Antimicrobial Resistance Needs Research, Regulation, Speakers Say

The issue of antimicrobial resistance has been in the spotlight in recent months as a growing awareness of the threat it represents for humanity has pushed discussions at the multilateral level. This week, the World Health Organization, World Intellectual Property Organization and World Trade Organization organised a symposium on the subject. Speakers discussed needs and potential solutions.

The 6th WIPO/WHO/WTO joint technical symposium was held on 25 October at WIPO. It sought to achieve a better understanding of the global challenge of antibiotic resistance and examine possible ways forward.

Global Intervention Costs Modest Compared to Risk

Hala Audi, head of the Review Team, representing Jim O’Neill, Chair of the Review on Antimicrobial Resistance [pdf] presented results of the review, originally published in May. Chaired by O’Neill, a British economist and previous former chairman of Goldman Sachs Asset Management, the review provided a set of recommendations to tackle the issue of AMR.

According to a first report by the Review Team, if nothing is done today, by 2050, 10 million deaths annually are to be expected. It is estimated that about 700,000 people die every year as a result of AMR, Audi said.

There is a need to shift the supply curve for new antibiotics, she said, and to encourage “push” funding to help early research and some early clinical work, but also “pull” incentives to correct the lack of investments.

Why are companies and venture capitalists not investing more in finding those new antibiotics that we need so much, she asked. Because antibiotics have different characteristics than most other drugs, she said, as they are less profitable than other drugs. The patented antibiotics represent about a US$4.7 billion market share, about 10 percent of the total market for antibiotics, she said (about US$40 billion).

So what is to be done if we want companies to invest, asked Audi. It is “incredibly important to create a new deal for antibiotics,” she said, adding that one option is to provide an entry reward, she said.

She underlined the role of vaccines and said there is a need to increase the take-up of vaccines, as well as water and sanitation as preventive measures to avoid using antibiotics.

The review came up with costs of the global interventions that they recommend. For example, they estimated that $US16 billion would be necessary over 10 years to promote the development of new antimicrobials including making better use of existing ones. A Global Innovation Fund supporting basic and non-commercial research in drugs, vaccines, and diagnostics would cost $US 2 billion over 5 years.

Those numbers are not huge, she said. US$20 billion is what AMR is costing the US health system alone, she said.

DNDi-WHO Partnership on Antibiotic Research

Jean Pierre Paccaud, director, Business Development & Legal, Drugs for Neglected Diseases initiative (DNDi), talked about the Global Antibiotic Research & Development Partnership (GARDP), a partnership between DNDi and the WHO, launched at the World Health Assembly in 2016 [corrected].

Paccaud said the market failure of antibiotics is similar to the one experienced by drugs for neglected diseases.

The GARDP wants to work with all actors and develop treatments that have less chance of being developed by other entities, like the private sector, he said.

The mission of GARDP is centred around research and development, and has three components: innovation, conservation and stewardship, he said. Those products should be accessible, he said, and prices “will be one of our worries.”

Since its inception in 2016 [corrected], GARDP has held various consultations meetings, the business plan is being written and ideally, at the end of 2017, this should lead to the creation of an entity that will be the offspring of DNDi and WHO, he explained. Currently, DNDi is incubating the initiative.

The initiative is supported by Germany, the Netherlands, South Africa, the United Kingdom, Switzerland, and Médecins Sans Frontières (MSF – Doctors Without Borders). The strategy of GARDP includes short and long-term approaches, he said.

Those approaches include: improving regimens, dosing of antibiotics, optimising existing antibiotics, and combining existing drugs, he said. DNDi is also working to recover forgotten antibiotics whose development was halted mostly due to change in market strategies, he said.

Key elements of the strategy include sustainable financial tools, he said, which may include having manufacturing costs plus a small margin to ensure sustainability but also accessibility. Resources will be needed from the public and the philanthropic sector, as well as from the private sector in terms of collaboration.

“We see ourselves as a complement to everything else that is going to be undertaken,” said Paccaud, adding “we are going to be a laboratory of ideas, we can test proof some of the concepts that are designed today,” such as prizes, push and pull incentives, and mixed economical models.

DNDi will explore different ways of using intellectual property for the benefit of patients and the accessibility of the drugs that will be developed, he said. Fair pricing based on Gross National Income can be envisaged for example.

Industry: Need Better Recognition of Societal Value

Brian Woolhouse, head, Hospital and Acute Care Business for Merck Sharp & Dohme (MSD), said antibiotic development presents significant challenges. Some of them are linked to development and complex regulatory pathways, others are economic challenges with limited returns on investment compared to other therapeutic areas, he said.

Novel antibiotics are also undervalued by reimbursement systems relative to the benefits they bring to society, he said.

There is no one-size-fits-all solution, he said. There is a need for a mix of push and pull incentives, market-based models that reward successful innovation, predictable and sustainable funding mechanisms, improve the recognition of the societal value of novel antibiotics, and reduce the tension between cost, access, innovation and stewardship with the appropriate balance.

Woolhouse said patent protection is vital to protect innovators to bring products to market and secure an appropriate return on investment.

Antibiotics in Animal, Need Good Vet Practices

Monique Eloit, director general of the World Organisation for Animal Health (OIE), talked about the challenges of controlling diseases in many different species of animals, such as cattle, poultry, fish and honeybees.

There is a global consensus to phase out the use of antimicrobials, she said, as well as a pledge to strengthen regulations of antimicrobials. Good veterinary practices are key to ensure that animals are kept in good conditions, the access to effective antibiotics to be used under veterinary supervision and used only when there is a need to control animal diseases is a vital for protecting animal health and welfare as it is for human health, she said.

Eloit warned against low-quality or counterfeit products currently in circulation in many parts of the world, and over-the-counter antibiotics which are available without information for appropriate use, administration and doses. She said the OIE is helping countries strengthen their veterinary services.

The OIE is currently setting up a global database on the use of antimicrobials, and is collaborating with the UN Food and Agriculture Organization, and the WHO, as well as other partners, she said, such as the World Customs Organization.

Eloit announced the Second Symposium on Alternatives to Antibiotics, to be held in Paris from 13-15 December, organised by the United States Department of Agriculture, with the support of OIE, where new technologies will be explored. This symposium should be a preliminary step for a global conference to be held in December 2017, she said.

Regulating Use in Animals, And Vets’ Profit on Drugs

Jørgen Schlundt, professor of food science and technology at Nanyang Technological University, Singapore, warned against use of antibiotics to promote growth in animals. This practice has been banned in the European Union since 2006, he said.

Total antimicrobial consumption can be reduced without compromising productivity, he said, adding that the use of antibiotics can be regulated, including preventing veterinarians to make a profit on the antibiotics they prescribe.

 

Image Credits: Catherine Saez