Sustaining the gains achieved in malaria control and prevention during the MDG era as we transition to the SDGs will require an ongoing commitment to research and development (R&D) of new tools, including drugs, diagnostics and health products. With up to two-thirds of malaria-endemic countries facing artemisinin resistance, and pyrethroid insecticide resistance rising throughout Africa with no available alternatives, elimination of malaria is contingent on an abundance of new malaria tools in the pipeline.
Historically, the private sector has played an important role in the R&D arena, spurring innovation and contributing approximately $100 million to malaria R&D each year over the 2007-2011 period. Some companies have invested in the development of novel drugs such as single exposure prophylaxis, combination therapy and seasonal chemoprevention, which could help combat the increasing prevalence of artemisinin-resistant strains. Others have supported the development of new tools like the malaria vaccine. GlaxoSmithKline, working in partnership with the PATH Malaria Vaccine Initiative, has led the efforts around the RTS,S vaccine, which has successfully completed stage III clinical trials and is seen as the only tenable malaria vaccine candidate.
Despite these successes, malaria R&D is not without its own set of challenges and the path to innovation is often rife with roadblocks. The private sector can play a pivotal role in helping to address these obstacles, as highlighted below. Business can also bring much-needed attention to the importance of innovation in the malaria ecosystem, ensuring it stays prominent on the global health agenda.
Boosting R&D Financing through a Partnership Approach
Financing for R&D is at the highest it has ever been, with public, corporate and philanthropic donors committing more than half a billion dollars a year (PATH MVI, 2013)1.
The R&D financing landscape is inherently complex due to different developmental timelines and costs for malaria products. One drug costs $150-250 million over 7-10 years; one vaccine costs $600-800 million over 10-15 years; one diagnostic cost $2-50 million over 3-5 years; and one vector control product costs $60-65 million over 10-12 years (PATH MVI, 2013). However, to contain emerging resistance, additional investments in R&D are needed to ensure there are new developments and innovations. PATH MVI projects that the annual R&D need for malaria in the 2013-2022 period will be $5.5 to $8.3 billion, with an average of $700 million per year needed for most of the decade. This is an increase from current funding levels of approximately $600 million annually.
Product Development Partnerships (PDPs) have emerged as an important solution to R&D financing, as they reduce the financial risk to each individual stakeholder. For example, Standard Diagnostics/Alere and the Foundation for Innovative Diagnostics (FIND) are collaborating on the development of a rapid diagnostic test for both malaria and sleeping sickness or human African trypanosomiasis (HAT). The dual test approach would be more sustainable, and has potential to be more widely used as all regions where HAT is found are also highly endemic for malaria2. Similarly, a collaboration between the Global Health Innovative Technology (GHIT) Fund, Takeda Pharmaceutical Company, and Medicines for Malaria Venture (MMV) has resulted in progress towards developing a promising antimalarial compound which targets the malaria parasite’s reproductive cycle. This new compound has potential for low dose cure and prophylaxis for malaria. As a result of the partnership, the project has moved to the clinical trials phase to investigate the safety and efficacy of treatments for malaria patients in Peru3. These examples represent only a handful of the many partnerships currently underway.
The success of product development partnerships like Innovative Vector Control Consortium (IVCC), demonstrate that partnerships remain paramount. IVCC has helped speed up the R&D process for partners by setting criteria for new products, and ensuring that forthcoming products are environmentally and medically safe and beneficial.
Navigating Regulatory Challenges
Companies developing new health products must undergo rigorous clinical trials and follow regulatory processes for each country and market. Some of these processes can be time consuming and can delay the introduction of products known to be successful and safe. They can raise the costs of innovation and serve as barrier to entry for manufacturers, effectively disincentivizing manufacturers. We are seeing this now in the case of antibiotics. Due to scientific and regulatory challenges, there has been a marked increase in the cost and timeline of their development, resulting in an economic disadvantage for manufacturers and greatly limiting innovative advances in the field of antibiotics. Only 2 systemic antibiotics have been approved between 2008 and 2012 for use by FDA in the US compared to 16 antibiotics between 1983-1987.
Causes for regulatory delays are varied and can include the time taken to create mechanisms or product categories, and to develop guidance and recommendations on where and when new tools can be used. To help address these challenges, the private sector can advocate for standardization of regulatory protocol, working collaboratively with in-country agencies and standard-setters.
Advocacy for R&D
Finally, the private sector has an important role to play in calling for prioritization of domestic funding for R&D as a long term intervention, in addition to malaria control and treatment. Local ownership of R&D programs will ensure easier access to products and ensure the sustainability of these programs. Local private sector especially can help spread the message that malaria R&D is ultimately a cost-effective endeavor if we consider the impact new tools can have on reducing malaria transmission. For instance, the projected cost for R &D in the Action and Investment to Defeat Malaria (2016-2030) is $673 million annually – an amount which seems steep. However, this increased R&D investment when combined with other interventions could lead to malaria elimination, resulting in a net economic benefit of $208.6 billion and saving more than 10 million lives, over the 2016-2035 period. The malaria community needs to come together to create an environment which fosters the development of new tools, if malaria is to be eliminated.
1 From Pipeline to Product: Malaria R&D Funding Needs Into the Next Decade
2 Alere and FIND extend partnership to support development of rapid test for simultaneous detection of malaria and sleeping sickness
3 GHIT, Takeda and MMV progress first-in-class antimalarial DSM265 to patient trials in Peruvian Amazon