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«Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits Report by the Open-Ended Working Group of ...»

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SIXTY-FOURTH WORLD HEALTH ASSEMBLY A64/8

5 May 2011

Provisional agenda item 13.1

Pandemic influenza preparedness: sharing of

influenza viruses and access to vaccines

and other benefits

Report by the Open-Ended Working Group of Member States on

Pandemic Influenza Preparedness: sharing of influenza viruses

and access to vaccines and other benefits

The Director-General has the honour to transmit to the Sixty-fourth World Health Assembly the

report of the Open-Ended Working Group of Member States on Pandemic Influenza Preparedness:

sharing of influenza viruses and access to vaccines and other benefits (see Attachment 1); as well as the Pandemic Influenza Preparedness Framework (see Attachment 2). In addition, at the request of the Open-Ended Working Group, a draft resolution is attached (see Attachment 3) for the consideration of the Health Assembly.

A64/8 ATTACHMENT 1 Report of the Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits

1. The Open-Ended Working Group of Member States on Pandemic Influenza Preparedness:

sharing of influenza viruses and access to vaccines and other benefits reconvened in Geneva from 11 to 15 April 2011 and was co-chaired by Ambassador J. Gomez-Camacho (Mexico) and Ambassador B. Angell-Hansen (Norway), with the following vice-chairs: Mr Faiyaz Kazi (Bangladesh), Ms Joanne Hamilton (Canada), Dr Nasr El Sayed1 (Egypt), Dr Masato Mugitani (Japan), Ms Jo Newstead (United Kingdom of Great Britain and Northern Ireland) and Mrs Petronellar Nyagura (Zimbabwe). The session was attended by approximately 80 Member States and one regional economic integration organization.

2. The Open-Ended Working Group reviewed work undertaken during the intersessional period.

An opportunity was also provided to receive inputs from industry and civil society.

3. The outcomes of the meeting are reflected in the attached Pandemic Influenza Preparedness Framework.

4. The Open-Ended Working Group requests the Director-General to submit this report and the Pandemic Influenza Preparedness Framework to the Sixty-fourth World Health Assembly for consideration and adoption and to transmit herewith a draft resolution for the consideration of the Health Assembly.

5. The Open-Ended Working Group strongly recommends that the Sixty-fourth World Health Assembly consider the options regarding the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, contained in brackets in the draft resolution,2 with a view to moving the agreed language into the Pandemic Influenza Preparedness Framework without otherwise re-opening it.

–  –  –

1. PRINCIPLES

2. OBJECTIVE

3. SCOPE

4. DEFINITIONS AND USE OF TERMS

4.1 Pandemic influenza preparedness biological materials or PIP biological materials……………………………………………………………...

4.2 Other technical terms ……………………………………..

4.3 Institutions, organizations and entities

4.4 Other terms

5. PANDEMIC INFLUENZA PREPAREDNESS SYSTEM FOR SHARING OF H5N1

AND OTHER INFLUENZA VIRUSES WITH HUMAN PANDEMIC POTENTIAL....... 11

5.1 General

5.2 Genetic sequence data

5.3 Traceability and reporting mechanisms

5.4 Standard Material Transfer Agreements

–  –  –

6.11 Access to pandemic influenza vaccines

6.12 Tiered pricing

6.13 Technology transfer

6.14 Sustainable and innovative financing mechanisms

–  –  –

ANNEX 1 Standard Material Transfer Agreement 1

ANNEX 2 Standard Material Transfer Agreement 2

ANNEX 3 Advisory Group terms of reference

ANNEX 4 Guiding Principles for the development of terms of reference for current and potential future WHO GISRS laboratories for H5N1 and other human pandemic influenza viruses

ANNEX 5 Terms of reference related to work with pandemic influenza preparedness biological materials

–  –  –

In relation to pandemic influenza preparedness: sharing of influenza viruses and access to vaccines

and other benefits, WHO Member States:

(PP1) Recall World Health Assembly resolution WHA60.28 on pandemic influenza preparedness:

sharing of influenza viruses and access to vaccines and other benefits;

(PP2) Note the continuing risk of an influenza pandemic with potentially devastating health, economic and social impacts, particularly for developing countries which suffer a higher disease burden and are more vulnerable;

(PP3) Recognize that Member States have a commitment to share on an equal footing H5N1 and other influenza viruses of human pandemic potential and the benefits, considering these as equally important parts of the collective action for global public health;

(PP4) This Framework will be guided by the goal of its universal application for the protection of all people of the world from the international spread of disease;





(PP5) Recall the need for rapid, systematic and timely sharing of H5N1 and other influenza viruses with human pandemic potential with WHO Collaborating Centres on Influenza and WHO H5 Reference Laboratories as a contribution to assessment of pandemic risk, development of pandemic vaccines, updating of diagnostic reagents and test kits, and surveillance for resistance to antiviral medicines;

(PP6) Reaffirm obligations of States Parties under the International Health Regulations (2005);

(PP7) Recognize this Framework is to be implemented in a manner consistent with applicable national and international laws, regulations, and obligations;

(PP8) Recognize that the benefits arising from the sharing of H5N1 and other influenza viruses with human pandemic potential should be shared with all Member States based on public health risk and need;

(PP9) Recognize the need for a fair, transparent, equitable and efficient framework for the sharing of H5N1 and other influenza viruses with human pandemic potential and for the 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;

(PP10) Recognize also the WHO leadership and oversight functions over these issues and the need for collaboration with United Nations System Influenza Coordinator and relevant intergovernmental organizations;

(PP11) Recognize the sovereign right of States over their biological resources and the importance of collective action to mitigate public health risks;

(PP12) Recall the global strategy on public health, innovation and intellectual property, adopted in resolution WHA61.21

–  –  –

(PP13) Recall that resolutions WHA60.28 and WHA61.21 recognize that “intellectual property rights do not and should not prevent Member States from taking measures to protect public health” and “that intellectual property rights are an important incentive in the development of new health care products.

However, this incentive alone does not meet the need for the development of new products to fight diseases where the potential paying market is small or uncertain”;

(PP14) Recognize that the commitment to share on an equal footing H5N1 and other influenza viruses of human pandemic potential and the benefits enables WHO Member States and the Director-General to assess the global risk of an influenza pandemic and allows WHO Member States and the Director-General to take actions to reduce the risk of the emergence of a pandemic and to facilitate the development and production of vaccines, diagnostic materials and other pharmaceuticals that can assist in rapidly responding to and containing an emerging pandemic;

(PP15) Acknowledge with serious concern that current global influenza vaccine production capacity remains insufficient to meet anticipated need in a pandemic;

(PP16) Acknowledge with serious concern that the distribution of influenza vaccine manufacturing facilities is inadequate particularly in developing countries and that some Member States can neither develop, produce, afford nor access the vaccines and other benefits;

(PP17) Note the WHO Global pandemic influenza action plan to increase vaccine supply (GAP)1 and its goal of reducing the gap between potential vaccine demand and supply during an influenza pandemic, by expanding the global capacity to produce influenza vaccine, including in developing countries;

(PP18) Recognize the importance of Member States, pharmaceutical manufacturers and other entities with access to relevant technologies in respect of influenza vaccine, diagnostics, and pharmaceuticals making specific efforts to transfer these technologies, skills, knowledge and know-how to countries, particularly developing countries, that do not currently have access to these technologies, skills, knowledge and know-how;

(PP 19) Recognize the need for financing mechanisms that would promote affordability and equitable access to quality influenza vaccines, medicines and technologies by developing countries.

–  –  –

2.1 The objective of the Pandemic Influenza Preparedness Framework is to improve pandemic influenza preparedness and response, and strengthen the protection against the pandemic influenza by improving and strengthening the WHO global influenza surveillance and response system (“WHO GISRS”), with the objective of a fair, transparent, equitable, efficient, effective system for, on an equal

footing:

(i) the sharing of H5N1 and other influenza viruses with human pandemic potential; and 1 Document WHO/CDS/EPR/GIP/2006.1;

http://www.who.int/csr/resources/publications/influenza/CDS_EPR_GIP_2006_1.pdf.

–  –  –

3.1 This Framework applies to the sharing of H5N1 and other influenza viruses with human pandemic potential and the sharing of benefits.

3.2 This Framework does not apply to seasonal influenza viruses or other non-influenza pathogens or biological substances that may be contained in clinical specimens shared under this Framework.

–  –  –

For the purpose of this Framework, the following terms have the meanings assigned to them below.

4.1 Pandemic influenza preparedness biological materials or PIP biological materials “PIP biological materials1”, for the purposes of this Framework (and its annexed Standard Material Transfer Agreements (SMTAs) and terms of reference (TORs)) and the Influenza Virus Tracking Mechanism (IVTM), includes human clinical specimens,2 virus isolates of wild type human H5N1 and other influenza viruses with human pandemic potential; and modified viruses prepared from H5N1 and/or other influenza viruses with human pandemic potential developed by WHO GISRS laboratories, these being candidate vaccine viruses generated by reverse genetics and/or high growth re-assortment.

Also included in “PIP biological materials” are RNA extracted from wild-type H5N1 and other human influenza viruses with human pandemic potential and cDNA that encompass the entire coding region of one or more viral genes.1

4.2 Other technical terms “Genetic sequences” means the order of nucleotides found in a molecule of DNA or RNA. They contain the genetic information that determines the biological characteristics of an organism or a virus.

“Reference reagents” are biological or chemical substances or organisms and parts thereof used in diagnostic or surveillance activities. They are rigorously characterized and shown to be suitable for use as standards in order to compare and validate results of analyses obtained in different laboratories.

1 OPERATIONAL EXEMPTION: materials shared within the WHO GISRS or with other laboratories specifically for non-commercial public health uses including surveillance activities, diagnostic applications, and quality assurance, are not handled as PIP Biological Materials. Their onward transfer for purposes other than those specified in the terms of reference of National Influenza Centres, WHO Collaborating Centres, Essential Regulatory Laboratories and H5 Reference Laboratories is not allowed under this operational exemption.

2 The definition for this term has been provided.

8 A64/8

“Reference reagents for potency determination of vaccines/vaccine potency reagents” means reagents used by vaccine manufacturers and regulatory laboratories for the purpose of testing and standardizing the potency of vaccines against H5N1 and other influenza viruses with human pandemic potential.

“Influenza virus with human pandemic potential” designates any wild-type influenza virus that has been found to infect humans and that has a haemagglutinin antigen that is distinct from those in seasonal influenza viruses so as to indicate that the virus has potential to be associated with pandemic spread within human populations with reference to the International Health Regulations (2005) for defining characteristics.

“Pandemic influenza preparedness vaccine virus” or “PIP vaccine virus” connotes any high-growth reassortant virus or any influenza reference virus, WHO-recommended influenza virus for vaccine use or other influenza virus material generated, including by new and emerging technologies, from H5N1 or other influenza virus with human pandemic potential that is provided to influenza vaccine manufacturers for the purposes of developing a prototype pandemic, pre-pandemic, pandemic or other influenza vaccine.

“Clinical specimens” means materials taken from humans or animals, in as far as the samples taken from animals are shared by originating countries/laboratories with the WHO GISRS. These include specimens collected from the respiratory tract (for example, swabs and aspirated fluid), and also blood, serum, plasma, faeces, and tissues, for diagnostic purposes, detection of pathogens and further characterization, study or analysis.



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