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Sequence release - WHO concedes that Indonesia has a point

Snowy Owl

Retired in 2010, In Memoriam
Why Indonesia is blocking a bird flu vaccine

article.gif

13.02.2007
http://www.electricmessage.co.uk/mailer/signup.php?sid=172&cc=MM_WEB_ARTICLE



<!-- START IN PAGE TEXT BOX --><!-- END IN PAGE TEXT BOX -->The circumstances surrounding the Bernard Matthews bird flu outbreak just get murkier and murkier.

[FONT=Verdana, arial, helvetica, sans-serif]Delays around vital documentation being handed over; news that birds have been shipped back to Hungary, possibly reintroducing the H5N1 virus into Europe, threaten to cause a diplomatic scandal; and meanwhile, sales of the company?s products have fallen by as much as 50%, reports The Times.[/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]But meanwhile, on the other side of the world, a different storm is brewing over bird flu. And this could be much more important, as it threatens to get in the way of finding a vaccine for any human variant of the virus...[/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]The Indonesian government is refusing to supply bird flu samples to foreign scientists. [/FONT]
[FONT=Verdana, arial, helvetica, sans-serif][/FONT]
[FONT=Verdana, arial, helvetica, sans-serif]GlaxoSmithKline has attacked the decision, which will hinder its efforts to develop a human vaccine for the virus.[/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]So what?s the problem? The Indonesians want the World Health Organisation (WHO) to provide guarantees that the samples won?t be used commercially. [/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]The Indonesian government is worried that if it hands over the samples, they?ll go from the WHO to big pharma vaccine-makers such as GSK, who?ll then create vaccines that the poor in developing countries won?t be able to afford.[/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]The reason that Indonesia is so important in the hunt for a bird flu vaccine is because it has seen the most human fatalities as a result of H5N1. [/FONT]
[FONT=Verdana, arial, helvetica, sans-serif][/FONT]
[FONT=Verdana, arial, helvetica, sans-serif]There have been 64 recorded deaths in the country, and as Robin Pagnamenta in The Times says, it is ?considered one of the most likely places where a human pandemic strain could emerge.?[/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]Any decision to pull out of the current WHO system, whereby countries share information on flu viruses freely, could have serious knock-on consequences. The agreement to share information on flu viruses has stood for 50 years. ?Any decision to pull out would be the first in the system?s history.?[/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]However, despite the worries, and the anger of the drug makers, the WHO concedes that Indonesia does have a point. ?Indonesia is rightly concerned about its access to a vaccine. [/FONT]
[FONT=Verdana, arial, helvetica, sans-serif][/FONT]
[FONT=Verdana, arial, helvetica, sans-serif]At most, manufacturers will be able to produce only 500 million doses - far short of what will be needed in the event of a pandemic. The vaccines will be in limited supply and will probably be available only to countries which have manufacturing capacity.? [/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]As 95% of that capacity is in North America, Europe, Japan and Australia, Indonesia would be some distance down the pecking order before it could get its hands on any vaccine.[/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]The country is already talking to US vaccine giant Baxter about a potential deal to develop a vaccine outside the WHO system, and others (such as Vietnam) might do the same. [/FONT]
[FONT=Verdana, arial, helvetica, sans-serif][/FONT]
[FONT=Verdana, arial, helvetica, sans-serif]As the WHO says, it?s understandable that these countries want to look after their own interests, but unfortunately, not sharing information is likely to delay the development of effective drugs.[/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]It?s a tough nut to crack, and has been a consistent bugbear of the drugs industry ? how do you find a model that encourages innovative and rapid research into killer diseases, but then make sure the results are available to those who need them, regardless of ability to pay?[/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]We don?t have the answer, but some reform of patent law is probably at least part of the solution. [/FONT]
[FONT=Verdana, arial, helvetica, sans-serif][/FONT]
[FONT=Verdana, arial, helvetica, sans-serif]As Graham Searjeant points out in The Times, the way patents work has a lot to do with why it?s becoming too expensive to develop cost-effective drugs. ?Trials and approval take up an ever bigger chunk out of the typical 20-year patent period,? he says. Because ?the clock starts when a chemical is first protected? companies have to charge high prices ?to recoup costs and earn returns fast? before the patent expires. [/FONT]

[FONT=Verdana, arial, helvetica, sans-serif]It does point up the problem with attempting to play bird flu by investing in vaccine makers. Under serious pandemic conditions, it would be very difficult to make any money from the vaccine. Governments would likely seize any supplies available and distribute them as they saw fit. [/FONT]
[FONT=Verdana, arial, helvetica, sans-serif][/FONT]
[FONT=Verdana, arial, helvetica, sans-serif]But that?s not to say that you shouldn?t buy into drug makers ? in the current issue, analyst Charlie Gibson suggests that GSK looks good value at the moment.[/FONT]
[FONT=Verdana, arial, helvetica, sans-serif][/FONT]
[FONT=Verdana, arial, helvetica, sans-serif]You can read his views in the current issue of MoneyWeek.[/FONT]
 
Re: Sequence release - WHO concedes that Indonesia has a point

> The Indonesian government is worried that if it hands over the samples,
> they?ll go from the WHO to big pharma vaccine-makers such as GSK,
> who?ll then create vaccines that the poor in developing countries won?t
> be able to afford.

and they withhold the samples, so that big pharma has no vaccine
and Indo needn't worry about how to pay for the nonexisting vaccine.
So they consider no vaccine for anybody as better than vaccine
only for the rich.
This is just blackmail.

> WHO concedes that Indonesia does have a point

I stopped wondering about WHO-statements in 2005.
WHO doesn't speak with one oice, though.

Now, the problem is of course not that the rich countries might have vaccine.
The problem is that the poor countries maybe/probably won't have it.
Just interesting that the envy-factor is so big here and that statements
as the above are issued.

Should the rich countries share their vaccine with the poor countries
so people in rich countries would die but people in poor countries could live ?
Unlikely to happen.

But what we should do is helping the poor countries to contain the disease.
Their health problems can be our future health problems.
Unfortunately research how to prevent a pandemic doesn't pay so well
for big pharma but "creating" or tolerating a pandemic and then selling
the vaccine does.
 
Re: Sequence release - WHO concedes that Indonesia has a point

http://www.reuters.com/article/homepageCrisis/idUSN15223795._CH_.2400

Indonesia's vaccine stance justified, journal says


Thu Feb 15, 2007 6:41PM EST

WASHINGTON, Feb 15 (Reuters) - Indonesia's decision to limit access to samples of birdflu virus is understandable and should force other governments and health experts to come up with a fairer system for sharing raw materials for vaccines, a leading medical journal said on Thursday.

The Lancet medical journal defended Indonesia's approach and said the World Health Organization must find a way to help poorer countries benefit more from medical research done by rich companies.

"Indonesia fears that vaccines produced from their viruses via the WHO system will not be affordable to them," the Lancet editorial reads.

Last week Indonesia declared it would only share its H5N1 bird flu virus samples with parties who agreed not to use them for commercial reasons, saying it was unfair for foreign drug firms to use the samples, design vaccines, patent them and sell the product back to the country.

It signed a preliminary agreement with a unit of pharmaceutical firm Baxter International Inc. (BAX.N: Quote, Profile, Research) to provide technology to help develop a vaccine.

"Their concerns are forcing the world to address this inequity problem. The fairest way forward would be for WHO to seek an international agreement that would ensure that developing countries have equal access to a pandemic vaccine, at an affordable price," the Lancet editorial read.

The H5N1 avian flu virus has infected 273 people and killed 166 of them since 2003. Indonesia has had more deaths -- 63 -- than any other country.

The fear is that the virus could mutate into a form that people could catch easily from one another. That could spark a pandemic that could kill millions, even if the fatality rate goes down.

Scientists have been examining samples of the virus to track its constant mutations. They have also been using these viral samples to make practice vaccines.

"To protect the global population, 6.2 billion doses of pandemic vaccine will be needed, but under current manufacturing capacity the world can only produce 500 million doses," the Lancet noted.

"And, in a pandemic, it is industrialized countries that will have access to available vaccines, whereas developing countries -- where a pandemic is likely to emerge -- will be left wanting," it added.

"In this context, Indonesia's move last week to try and secure an affordable vaccine supply for its population is understandable," it said.
 
Re: Sequence release - WHO concedes that Indonesia has a point

http://www.alertnet.org/thenews/newsdesk/SP294637.htm


RPT-INTERVIEW-Indonesia wants fair deal on H5N1 vaccine-minister
16 Feb 2007 01:41:01 GMT
<!-- 16 Feb 2007 01:41:01 GMT ## for search indexer, do not remove--> Source: Reuters

(Repeats story issued on Thursday) By Achmad Sukarsono and Fitri Wulandari

JAKARTA, Feb 15 (Reuters) - Indonesia has restricted sharing bird flu strain samples overseas to ensure its own people benefit from any vaccine and to stop foreign parties "dancing over the corpses of others", the health minister told Reuters on Thursday. In a controversial move, Jakarta last week declared it would only share its H5N1 bird flu virus samples with parties who agreed not to use them for commercial reasons, insisting it was unfair for foreign drug firms to use the samples, design vaccines, patent them and sell the product back to the country. Health Minister Siti Fadillah Supari said in an interview that the reason why rich countries and pharmaceutical firms want access to the Indonesian strain is because it "has a better cross-protection and can be used against H5N1 strains from other countries". "The ones who are egotistical here are the ones with capital. They are dancing over the corpses of others," she said during the interview at her office in South Jakarta. Some health and aid agencies have condemned Indonesia for refusing to share samples, although others have defended the stance because developing countries often struggle to get access to life-saving drugs due to patent laws and high costs. Supari said Indonesia had sent H5N1 samples to the World Health Organisation for diagnosis and was shocked when a commercial entity was given access to them without Jakarta's knowledge. "WHO should have had walls to protect us as victims. It turned out to be that's not the case and this is how it is in the world. Developing countries are always on the losing side like what happened to the AIDS and heart disease drugs," she said. "REACTION TO INJUSTICE" She insisted Jakarta was not trying to stop a virus being developed that could produce a vaccine saving the world from a potential bird flu pandemic for itself as long as parties agreed to Indonesian laws on material transfer. "They have to respect our laws. Why do (WHO-sanctioned labs) refuse to sign? If they don't sign, we won't give the virus. This is a reaction to injustice," said the 56-year-old minister, who was wearing a pink headscarf. Sharing of virus samples is crucial as it allows experts to study their make-up and map the evolution and geographical spread of any particular strain. Samples are also used to make vaccines. Although H5N1 bird flu remains essentially a bird disease, it has killed 166 people since 2003, mostly in Asia with Indonesia having the highest deathtoll of 64 fatalities. The big concern is that it could mutate into a disease that easily passes from human-to-human triggering a global pandemic. Indonesia last week signed a preliminary agreement with a unit of pharmaceutical firm Baxter International Inc. Under the pact the health ministry's research and development institute will supply the U.S. firm specimens of H5N1; Baxter will provide technology to help develop a vaccine. Defending Indonesia's actions, Supari used an example of the anti-influenza drug Tamiflu, an antiviral medicine that can be used to treat patients with bird flu, complaining the country's access to the drug was limited. "We had to line up from the back when clearly we were the ones who had the patients. That's unfair. My reaction is to remind the world to act fairly." "I want to save mankind but I want fairness. If things are fair, we won't have diseases in the world. This is my way of protesting," the cardiologist-turned-minister added. (Additional reporting by Telly Nathalia)
 
Re: Sequence release - WHO concedes that Indonesia has a point

This may represent the tip of the iceberg.

During any severe pandemic, there may be many countries acting in their own self-interest.

Will the countries that produce PPEs share their insufficient supplies with other countries? In this case, it may be the developing countries shorting the developed countries.

I'm disappointed that the phrase "dancing over the graves" was used. I doubt many people would do that.

.
 
Re: Sequence release - WHO concedes that Indonesia has a point

I'm disappointed that the phrase "dancing over the graves" was used. I doubt many people would do that.

It sure sound like a Jerome Bosch painting... vbrrrrrf!

But a cheap furniture of vaccine in Indonesia would certainly save lifes & not just inside Indonesia.

The closer & the sooner vaccination is provide close to the epicenter, the more the pandemic can be delayed.
 
Re: Sequence release - WHO concedes that Indonesia has a point

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Re: Indonesia May Sell, Not Give, Bird Flu Virus to Scientists
<HR style="COLOR: #cccccc" SIZE=1><!-- / icon and title --><!-- message -->Govt to meet WHO over virus samples
[FONT=Arial, Helvetica]
The Jakarta Post, Jakarta

The government is set to meet with high-ranking officials from the United Nations health organization Friday to settle a disagreement over the sharing of bird flu virus samples.


Health Minister Siti Fadillah Supari declined to disclose details of the agenda Thursday but hinted that she would bring up the substance of the Material Transfer Agreement (MTA), a protocol for virus-sharing.

"I will meet both Heyman and Fukuda here, tomorrow," she said, referring to David Heyman, World Health Organization (WHO) acting assistant director general for communicable diseases and Keiji Fukuda, acting director of WHO's Global Influenza Program.

Under the transfer agreement, the recipient agrees to specific constraints, such as not sharing the sample with others or using it for commercial purposes.

Indonesia has refused to send its virus samples to foreign laboratories, including collaborating centers under the WHO, since the beginning of this year. Siti termed the move a "reaction" after Australia-based pharmaceutical company CSL Ltd. developed human vaccines "without Jakarta's consent" using the Indonesian strain sent to WHO centers.

Siti called it a timely move to 'speak up' for equality and justice.

Indonesia last week appointed Swiss-based Baxter Healthcare SA, a subsidiary of U.S. drug maker Baxter International Inc., to develop human vaccines with the Indonesian strain.

The refusal to share drew immediate criticism from many who said Indonesia's move could jeopardize the world's access to a pandemic vaccine, especially if Indonesia became the epicenter of a global outbreak.

According to Siti, Indonesia's decision to control its virus samples has gained support from other developing countries.

"The most important thing is that we speak out. I don't really care about the result. Besides, usually, we, the third world, lose the battle," she said with a smile.

"But as an international organization, WHO should have been wise, fair and neutral."

Several countries are developing vaccines to protect against H5N1, the strain of bird flu that has claimed the lives of at least 167 people globally, more than one-third of them in Indonesia. The hardest-hit country has confirmed a death toll of 64 people from 84 infected since the virulent H5N1 first appeared here in July 2005.
No comments were available from WHO office in Jakarta on the scheduled meeting.

http://www.thejakartapost.com/detail...216.H02&irec=1
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"The next major advancement in the health of American people will be determined by what the individual is willing to do for himself"-- John Knowles, Former President of the Rockefeller Foundation
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AMC to combat deadly diseases in poor nations

AMC to combat deadly diseases in poor nations

This is a fight for the survival of whole cultures. Indonesia has every right to demand that the biological specimens in their possession are used for the common good of all of mankind.



Five nations and the Bill & Melinda Gates Foundation launch Advance Market Commitment for vaccines to combat deadly disease in poor nations

<TABLE id=mainContent cellSpacing=0 cellPadding=0><TBODY><TR><TD id=mainContentTD>US$1.5-billion pilot programme expected to save 5.4 million lives, protecting children from pneumonia, meningitis

ROME, ITALY (9 February 2007) ? Canada, Italy, Norway, Russia, the United Kingdom, and the Bill & Melinda Gates Foundation today committed US$1.5 billion to launch the first Advance Market Commitment (AMC) to help speed the development and availability of a new vaccine which is expected to save the lives of 5.4 million children by 2030. The AMC pilot represents the first step in a historic effort to create a market for life-saving vaccines for children in the world?s poorest countries. The new initiative will target pneumococcal disease, a major cause of pneumonia and meningitis that kills 1.6 million people every year.
World Bank President Paul Wolfowitz joined Her Majesty Queen Rania Al-Abdullah of Jordan and high-level representatives of Canada, Italy, Norway, Russia, and the United Kingdom in announcing the pilot AMC, which will test a new model for spurring development of vaccines, specifically those that prevent disease strains prevalent in developing countries. The pilot will provide 7 to 10 years of funding to support the development of future vaccines against pneumococcal disease and will include provisions to assure the long term sustainable supply and price for the poorest countries.
?With the launch of the first AMC, we can save lives, and we will do it with the investment and expertise of industry,? said Wolfowitz.

?The key aim is to accelerate the production of viable and urgently needed vaccines for the poorest countries where thousands of children die every day from diseases that can be prevented.?

The AMC concept was developed in response to a tragic dilemma, noted Italian Finance Minister Tommaso Padoa-Schioppa, whose government has committed US$635 million to the AMC pilot.
?The AMCs are an absolutely innovative approach which combines market-based financing tools with public intervention. This innovative instrument opens a new frontier in the financing of the fight against poverty and endemic diseases,? said Padoa-Schioppa, whose ministry has led the drive to adopt the AMC pilot. ?International projects such as this one will make possible to save millions of human lives and demonstrate that development can and must go together with the need to ensure equality and guarantees of a better future for the poorest and the weakest.?
The AMC for pneumococcal disease will offer an improved market for vaccines now in development. Vaccines are bought only if they meet pre-determined standards of efficacy and safety, and if developing countries ask for them. After 7 to 10 years, the AMC funding is likely to be depleted. The AMC will include terms that help assure a sustained and affordable supply in the long term.
Her Majesty Queen Rania, a member of the board of the GAVI Fund, pointed out that in the poorest regions of the world, two to three million children die of preventable diseases every year.
Her Majesty took particular note of the donor nations that are helping to meet the goal of reducing by two-thirds the number of deaths among the world?s most vulnerable children.
?You are giving the gift of health, and, more than that, the gift of hope,? said the Queen. ?Thanks to you, more families will have a fighting chance to see their babies survive, to see their boys and girls grow up, their sons and daughters live productive lives. Thanks to you, entire communities may find the strength to push back against poverty and entire countries may take a step up the ladder of human development.?
Julian Lob-Levyt, executive secretary of the GAVI Alliance, noted that an early version of pneumococcal vaccine is being widely used in developed countries with striking success in preventing disease. However, he added, manufacturers lack the capacity to provide a vaccine well-suited to the developing world on a large scale, and extended protection vaccines are needed to bring pneumococcal disease under control in developing countries.
An independent expert committee, with representation from developing and industrialised countries, recommended that pneumococcal disease be the target of the initial AMC pilot. Going forward, the AMC will be overseen by an independent assessment committee, which will set and monitor standards for the vaccines. The World Health Organization will facilitate the establishment of the target product profile and assess the quality, safety and immunogenicity of AMC vaccines. The GAVI Alliance and the World Bank will be responsible for supporting the programmatic and financial functions of the AMC.
?We expect that new pneumococcal vaccines will reach developing countries by 2010, at least 10 years earlier than if the AMC were not available,? Lob-Levyt said. ?Today?s decision will save lives by bolstering efforts to prevent this disease, while paving the way for future AMCs focused on other deadly diseases.?






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The World Bank
The World Bank is a vital source of financial and technical assistance to developing countries around the world. The Bank comprises two unique development institutions owned by 184 member countries?the International Bank for Reconstruction and Development (IBRD) and the International Development Association (IDA). Each institution plays a distinct role in the Bank's mission of global poverty reduction and the improvement of living standards. The IBRD focuses on middle income and creditworthy poor countries, while IDA focuses on the poorest countries in the world. Together, these two institutions provide low-interest loans, interest-free credits, and grants to developing countries for health, education, infrastructure, communications, and other development purposes. For more information, see www.worldbank.org.
The GAVI Alliance
The GAVI Alliance includes among its partners developing country and donor governments, the World Health Organization (WHO), UNICEF, the World Bank, the vaccine industry in both industrialised and developing countries, research and technical agencies, NGOs, and the Bill & Melinda Gates Foundation. It is estimated that more than 2.3 million early deaths will have been prevented as a result of support by GAVI up to the end of 2006. GAVI's efforts are critical to achieving the Millennium Development Goal on child health, which calls for reducing childhood mortality by two-thirds by 2015. Of the more than 10 million children who die before reaching their fifth birthday every year, 2.5 million die from diseases that could be prevented with currently available or new vaccines. For more information, see www.gavialliance.org.


http://www.vaccineamc.org/launch_event_01.html
 
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Re: AMC to combat deadly diseases in poor nations

Re: AMC to combat deadly diseases in poor nations

The Waiting Time for Inter-Country Spread of Pandemic Influenza

Conclusions

The delay until an epidemic of pandemic strain influenza is imported into an at-risk country is largely determined by the course of the epidemic in the source region and the number of travelers attempting to enter the at-risk country, and is little affected by non-pharmaceutical interventions targeting these travelers. Short of preventing international travel altogether, eradicating a nascent pandemic in the source region appears to be the only reliable method of preventing country-to-country spread of a pandemic strain of influenza.

Even with the better firesuit, you better extinct the fire at the source.
 
Re: Sequence release - WHO concedes that Indonesia has a point

Indonesia agrees to resume sharing sample bird flu viruses with WHO


JAKARTA, Indonesia (CP)

Indonesia will shortly resume sharing samples of H5N1 avian flu viruses with the World Health Organization, officials announced Friday, in a decision linked to efforts to improve affordable access to pandemic influenza vaccines for developing countries.

Indonesia had refused since the beginning of the year to share sample viruses, angered that pharmaceutical companies elsewhere were potentially profiting from sales of vaccine made from Indonesian viruses with no gain to the country itself.

"The (Indonesian health) minister has assured the WHO they would not hold WHO hostage to the virus," Dr. David Heymann, the WHO's pandemic influenza czar, said after high-level talks Friday in the Indonesian capital.

Heymann and Dr. Keiji Fukuda, head of the WHO's global influenza program, travelled to Indonesia to meet with Health Minister Siti Fadilah Supari and other senior government officials in a bid to resolve the sample sharing row.

"They will share the virus for global public health services," Heymann said.

A statement issued jointly by the WHO and Indonesia credited Indonesian authorities had alerted the international community to the needs of developing countries to benefit from sharing sample viruses, specifically through access to pandemic vaccines sold at affordable prices.

"It's a very admirable accomplishment," Heymann said.

Supari, the health minister, said she felt it was important to take a stand.
"We tried to create a balance between developed and developing countries in facing catastrophe," she told reporters. "The WHO has been siding with capital owners, which sometimes forget the good of the people. We want to change that."

The statement said the WHO will continue to work with the Indonesian Ministry of Health and with other countries to try to develop ways to promote fair distribution and availability of pandemic influenza vaccines developed and produced from viruses from affected countries.

It said the Geneva-based agency and the Ministry of Health will jointly convene a meeting of selected Asia-Pacific countries to work on ways to enhance fair access to influenza vaccine and production.

"Until then, Indonesia will not share it (viruses)," Supari said after the meeting.

Jakarta triggered a storm of criticism earlier this month when it said it would no longer share its viruses with WHO if the agency made the viruses available to vaccine makers.

WHO needs flu viruses from affected countries both to provide companies with so-called seed strains for vaccine manufacture and to track the evolution of the viruses to look for important mutations.

Changes in the viruses could indicate whether it is becoming resistant to flu drugs or whether it is evolving to become more easily transmitted person to person - a sign of a potential emerging pandemic.

Under the new International Health Regulations ratified by WHO member states, countries have a responsibility to share information about disease outbreaks within their borders that threaten the health of the global community. Withholding virus samples could put Indonesia in violation of those regulations.

The full regulations come into effect in June. But countries agreed last year to voluntarily push forward the coming into force of the regulations for avian and pandemic influenza.

Sixteen companies from 10 countries are developing vaccines to protect against H5N1, which has infected at least 273 people since late 2003, killing 167. Indonesia has had the second most human cases (after Vietnam) but the most deaths (63).

Indonesia was also criticized when it signed a memorandum of understanding last week with U.S. drug manufacturer Baxter International Inc. to develop an H5N1 vaccine.

Under the agreement, Indonesia would provide H5N1 virus samples in exchange for Baxter's expertise in vaccine production.

"We believe the minister of health has done the right thing. She is in discussion with Baxter to see how she can make the vaccine available in Indonesia. That is what all countries do when they need vaccine. They negotiate deals with companies," Heymann said.

? The Canadian Press 2007​
 
Re: Sequence release - WHO concedes that Indonesia has a point

WHO must follow rules, like everyone else

http://www.thejakartapost.com/detailheadlines.asp?fileid=20070217.B07&irec=6

Indonesia stopped sharing its bird flu samples with the World Health Organization after CSL, an Australian drugmaker, developed and tried to market a vaccine using the Indonesian strain of the virus without the Health Ministry's consent. Triono Soendoro, director general of the National Institute of Health Research and Development, spoke with The Jakarta Post's Alvin Darlanika Soedarjo about the controversy.

Question:How was the sharing of samples done before the controversy?

Answer: Let's start with the legal components first.

We have the 1992 Health Law, which generated a 1995 presidential regulation. There are also the 2002 Technology Law and a 2006 presidential regulation governing the matter.

All of these say that there are certain regulations for the sharing of specimens. Each specimen we send abroad should be accompanied by a Material Transfer Agreement (MTA), which is internationally recognized.

The agreement stipulates that the permission of the sending party is required if the sample is to be developed for commercial purposes. It also states that there should be a benefit-sharing scheme if it is to be used commercially.

However, when bird flu broke out in 2005, health officials and scientists around the world were in a panic. Because of the chaos in the global health world, the MTA was scrapped in order to make sample sharing easier.

Since then, every sample transfer was done based only on the trust that nobody would violate the MTA. If we had insisted on using the MTA, many countries might have accused us of being overly bureaucratic in the midst of a global health scare.

If there is no legal agreement or MTA between Indonesia and the WHO, why does Indonesia feel it has been mistreated?

We have been treated unfairly. We screamed when we heard that an international company wanted to sell us the vaccine, which was developed from our strain without our permission.

Although there was no MTA at the time, they should have been more ethical. Just because it's the WHO does not mean that they can violate the rules.

There are only four places where WHO Collaborating Centers are associated: London, Tokyo, Atlanta and Melbourne. All were selected by the organization to do diagnoses or research under the WHO.

How is Indonesia's relationship with the WHO?

WHO does have good intentions and the Health Ministry has had a great relationship with them in the past. However, each of its country members have their own priorities.

The WHO Collaborating Centers act like Santa Claus. They are generous in sharing data. It has been a tradition over the decades that a country with a seasonal flu gives out virus strains to whoever asks for it.

In Indonesia we are concerned about bird flu because it has a higher risk of fatality, with an average of eight deaths in 10 cases. Compare this with dengue fever, which has an average of one death out of 100 cases.

Why collaborate only with Baxter in producing a vaccine?

Baxter is the only company that contacted us and was ready to follow all of our conditions. They even agreed to sign the MTA agreement. There are several pharmaceutical giants in the world, including Baxter.

Many parties tried to reach out to us, but they offered us a vaccine produced from Vietnam's samples so we rejected them.

What are the consequences of stopping the sharing of Indonesia's bird flu samples?

Making a vaccine is a dilemma. We are ****ed if we produce and ****ed if we don't. Many foreign media have criticized Indonesia because of our decision to stop sharing samples.

However, health officials and the media in Asia have supported us for our effort to ensure fairness. We have no commercial interests; we want the whole world to benefit.

The bird flu virus strain in Indonesia matters because 80 percent of bird flu deaths have been caused by the distinct Indonesian virus. Producing a vaccine from the local strain would protect other countries from the virus.

How do you think the next flu pandemic will happen?

Every virus transmission occurs through a medium, which can be an animal, mosquitoes, humans or from the sky.

Many people believe that a pandemic will happen because of a mutation that would enable the virus to travel easily between humans. This is misleading.

I meet regularly with leading global health experts. We can't agree yet on the kind of transmission that would cause a pandemic because we have no evidence.

In 1918, 50 million people died because of the Spanish influenza. It used to be the H1N1 virus that caused pandemics. Now, we don't know which type of virus will turn out to be the one.

But based on scientific predictions, it's just a matter of time before the next pandemic occurs.

How does the bird flu vaccine work?

A vaccine creates stronger anti-bodies to fight the bird flu virus entering one's body. People can get the vaccination through an injection.

In the meantime, the price and doses needed are still unknown because the product is still in trial. The active period of the vaccine in the human body is also still unknown.

If every pharmaceutical company was forced to produce the vaccine, they would still only be able to produce about 500 million doses. This means that only 250 million people in the world would receive the vaccine, and Indonesia would get nothing.
 
Re: Sequence release - WHO concedes that Indonesia has a point

Indonesia agrees to resume sharing sample bird flu viruses with WHO


JAKARTA, Indonesia (CP)

Indonesia will shortly resume sharing samples of H5N1 avian flu viruses with the World Health Organization, officials announced Friday, in a decision linked to efforts to improve affordable access to pandemic influenza vaccines for developing countries.


Heymann and Dr. Keiji Fukuda, head of the WHO's global influenza program, travelled to Indonesia to meet with Health Minister Siti Fadilah Supari and other senior government officials in a bid to resolve the sample sharing row.

"They will share the virus for global public health services," Heymann said.

"It's a very admirable accomplishment," Heymann said.

Supari, the health minister, said she felt it was important to take a stand.
"We tried to create a balance between developed and developing countries in facing catastrophe," she told reporters. "The WHO has been siding with capital owners, which sometimes forget the good of the people. We want to change that."

"Until then, Indonesia will not share it (viruses)," Supari said after the meeting.

Sixteen companies from 10 countries are developing vaccines to protect against H5N1,

Indonesia was also criticized when it signed a memorandum of understanding last week with U.S. drug manufacturer Baxter International Inc. to develop an H5N1 vaccine.

Under the agreement, Indonesia would provide H5N1 virus samples in exchange for Baxter's expertise in vaccine production.

"We believe the minister of health has done the right thing. She is in discussion with Baxter to see how she can make the vaccine available in Indonesia. That is what all countries do when they need vaccine. They negotiate deals with companies," Heymann said.


? The Canadian Press 2007​

Indonesia deserve a huge thank you in their stand against the Big Pharma thorning the arm of WHO and a big thank you to Fukuda/Heymann for their work. And specially the acknowledgement of Heymann,

"We believe the minister of health has done the right thing. She is in discussion with Baxter to see how she can make the vaccine available in Indonesia. That is what all countries do when they need vaccine. They negotiate deals with companies," Heymann said.

It is now time for investors to understand that the Health ''market'' will be regulated by fairness not by ROI (Return of Investment).

I hope India will win in their stand against Novartis (Klaus Storh, former WHO director).

MSF (Doctors without Borders is supporting India in this fight and sadly they pay a dramatic price.

Anyhow, the Big Pharma will now have to adapt to the Humanitarian aspect of this 'market', it seems now imperative.
 
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