Ethics & Pandemics

World Health Assembly Resolution

Last week, the WHO concluded the 60th World Health Assembly, and adopted a resolution on "sharing of influenza viruses and access to vaccines and other benefits."  The entire statement is available from the WHO's website here (PDF).  Below, I've copied what I take to be some of the most salient points. 

Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits

The Sixtieth World Health Assembly,
Having considered the report on avian and pandemic influenza: developments, response and follow-up
.....
Stressing the need for effective and transparent international mechanisms aimed at ensuring fair and equitable sharing of benefits, including access to, and distribution of, affordable diagnostics and treatments, including vaccines, to those in need, especially in developing countries, in a timely manner;

1. URGES Member States:
(1) to continue to support, strengthen and improve the WHO Global Influenza Surveillance Network and its procedures through the timely sharing of viruses or specimens with WHO Collaborating Centres, as a foundation of public health, to ensure critical risk assessment and response, and to aim to ensure and promote transparent, fair and equitable sharing of benefits arising from the generation of information, diagnostics, medicines, vaccines and other technologies;
.....
(3) to support WHO as appropriate in order to identify and implement mechanisms referred to in paragraph 2, subparagraph (1) [see below];

2. REQUESTS the Director-General:
(1) to identify and propose, in close consultation with Member States, frameworks and mechanisms that aim to ensure fair and equitable sharing of benefits, in support of public health, among all Member States, taking strongly into consideration the specific needs of developing countries, such as, but not limited to:
(a) innovative financing mechanisms to facilitate timely and affordable procurement of pandemic vaccines for and by Member States in need;
(b) facilitation of acquisition by developing countries of capacity for manufacturing in-country influenza vaccine;
(c) access to influenza-vaccine viruses developed by WHO Collaborating Centres for the production of vaccines by all influenza-vaccine manufacturers, particularly in developing countries;
.....

(2) to establish, in close consultation with Member States, an international stockpile of vaccines for H5N1 or other influenza viruses of pandemic potential as appropriate, for use in countries in need in a timely manner and according to sound public-health principles, with transparent rules and procedures, informed by expert guidance and evidence, for operation, prioritization, release of stocks, management and oversight;
.....
(4) to mobilize financial, technical and other appropriate support from Member States, vaccine manufacturers, development banks, charitable organizations, private donors and others, in order to implement mechanisms that increase the equitable sharing of benefits as described in paragraph 2, subparagraphs (1), (2) and (3);
.....

Over the past several months, I've grown wary of anything that looks like a "breakthrough," since it takes a great deal of cooperation from multiple actors to implement a workable solution.  But there is cause for hope here. 

Happily, this resolution focuses serious attention on the need for increased capacity for producing influenza vaccines.  Ensuring fair and equitable access to vaccines requires more than simply distributing the resources that happen to be available as broadly as possible.  Existing manufacturing technology and capacity simply won't be able to supply enough vaccine to meet global demand in the event of a pandemic.  An ideal solution would enable more countries to produce vaccine locally (or regionally). 

If a pandemic began tomorrow, the countries that can afford to purchase vaccine at the going market rate could easily gobble up as much vaccine as could be produced in the first 6 or 8 (or more) months of a pandemic.  In the short term, I doubt there's much that can be done about this.   A medium term solution would involve, as the WHO says, "facilitation of acquisition by developing countries of capacity for manufacturing in-country influenza vaccine"--that is, establishing the know-how and the physical means for producing vaccines locally.  This would reduce competition for already scarce supplies and allow countries to obtain a degree of self-sufficiency.

Also of note is the WHO's mention of "innovative financing mechanisms" for the procurement of vaccines.  It's not immediately clear what such mechanisms would be (probably because they haven't been fleshed out yet), but if enough energy and funding are directed at the problem, something could happen.

The tricky part, I think, will be to get different parties to agree on what sequence of steps is necessary to move forward.  Indonesia's provision of a few clinical samples from H5N1 infected patients to the WHO Collaborating Center in Tokyo is a start, but as far as I know, they haven't provided samples from each new case this year.  If this good will gesture turns out to be nothing more than that--a gesture, rather than an actual policy shift--it's possible that potential donors will be reluctant to take the next step. 

New Flu blog from CARE

Back in March, CARE launched a new blog focused on avian flu: What's new in the world of avian flu?.  It's geared primarily toward sharing information among CARE's network of country-level offices, but will be of interest to anyone trying to follow developments on the ground in the countries where avian influenza is currently circulating. Fitting with the organization's mission, there's a strong emphasis on the developing world.   

The blog's description reads:

The purpose of the CARE Avian Flu Blog is to create a simple site where CARE staff can stay updated on the latest and most important AI news. Since we have access to information and are constantly looking over AI related news and materials, it helps us narrow down the best information and provide an easy place for CARE staff to stay updated with AI information that is particular to their needs.

The types of news and information that are posted include:

1. New outbreaks in poultry or human cases

2. News stories related to pandemic preparedness

3. New tools and materials, especially for community level work or pandemic preparedness

4. Programs and ideas being implemented by CARE staff

5. Upcoming conferences, events, trainings

I've added it to the list of "Links" on the side.  (And In the process, I've realized headings like "Links" and "News Sources" are far too vague to be helpful, so I hope to reorganize these lists soon.)

Indonesia seeks further assistance from WHO

In a post last week, I predicted that the virus-sharing dispute that has arisen between Indonesia and the WHO, despite some encouraging news, was far from over.  This article from Bloomberg News seems to confirm that suspicion:

 Indonesia is disrupting the 50-year- old system that supplies the world with flu vaccines by demanding compensation from drugmakers GlaxoSmithKline Plc and Novartis AG.                
Siti Fadilah Supari, Indonesia's Health Minister, stopped sending the World Health Organization live viruses taken from birds and humans that scientists use for vaccines in December. Supari said shipments will resume only after the WHO helps Indonesia negotiate free supplies of pandemic-flu shots and money to build vaccine plants, the first-ever such requirement.         

Without the latest versions of the avian-influenza virus, doctors can't produce the most up-to-date vaccines. The WHO said last week it will press companies to meet some of Indonesia's needs. Glaxo Chief Executive officer Jean-Pierre Garnier will meet with WHO director-general Margaret Chan today to discuss the dispute, said Nancy Pekarek, a company spokeswoman for the London-based drugmaker.                

``I cannot tolerate this misuse of our viruses,'' said Triono Soendoro, who runs the flu research for Indonesia's health ministry. His Jakarta lab stores the samples Indonesia says it will withhold until an agreement is brokered.         

Indonesians spend an average of $30 annually on health care, compared with $5,700 in the U.S., according to the World Health Report. Glaxo's flu vaccine costs $6 to $11 a shot in markets around the world, and receiving a flu shot from a doctor can cost as much as $59 in Jakarta.         

....

The WHO is working on an agreement that would cover access to seasonal and avian flu, including the H5N1 virus WHO says has killed at least 170 people since late 2003, mostly in Asia.         

Following a two-day meeting last week with Indonesia, Thailand and other nations hit by avian flu, WHO officials pledged to develop new guidelines regulating how the agency distributes viruses now provided free by poor nations.         

The new rules may require the WHO to disclose for the first time which companies use the viruses to make vaccines, said David Heymann, the agency's assistant director general for communicable diseases, who met with the countries' health officials in Jakarta. WHO also will ask the drugmakers to provide free vaccine for use by poorer countries, Heymann said

[Continue reading at bloomberg.com]

The article goes on to note something that I haven't seen yet in the mainstream press, or by WHO itself, though it's been more or less obvious to people following the news:  The WHO has stopped acknowledging/confirming cases of H5N1 in Indonesia.  On its website, the number of cases and deaths in that country hasn't budged since the last "Situation Update" on January 29. 

Of course, blogs have been closely following local news sources, so we can be pretty confident that the current count, as of April 6, is: 93 cases and 73 deaths. 

It's not clear whether this is because Indonesia has stopped reporting cases to the WHO (at all), or whether the WHO has stopped confirming those reports.  However, we know that the WHO had been providing updates (including reports of 5 deaths) through the end of January, a full month after they stopped receiving viral samples, so clearly it's not impossible for the WHO to confirm deaths from H5N1 without having access to viral samples for each individual case. 

Either way, to me it suggests a severe breakdown in cooperation that goes far beyond the debate about ownership of physical viral samples. 

The Beginning of a Solution?

The news from Jarkarta, according to Reuters and the WHO, seems to be that Indonesia has agreed to resume sending avian flu isolates to the WHO.  According to Minister of Health Siti Fadillah Supari, this will begin "immediately." 

A report in the Wall Street Journal (subscription required), however, adds what seems to be a pretty important qualification:

The compromise, announced at the end of a two-day meeting organized by the WHO in Jakarta, means scientists around the world will be able to study the freshest and potentially most important strains of the avian-influenza virus. However, that access won't be extended to drug companies such as Sanofi-Aventis SA of France and GlaxoSmithKline PLC of Britain, both of which manufacture bird-flu vaccines and need access to new strains of the disease to make sure their products are up-to-date and effective.

This, in short, means the debate is far from over.  As part of the agreement, the WHO will be revising the Terms of Reference for WHO laboratories.  My fingers are crossed, but it seems to me like there's still a lot that could go wrong here.  Lest we think the problem is entirely behind us, MoH Supari remarked, "We trust WHO will not violate our trust, because this is related to the WHO's credibility."  In other words, they've offered to take the first step to break the stalemate in exchange for a pledge from WHO that the status quo will indeed change.  But this first step is clearly a conditional one. 

Some have advanced the entirely foreseeable and quite disastrous long-term consequences of not sharing samples as proof that Indonesia should never have done what it did.  I would disagree--up to a point.  Sadly, barely anyone would have paid attention if Indonesia had simply registered it's complaint without threatening any real consequences. 

While Indonesia has a made a clear case for why the status quo for sharing virus samples is inadequate in the short term, it's also becoming clear (if it wasn't already) that no one's interests--not even Indonesia's--are advanced in the long term if different manufacturers don't have access to new samples. It's impossible for me to envision a solution that would not somehow involve for-profit companies having access to viral isolates.  This makes me wonder how far the current agreement can really go.

It's true that Indonesia is collaborating with one company (Baxter) but their candidate vaccine is a 'whole-cell' vaccine, quite different from those being developed by Sanofi, GSK, and other companies.  Clearly it's prudent to move forward with studies of as many different candidate vaccines, adjuvants, and production technologies as possible (and hence, to supply seed viruses to as many manufacturers as possible). 

I see two reasons for this.  This first relates to global supply: More manufacturers means more vaccine available globally, which I think all can agree is a good thing.  The second relates to safety and efficacy of the vaccines: What if it turned out that Company X's vaccine was unsafe or ineffective (or just less safe or less effective than Company Y's)?  Note: I'm not saying this is the case with Baxter's vaccine.  I'm just saying that bad things can happen, even to good vaccines, as with Chiron's seasonal flu vaccine in 2004. 

 

Global Equity and Intellectual Property

As usual, Indonesia is foremost on my mind these days.  From the Intellectual Property Watch blog, this post by Tove Iren S. Gerhardsen provides an interesting analysis of the current impasse on virus sharing.  Apparently, Indonesia may have a sovereign right to viruses circulating in the country, since the Convention on Biological Diversity (to which Indonesia is a party) protects countries' ownership of genetic material.  They may have a sovereign right to it -- this hasn't exactly been tested.  I've heard someone at the World Bank suggest the same thing.  I'm no expert on intellectual property, so I'll let the IP-Watch post speak for itself:

Indonesian Avian Flu Stance Reveals Potential Weakness in Global System

The Indonesian government’s reluctance to share avian influenza virus samples to help develop a global vaccine for humans has revealed a weakness in the international flu research system related to developing countries’ concern with the impact of intellectual property rights on public health.

Developing countries are concerned that if they supply avian influenza virus samples for free to the international health community under the World Health Organization (WHO) system, the samples will be used to develop patented vaccines targeted to wealthy countries and too expensive for developing countries to purchase. The market for traditional influenza vaccines has been in industrialised countries, so it has been a “north-north process,” a WHO official told Intellectual Property Watch. 

“We are very worried,” an Indonesian official told Intellectual Property Watch, adding that there is an “unfair mechanism” regarding the sharing of samples of viruses. Some manufacturers will use the samples to develop vaccines, but there is no guarantee that poor developing countries such as Indonesia would be provided with the vaccine, as manufacturers’ production capacity is only 40 million, he said, referring to the more than 6 billion people in the world. There is a “high gap in demand and supply,” he said.

Indonesia is the hardest-hit country in terms of human deaths from avian influenza, according to the WHO, which said there has been a total of 277 cases of avian flu in human beings worldwide.

The sharing of virus strains links into another current IP policy issue. The virus samples taken from people affected by H5N1, the most common avian flu virus, also may be considered genetic material to which, according to the Convention on Biological Diversity (CBD), countries have a sovereign right. If others want to use the genetic material to develop a medicine, for example, they would have to ask permission, disclose the source of the material, and share the possible benefit of the outcome with the owners of the genetic material.

But as the CBD is soft law and not legally binding, a number of developing countries are pushing to amend the legally binding World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to include this requirement in patent applications. The relationship between the CBD and TRIPS is one of the most important issues for developing countries in the current round of trade liberalisation negotiations at the WTO, referred to as the Doha Round.

continue reading this post at Intellectual Property Watch....