More access plans and strategies to expand access to more products, but with limited breadth and depth

• While companies are taking steps to improve access to their products in low- and middle-income countries, their plans and strategies consistently overlook the poorest countries.

• For some products, companies are moving to consider availability, affordability and sustainable supply, signalling possibility for change.

Access plans are ways for companies to ensure they take account of public health needs while new products are still in development, so that people in LMICs can gain access to products more rapidly and affordably following their market entry. Companies should have plans in place for products in the pipeline from at least Phase II of R&D.

Access strategies are ways that companies can ensure equitable access to the products in their portfolios. Companies are expected to apply access strategies to key products across LMICs, maximising the availability of these products to those with less income.

Out of the 20 companies assessed by the Index, six now have access plans in place for 100% of late-stage R&D projects. This is the first time any single company has hit that milestone, and is an encouraging sign that companies will make their new products more available to the people who need them in low- and middle-income countries (LMICs). For products already on the market, the data also demonstrates progress; 83% of the products assessed by the Index are covered by an access strategy in at least one of the LMICs in scope, compared with 58% in the previous Index.

Yet, analysis of companies’ access plans and strategies shows that they are often limited in depth and breadth, sometimes only containing the most basic elements. As ever, low-income countries are paid the least attention. A few examples from a handful of companies show, however, that this situation is not inevitable, and that it is possible to expand access to essential healthcare products so that people worldwide get the treatments they need.

Steps forward in R&D access planning, but low-income countries left out

Astellas, Boehringer Ingelheim, Johnson & Johnson, Merck, Novartis and Takeda have now provided evidence that they have developed project-specific access plans for all their latestage R&D projects in scope of the Index.¹

Yet, despite an industry-wide expansion of access planning during the R&D stage, the number of countries included in plans is low. On average, an access plan includes only six of the 108 countries in scope of the Index. Only 15% of access plans include at least one of the 27 low-income countries; conversely, 85% include at least one of the 26 upper-middle income countries. Upper-middle income countries are six times more likely to be included in companies’ access plans for an R&D project.

Currently, 52% of the access plans assessed by the Index consist solely of plans to register products in at least one LMIC, once approved. Companies mostly commit to filing for registration in the countries where clinical trials have been conducted – predominantly in upper-middle income countries such as South Africa, China, Mexico, Colombia and Brazil. Registering a product is a vital step, but it should not be the only element of an access plan.

However, some companies have access plans that are more comprehensive, and include low-income countries. For example, Novartis includes five low-income countries in clinical trials for cipargamin (KAE609), for the treatment of severe malaria; in line with its post-trial access policy, the company commits to registering the medicine in those countries once approved. Takeda’s access plan for its dengue vaccine QDENGA® (TAK-003) considers burden of disease in its plans for where to file for registration, as well as innovative equitable pricing models and methods to ensure sustainable cold chain supply.

Companies’ efforts to ensure existing products reach patients still overlook low-income countries

Although the number of products in scope covered by access strategies has increased overall, companies are still far less likely to include low-income countries in their strategies, despite the urgent need for greater access to medicine in these countries.

Expanding access in low-income countries can present complex challenges for companies, for example if the country lacks regulatory capacity, has weak healthcare infrastructure, or is less likely to provide a high yielding market. Even though there is no ‘one-size-fits-all-products’ approach, companies can utilise a wide range of tools and approaches to directly address access and affordability in LMICs. Companies can implement equitable pricing strategies, or can work with other stakeholders, e.g. by using non-exclusive voluntary licensing agreements (NEVLs) to facilitate an increase in generic supply in LMICs, or by engaging with supranational procurement organisations.

Some companies are already taking steps to implement access strategies in low-income countries (see figure, right). Yet, when companies were asked to provide an example of a strategy used to expand access in a low-income country for each of up to 10 products from their portfolios, the positive examples outlined above were the exception, not the rule. Two thirds of all products analysed by the Index were still not covered by any access strategies in a low-income country.

What next?

More companies can now ensure all their late-stage R&D projects have comprehensive access plans in place that contain a variety of measures to increase access, and cover more countries – including low-income countries.

Companies can also expand the quality and quantity of their access strategies to cover a wider range of countries, people and treatments. To sustainably expand access in low-income countries, companies need business plans that account for such challenges and facilitate access across all LMICs. Some companies are already seeking ways to develop such plans; Sanofi, for example, launched a new Global Health Unit in 2021, though which it commits to expanding access to 30 of its products in 40 of the world’s poorest countries, while Pfizer has made a commitment to creating sustained and equitable access to all of its patented products in 45 lower-income countries through its 2022 Accord for a Healthier World. These are signs that the companies are taking the challenge of expanding access in low-income countries seriously, but their success will depend on their implementation.

1 Projects from Phase II and onwards (late-stage) were selected for analysis based on their priority disease designation or if they were identified as having a public health benefit in LMICs.

*Companies were requested to submit up to 10 products each for this analysis, including healthcare practitioner-administered and self-administered products.