World Health Summit: Failing Business Models In AMR And Vaccination

BERLIN — With antimicrobial resistance (AMR) on the rise worldwide there is no time to lose for developing new antibiotic drugs, experts said during one of the last panels of this year’s World Health Summit in Berlin Tuesday. As in several other rounds during the three-day event, industry representatives underlined that there is an issue with the business model due to high risk and low return of investment for research in this area.

“We have only seen the tip of the iceberg,” said Rüdiger Krech, director at the Office of the Assistant Director-General of the World Health Organisation. “We already have a lot of deaths due to antimicrobial resistance, but we will have many more, if concrete action is not taken.”

Speaking at the panel organised by the Geneva-based International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Krech said pathogens for gonorrhea, tuberculosis, and ecoli are increasingly resistent. “Less and less you can be cured with antibiotics” for these type of infections, he warned. Krech welcomed special funding initiatives by the Wellcome Trust and the German Government.

The Wellcome Trust, according to Jeremy Knox, who is the policy lead for Drug Resistant Infections at the British organisation, will spend £175 million British pounds over the next five years. Up to £125 million pounds will go to USAID‘s CARB-X initiative, which according to Knox could become an international pool for funding antibiotics research.

How much the organisation is alarmed by AMR was illustrated, Knox said, by the change from the regular application-based, reactive funding policy to a proactive approach. “It is a paradigm shift,” he said. Also the Trust is engaged in setting up a new WHO-based expert group on behavioural change for the use of antibiotics.

The German government, besides making AMR and a Joint Programming Initiative on AMR a top issue at the recent G20 conferences it hosted, has committed 50 million euros for the Global Antibiotic Research and Development Partnership (GARDP). While regulation in Germany to counter misuse of antibiotics is in place, most well-known problems persist in practice, said Karin Knufmann-Happe from the Federal Ministry of Health.

Major concerns are the rampant use of antibiotics in livestock farming and out of care patient use and careless throwing away of antibiotics. All these trends are seen as nurturing the development of resistance. Germany is one of the first countries to have implemented the recommendations from the 2015 WHO AMR Action Plan guidelines, she said. But “we cannot move nationally only,” said Knufmann-Happe. The question of whether it is time for a legal ban on antibiotics use in agriculture was met with a mixed response during the panel.

“Antibiotics are too cheap,” said Thomas Cueni, director general of the IFPMA. It was, Cueni said, cheaper to just use antibiotics instead of first using diagnostic tools to test for the pathogens, for example. And, when even generic companies stopped production and there was a shortage of the drugs “you must ask the question, is it right that public procurement simply focuses on ‘cheap’?” Wellcome Trust expert Knox reminded participants that “more people die from lack of access to antibiotics.”

Lack of Sustainable Business Model

Cueni underlined that new antibiotics have to come from the pharmaceutical companies. “But the sustainable business model simply is not there.“ The classical model worked for cancer or cardiovascualar drugs. “Here we are asked to come up with new drugs, the research and development is the same, and the risk factor is the same. But then we are asked, and rightly so, to put the new drugs in the poison box.” There is, Cueni said, a need to address the incentive model together with governments.

The issue of business models came up in other panels during World Health Summit panels as well. Richard Hatchett, CEO of the Coalition of Epidemic Preparedness Innovations (CEPI), during a panel on vaccine research and development said: “It is a tough nut to crack.”

From his time as an official at the US Biomedical Advanced Research and Development Authority (BARDA), Hatchett could report about some inroads made through what he described as “carefully crafted push incentives, funding R&D contracts, pull incentives, procurement contracts, providing technical assistance and giving privileged access to regulators.” This system allowed the creation of 23 licence-clear products for which there was no market, like smallpox or anthrax.

“We can address the getting the industry to the table piece,” he said, “but the problem we have never been able to solve in the US government or in the global health space is sustainable solutions.” If no market can be created for the drugs developed by special programs, “you have to take responsibility for the tail, and that is hard.”

CEPI itself might face this very problem, as the initiative has been formed – and officially took off at the start of this year, to fund the development of promising vaccine candidates for MERS, Lassa and Nipah, all neglected and poverty diseases from the WHO Blueprint priority list.

Bringing Academia and Big Pharma Together: “Sometimes Very Difficult”

Stefan Kaufmann, director of the Max-Planck Institute for Infection Biology, a long-time advocate of public funding in the research of neglected diseases spoke about the gap between R&D and commercial production. Kaufmann at his institute did the research for a new vaccine on tuberculosis that will be a successor to current decade-old vaccines that have become less effective due to resistance. In 2008, the Max-Planck Institute started with phase 1 clinical trials. Currently phase 3 trials are underway with the India Serum Institute.

“There was a lot of serendipity to find an industry partner that was interested in developing this further,” reported Kaufmann. “And i still think it is interesting that it was not one from the big European or US players, but one of a developing country.”

Licence issues were taken care off by Vakzine Project Management, a private vaccine and biopharmaceutical development company in Germany, which sub-licensed to the India Serum Institute. Kaufmann said he ensured that affordability was granted by keeping costs low.

Kaufmann recommended lending more support to initiatives like the Innovative Medicine Institute, which would help to bring academics and big pharma together – “that can be really difficult,” he said. In his opinion, also the European & Developing Countries Clinical Trials Partnership (EDCTP) was a successful project in the attempt to address neglected diseases. Compared to the time when Kaufmann started his endeavour for a TB vaccine a lot had changed, he acknowledged, with Ebola having been a wakeup call for many governments. Still, in his view, “the glass remains half empty,” he said.

Another appeal to the pharmaceutical industry with regard to affordability made at the Summit was the one on pricing transparency. WHO representative Krech told representatives from pharmaceutical industries that pricing transparency was indispensable. While industry representatives like Cueni tried to make a case for tiered pricing, Krech said, it was high time to end the black box system that hid profit margins as high as several hundred percent. An informal WHO group, the fair pricing forum, started to look into this issue, which had been on the agenda of critical NGOs for quite some time.

Globalisation of Fragility and War against Health

With many panels touching on innovation in the health sector and big data being discussed for the first time at the World Health Summit, some high-level speakers sent stern warnings to participants. Elhadj As Sy, director general of the International Red Cross, painted a bleak picture of the consequences for health and health security from rising conflicts, dislodged populations and mass migration. Never before have so many people been on the move. “Fragilities also become global,” he warned.

Panel moderator Ilona Kickbusch, director of the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva, asked panellists in that debate to measure the path travelled toward the UN Sustainable Development Goals. Given the “new political context,” she said, referring to countries withdrawing from multilateral fora and rising xenophobia, realising the SDGs will be tough.

A new kind of warfare that targeted health workers and hospitals was discussed in a special panel on the health impact of war and terror. In Yemen, bombs were dropped beside hospitals, and traumatization of children from constant bombing by the Coalition forces became epidemic, said Susanne Krüger from Save the Children. In Syria, bombs were not dropped “next to hospitals, but on hospitals,” said Ahmad Tarakji, president of the Syrian American Medical Society. After the UN resolution 2286, which condemned attacks on medical facilities, the rate of attacks had even gone up, said Taraji.

“We have reached very little,” a representative of the German Section of Doctors without Borders (Médecins Sans Frontières, MSF) said, referring to attacks on hospitals. Instead, the war on terror had resulted in a criminalization of health workers, as their work, for example in areas controlled by ISIS, was labelled as “support for terror”. Humanitarian law was swept aside under this new kind of war, he said.