Health: WHO admits patents taken on avian flu virus
Patents have been taken on the avian influenza virus, and WHO Collaborating Centres have also entered into Material Transfer Agreements with vaccine manufacturers. This was admitted by the World Health Organisation's most senior official dealing with avian flu, in response to questions during a WHO technical briefing session on avian influenza at the World Health Assembly.
After presentations at the session, a question was raised on what kinds of agreements exist involving the flu virus between WHO collaborating centres and manufacturers.
Another participant noted that techniques to manufacture avian flu vaccines were protected by intellectual property and asked whether, given this situation, developing countries would have access to the technology.
Commenting that some parts of the viruses contributed by developing countries to WHO collaborating centres had been patented, the participant asked whether proper procedures have been followed by the WHO since there seemed to be loopholes in implementing the 2005 WHO Guidance on sharing viruses which states that the consent of countries sharing the viruses had to be obtained first if the centres wanted to pass on the viruses to other parties. It was not clear if prior consent had been obtained.
The WHO's Assistant Director-General for Communicable Diseases, Dr. David Heymann, replied that the WHO Guidance document had been removed from the WHO website. The guidelines had been modified.
Dr. Heymann said that intellectual property exists on avian influenza viruses that had been modified. Stating that there was a need to identify best practices and that the WHO is transparent, he said that there are material transfer agreements and that there are patents. There was also a need to learn from the lessons.
Earlier, Dr. Heymann had also told a World Health Assembly committee session discussing the sharing of avian flu virus that the WHO's 2005 Guidance had been "removed" and would no longer be in effect, after an advisory group had looked at "best practices."
The patenting of products and techniques containing viruses or parts of viruses, by drug companies and research institutions, has been a controversial part of the WHA's discussions on sharing flu viruses.
The announced "withdrawal" of the WHO Guidance 2003 and its "replacement" with a "best practices" document has also become a controversial element of the WHA discussion.
Twenty developing countries coordinated by Indonesia have submitted a draft WHA resolution calling for "responsible practices" for the sharing of avian influenza viruses as well as the resulting benefits.
The resolution was prompted by concerns that viruses voluntarily contributed by developing countries having avian flu outbreaks under a WHO scheme have been commercialized by drug companies, while there is no scheme ensuring the availability of vaccines at affordable prices for developing countries in the event of a pandemic.
The developing countries are particularly upset that viruses (or parts of viruses) freely given to WHO collaborating centres are being provided to companies, and that patents may have been applied for.
Senior WHO officials, including Heymann, have been quoted in the media as opposing Material Transfer Agreements (MTAs) between the country of origin of the virus and the WHO centres or companies. Such MTAs are common in the case of agricultural materials.
The United States, in its statement to WHA on 15 May, also opposed MTAs and other "encumbrances" which it said would hinder virus transfer from countries of origin.
However, WHO documents show that WHO collaborating centres such as the Centres for Disease Control in the US have themselves entered into MTAs with companies when transferring vaccine strains containing parts of the viruses contributed by developing countries such as Indonesia, Vietnam and China.
The confirmation by Heymann that there have been patents as well as MTAs between WHO centres and companies emphasizes the developing countries' charges of double standards, whereby countries of origin are told to give their viruses freely and not to enter into MTAs, while WHO centres (which are national institutes located in developed countries) are entering into MTAs, and patents are being claimed in the developed countries on parts of the viruses.
The non-compliance with the WHO's 2005 Guidance has also been brought up by several delegations at the WHA. One of the principles of the Guidance is that the WHO centres will not distribute viruses to other parties without permission from the originating country. It is now evident that this principle has not been followed, and as a result, confidence in the WHO influenza surveillance network system has plummeted.
The WHO's new "Best Practices" are based on directly opposite principles. One "best practice" states that the WHO centres receiving viruses should provide vaccine strains (which contain parts of the viruses) to any requesting vaccine producer. There is no mention of the need for permission from the originating countries, nor are there prohibitions on patenting of the viruses or obligations on benefit sharing.
Other principles prohibit the originating country from charging fees or in any way seeking to profit from sharing their viruses. This in effect seeks to prevent the countries from having benefit-sharing arrangements. However, while the countries are obliged to share their viruses freely and the WHO centres are obliged to give vaccine strains freely, the companies which obtain these free materials are not placed under any obligations whatsoever by the "Best Practices."
According to the WHO secretariat, the 2005 Guidance has been "replaced" by the "Best Practices". However, delegates that attended an avian flu meeting in Jakarta at the end of March (co-organised by Indonesia and the WHO) confirmed that the Guidance document was distributed at the meeting by the WHO and that it was thus still in effect then.
Heymann confirmed that the WHO had withdrawn the Guidance document from the WHO website. But an Indonesian official said that he had accessed the document only two weeks ago.
There is speculation that the withdrawal could have been caused by the embarrassment suffered by WHO staff when developing countries' health officials pointed out that the Guidance principles had not been adhered to.
Several delegates, speaking in the corridors of the WHA, were concerned that the WHO is attempting to legitimize the illegitimate practices of the WHO collaborating centres (which had not followed the 2005 Guidance), by coming up with so-called "Best Practices" which now oblige the WHO centres to do what they were not permitted to do before. While the Guidance seemed to recognize the originating countries' right to prior consent, the Best Practices now prevent the same countries from implementing their rights to prior consent and benefit sharing.
At the WHA, the United States on 15 May also submitted a draft resolution on access to flu pandemic vaccine for developing countries. The two drafts, together with a WHO Executive Board resolution, are being discussed in a working group, which will attempt to produce an outcome by the end of the WHA on 23 May.
Several developing countries voiced their concerns over the system of virus sharing when the WHA session on avian flu resumed on 15 May afternoon.
India said that a major problem is the availability of the commercial products. India could not afford prices of vaccines in the world market. It was planning to produce vaccines; otherwise, the price will not be affordable.
It expressed concern that if some of the gene sequences are patented, India would not be able to make such products. It proposed that a committee be set up to discuss these issues in an unhurried manner, to discuss issues including IPRs, availability of technology, and a system to support access and development of products in developing countries.
India stated that in an emergency, countries should be able to make vaccines, regardless of who holds the patent. If compulsory licencing is automatically allowed, countries would be enabled to make the vaccines.
Egypt, speaking for the Eastern Mediterranean region, said that while the sharing of the virus is important, the following should be guaranteed without which trust and confidence will not be maintained: the vaccine produced will be made available without condition and costs; and the WHO should ensure transfer of technology for vaccine production to developing countries.
Bangladesh said that the sharing of viruses and support for vaccine production in developing countries should be reciprocal. It supported the application of principles of the Convention on Biological Diversity in this issue.
Venezuela said that developing countries should have free access to drugs. It stressed the principle of equity in the distribution of vaccines, and that public health is more important than private interest.
Iran, a co-sponsor of the developing countries' resolution, stressed that States have sovereign rights over genetic resources and viruses. The authority to determine access rests with governments which have rights to prior informed consent under mutually agreed terms. Developing countries of origin should be assisted to produce vaccines. Access to affordable diagnostics is also important.
Iran called for an effective and transparent multilateral system. Trust given by states should be used to provide pro-development results, instead of the other way around.
Cote d'Ivoire, speaking for the Africa Group, said the threat of a pandemic is imminent and Africa needs an early warning. It was worried about the countries' lack of funds and thus the lack of capacity to undertake research or strengthen diagnostics. It also supported the outcome of the Jakarta meeting on virus sharing.
Vietnam said that there should be transparency in the sharing of information and the sharing of virus. It was important to know how the virus samples are being used and that there is equitable sharing of benefits such as vaccines, especially for developing countries.
East Timor supported the Indonesian resolution. It called for strengthening the capacity of developing countries and strong global partnership.
St. Kitts and Nevis, supporting the Indonesian resolution, said that universal availability of vaccines and anti-virals is important. It was aware that there is scarce supply of vaccines, and it was concerned that those without capacity will be excluded.
Malaysia supported the developing countries' resolution and stressed the need for a transparent mechanism.
Germany, speaking for the EU, said that information-sharing needs improvement. It said that cooperation was needed without restrictions in accordance with the international health regulations. Common efforts are needed to fully implement the plan on vaccines supply.
France supported a stockpile of pre-pandemic vaccines to deal with infected zones in Asia and Africa. How such stockpile is to be established and criteria for use should be considered in depth.
Japan said that its collaborating centre had received Indonesian virus samples. Information should be shared through the Global Influenza Network without specific material transfer agreements. As for access to vaccines, there is need for a multilateral framework and to strengthen partnerships with the vaccine industry.
At the WHO technical briefing session, senior Thai health official Dr. Suwit Wibulpolprasert said that the avian flu virus and vaccine issue had become very sensitive.
The developing countries were concerned because the manufacturers were making the vaccines in developed countries, which had the demand, and the developing countries may be left with no vaccines, in the event of a pandemic.
He said that the WHO's 50-year-old influenza network was like an old antique that needs to be protected. However, the system benefited mainly the rich countries. The developing countries send the viruses but do not get the flu shots. The benefits were skewed.
He added that there was need for a new global system based on equity. When developing countries copy CDs or produce generic medicines, they are accused of intellectual property "piracy" by developed countries. When developed countries get the viruses from developing countries, they can be accused of "biopiracy".
These are two extremes that kill solidarity. There is need to share intellectual property and biodiversity for humanitarian goals.
The flu pandemic is a national security issue. Up to 30 countries now have avian flu cases and countries need to take up it up as an issue of national public interest, not one of narrow economic interest. If developing countries are interested to invest in a flu vaccine plant, they are often questioned on the economic rate of return they could get, and whether it is inefficient to have vaccine production.
When the Navy buys a submarine, no one asks about the financial rate of return. For suggesting a flu vaccine plant, questions are asked about the rate of return, although avian flu is also a national security issue.
Dr Suwit said that national surveillance capacity for avian flu should be strengthened. On stockpiling, countries with limited funds face a dilemma whether to stockpile anti-virals (where there is no proof of effectiveness) and pandemic vaccines (where if there is stockpiling it could be for something without knowing whether a pandemic would actually happen).
He proposed that there should be the build up of a "stockpile" of knowledge, to develop skill among health workers on how to manage when a pandemic occurs, and not to depend on pharmaceuticals alone.
Dr Suwit remarked that on the intellectual property issue, the developing countries' concern is with developing the capacity to produce the necessary medical products and technology to protect themselves from a pandemic.
He said that even in a normal situation like the present, countries like Brazil and Thailand that make use of the flexibilities in the WTO's TRIPS agreement were facing pressures that they had never experienced before.
In a pandemic situation, the countries' use of such flexibilities in relation to intellectual property should not be questioned at all, he said.