This was an incident waiting to happen. Indonesia has signed a preliminary agreement with vaccine maker Baxter international an arrangement to supply with with viral vaccine seed in exchange for an unknown compensation. It is unclear whether the arrangement is exclusive to Baxter or not (see today’s New York Times, says not). Until the deal is completed they will not continue to send viral isolates to other scientists for research or other purposes. Sharing of sequence data is said to be unaffected. The deal with Big Pharma Baxter International puts viral seed strains from the world’s current bird flu hotspot and plausible origin of a future pandemic in the hands of a single manufacturer. Whether exclusive or not, it seems Indonesia has decided to get compensation for its viral isolates. The action underscored in dramatic fashion Indonesian displeasure over the production of a vaccine from a strain of H5N1 the Indonesians sent to WHO. WHO in turn sent it to Australian blood products company CSL to produce an H5N1 vaccine, using a model of non-exclusive seed strain sharing with vaccine makers now used for seasonal influenza. In this context, CSL did not notify or ask permission of the Indonesians:
[The] news this week that the Australian pharmaceuticals company CSL had developed a vaccine against the H5N1 bird flu virus was met with alarm by Indonesian Health Minister Siti Fadillah Supari.
She says Indonesia is seeking intellectual property rights over the Indonesian strain of the virus on which the vaccine is based.
But CSL spokeswoman, Dr Rachel David, says it is not possible to “own” strains of bird flu.
Dr David says the company received its stock of the virus from the World Health Organisation (WHO).
“To talk about strains of the flu as being something you can own is no a useful concept – it’s like trying to grasp smoke,” she said.
“It’s not a useful concept in dealing with this disease.” (Australian Broadcasting Corporation)
One sympathizes with both sides of this dispute. The Indonesians, like other developing countries are angry that viruses isolated on their territory from their citizens and provided voluntarily to the international community would be used by companies in rich countries to produce a vaccine they can’t afford and in any case would be far down the queue for available supplies.
A number of developing countries affected by H5N1, most notably Thailand and Indonesia, have been increasingly vocal in airing concerns that their people will not have access to vaccine made from viruses isolated in their countries if H5N1 goes on to become a pandemic.
“Developing countries in many instances would like to have their own stockpiles or would like to have some benefit from the viruses that they’ve given, seeing that there is not a great access to vaccines in the world,” Dr. David Heymann, the WHO’s influenza czar, said in a teleconference from Geneva on Tuesday.
A retired industry expert who follows pandemic vaccine production issues closely said there is little surprise that Indonesia has upped the ante in this way.
“One could view this as a hard-nosed negotiating tactic on the part of a developing country to gain access to the vaccines it will need for its population. And this is perfectly understandable,” said Dr. David Fedson, speaking from his home in France.
“This was inevitable and we should have seen it coming.”
In fact, Thailand served notice of these concerns at last month’s meeting of the WHO executive board, saying the current situation where pandemic vaccine would flow almost exclusively to developed countries with vaccine manufacturing plants is untenable.
“We are sending our virus (samples) to the rich countries to produce antivirals and vaccines. And when the pandemic occurs, they survive and we die,” Thailand’s representative Suwit Wibulpolprasert told the meeting.
“It is unfair to let the poor die and the rich survive. . . . We are not opposing the sharing of information and virus, but on the condition that every country will have equal opportunity to get access to vaccine and anti-virals if such a pandemic occurs.” (Branswell, Canadian Press)
The Indonesian action may or may not have been triggered by the CSL incident. WHO says they have been threatening to sign an exclusive license since last November and have sent no isolates to WHO since the first of the year. That means the new isolates from last month’s cases in Indonesia have not been shared. On the other hand, CSL’s David is also right that you shouldn’t be able to license a life form, especially the seed for a dangerous viral disease. Current Intellectual Property doctrines favor this, but it is a monstrosity that shouldn’t be allowed.
What’s the solution? Here’s one suggestion. Influenza vaccine is too important to be in private hands. This episode is a good example of what happens. WHO should set up a dozen or so geographically distributed international vaccine institutes whose task it is to manufacture and provide at cost seasonal and pandemic vaccines for their regions. The vaccine would be distributed according to need to countries in the region of the institute.
For years Big Pharma has explained its neglect of the vaccine business as the failure of the market where the profit was insufficient to justify investment. That’s fine. Those companies have a duty to their shareholders that trumps global health. They are profit making corporations. But if the market doesn’t work, then we shouldn’t distort market forces by subsidizing or guaranteeing profits from these same companies. Let’s take this vital commodity outside the market and manufacture it as a public good. Benefitting from the expertise of the regional vaccine institute would be contingent upon sharing viral isolates in a timely fashion. Meanwhile viral isolates should be in the public domain.
There may be other, better solutions than this, but this is better than what we have now. The Intellectual Property fascists have gone beyond suing elementary school students and grandmothers for downloading a few songs. Time to stop this nonsense before it kills us all.