Market Failure, Not IP, The Issue In Ebola Treatment Shortage, WHO Says

Faced with the worst outbreak of Ebola since its discovery some 40 years ago, the world is scrambling for treatments. A World Health Organization-convened panel of experts has decided it is ethical to use experimental treatments. Why is there no treatment available even after 40 years? Market failure, not intellectual property rights, says the WHO.

As of 20 August, some 2,615 people had contracted the virus and 1,427 had died from it, including an “unprecedented number of medical staff infected with Ebola,” according to the WHO.

With no registered drug to cure the disease, on 11 August, the WHO convened a consultation with experts to consider the ethical implication of using drugs still at the experimental level. WHO Assistant Director General Marie-Paul Kieny, according to a transcript of a 12 August press briefing, said “there was unanimous agreement among the experts that [given] the special circumstances of this Ebola outbreak it is ethical to offer unregistered interventions as potential treatments or prevention.”

According to the transcript, very few courses of treatment are available even for those unregistered products.

The main reason for the shortage of treatments is market failure, Kieny said. “It’s a market failure because this is typically a disease of poor people in poor countries where there is no market,” the transcript says.

Drugs and vaccines are developed mainly by industry which carries out clinical trials and production, she said, but “if it hadn’t been for the investment of a few governments into the development of these drugs and vaccines, we would be nowhere in that.” Some treatments have been developed to a certain stage but have not gone through clinical trials, “which is the most expensive,” she said.

According to some sources, a number of patents applications have been submitted relating to the Ebola virus. For example, a search on the word “Ebola” on the World Intellectual Property Organization’s Patent Scope shows some 241 entries. A large number of those entries contain a reference to Ebola without being entirely focused on the specific virus.

However, some are directly related to the disease, such as US patents for “Compositions and methods for inhibiting expression of a gene from the Ebola virus” (20130225654), and for ” Human Ebola Virus Species and Compositions and Methods Thereof” (20120251502). Several patents have been submitted by the US government, such as “Human Ebola virus species and compositions and methods thereof.”

Also a patent on “Lipid formulated compositions and methods for inhibiting expression of a gene from the Ebola virus” (2464336) by US pharmaceutical company, another one for “Ebola virus liposome vaccine” (WO/2012/050193      ) for a US medical university, and a patent on ” Novel Ebola virus fluorescent quantitative PCR (Polymerase Chain Reaction) detection method and system” (102140532) from a Chinese academy.

It seems legitimate to wonder if intellectual property rights on the virus or its treatments would constitute a barrier to availability of those treatments in poor countries directly affected by this neglected tropical disease.

However, according to two WHO IP specialists, “at the moment, the barrier to access of any of the experimental Ebola treatments is not intellectual property.”

Among the reasons is the high level of technical expertise to achieve manufacturing of such products. For example, ZMapp is one of several experimental treatments and vaccines for Ebola that are currently undergoing investigation, according to the WHO. According to the WHO sources, “The manufacturing of ZMapp is a very complex and lengthy biological process.”

“As with many neglected diseases, the problem is market failure because it is a regional disease afflicting very poor populations in Africa, with mainly small outbreaks spreading over longer time periods,” they told Intellectual Property Watch.

“Certainly there are intellectual property rights attached to the experimental treatments, but to focus the discussion on intellectual property considerations seems premature in a context where these treatments are not registered or approved and when clinical trials have not yet been undertaken,” they said.

According to some sources, procurement schemes would be the only solution to available and affordable treatments for Ebola to counter market failure.

The report of the advisory panel to the WHO [pdf] also stated that “appropriate scientifically useful data generated on clinical and other relevant outcomes resulting from use of these agents, including from compassionate use, should be collected and shared transparently and rapidly with the scientific community.” However, they said, “It should not preclude or delay the initiation of more conclusive investigations of the intervention in properly designed clinical studies.”

On 4-5 September, the WHO will host a consultation on potential Ebola therapies and vaccines, according to the organisation.

Race against Time to Find Cure

According to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), GlaxoSmithKline “is co-developing a pre-clinical vaccine for filoviruses Ebola and Marburg, including the Zaire Ebola strain which is responsible [for] the current outbreak with the US National Institutes of Health’s Vaccine Research Center (VRC).”

Clinical development for a new vaccine is a long and complex process, spanning an average of 10 years, and involves a combination of public and private involvement, Mario Ottiglio, IFPMA director of public affairs and global health policy told Intellectual Property Watch. In this instance, given the urgency of the international health emergency, and “WHO’s request to GSK to provide assistance to control the Ebola outbreak, GSK is evaluating a number of possible steps to accelerate the development of this vaccine,” Ottiglio said.

Another vaccine developed by Crucell, one of the Janssen Pharmaceuticals companies of Johnson & Johnson, is in pre-clinical stage, according to the IFPMA.

“This is a development project financed by the Division of Microbiology and Infectious Diseases (DMID), part of the National Institute of Allergy and Infectious Disease (NIAID) of the US National Institutes of Health (NIH) as part of their program to develop candidate vaccines to prevent Ebola and Marburg virus disease,” said Ottiglio.

A number of IFPMA members are supporting countries’ infrastructure through donations to local non-governmental organisations, he added.