research policy and management of risks in life sciences ...scientific working group’s...

EPIDEMIC AND PANDEMICALERT AND RESPONSE

Research policy and managementResearch policy and managementResearch policy and managementResearch policy and managementResearch policy and managementof risks in life sciences research forof risks in life sciences research forof risks in life sciences research forof risks in life sciences research forof risks in life sciences research forglobal health securityglobal health securityglobal health securityglobal health securityglobal health security

Report of the meeting

Bangkok, Thailand10–12 December 2007

WHO/HSE/EPR/2008.4

Research policy and managementResearch policy and managementResearch policy and managementResearch policy and managementResearch policy and managementof risks in life sciences research forof risks in life sciences research forof risks in life sciences research forof risks in life sciences research forof risks in life sciences research forglobal health securityglobal health securityglobal health securityglobal health securityglobal health security

Report of the meeting

Bangkok, Thailand10–12 December 2007

© World Health Organization 2008

All rights reserved.

The designations employed and the presentation of the material in this publication do not imply theexpression of any opinion whatsoever on the part of the World Health Organization concerning the legalstatus of any country, territory, city or area or of its authorities, or concerning the delimitation of itsfrontiers or boundaries. Dotted lines on maps represent approximate border lines for which there maynot yet be full agreement.

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This publication contains the collective views of an international group of experts and does notnecessarily represent the decisions or the stated policy of the World Health Organization.

Research Policy and Management of Risks in Life Sciences Research for Global Health Security Bangkok, Thailand, 10–12 December 2007

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Contents

Foreword ............................................................................................................. 2 I. Introduction...................................................................................................... 3 II. Recommendations for action.......................................................................... 4 III. Biorisk reduction framework ........................................................................ 5 IV. Managing the risks posed by life science research....................................... 7 V. Summary of country perspectives................................................................ 10 VI. Country needs and priorities ....................................................................... 11 References ......................................................................................................... 14 Annex 1: agenda................................................................................................ 15 Annex 2: list of participants .............................................................................. 17


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Foreword This meeting report summarizes the recommendations, presentations and discussions made at the meeting on Research Policy and Management of Risks in Life Sciences Research, held in Bangkok, Thailand, on 10-12 December 2007. The selection of countries was made in collaboration with the WHO Regional Office for South-East Asia and the WHO Regional Office for the Western Pacific. Participants included representatives of public health authorities, national institutes of public health and national public health laboratories. Scientists, research policy experts and ethicists from international organizations, academia, nongovernmental organizations (NGOs) and WHO participated as facilitators. This meeting report is part of the "Life science research and development and global health security" project. The project is aimed at raising awareness among WHO Member States about the potential implications of life science research and development (R&D) for global health security. It underlines the importance of carrying out life science R&D for improving the health of all people, as well as the potential risks linked with life science R&D. Such risks and opportunities should be assessed from a public health perspective. As part of this project, a scientific working group met in Geneva, 16–18 October 2006. Its report highlights five areas for action: education and training; preparedness for a possible major outbreak of disease; development of risk assessment methodologies; engagement of all stakeholders in the life science community and guidelines for oversight; and capacity building at country level, including ethics, clinical practice, laboratories and research (1). The Bangkok meeting, other regional activities and an online consultation process that began in June 2007 are all aimed at raising awareness of these issues, gathering feedback on the scientific working group’s recommendations and seeking input into the development of guidance and training materials. The project, which is contributing to the implementation of the World Health Assembly resolution WHA55.16 of 18 May 2002,1 is the follow-up to an exploratory phase that concluded in 2005 with the publication of a working paper (2). The project is being implemented by the department of Epidemic and Pandemic Alert and Response in close collaboration with three other departments: Research Policy and Cooperation; the Special Programme for Research and Training in Tropical Diseases; and Ethics, Trade, Human Rights and Health Law.

1 http://www.who.int/gb/ebwha/pdf_files/WHA55/ewha5516.pdf


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I. Introduction Human, national and international health and security interests are inextricably linked when fighting transnational infectious diseases – whatever their origin or source. SARS and avian influenza have demonstrated the threat infectious diseases pose to public health, economic growth and security and reminded the world of the need for strong national public health systems for prevention, surveillance and response. WHO advocates for countries to be better prepared to meet these challenges. The WHO Regional Offices for South-East Asia and the Western Pacific have defined a road map – the Asia Pacific Strategy for Emerging Diseases – for countries to strengthen their core capacities for effective preparedness. This is an important step in fulfilling the requirements set by the revised International Health Regulations (IHR 2005) (3). Life science research offers unprecedented opportunities in the fight against emerging infectious diseases, including the possibility of new tools and interventions for early detection, prevention and response. Much more is expected from life science research in terms of improving many other aspects of human health and well-being, agriculture, animal health, animal production and overall economic development. However, along with all the opportunities that life science research has to offer, it also carries some potential risks. These risks are related to unintended consequences or potential misuse of life science research – which is sometimes referred to as “dual use” research. Because of these risks, life science research requires strict adherence to laboratory biosafety and laboratory biosecurity standards. In addition, life science research needs to be guided by research policies and strategies and informed by ethical considerations as well as national and international norms and standards. In order to safeguard the benefits of life science research, the public health and scientific communities need to be aware of its potential risks and involved in the development and implementation of policies and strategies aimed at managing these risks. The Bangkok meeting brought together representatives from several countries in the Asia Pacific region as well as several experts in managing the risks of life science research (see Annexes 1 and 2 for the agenda and list of participants). Dr Vichai Chokevivat from the Ministry of Public Health of Thailand chaired the event on the first and third day and Professor Raymond Lin Tzer Pin from the Ministry of Health of Singapore chaired the meeting on the second day. Dr Virginia Hope from the Institute of Environmental Science & Research Limited in New Zealand was the rapporteur of the meeting. The objectives of the meeting were to:

• provide countries with an enhanced understanding of the public health risks posed by the advances of life science research and of their risk management options;

• exchange knowledge and experience of policies and best practices related to the risks posed by life science research; and

• identify the needs and priorities of countries and draft recommendations of research policy and management for further action.


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II. Recommendations for action Representatives from the participating countries agreed to the following recommendations. WHO actions: 1. Raise awareness among all stakeholders (policy-makers, scientists, public health and

security communities, industry, education and science institutions, ministries of foreign affairs, agriculture, environment and defence, NGOs, the media and the public) on “dual use”1 issues through national and regional workshops and seminars and in international fora. Advocate for increased funding to support these activities.

2. Provide technical support, including expert scientific advice, to strengthen laboratory

biosafety and laboratory biosecurity. Develop guidelines for risk assessment and the management of dual use research, including its social and ethical implications. Build on existing mechanisms such as biosafety guidelines, ethical review bodies and accreditation processes (for example, ISO 15189, which includes some safety and ethical considerations).

3. Support laboratory infrastructure and capacity building for research, including training

material and tools, specialized training programmes and fellowships, and networking and collaboration with other international organizations and actors including the Global Outbreak Alert and Response Network (GOARN).

4. Facilitate local and regional networking and north-south and south-south collaboration

between scientists, laboratories and research institutions and between different sectors. 5. Create mechanisms for sharing information on life science research programmes and

findings; promote transparency and openness on research programmes and activities. 6. Provide tools and support in such a way that they can be tailored to help countries to

develop or strengthen research policies and strategies and related laws according to their needs and priorities.

Country actions:

1. Develop, implement and monitor regulation, legislation, guidelines and standard operating procedures for laboratory biosafety, for laboratory biosecurity, and for assessing and managing the risks of dual use life science research. These tools should be in line with international guidelines and standards; built on existing regulations for laboratory safety and security, accreditation, etc; adequately funded and monitored; consistent with national research policies; and applied across all agencies involved in life science research.

2. Provide adequate financial resources to 1) develop and maintain laboratory

infrastructure 2) fund research activities and 3) strengthen human resources for research, including training programmes in laboratory biosafety, laboratory biosecurity, and the management of the risks of dual use life science research.

1 “Knowledge and technologies that result from life science research used for legitimate research and technology

development may also be appropriated for illegitimate intentions and applications”. Scientific working group on life science research and global health security. Report of the First Meeting. Geneva, Switzerland, 16-18 October 2006. World Health Organization (WHO/CDS/EPR/2007.4).


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3. Raise awareness among all stakeholders at the country level and bring the implications of dual use life science research for public health to the attention of international fora, including the World Health Assembly, for appropriate action.

4. Promote information exchange and laboratory networks and foster dialogue among

stakeholders in different sectors and agencies at country level (agriculture, industry, environment, defence, etc).

III. Biorisk reduction framework The biorisk spectrum includes naturally occurring infectious diseases, laboratory accidents and deliberate misuse of dangerous pathogens. The dangers are real: from 2001 to 2007, WHO verified more than 1 000 events fulfilling the criteria of a “public health emergency of international concern”, most of which were naturally occurring. In 2007, global health security was the topic of the World Health Report and World Health Day (4). The main messages were that collective responsibility calls for collaborative action in order to address these global risks and that IHR (2005) is the international framework for managing the risks to global health security. The main conclusions and recommendations of the World Health Report included, among others: full implementation of IHR (2005) by all countries; sharing of knowledge, technologies and materials, including viruses and other laboratory samples, necessary to optimize global public health security; and building and enhancing of laboratory capacity. IHR (2005) are legally binding regulations to “prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade” (5). “Disease” means an illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans. A great deal of work needs to be done in almost all countries in the Asia Pacific region in order for IHR (2005) to be fully implemented. A first step is to raise awareness of IHR (2005) by briefing staff at all levels and in all sectors. More resources are needed but it is also important to make the best use of available resources. Other priority areas include: health facility planning for mass casualties from a dangerous pathogen; surveillance and rapid response systems and referral arrangements; a regional laboratory network for emerging infectious diseases; laboratory biosafety and laboratory biosecurity programmes, including surveillance of laboratory-acquired infections; and transport of infectious materials, including national guidelines. The Asia Pacific Strategy for Emerging Diseases (APSED) is addressing many of these concerns. APSED’s objectives are to 1) reduce the risk of emerging diseases 2) strengthen early detection of outbreaks 3) strengthen early response 4) strengthen preparedness and 5) develop sustainable technical collaboration within the Asia Pacific region (6). Its workplan is a five-year stepwise approach to achieve the minimum surveillance and response core capacity requirements of IHR (2005) in all countries by 2010. The Global Outbreak Alert and Response Network (GOARN), which is coordinated by WHO, is recognized as the operational arm of IHR (2005). It is a partnership of more than 150 public health institutions and networks providing rapid, international, multi-disciplinary support for


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outbreak response (7). GOARN assists countries with disease control efforts by ensuring rapid and appropriate technical support to affected populations. It supports national efforts to investigate and respond to events and assesses risks of rapidly emerging epidemic disease threats. National capacity is central to the biorisk reduction framework. This is because the best way to prevent the international spread of diseases is to detect public health risks early and implement effective response actions when the problem is small. This requires capacity in two areas: 1) early detection of unusual disease events by effective national surveillance and 2) coordinated systems to ensure response at all levels: local, regional, national and, when necessary, international. Addressing the opportunities and risks of life science research for global health security is an important component of the biorisk reduction framework. Around the world, the number of people working with biological agents and pathogenic microorganisms is increasing, national laboratory capacity for preparedness and response is expanding, and more and more biological agents and pathogens are being transported between countries. It was noted that any country engaging in this type of work has an ethical responsibility to adhere to laboratory biosafety and laboratory biosecurity procedures, to instil a culture of responsible biomedical research, and to address the dual use dilemma. The risks posed by life science research – whether accidental or deliberate misapplication – have important legal, ethical, security and public health implications. It also requires an understanding of who and what is at risk, that is, researchers, research itself, communities, the environment and/or the economy. Biorisk reduction takes place at international, regional, national and institutional levels. In addition, it involves a diverse array of actors: national academies, scientific associations, public health agencies, laboratories, publishers, private sector, funders, security communities and the public. There are already existing frameworks that cover ethics, research policy, laboratory biosafety and laboratory biosecurity and different risk management options. In collaboration with Member States, WHO’s "Life science research and development and global health security" project is exploring these options. The matrix on the following page is aimed at helping Member States collect information on the different frameworks in order to map what already exists and what might be needed at the country level. The supportive activities (such as training, raising awareness, education, risk communication and collaboration with other stakeholders) can be implemented along with the different frameworks.


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Table 1: Matrix to collect information on the different frameworks for risk management

Ethical framework Research policy

framework Laboratory biosafety and laboratory biosecurity

Measures

Actors self-governance, legislation/regulation, standards, structures, etc.*

International Regional** National Institutional/individual

Information – Raising Awareness – Education – Risk Communication –

Collaboration with other stakeholders

* The forms of governance can be of different types. Countries should use the ones that are the most adapted to their needs and capacities.

** Regional actors refers for instance to the European Union and its institutions.

IV. Managing the risks posed by life science research There is no single solution to managing the risks posed by life science research. The challenge is to protect scientific discovery and preserve scientific creativity and, at the same time, to prevent any potential accidental or misuse of science. The dual use dilemma is essentially an ethical dilemma that involves weighing risks and benefits. The central ethical questions include:

1. How to weigh the potential benefits of research against the risk of abuse? 2. How to weigh the individual interest of researchers against the common good of

public health? 3. How to best manage the risks associated with such research, without hindering its

beneficial application to public health? One potential solution put forward is self-governance. A code of conduct for researchers provides specific guidelines with respect to what is considered appropriate behaviour. A code of ethics lays forth the ideas to which practitioners should aspire, such as standards of objectivity or honesty (8). Such codes help raise awareness, foster norms, sensitize scientists and the public health community, and establish public accountability. However, there is little evidence about the effectiveness of codes in practice and people may not comply. One of many examples: the International Centre for Genetic Engineering and Biotechnology (ICGEB) is assisting the United Nations Secretariat in fulfilling a mandate received by the Security Council to reinforce ethical norms and the creation of codes of conduct for scientists. Codes for publishers can complement codes for researchers. Publication is essential for the advancement of science, for scientific openness and collaboration, to enable important beneficial research and to inform about new kinds of threats. "Materials and methods" sections are important for reproducibility. At the same time, some have raised concerns about


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the risks of published data being misused. In February 2003, a joint Statement on Scientific Publication and Security by the Journal Editors and Authors Group stated: "We recognize that on occasion an editor may conclude that the potential harm of publication outweighs the potential societal benefits. Under such circumstances, the paper should be modified or not published." (9) Several important questions remain to be answered: Who should devise codes of conduct? Should they be voluntary or enforceable? What issues should they cover? Should there be a single universal code or various local ones? Another potential solution put forward to manage the risks posed by life science research is addressing the dual use dilemma through regulation or oversight of research and researchers. For example, the United States National Science Advisory Board for Biosecurity (NSABB) is in the process of making recommendations on (10):

criteria for identifying dual use research of concern; national guidelines for oversight of dual use research at both local and federal

levels, including local review and approval processes (e.g. Institutional Biosafety Committees) and criteria/processes for referral of issues to NSABB; and

strategies for oversight of new classes of experiments and technologies.

The mission of the NSABB’s international engagement working group is to share the NSABB “toolbox”. The current focus of this working group is to identify relevant stakeholders, understand how other countries perceive “biosecurity” risk, and develop strategies to engage the global scientific community in cooperative efforts. The Center for International and Security Studies at Maryland University (CISSM) advocates a mandatory approach (11). CISSM’s Controlling Dangerous Pathogens project is aiming to develop uniform procedures and rules that are global in scope, including binding obligations applied to all relevant institutions (government, academia and industry). Key elements of the project are the licensing of researchers and facilities engaged in relevant research and peer review of experiments in advance. Different approaches may be required in different regions and countries. There is a need to strengthen and sustain a culture of responsibility and accountability, maintain a productive scientific enterprise and minimize the potential for harm. It was noted that action is needed in two areas: 1) to provide guidance on dual use to the broader scientific community, defining the problem and the challenges and 2) to promote continued awareness of the dual use research issue and thereby build a layered, integrated, international web of prevention, protection, awareness and understanding.


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BOX: Research that has triggered concerns among scientists and the public Chemical synthesis of poliovirus cDNA

Researchers synthesized a poliovirus genome using chemically synthesized oligonucleotides and a map of the polio genome that was publicly available on the internet (12). The result was a "live" polio virus that paralyzed mice. The paper that was published in Science in 2002 included a description of methods and materials. Concerns were raised that this provided a recipe that could be used to reconstruct the virus without obtaining a natural virus. One of the authors has stated: “The widespread attention generated by our publication raised the overall awareness of the new reality of synthetic viruses and its possible consequences.” (13)

Reconstruction of the 1918 flu virus

The successful reconstruction of the influenza A (H1N1) virus responsible for the 1918 "Spanish Flu" pandemic was published in Science and Nature in 2005 (14-15). Some people raised concerns about the "dangers of resurrecting the virus" and questioned whether the research should have been published. In its defence, the Centers for Disease Control and Prevention in the United States of America, one of the collaborators of the Science article, stated: “While there are concerns that this approach could potentially be misused for purposes of bioterrorism, there are also clear and significant potential benefits of sharing this information with the scientific community: namely, facilitating the development of effective interventions, thereby strengthening public health and national security.” (16)

Inadvertently increasing the virulence of mousepox

In an attempt to control mice as pests, Australian scientists unexpectedly increased the virulence of mousepox. Their research, which was published by the Journal of Virology in 2001, was originally aimed at producing an infectious contraceptive for mice (17). By inserting a gene responsible for the production of interleukin-4 into the mousepox genome, the scientists created a pathogen that overcame the immune defence of mice and even killed mice that had been vaccinated. This unforeseen result and its publication raised the questions of whether the same technique could be applied to other orthopox viruses, such as smallpox, and what the consequences in terms of vaccination circumvention might be.


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V. Summary of country perspectives Representatives from several countries across the Asia Pacific region gave brief presentations at the meeting that provided an overview of the following topics:

• current national capacities for life sciences research: institutions, laboratories, scientists, etc.

• existing research policy and ethical frameworks: policy, regulation/legislations, advocacy, ethics review boards training and future activities;

• existing laboratory biosafety and laboratory biosecurity frameworks: policy, regulations/legislations, advocacy, training and future activities; and

• life science research and its potential for accidental or deliberate misapplication (and the extent to which this issue had been discussed at the national level eg as part of research policy, ethical or laboratory biosafety and laboratory biosecurity frameworks).

As anticipated, research capacity, research activities and countries' needs vary from country to country. Nevertheless, some commonalities emerged from the presentations. Most governments recognize R&D to be an important factor in driving a country’s socio-economic development and, as such, are strongly committed to life science research. Emerging and re-emerging infectious diseases with new characteristics represent a major risk for all countries in the Asia Pacific region. Given recent experiences with SARS and avian influenza, countries are all too aware of the severity of their potential social and economic burden. It is widely acknowledged that public health systems must be prepared to deal with such diseases. To this end, collaborative efforts have been increasing in recent years between scientists working in laboratories in universities, research institutes, government agencies and privately funded agencies (where relevant), and clinical investigators who work with patients. Researcher expertise ranges widely from country to country, as does laboratory capacity. Some countries have sophisticated infrastructure and facilities (including advanced computational modelling for developing new biological and medical knowledge, high-throughput technologies in genome sequencing, diagnostics tools, modern immunological tools to understand disease immune-correlates etc) whereas other countries have more basic facilities and levels of expertise. Most countries have Biosafety Level 2 (BSL-2) laboratories. The number of Biosafety Level 3 (BSL-3) laboratories is increasing and is forecast to more than double in the next few years. The number of Biosafety Level 4 (BSL-4) laboratories, although currently limited across the region, is also projected to increase. In most countries the Ministry of Health has put in place a national research policy and ethical framework to monitor research in the area of infectious diseases, including proper handling, biosafety, biocontainment and training for all personnel. In most countries the institutional framework for R&D includes many different organizations ― government research institutions under various ministries, government-linked agencies, public and private universities and the private sector. Legislation governing life science research also varies from country to country. However, it is notable that there is no single integrated legislative framework that governs all research issues within a given country. Malaysia is a typical example. Researchers are bound by all national


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and international legal requirements, including health and safety requirements and environmental standards. Several regulatory policies and guidelines exist at institutional and university level that govern the funding and priorities of research as well as monitor research proposals and progress. Researchers working in the fields of medicine and health sciences are required to adhere to the Malaysian Good Clinical Practice Guidelines and Medical Research Ethics Committee. Researchers working in scientific laboratories that provide or receive biological materials are required to abide by the Material Transfer Agreements and Regulations. The Biosafety Act, that came into force in 2007, regulates the import, export, handling and use of genetically-modified organisms. Malaysia is one of the States Parties to the Biological and Toxins Weapons Convention (BTWC), which was signed in 1972 and ratified in 1991. Legislation to introduce a national BTWC bill is in progress. A key challenge for almost all countries is strengthening preparedness for health emergencies arising from natural, accidental or deliberate outbreaks of disease. This calls for the formulation of national biosafety policies with the participation of all stakeholders in the life science community, strengthening public health surveillance, inter-country cooperation with shared use of technical expertise and facilities, capacity building at all levels through integrated training programmes and collaboration between international partners. To ensure the safe management of high-risk pathogens in laboratories in the Republic of Korea, for example, the Act of Prevention of Contagious Disease was revised in 2005 to include the duty to notify the identification, transfer and conservation of a number of highly dangerous pathogens. To enforce the observance of BTWC, the Act on Prohibition of Biological or Chemical Weapon and Production or Moving Restriction on Special Biological or Chemical Agents was legislated in 2006. In addition, the government of the Republic of Korea enacted the Bioethics and Safety Act on 29 January 2004 to offer an essential bioethical framework for all kinds of life sciences research. Measures to deal with the "dual use" issue, including a practical code of conduct for scientists, formal research oversight requirements, and education and training programmes will be developed in conjunction with efforts to promote beneficial applications of life science research. Most countries stated that laboratory biosafety and laboratory biosecurity must be further strengthened in order to prevent any effects that will harm people, communities or the natural environment and thereby strengthen global health security.

VI. Country needs and priorities Participants were divided into four groups to discuss and make recommendations for further action. Each group was asked to identify up to three recommendations for specific WHO action and up to three recommendations for specific country action (see recommendations for action on page 4). This section combines the outcome of each group’s discussion, which were presented during the plenary session that concluded the meeting. Advocacy Raising awareness about the risks associated with the misuse of life science research (bio-informatics, genomics, R&D related to vaccines etc) and the potential dual use dilemma is a high priority area. This includes educating students, scientists, government officials, publishers, industry and the general public. There is also a need to inform scientists of laboratory biosafety and laboratory biosecurity guidelines and the existence of relevant


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regulatory bodies (both international and national). A wide range of activities were identified that could contribute to raising awareness from training programmes, workshops, seminars and “road-shows”, to engaging with policy-makers and the media, to publishing guidelines and other related materials. Another suggestion was to monitor the risks of ongoing life science research. Technical support Priority areas for technical support include guidelines for laboratory biosafety, laboratory biosecurity and biosecurity of life science, as well as criteria for assessing the social and ethical implications of dual use research. Consistency internationally of classification and of handling high-risk pathogens would assist in improving standards and harmonization. Other urgent priorities are capacity building for laboratory infrastructure, personnel and research support, for training in the implementation of laboratory biosafety and laboratory biosecurity and for trainers to train laboratory staff in risk assessment and management. Several groups called for the establishment of a regional laboratory for emerging infectious diseases. Economic resources Resources are needed to address infectious diseases priorities (research, facilities, equipment and personnel), for advocacy and awareness, and for technical support activities including training. Strengthening BSL-3 and BSL-4 laboratories requires financial assistance for infrastructure, equipment, manpower and training. An increase in the health budget and a more equitable sharing of resources would help meet country needs but some developing countries will require dedicated funding from the international community. Legislation and regulation National regulations are required:

• to implement laboratory biosafety and laboratory biosecurity requirements; • for handling, packaging and transferring biological materials; • for storage of biological materials; and • for monitoring and surveillance of laboratory biosafety and laboratory biosecurity

In addition, countries may also wish to adopt policies that address dual use research and the licensing and certification of scientists. All countries should comply with internationally accepted standard operating procedures and international codes and guidelines for ethics in life science research. Partnerships Countries may reap considerable benefits from forging partnerships within and between countries and internationally (e.g. GOARN, PulseNet, etc). Partnerships could include scientific exchanges, secondments and training, sharing of international expertise and knowledge of availability in each area. Setting up a network for referral laboratories would be one way to facilitate collaboration. Other examples include bilateral collaboration to exchange information, experience, technology and materials, and publishing domestic and international directories. Communication Clearly articulating the objectives behind improving laboratory biosafety and laboratory biosecurity (i.e. not to prohibit research but rather to enable it to proceed safely and securely) requires a multifaceted approach: 1) communication training for scientists and research institutions 2) effective communication within and between countries and across relevant sectors 3) effective risk communication with the public through the media 4) timely and effective communication and especially rapid collection and dissemination of accurate information during a pandemic/bioterrorism event. Encouraging open and effective communication depends first and foremost on access to reliable information. Building relationships with a select group of media representatives such as specialist reporters in


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science and establishing an international centre for laboratory biosafety, laboratory biosecurity and biosecurity of life science were among the many suggestions for how to facilitate open communication. The groups viewed advocacy, technical support and economic resources as a high priority; legislation and partnerships as a medium to high priority; and communication as a medium priority. Two other areas One of the four groups added two additional areas that require further action: networking and emergency response. Networking is essential to facilitate collaboration and communication among sectors and countries. Laboratory networking within countries and regionally could provide valuable information on facilities and capabilities. This was viewed as a high priority for WHO, and a regional information centre was suggested as one possible solution. Developing effective emergency response plans is an overarching need of each and every country and thus a high priority for all countries. In addition to the roles of individual governments (ministries of health, foreign affairs, agriculture, environment, defence, education, science and technology, public information) and WHO, numerous other groups are in a position to assist countries to meet their needs in different ways. These include, among others, individual scientists, research institutions, professional societies, academic groups, pharmaceutical and biotech companies, international organizations (including ICGEB, UNESCO, FAO, OIE), international financial institutions (World Bank, Asian Development Bank, Inter-American Development Bank, etc), inter-governmental organizations (such as ASEAN and the European Union), bilateral donors (such as JICA and AusAID), private foundations and other donors (the Bill & Melinda Gates Foundation, the Pasteur Network, the Mérieux Foundation and the Rockefeller Foundation, among others), the media and NGOs.


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References

1. Scientific working group on life science research and global health security. Report of the First Meeting. Geneva, Switzerland, 16-18 October 2006. World Health Organization, 2007. (WHO/CDS/EPR/2007.4)

2. Life science research: opportunities and risks for public health. Geneva, World Health Organization, 2005 (WHO/CDS/CSR/LYO/2005.20).

3. WHO. Revision of the International Health Regulations. World Health Assembly Resolution 58.3. May 2005. (www.who.int/gb/ebwha/pdf_files/WHA58/WHA58_3-en.pdf)

4. The World Health Report 2007—A safer future: global public health security in the 21st century. Geneva, World Health Organization, 2007 (www.who.int/whr)

5. International Health Regulations (2005) www.who.int/csr/ihr (last accessed May 2008)

6. World Health Organization South-East Asia Region and Western Pacific Region. The Asia Pacific strategy for emerging diseases. World Health Organization, 2005. (www.searo.who.int/LinkFiles/CDS_AsiaPacificStrategyFINAL.pdf)

7. Global Outbreak Alert & Response Network www.who.int/csr/outbreaknetwork (last accessed May 2008)

8. Somerville MA, Atlas RM. Ethics: a weapon to counter bioterrorism. Science, 2005, 307:1881–1882.

9. Statement on the consideration of biodefense and biosecurity. Nature, 2003, 451:771.

10. National Science Security Board for Biosecurity www.biosecurityboard.gov (last accessed May 2008)

11. Center for International and Security Studies at Maryland www.cissm.umd.edu/projects/pathogens.php (last accessed May 2008)

12. Cello J, Paul A, Wimmer E. Chemical synthesis of poliovirus cDNA: generation of infections virus in the absence of natural template. Science, 2002, 297: 1016–1018.

13. Wimmer E. The test-tube synthesis of a chemical called poliovirus. The simple synthesis of a virus has far-reaching societal implications. Special issue, EMBO reports, 2006, Vol 7.

14. Taubenberger JK et al.Characterization of the 1918 influenza virus polymerase genes. Nature, 2005, 437: 889–893.

15. Tumpey TM et al. Characterization of the reconstructed 1918 Spanish influenza pandemic virus. Science, 2005, 310: 77–80.

16. Centers for Disease Prevention and Control. Reconstruction of the 1918 Influenza Pandemic Virus. www.cdc.gov/flu/about/qa/1918flupandemic.htm (last accessed May 2008)

17. Jackson RJ et al. Expression of mouse interleukin-4 by a recombinant ectromelia virus suppresses cytolytic lymphocyte responses and overcomes genetic resistance to mousepox. Journal of Virology, 2001, 75:1205–1210.


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Annex 1: Agenda

Day 1

Monday, 10 December 2007

Speakers

Session 1: Introduction

08:30-09:00 Registration

09:00-09:30

Welcome and opening remarks Dr Maureen Birmingham

Dr Vichai Chokevivat,

09:30-10:00

Administrative arrangements

Objectives of the meeting

Dr Ottorino Cosivi

Session 2: Biorisk reduction framework

10:00-10:30 Biorisk reduction for global health security Dr Ottorino Cosivi

10:30-11:00 Legislation and regulations related to bioethics and management of risks in life science research

Professor Leonardo de Castro

Group picture and coffee break

11:30-12:00 Emerging infectious diseases: the importance of biosafety and biosecurity in the laboratory

Professor John S. MacKenzie

12:00-12:30 Life science research and global health security Dr Ottorino Cosivi

12:30-13:00 Questions and answers Dr Ottorino Cosivi

Lunch

Session 3: Country perspectives

14:00-16:00 Country perspectives

Country representatives

Coffee break

16:30-18:00 Country perspective (follow-up)

Wrap-up

Country representatives

Day 2

Tuesday, 11 December 2007 Speakers

Session 4: Managing the risks posed by life science research

09:00-09:30 International Health Regulations (2005): regional perspectives

Asia Pacific Strategy for Emerging Diseases

Dr Maureen Birmingham

Professor John S. MacKenzie

09:30-10:00 Life science research and dual use perspective Dr David Franz

10:00-10:30 Ethical perspective Dr Andreas Reis

Coffee break


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11:00-11:30 Regulation of research perspective: protective oversight of dual-use life science research

Mrs Elisa D. Harris

11:30-12:00 Regulation of research perspective at the research level: regulating the conduct of research, publications, communicating results

Dr David Franz

12:00-12:45 Case-study exercise and discussions

Dr Ottorino Cosivi

Lunch

13:45-14:15

Reports on the case studies

Session 5: Working group discussions

14:15-16:30

Four working groups discussions

Coffee break

17:00-17:30 Working group discussions (continued)

Group chairs

Day 3

Wednesday, 12 December 2007

Speakers

Session 6: Reports of the working group discussions

09:00-10:30 Presentation of reports Group chairs

Coffee break

Session 7: Conclusions and recommendations

11:00-11:30 Conclusions and recommendations Chairman and WHO

11:30-12:00 Meeting evaluation and closure of the meeting


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Annex 2: List of participants Temporary Advisers Professor Dr Boungnong Boupha, Director General, National Institute of Public Health Ministry of Health, Vientiane, Lao People's Democratic Republic Dr Leonardo de Castro, Professor of Philosophy, Department of Philosophy, College of Social Sciences and Philosophy, University of the Philippines, Quezon City, Philippines Mr Mom Chandara, Deputy Head, National Institute of Public Health Laboratory, National Institute of Public Health, Blvd Kim YI Sung, Khan Tuol Kork, Phnom Penh, Cambodia Dr Vichai Chokevivat, Advisor to the Minister of Public Health, Office of Permanent Secretary, Ministry of Public Health, Nonthaburi, Thailand Dr David R. Franz, Vice-President & Chief Biological Scientist, Midwest Research Institute, Maryland, United States of America Dr Nirmal K. Ganguly,* Director General, Indian Council of Medical Research, New Delhi India Mrs Elisa D. Harris, Senior Research Scholar, Center for International & Security Studies, School of Public Policy, University of Maryland, Maryland, United States of America Dr Virginia Hope, Programme Leader, National Centre for Biosecurity and Infectious Disease, Institute of Environmental Science and Research Limited, Kenepuru Science Centre, Wellington, New Zealand Dr Li Huang, State Key Laboratory of Microbial Resources, Institute of Microbiology, Chinese Academy of Sciences, Datun Rd. Chaoyang District, Beijing, China Dr Shahid Jameel, Group Leader, Virology, International Centre for Genetic, Engineering and Biotechnology (ICGEB), New Delhi, India Dr Shigeyuki Kano, Director, Department of Appropriate Technology Development and Transfer Research Institute, International Medical Center of Japan, Ministry of Health Labour and Welfare of Japan, Tokyo, Japan Prof Raymond Tzer Pin Lin, Head and Senior Consultant, National Public Health Laboratory, Communicable Diseases Division, Ministry of Health, College of Medicine Building, Singapore Dr Jinxing Lu,* Deputy Director, National Institute for Communicable Disease Control and Prevention, Beijing, China Dr Gary Lum,* Assistant Secretary, Health Emergency Management and Biosecurity Branch, Office of Health Protection, Department of Health and AgeingCanberra, Australia Dr Noel Macalalad, Division Chief, Laboratory Research Division, Research Institute for Tropical Medicine, Filinvest Coporate City, Alabang Muntinlupa City, Philippines


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Prof John S. Mackenzie, Premier’s Fellow and Professor of Tropical Infectious Diseases, and Deputy CEO, Australian Biosecurity CRC, Curtin University of Technology, Perth, Australia Dr Junichiro Mori, Deputy Director,Health Sciences Division, Minister's Secretariat, Ministry of Health, Labour and Welfare, Tokyo, Japan Dr Lisa Fong-Poh Ng, Senior Scientist, Communicable Diseases Division - MOH Laboratory of Systems Immunology, Infectious Diseases, Singapore Immunology Network (SIgN), Immunos, Singapore Dr Phan Thi Nga, Vice Leader, Department for Training and Research Management National Institute of Hygiene and Epidemiology, Hanoi, Viet Nam Dr Tran T. Mai Oanh, Vice Director, Health Strategy Policy Institute, Ba Dinh District, Hanoi, Viet Nam Prof Ian A. Ramshaw, Director, National Centre for Biosecurity, The John Curtin School of Medical Research, Australian National University, Canberra , Australia Professor Kameswara C. Rao, Foundation for Biotechnology Awareness and Education Bangalore, India Dr Rohani Yasin, Head of Special Diagnostic Centre, Institute For Medical Research Ministry of Health Malaysia, Kuala Lumpur, Malaysia Dr Pretty Sasono, Centre for Biomedical and Pharmaceutical Research and Development, National Institute of Health Research and Development Ministry of Health, Republic of Indonesia, Jakarta, Indonesia Dr Sunita Saxena, Director, Institute of Pathology, ICMR, New Delhi, India Dr Won Keun Seong, Director, Biosafety Evaluation and Control Team, Korea Centre for Disease Control and Prevention, Seoul, Republic of Korea Dr Uma Sharma, Senior Pathologist, Department of Pathology New Delhi, India Dr Panadda Silva, Advisor to the DG, Quality Assurance Director, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand Professor Chuop Sokheng, Acting Head of National Institute of Public, Health Laboratory, National Institute of Public Health, Phnom Penh, Cambodia Ms T Saraswathy Subramaniam, Research Officer, Institute For Medical Research, Ministry of Health Malaysia, Kuala Lumpur, Malaysia Dr Lusianawati Tana, Centre for Biomedical and Pharmaceutical Research and Development, National Institute of Health Research and Development, Ministry of Health, Republic of Indonesia, Jakarta, Indonesia Dr Fiona Thomson-Carter, General Manager, Environmental Health Institute for Environmental Science and Research Ltd., Wellington, New Zealand


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Dr Phengta Vongphrachanh, Director General, National Center for Laboratory and Epidemiology, Ministry of Health, Vientiane, Lao People's Democratic Republic Dr Byung Guk Yang, Director, Division of Bioethics and Biosafety, Ministry of Health and Welfare Anyang-Si, Gyeonggi-Do, Republic of Korea Dr Qiang YE, Chief, Division of Type Culture Collections, National Institute for the Control of Pharmaceutical and Biological Products, National Center for the Medical Culture Collections, Beijing, China WHO Secretariat Dr Maureen Birmingham (a.i.), WR/Thailand

Dr Ong-Arj Viputsiri, * SEARO/Regional Advisor, Research Policy and Cooperation, New Delhi, India

Dr Reijo Salmela, * WPRO, Medical Officer Situation Analysis for Policy, Manila, Philippines

Dr Peter Ibarra Galace,* WPRO, Technical Officer, Communicable Disease Surveillance and Response, Manila, Philippines

Dr Tikki Pang, Director, Department of Research Policy and Cooperation (RPC)

Dr Ottorino Cosivi, Scientist, Biorisk Reduction for Dangerous Pathogens (BDP), Department of Epidemic and Pandemic Alert, and Response (EPR)

Dr Andreas Reis, Technical officer, Department of Ethics, Equity, Trade and Human Rights (ETH)

Dr Emmanuelle Tuerlings,* Scientist, Biorisk Reduction for Dangerous Pathogens (BDP), Department of Epidemic and Pandemic Alert and Response (EPR)

Ms Joanne McManus, Temporary Adviser, Biorisk Reduction for Dangerous Pathogens (BDP), Department of Epidemic and Pandemic Alert, and Response (EPR)

* unable to attend

research policy and management of risks in life sciences ...scientific working group’s...

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