|Year : 2017 | Volume
| Issue : 2 | Page : 89-96
Existing and recommended legislative framework for a national blood transfusion policy
Cees Th. Smit Sibinga
IQM Consulting for International Development of Quality Management in Transfusion Medicine, Zuidhorn, NL
|Date of Web Publication||11-Sep-2017|
Cees Th. Smit Sibinga
IQM Consulting for International Development of Quality Management in Transfusion Medicine, Zuidhorn
Source of Support: None, Conflict of Interest: None
Blood transfusion contributes to saving millions of lives every year, improves life expectancy, and the quality of life of patients suffering from life-threatening conditions and supports complex medical and surgical procedures. Every country should put in place policies, a legislative framework, systems and structures to ensure the safety, quality, accessibility, and timely availability of blood and blood products to meet the needs of all patients who require transfusion. However, there are numerous situations, particularly in the less developed world, where these prerequisites have barely been implemented. A literature search was done on matching combinations of legislation, regulation, legislation framework, with blood and blood transfusion, which resulted in almost exclusively references with respect to national and international legislation. The Ministry of Health should provide effective leadership and governance in developing a national blood system that is fully integrated into the health-care system. Essential functions of a national blood system include policy formulation, a legislation framework spelling out the principles and boundaries, standard setting, strategic and operational planning, provision of resources and national coordination, and management to ensure an adequate supply of blood and blood products and safe clinical transfusion. The structure of the national blood system will depend on the organization and level of development of the health-care system. However, all critical activities within a national blood system should be coordinated nationally to promote uniform standards, economies-of-scale, consistency in quality and safety of blood and blood products. and best transfusion practices. Keys are formulation and oversight of the implementation of the national blood policy and strategic plan; defining the roles, responsibilities, and accountability of institutions; and setting national standards for blood and blood products, services, processes, and systems; defining requirements for the registration, licensing, and operation.
Keywords: Legislation, legislative framework, regulation, transfusion medicine
|How to cite this article:|
Smit Sibinga CT. Existing and recommended legislative framework for a national blood transfusion policy. Glob J Transfus Med 2017;2:89-96
|How to cite this URL:|
Smit Sibinga CT. Existing and recommended legislative framework for a national blood transfusion policy. Glob J Transfus Med [serial online] 2017 [cited 2018 Apr 26];2:89-96. Available from: http://www.gjtmonline.com/text.asp?2017/2/2/89/214281
| Introduction|| |
Millions of lives are saved each year through blood transfusions. However, it is as well a potential source of infections and other adverse events.
In many developing countries, people still die due to unavailability or shortage of blood and blood products while many millions more are at risk of being infected by untested blood transfusions. The lack of adequate blood donor motivation and retention services, combined with the high prevalence of infectious agents, lead to high prevalence rates of infections in donated blood, for example, hepatitis B and C viruses, HIV, syphilis and other infectious diseases, such as malaria, Brucellosis More Details, and chagas.
The HIV/AIDS pandemic focused particular attention on the importance of preventing the transmission of infection by transfusion, especially in countries with a high incidence and prevalence of the disease. However, HIV infections continue to be transmitted through the transfusion of infected blood and blood products, particularly in the developing world.
Another aspect of this problem area is the cost of unsafe blood. Availability of safe supplies of blood and blood products cannot be achieved without costs. However, an unsafe or inadequate blood supply is ultimately even more costly, in both human and economic terms.
Blood transfusion is an essential part of health care. Hence, the organization of blood transfusion services should be an integral part of the national health policy and health-care infrastructure.
A literature search was done on matching combinations of legislation, regulation, legislative framework, with blood and blood transfusion, which resulted in almost exclusively references with respect to national and international legislation.
Fundamental values, principles, and ethics of the blood transfusion system
There are some universal principles and ethical norms related to a blood transfusion system with which all the specifics of the legislation must be consistent:
- Blood is a national resource;
- Blood donation is an act of human solidarity. No coercion or pressure should be brought to bear on a potential donor to donate;
- It is a nonprofit system based on voluntary, altruistic, and nonremunerated blood donation;
- The blood transfusion system is a public health responsibility and is governed by the public health philosophy. A fully integrated approach is essential;
- The safety of the blood transfusion system is paramount;
- Self-sufficiency of the country is a desirable goal;
- Optimal and rational use should be made of blood so as to avoid all wastage;
- The system should be financially viable;
- Authorities, responsibilities, and accountabilities must be clear and the system must be transparent;
- All citizens should have equal and affordable access to blood products;
- National standards must ensure that products are of uniform and high quality;
- Blood transfusion is a medical intervention that should be indicated and prescribed by a licensed physician and carried out under medical supervision and responsibility;
- The rights and duties of patients and physicians should be observed.
| Who Policy and Strategy for Blood Safety|| |
Since 1975 blood safety has been accorded a high priority by the WHO Director-general and is an issue of concern to many WHO Member States in the developed world and all of the developing countries.
Blood is a potential source of infection but also a major beneficial component of supportive treatment. Ensuring an availability of safe blood is still recognized as a neglected health-care area in many countries. Work is required not only in standard settings, but more importantly in system development, the creation of partnerships between different interests involved in the system, and legislative framework to support a proper development of the National Blood Programme.
Evidence from all over the world indicates that poor organization and a lack of coordination of blood transfusion services, as well as poor donor selection practices and unnecessary clinical use of blood and blood products are equally important factors to unsafe transfusion. To promote the provision of safe and adequate supplies of blood and reduce the risks associated with transfusion, the WHO has developed the following integrated strategy  consisting of:
- Establishing of well-organized, nationally-coordinated blood transfusion services, with quality systems in all areas that can provide adequate and timely supplies of safe blood for all patients who require it
- Collection of blood only from voluntary nonremunerated blood donors from low-risk populations and the use of stringent donor selection procedures
- Testing of all donated blood for transfusion-transmissible infections, such as HIV, hepatitis viruses, syphilis and other infectious agents, and for blood group serology
- Reduction in unnecessary transfusions through the appropriate and evidence-based clinical use of blood, including the use of intravenous replacement fluids and other simple alternatives to transfusion, wherever possible.
Effective implementation of this strategy requires a systematic approach to the organization of the National Blood Programme, including:
- Formulation of a national blood policy that defines the organizational, financial, and legal measures that will be taken to ensure adequate supplies of safe blood and blood products
- Development and implementation of a national blood plan
- Appointment of a statutory authority with responsibility for the National Blood Programme
- Establishment of a legislative framework for the National Blood Programme
- Formation of a nationally-organized or nationally-coordinated blood transfusion service, with appropriate and competent leadership
- Assurance of adequate financial resources to ensure a sustainable National Blood Programme, either through an annual fiscal budget or cost recovery
- Establishment of a quality and quality management system with an operational monitoring and evaluation (M&E) system.
| Legislative Framework for the National Blood Transfusion Policy|| |
Several countries with a long tradition of public health legislation, for example, Australia, Canada, USA, and the EU have already developed efficient and comprehensive framework legislation on blood transfusion.,,, The WHO is eager to support this development in countries which still have to build an adequate legislative framework with less resources. Hence, the initiative to encourage and facilitate the updating or revising of legislation and regulations, particularly in developing countries. It is a tool to facilitate an exchange of experience between countries and offer guidance on main issues that countries should consider when designing blood supply legislation and regulations. It focuses on the components of the blood supply system that are amenable to legislation and regulation and aims at ensuring the quality and safety of blood and blood products, as well as their equitable availability and affordability, and their appropriate and cost-effective use. The document has been developed with an awareness of two factors: Countries not only have different health systems through which they implement policies, but they also have diverse legal traditions, resources, and experiences, for example, former Soviet Newly Independent States and former colonial states. Countries need flexibility to choose a legal strategy for blood safety, appropriate to their particular needs and circumstances.
The role of blood transfusion legislation
Legislation gives expression to public policy and provides support and governance to those who are charged with authority and responsibility to implement the policy. Whatever its merit, without law no public policy could be clearly formulated, effectively implemented, and sustained. Appropriate blood transfusion legislation and an adequate regulatory system are a public health priority because of the control of the transmission of diseases by blood products.
Legislation and regulation of the vein-to-vein blood transfusion chain is a process encompassing various activities that aim to ensure that a nationally coordinated blood transfusion system under the final responsibility of the Minister of Health (MoH) is established and maintained. Such a system should be adequately financed to ensure the sustainability and affordability of the blood transfusion program on a cost recovery basis. Legislation also aims to improve the safety, quality, and efficacy of the blood transfusion system as an integral part of the health-care system. The ultimate goal is to promote and protect public health and in particular to protect and promote the health of blood donors and of recipients of blood and blood products.
The law has a specific role to play in blood transfusion due to the distinct nature of blood as a tissue. Legislation should recognize that blood is a precious and unique biological product donated voluntary and altruistically by blood donors. Thus, blood should be regarded as a national resource and not as a commercial commodity. The government, therefore, should take full responsibility for legislation and regulation of the whole spectrum of the blood transfusion process from vein-to-vein. This should include the principles of “product liability” of the procurement part and “consumer rights protection” of the clinical consumption part.
Experience in countries has shown that the development of blood transfusion legislation and regulations has occurred in successive phases, gradually and over a long period of time. Factors such as the level of development of the country (human development index), the availability of educated and trained human resources, infrastructure, and financial resources influence the type of legislative and regulatory functions that can be carried out, as well as the size and sophistication of the regulatory agency. The evolution in countries also shows that improvements in the quality of blood transfusion legislation have often occurred in response to serious blood transfusion accidents and the resulting pressure exerted on decision-makers by public groups.
| Objectives and Key Elements of the Legislative Framework|| |
An act legislating blood or blood transfusion encompasses the promotion and protection of public health through measures that guarantee the availability, quality and safety, access and affordability, and appropriate use of blood and blood products. The act should ensure that health authorities and other stakeholders coordinate their efforts to implement the measures necessary to achieve the aims (policy) of the act. The rights of citizens who may be affected by measures pursuant to the legislation should be protected and safeguarded, where the manufacturing of blood products should observe the principle of product liability.
Objectives of the act
The aim of the act shall be:
- To guarantee the quality and safety, access, and appropriate use of blood products;
- To enunciate the fundamental principles and ethics of the blood transfusion system;
- To express government support, commitment and accountability to establish and maintain a system that will ensure the safety and adequacy of the blood transfusion service as an integral part of the National Health program;
- To set up the legal framework to provide for the existence and organization of a co-ordinated network of blood transfusion services; in particular to define the statutory roles and responsibility of each of the stakeholders constituting the National Blood Programme: The MoH, the National Blood Committee/Council, the National Blood Transfusion Service, and the components of the organization to which certain responsibilities have been delegated;
- To establish the requirements for a quality system to maintain the highest possible standards in all aspects of transfusion practice and to manage, monitor and evaluate the quality of care
- To define the statutory role, responsibility, and accountability of the staff;
- To protect and promote the health of blood donors;
- To protect and promote the health of recipients of blood products;
- To provide for adequate financing of the blood transfusion system;
- To establish oversight, inspection, and enforcement authorities.
Key elements of the legislation framework
Essential issues to be covered by legislation should be read in conjunction with the principles previously elaborated. The key elements of the legislative framework are as follows:
- Expression of government commitment and responsibility to organize the blood transfusion program based on a national policy;
- Definition of the mandate, statutory role, and responsibilities of the MoH to establish and organize the national blood transfusion system and its components;
- Definition of the fundamental principles and ethics of the blood transfusion system, with which all the specifics of legislative provisions must be consistent;
- Establishing the organizational structure of the system, in particular constituting and defining the statutory role and responsibilities of the National Blood Committee:
- Constituting and defining the statutory basis either for a National Blood Transfusion Service or for a National Blood Supply and Transfusion Organization as a single agent responsible for an integrated system, nationally organized, and coordinated, to procure, process, issue, monitor and evaluate the use, outcome and adverse effects of blood products;
- When the Health Ministry entrusts all or part of the blood transfusion program to a nongovernmental organization, the law should provide for the definition of the terms of the cooperation agreement with this organization and the definition of its statutory role and responsibilities;
- Regulate the manufacture, contract fractionation, and export or import of plasma derivatives;
- Regulate the import and export of all blood products within the framework of national self-sufficiency;
- Prevent commercialization of blood transfusion and the exploitation of blood donors;
- Make provision for the registration and validation of imported equipment, disposables, reagents, test kits, and other supplies;
- Specify and make provision for control of the financial system that will ensure a viable, affordable, and sustainable blood supply and transfusion system for the country;
- Provide for human and technical resources and set the qualifications and standards required for those involved in the practice of blood transfusion;
- Define the norms, quality, standards and specifications necessary for ensuring the safety, efficacy, and quality of blood and blood products and the information required to manage the service;
- Provide for inspection and oversight of the blood transfusion system and create mechanisms for inspection, licensing, audit, and accreditation to ensure compliance with the provisions of blood transfusion legislation and the set standards and technical requirements;
- Institute penalties that are effective and proportionate and will deter transgressions that will hinder implementation of the National Blood Policy;
- State the terms and conditions under which accreditation and licences will be suspended, revoked, or canceled;
- Establish the links with other relevant interactive national legislation such as laws on health services; laws on drugs, medicines, reagents, test kits, and medical devices; laws on product liability; laws on communicable diseases; laws on data protection and privacy of medical data; laws on medical practice and treatment; and laws on the rights of patients.
Formulation of adequate national blood transfusion legislation
The legislation framework should be in accord with national policies, the degree of regulation that the government considers desirable and practicable to exercise, and the level of development in the blood supply sector. The legislative framework should be based on the key elements of providing adequate, safe, and clinically effective blood and blood products to all patients in need.
In particular, blood transfusion legislation should be sufficiently comprehensive and flexible to meet the objectives of the National Blood Transfusion Policy and the government. Flexibility can be achieved by promulgating a basic law on blood transfusion. The MoH, advised by the National Blood Committee/Council, formulates the detailed regulations to satisfy the requirements relative to the necessary quality system: organization and structure, donors, technical and quality standards, quality control and testing, inspection and audit, clinical use and patients, and oversight through appropriate monitoring and evaluation.
What is effective varies from country to country, thus the delineation between law and regulation will vary according to the country's health and legal system, infrastructure, state of development and tradition. However, in all countries the law must include the following items:
- Express government commitment and responsibility to organize the blood transfusion program and system, based on a national policy;
- Lay down ethical/legal principles that govern the blood transfusion system;
- Set up the organizational structure of the system;
- Define the areas and activities to be regulated;
- State the roles, responsibilities, rights and functions of all parties involved with blood transfusion regulation, including those of the regulator and regulated;
- Create the administrative bodies necessary for implementation of blood transfusion and define their structural and functional relationship (authority, responsibility, and accountability);
- Set up the human, financial, and technical resources;
- Set the qualifications and standards required for those handling blood and plasma;
- Define the norms, standards, and specifications necessary for ensuring the safety, efficacy, and quality of blood products and the appropriateness and accuracy of information;
- Create mechanisms to control whether the practice complies with the legislation and regulations. In particular to create mechanisms to ensure that all responsible parties are duly inspected, licensed and accredited, to ensure compliance with the provisions of blood supply legislation, as well as with the standards and specifications set for persons, premises, and practices;
- State the terms and conditions under which licences and accreditation will be suspended, revoked, or canceled;
- Establish the administrative measures and legal sanctions that will apply when provisions of blood transfusion legislation are violated.
Key components of regulations for the national blood transfusion system
Regulations pertaining to the national blood transfusion system spell out the details of the policies and Acts to which Parliament has given statutory approval. Regulations cannot be made without a special authorization from Parliament and cannot be contrary to the primary legislation. Regulations are the basis on which the operation of the blood transfusion system is based and indicate how the system should function to implement the relevant policies, strategies, goals, and objectives.
Roles and responsibilities
The principal aims of the regulations are to:
- Insure compliance with all national legislation and regulations related to blood transfusion;
- Establish efficient systems for cost-effective operational and financial management and control of the National Blood Transfusion Service;
- Ensure that sufficient and safe blood products are available to all patients;
- Establish a system for the collection of blood, platelet, and plasma donations only from voluntary nonremunerated blood donors from low-risk groups in the population who meet specified criteria for donor selection;
- Establish a program for the education, motivation, recruitment, and retention of voluntary nonremunerated safe blood donors;
- Establish a national quality system and management that will ensure appropriate quality and operational standards for the National Blood Transfusion Service and ensure that there are appropriate education and training of personnel and corrective action instituted if defects in the system or noncompliance is observed in an audit;
- Develop, document, and implement optimal standards of care for all donors;
- Develop, document, and implement a national strategy for the testing of all donations for transfusion-transmissible infections using the most appropriate and effective tests in accordance with good laboratory practice;
- Establish quality systems to ensure high standards for blood group serology, compatibility tests, and the preparation of blood components;
- Establish and maintain a national cold chain for the storage and transportation of blood and blood products;
- Establish and maintain an appropriate hemovigilance (surveillance) system and ensure that the cases of severe adverse effects or errors are reviewed and appropriate corrective and preventive action instituted;
- Provide continuing education and training for all personnel and including hospital staff who may have multidisciplinary responsibilities;
- Develop and implement a suitable and affordable information system to enable the National Blood Transfusion Service to establish and maintain a database that would form the basis for measuring the outcomes of all policies, strategies, and programs;
- Develop and promote the effective implementation of the national guidelines through the education and training of all clinical and blood bank staff involved in the transfusion process;
- Promote and contribute to research and development in relation to relevant transfusion medicine and blood safety;
- Establish and maintain an appropriate and effective system for the inspection, licensing, audit and accreditation;
- Provide periodic reports on all relevant issues to its governing body, the National Blood Committee/Council or equivalent.
| The Need to Assess and Strengthen Blood Transfusion Legislation Performance|| |
For many years most countries, the WHO  and other international organizations, for example, the EU ,,,, have striven to improve blood transfusion legislation and regulation at national and international level. These efforts have included the development of adequate norms, standards, recommendations, and guidelines. However, despite these efforts, a relatively small number of countries in the world, largely belonging to the Very High Human Development Index group  have a well-developed blood transfusion system based on an adequate and appropriate legislation and regulatory framework.
Planning for a legislative and regulatory framework
The approach should be stepwise and logic [Flow Chart 1]. Governments should assess blood transfusion legislation in their own countries using 2012 WHO Assessment Criteria for National Blood Regulatory Systems. The deficiencies disclosed in the existing legislative framework should be addressed. It is important to identify strengths and weaknesses of the legislative framework and the reasons for them. It is equally important to identify opportunities to develop and improve the system and remove all threats to the public health. Priorities should be identified and a regulatory system established that takes into account, on the one hand, local conditions and available resources and on the other hand, the international principles related to blood transfusion.
However, the main barriers that are encountered to effectively legislate for the transfusion of safe and efficacious blood to all patients in need are:
- Lack of 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;
- Weak or nonexistent consumer and professional associations.
There is a need to elaborate a comprehensive legislative framework to support a national blood transfusion system that will be more vigilant, proactive, and sustainable. This will give greater impetus to sustained control efforts and make national legislation a more effective tool. Appropriate legislation should:
- Acknowledge a policy commitment to action;
- Communicate government policy to the people;
- Set the foundation for executive action;
- Ensures that policies and strategies are effective and sustainable;
- Protects public health and the health of donors and recipients of blood and blood products;
- Respect and promote human rights and the rights of patients;
- Supports programs that produce results, by clearly defining authorities, duties, and responsibilities at every level;
- Make provisions for the human, financial, and technical resources that are necessary for quality and safety, access to, and appropriate and rational use of blood and blood products;
- Facilitate the coordination of all activities of the national blood transfusion program;
- Support and recognize international solidarity in addressing the global blood safety.
The characteristic of a good legislative process is that it is an ongoing, dynamic, and interactive process. The authorities constantly have to decide which particular interests they can satisfy within the framework of the Nation's health policy.
| Conclusion|| |
Blood transfusion is an integral part of health care and needs for its day-to-day practice from collection in the community to transfusion in the hospital, a well-designed and sustained governance and leadership, coordination and collaboration, controlled and documented provision, evidence-based clinical use and a comprehensive quality system and management.
The fundament is in the international obligation of the government to protect citizens against flaws and deviations from the universal human rights as spelled out by United Nations in 1948. To achieve the goal, a proper legislation framework is needed in which the principles are anchored and on which an adequate regulatory system is built to secure compliance and guarantee availability, safety, affordability, and universal quality of blood and blood products.
In a substantial number of countries in particular in the low and medium HDI part of the world, adequate governance and a workable legislative framework are missing or obsolete. However, in the more advanced part of the world, proper legal and regulatory systems have been instituted based on a simple framework.
WHO has developed global assessment criteria for the development and/or strengthening of national blood regulatory systems  and at regional level the Eastern Mediterranean Region (22 countries) endorsed a resolution on a strategic framework for action for blood safety and availability 2016-2025 which starts with priority interventions including the strengthening of existing legislation. These initiatives could support countries seeking such enforcement of the governance of their health care and blood transfusion system and allowing a better oversight and control.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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