Biosafety and biosecurity
WHO informally consulted relevant scientific bodies and experts from the human health and animal health laboratory communities. The purpose was to understand their perspectives on the need for further biosafety and biosecurity guidance so as to define the conditions of conduct of further research on the modified H5N1 viruses.
WHO evaluated the following internationally recognized standards that can be applied by national authorities to assist in defining the appropriate conditions for further work on these modified H5N1 viruses:
• International Health Regulations, 2005
• WHO Laboratory Biosafety Manual, 3rd edition, 2004
• WHO Biorisk Management: Laboratory biosecurity guidance, 2006
• WHO Responsible life sciences research for global health security, 2010
• CEN CWA 15793:2011 Laboratory biorisk management
• CEN CWA 16393:2011 Laboratory biorisk management – Guidelines for the implementation of CWA 15793:2008
• Other information, e.g., where applicable, OIE standards, etc.
Given the current understanding of the nature of these modified H5N1 viruses and the requirement under the International Health Regulations (2005) for prevention and control of the international spread of disease, any unintended release of the modified H5N1 viruses from laboratories conducting such research would have the potential for serious global consequences. It is essential that the storage of and research on these materials meet appropriate requirements for biosafety and biosecurity.
Increasing awareness
A comprehensive communications plan focusing on the two H5N1-affected countries and other Member States was launched in March. The primary objectives were to:
• raise awareness and understanding of H5N1 research and its public health value;
• ensure that Member States (particularly H5N1-affected countries) had information to respond to public anxiety about biosafety and biosecurity issues related to these two new laboratory-modified viruses, and the implications of these findings for the risks from naturally occurring H5N1 viruses;
• support the continuation of responsible research and dissemination of results while recognizing the need for appropriate biosafeguards and mechanisms for surveillance.
A WHO web page on H5N1 research was launched, with Frequently Asked Questions for the public and media, access to technical guidance for countries, and outcomes of the February technical consultation.
The Secretariat was also in regular contact with WHO Regional and Country offices to focus on their public communications needs. We continue to confer with governments and other public health partners to assist their risk communications efforts on the topic.
Broader discussions
WHO is planning an international consultation on broader issues highlighted by the debate surrounding the two H5N1 research studies. A discussion engaging multiple stakeholders, including the scientific, public health and security communities, government agencies, international agencies, and the public is envisaged.
The objectives of the meeting are to:
• identify the key issues and concerns around Dual Use Research of Concern (DURC);
• assess gaps in managing DURC;
• discuss innovative mechanisms to address gaps.
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