By Erica Ciaraldi, Program Officer, Global Fund Private Sector Delegation, Global Health Corps Fellow, GBCHealth
Breakthrough innovations have the power to disrupt the status quo and tackle some of the world’s biggest challenges. In the field of global health, we measure the value of these innovations – whether they are products, service delivery methods or partnerships – by the impact they have on saving and improving the lives of the most vulnerable. There was exciting news last month from the International Partnership for Microbicides (IPM) that two large studies had demonstrated efficacy of a low-cost, monthly vaginal ring that delivers an ARV drug to protect women against HIV infection. The ring is made of silicon, is easily shipped, has a shelf life of five years and only costs US $5. It is the first time two separate Phase III trials have confirmed statistically significant efficacy for a microbicide to prevent HIV.
Partnership Innovation for Product Development
The IPM project represents an unprecedented joint effort to accelerate access to urgently needed products that enable girls and women to protect themselves against HIV.
In 2004, Janssen Pharmaceuticals granted IPM a royalty-free, non-exclusive license to develop the ARV dapivirine as a microbicide (think of it as topical pre-exposure prophylaxis) in resource-poor countries. Multiple donors – including USAID through PEPFAR, Irish Aid, Norad, DfID and the Gates Foundation– then provided funding and technical support for ring licensure and clinical trials. Through this partnership, IPM was able to design and test the product with feedback from low-income consumers.
Based on the success of their earlier work, Janssen and IPM reached an extended agreement, granting IPM exclusive worldwide rights to continue researching applications of dapivirine in combination with other ARVs and contraceptives, effectively expanding the scope of their work on multi-purpose prevention technologies and laying the groundwork for a pipeline of affordable, high-impact, female-initiated HIV prevention technologies.
Yet, while the initial clinical results are promising there is still work to be done.
New iterations of the product will try to improve on limited efficacy for younger women enrolled in the study. In addition, further partnerships must be developed to create a market entry strategy which will ensure access and education on proper usage for at-risk women and girls.
Why this is so important
When it comes to HIV prevention, the evidence for tailoring approaches that address the differentiated needs of adolescent girls and women is compelling. While rates of HIV infection have decreased significantly over the past 15 years, girls and women have largely been left behind.
Gender inequality, social and behavioral norms, and structural barriers are just a few of the factors preventing women from protecting themselves against HIV. The lack of female-controlled methods that give girls and women the tools to protect themselves from HIV infection is a critical gap that must be addressed. At-risk women are not a homogenous group and it is imperative that we meet the needs of different women where and how they live.
To meet UNAIDS Fast Track Targets to end the epidemic by 2030, HIV prevention programs must be focused on the groups where the majority of new infections occur. HIV/AIDS is now the leading cause of death among women of reproductive age (15-44 years) globally and almost 2,400 women are newly infected each day. Girls and women are at higher risk of HIV infection – in some high burden countries, adolescent girls constitute up to 80 percent of new infections. But they also disproportionately bear the socio-economic burden of disease and are subject to extreme stigma, discrimination and violence.
There is irrefutable evidence to suggest that when women are healthy and empowered their households, communities, countries and, by extension, the global economy, benefit.
What the IPM Ring Can Teach Us About Maximizing the Impact of Private Sector Innovations
The Janssen-IPM partnership offers a number of lessons for practitioners looking to maximize the impact of health innovations:
Continue to Reduce Risk of Market Entry for the Private Sector to Invest in Innovative Product Development: The private sector should continue to dedicate efforts to developing innovative new products and technologies geared toward the unique needs of the end-user, because only those products that women want to and can use correctly will prove effective. However, the cost of R&D coupled with the risk of long, uncoordinated processes for regulatory approval often makes it a risky proposition for the private sector to invest in developing products for low-income markets. Incentives to balance this risk, such as Advanced Market Commitments and priority review vouchers, are still being developed and improved. Yet, it is important that donors and other development stakeholders recognize that the private sector needs to feel reassured that they will generate an appropriate return on their investment.
In IPM’s case, several other pharmaceutical companies – including Gilead, Merck & Co, ViiV Healthcare, Janssen, and Bristol-Myers Squibb – have entered into royalty-free licenses that will further expand access to microbicides in developing countries. To improve access to new tools by ensuring they are made available at affordable prices in all countries where they are needed, we must harness the amazing advances in science and technology through effective partnerships, such as IPM.
Improve Healthcare Delivery: Many women around the world seek healthcare through the private sector. Private healthcare providers can and should play a key role in expanding access to comprehensive, quality sexual and reproductive healthcare generally, and to products such as the IPM ring when they reach the market. The private sector writ large can leverage and strengthen their networks and partnerships to ensure that a full range of affordable, quality-assured products are available. Moreover the private sector can collectively inform the development of policies that ensure quality and safety in low-resource settings, and train providers to deliver respectful and comprehensive care to at-risk and marginalized populations. After all, no one benefits from an innovative product that never makes it out of the warehouse to the end-user.
Leverage Private Sector Competencies to Generate Demand: While we often think of the private sector’s expertise in procurement and supply chains, the business community is equally well-positioned to generate demand and increase uptake of new products among providers and clients alike. When planning for effective product introduction, the private sector uses market research to better understand important perspectives of a variety of prescribers and end-users. Utilizing these methods will help suppliers develop targeted messaging that serves to increase uptake of new and under-utilized tools, ensuring women are both well-informed and have access to a range of products that will meet their needs.
Stakeholders around the world are recognizing that to turn the tide of the HIV epidemic, reaching and protecting adolescent girls and women is paramount. IPM and the partners that have enabled the development of ARV ring have taken a gigantic leap in the right direction. Girls and women are central to the sustainable development agenda and all sectors of society must work together to break down barriers to gender equality and empower women to lead healthy lives.