Introduction

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    The World Health Assembly has passed more than 25 resolutions on various aspects of blood safety since 1975. The resolutions essentially urge the Member States to promote the development of national blood transfusion services based on voluntary non-remunerated blood donors and enact effective legislation which should govern operations of the blood transfusion services. The World Health Organization also advocates the need for a standardized Blood Safety Legislation with a policy commitment to action; communicating government policy; setting the foundation for executive action; ensuring that policies and strategies are effective and sustainable; protecting public health, health of donors and recipients of blood; making provisions for the human, financial and technical resources that are necessary for quality and safety; and facilitating co-ordination of all activities of the blood transfusion programmes.

    The regulation of blood sector implies enactment and enforcement of laws and rules by the government for safe blood transfusion practices. The independent, autonomous Blood Transfusion Authority (BTA) performs a steering role to guide the overall development of the Blood Transfusion Services and regulates the transfusion system on the internationally accepted blood transfusion system models. BTAs are responsible for the implementation of the Blood Safety Laws. Regulation of the Blood Transfusion Services indicates how the system is functioning for implementing the relevant policies, strategies, goals and objectives.

    The specific functions of a BTA include; registration and inspection of the blood banks; issuing licenses to the blood banks that fulfill the minimum licensing criteria; annual and surprise inspections of the licensed blood banks; haemovigilance, surveillance of all components of the vein-to-vein transfusion chain; compliance with the legislation, bylaws and regulations; and data management.

     

    The regulatory authorities in the developed countries include the European Blood Inspection System (EuBIS), Health Sciences Authority-Blood Services Group of Singapore, National Blood Authority of Australia and Medicines & Healthcare products Regulatory Agency of the UK, etc. In the developing countries, the common barriers to the implementation of a legislative framework include insufficient political commitment and support; absence of or weak blood transfusion policy and strategy; insufficient or inadequate human, technical and financial resources; inappropriate priority setting; absence of norms, standards and transparent procedures; lack of inspection and control mechanisms; poor communication between stakeholders; poor attention to cultural and religious constraints; and weak consumer and professional associations.

    In Pakistan, during the period 1997-2004, all the provinces and the state of AJK passed their respective legislation on blood safety. The BTA for Islamabad was established in 2005, through the ICT Blood Safety Ordinance promulgated in 2002. After the approval of ordinance, the blood banks cannot opt in or out of the law, compliance is mandatory and is to be ensured by the IBTA. In 2005, the Federal Government notified the establishment of the Islamabad Blood Transfusion Authority and appointed Prof. Khalid Hasan, Consultant Haematologist, Pakistan Institute of Medical Sciences (PIMS), Islamabad as its Chairman. In the absence of a proper structure or resources, the IBTA secretariat was established in PIMS. An Advisory Committee of technical experts consisting of haematologists, transfusion medicine experts, microbiologists, representative of the armed forces and members of private sector and other stakeholders was notified. The Committee published advertisements in the press for ICT blood banks registration and licensing. A database of the ICT blood banks was thus generated and blood banks registered and licenses issued.

    From 2007-09, Maj. Gen. (R) Masood Anwar, Executive Director, National Institute of Health (NIH), Islamabad remained Chairman IBTA and the IBTA secretariat was shifted to the NIH. During this period, some inspections were made and licenses issued. In 2009, Dr. Birjees Mazhar Kazi, Executive Director, NIH, was appointed Chairman IBTA by the Ministry of Health.

    The IBTA was revived by the Ministry of National Health Services, Regulation and Coordination (M/o NHSR&C) in October 2013, following the devolution of the Ministry of Health in June 2011. A new Chairman, Prof. Hasan Abbas Zaheer, and a new Advisory Board consisting of eminent transfusion experts, haematologists, pathologists and public health experts were also notified by the Ministry.

    The functions of the IBTA include registration, inspection, licensing, haemovigilance, developing by-laws and regulations, and data management of all the blood banks functioning in the federal capital. In addition, IBTA also has the mandate for coordination, strengthening and capacity building of the provincial BTAs. The IBTA is thus mandated to perform a steering role to guide the overall development of the Blood Transfusion Services in the country and promote uniform regulation of the transfusion sector throughout the country.

     


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