Giuseppe
Emeritus
(1g) P.H. DEVELOPMENTS -AVIAN INFLUENZA ? VIRUS SHARING - Towards mutual trust, transparency and equity in virus sharing mechanism: the avian influenza case of Indonesia
Sedyaningsih ER, et al, Ann Acad Med Singapore 2008;37:482-8
Description:
Through this paper, Indonesian researchers and the Indonesian Ministry of Health report one point of view and interpretation of the facts around the Indonesia?s decision to withdraw from sharing A(H5N1) virus samples with other countries through the World Health Organization (WHO) Global Influenza Surveillance Network since January 2007.
The first part of the article describes the epidemiology of A(H5N1) human infections occurred in Indonesia since the first cases reported in 2005. This part includes interesting information such as on how the case fatality rate varied by age, in clusters vs sporadic cases, and by time elapsed since symptoms? onset and antiviral treatment received.
The second part focuses on their arguments against the practice of sharing their viruses with other countries through WHO.
The authors state that the event that triggered the Indonesian decision to stop sending any virus to WHO was the information received that a pharmaceutical company in Australia was planning to develop an A(H5N1) vaccine using virus strains that Indonesia had provided.
Their view is that it is unacceptable for developing countries like Indonesia to provide biological specimens that will be used to produce vaccines that will be sold back to developing countries at what are often unaffordable prices.
Additional arguments included that the WHO did not inform Indonesian authorities with enough advance notice before presenting data that involved analysis of viruses from Indonesia and that once Indonesia developed the capacity to perform confirmatory virological testing, there was no need anyway to send specimens for further confirmation.
The paper finishes by describing the WHO-led international initiatives that followed on this crisis, but their conclusion is that there remains an ?unresolved imbalance between the affluent high-technology countries and the poor agriculture-based countries? and therefore ?regional, global and in-country meetings must continue to be conducted to find solutions acceptable to all?.
ECDC comment (23/07/2008):
This is an important article in that it?s only the second article on the topic to have appeared in a peer-review journal.(1)
It should also be read in the context afforded by a book on the topic by one of the authors of the article who is the Minister of Health.(2)
ECDC has produced a series of public briefing documents on this and the most recent is from May of this year.(3)
There is no need to rehearse the arguments in that but it is important to point out how difficult it is for a country or individual to ?own? a virus.
Consider a real human A(H5N1) case where the infection was caught from poultry in one country but where the patient eventually sought care in another country where H5N1 infection was diagnosed.
The specimen then passed onto the WHO Collaborating Centre in a third country where the virus was isolated. It could then pass onto a specialist laboratory in a fourth country to be made suitable for vaccine production by commercial companies in yet other countries.
If the virus passed on becomes the source of a vaccine who would be the owner?
Is it the owner of the bird, the patient or his / her family, the authorities in one of the first three countries, the Institution where the Collaborating Centre is based or WHO?
There is also almost an accidental element as to where a virus is isolated that finally proves suitable for vaccine production. What about the other countries which contributed viruses but did not happen to be suitable?
A way round this has always been to cite the Gift Relationship, developed for sharing of human fluids (blood) and tissues whereby biological products are shared unconstrainedly according to need and their effective use without reference to ownership, payment or country of origin.(5)
Essentially this is seeing influenza virus isolates as Public Goods not Private Property (6-7). Having said that progress is being made in this area. The next Intergovernmental Meeting will take in November this year.
References:
1 - Sedyaningsih ER, et al, Towards Mutual Trust, Transparency and Equity in Virus Sharing Mechanism: The Avian Influenza Case of Indonesia Ann Acad Med Singapore 2008;37:482-8
2 - Fidler DP. Influenza virus samples, international law, and global health diplomacy. Emerg Infect Dis. 2008;14:88-94
3 - Supari SF. Its time for the world to change, divine hand behind avian influenza. PT. Sulaksana Watinsa Indonesia SWI 2007 ISBN 978-979-17357-0-4
4 - Interim ECDC Scientific and Public Health Briefing: Sharing influenza Virus Samples ? Updated May 2008 available at: http://ecdc.europa.eu/pdf/ECDC_influenza_briefing.pdf
5 - Titmuss RM The Gift Relationship: From Human Blood to Social Policy Original edition with new chapters, Eds Oakley A, Ashton J. LSE Books London 1997.
6 - World Intellectual Property Organization. Expert Report for WHO. Patent issues related to influenza viruses and their genes (document still undergoing expert review) October 2007. http://www.who.int/csr/disease/avian_influenza/WIPO_IP_%20paper19_10_2007.pdf
7 - WHO Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits. Intergovernmental Meeting: report of progress to date. WHO Executive Board Paper EB122/5. January 2008 http://www.who.int/gb/ebwha/pdf_files/EB122/B122_5-en.pdf
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http://www.ecdc.europa.eu/Health_topics/influenza/news/news_Influenza_080724.html
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Sedyaningsih ER, et al, Ann Acad Med Singapore 2008;37:482-8
Description:
Through this paper, Indonesian researchers and the Indonesian Ministry of Health report one point of view and interpretation of the facts around the Indonesia?s decision to withdraw from sharing A(H5N1) virus samples with other countries through the World Health Organization (WHO) Global Influenza Surveillance Network since January 2007.
The first part of the article describes the epidemiology of A(H5N1) human infections occurred in Indonesia since the first cases reported in 2005. This part includes interesting information such as on how the case fatality rate varied by age, in clusters vs sporadic cases, and by time elapsed since symptoms? onset and antiviral treatment received.
The second part focuses on their arguments against the practice of sharing their viruses with other countries through WHO.
The authors state that the event that triggered the Indonesian decision to stop sending any virus to WHO was the information received that a pharmaceutical company in Australia was planning to develop an A(H5N1) vaccine using virus strains that Indonesia had provided.
Their view is that it is unacceptable for developing countries like Indonesia to provide biological specimens that will be used to produce vaccines that will be sold back to developing countries at what are often unaffordable prices.
Additional arguments included that the WHO did not inform Indonesian authorities with enough advance notice before presenting data that involved analysis of viruses from Indonesia and that once Indonesia developed the capacity to perform confirmatory virological testing, there was no need anyway to send specimens for further confirmation.
The paper finishes by describing the WHO-led international initiatives that followed on this crisis, but their conclusion is that there remains an ?unresolved imbalance between the affluent high-technology countries and the poor agriculture-based countries? and therefore ?regional, global and in-country meetings must continue to be conducted to find solutions acceptable to all?.
ECDC comment (23/07/2008):
This is an important article in that it?s only the second article on the topic to have appeared in a peer-review journal.(1)
It should also be read in the context afforded by a book on the topic by one of the authors of the article who is the Minister of Health.(2)
ECDC has produced a series of public briefing documents on this and the most recent is from May of this year.(3)
There is no need to rehearse the arguments in that but it is important to point out how difficult it is for a country or individual to ?own? a virus.
Consider a real human A(H5N1) case where the infection was caught from poultry in one country but where the patient eventually sought care in another country where H5N1 infection was diagnosed.
The specimen then passed onto the WHO Collaborating Centre in a third country where the virus was isolated. It could then pass onto a specialist laboratory in a fourth country to be made suitable for vaccine production by commercial companies in yet other countries.
If the virus passed on becomes the source of a vaccine who would be the owner?
Is it the owner of the bird, the patient or his / her family, the authorities in one of the first three countries, the Institution where the Collaborating Centre is based or WHO?
There is also almost an accidental element as to where a virus is isolated that finally proves suitable for vaccine production. What about the other countries which contributed viruses but did not happen to be suitable?
A way round this has always been to cite the Gift Relationship, developed for sharing of human fluids (blood) and tissues whereby biological products are shared unconstrainedly according to need and their effective use without reference to ownership, payment or country of origin.(5)
Essentially this is seeing influenza virus isolates as Public Goods not Private Property (6-7). Having said that progress is being made in this area. The next Intergovernmental Meeting will take in November this year.
References:
1 - Sedyaningsih ER, et al, Towards Mutual Trust, Transparency and Equity in Virus Sharing Mechanism: The Avian Influenza Case of Indonesia Ann Acad Med Singapore 2008;37:482-8
2 - Fidler DP. Influenza virus samples, international law, and global health diplomacy. Emerg Infect Dis. 2008;14:88-94
3 - Supari SF. Its time for the world to change, divine hand behind avian influenza. PT. Sulaksana Watinsa Indonesia SWI 2007 ISBN 978-979-17357-0-4
4 - Interim ECDC Scientific and Public Health Briefing: Sharing influenza Virus Samples ? Updated May 2008 available at: http://ecdc.europa.eu/pdf/ECDC_influenza_briefing.pdf
5 - Titmuss RM The Gift Relationship: From Human Blood to Social Policy Original edition with new chapters, Eds Oakley A, Ashton J. LSE Books London 1997.
6 - World Intellectual Property Organization. Expert Report for WHO. Patent issues related to influenza viruses and their genes (document still undergoing expert review) October 2007. http://www.who.int/csr/disease/avian_influenza/WIPO_IP_%20paper19_10_2007.pdf
7 - WHO Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits. Intergovernmental Meeting: report of progress to date. WHO Executive Board Paper EB122/5. January 2008 http://www.who.int/gb/ebwha/pdf_files/EB122/B122_5-en.pdf
-
http://www.ecdc.europa.eu/Health_topics/influenza/news/news_Influenza_080724.html
------
