Pharma must ramp up access, stewardshipefforts in AMR research, new report finds

Ensuring new therapies reach low- and middle-income countries could save hundredsof thousands of lives.

While debate on fighting AMR tends to focus on encouraging big pharma companies to re-enter antimicrobial R&D, theresults of such measures will take years to pan out. | Loic Venance/AFP via Getty Imagesby Claudia Chiappa · 17 HOURS AGO · 5 MINUTES READ

Pharmaceutical companies involved in antimicrobial research and development must
do more to ensure new antimicrobial treatments reach patients across the world,according to a new report that faults their access and stewardship plans.
The study, published by the Access to Medicine Foundation, looked at five late-stage
clinical develop­ment projects currently in the pipeline to assess their efforts to ensurethat new antimicrobial drugs — which can treat drug-resistant pathogens — reachpatients in low- and middle-income countries and remain effective as long as possible.
It found that while pharmaceutical companies are already pursuing several access andstewardship strate­gies, “structured advance planning has not yet become standard,risking patient care globally.”“To save as many lives as possible, it is vital to ensure these much-needed med­icinesreach the patients who need them most, particularly in countries that face the highest
burden of drug resistance,” the report reads.
Antimicrobial resistance (AMR) is widely regarded as one of the most pressing threats
to human, animal and environmental health — even worse than the Covid-19
pandemic.
Experts and lawmakers are encouraging restraint in the use of antibiotics, to reduce
overexposure. They also warn, conversely, that high-quality antibiotics must be mademore available to countries that don’t have enough, as the lack of effective
antimicrobials kills more people than does resistance to the drugs.
There is also a need to develop novel antibiotics and antifungals to treat infections thathave grown resistant to existing therapies, and to make these drugs available
everywhere they are needed.
Despite the urgency of these needs, however, only a handful of projects are currently
in the pipeline, with pharma companies having largely abandoned antimicrobial
research and development. Firms that do have projects in the pipeline thus bear aneven greater responsibility, because “there is no backup,” said Marijn Verhoef, directorof operations and research at the Access to Medicine Foundation.

“Especially because the pipeline is … so empty, there’s even more pressure on the few
companies that are still developing these novel antibiotics or novel antifungals to reacheverybody across the globe,” Verhoef told POLITICO.
While debate on fighting AMR tends to focus on encouraging big pharma companies
to re-enter antimicrobial R&D — by using incentives such as market-entry rewards —the results of such measures will take years to pan out.
In the meantime, ensuring access to the therapies currently in the pipeline is “the way
to catch up,” Verhoef said.

Get planning early

The five projects analyzed in the report — submitted by GSK, F2G, Innoviva, Venatorx
and Pfizer — could could save at least 160,000 lives from drug-resistant bacterial andfungal infections annually, as long as they are available to patients in low- and middleincome countries, the report found.
But planning shortcomings must be addressed first, the report noted, as researchers
found the firms had submitted concrete plans for registration in only five out of 113
low- and middle-income countries.
This was “surprising,” said Martijn van Gerven, research coordinator for the AMRprogram.
“When we look at the big pharmaceutical companies like GSK and Pfizer, which wehighlight in the report, we didn’t see plans that were really detailed, which is what wekind of expect from these companies because they have all their resources, all themeans to do so,” he said. “So we were expecting a bit more details from that end.”
Another shortfall was the lack of pricing strategies to ensure affordability andstewardship. This was the case in four of the projects analyzed in the report — fromGSK, F2G, Innoviva and Venatorx — where no robust plans for making new products
affordable to patients could be identified.
Pfizer, meanwhile, reported it would implement equitable pricing strategies for its
treatment, and also consider it for its “Accord for a Healthier World” initiative, throughwhich the company offers its full portfolio of medicines and vaccines on a not-forprofit basis to some countries.
The report also showed that pharma companies are increasingly prioritizing children in
their clinical trials, with four out of the five companies featured in the report — GSK,Pfizer, Innoviva and Venatorx — conducting or initiating such trials.
The study examined the roles of other actors and stakeholders, including partners
such as the Global Antibiotic Research & Development Partnership (GARDP), publicand private funders and the government, in promoting access and stewardshipplanning. For example, funders could help make the product accessible and holdcompanies account­able.
“This is a worldwide problem, and therefore these funders have an opportunity to put
provisions in place that mandate access and stewardship globally,” van Gerven said.
At the same time, it’s important that big pharma companies “step up” and support
smaller firms.
“That really needs to change,” van Gerven said. “We cannot depend on organizations
like GARDP to take responsibility in low- and middle-income countries. We needcompanies, big companies, to step up.”