High vaccine cost raised in bird flu discussion at WHA

Lim Li Ching

24 May 2006
The high cost of vaccines for avian flu and the need to prevent commercial monopoly over the medicines that are developed from stocks of the virus provided by affected countries emerged as a key issue as discussions on health issues began at the World Health Assembly being held here this week.

And at a technical briefing session, questions were raised by some Health Ministers about the usefulness of stockpiling so much avian flu drugs, as well as to whether these drugs would be effective.
At the WHA's Committee A on health issues on Tuesday, Thailand raised the issue of the high costs of vaccines against bird flu. The Thai delegate stressed that "affordability is a problem for HPAI [highly pathogenic avian influenza] vaccine" and that the WHA "must not ignore" the cost problem. He insisted that the price of bird flu vaccines should be brought down.
Currently, WHO Member States that experience bird flu outbreaks provide samples of the virus isolates to WHO collaborating centers. At these centers, the isolates are used in the process of creating vaccines seed stocks, frequently using patented techniques. WHO then provides the seed stocks to vaccine producers. But the vaccine producers, say many developing countries, are charging too much for the vaccines.
For this reason, Thailand proposed an amendment to resolution EB117.R7 on the Application of the International Health Regulations (2005). Thailand proposed the insertion of the language "for non-commercial purposes only" in relation to the dissemination, to WHO collaborating centers of information and the biological materials related to avian influenza and other novel influenza strains. The amendment would restrict the commercial use of the vaccine seed stocks developed from the samples provided to the collaborating centers.
The relevant section (paragraph 4.4) would read as follows: "to disseminate to WHO collaborating centres information and relevant biological materials related to highly pathogenic avian influenza and other novel influenza strains [for non-commercial purposes only (Thailand)] in a timely and consistent manner". This amendment was contained in the document A59/A/Conf. Paper No. 3 (24 May 2006).
In response to the Thai proposal, the WHO Secretariat said that private sector collaboration was required to produce bird flu vaccines due to limited global production capacity, and that the proposed amendment was a serious issue on which the Secretariat required more input from Member States. The Secretariat thus encouraged informal consultations between countries.
In response, Thailand defended its proposed amendment by noting that under the current system of vaccine seed stock development and distribution, "the result will be a monopoly", and that "measures must be implemented" to address the problem. Thailand's comments drew applause from many delegates.
On Wednesday afternoon, Thailand reported that after informal discussions with other delegates, it would withdraw its proposed language and instead propose two new paragraphs.
These paragraphs urged member states to develop domestic influenza vaccine production capacity or work with neighbouring States to establish regional vaccine in the event of public health emergency of international concern caused by a novel influenza virus; and requested the Director-General to immediately search for solutions to reduce the current global shortage and inequitable access to influenza vaccine and also to make them more affordable for both epidemic and global pandemic.
Thailand stressed that this "trade-off" (of their original language for the two new paragraphs) was "very painful." It believed this trade off was a win-lose solution where the winner was developed countries which can produce vaccines and the loser was developing countries which cannot access the vaccine, whereas it is the developing countries that are submitting the flu strains to the WHO collaborating centers.
Thailand however said it did not want a lose-lose situation where no one has the vaccine and everyone dies.
There were no objections to this and another minor proposal and the resolution was adopted as amended by the Committee. It will still have to be adopted by the plenary.
The Thai intervention came during discussions on "Strengthening pandemic-influenza preparedness and response, including application of the International Health Regulations (2005)". The two issues were linked because countries were being urged to comply immediately, on a voluntary basis, with provisions of the IHR 2005 considered relevant to the risk posed by avian influenza and pandemic influenza.
The discussion initially saw many interventions in support of the documents prepared by the WHO Secretariat and the related draft resolution. Many countries spelled out what they were doing to implement the IHR in relation to pandemic and avian influenza.
Countries like Nigeria and Turkey, which have experienced avian influenza outbreaks, including in humans, outlined their experiences in dealing with the crisis. They emphasized the importance of preparedness and the need for capacity and resources.
Meanwhile, a WHO technical briefing, also on Tuesday, on avian influenza and pandemic preparedness, convened a high-level panel consisting of Health Ministers from Canada, China, Egypt, Nigeria and the United States.
The Ministers all stressed the importance of prevention and preparedness, to be able to deal with a potential avian or other influenza pandemic. They outlined the steps they had taken at the national level. China, Egypt and Nigeria, which have all had avian influenza outbreaks, shared their experiences in how they dealt with the outbreaks, and the lessons learnt.
The Egyptian Minister of Health and Population, Dr. El-Gabaly, also raised the issue of stockpiling of drugs. He said that the importance of drugs stockpiling has been exaggerated by some governments and the pharmaceutical industry. In his personal view, he didn't think it was worthwhile stockpiling so much of the drugs.
The Chinese Minister of Health, Gao Qiang also mentioned that there are questions about how effective such drugs would prove to be, and that guidance from WHO and cooperation from governments are needed.
The US Secretary of Health and Human Services, Mike Leavitt, emphasized the need for pandemic preparedness and called for donors to prepare practical and coordinated action plans. He noted that not just H5N1 (the deadly avian influenza type) but other influenza strains could give rise to a pandemic.
At question time, Edward Hammond from The Sunshine Project asked US Secretary Leavitt about the serious risks posed by the escape of pandemic influenza strains from a laboratory. Several US labs are creating and handling novel influenza types that could provoke a pandemic if they escaped.
In one well-known example, US scientists recently recreated the previously extinct 1918 Spanish flu, controversially claiming that bringing the deadly bug back to life will help the world prepare for a possible H5N1 pandemic. (Their argument is rejected by many scientists.)
US researchers are also conducting laboratory studies that involve mixing genes from influenza strains, including H5N1, in combinations that could provoke a man-made pandemic, were they to escape from a lab. As experience with the SARS virus showed, such accidents can happen.
Hammond pointed out that at least with H5N1, there is some warning and opportunity for preparedness for a possible pandemic. In contrast, if a deadly virus such as the recreated 1918 type escaped the lab, a pandemic might ensue almost immediately. He asked if it was wise to continue these lab experiments, which are spreading to more and more laboratories (hence raising the risk of an accident), and what was being done to control the risks.
Leavitt did not answer the question in detail. He said that this was an issue that had to be confronted and dealt with. He acknowledged that there are risks, but that the government would move forward with good judgment and care.
In another intervention, a representative from the Peoples' Health Movement raised the issue of equity and the disproportionate burden of dealing with bird flu falling on the poor who, for example, must slaughter domestic birds, which are in fact assets to them.

Lim Li Ching
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