Innovations are critical to address some of the biggest needs in global health. The Ebola epidemic in West Africa spurred tremendous interest in innovation and resulted in the development of rapid diagnostic tests, a vaccine, and novel treatments. There are many other such issues that are desperately in need of innovation. For example, we urgently need good vaccines for TB, HIV, dengue and malaria. We need simple, point-of-care tests for acute fevers which often go undiagnosed in many settings. There are many neglected tropical diseases that need new, simpler therapies.
Many companies, both large and small, are keen to innovate in the global health space. Apart from the traditional big pharma companies, there are diagnostic companies, product development partnerships, mobile technology firms, biotechs, digital health start-ups, artificial intelligence labs, and academic laboratories aiming to work in global health. The Bill & Melinda Gates Foundation has launched its own non-profit biotech called Bill & Melinda Gates Medical Research Institute.
But, in the absence of good guidance on what products are needed and what specifications they should meet, it is a struggle for innovators to develop products that are economically viable and have an impact.
Target product profiles
Over the past few years, the global health community has been trying to guide innovators by developing and publishing target product profiles (TPPs). They include product characteristics such as intended use, scope, target condition, acceptable or ideal level of performance (e.g. efficacy of a vaccine or drug, or sensitivity & specificity for a test). Target cost of the product is often included in the TPP. Most TPPs include specifications categorized as minimal versus optimal (ideal).
I was engaged in developing TPPs for novel tests for tuberculosis. Similar TPPs have been developed for products for malaria, HIV, Zika virus, Lassa virus, sleeping sickness, antimicrobial resistance, etc. These product profiles, typically, are developed by doing needs assessments, expert consultations, and stakeholder surveys. Each TPP is a fair bit of time and effort.
New database by WHO
Until recently, there was no single database of all TPPs relevant to global health. This week, WHO's new Science Division met this felt need, and unveiled a new resource, the Health Product Profile Directory. This resource aims to promote R&D for technologies to combat neglected diseases and threats to global health, including antimicrobial resistance and diseases which pose a pandemic threat.
The Health Product Profile Directory is a free-to-use online, searchable database of profiles for health products needed to tackle pressing health issues in global health. Each TPP outlines 8-10 key characteristics (such as indication, intended use, target population, measures of efficacy, safety, and dosage) for the development of health products, including medicines, vaccines, diagnostics and digital technologies.
Currently, the Directory contains 196 TPPs developed by 24 agencies, of which 191 are focused on infectious diseases. According to WHO, the top four diseases with product profiles are TB, malaria, HIV and Chagas. The lack of TPPs focused on non-communicable diseases is a gap that will need to be addressed, since the Global Burden of Disease study clearly shows the growing importance of NCDs. New TPPs can be submitted to WHO for inclusion in the Directory.
While there are no rigorous studies on whether TPPs actually inspired the development of products to meet them, anecdotal evidence suggests that they have played a key role in diseases such as Ebola, meningitis, and Lassa fever.
Should TPPs address affordability?
As a TB researcher, I am aware of innovators who have used the TPPs to guide product design and development. But many have struggled with the target costs included in the TPPs. Since TB is a disease of poverty and primarily affects low- and middle-income countries, affordability is a key consideration for the global TB community. This explains the explicit inclusion of target costs within TPPs focused on TB. Product developers, on the other hand, see cost as a variable that heavily depends on volumes, and are reluctant to begin the R&D process with set limits on costs. They also argue that a low target cost will scare away their investors.
Innovations in global health mean little if they cannot reach those who need it the most. In my field of TB, we have seen two wonderful new innovations, the Xpert MTB/RIF test for TB and drug-resistance, and bedaquiline, a new drug that has great potential to shorten treatment for drug-resistant TB. Both products have already had an impact, but are yet to reach those who need it the most. Cost has been a critical barrier for access.
So, it is not surprising that product profiles in global health include cost targets as way of reminding innovators that cost and access must be considered, even at the design stage. This requires companies to think outside the box, and consider frugal innovation as well as new business models aimed at emerging markets.
Tapping the potential of emerging innovators
While innovators in the global North will struggle with frugal innovation, there is tremendous scope for innovators in the global South to meet the biggest needs in global health. This already happening. Innovators in China and India are starting to make their presence felt in the area of biotechnology, information & communications technology, artificial intelligence, mobile/digital solutions, medical devices, and new vaccines. So, the global health community might need to look beyond the United States as the hub of innovation; Beijing and Bangalore might well be the future.
Improving the WHO resource
TPPs are neither perfect nor static. But they have a role in global health, as they send a clear signal to innovators on what products the global health community wants to see, and provide clarity on how such products should look like. The new Health Product Profile Directory by WHO will go a long way in serving as a central clearing house on product profiles, and will, hopefully, encourage more innovation in global health. Inclusion of new TPPs, especially those focused on non-communicable diseases, will enhance the value of the WHO database. I would also like to see older TPPs updated (and kept 'live'), if there is still an unmet need. Lastly, the Science Division at WHO could commission a study on how many TPPs resulted in products and how exactly they were used by product developers.
Note: I have no financial conflicts or industry relations to disclose
