Increased access and stewardship planning in R&D is hopeful sign for poorer countries

• Small R&D pipeline for antibiotics and antifungals means access and stewardship planning is essential for each new product

• 18 out of 20 late-stage medicine projects in this analysis have both access & stewardship plans in place, a marked increase since previous Benchmarks

Large research-based pharma companies are increasingly treating access and stewardship planning as an integral part of the R&D process, making and sharing plans for a growing proportion of their late-stage clinical projects. There are also signs that these plans are becoming more in-depth and more tailored, which means that new treatments will be more likely to reach people who need them – wherever they live.

Why is this important?

Given the frequent unavailability of medications in many poorer countries, as well as the rising threat of drug resistance, there is an acute need for pharma companies to improve their access and stewardship planning. It is especially important that these plans are baked into the R&D process for new antibiotics and antifungals, for two major reasons. 

The eight large research-based pharma companies have 31 antibacterial and antifungal projects in late-stage clinical development (Phase II and onwards) that target priority pathogens.

Firstly, despite some improvements in recent years, there are still not enough products in the pipeline to replace those losing their effectiveness – so it is essential that pharma companies ensure each new medicine is protected from misuse and overuse; and secondly, access to new medicines and vaccines can be life-changing for those suffering the greatest burden of resistant infections. Plans must therefore already be established while any new product is still in clinical development.

What did the Benchmark analysis find? 

The Antimicrobial Resistance Benchmark has closely examined this area since the first report in 2018, when only two of 28 antibiotics in late-stage clinical development had both access and stewardship plans in place. Zooming in on the eight large research-based companies in the Benchmark’s scope, there has since been an upward trend, with four out of 13 late-stage medicine R&D projects covered by both access and stewardship plans in the 2020 Benchmark; this rises to 18 of 20 late-stage medicine R&D projects in this latest report. 

Companies that have significantly improved their efforts in this area include Pfizer, Otsuka and Shionogi. Pfizer, for example, has added depth and specificity to its plans, which include a wide range of strategies to ensure access in low- and middle-income countries (LMICs), such as filing for registration, equitable pricing, and measures to strengthen supply. Both Pfizer and Otsuka report detailed and varied access and stewardship plans for most late-stage medicine projects in the pipeline.

Progress is also seen in the case of Shionogi, which has now signed a Memorandum of Understanding with the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI) to accelerate access to its late-stage antibiotic cefiderocol for gram-negative bacterial infections in patients with limited treatment options. The range of stewardship and access plans which the companies intend to enact when their late-stage projects are launched includes registration commitments, potential technology transfers to generics companies, tender agreements to bring down prices, and surveillance programmes.

GSK, which has five late-stage R&D projects included in this analysis, employs an equitable pricing strategy framework in LMICs and as part of its Launch Excellence programme. From Phase III onwards, GSK develops launch plans for each market based on disease burden, regulatory requirements, market readiness and market archetype. 

Companies behind five of the 11 vaccines in late-stage trials have plans to apply for WHO prequalification and to partner with Gavi The Vaccine Alliance, to make their vaccines available to the populations that need them most. For example, Sanofi has developed its paediatric Shan6™ specifically for the LMIC market, with an extensive access plan that includes local manufacturing, equitable pricing strategies, WHO prequalification, and sustainable manufacturing and supply.

Overall, the Benchmark identifies particularly strong access and stewardship plans when it comes to tuberculosis products, supported by consistent proritisation by funders and international organisations. Johnson & Johnson’s multidrug-resistant (MDR-TB) medicine bedaquiline has been made widely available through the Stop TB Partnership’s Global Drug Facility, and Otsuka is now taking a similar approach by partnering with the Bill & Melinda Gates Foundation as it makes plans for its own late-stage TB candidate.

What needs to happen next? 

Pharma companies must make sure that they put access and stewardship plans in place for every single one of their medicines in late-stage clinical development, and that they likewise support their vaccine projects with access plans. In addition, plans for each new product must become more comprehensive, with companies considering using multiple strategies – and deploying them more widely, with tailoring to local needs. Promising steps in the right direction would then accelerate into strides. 

It would also be helpful to see a greater number of products reaching the final stages of the R&D pipeline. In a June 2021 research paper, the Access to Medicine Foundation found that small- and medium-sized enterprises (SMEs) account for 75% of all clinical-stage antibiotics in development and are pivotal in driving new antimicrobial innovation – yet these smaller biotechs often face funding shortfalls and bankruptcy, leaving promising new drugs stranded on the lab bench. As outlined in the report, there is much that large pharmaceutical companies can do to address this problem.

If and when their late-stage medicines and vaccines reach the market, pharmaceutical companies must follow through and turn their commitments into a reality. That means registering new products in large numbers of LMICs, and executing the access and stewardship plans to the fullest extent.