15 November 2007

Joint NGO Statement on Influenza Virus Sharing

As you may know the issue of sharing of avian flu virus and sharing of benefits from the use of virus (especially access to affordable vaccines) has been a very hot issue especially at the World Health Assembly (WHA) in May.

The WHA mandated that an inter-governmental meeting (all countries invited to attend) be held to discuss a reform of the whole global influenza network system (now operating under WHO). It will meet in Geneva on 20-23 November.

Several developing countries have been sharing influenza viruses particularly H5N1 viruses with some WHO designated labs based in US, Aust. UK, and Japan. These viruses were shared outside the network with companies for the development of vaccines, without permission from the originating country, in violation of WHO's own 2005 guidance that does not allow the sharing of viruses outside the network unless with the permission of the country providing the viruses. Several of these viruses are used in vaccines which are sold at high prices to developing countries which definitely cannot afford these vaccines. These limited vaccines are also patented by companies and stockpiled by several developed countries in preparation for a pandemic.

As a result, several developing countries have slowed the sharing of influenza viruses. A draft resolution was presented at the WHA by over 20 countries leading to Resolution WHA 60.28. [For more background information and news please see
http://www.twnside.org.sg/avian.flu_main.htm]

Some developing countries are now considering what should be proposed in terms of establishing a system which will give public health benefits such as vaccines, technology transfer so that poorer countries can also produce their own vaccines, stockpile of pandemic influenza vaccines etc.

Below is a draft of a joint CSO statement. We urge you to read it and if you agree with it, please sign on to it. We will then convey the statement to the media as well as to the delegations that are coming to the meeting on 20-23 Nov.

Please send your response to Sangeeta of TWN at her email address –
ssangeeta@myjaring.net

Please also send this on to other groups that you think may be interested.


With best wishes,
Martin Khor
Third World Network
Malaysia

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JOINT CIVIL SOCIETY STATEMENT

WHO Meeting on Influenza Virus Sharing and Benefit Sharing Should Establish New Framework To Ensure Developing Countries’ Access to Influenza Vaccines and Technology

We the civil society organisations listed below are concerned about the present imbalanced system on influenza in which countries are asked to contribute viruses to the WHO global influenza system but in which the developing countries are not assured they can have access to vaccines and other health products required to deal with the problem of influenza.

In particular we are concerned that: (1) many patent applications have been filed for influenza viruses or their parts and vaccines (and methods to produce them), which can increase the problems of access to vaccines for developing countries; and (2) in the event of a breakout of pandemic influenza (which experts fear has the potential to cause many millions of deaths) there is no assurance that countries in greatest need will have access to vaccines or treatment due to high prices and lack of supplies especially in developing countries.

We are encouraged that the World Health Assembly in its May 2007 session decided to deal with these problems by establishing an inter-governmental meeting to discuss the sharing of viruses and the sharing of benefits.

We call on Member States of the World Health Organisation (WHO) meeting at the Intergovernmental Meeting in Geneva on 20-23rd November to establish a fair and equitable framework that ensures that developing countries have timely access to adequate and affordable vaccines, diagnostics and other medical products, and that they have immediate access to all the tools and knowledge needed for local production of vaccines and anti-virals, which are required for them to prepare for a possible pandemic.

The framework must not put commercial interests and profits before public health and must ensure that developing countries’ needs and interests are reflected and prioritized.

The framework must also prevent the misappropriation of biological resources. For a long time, countries have been contributing influenza viruses to laboratories from developed countries designated by WHO, which then in turn pass on the viruses and/or parts of it contained in vaccine seed viruses to companies without the permission of the contributing country, in violation of the WHO March 2005 Guidance.

In fact, several companies/institutions including a WHO designated laboratory are seeking patents on viruses, parts of the viruses and on products derived from the influenza viruses such as vaccines. These companies and institutions see this as an occasion to obtain patents and extra profits, and there has been a rapid increase in patenting activity related to avian influenza,

Developing countries cannot afford the expensive vaccines especially if entire or major parts of the populations have to be vaccinated.

Availability of vaccines in a timely manner and in sufficient quantities is also a major problem in the event of a pandemic as current global supply capacity is only at about 500 million doses, much less than potential demand of the billions of doses needed. Thus acute shortages particularly in the developing world are foreseen as developed countries having financial and other resources are already booking in advance treatments including vaccines for pre-pandemic and pandemic use.

The ability to locally and/or regionally produce adequate vaccines is a critical element in any pandemic preparedness. However many of the technologies and the know-how needed to develop and produce vaccines are also either protected by proprietary rights and/or not easily accessible to developing countries.

The current framework favours industry and the developed countries that have the financial resources to build up stockpiles of pre-pandemic vaccines and to purchase in advance pandemic vaccines.

According to WHO the world is presently at a phase 3 pandemic alert (out of 6 phases) and is now closer to another influenza pandemic than at any time since 1968.

In the event of a global pandemic, it is likely to be 'each country for itself', with those countries that have stockpiled vaccines being reluctant to share their stockpile of vaccines with other countries. An international stockpile would also have limited use. Developing countries including countries that have contributed their viruses are likely to face an acute shortage of badly-needed vaccines and medical products.

This issue reflects current inequities in the global health system.

We call on WHO Member States to take immediate action to correct the situation.

Our action proposals:

1. We call on WHO Member States to establish a new, fair and equitable framework on influenza viruses and sharing of benefits arising from the utilization of the influenza viruses.

2. The priority of the framework should be to meet public health needs, particularly that of developing countries. The framework should:

(a) recognise the principles of national sovereignty over biological resources, prior informed consent, and fair and equitable sharing of benefits arising from the utilization of the viruses (and parts thereof such as sequence data). Benefit-sharing has to be specific and mandatory to enable adequate benefits to developing countries as the core of the framework.

(b) ensure that institutions and companies receiving the viruses or products containing parts of the viruses are required to adhere to ethical and equitable conditions, including the sharing of benefits to developing countries and to those that contribute their viruses in line with their health needs.

(c) ensure that the WHO designated laboratories, companies and other institutions do not patent the viruses or parts thereof such as the gene sequences and derived products (e.g. vaccines). This is especially since the potential influenza pandemic represents an international public health threat of major and possibly catastrophic proportions and this requires public health needs to be given highest priority.

(d) ensure that an adequate portion of the limited global supply of vaccines are set aside for WHO-organised international/regional stockpiles for the use of developing countries and made available on the basis of need and either free or at an affordable cost.

(e) Ensure that developing countries that (in addition to the supplies in the WHO stockpile) wish to purchase vaccines should have access to these at an affordable price;

(f) establish systems by which scarce vaccines/anti-virals can be produced, stocked and distributed according to the principles of public health needs (where and when they are needed) and not according to financial, technological capacity and power (i.e. vaccines channelled to those who can pay for them).

(g) oblige developed country governments and the private sector to share technologies and know-how (in relation to influenza-related vaccines and other health products) with developing countries and provide the necessary capacity building in order to promote local/regional pharmaceutical R and production activities in developing countries, including by not-for-profit and public-owned organizations.

(h) Take concrete measures to build capacity in developing countries and their regions on activities needed for influenza risk assessment (.e.g identifying viral shift, drift or mutations) and risk response (preparedness for influenza epidemic/pandemic including developing seed viruses, diagnostic test kits); at present such capacity exists mostly in developed countries.

3. Developing countries should be assisted to build the capacity of their public health system to ensure an effective delivery of health services in the event of a pandemic.