Legal and Regulatory Framework

Legal and Regulatory Framework

Pakistan has been at the forefront of the movement to improve blood safety as mandated by World Health Assembly resolutions. The objective is to ensure provision of safe and quality assured blood and blood products. However, Pakistan’s blood transfusion system has developed without the guidance of an overall regulatory framework, so that competing concepts can be observed in a framework of fragmentation. The legal and regulatory framework is the cornerstone of optimum blood safety so without a comprehensive blood safety legislation, improvements in access and quality of services will remain a challenge.

The Blood Transfusion Services in Pakistan are based on provincial structures guided by the Blood Safety Acts introduced between 1997 and 2004 in all provinces including the state of Azad Jammu & Kashmir. The blood safety legislations have never been fully or properly implemented for various reasons including insufficient political commitment, capacity issues etc. These legislations are not uniform, comprehensive, up-to-date and some key aspects missing altogether. In addition, the transfusion medicine has undergone rapid advances in the recent past which are not fully covered in these legislations developed more than 15 years ago. At the same time, the blood transfusion authorities notified under these laws are barely functional or effective except the Islamabad Blood Transfusion Authority. The regulatory authorities have thus been unable to make the envisaged impact.

BT Law Compendium

In 2012, SBTP team conducted an exercise to review all existing legislations on blood safety.  Facsimile of the existing BT laws of key territorial units were developed. In addition to this reproduction of existing laws, they have been put into a synoptical presentation which allows a comparison of twenty three key concepts at one glance. The summary highlights a considerable degree of diversity between the legislations and the current EU directives. The key findings about the limitations of the current legislations are omission of haemovigilance, quality management, sector diversity, hospital interface, functional separation and considerable latitude in the financial penalties and physical imprisonment. The current document ‘BT Law Compendium’ represents a collection of blood acts which have fed into a comparative matrix.

Template for Blood Transfusion Law 2013

SBTP team developed and proposed a template for BT law in 2013, which is consistent with modern concepts and trends in transfusion medicine. It is based mainly on the 2003 EU Directive on SBT and will regulate the whole spectrum of vein to vein blood transfusion process, thus ensuring uniformity in the quality of blood products across the country. A proposed law is denominated ‘bill’, while the bill passed is called ‘law’ or ‘act’ of parliament. The ‘bill’ has to be included in the ‘list of business’ for the respective day of introduction, a fact to be published in the parliamentary ‘gazette’. The bill is referred to the respective standing committee, passed through a series of readings (and amendments) up to approval by majority vote. With the governor’s assent, the new law is published in the Gazette as an Act of Provincial Legislation.

The revised legislation is at various stages of approval in the respective provinces/regions. In AJK, the draft law was forwarded to the legal department, which recommended that the existing law be rather revised than the draft new law introduced; in Baluchistan an advocacy workshop (with participation of the law section) was conducted, but the legal process is still pending. For ICT, the specific status of legislation in the post-devolution environment has to be clarified. In 2016, Punjab and KP approved the legislation while in 2017, it was approved by the Sindh Legislative Assembly. 

Activation of BTAs and Technical Assistance in Field Inspections

The regulation of the blood transfusion sector is being strengthened in Pakistan through the activation of blood transfusion authorities in the provinces on the model of IBTA. The Islamabad Blood Transfusion Authority has provided technical assistance to the Balochistan, Punjab, AJK and KP BTAs and initiated the process of registration and licensing of blood banks in these regions. WHO will also be providing technical assistance to strengthen this initiative. In addition, the political and executive leadership has been sensitized and the respective BTAs are in the process of becoming fully functional with allocation of resources.

Appreciations by the Parliament

Matters relating to blood safety and its regulation are regularly debated in the national parliament. To present the government position on these issues the SBTP is frequently asked to appear before the various forums of the National Assembly and Senate. During a meeting of the ‘Parliamentary Committee on Government Assurances’, the performance of the Islamabad Blood Transfusion Authority was appreciated. Acknowledgement of the success of the blood safety reforms by the political leadership is indeed a very significant milestone for the Programme.

Logistic Support to BTA

The Blood Transfusion Authorities have been provided with the logistics support according to the PC-1 by GIZ. This included handing over of a vehicle, desktop computers and a photocopier.

Rules of Business for BTA

The Rules of Business are defining possible roles and functions of the BTA.  These ROB provide detailed guidance about how a strategy can be translated to action. These will be used to conduct trainings for BTAs.

Business Plan for BTS

The SBTP team developed a model Business Plan, which would be used as a decision-making tool. The core elements of this plan are cost and revenue estimates (indicating the viability of the BTS). Decisions will have to be taken, though, about the funding and financial management of RBCs on the one hand and their interaction with HBBs on the other hand.

Functional Brief for BTA

A model ‘Functional Brief’ for BTA was also drafted which provides guidelines and tools for proper functioning of BTA. The Functional Brief provides guidelines for the functioning of BTA as regulators of a modern Blood Transfusion System as sanctioned by the new Safe Blood Transfusion Law and may be used as a communication tool with the Health Department to explain which resources are required to conduct the actions defined. This would include the identification of BTA staff requirements, the elaboration of registration documents to be filled by all Blood Establishments operating in the province/state/ICT and the mapping of all these facilities. On the basis of this first overall data collection BTA and DOH will have more clarity about expected workloads and the resources to be allocated. While an effort has been made to cover all essential requirements of a Blood Transfusion Authority according to international guidelines, the document has been developed for the context of this country.

Functional Brief for Blood Bank Inspectors

The provincial Health Departments have made efforts to strengthen the regulation of the blood banks. In 2015, the Punjab and Sindh BTAs organized training workshops for the blood bank inspectors which were facilitated by the SBTP Technical Expert from Romania. The trainings were first of its kind in Pakistan and will go a long way in strengthening the regulatory arm of the blood transfusion services. During the trainings, a need was felt to develop a technical document to guide the blood bank inspectors in their field visits. Thus the IBTA and the Safe Blood Transfusion Programme through technical assistance from the GIZ Health Programme, developed “Field Manual for Blood Bank Inspectors”.

The blood transfusion inspector who is directly involved in ensuring compliance of a blood establishment is not only expected to be well versed with vein to vein transfusion processes but should also have some awareness about the regulatory and organizational aspect of blood transfusion services. Therefore, the main intention of developing the Inspection Manual is to outline the role of an inspector within blood transfusion service organization.

The document is divided into sections providing the reader a clear and comprehensive knowledge of regulatory framework of BTS, the structure and functioning of BTA, and the step by step approach in registration and licensing of a blood establishment and management of post inspection data. The inspection checklist is elaborated in such a way that the inspector knows the significance of each question and how each question should be presented during inspection in order to get maximum and relevant information from the blood establishment Therefore it will serve as a useful tool for guiding blood transfusion inspectors in conducting inspection of Blood Establishments in a systematic manner.

This book also gives the inspector an insight on their rights and responsibilities which accompany their optimal training. Well trained inspectors are the backbone of safe blood transfusion practice in the country and ensure progress of blood safety.

Functional Brief for HBB

This Functional Brief gives an overview of key concepts of BTS provided by the post-reform HBBs while at the same time identifying some important areas to be addressed in a coordinated manner in the course of project implementation. The text has been elaborated to spell out the future scenario in HBBs, input for the architectural design, hospital managers, and BTAs. The document not only provides inputs for the architectural design, but also presents useful background information to the hospital administration and transfusion committee with regard to staffing and functional areas.

Functional Brief for RBC

The ‘Functional Brief’ for the new Blood Transfusion System is part of the BT reform. It has been elaborated by the Technical Cooperation Team  on the basis of a WHO template, which was reinterpreted in the light of the specific conditions of the country. A team of architects and equipment specialists of the Financial Cooperation Team (KfW/EPOS) then elaborated the corresponding ‘Design Brief’. The ‘Functional Brief’ does not only serve as a guide to the architects and equipment specialists, but it will also be used by the future operational staff and help them to comprehensively understand their roles and functions within the system.

HBB Fact Sheets

These fact sheets provide information required for initial procurement, current status of staff, blood demand, functions performed by the blood bank, clinical use of blood, etc. It was a qualitative and quantitative study conducted among the HBBs which are included in the TC first phase.  As special emphasis of the survey has been placed on operational capacities, which will permit the TC team to develop targeted human resource development measures, but capacity development will also be supported through equipment upgrades (under the responsibility of the Financial Cooperation Team), which are planned to be performed in a staged approach already before the construction of RBCs.