Friday, July 14, 2006

The call for the CDC and WHO to release H5N1sequences misguided

This is something that has been bothering me for a little while. I think a lot of people who aren't studying biology or have had to deal with "biodiversity laws" are missing a few critical pieces of this issue.

WHO is not at fault for not releasing the Indonesian H5N1 sequences. Indonesia has very, very stringent nucleic sequence I.P. laws. All genetic material recovered there is their property. Their Convention of Biological Dviersity Law No.5 (1994) and Cultural Practices Law No. 12 (1992) effectively prevent all non-Indonesians from removing biological materials from the country for study (academic or commercial). If you are granted permission to remove the material, Indonesia is still the owner and licensee of that material. The WHO and CDC cannot release those sequences. It is not within their legal wherewithall. Nature and Science are aware of this - what's eating at me is that when the story is referenced, no one ever notes that the release of these sequences would violate Indonesia law, international patent and property conventions and make research in that country much more arduous for foreign researchers.

Indonesia is what is referred to as a mega-biodiverse country. As such,they are a hotbed for pharmaceutical research. They have stringent laws governing genetic material export to ensure that they get a return on the research that is undertaken there by corporations. Given that the same patent protections are offered pharmaceutical companies in this country, I don't have a problem with this. Everyone deserves the guarantee of a return on their investment.

WHO and CDC release of these sequences would be an act of bio-piracy, and violation of the trust and agreements between Indonesia and foreign researchers......and act that would make it much more difficult for the rest of us to acquire biological material in Indonesia and countries with similar laws, such as Brazil. Let's not forget that, despite their research and economic prowess, the WHO and CDC cannot just enter countries to gather data at will. They have to be granted permission. The release of these sequences without Indonesia's consent could make it much more difficult to research influenza on the whole (you have to remember that novel influenza strains typically emerge in Asia. Indonesia, with high influx of people annually and cultural traditions that include backyard farming makes it a logical place to conduct influenza research). If you want to put pressure on someone, put it on the Indonesian government. Their explicit permission to release these sequences is required.

I read the letter being passed around congress. Undermining the authority of other governments in the interest of medical research is not altruistic and it isn't in the majority's best interests. These sequences end up in Genbank without Indonesian holding the patents, and Western pharmaceutical companies can use them without paying fees. Academics typically don't pay fees to use sequences that have been patented by a government.....so who is really interested in the release of these sequences? Influenza anti-virals are a booming sector in pharmaceutical research. In my view, as I have stated many, many times before, the emphasis on H5N1 as a disease threat is distorted and overblown.

If this were being done with the interests of Indonesians in mind (who - incidently- are actually under immediate threat of highly pathogenic human-human H5N1 strains), governments and patenting offices worldwide would be clammering to speed any requested or required patents of these sequences so that they could be released without the concern of piracy.

Would I like to see them in Genbank. Of course.....but put this issue in perspective. Do you have any idea how many HIV sequences are held without release by pharmaceutical companies? Thousands. When people read this story do they consider how much human proteomic information relevant to TB, HIV and cancer research is being held by companies hoping to make a profit on licensing the sequences and structures? TB and HIV kill 100s and 1000s x more people annually alone than H5N1 has in the last 2 years. Again, I ask why undermine a nation and put everyone's research and health in jeopardy? If you want the sequences, put the pressure on Indonesia and make arrangements for free academic but fee-based commercial use.


I've been on a number of key blogs that have been following this story. Their front pages and links do not discuss the legal problems the CDC and WHO face in releasing these sequences. It's very possible that someone else has mentioned this and I've just missed it. Still, it's been irking me for weeks, so I just wanted to put it out there.