Blood transfusion is an indispensable, potentially life-saving medical intervention. However, the inherent risks of blood and the complexity of providing adequate, timely and equitable access to safe blood and blood components require an organized national or regional blood regulatory system. Within that system, a competent blood regulatory authority assures that appropriate standards are met for production of blood products and monitoring of blood safety. 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 Regulationss 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.
In exercise of its functions, the BTA not only conduct inspections and other control measures, but also develops, adopts or adapts rules, Regulations, standards, guidelines and other tools to achieve the objective, provides training and education to blood banking professionals and blood bank staff on how to achieve the standards set by the Authority and collaborates with other professionals in the field of education, training and other related purposes. To achieve Regulationss and harmonization of blood transfusion services in the country, it is essential that the blood establishments comply with the provisions of blood transfusion law by conforming to the rules and Regulations, standards and guidelines developed under the light of blood transfusion act. 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, the blood transfusion laws were developed from 1997-2004. A consensus uniform updated draft legislation was developed in 2015 by all the stakeholders under the auspices of the SBTP. Three provinces (KP, Sindh and Punjab) have adopted this new legislation through their respective legislatures .
These legislations intend to regulate collection, testing, processing, storage, distribution, issuance and transfusion of human blood and blood components, ensuring health protection and prevention of transfusion transmissible diseases. Approval and enactment of the law requires a Blood Transfusion Authority to be established as a truly operational regulatory authority. This BTAregulates all aspects related to safe blood transfusion structures and processes, including registration and licensing, introduction of standards, quality systems and haemovigilance. In the Blood Transfusion Law, a ‘Blood Transfusion Authority’ is defined as “a regulatory body” established under the Department of Health with the objective to regulate the Blood Transfusion Services of the Region. The regulatory body for Islamabad, Islamabad Blood Transfusion Authority, was established in 2005, through the ICT Blood Safety Ordinance promulgated in 2002. After this Ordinance, the blood banks cannot opt in or out of the law, compliance is mandatory and 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 first 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. (Retd.) Prof. Masood Anwar, Executive Director, National Institute of Health 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. After the devolution of the Health Ministry in 2011, the IBTA was revived by the Ministry of National Health Services, Regulationss and Coordination (M/o NHS,R&C) in October 2013.
A new Chairman 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 and inspection of the blood banks; issuing licenses to the blood banks that fulfil 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 of all the blood banks functioning in the federal capital .
In addition, IBTA also coordinates, strengthens and built the capacity of the provincial BTAs. The IBTA thus performs a steering role to guide the overall development of the Blood Transfusion Services in the country and promote uniform Regulationss of the transfusion sector throughout the country.