Pharma companies make limited use of the many ways to improve access to antibiotics

• Just one third of products are covered by any access strategy in any of the low and middle-income countries in scope

• A handful of encouraging examples of pharmaceutical company action suggest possibilities for change

Pharmaceutical companies are not taking the necessary steps to provide access to the antibiotics and antifungals in their portfolios in low- and middle-income countries (LMICs) – and where access strategies are in place, they remain focused on a small set of countries, people, and diseases. 

However, there are clear and tangible ways that access could be improved, and strategies which could make a real difference to millions of people if deployed more widely.

Why does this matter? 

The world’s poorest countries experience the greatest rates of infectious disease and the highest levels of antibiotic resistance – but it is precisely these countries that suffer the biggest gaps in access to appropriate medication.

An estimated 5.7 million people, mainly those living in LMICs, currently die each year from lack of access to antibiotics. Unavailability of suitable antibiotics has a huge toll on those directly affected, but is also a hazard for the world, because doctors often resort to suboptimal treatments when the right medicines are unavailable. This gives pathogens an opportunity to develop resistance.

What did the Benchmark analysis find?

The 2021 Antimicrobial Resistance Benchmark examined the access strategies used by pharma companies for a total of 166 established antibacterial and antifungal medicines and vaccines. 

Of these, only 54 – just one third – are reported to be covered by at least one access strategy in any of the 102 LMICs in scope. The remaining 112 products are either not covered by any access strategy, or the data has not been made available by the companies.

Breaking down those 166 products, only 26% of off-patent/generic medicines are covered by access strategies, compared to 46% of the on-patent medicines. The picture is better for on-patent vaccines, with 72% supported by at least one access strategy – likely reflecting the role of supranational procurement mechanisms such as Gavi, The Vaccine Alliance.

Product registration in local markets is a vital first step in making medicines widely available. There has been incremental progress here, but products are still not widely filed in LMICs. 

The 2021 Benchmark found only six on-patent medicines had been filed in 10 or more of the 102 countries in scope, including 30 filings for Johnson & Johnson’s multidrug-resistant tuberculosis medicine bedaquiline, and 25 for MSD’s ceftolozane/tazobactam, which is used to treat complicated urinary tract and intra-abdominal infections. These numbers are an improvement from just four products with more than 10 filings in the 2020 Benchmark, but the figures are still too low.

Registration, however, is only part of the story. There are a wide range of tools available to pharmaceutical companies to increase local availability of vital antimicrobials in poorer nations, such as tiered pricing, voluntary licensing agreements, technology transfers, and public-private partnerships. Under certain circumstances, patient assistance programmes and donations can also be used to increase access. 

Several companies are showing what can be done in this space. For example, GSK provides access to its antibacterial vaccines through tiered pricing policies and public or private partnerships, including with Médecins Sans Frontières.

While the use of technology transfers is limited – with initiatives being undertaken in only 14 of the countries in scope – this approach could be a cornerstone for long-term security of supply and access.

Pfizer is one of the 10 companies with at least one such initiative in place, working with the South African government and Biovac Consortium Cape Town to produce its pneumococcal vaccine Prevnar13. locally, from raw materials to fully released and packaged products.

In terms of medicines, Novartis partners with third parties to produce penicillin products in Pakistan and to transfer manufacturing knowledge – which is significant for patients as penicillin is such a widely-needed antibiotic. Meanwhile, Sanofi has been involved in technology transfers in Nigeria since 2008, enabling a local site to manufacture products including metronidazole (Flagyl), an antibiotic used to treat a  range of conditions from bacterial vaginosis to skin infections.

Access strategies have also been widely used to get tuberculosis medicines to the places where they are most needed. For example, in 2020, more than 125,000 treatment courses of Johnson & Johnson’s bedaquiline (Sirturo) were ordered through Stop TB Partnership’s Global Drug Facility, and between 2016 and 2020 at least 25,000 treatment courses of Otsuka’s delamanid (Deltyba) were distributed across more than 80 countries. Viatris is now a generic licensee of delamanid, which will help increase access to this medicine.

What needs to happen next?

The industry needs to reach more people with more products, both old and new. Current industry access strategies do not go far enough, and many of the world’s most vulnerable patients are still not receiving the life-saving medicines they need. Future strategies need to increase in quality and reach, in order to cover a wider range of countries, people, and treatments – with the fragments of different strategies coming together to form a more comprehensive picture.

With each medicine or vaccine, pharmaceutical companies should consider the full range of access strategies in the toolkit to work out what is most useful, while always taking affordability into account. This encompasses registering products more widely, including in the poorest countries; further donations and patient assistance programmes; voluntary licensing; entering into partnerships with external stakeholders to increase access; schemes to ensure continuous supply and reduce the risk of shortages; and investing in local capacity-building and technology transfers.