Indonesia's move on bird
flu samples highlights key access issues
The Indonesian government's announcement that it would stop sharing bird flu samples with the WHO unless the agency stopped providing the strains to commercial vaccine makers won the support from health officials in other Asian countries as well as sympathy from mainstream media such as the New York Times and New Scientist.
Earlier this month,
Indonesian health officials explained that the move was to ensure that the people had access to the vaccine during a pandemic, as otherwise it would have to buy the vaccines from commercial drug manufacturers at high prices. They maintain that the WHO's virus-sharing mechanism has been misused for commercial purposes.
According to an Associated
Press article: "Other countries, including
Up to now, WHO Member States that experience bird flu outbreaks provide samples of the virus isolates to WHO collaborating centres. At these centres, the isolates are used in the process of creating vaccine 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. Several countries raised the issue at the World Health Assembly last May (See SUNS #6035 dated 29 May 2006).
However, the Indonesian withholding of its samples appears to be short-lived. On
16 February, the Indonesian
Health Minister announced that the country would resume sharing influenza
viruses with the WHO. A joint statement between
The WHO will also work with
An IPS article quoted UNICEF
East Asia regional immunization officer Basil Rodriques as saying that
''Indonesia has tossed the latest salvo into a debate that has been
simmering under the surface for a long time. It is an issue of relevance
that the world needs to come to grips with", adding that
A health official in
IPS also quotes
Last May, the US-based NGO Sunshine Project revealed that patents had been granted for anti-viral drugs for the treatment of smallpox and that a smallpox vaccine had also been granted a European patent.
Many developing countries
had handed over to the WHO their stocks of the smallpox (variola) virus,
and the World Health Assembly had mandated that the remaining smallpox
virus stocks would eventually be destroyed. Meanwhile, two laboratories
(one in the
In an article in SUNS (No #6034 dated 24 May 2006), Edward Hammond of the Sunshine Project revealed that several of the drugs (or their components) that have been developed are under patent, or under patent application. This will affect the affordability or availability of the drugs in the event they are needed.
There are two principal compounds
(cidofovir analogs and SIGA-246) under consideration in the
Cidofovir analogs for treatment
of variola virus infection are covered by patents issued to the
The other smallpox anti-viral
compound under consideration in the
The Danish company Bavarian
Nordic also holds a European patent on a smallpox vaccine, and the company
was suing the company Acambis for infringing its patent. Acambis was
then planning to take part in a $1.9 billion contract to provide smallpox
vaccines to the
"With several patents granted or pending on smallpox anti-virals and legal fights taking place over a patent on a smallpox vaccine, it is clear that there is a range of issues on who owns the stocks of the smallpox virus, whether patents should be issued on drugs relating to the virus, and the cost to, and access of, people especially in developing countries in the event they require the drugs," said Hammond.
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 was also a key issue at the World Health Assembly last May
(See SUNS #6035 dated 29 May 2006).
It proposed an amendment to the WHA resolution on the Application of the International Health Regulations, suggesting the insertion of the language "for non-commercial purposes only" in relation to the dissemination to WHO collaborating centres 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 centres.
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.
However, because of objections by other countries, Thailand had to compromise and the eventual resolution urged member states to develop domestic influenza vaccine production capacity or work with neighbouring States to establish regional vaccine; 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.
In response to the Indonesian
move, the New York Times in its editorial on 16 February said: "
"If a pandemic struck, the current vaccine makers could produce only 500 million doses of vaccine per year if they ran 24 hours a day. That is far short of what would be needed to vaccinate all 6.7 billion people in the world," said the Times editorial.
"Thus, there seems no
doubt that in a crisis, the countries that are home to the vaccine makers
would tend to their own citizens first - or those willing to pay the
highest prices - leaving little or no vaccine for everyone else. The
WHO needs to work much harder to encourage the transfer of vaccine production
technology to countries like
In its 17 February issue,
The New Scientist published an editorial, "Self defence over bird
flu is no crime." It said: "Good for
"It has also brought
an unpalatable truth out into the open. In a fair world,
"By withholding the
"The country says it
is will do this only under material transfer agreements that ban commercial
use except by prior agreement... We need a system that works for everyone.
In its absence, those material transfer agreements should be signed
now. We need to see what H5N1 is up to in
However, the Indonesian move to stop sending its virus samples to the WHO may be short-lived as it announced that it would resume sharing these samples.
A joint statement was issued
The statement said that
Said the statement: "In
the long term,
"The Minister agrees that the responsible, free and rapid sharing of influenza viruses with WHO, including H5N1, is necessary for global public health security and will resume sharing viruses for this purpose.
"WHO will continue discussions and work with the Ministry of Health and other countries to assess and develop potential mechanisms, including Material Transfer Agreements, that could promote equitable distribution and availability of pandemic influenza vaccines developed and produced from these viruses."
To this end, WHO and the
Health Ministry will convene a meeting of selected countries in the