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PATH

PATH is the leader in global health innovation.

Lobbying Activity

Meeting with Daphne Von Buxhoeveden (Cabinet of Commissioner Stella Kyriakides), Ines Prainsack (Cabinet of Commissioner Stella Kyriakides), Ralf Kuhne (Cabinet of Commissioner Stella Kyriakides)

16 Jun 2022 · Meeting on global health

Response to European Health Emergency Response Authority

24 Feb 2021

Please see attached file. PATH has been dedicated to advancing health equity through technology for more than 40 years. We work in more than 70 countries to transform bold ideas into sustainable solutions that improve health and wellbeing for all. We develop, introduce, and advance vaccines, drugs, devices, diagnostics, digital tools, and innovative approaches to strengthen health systems worldwide. Our team shapes global conversations about health and technology, advises ministries of health, trains providers, scales teams of health care workers, and breaks down barriers to increase the supply of life-saving commodities. PATH delivers innovation at scale, reaching approximately 150 million people each year.
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Response to EU-Africa Global Health Partnership

26 Aug 2019

As an organization with over 40 years of experience working to develop drugs, diagnostics, vaccines, and devices for use in low and middle income countries to reduce the global burden of poverty-related and neglected diseases (PRNDs), we strongly welcome the European Commission’s commitment to reducing the global social and economic burden of infectious diseases through the EU-Africa Global Health Partnership. Highly Valuable Initiative: The EU-Africa Global Health Partnership predecessor, the European and Developing Countries Clinical Trials Partnership (EDCTP), has demonstrated tangible benefits and impact by boosting scientific excellence, strengthening clinical research capacity across the EU and Sub-Saharan Africa (SSA), advancing tools against PRNDs and enhancing the safety and quality of clinical research and products. We encourage the EU to build on the success of EDCTP and increase its support to the partnership to further reduce the burden of disease, contribute to the realisation of the Sustainable Development Goals, and create strategic value for the EU and its economy. According to a recent report, the EU needs to better explore science diplomacy with Africa, as “a more competitive international environment carries the risk that African countries will ultimately prioritise other relationships over their ties with Europe”. Scope: The partnership should retain its current focus on the development of new products against TB, HIV/AIDS, malaria and neglected tropical diseases in sub-Saharan Africa. Retaining this scope should allow EDCTP to grow its investment in late stage clinical development, a requirement to successfully bringing products to market and into the hands of those in need. Funding for health security should not divert funding for PRNDs, as they are already being addressed by other EU-funded initiatives, or do not primarily affect vulnerable populations. Policy Option: Only an institutionalised partnership (Art. 185 or 187) can offer the structure and level of commitment by Participating States that is needed to achieve the expected scientific, social, economic and other impacts; pool the necessary resources and facilitate the alignment and integration of collaborative research efforts. We note that an Institutionalized Partnership under Art.187 would grant greater flexibility to attract both private and public stakeholders for cooperation in global health R&I, offering opportunities to leverage new sources of funding. Budget: The EDCTP has proved that R&D investments to combat PRNDs represent a great return of investment for Europe, boosts its research capacity and global competitiveness, and makes a critical contribution toward Sustainable Development Goals (SDGs), particularly SDG3. To this end, we call on the European Commission to ensure an ambitious doubling of funding to €1.36 billion, as well as increasing contributions from the EU and SSA participating states. Greater Inclusivity and Flexibility to Get the Job Done: Current restrictions around EDCTP, and particularly, strict geographic restrictions, limit the scientific expertise that a global health partnership could benefit from. These restrictions often limit the involvement of relevant product development organizations which may not be based in Europe or sub-Saharan Africa. This limitation creates undue organizational and financial hurdles that delay and increase the costs of product development. Regardless of which partnership modality is advanced, it should allow for greater flexibility to bring together a wider group of stakeholders. We also encourage greater flexibility to invest in a portfolio of products, this will allow for shifts in funding priorities between products from those showing diminishing promise to those with increasing promise. This approach allows technical experts to make the most strategic decisions about which products show the most promise and helps reduce stranded assets and risks to funders.
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Response to MFF: 9th Framework Programme for Research and Innovation and Rules for Participation and Dissemination

20 Aug 2018

Horizon Europe (HE) as a public programme must generate tangible societal benefits and public returns, focusing on areas where there is a clear lack of commercial markets to drive innovation, such as in the field of poverty-related and neglected diseases (PRNDs). While we welcome that the proposal acknowledges Research and Innovation (R&I) as key instrument to tackle global societal challenges as per the Sustainable Development Goals (SDGs) it is regrettable that it does not explain how the programme will deliver on the SDGs, with the exception of a budget target for climate-related R&I. We are also concerned about the merging of industrial competitiveness and societal challenges in Pillar 2 -questioned both by the ex-ante impact assessment and the opinion of the regulatory scrutiny board. The capacity to address societal challenges should also be an essential criteria to define R&I missions, regardless of any economic consideration. HE should focus investments in global strategic areas where societal impact can be maximised such as health, climate change/environment or food security and nutrition. And in order to ensure that societal needs and the SDGs are sufficiently addressed, HE needs to include adequate safeguards that prioritise societal impact, mainstream sustainable development, and better define and monitor societal impact. The need to deliver accessible, suitable, safe, effective and affordable products and innovations should be at the core of Pillar 2 and a requirement for the entire framework programme. Although the EU is strongly committed to promoting R&I across its borders, international cooperation and in particular, third country participation has dwindled in the last decade, currently representing only around 3% of Horizon 2020 projects. EU R&I framework programmes have fallen short of becoming effective science diplomacy tools or of complementing EU’s development and cooperation programmes, through R&I collaboration with Low and Middle-Income Countries (LMICs). Existing R&I cooperation platforms such as the Africa-EU high level policy dialogue on science, technology and innovation or the European and Developing Countries Clinical Trials Partnership (EDCTP) are key cooperation schemes that should be preserved and enhanced. For that, LMICs need to continue to be automatically eligible for funding, not depending on the call text or whether the Commission considers their participation necessary. Similarly, in the interest of international collaboration for global health innovation, US entities should continue to be considered eligible for funding under the Health Cluster of Horizon Europe. Civil society organisations (CSOs) are key stakeholders in R&I. CSOs can contribute to identifying, and co-creating solutions to addressing societal challenges, improving public accountability and ensuring that work programmes are needs-based and fit-for-purpose to address societal needs. We recommend that stakeholders focusing on societal impact, such as CSOs, are consulted throughout the programming cycle: from priority setting including on R&I missions and partnerships and the Strategic Planning Process implementation, to the monitoring and evaluation. We noted with particular concern that the proposed budget dedicated to health has not increased compared to H2020 in terms of percentage of the total budget,and remains considerably lower than most of other clusters. Recent evidence shows that we will not reach the ambitious SDGs health targets without new and improved health technologies. To ensure the EU continues to play a leading role in this area, HE should maximise the EU’s contribution to eradicating PRNDs through increased funding and an ambitious R&I mission, with a portfolio of projects and follow-up funding mechanisms based on the attainment of scientific criteria.
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Response to Protecting citizens against health threats

20 Apr 2018

PATH welcomes the initiative of the European Commission to devote increased attention to infectious diseases and enhance the EU’s role as a partner in global health security. These are essential elements to achieving the Sustainable Development Goals. We particularly welcome the effort to “strengthen the impact of research and innovation by embedding research gap analysis and priority setting together with the Member States under the Permanent Working Group of the Health Security Committee on Preparedness and Response Planning”. We call on the communication to draw attention to areas that lack a lucrative market and thus need public investments to accelerate the development of innovative medical countermeasures, most notably for poverty-related and neglected infectious diseases (PRNDs) and emerging infectious diseases. Major product- and research-gaps persist although PRNDs affect more than one billion people worldwide and impose an unacceptable moral and health burden on individuals and societies, costing lives and hampering economic development. Many PRNDs affect and increasingly threaten the health of EU citizens. Global Research & Innovation (R&I) into new and improved tools to address PRNDs is chronically underfunded. We thus call on the EU to increase its investment in PRND R&I to help fight both ongoing and future epidemics, saving millions of lives, including within EU. The Communication should include clear actions related to EU research investments towards infectious diseases as part of the next EU Research Framework Programme. We welcome that the 3rd pillar of the future strategy aimed to “enhance the EU´s role as a partner in global health security, […], including through support for [LMICs]”. We agree that top priority should be given to building the preparedness of LMICs, especially those that have a high burden of infectious diseases and limited capacities to deal with it —where the next deadly outbreak is most likely to occur due to weak health systems. Furthermore, the EU with the support of the ECDC should not only “mobilise EU expertise […] for better and swifter outbreak response”, but should moreover increase its efforts to transfer this expertise to public health authorities (including regulatory authorities) and research entities in LMICs. Initiatives must happen in close collaboration between different DGs concerned, incl. RTD, SANTE, and DEVCO, and in synergy or complementary to existing initiatives. As part of this communication, the EU should improve synergies between Directorate-Generals (DGs) through the development of a joint science, technology, and innovation for development strategy. The regulation of health products is an essential aspect of a functioning health system and play a critical in epidemic preparedness. National regulatory authorities (NRAs) play a critical role in ensuring the safety and efficacy of research, and support timely access to quality-assured, safe, and effective health products. Unfortunately, many LMICs lack sustained funding and the technical expertise necessary to robustly and comprehensively regulate the research and registration of new health technologies. As a result, many NRAs are unable to fulfil their mandate, causing delays throughout the product development process. As the political body with one of the most regionally harmonized medical regulatory systems in the world, EU is the ideal partner to support regulatory harmonization in Africa. Both the EDCTP and Horizon 2020 present ideal opportunities to provide increased financial and technical support between the EU and the AU for accelerated regulatory harmonisation. Our interconnected world is at increasing risk from infectious diseases. However, the global interconnectivity that creates the risk of pandemics also provides the means to collaborate on the systems and solutions that enable the world to prevent, detect, and respond to public health threats.
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