COVID-19 threw pharma’s performance on access to medicine into the spotlight. Has the industry passed the test?

People living in low-income countries (LICs, World Bank classification) are most consistently overlooked by the biggest pharmaceutical companies. This is despite being home to almost 700 million people.

The current COVID-19 pandemic is a litmus test of the resilience of health systems and of the pharmaceutical industry’s ability to address issues of access, affordability and sustained supply of medicines, diagnostics and vaccines.

The 2021 Access to Medicine Index establishes how far the industry has come toward passing that test. It analyses data on 20 of the world’s largest pharmaceutical companies to assess their performance on access to medicine in relation to 106 low- and middle-income countries and across 82 diseases, conditions and pathogens, including coronaviruses.

More than 80% of people alive today live in low- and middle-income countries (LMICs) and face the bulk of the global burden that disease places on our daily lives, through ill health, disability or death. To bridge this gap, the United Nations has called for a decade of urgent action to achieve the Sustainable Development Goals and Universal Health Coverage by 2030. These objectives mean delivering health products to everyone in need, wherever they live. Success depends on pharmaceutical companies systematically addressing access at all points of the pharmaceutical value chain from R&D to delivery, and enabling access for people at all levels of the health system, including community, primary health systems and tertiary care.

At the Access to Medicine Foundation, we have been monitoring and incentivising the pharmaceutical industry to do more for improving health for people living in LMICs for over a decade. Our findings are published every two years in the Access to Medicine Index, and provide insights on progress made and how pharmaceutical companies can further contribute to access to medicine.

The 2021 Index finds that the industry continues to inch forward in integrating access to medicine into governance structures, R&D processes and monitoring efforts, yet its initiatives to address access to specific products – including antibiotics, cancer treatments and heart medicines – remain focused on a few countries. Further, the industry was ill-prepared for the COVID-19 pandemic, despite prior warnings.

Ensuring broad access upon product launch

In the past, pharma executives stated that their products were not developed with global usage in mind. The 2021 Index finds evidence of a shift away from this mindset. For example, a group of eight companies is moving to systematically ensure all products in development are paired with access plans in poorer countries soon after they leave R&D pipelines. This is up from only one company in 2018, and is an encouraging sign of momentum.

However, this policy shift has not yet impacted significantly on practice. The Index looked for evidence of access plans for 114 late-stage projects that target established R&D priorities, including for new antibiotics, or medicines against STDs. Only 59% (67) of projects were covered by such plans. For projects that target other public health needs, such as the need for heat-stable medicines, this drops to 31% of candidates (87/280).

An access plan can be comprised of a range of activities, from prioritising registration in countries with the highest disease burden, strengthening supply chains in advance of launch to ensure all populations gain fair access, equitable pricing schemes, voluntary licensing, other IP agreements and more.

In an example of good practice, GlaxoSmithKline (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.

Lack of access in low-income countries

The backlog is greatest when looking at efforts to improve access to products already on the market. People living in low-income countries (LICs, World Bank classification) are most consistently overlooked by the biggest pharmaceutical companies. This is despite being home to almost 700 million people, more than ten times the population of the UK.

For example, for products that need to be administered by nurses and other healthcare professionals – such as injectable treatments for cancer – only 13% of products analysed are covered by access strategies in even one LIC. In all cases, companies mainly focus their access strategies on countries that are generally wealthier, namely Brazil, China, India and Mexico. For self-administered products, for example for diabetes or contraceptives, the figure is 26%. In comparison, these figures jump to 42% and 43% respectively for LMICs.

While COVID-19 R&D increased, other pandemic risks go unaddressed

Despite years of warnings that novel coronaviruses were among the pathogens most likely to cause a global health emergency, the pharmaceutical industry, as well as society at large, was not well prepared for the COVID-19 pandemic.

R&D for COVID-19 surged in 2020, from zero projects in 2018 to 63 projects, reflecting a clear and vigorous response. However, R&D pipelines for other emerging infectious diseases (EIDs) looked at by the Index remain alarmingly low, despite being identified by WHO in 2016 as posing a pandemic risk. In fact, for ten of the 16 EIDs analysed, including diseases such as Nipah and Rift Valley Fever, the pipelines from these 20 companies are empty. While these may not be global threats today, they are already deadly killers, crippling populations and economies.

The COVID-19 pandemic has seen a range of responses by pharma companies. It revealed some companies’ agility and adaptability in health system strengthening, as they leveraged existing local networks in response to COVID-19. However, the shift of focus away from crucial public health issues may hinder progress in other disease areas. Some companies demonstrated the ability to anticipate and react to significant supply chain disruptions. For example, Bayer, GSK, Novo Nordisk and Novartis mobilised dedicated teams to provide support and guidance to local and global supply chain activities, aimed at ensuring continuous supply of the existing portfolio.

Ending any pandemic requires not only rapid and transparent engagement in R&D, but also assurance that products will be fairly distributed so that people living in low- and middle-income countries are not last in line – or left behind altogether. Pharmaceutical companies must do more to embed equitable allocation of access into their strategies, including showing greater flexibility in sharing their intellectual property, in addition to a sustained commitment to invest more in emerging infectious disease R&D. Lessons from the COVID-19 pandemic include the value of collaboration and close coordination by both private and public sector entities, and the important role played by pharmaceutical companies in accelerating products through clinical development and approval, to manufacture and supply at global scale without disrupting any activities.

Looking ahead

The scale of the need for better access to medicine is big. Yet the pandemic has underscored that progress in global health does not need to be gruesomely slow. Pharmaceutical companies can become a main driver for achieving rapid access to innovative products, mainstreaming access planning and finding transparent, collaborative ways to solve access challenges, and prioritising the most vulnerable populations. The industry’s successes against COVID-19 should provide a springboard for change, rather than remaining a one-off wonder.

Jayasree K Iyer is executive director of the Access to Medicine Foundation