Do companies plan ahead to ensure their products are accessible to patients in low- and middle-income countries?
New medicines, vaccines and other life-saving products must be made rapidly available in low- and middle-income countries as soon as they have been approved for sale. This requires tactical planning throughout the research and development process.
The Index assesses companies’ efforts to engage in R&D for 82 diseases, conditions and pathogens identified as the most critical priorities regarding access to medicine. More than 80% of people alive today live in low- and middle-income countries and face the bulk of the global burden imposed by these diseases.
Behind these numbers are millions of people who cannot rely on access to affordable, quality medicine. To ensure new products are accessible and affordable for patients in low- and middle-income countries once they are approved for sale, companies should have concrete plans in place — known as access plans. Such access plans help facilitate the availability, accessibility, affordability and supply of products for patients in these countries. Access plans are expected for projects that are in clinical development Phase II and onward (‘late-stage projects’).
Concrete tactics that help ensure new products are accessible and affordable for patients once they become available on the market. Projects that have fairer pricing strategies - here termed 'equitable pricing', wide-spread registration strategies and broad licensing agreements in place have the best outlook for access.
- Registration preparation: Commit to filing products in all countries where there is a need, and prepare registration dossiers in parallel with EMA, FDA or PMDA approval.
- Non-exclusive voluntary licensing: Voluntarily enter licensing agreements under pro-access terms to facilitate generic entry.
- Patent waivers: Publicly waive patent rights and pledge not to enforce patent rights in specific territories.
- Supply and demand plans: Plan for and align with other actors along supply chains to ensure the timely supply of quality product and prevent stock-outs.
- WHO prequalification: Submit products to WHO’s prequalification process to allow for UN procurement and accelerate registration process in countries with weak national regulatory authorities.
- Equitable pricing strategies: Set prices within the ability of specific populations to pay, with reference to a range of socioeconomic factors.
- Product donation plans: Identify populations with no capacity to pay for the new product and prepare to donate as appropriate, working with local partners.
- Access planning through partnership: Conduct R&D with organisations that explicitly commit to using access plans.
No ‘one-size-fits-all-products’ approach
Different therapeutic areas, products, etc. dictate different access needs. Access plans tend to be developed through collaboration with global health donors and Product Development Partnerships (PDPs), including the Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Drugs for Neglected Diseases initiative (DNDi), International AIDS Vaccine Initiative (IAVI), International Partnership for Microbicides (IPM), Medicines for Malaria Venture, TB Alliance, Wellcome, PATH and Unitaid. Companies can, however, also apply such plans to in-house projects independently, especially for their late-stage R&D projects.
How many projects have access plans in place?
The 2021 Index looked at access plans across two categories:
- Projects that target established global health priorities i.e. priority R&D projects, and
- Other projects that, based on the Index’s criteria, would also constitute a clear health benefit for people living in low- and middle-income countries.
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 majority of these are not yet supported by an access plan.
Most projects that target an R&D priority are covered by access plans, mainly because they are conducted within PDPs. By contrast, projects targeting a disease that has not yet been established as a priority by global health stakeholders tend to be covered by fewer access plans.
Which companies have comprehensive access plans in place? Of the 20 companies analysed by the Index, 19 have provided evidence of access plans implemented for at least one project during R&D. Boehringer Ingelheim had no late-stage priority projects during time of analysis. When comparing the same priority projects in 2018 and 2020, five projects have gained access plans.
The Index finds that eight companies are taking the lead in integrating access planning into all 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 at launch.
The charts below shows which companies are planning ahead, looking at the proportion of their late-stage pipelines that are supported by access plans and whether these plans are comprehensive. In other words, if they include all of the following access components:
- Supply and
- Breadth (covering more than five countries in scope)
In general, access plans are mostly focused on availability rather that affordability or supply. Priority R&D projects tend to be covered by stronger and more comprehensive access plans. GSK has the largest proportion of projects that are covered by different access components.
Opportunity for pharmaceutical 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. 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 enter into areas that are not yet prioritised for global health, such as cancer and diabetes, stimulate early access planning for the projects they support.