National And Regional Initiatives To Spur Research For New Antibiotics

A side event to the World Health Assembly organised by a number of delegations on antibiotic research and innovation reflected the deep global concern about antimicrobial resistance and the lack of candidates to replace what was once considered as a miracle of modern medicine.

The side event was organised today by the delegations of Australia, Canada, Colombia, Japan, the Netherlands, Norway, Sweden, South Africa, Thailand, the United Kingdom, and Zambia. Antimicrobial resistance has been high on the agenda of the WHA and last year, the WHA adopted a global action plan on antimicrobial resistance.

Bernard Pécoul, executive director of the Drugs for Neglected Diseases initiative (DNDi) presented the Global Antibiotic Research and Development (GARD), launched a few days ago (IPW, Public Health, 24 May 2016).

He underlined the need for new antibiotics to be affordable. The next step of the next project is to set up priorities and select projects as soon as possible, he said. Two projects are foreseen by the end of 2016, and two additional projects should be initiated in 2017.

A representative from the European Union detailed the EU actions on antimicrobial resistance, which started in 1999, he said. EU initiatives include the Commission’s 2011 Action Plan against the rising threats from AMR [pdf], and the “One Health” approach, which addresses the issue in a broad manner.

He also mentioned the Innovative Medicine Initiative, a joint undertaking between the EU and the pharmaceutical industry association EFPIA.

WHO Director General Margaret Chan made an appearance at the side event and said if nothing is done antimicrobial resistance will become a bigger issue than cancer. WHO is moving forward to help countries to develop national plans to implement the five pillars of the global action plan on antimicrobial resistance.

Addressing Market Failure

Joseph Larsen of the Biomedical Advanced Research and Development Authority (BARDA), at the United States Department of Health and Human Services said BARDA was created to address market failure in public health emergencies.

“We view antimicrobial resistance as a public health emergency,” he said.

The cornerstone of BARDA is to form novel, flexible public-private partnerships with the industry, he said.

He mentioned a project ready for launch, named the “Combating Antibiotic Resistant Bacteria (CARB) Biopharmaceutical Accelerator.” This aims at creating an infrastructure that can support a global innovation fund, he said. The accelerator is supposed to be set up this summer, he said. It is BARDA’s hope that this accelerator becomes a sort of catalyst to create a global innovation fund, he said.

The only way to fix market failure is to create a set of incentives which guarantee the return on investment and increases the net present value for companies, he said.

For antibiotics, the net present value starting at pre-clinical development is negative US$50 million, he said. Pharmaceutical companies are likely to favour oncology drugs over the development of an antibiotic, he said.

It is important to use pull incentives, he said. For example, he cited a partial de-linkage model with a series of small milestone payments. The companies are allowed to sell the product in the commercial marketplace, but there is a restriction on marketing and maybe on the volume that can be sold on an annual basis, he said. If this volume is exceeded, the company no longer qualifies for the payments, he added.

James Anderson from GlaxoSmithKline talked about the Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance launched in January.

The declaration, which is a set of commitments from industry to combat antimicrobial resistance in a broad sense, now has a hundred signatories, he said, and it includes big companies, smaller companies and even generic companies.

John-Arne Røttingen, director of the Division of Infectious Disease Control at the Norwegian Institute of Public Health, said innovation should be coupled with securing access, and the goal of preservation and conservation. Those three objectives have to be built in a new economic model, he said.

A representative of the Thailand Food and Drug Administration of the Ministry of Public Health said Thailand as a non-research and development nation, is working on improving its health system to minimise the use of antibiotics.

Javier Guzmán, director from the National Institute of Drug and Food Surveillance of Colombia, said usually low and middle-income countries are on the demand side of the equation: surveillance, improving vaccination, and rational use. However, developing countries are also interested in being part of the supply side of that equation.

Being on the supply side means creating capabilities in research and development institutes and industries, he said. The Colombian government is committed to science and technology, he added.

“We should not forget that we had a similar problem with malaria and tuberculosis… and other neglected diseases,” he said, adding that product development partnerships have given a track record of delivering products. That is a proven mechanism that should be fostered, he said.

The 69^th World Health Assembly is taking place from 23-28 May.

In a related development, the Financial Times reported that today UK Prime Minister David Cameron is expected to urge leaders at the Group of 7 Summit in Japan to set up a $1.6 billion a year global fund to reward pharmaceutical companies that develop drugs to fight “superbugs”.

 

Image Credits: Catherine Saez