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E3 BIOTECHNOLOGY AND BIOSECURITY INITIATIVES IN PAKISTAN: A COUNTRY REPORT Anwar Nasim,1 Ph.D. and Erum Khan,2 MBBS, FCPS, M. Sc. 1 Ministerial Standing Committee on Scientific and Technological Cooperation 2 Pakistan Biological Safety Association and Aga Khan University Hospital What high-containment biological research facilities exist in your country? What are the facilities’ main goals and priorities? In Pakistan, many institutes work using BSL-1 and BSL-2 level facilities. The National Institute of Health, Islamabad has been working at BSL-2+ and is constructing BSL-3 facilities. BSL-3 facilities exist at Aga Khan University and Indus Hospital Karachi. Priorities and goals vary among facilities. The National Institute of Health, for example, fulfils the 22 objectives defined in ordinance No. XLIII of 1980 including advising the Federal Government on disease control, investigating epidemics, developing an Institute of Tropical Diseases for Research and Training, developing a National Virus Reference Center, and functioning as a National Type Culture Collection Centre (http://www.nih.org.pk/). The BSL-2 and BSL-3 laboratories at Aga Khan University are private diagnostic laboratories that process routine clinical samples. The BSL-3 laboratory is primarily used for processing samples from patients suspected of Mycobacterum tuberculosis (TB) infection. The BSL-3 lab at Indus Hospital is used mainly for TB diagnosis. What government organizations are responsible for safety and security of high-containment biological (high BSL) laboratories? Responsible organizations include the Disarmament Division, the Ministry of Foreign Affairs, and the National Biosafety Committee. Additionally, the Pakistan Biosafety Rules 2005 require organizations involved in biotechnology or genetic manipulation to have Institutional Biosafety Committees and to designate a Biosafety Officer. If there are BSL laboratories in your country, are there established criteria for deciding: a. Whether or not to establish such facilities? b. What criteria are used to select the placement of such facilities? c. What criteria are used to decide what research will be conducted in such facilities? d. What scientific, technical and management advice is available to governments when making their decisions? The Pakistan Biosafety Rules, 2005, which concerns genetically modified organisms, established the following entities: • The National Biosafety Committee whose responsibilities (related to genetically modified organisms) include establishing procedures and standards for risk-assessments, facilitating the exchange of technical advice, developing guidelines for assessing biohazards, informing individuals engaged in genetic manipulations about new biosafety guidelines, coordinating efforts to prepare for biological emergencies, and certifying and inspecting laboratories that intend to perform high-risk work. • The Technical Advisory Committee that examines applications and provides advice concerning work on and the release of genetically modified organisms. • Institutional Biosafety Committees Criteria used to decide what research will be conducted vary between facilities. Research at the National Institute of Health, for example, fulfils the 22 objectives defined in ordinance No. XLIII of 1980. 159
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160 Biosecurity Challenges 1. What standards exist for BSL laboratories? No standard formulations have been devised or received from the Government of Pakistan. The National Institute of Health, Islamabad, for example, follows the criteria and standard guidelines devised by WHO, the United States CDC’s Biosafety in Microbiological and Biomedical Laboratories (BMBL), and ABSA-Canada (Canadian Association for Biological Safety). Additionally, in May 2005, The Pakistan Environmental Protection Agency issued National Biosafety Guidelines. The document provides guidelines on laboratory research, field trials, and release of genetically modified organisms. 2. Have there been any BSL accidents in your country? a. If yes, how and why did accidents at high-containment facilities occur? b. How, to whom and when are they reported? c. Who has authority to investigate accidents? d. What disciplinary or legal actions can be taken? According to the Pakistan Biosafety Rules, 2005, the Technical Advisory Committee must be notified following any accident that could lead to the release of genetically modified organisms. 3. Have any steps been taken to minimize BSL laboratories accidents? If so, by whom (i.e., regulation, voluntary measures, individual laboratory practices)? In his December 6, 2010 address to the BWC Meeting of the States Parties, Ambassador Zamir Akram stated that, “The subject of Biosafety has been incorporated in the curricula of relevant university disciplines.” The Pakistan Biosafety Rules 2005 require an organization involved in bio-technology or genetic manipulation to designate a Biosafety Officer. Pakistan currently has three Biosafety organizations including the Pakistan Biological Safety Association (PBSA), which is affiliated with the National Core Group in Life Sciences (NCGLS) of the Higher Education Commission and the Organization of the Islamic Conference (OIC) Committee on Scientific and Technological Cooperation (COMSTECH) and was started in 2008. Additionally, a number of training activities and seminars on biosafety have taken place in Pakistan, and Pakistanis have participated in similar events abroad. For example, in 2009, Aga Khan University in Karachi held two seminars on Laboratory Biosafety and a National Training Seminar on Biosafety and Biosecurity Initiatives took place in 2007 in Islamabad. Similarly, Pakistanis attended the Asia Conference on Laboratory Biosafety and Biosecurity (Bangkok, Thailand, 2007); the Biosafety and Biosecurity International Conference: Healthier and More Secure Communities in the Middle East and North Africa Region (Casablanca, Morocco, 2009); the Biosafety and Biosecurity Risk Assessment and Risk Mitigation Training Event for Pakistani Bio-scientists (Dubai, United Arab Emirates, 2010); and the ICLS-COMSTECH-PAS International Conference on Conduct of Responsible Science: Safety, Security and Ethics (Islamabad, Pakistan, 2010). 4. Have any steps been taken to increase security at BSL facilities? If so, by whom (i.e., regulation, voluntary measures, individual laboratory practices)? In 2010, the Government of Pakistan’s Planning Commission issued a report on Biosafety and Biosecurity in Biological Laboratories that describes good microbiological practices and suggests that one lab in each province be brought into full compliance with BSL-2 practices and then used as a model. In his December 6, 2010 address to the BWC Meeting of the States Parties, Ambassador Zamir Akram stated that, “the Inter-Agency Task Force on BWC issues has finalized ‘Guidelines for development of Code of Conduct for the Life Scientists’ and circulated them to all our national stakeholders.” Additionally, the documents were translated into the national language, Urdu.