Are companies developing health products that are urgently needed and offer a clear public health benefit?
There is a huge call for action from the global health community for R&D that targets the needs of people living in low- and middle-income countries.
The World Health Organization (WHO) and Policy Cures Research, an independent R&D-focused policy group, have published lists of the most urgently needed new products to help spur action in this area. The pharmaceutical companies’ response to these priorities can have a considerable effect on increasing access to medicine. On top of that, the COVID-19 pandemic has made governments, pharmaceutical companies, investors and other health stakeholders recognise the urgent need to mobilise, collaborate and coordinate towards new treatments and vaccines.
However, the WHO and Policy Cures Research priority lists do not include every single product needed by patients in those countries even though they may have a clear public health benefit. As clinical trials are being conducted in low- and middle-income countries, companies should consider the needs of patients in low- and middle-income countries and reduce the risk of further delays in access to the newest medicines in the countries that need them the most. For this reason, companies should not only answer calls to carry out priority R&D, but also ensure that all products are suitable and accessible for populations in low- and middle-income countries.
What R&D projects does the 2021 Index analyse?
The 2021 Index assesses companies’ efforts to engage in R&D for 82 diseases, conditions and pathogens in scope (i.e. those that cause the greatest burden in low- and middle-income countries). The 2021 Index assesses the companies' R&D activity against:
- Defined and published R&D priority lists: WHO and Policy Cures Research have identified 211 specific medicines, vaccines, diagnostic tests or other products that are urgently needed by people living in low- and middle-income countries– hereinafter termed ‘priority R&D’; covering a total of 50 diseases.
- Other diseases or products that have not yet been independently established as priority by global health stakeholders, but have a clear public health benefit in low- and middle-income countries. The Index uses a set of criteria to identify such projects.
On which diseases is the focus of the 1,073 R&D projects?
Non-communicable diseases (NCDs) dominate the 20 companies' pipelines. In fact, the diseases with the most R&D projects are cancer (461) followed by coronaviral diseases (63), malaria (56), lower respiratory infections (45) and HIV/AIDS (41).**
93 projects in development focus on paediatric healthcare (patients aged ≤12 years), mostly targeting cancer, lower respiratory tract infections, followed by HIV/AIDS. Many of these projects for the paediatric population are being developed by GSK followed by Johnson & Johnson and Sanofi.
What does each company's pipeline look like?
19 out of 20 companies are developing the 374 priority R&D projects identified. Novo Nordisk is the only company in scope that is not active in priority R&D. All 20 companies are developing projects with a clear public health benefit to patients in low- and middle-income countries.
How many priority R&D projects are in development?
The Index identified 374 priority R&D projects. The majority of them focus on malaria, HIV/AIDS and coronaviral diseases (i.e. COVID-19), with the most projects for communicable diseases in preclinical phase. More than half of the malaria projects (62%) and more than a third of the tuberculosis projects (36%) are under Product Development Partnerships (PDPs). Yet, a total of 149 of the 211 identified priority gaps are unaddressed. Despite almost 94% of all maternal deaths occurring in low- and middle-income countries***, only 11 R&D priority projects are in the pipeline for maternal and neonatal health conditions. Unaddressed gaps also include such diseases as Bunyaviral diseases, several diarrhoeal diseases and sexually transmitted infections (STIs). Noteworthy is the increase in projects targeting COVID-19 but product gaps for the other highly pathogenic coronaviral diseases remain unaddressed.
Developing other projects with a clear public health benefit for low- and middle-income countries
Thirty-two of the 82 diseases and conditions have not yet been established as priority by global health experts. For these 32 diseases, the Index used a set of criteria to determine which projects offer a clear public health benefit to patients in low- and middle-income countries, for example, projects aiming for heat stability. The charts below show the number of such projects identified and the companies who are developing them. Only projects in the clinical stages of development were included for this analysis (Phase I onwards). Out of the 440 projects, almost all are targeting NCDs and are mostly first-in-class projects targeting cancer or projects conducted in the countries in scope. Few first-in-formulation projects were identified i.e., projects that could significantly improve the administration of existing products.
Target product profiles
Companies can optimise the development of products by including the needs of LMIC patients in their target product profiles. An example of such a target product profile is the profile set up by the WHO Preferred Product Characteristics. The WHO’s Department of Immunization, Vaccines and Biologicals has formulated WHO’s preferences for new vaccines in the priority disease areas.† These product profiles promote the development of new products with high public health impact that are suitable for use in low- and middle-income countries.
* Other includes projects that are market approved, applied for first global registration, technical lifecycle and projects that follow a different development cycle (e.g. diagnostics).
** The total is the sum of all projects counted. Some projects fall into several disease categories.
*** World Health Organization. Maternal mortality; Key facts. September 2019. https://www.who.int/news-room/fact-sheets/detail/maternal-mortality Accessed December 22, 2019.
† World Health Organization. Target product profiles. WHO. 2020. http://www.who.int/research-observatory/analyses/tpp/en/. Accessed December 23, 2020.