Eight companies adopt processes to systematically address access to medicine for all new products
Making new medicines rapidly available to patients who need them, requires tactical planning throughout the development phase. The 2021 Index finds that eight companies are leading the way in their approach to planning ahead for access.
Eight companies are taking the lead in integrating systematic access planning into their development processes. They are developing structured approaches for pairing each R&D project with a plan for rapidly ensuring people living in low- and middle-income countries gain access soon after the first global launch.
This represents a significant expansion in good practice since the previous Index, when Novartis was noted as the first to begin mainstreaming access planning across its pipeline. Joining Novartis in 2021 are AstraZeneca, GSK, Johnson & Johnson, Merck*, Pfizer, Sanofi and Takeda, comprising 40% of companies in the Index.
Advance planning during the late stages of clinical development can accelerate the speed at which new products become accessible to people living in low- and middle-income markets. For example, Pfizer’s new approach stipulates that planning for access begins two years before a product is launched.
What is an access plan?
An access plan can comprise a range of activities, from prioritising countries with the highest disease burdens during registration, to strengthening supply chains to ensure all populations gain fair access. Access planning enables companies to pursue a sustainable presence in low- and middle-income countries, by balancing commercial interests with their responsibility to support efforts to provide equitable access. The demand for access planning is gaining momentum among global health actors, including the World Health Organization, which is developing access planning principles to accompany its list of priority R&D targets.
In 2021, the Index examined to what extent 20 of the world’s largest pharmaceutical companies are engaging in access planning during clinical trial phases II and III. It examined projects that target 82 diseases, conditions and pathogens that impose a high or disproportionate burden in low- and middle-income countries. It looked for access plans such as registration filings, equitable pricing schemes or voluntary licensing arrangements.
What does systematic access planning look like?
Majority owned by GSK with Pfizer and Shinogi, develops access plans for all projects once phase II trial results are positive.
Aims to have the access planning process for all new products underway by phase II of development. The company’s approach is outlines in its Access Principles, with a focus on needs based R&D, medicines affordability and contributing to health system strengthening.
Has expanded its access planning processes during development from vaccines to all products, and launched a global pricing and access strategy, initiating access planning for all products across markets at least two years prelaunch. Each plan is finalised well in advance of launch. Access plans include guidance on equitable pricing, as well as innovative arrangements and approaches that support broad access and affordability.
Systematic approaches yet to close gap in access planning
While the systematic approach is starting to become mainstream, not all late-stage R&D projects are yet supported by an access plan. To date, GSK goes furthest, covering 80% of its relevant projects with access plans, followed by Johnson & Johnson, Pfizer, Takeda, Novartis and Sanofi.
Companies’ engagement in R&D and access planning is driven by clear priorities or demand from global health stakeholders. The 20 companies have 394 projects in late-stage development that target either established global health priorities (114) or offer benefits to people living in low- and middle-income countries (280).
The first category comprises projects that target diseases or specific product gaps that global health stakeholders have already established as an R&D priority. These reflect global priorities such as coronavirus, malaria, tuberculosis and HIV, and are commonly the focus of public-private Product Development Partnerships (PDPs) or other donor-supported initiatives. For such projects, many PDPs systematically require advance access planning.
The second category comprises projects that, based on the Index’s criteria**, would constitute a clear health benefit for people living in low- and middle-income countries but have not been the focus of large donor-supported initiatives or R&D prioritisation initiatives. In such cases, companies can still develop advance access plans, whether or not a public-sector partner requires it. Overall, 59% of the projects in the priority R&D category, and only 31% of those in the second category, have evidence of an access plan.
What next? Opportunity for pharma industry to become driver for access
The Index concludes that, as access planning does not yet cover even half of late-stage projects, it is encouraging that eight companies are integrating access planning fully into their development processes, including for projects without donor involvement. This signals that access planning should begin to increase as more projects enter later clinical phases, and could become standard across the industry. To have maximum impact, access plans should have a broad geographic focus, explicitly aiming to reach the majority of people affected by a disease or in need of a vaccine or new diagnostic tool.
To have maximum impact, access plans should have a broad geographic focus, explicitly aiming to reach the majority of people affected by a disease or in need of a vaccine or new diagnostic tool.
If this happens, people living in low- and middle-income countries, especially resource-limited settings or remote areas, will no longer need to be last in line for pharmaceutical innovations, which is key for achieving universal health coverage (UHC). Pharmaceutical companies can become a main driver for rapid access to innovative health products in low- and middle-income countries. This shift could be accelerated if donors that focus on areas of R&D that are not yet prioritised for global health, such as cancer and diabetes, stimulate early access planning for the projects they support.
*Merck KGaA (Darmstadt, Germany)
** For example, projects aiming for heat stability or with clinical trials running in countries in scope.
***The Index only looks at capacity building initiatives where companies mitigate the risk of conflict of interest.