Investing in Research, Development and Innovation for Global Health

Transcription

1 The Malaria Advocacy Working Group (MAWG) of the Roll Back Malaria Partnership s (RBM) contribution to the European Commission consultation on the Green Paper - From Challenges to Opportunities: Towards a Common Strategic Framework for EU Research and Innovation funding The RBM Partnership brings together more than 500 partners, including malaria-endemic countries, bilateral and multilateral development partners, the private sector, nongovernmental and communitybased organizations, foundations, and research and academic institutions to ensure intensified action towards the achievement of the malaria-related Millennium Development Goals and beyond. The MAWG coordinates RBM s advocacy efforts, to increase the allocation of resources for malaria control for scaling-up malaria prevention, treatment, and operational research. The purpose of the MAWG is three-fold. Its first role is to provide strategic counsel to the Partnership and Partnership Secretariat on advocacy. Secondly, it consults with other working groups to produce timely and accurate information and tools for use in advocacy. It also provides information on opportunities for effective advocacy at global, regional and national levels. Finally, it works with RBM partners and working groups to ensure the wide dissemination of accurate information on resource allocations to inform the malaria community of current status and improve accountability both by donors and implementers. Research and development (R&D) for poverty related diseases are key to ensuring that EU, national and multilateral development efforts are successful. For while investments in health systems are critical to tackling the health problems of developing countries, investments in R&D are also needed to ensure the availability of health technologies to diagnose, prevent and treat specific diseases. Development cooperation alone cannot meet the needs of developing countries. The EC Communication entitled The EU s Role in Global Health (the Global Health Communication) describes extensively the importance of R&D, stating specifically that the EU should coordinate more effectively research on global health in order to address the highly fragmented landscape and identify shared global priorities for health research. It should promote effective and fair financing of research that benefits the health of all people. 1

2 Investing in Research, Development and Innovation for Global Health Increased coherence between the EU s relevant internal and external policies such as Development and Research will reinforce the EU s role as a global actor. The sheer nature of the EU: its diversity, safety norms, collaboration and position in innovation, allow it to play a major role in improving global health. By engaging the best scientists to work with and in Europe, European competitiveness will be supported and promoted by means of strategic partnerships, whether with European or non-european entities, to address specific global health problems, such as malaria. The Strategic European Framework for International Science and Technology Cooperation outlines the main objective of contributing to global sustainable development and of fostering Europe s scientific and technological excellence in order to address these societal challenges through research and innovation. Global health research should feature prominently in the new Framework Programme, whether in the field of international public health and health systems, poverty related diseases, or neglected infectious disease research. Furthermore, the Framework Programme should focus more strongly on supporting the research necessary to achieve the health-related Millennium Development Goals (MDGs). We therefore urge the EU to substantially increase funding for Research & Development into neglected and poverty related diseases in general, and in the next Framework Programme specifically. Vital investments for research, development and innovation in the fight against malaria Despite great gains in the fight against malaria over the past decade, the diseases still infects 225 million people every year and causes almost 800,000 deaths, almost all of them among young children and pregnant women in Africa. International funding for malaria control has risen in the past decade to reach EUR 1.24 billion in 2010 and tremendous progress has been achieved, with 11 malaria-endemic African countries and 32 countries outside Africa showing a reduction of more than 50% in malaria cases and deaths 1. However, much more remains to be done if we are to achieve near-zero deaths by At each stage along the continuum from malaria control to elimination and ultimately eradication, R&D investments are critical to ensure that new tools are developed. These include new technologies to prevent, diagnose, and treat the disease, whether drugs, vaccines, pesticides or diagnostic tools. Current estimates indicate that R&D will cost approximately EUR million per year through 2018 for new malaria control tools. Today progress in both malaria control and elimination is being made, and malaria indicators are moving in the right direction in most countries. However, much remains to be done and increasing investment in R&D today for these crucial new tools will save lives tomorrow. 1 WHO 2010 Malaria report 2

3 The EU has recognized the critical role of health in poverty reduction and development, and has given particular attention to poverty-related diseases such as malaria. Since 2002, the European Union has invested nearly EUR 180 million in malaria research through the EU's Framework Programmes for Research (FP6 and FP7). The EU is also a major contributor to the European and Developing Countries Clinical Trials Partnership (EDCTP) with 10 clinical trials to date on malaria, 50 percent financed by the European Union (EUR 35 million of a total cost of EUR 69 million). The European Commission Framework Program for research and development is the biggest public research program in the world. Therefore, the European Commission has the opportunity to be a leader in financing malaria R&D. Moving toward malaria elimination and eradication requires long-term commitments and continued R&D funding from donors, but the investment is worthwhile. Sufficient R&D investment today in new and improved interventions can help countries eliminate malaria faster in the future and reduce the need for even greater R&D investments over the long term. Moreover, reducing the malaria burden more rapidly will yield positive economic benefits sooner and help to reduce poverty. Minimizing the malaria burden means more people at work, more children at school, and a break in the cycle of poverty. In its proposal for the upcoming Common Strategic Framework, the European Commission should earmark more funds for poverty-related diseases so that R&D programmes to develop new antimalaria interventions and to inform policy decisions on the use and effectiveness of these interventions in the field can be financed. We would also encourage the Commission to increase the flexibility of such funding to make possible support for portfolio-based approaches to product development. The European Commission and the Member States in 2010 have demonstrated a strong commitment to global health and to giving priority to initiatives addressing global health challenges in the next research programme. We hope this call will be translated into action by DG Research & Innovation to make the malaria research agenda a priority of the EU. The RBM Partnership calls for more substantial funding for poverty-related diseases in the next calls under the FP7 Programme and in the upcoming Common Strategic Framework ( ). Vector control Investing in research for new and improved tools for malaria control and eradication is vital for continued progress and for sustaining the achievements made to date. Economic barriers to innovation have meant that no new insecticides have been introduced to the vector control market for 20 years. Some new products are under development for Indoor Residual Spraying (IRS), but prospects for new insecticides for Long-Lasting Insecticide treated Nets (LLINs) are far less promising. As the world is faced with the growing problem of insecticide resistance, there is a need for new insecticides to combat malaria. The development of new, safe and long-lasting insecticides together 3

4 with new formulations of currently-available insecticides designed for resistance management will be vital in the mitigation of insecticide resistance Diagnostics In the context of malaria elimination all people who carry malaria parasites need to be identified and treated to reduce transmission. All suspected cases of malaria should be confirmed through parasite-based diagnosis, as the latest WHO standards mandate. The move towards universal diagnostic testing of malaria is a critical step forward as it will allow for the targeted use of treatments help to reduce the emergence and spread of drug resistance. Diagnostic tools for successful case management of malaria are currently available; rapid diagnostic tests (RDTs) have shown their effectiveness in bringing accurate diagnosis. But developing more stable rapid diagnostic tests (RDTs) has been identified as a priority for future research. Drugs Successes have been achieved in the past 10 years to reduce the burden of malaria, one of the world's major killer diseases. Strong malaria control programmes have lowered infection rates in several countries. The recent shift from low-quality, ineffective drugs to the highly effective artemisinin-based combination therapies (ACTs) has been a breakthrough. Appropriate treatment with ACTs succeeds in more than 90% of cases. But malaria drug resistance now emerging along the Thai-Cambodia border threatens all recent gains. Continuous investment into Research & Development of new effective medicines is urgently needed including drugs to treat severe malaria and treatments for specific patient groups including pediatric formulations for children and preventative treatments for infants and pregnant women as well as drugs with transmission-blocking capability. Drug resistance poses serious threats, both for individual health and for entire health systems. There is an urgent need to develop new, safe and effective drugs. Governments can take the lead by enacting and enforcing policies that provide incentives for research, eliminate taxes and tariffs on anti malaria commodities, and ban the use of monotherapies and substandard and counterfeit drugs, and further expand access to arteminisin based combination therapy, the current standard for treating uncomplicated cases of malaria and invest in research of totally new classes of medicines. Current medicines available to treat falciparum malaria require a 3-day treatment course. We urgently need a drug that requires just one administration to ensure that treatment can be directly observed by the healthcare worker. This is especially important when treatment follow-up is difficult, as is the case in many malaria-endemic countries. A long-sought one-dose cure is now entering Phase II a trials. Blocking the transmission of the parasite from patient to patient is key if we are to achieve our goal of malaria eradication. In an infected patient some of the parasites continue to replicate asexually resulting in the clinical symptoms of malaria, while others form gametocytes or the sexual form of the parasite. Drugs will continue to be used to treat acute malaria and prevent complications in vulnerable groups. Further investments are urgently needed to eradicate this deadly disease. 4

5 Vaccines The world urgently needs a safe and effective malaria vaccine. Immunization is one of the most effective and cost-effective health interventions available. Just as it was necessary to use vaccines to control polio and smallpox around the world, vaccines are needed along with other tools for an effective malariacontrol strategy in Africa and other malaria-endemic regions. Vaccines against common childhood diseases such as polio and measles already save the lives of more than 2 million children every year. In the case of malaria, a vaccine will be an essential complement to existing interventions such as bed nets and effective drug therapies. The future of malaria vaccine development is very promising, with the RTS,S malaria vaccine candidate in the midst of a large-scale Phase 3 trial that involves 11 study centers in seven African countries. In previous studies, RTS,S was the first malaria vaccine candidate to demonstrate that it can provide substantial, although not complete, protection for young children and infants in malaria-endemic areas against infection and clinical disease caused by Plasmodium falciparum, the most deadly species of the malaria parasite. Despite this progress, more resources are still needed for malaria vaccine R&D to ensure that the international community s goal of a highly efficacious vaccine by 2025 is met. Operational Research Efforts to control malaria cannot be sustained and extended without timely surveillance systems that provide the data needed for district-level and national-level programme managers to make evidence-based decisions. Indeed, operational research is designed to enable policy change by determining strategies and tools that improve programme quality and effectiveness together with identifying solutions to problems that limit performance. Therefore, the facilitation of operational or implementation research is critical to ensure the continued effectiveness of malaria interventions and to ensure the efficiency of our investments. Malaria endemic countries must have the capacity to create an inventory of evidence gaps for programme implementation, to prioritize those lists, to develop the key ideas into proposals, seek funding for those studies, execute the work, and be able to use the information to modify existing programmatic approaches. In addition, setting up supervisory and monitoring structures and increasing data collection capacity and analysis will contribute to strengthen health systems. Covering the Full R&D cycle Only a small percentage of the funding for research and development is dedicated to creating new technologies for neglected diseases. Currently available funds are insufficient to deliver the drugs, microbicides or vaccines that are urgently needed to combat these diseases. Product development partnerships (PDPs) were established in the mid-1990s to help address the 10/90 gap that only 10% of health research funding was targeted toward diseases that accounted for 90% of the global disease burden. 5

6 While each PDP operates differently depending on the disease area(s) of focus, they typically employ a portfolio approach to R&D to accelerate product development by pursuing multiple strategies for the same disease area. They also work in close partnership with academia, large pharmaceutical companies, the biotechnology industry and governments in developing countries. There are five PDPs actively working in the field of malaria research and development: PATH Malaria Vaccine Initiative, Medicines for Malaria Venture, the Innovative Vector Control Consortium, the European Vaccine Initiative, and the Foundation for Innovation New Diagnostics. Although PDPs typically use private industry approaches to portfolio management, they focus on disease areas that lack viable commercial markets. PDPs with products in advanced stages of development have also focused additional efforts on ensuring equitable access and uptake of new products they have helped develop. According to the WHO expert working group on R&D, financing PDPs provide an optimal funding allocation at all stages of research and development, in a manner best designed to maximize public health returns in the developing world. As the R&D pipelines for PDPs mature, they have become increasingly involved in developing access strategies. PDPs have evolved into an innovative organizational model to advance global health and development priorities. Investments in PDPs are impacting disease-endemic countries both as a result of the development of new biomedical technologies to combat debilitating diseases and the partnerships forged with developing countries as part of PDPs routine activities. With adequate political and financial support, PDPs can continue to build unique partnerships with private industry, academia, donors and developing countries to develop new health technologies and to ensure access for those who need them most. PDPs also have access commitments anchored in all their collaborations, meaning that they will ensure that the products they develop will be made available in developing countries rapidly after licensure, at reasonable prices and in sufficient quantities. Over the past years, twelve new technologies have been brought to market already by PDPs, and there are currently 122 candidates in the development pipelines of the PDPs collectively, addressing many global health needs. This includes 90 biopharmaceutical candidates (up from 5 projects in 1990) and 32 diagnostic / vector control candidates. Therefore, within the context of the Framework, we urge the EU to enhance their support for models which cover the full innovation cycle, i.e. from research to market. PDPs have proven their effectiveness as cost-effective ways to bring innovative products for neglected diseases whilst incorporating market access into their core strategies. 6

7 Conclusions New tools in the fight against malaria are within reach. It is vital that the EU ensure that research for malaria and other poverty-related and neglected diseases receives robust funding in the next Framework Programme. The European Union can play a key role in addressing the weaknesses that are currently preventing the realization of the full benefits that research can bring to global health. The new Framework should support these priorities whilst at the same time offering support to partnerships and mechanisms which address the grand challenges outlined in the Framework Document, as well as those which address the priorities of full coverage of the innovation cycle, such as Product Development Partnerships. RBM, therefore, strongly supports a framework in which the EU specifically addresses poverty-related and neglected diseases through investments in research and development into neglected and poverty related diseases, and in particular, malaria. 7