February 9, 2015
What do getting oral misoprostol approved by national and global regulatory agencies for the treatment of postpartum hemorrhaging, lowering the cost of the HPV vaccine for low and lower-middle income countries by 97 percent and introducing an existing antiseptic to reduce neonatal sepsis as a cause of newborn deaths have in common? Where all of these steps have happened, they have been part of the successful launch of products with the potential to save lives on a global scale.
How were these products successfully launched? What were the steps taken to ensure use, accessibility and affordability? And how can lessons learned be applied to other products that represent major scientific breakthroughs whose main application is in poorer countries?
USAID’s Center for Accelerating Innovation and Impact (CII) developed IDEA to IMPACT: A Guide to Introduction and Scale of Global Health Innovations, dissecting “best practices” for taking innovations to scale and identifying key activities along the research to rollout continuum that need to happen in order to successfully bring a new product to market and into a health system. The guide provides a delivery framework (Figure 1), and a series of case studies highlighting each stage of the process. A companion workbook and toolkit (zipped file) provide practical steps for those coordinating introduction and scale programs (i.e., donors, non-governmental organization implementing partners, or others such as social entrepreneurs and innovators) that can be taken towards product launch.
Many of these “best practices” towards product launch are nothing new. However, what is new are donors and implementing partners thinking along the lines of the pharmaceutical industry model, which dedicates millions of dollars and significant human resources towards these types of product launch activities in close collaboration, and in conjunction with, the research and development stages. The guide ties the time to scale-up of product introduction to an increase in reach (i.e., the faster a product gets offered to those who need it and will use it, the more people will get and use the product). Industry typically takes about five to seven years to reach their intended product users at scale. However, a recent analysis showed that slow product launches are unfortunately norm for products launched to meet the needs of those in poorer counties—meaning that many times life-saving innovations are not reaching all those who are in need (Figure 2). Further, there is a limited window of time during which a product launch needs to happen to be successful, following which achieving scale (i.e., reaching all potential users) becomes very difficult (IMS Health, Launch Excellence IV: A New Launch Environment. 2013).
On Monday, February 2, USAID launched the guide bringing together a panel of global health practitioners with experience delivering a diverse range of products in resource-challenged settings. The delivery framework (Figure 1) outlined in the guide provides steps to address the narrow window of time within which product launch needs to happen so that products (including drugs, devices and vaccines) can get in the hands of those who need them. The panelists named a lengthy list of conditions for a successful product launch, which served to amplify how complex launching a product for populations in developing settings can be. Beyond and within the framework above, a successful product launch requires many elements, including advocacy; the appropriate technology; funding commitments; policy and guideline changes; training of clinicians; clinical effectiveness; partnerships; and alignment among different global health actors.
A big global health need does not equal end user demand or use.
While all of these elements remain important, the panel honed in on one key component that a product launch cannot take place without: the end-user. How product developers and implementers think about the user, and how a product is designed with the user in mind is the key to a successful product. Especially keeping in mind that a big global health need does not equal end user demand or use. When a product does not fully consider the end user, the product may be used for a different purpose, not actually reach the user or simply not be used, for instance: malaria nets used for fishing and wedding dresses; breastfeeding initiatives in clinical settings that don’t work where most births take place outside of hospitals; and in the HIV prevention space when the available prevention methods fail to meet the needs of the user (whether those needs be discretion, control or pleasure). The nonprofit and government agencies involved in developing and delivering global health products need to be “user-obsessed”, not just “user-centric”. And like industry, they need to plan for product launch with the end-user in mind long before a product is ready for launch to ensure the window of time to take a product to scale is maximized.
Wendy Taylor, Director of USAID’s CII, explained that the best outcome is either a product that will be used, or a product that won’t be used, but gets “killed” early in the research and development process. The HIV prevention field needs to ensure that products are not just needed, but that users want them, want to use them and can use them. AVAC’s partners in Africa are doing just this—working on a number of different advocacy fronts to define priorities in HIV prevention. Whether by involving civil society groups focused on women’s health in the processes related to moving a microbicide from trial result to eventual piloting and introduction in South Africa, or advocating for the development of guidelines for tenofovir-based PrEP rollout in Uganda, AVAC’s partners are already undertaking many of the key product launch activities outlined by the panel and in the USAID guide.
(Note: At the recent HIV R4P 2014 conference in October, many of these issues particular to HIV prevention were discussed at a roundtable: Diffusion of Innovation: Accelerating Along the Research to Rollout Continuum. The session included presentations a number of presentations: Moving from Evidence to Demonstration Projects to Policy and Programs in HIV Prevention; Rapid rapid-scale-up of VMMC; Challenges for PrEP Implementation in the US; and From Research Result to Public Health Impact: What Have we Learned and how Can we Do it Better and Faster. Check out the webcast here.