Novartis was the first company to develop a systematic access planning approach. It is now joined by AstraZeneca, GSK, Johnson & Johnson, Merck KGaA, Pfizer, Sanofi and Takeda.
Not all late-stage R&D projects are supported by an access plan: 155/394 projects have plans in place.
Products already on the market are largely overlooked when it comes to efforts to improve access.
While R&D for COVID-19 has increased, pipelines remain empty for other pathogens posing a pandemic risk.
The Index in 2021 is led by GSK, which narrowly holds the top spot ahead of Novartis.
Amsterdam, the Netherlands, 26 January 2021 – A new shift in pharmaceutical company policy could shorten the time people in lower income countries must typically wait for new medicines and vaccines, reports the 2021 Access to Medicine Index, published Tuesday. Eight leading pharmaceutical companies are moving to systematically pair candidates in their R&D pipelines with plans for making them accessible in low- and middle-income countries soon after the products are launched onto markets.
Advance planning in this way during clinical development can accelerate the speed at which new products become accessible in poorer countries. Access plans can cover activities such as pricing to ensure affordability, registering products for sale in countries facing high disease burdens and advance licensing agreements that allow manufacturers to start making generic versions.
“Too many people lack access to innovative health products emerging from R&D pipelines. After years of encouraging access planning, we are now seeing a strategic shift in this direction by pharma companies. This could radically change how fast access to new products is achieved – if company leadership is determined to ensure people living in low- and middle-income countries are not last in line,” says Jayasree K. Iyer, Executive Director of the Access to Medicine Foundation.
Gap between new R&D policy and current performance
Although the systematic approach to access planning is moving into the mainstream, not all late-stage R&D projects are yet supported by an access plan. Overall, 59% of candidates addressing established R&D priorities have evidence of an access plan, compared to 31% of candidates targeting other diseases or product gaps. The company with the most candidates covered by access plans is GSK (80% of projects assessed), followed by Johnson & Johnson, Pfizer, Takeda, Novartis and Sanofi.
In an example of good practice, GSK systematically develops access plans for all projects once phase II clinical trial results are positive. Meanwhile, Pfizer requires access planning to start for all products two years before the product is launched. Takeda’s access plan for its dengue vaccine project includes a commitment to register the vaccine in dengue endemic countries, voluntary licences and tiered pricing strategies.
There is a backlog when it comes to access to products already on the market. Companies are addressing access for the poor for less than half of products analysed by the Index. Countries in lower income tiers are most consistently overlooked. Just 13% of the products that must be administered by a healthcare practitioner – such as injectable treatments for cancer – are offered through access strategies in low-income countries. This rises to 26% of self-administered products, which are mainly pills. The Index finds that small numbers of people per country are gaining access through these initiatives, which largely comprise equitable pricing strategies.
The Access to Medicine Index is an independent ranking of 20 of the world’s leading pharmaceutical companies on their actions to improve access to medicine in 106 countries. Pfizer is new in the top 5 in 2021, just behind GSK, Novartis and Johnson & Johnson, which hold the top three places. GSK and Novartis are almost tied for first place. The four top-ranked companies together with Sanofi (5), Takeda (6), AstraZeneca (7) and Merck KGaA (8) comprise the eight companies setting the pace in access planning. Engagement in systematic access planning has increased from one company in 2018 to 40% of companies in the Index.
Although GSK tops the Index, its lead on Novartis is significantly narrower than in 2018. It stands out for its R&D focus and for embedding a clear strategy for addressing access to medicine in its overall corporate strategy. GSK also performs strongly in product delivery, which includes activity in pricing, licensing, donations and capacity building in low- and middle-income countries. However, it has been surpassed in this area by Novartis, which is the only company to demonstrate that it applies equitable access strategies in low-income countries (LICs) for all products analysed, including products from its cardiovascular portfolio. Pfizer has made the most progress in rising from the bottom half of the ranking into the top 5. It owes its rise to a strong performance in access strategies and capacity building as well as access planning in the R&D phase.
R&D in 2020 dominated by cancers and COVID-19
As in 2018, a handful of diseases are the main focus of the pharmaceutical companies’ R&D activity. Among infectious diseases, HIV/AIDS, tuberculosis (TB) and malaria once again receive most attention, with COVID-19 newly joining the group in 2020. These diseases account for more than half of projects (198/321 in the communicable disease pipeline. Cancers dominate the pipeline for non-communicable diseases (NCDs), accounting for more than two thirds of such projects (461/663).
R&D activity for COVID-19 patients has been under scrutiny throughout the pandemic. Compared to before the start of the pandemic, the Index finds that the portfolio of experimental drugs and vaccines has filled up for coronavirus patients (from zero to 63 projects), yet remained empty for other pathogens that pose a pandemic risk, such as Ebola, Zika and SARS. Ten of the 16 emerging infectious diseases examined by the Index have empty pipelines from the 20 companies. The 2021 Index assesses companies on their actions to improve equitable access to products on the market and to make new products available. It covers 82 diseases, conditions and pathogens, including common killers, such as HIV and AIDS, TB and malaria, lower respiratory tract infections, diarrhoeal diseases, maternal health conditions and cancers. People in low- and middle-income countries face more than 80% of the global burden of these diseases. The 20 companies in the Index represent 70% of global pharmaceutical revenues.
Almost all of the companies are developing projects that target established priorities for R&D (established by WHO and others). Collectively, 19 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.
Media materials: The ranking, graphs and figures in the report, and underlying data, are available upon request.
About the Access to Medicine Index: The Access to Medicine Index analyses 20 of the largest research-based pharmaceutical companies with products for high-burden diseases in low- and middle-income countries. It ranks them on their efforts to improve access to medicine, identifies best practices, highlights where progress is being made and uncovers where critical action is still required. The Index is endorsed by more than 100 investors, collectively managing assets worth over USD 14 trillion. It is published every two years by the Access to Medicine Foundation, an independent non-profit organisation funded by the UK Government (UK AID), the Bill & Melinda Gates Foundation, the Dutch Ministry of Foreign Affairs, the Wellcome Trust and AXA Investment Managers.