____________________________________________ High-Level Preparatory (HLP) Meeting for the Regional Committee WHO/SEARO, New Delhi, 29 June – 2 July 2009 Agenda item 5.7 SEA/HLP-Meet/5.7 8 June 2009 FOLLOW-UP ACTION ON PENDING ISSUES AND SELECTED REGIONAL COMMITTEE RESOLUTIONS/DECISIONS FOR THE LAST THREE YEARS: PANDEMIC INFLUENZA PREPAREDNESS: SHARING OF INFLUENZA VIRUSES AND ACCESS TO VACCINES AND OTHER BENEFITS Viruses have been freely shared through WHO Collaborating Centres on Influenza for the purpose of risk assessment and vaccine production. In 2007 Indonesia proposed that sharing of H5N1 avian influenza viruses should be tied to benefits of affordable and available vaccine. This led to a halt in the practice of freely sharing influenza viruses. A number of unsuccessful attempts have been made to resolve this impasse. The last inter-governmental meeting (IGM) was convened before the World Health Assembly, on 16-17, May 2009 in Geneva. The meeting ended with a consensus on most issues, but left data- sharing between laboratories and intellectual property rights on viruses unresolved. The main areas of progress have been in consolidating the system, structure and mechanisms of virus sharing and include the establishment of a traceability mechanism in January 2008 to track all shared H5N1 viruses; an interim system providing full disclosure of information on transfer and movement of virus; establishment of an advisory mechanism by the WHO Director-General to monitor the functioning of the NIC and WHO Collaborating Centres; establishment of an international stockpile of vaccines for H5N1 funded by the Gates Foundation and strengthening surveillance at animal-human interface through collaboration between WHO, FAO, UNICEF and OIE. In addition, two working groups on Standard Material Transfer Agreement (SMTA) and terms of reference for WHO CCs and WHO H5N1 Reference labs were established. The specific policy- related technical issues are: specific clauses of IHR (2005) may need to be modified to ensure compliance with virus sharing; vaccine sharing mechanisms and agreements need to be developed between Member States; benefits must be concrete and, clear and provided to developing countries, especially affected countries; do countries have sovereign right over their biological resources?; epidemiologic data related to influenza burden (both seasonal and novel pandemic influenza) are needed to justify expansion of influenza vaccine production. In addition, there is a need to explore innovative mechanisms for licensing existing or future intellectual property rights and of platforms to promote access to vaccine technology by developing countries and specific financing and funding mechanisms that could be made available to developing countries to purchase vaccine and to ensure adequate funding for needed activities such as rapid vaccine deployment. The attached working paper is submitted to the High-Level Preparatory (HLP) Meeting for its review and recommendations. These recommendations will be submitted to the Sixty-second Session of the Regional Committee for its consideration.
SEA/HLP-Meet/5.7 Background 1. Until recently viruses were freely shared through WHO Collaborating Centres on Influenza and WHO H5 Reference Laboratories for the purpose of risk assessment and vaccine production. However, in 2007 Indonesia proposed that virus sharing for H5N1 avian influenza viruses should be tied to benefits of affordable and available vaccine. This led to a halt in the 50-year practice of freely sharing influenza viruses. 2. A number of unsuccessful attempts have been made to resolve this impasse, starting with the meeting organized in Jakarta in March 2007 by WHO headquarters. The matter was debated in 2007 at the Sixtieth World Health Assembly, and resolution WHA60.28 urged the WHO to address the issue of equitable virus sharing and resulting benefits as a first step an Inter-Disciplinary Working Group (IDWG) met in Singapore in July 2007. After the group failed to reach a consensus, the matter was addressed in a series of Inter-governmental Meetings (IGM) and technical open-ended working group meetings, the last of which was a week-long meeting in December 2008. That meeting ended without resolving critical issues. An informal meeting was held in Norway in March 2009 to discuss further these unresolved issues. The IGM reconvened before the World Health Organization, on 16- 17 May 2009 in Geneva. This meeting ended with a consensus on most issues, but left the issues of data-sharing between laboratories and intellectual property rights on viruses unresolved. 3. There is broad consensus that: • the threat of pandemic influenza continues; • WHO is to actively craft a Pandemic Influenza Preparedness (PIP) Framework for sharing of influenza viruses and ensuring equitable access to effective vaccines and other benefits in order to implement a fairer and more transparent and equitable system; • benefits arising from sharing of H5N1 and other influenza viruses with pandemic potential should be shared with all Member States based on public health risk and need; • global capacity to produce influenza vaccine is limited and that critical time constraints will be faced in developing a pandemic vaccine following isolation of the strain; • An international H5N1 vaccine stockpile is being established. The Secretariat is drawing up rules and procedures for placement and deployment options for the Director-General’s consideration. (IGM/2 Rev.1) • increasing the use and demand of seasonal influenza vaccine will trigger an expansion of manufacturing capacity; • A mechanism for resource mobilization needs to be developed to finance global capacity for manufacturing influenza vaccine particularly for developing countries. 4. The Intergovernmental Meeting on Pandemic Influenza Preparedness (IGM) was convened on 8 December 2008 to establish a framework for the sharing of the viruses and sharing of benefits such as access to vaccines. At this meeting a consensus was reached on the text for virus and benefit sharing… “Recognize that Member States have a commitment to share on an equal footing H5N1 SEA/HLP-Meet/5.7 Page 2 and other influenza viruses of human pandemic potential, considering these as equally important parts of the collective action for global public health”. 5. To date, the main areas of progress have been in consolidating the system, structure and mechanisms of virus sharing and include: • the establishment of a traceability mechanism launched in January 2008 to track all shared H5N1 viruses; • an immediate interim system providing full disclosure of information on transfer and movement of virus; • the establishment of an advisory mechanism by the WHO Director-General to monitor the functioning of the NIC and WHO CC; • establishment of an international stockpile of vaccines for H5N1 funded by the Gates Foundation and, • strengthening surveillance at animal-human interface through collaboration between WHO, FAO,UNICEF and OIE . • To establish two working groups: (1) Standard Material Transfer Agreement (SMTA); (2) Terms of reference for WHO CCs and WHO H5N1 Reference labs 6. It was agreed to further strengthen national laboratory capacity for risk assessment by expanding collaboration with the Global Influenza Surveillance Network, and strengthening the capacity of existing laboratories, upgrade laboratory information systems, as well as national regulatory agencies’ ability to assess and approve vaccines. 7. It was agreed that members of the Global Influenza Surveillance Network and National Influenza Centres will receive annual supplies, without charge, of non-commercial diagnostic test materials and reagents for the identification and characterization of influenza-related biological specimens collected in their country. (IGM/2 Rev.1) 8. There is a consensus in going forward with a framework for virus-sharing and for sharing of benefits such as vaccine. Unresolved issues 9. Disagreement continues on the Standard Material Transfer Agreement (SMTA) and includes issues related to biological materials and how to deal with third party involvement: • If the recipient shares with someone who is not a signatory to the agreement, is the agreement binding with this third party? • If they use the materials for purposes it was not intended, is there any legal recourse? SEA/HLP-Meet/5.7 Page 3 Regional perspective on issues • The lack of an agreement on virus sharing has serious consequences for health security and implications for vaccine development. • It is in the interest of Global Public Health Security and SEAR countries to have a successful solution; no single country is fully prepared for an influenza pandemic. • The current pandemic of influenza A/H1N1 have influenced the discussions due to perceived urgency. • The capacity of laboratories needs to be strengthened in Member States so that each Member State has an established link with a National Influenza Centres in the Region. • Resource mobilization efforts need to be expanded to insure adequate funding for needed activities such as rapid vaccine deployment and access to vaccine. • It is necessary to explore a specific financing and funding mechanism that could be made available to developing countries to purchase vaccine. Specific policy-related technical comments • Specific clauses of IHR (2005) may need to be modified to ensure compliance with virus sharing. • Vaccine sharing mechanisms and agreements need to be developed between Member States. • Benefits must be concrete, clear and provided to developing countries, especially affected countries. • Do countries have a “sovereign right over their biological resources”? • Epidemiologic data and surveillance activities related to influenza burden (both seasonal influenza and novel pandemic influenza) are needed to justify expansion of influenza vaccine production. • There is a need to explore innovative mechanisms for licensing existing or future intellectual property rights and of platforms to promote access to vaccine technology by developing countries. • It is necessary to explore specific financing and funding mechanisms that could be made available to developing countries to purchase vaccine and to ensure adequate funding for needed activities such as rapid vaccine deployment. *****