WHO: Fight Ebola Now, Solve Patent Issues Later

The world and the global health community have been taken by surprise by the worst outbreak of Ebola so far. The World Health Organization today (5 September) said a vaccine could be available in November 2014 if proven safe. So far, according to the WHO, intellectual property issues have not acted as a barrier to accessing potential treatments and vaccines, and the focus for now is on emergency measures to find health solutions.

The WHO convened a two-day meeting of international experts ending today to evaluate potential Ebola therapies and vaccines. A vaccine could be available in November if proven safe, according to Marie-Paule Kieny, WHO assistant director general, Health Systems and Innovation, speaking at a press briefing at the close of the second day of the WHO consultation on potential Ebola therapies and vaccines.

According to a statement on the conclusions of the consultation, over 150 participants [pdf] attended the meeting. Experts agreed to recommend using the blood of people who have recovered from the illness to cure sick people. They said the use of whole blood therapies and convalescent blood serums needs to be considered as a matter of priority.

Safety studies of the two most advanced vaccines identified are being initiated in the United States and will be started in Africa and Europe in mid-September, the statement said. If proven safe, a vaccine could be available in November, Kieny said, and this vaccine would be used in priority for healthcare workers in affected countries.

Patent Negotiations to Come

Asked about the potential barrier that could constitute intellectual property rights on the virus or on the potential treatments, Kieny said the WHO had not had time to assess the intellectual property characteristics of all those new medicines.

“It is most likely that there are IP rights and patents which have been filed,” she said, but “so far we have seen absolutely no problem and no barrier to the development and most rapid use of these drugs.”

“At the end, when the Ebola outbreak will fortunately be terminated, there will need to be discussions with the owners of the patents and the manufacturers who are making these products to see how they can be made available at appropriate and affordable cost to the populations who need them,” she added.

Oyewale Tomoro, professor of virology at Redemer’s University in Nigeria, told the press briefing, “if you do what needs to be done,” the disease can be brought under control. He underlined the importance of detection material and communication to explain how the disease is spread.

According to Samba Sow, director general, Center for Vaccine Development at Bamako, Mali, this outbreak is historical for several reasons. The first one is that there has never been such a fast killer in this part of the world. It also affects the poorest countries in the world with limited resources and health infrastructures and almost no border, which makes control very difficult, he said.

Mali has been selected to run vaccine trials, he said, explaining that Mali had not experienced an Ebola epidemic yet and presents a similar environment to places facing an Ebola outbreak. If a vaccine were available, he said, “I would love to be the first African to test the vaccine,” explaining that he is working in close contact with patients.

The expert consultation also concluded that in addition to blood therapies and candidate vaccines, it is worth considering “the availability and evidence supporting the use of novel therapeutic drugs, including monoclonal antibodies, RNA-based drugs, and small anti-viral molecules,” as well as the potential use of existing drugs approved for other diseases, according to the statement.

The statement also underlines the scarcity of the supplies of experimental medicines, and the efforts underway to accelerate production. The prospects of having larger supplies of vaccines rapidly “look slightly better,” it says.

According to a background document [pdf] on potential Ebola therapies and vaccines set out at the start of the meeting, the WHO “estimates that from six to nine months will be needed to control the outbreak.”

The WHO also released today (5 September) the Ebola Response Roadmap Situation Report 2 [pdf], which is the second report in a series of updates on the Ebola Response Roadmap.

MSF Cites Need to Navigate Patents

Médecins Sans Frontières (MSF, Doctors without Borders) is calling on manufacturers, biotechnology firms and researchers to provide updated estimates of product quantities, they told Intellectual Property Watch.

MSF also urged manufacturers to provide “access plans” including immediate donation of products for compassionate use, and said additional manufacturing capacity must be identified and harnessed to scale up production of the most promising products.

They referred to patents on medical products. “Although a number of patents have already been issued on the Ebola virus itself and various vaccines and treatments for Ebola,” they said. “We stress that patents cannot stand in the way of affordable and accessible treatments.”

“If other companies can scale up manufacturing capacity rapidly, patents and other know-how should be made available to these companies, whether through voluntary licence agreements with relevant patent holders or via governments using public health safeguards to enable scale up of production,” they added.

Pharma Consortium for Fast-Track Vaccine Trials

At the end of August, GlaxoSmithKline announced that human trials of a candidate vaccine, co-developed by the US National Institutes of Health and GSK were to be accelerated with funding from an international consortium.

A “£2.8 million grant from the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Development (DFID) will allow a team …to start safely tests of the vaccine alongside similar trials in the USA run by the National Institute of Allergy and Infectious Diseases,” according to the release.

According to the WHO, as of 31 August, 3,685 (probable, confirmed and suspected) cases and 1,841 deaths were reported in the current outbreak of Ebola virus disease by the Ministries of Health of Guinea, Liberia and Sierra Leone.

In issuing an “international rescue call” UN Secretary General Ban ki-Moon today said, “We need contributions – people, material and funding – from Governments, the private sector, financial institutions, non-governmental organizations and other groups at the grassroots.”

“At the meeting [in the US] we have just held, we agreed to establish an Ebola crisis centre to bring synergy and efficiency to the efforts of these many partners within and beyond the United Nations,” he said.

The goal is to stop Ebola transmission in affected countries within six to nine months, and to prevent the international spread of the virus,” he added. “This can be done only if the urgent and necessary mobilization is done both in the affected countries and by the international community.”