Pharmaceutical Industry’s Medicine Access Efforts Stall in Poor Nations, Watchdog Finds
Lab technicians work in laboratories in Afrigen, a company in Cape Town selected as the WHO Vaccine Hub, in South Africa.

Major pharmaceutical companies have made minimal progress in expanding access to essential medicines since the COVID-19 pandemic, according to an industry watchdog report released Tuesday.

The 2024 Access to Medicine Index, which evaluates 20 of the world’s leading drugmakers, found that despite modest improvements from certain companies, the overall pace of change in improving availability of life-saving medicines remains slow across more than 100 low- and middle-income countries.

The biennial rankings show major access initiatives launched by firms like Pfizer, Novo Nordisk and Bristol Myers Squibb to make treatments more affordable and available are operating in less than a quarter of their target countries.

The 20 companies assessed by the index, which control over half of global pharmaceutical revenue, face mounting pressure to improve access amid growing threats from drug-resistant infections and future pandemics. Two billion people, particularly in the world’s poorest countries, still lack access to essential medicines accessible for decades in other parts of the world. 

“Companies could do a lot more to scale up their initiatives to make lifesaving treatments accessible and affordable everywhere they are needed,” said Dr Jayasree Iyer, CEO of the Access to Medicine Foundation. “Until that happens, many essential medicines and healthcare products will remain out of reach for billions of people living in low- and middle-income countries.” 

Nearly half of essential medicines – from treatments for diabetes and cancer to cardiovascular and infectious diseases – remain unregistered in countries where disease burdens are highest, the report found. As clinical trials continue to bypass low-income countries, and with most drugmakers having policies to seek approval only where they run trials, new treatments do too, the analysis showed.

“We’ve seen what’s possible when global health becomes a priority, as it did during the COVID-19 pandemic,” Iyer said. “The tools exist, and so do the partnerships. What we need now is sustained commitment and deliberate action to reach those who have been left behind for far too long.”

“Why create medical innovations if they’re out of reach to those who need them?” Iyer added.

Clinical trial disparities widen access gap

Over half of the 117 low- and middle-income countries covered by the Index have no active clinical trials.

Clinical trials remain heavily skewed toward wealthy nations. While low- and middle-income countries are home to 80% of the world’s population, they host only 43% of trials for new medicines, with just 3.6% taking place in low-income nations, according to the report.  

Even within developing regions, trials cluster in a handful of upper-middle-income countries like China, Brazil and South Africa, leaving over 70 of the 113 nations covered by the Index with no active trials at all. 

This matters, as a majority of pharmaceutical companies covered in the index only file for drug approvals in countries where they run clinical trials, making early access planning critical for ensuring treatments reach patients in low-income regions after regulatory approval.

“Since trials are conducted only in a few low- and middle-income countries, access plans are often confined to these regions, ultimately widening the access gaps instead of closing them,” Iyer explained. “This is a big problem.” 

Registration gaps leave the poorest nations behind

The disparity in clinical trials has led companies to register products five times more frequently in upper-middle-income countries than in low-income ones. Of 179 products analysed in the Index, 87 are not registered in any of the top 10 countries with the highest disease burdens associated with the medications.

While 85% of products have company-led programs to ensure availability and affordability in upper-middle-income countries through measures like equitable pricing and licensing agreements, this drops to just 39% for low-income nations. The proportion of products lacking any affordability or access programs in low-income countries has barely improved, falling to 61% from 65% in 2022.

“This low overall registration coverage of countries with high disease burdens means that products may not be available where people need them the most,” the report found.

Nearly half of innovative medicines approved in the past five years remain unregistered in any African country as a result, contributing to $2.4 trillion in annual costs from preventable disease across the region.

“This imbalance is unacceptable,” Iyer said. “Every delay in expanding access to medicine translates to more lives lost and communities devastated.”

Manufacturing gap widens as technology transfers stall

Sub-Saharan Africa is largely overlooked by companies’ technology transfer efforts. As a result, 43% of innovative products approved within the past five years have not been registered in any African countries.

The barriers to access are further compounded by stagnating efforts to boost local manufacturing capacity in low-income countries. Technology transfers, where companies share manufacturing knowledge with local producers, remain heavily concentrated in a handful of emerging markets.

Like clinical trials, the majority of technology transfers undertaken by major pharmaceutical firms benefit a small share of upper-middle-income nations. Of 47 ongoing technology transfer initiatives identified, India hosts 11, Brazil nine, and China seven. 

Sub-Saharan Africa, which bears 20% of the global disease burden and relies on imports for up to 90% of its pharmaceutical products, sees minimal investment outside South Africa. The manufacturing gap is at its widest when it comes to vaccines, with Africa importing 99% of its doses. 

“Right now, these efforts are heavily skewed toward upper-middle-income countries like China and India, leaving Africa behind,” said Claudia Martinez, Research Director at the Access to Medicine Foundation. 

Progress in voluntary licencing agreements, which allow generic manufacturers to produce and distribute patented medicines at lower costs, has also slowed, with just two new agreements in 2024, down from six in 2022.

“The infrastructure exists in places like South Africa, Nigeria, and Kenya,” Martinez said. “The challenge lies in companies’ willingness to expand their efforts and commit to long-term partnerships.”

New access models show mixed early results

Five companies – Novartis, Novo Nordisk, Sanofi, Pfizer, and Bristol Myers Squibb – have pledged to tackle systemic access barriers by making their products available in 102 countries through “inclusive business models” (IBMs), targeting all 48 low-income and least developed nations.

Early results show varying progress. Bristol Myers Squibb’s ASPIRE program, launched this year, is active in 19 of its 85 target countries – an implementation rate of 22%. Pfizer’s Accord for a Healthier World, announced in 2022, has signed agreements with only eight of the 45 countries covered in the plan.

Longer-running programs fare better. Novo Nordisk’s iCARE, launched in 2021, is active in 17 of 46 countries. Novartis, with the oldest program launched in 2019, states its products are available in “most” of its target countries but does not provide specific numbers.

Sanofi is the only company providing specific patient numbers under its IBM, the report said. The drugmaker reached 261,977 patients with treatments for non-communicable diseases across 31 countries, while serving 23 countries for tuberculosis and 19 for malaria, though it doesn’t provide country-by-country breakdowns.

New leader, slow pack 

Overall rankings of the 2024 Access to Medicines Index.

The Index ranks companies on a five-point scale, measuring their efforts to improve medicine access in poorer nations. While Novartis claimed the top spot for the first time with a score of 3.78, displacing long-time leader GSK to second place, even these best performers remain well below the maximum score.

The Index shows steady progress over its 15-year history, with the average scores across the 20 pharmaceutical companies rising more than a third since 2010 and the gap a steadily narrowing gap between the best and worst performers. 

Companies like GSK and Novartis have consistently maintained the top spots, while Gilead, despite its crucial role in HIV/AIDS and hepatitis treatments, has seen its score decline significantly.

David Reddy, director of IFPMA, the pharmaceutical industry group representing most indexed companies, points to initiatives like tiered pricing models and voluntary licensing agreements as evidence of progress.

“These efforts demonstrate the value of partnerships with governments, healthcare systems, and local organisations,” Reddy said. Despite these strides, the report underscores the need for accelerated efforts to close persistent gaps in access, particularly in low-income countries.” 

Researchers at the United Nations University International Institute for Global Health have questioned the rankings’ reliability, noting they rely heavily on self-reported corporate data that cannot be independently verified. 

Image Credits: WHO.

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