BACK TO MAIN  |  ONLINE BOOKSTORE  |  HOW TO ORDER

WHA avian flu decision links sharing of virus and benefits

Geneva, 24 May (Sangeeta Shashikant) -- The World Health Assembly has adopted a resolution on pandemic influenza which links the sharing of influenza viruses by countries affected by the avian flu outbreak, to the access of developing countries to vaccines and other benefits.

The resolution was the product of more than a week of hard negotiations following criticisms by countries that have contributed influenza viruses that their viruses had been commercialized without their knowledge or permission.

They had also expressed concern that the developing countries had not received any benefits and would face shortages of vaccines if a pandemic occurs due to high vaccine prices and their inability to make advance purchases, unlike the developed countries.

Many developing countries, coordinated by Indonesia, had put forward a draft resolution seeking a linkage between virus sharing and the sharing of vaccines and other health products as well as other benefits such technology transfer to enable local vaccine production.

The final resolution adopted at the end of the WHA on 23 May recognized this linkage in the title itself, which was "Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits."

A major part of the resolution is its outlining of processes for agreeing to terms and conditions for sharing of viruses between the originating countries, WHO Collaborating Centres and third parties, as well as for ensuring resulting fair and equitable sharing of benefits.

This resolution signals the view by many members that the current practices of the WHO Global Influenza Surveillance Network (GISN) do not bring about fair results, and that these practices need to be overhauled with transparent mechanisms to be put in place for fair and equitable benefits resulting from the use of the viruses.

The resolution requests the WHO Director General to convene an interdisciplinary working group (IDG) to "revise the terms of reference of the WHO Collaborating Centres, H5 Reference Laboratories and national influenza centres; devise oversight mechanisms; formulate draft standard terms and conditions for sharing viruses between originating countries, WHO Collaborating Centres and between the WHO Collaborating Centres and third parties; and to review all relevant documents for sharing influenza viruses and sequence data..."

The Director General (DG) is to identify and propose in close consultation with Member States, frameworks and mechanisms that aim to ensure fair and equitable sharing of benefits, taking strongly into consideration the specific needs of developing countries.

The resolution also calls on the DG to establish an international stockpile of vaccines for flu viruses of pandemic potential for use of countries in need; and to formulate mechanisms and guidelines for fair and equitable distribution of pandemic influenza vaccines at affordable prices in the event of a pandemic.

An expert report on patent issues related to influenza viruses and its genes is also to be commissioned by the DG.

The resolution also asks the DG to convene an intergovernmental meeting to consider the report of the inter-disciplinary working group as well as the reports of the DG (on her efforts to propose benefit-sharing frameworks and mechanisms; vaccine stockpiling; equitable distribution of vaccines; and the report on patents).

The meeting is to be open to all Member States and regional economic integration organisations, with the outcomes reported to the 61st World Health Assembly through the Executive Board.

The resolution is the result of a week of tense negotiations in a drafting group convened following general debate on the matter.

Five days after the negotiations began, member states were still deadlocked over thecontent of the resolution. Finally, two days before the close of the Assembly, Members entered into a "marathon" negotiation to come up with a resolution.

During the negotiations, there were attempts to downplay the role or rights of countries contributing the viruses. Some of the proposals tried to distinguish between "wild viruses" and "vaccine virus" although no such distinction exists in any of the WHO documents. Some countries counter-argued that without the wild virus there would be no vaccine virus. The attempts to make this distinction were not successful.

There was also a refusal on the part of the US to include in the resolution any language that gives "ownership" or "rights" to contributing countries over the viruses contributed, according to some diplomats. Indonesia and other developing countries wanted the principles of sovereign right over biological resources, prior informed consent and benefit sharing included as principles.

In the end this was resolved by including in the preamble, "Recognizing the sovereign right of States over their biological resources".

This language is from the Convention on Biological Diversity which defines "biological resources" as including "genetic resources, organisms or parts thereof, populations, or any other biotic component of ecosystems with actual or potential use or value for humanity". Almost all WHO member states are also members of the CBD.

The US objected also to the term "prior informed consent" although all other delegations could accept the term "prior consent". This led to a deadlock in the negotiations, in the final stages of the negotiations, leading to the Chair, Dr. Viroj Tangcharoensathien from Thailand, reportedly threatening to resign from the Chairmanship. Prior informed consent is a concept from the CBD that is well known when dealing with biological materials.

The refusal of the US was seen by many as a practice of double standards, with wanting countries of origin to give up their right to ownership and consent through the free sharing of viruses, while asserting and maintaining the intellectual property rights of its vaccine manufacturers.

On benefit sharing, Indonesia explained in the negotiations on behalf of more than 20 of its co-sponsors that it wants benefits for all developing countries, and not to accrue only to countries contributing the viruses.

It explained through a power point presentation that it was interested in sharing viruses, as part of a package that resulted in a win-win situation for all. It said that while it was willing to place its virus in the public domain, the developed countries should also allow access to the vaccines and other medical products (produced through the use of the viruses and parts thereof), transfer of technology and know-how and the involvement of scientists from developing countries in the research, development and production of vaccines and other medical products.

Indonesia on behalf of its co-sponsors said that the current system required free virus sharing which are within the control of developing countries but not free sharing of treatments and technologies which are within the control of developed countries and often protected by intellectual property rights.

The final resolution does not elaborate on benefit sharing but leaves it to the DG to identify and propose appropriate mechanisms for this.

It however does ask the DG to establish an international stockpiling of vaccines for H5N1 or other influenza viruses of pandemic potential as appropriate.

It also requests the DG to formulate mechanisms and guidelines in close consultations with Member states aimed at ensuring fair and equitable distribution of pandemic influenza vaccines at affordable prices in the event of a pandemic in order to ensure timely availability of such vaccines.

Some experts remarked that there is limited value of these proposals to protect public health particularly in developing countries in the event of a pandemic.

A global stockpile of even large quantities such as 100 million doses may not satisfy the needs of countries such as Indonesia, China, Vietnam and even Thailand, due to the large sizes of their population.

These countries require the capacity to manufacture vaccines in large quantities, to meet their large needs. However, to build this capacity requires the transfer of know-how and technology, much of which may be patented.

Several developing countries were positive about the resolution in that it implicitly recognises that the current system (i. e. sharing of viruses without any concrete resulting benefits to countries contributing the viruses) is unfair, unsustainable and needs to be revised.

According to a diplomat, the WHA and the WHO have recognised for the first time the need for "fair and equitable benefits" to be returned to those countries that share viruses and other developing countries and this in itself is a victory.

According to some diplomats involved in the negotiations, the US, often supported by several other developed countries, were hesitant to share any "benefits" arising from the use of the viruses that were contributed.

At one stage, the US called the sharing of benefits "hypothetical", preferring the use of diluted language such as "to promote" sharing of benefits. This was not acceptable to other participants in the negotiations.

The language now reads "to ensure" fair and equitable sharing of benefits.

While Member States generally saw this resolution as a good first step forward, the US delegation soured the outcome with a statement riddled with inaccuracies and contradictions delivered by the Assistant Secretary for Health Dr. John O. Agwunobi prior to the adoption of the resolution at the plenary.

The US stated that nations have a responsibility under the revised International Health Regulations (IHRs) to share data and virus samples on a timely basis and without preconditions and that under the resolution Members "must continue to share specimens and viruses with WHO Collaborating Centres" and that its understanding was that "response activities include the development and production of pandemic-influenza vaccines".

Part of the US statement is inaccurate as there is nothing in the IHR that obliges members to share virus samples. It is also not clear what is the basis for its assertion that "response activities include development and production of pandemic influenza vaccines".

The US statement also revealed double standards. It acknowledged each State's sovereign rights over its biological resources but favoured free sharing of viruses in view of the potential of a global pandemic.

Immediately following this strong statement, it then spoke of intellectual property rights and how the DG should collaborate closely with other international organizations with expertise in intellectual property rights, particularly the World Intellectual Property Organization and the World Trade Organization, to address any issues related to intellectual property rights that could arise in the context of the Global Influenza Surveillance Network, although there is nothing in the Resolution that requires the WHO to work with the WIPO or WTO.

Intellectual property rights are "exclusive rights" that are a barrier to others having access to technologies and the medical products themselves.

In the preamble, the Resolution recognized "the sovereign right of States over their biological resources". This language is derived from the Convention on Biological Diversity (CBD), thus the resolution implicitly recognizes the relevance of this international convention.

The resolution also recognised that "intellectual property rights do not and should not prevent Member States from taking measures to protect public health".

It further recognised international sharing of viruses as a "contribution" by countries and stressed 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".

On the morning of the adoption of the resolution, following the negotiations, an additional preamble paragraph was included at the last moment, that noted a document prepared by the Secretariat i. e. on a WHO Global Pandemic Influenza Action plan to increase vaccine supply, although this document was not the subject of debate during the week-long negotiation.

In the operative paragraphs, the resolution urged Member States 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" 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".

The Resolution also required Member States "to support WHO, as appropriate in order to identify and implement mechanisms in relation to fair and equitable benefit sharing."

The Resolution required the DG 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:

-- innovative financing mechanisms to facilitate timely and affordable procurement of pandemic vaccines for and by Member States in need;

-- access to influenza-vaccine viruses developed by WHO collaborating centres for the production of vaccines by all influenza-vaccine manufacturers, particularly in developing countries;

-- in times of public health emergencies of international concern, full access of all influenza-vaccine manufacturers to pandemic influenza-vaccine viruses developed by WHO collaborating centres for the production of pandemic influenza vaccines;

-- facilitation of acquisition by developing countries of capacity for manufacturing in country influenza vaccine; technical assistance to developing countries to enhance local research and surveillance capacity, including staff training, with the objective of assuring work on influenza viruses at national and regional levels;

-- upon request, provision of support to Member States, especially developing and affected countries, to improve their capacity to establish and strengthen testing capacity for H5 and other influenza viruses, including identification and characterization, and to establish and strengthen their capacity to meet WHO requirements for becoming a reference laboratory or Collaborating Centre, if desired.

The Resolution also requested the DG to "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".

It requested the DG to formulate "mechanisms and guidelines, in close consultation with Member States, aimed at ensuring fair and equitable distribution of pandemic-influenza vaccines at affordable prices in the event of a pandemic in order to ensure timely availability of such vaccines to Member States in need".

It further requested the DG to "to convene an interdisciplinary working group to revise the terms of reference of WHO Collaborating Centres, H5 Reference Laboratories, and national influenza centres, devise oversight mechanisms, formulate draft standard terms and conditions for sharing viruses between originating countries and WHO Collaborating Centres, between the latter and third parties, and to review all relevant documents for sharing influenza viruses and sequencing data".

According to the Resolution, this revision will take place based on mutual trust, transparency, and overriding principles such as:

(a) timely sharing of viruses within the Global Influenza Surveillance Network;

(b) application of the same standard terms and conditions to all transactions, as appropriate;

( c) timely consultation and sharing of information with originating countries, especially on use outside the Network;

(d) that for any use of influenza viruses outside the scope of the terms of reference of WHO Collaborating Centres, H5 Reference Laboratories, and national influenza centres submission of a request directly to the relevant national influenza centre or other originating laboratory of the country where the virus was collected and require appropriate response from the national influenza centre; such requests would be bilateral activities not requiring the intervention of WHO;

(e) recognition and respect of the crucial and fundamental role and contribution of countries in providing viruses for the Global Influenza Surveillance Network;

(f) increased involvement, participation and recognition of contribution of scientists from originating country in research related to viruses and specimens;

(g) attribution of the work and increased co-authorship of scientists from originating countries in scientific publications; and

(h) due consideration of relevant national and international laws.

The term "overriding principles such as" was a last minute inclusion prior to the adoption of the Resolution in the Committee discussing the resolution. It replaced the term "following high level principles such as". It is not clear who initiated this change on a document that was the subject of a tense negotiations for 8 days preceding its adoption.

Several other language changes were also made by the WHO Secretariat on other areas on the document as it worked to prepare a formal document for adoption. However, these changes were not objected to by member states, although it is unclear why these changes were made and the implications of these changes.

The Resolution also requests the DG to "assure a membership of the interdisciplinary working group consisting of four Member States from each of the six WHO regions, taking into account balanced representation between developed and developing countries and including both experts and policy makers."

The DG is also expected to commission an expert report on the patent issues related to influenza viruses and its genes.

The DG's report on benefit sharing and stockpiling, as well as fair and equal distribution of pandemic vaccines, the outcome of the Inter-disciplinary Working Group and the expert report on patent issues will then be provided as inputs into an intergovernmental meeting that shall be open to all Member States and regional economic integration organizations.

In a surprising move, the US objected to other participants including non-governmental and intergovernmental organisations participating as observers in the process.

The intergovernmental meeting is to report on the progress on implementation of the Resolution, including the work of the intergovernmental meeting to the 61st World Health Assembly.

 


BACK TO MAIN  |  ONLINE BOOKSTORE  |  HOW TO ORDER