Antimicrobial resistance needs new R&D models, NGOs say

Médecins Sans Frontières (Doctors Without Borders – MSF), the Drugs for Neglected Diseases initiative (DNDi), Health Action International (HAI), and Medicus Mundi International Network (MMI) organised an event on the opening day of the World Health Assembly, taking place from 22 – 31 May.

Anthony So, director of ReAct-Action on Antibiotic Resistance Strategic Policy Program, and founding director of the Innovation + Design Enabling Access (IDEA) Initiative in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, said AMR is one of the looming public health challenges of our time.

He said rationing antibiotics through higher drug prices is not an effective way to ensure rational use, and warned against non-therapeutic uses of antibiotics, in particular in agriculture. He cited as examples antibiotics used for growth promotion of farm animals.

There is a need to delink the return on investment from both price and quantity, he said. “When we hear talk of courses of antibiotics costing thousands of dollars, we should begin to wonder how we will ensure access and stewardship for such an innovation pipeline.”

Antibiotics fare much worse than other therapeutics areas when it comes to the R&D pipeline, he said, with only a 7 percent of yield for promising leads, compared to 80 percent yield in all therapeutic areas.

When policymakers and industry call for billion-dollar market-entry rewards, “it may be too much too late,” he said. Such market entry rewards focus too much on public resources on the wrong part of the pipeline, he said.

The challenge is how to ensure fair returns on public investment on R&D, according to So. There is a need for new business model that delink return on investment for companies from price and quantity, he said. However it is necessary to make sure that delinkage contributes to sustainable access and stewardship, he added.

Monopoly Model Not Working, Delinkage as New Way

Michelle Childs, head of policy advocacy for the Drugs for Neglected Diseases initiative (DNDi), said the current incentive for R&D relying on monopoly through IP does not work for AMR. The equation is different, as there is a need to conserve the medicines, so the model cannot rely on volume sales, and at the same time has to ensure access.

R&D should focus on public health priorities with an emphasis on global needs. There is an opportunity for member states to ensure that if they are putting up financing, that globally agreed norms and principles in terms of affordability, effectiveness, efficiency, and equity are applied, she said.

There is also the need for sustainable financing, and exploring new incentives for innovations, such as push and pull incentives. Pull incentives include entry rewards and transferable IP rights, but incentives have to be based on agreed priorities on needs, on the basis of delinkage between the cost of R&D and the price of medicines.

Price of Vaccines, High-Level Panel Recommendations

Els Torreele, executive director of MSF Access Campaign, underlined the growing burden of AMR across countries. MSF wants “one world approach” adapted to the needs of patients wherever they are.

Torreele underlined the lack of appropriate diagnostics tools, and the need to increase access to vaccines, as they could reduce the use of antibiotics.

High prices of vaccines are a key barrier to ensure vaccination coverage, in particular in middle-income countries, she said, adding that medical innovations are only relevant if the resulting products are affordable and accessible to those in needs.

She underlined the findings and the recommendations of the United Nations Secretary General’s High Level Panel on Access to Medicines, qualifying them as “extremely important” for governments to find the right intervention to answer the challenges of AMR.

Garance Upham, vice-president of ACdeBMR/WAAR, World Alliance Against Antibiotic Resistance, and member of Medicus Mundi International, said AMR infections spread in the same manner as epidemics.

She said one factor was the absence of infection prevention and control, and noted that the issue is not only found in developing countries, but as many as 20 countries in Europe do not have such prevention and control systems.

Untreated waste from the pharmaceutical industry, and the fruits and vegetable industries, including organic, are releasing antibiotics into the environment, she said.

Biological waste from hospitals and healthcare centres is not properly recycled, she said, adding that the Leman lake bordering Geneva is not spared from this phenomenon.

In the audience a biologist underlined the complexity of AMR, and the resistance being able to be transmitted from bacteria to bacteria. He advised to take this biological factor into consideration, as he said that this issue is independent from the overuse of antibiotics.

New Publications

Separately, a new research paper was published from the South Centre: Access to Hepatitis C Treatment: A Global Problem.

Health Action International also issued a new report [pdf] on AMR this week. The report calls upon European Union member states to address four key challenges: the global antibiotic R&D landscape lacks coordination and information sharing; there is a shortage of coordinated priority setting on antibiotic R&D spending; current publicly funded antibiotic R&D initiatives lack “effective conditions that steer antibiotic innovation towards priority areas and manage results,” including intellectual property, “to ensure affordable access and conservation of funded products.”

The third challenge includes the lack of exploration of alternative R&D mechanisms that use delinkage to stimulate R&D. Finally, the report found that the EU members “bear a global responsibility and self-interest in ensuring global access, conservation and priority setting in low-and middle-income countries.”

The report also provides a set of recommendations for the EU, such as attaching conditions to publicly funded R&D for antibiotics ensuring global access and conservation, and exploring how R&D model based on delinkage can be coupled with global measures to ensure conservation and stewardship.

Source: Intellectual Property Watch