure affordable access and responsible use of any end-product that emerges. 2) Develop an alternative public funding pathway for translational research and clinical development targeting the small biotech companies currently in the field. Upfront financing through a mix of push and pull funding could cover R&D costs and provide an attractive exit-option suitable for the SME business model (thereby emulating private compound acquisition). This would allow HERA to gain a level of control over the formulation of access and stewardship policies for some of the ‘novel’ antibiotics currently in in clinical development (and prepare the ground for testing novel models of publicly-led production, registration of drugs as well as public purpose management and licensing of IP). (See attachment for more detail)
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

ReAct - Action on Antibiotic Resistance welcomes a new EC led Pharmaceutical Strategy. We wish to note some shortcomings of the pharmaceutical system and concerns with how the EC seeks to overcome these challenges. See specific recommendations in attachment. Public-health driven priority setting To ensure pharmaceutical industry outputs are aligned with public health needs, the EC must set priorities based on unmet needs, and not what generates economic returns for pharmaceutical companies. Although COVID-19 could not have been predicted, there have been several coronavirus outbreaks over the last two decades. And yet commercially driven priority setting means that unmet health needs were ignored. Despite decades of warnings, there has not been adequate investment to anticipate and address rising drug-resistant infections. Unless the EC and governments set such challenges as a priority and put forward appropriate funding, the EU will lurch from crisis to crisis. One intervention to set priorities is through target product profiles (TPPs) generated via consensus amongst health experts. TPPs encourage the development of products that are effective, appropriate, and affordable. Transparency To ensure an effective end-to-end system, the EC should improve transparency of: (1) the terms and conditions negotiated between funders and recipients of research and innovation (R&I) funding; (2) the public and private sector contributions for such partnerships, (3) the actual cost of R&I for each new product, (4) the patenting and licensing terms and conditions of government-funded innovations, (5) preclinical and clinical trial data, and (6) prices paid across the public and private sectors. Avoiding trade-offs between innovation and access Relying on patent monopolies and high prices as the sole means to pay for new medicines and vaccines discourages the development of new medicines and vaccines that address unmet public health needs. High medicine prices also deprive people of access to medicines. While COVID-19 has illustrated that the EC can pay for most or all of the R&I to address an unmet need, and assume most of the risk, the EC has not restricted patenting or mandated open-licensing of publicly funded inventions. It is time for the EC to not rely upon the patent system to encourage companies to develop new drugs, especially antibiotics. The EU should seek to introduce new mechanisms and approaches to R&I that separate the returns of R&I from volume-based sales revenue. Antibiotic resistance (ABR) ReAct welcomes the focus on ABR in the new strategy. However, there is no way to quickly tackle ABR only through developing a new antibiotic, as resistance can emerge quickly unless appropriately used. Only through consistent, sound, transparent, and predictable investments over the coming decades across the health system can the EU reduce the negative consequences of ABR. COVID-19 has also pointed to some of the challenges that need to be addressed comprehensively through an ABR strategy, including shortages of both active pharmaceutical ingredients and end-products and the misuse of antibiotics. Such shortcomings should be addressed in a new strategy. Protecting the public interest from the private sector: ReAct recognises that the pharmaceutical industry must play a role in supporting the development of new medicines and vaccines to tackle ABR. However, EC-led initiatives, such as the Innovative Medicines Initiative, have allowed conflicts of interest to affect the projects, which can undermine goals of transparency, affordability, and public-health led priority setting. We are also concerned that a new partnership of the European Investment Bank with the pharmaceutical industry will undermine priority setting, transparency, and sustainable access to new products that emerge from this partnership. ReAct looks forward to working with the EC to both develop the strategy and ensure its success.
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Meeting with Anne Bucher (Director-General Health and Food Safety)

29 Jun 2020 · IMI project ENABLE; explore opportunities on areas of work under crosborder health threats and health systems strenghtening; AMR

Meeting with Annukka Ojala (Cabinet of Commissioner Stella Kyriakides), Tove Ernst (Cabinet of Commissioner Stella Kyriakides)

4 Mar 2020 · Antimicrobial Resistance

Meeting with Anne Bucher (Director-General Health and Food Safety)

4 Mar 2020 · discuss core priorities of ReAct as well as initiatives in the area of AMR

Meeting with Renaud Savignat (Cabinet of Commissioner Jutta Urpilainen)

2 Mar 2020 · Discussion on anti-microbial resistance.

Response to European Partnership for innovative health

27 Aug 2019

The public interest should be the core of any European partnership. ReAct’s prior experience within previous partnerships funded through IMI2, and in particular DRIVE-AB (1), revealed significant conflicts of interest when there was full participation of drug companies in shaping policy recommendations. Such conflicts must be addressed through appropriate governance of public-private sector partnerships. Furthermore, EU guidance for partnerships should require full transparency in decision making processes, and transparency regarding the actual contributions by corporate entities within these partnerships. Research & Innovation priority setting should be determined by public health needs EU should adapt priority setting procedures to ensure that priorities for Research & Innovation (R&I) are driven solely by government and by the public interest, and not to base priority setting upon the preferences of the private sector, which may wish, for example, to align priority setting with what is already present in a company’s pipeline. The next European Partnership for Innovative Health should fund R&I initiatives that focus on unmet public health needs, including addressing antibiotic resistance. The world is running out of effective antibiotics and the current antibiotic pipeline is not sufficient in terms of either numbers or the target of the drug candidates to address the increasing threat of antibiotic resistance. There is a need for drastic increases in investment into antibiotic discovery, research and development to reverse this threat. Ensure public return on public investment & safeguard equitable access to publicly funded biomedical Research & Innovation The public sector contributions stand for a significant percentage of R&I funding, in particular for high-risk early stage R&I. There is a growing demand that new products are brought to the market through public contributions, but also that parties receiving EU biomedical R&I funding should agree on provisions that address the end product’s affordability, accessibility, availability and efficiency along all the R&I stages. Ownership and management of publicly funded R&I results should be driven by public interest and explore various forms of IP management and licensing, including equitable licensing. The EC should consider equitable sharing of IP between the public and private sector according to the contribution of each. This could include only providing a non-exclusive license to a private sector entity for IP that is generated through public sector contributions. Even if IP is mostly assigned to a private sector actor, the EC should introduce obligations when assigning such IP including: restricting the subsequent use of secondary patenting by the recipient for the end product, or to require voluntary licensing of the relevant IP (generated with public support) to ensure generic competition across Europe and for low- and middle-income countries. Increase transparency Greater transparency is needed for several stages of R&I. Five types of transparency that are needed include: (1) transparency of the terms and conditions negotiated between funders and recipients of R&I funding; (2) transparency as to the extent of the public and private sector contributions for such partnerships, (3) transparency as to the actual cost of R&I for each new product, (4) full transparency of preclinical and clinical trial data and (5) transparency of prices paid across the public and private sectors. Footnote: (1) https://www.reactgroup.org/news-and-views/news-and-opinions/year-2017/react-withdraws-from-imi-project-drive-ab/
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Meeting with Vytenis Andriukaitis (Commissioner) and

11 Sept 2017 · Antimicrobial resistance, availability of antibiotics