|Year : 2019 | Volume
| Issue : 1 | Page : 6-15
Review of existing legislative instruments for blood systems of Countries in the WHO Eastern Mediterranean Region
Cees Theodoor Smit Sibinga1, Yetmgeta Eyayou Abdella2, Frank Konings2
1 IQM Consulting, Zuidhorn, Netherlands
2 Department of Communicable Disease Control and Prevention, Public Health Laboratories Unit, WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt
|Date of Web Publication||22-Apr-2019|
Prof. Cees Theodoor Smit Sibinga
IQM Consulting, Zuidhorn
Source of Support: None, Conflict of Interest: None
Blood transfusion is an essential part of health-care systems; contributes to saving millions of lives; improves patient expectancy and quality of life; and supports medical and surgical procedures. Blood and blood products-whole blood, red blood cells, platelets, and plasma were added to the WHO Model List of Essential Medicines (EMs) in 2013. Effective blood regulation is crucial for establishing blood products as EMs which requires countries to implement an appropriate regulatory framework and functioning regulatory authority (RA). There are numerous situations, for example, in the less developed world, where these prerequisites have barely been implemented. Existing legislative tools of the Eastern Mediterranean Region countries were collected, analyzed for relevance and appropriateness for the regulation of blood products, associated substances and relevant medical devices. Literature search on matching combinations of regulatory system/framework, legislation, regulation, with production and use of blood products resulted in few references on national and international legislation. The WHO recommendations and EU Directives were used as reference. Formal legislative and regulatory documents issued by nine countries from 1960 to 2017 were reviewed. Most are descriptions of RA, operational establishments, and specific requirements. None comply with the WHO/EU recommended format and contents; will not support effective regulatory oversight to promote and enhance the quality, safety, and availability of blood and blood products. National authorities should provide effective leadership and governance in developing a national blood system (NBS), fully integrated into the national health system. Essential functions of NBS include an appropriate regulatory framework; legislation, regulations, and nonlegislative instruments administered by an RA. These should spell out ethics, principles and boundaries, standard setting, and organization of NBS to ensure and sustain an adequate supply of quality-assured blood products and safe clinical use.
Keywords: Legislation, regulation, regulatory authority, regulatory framework, safe blood, transfusion medicine
|How to cite this article:|
Sibinga CT, Abdella YE, Konings F. Review of existing legislative instruments for blood systems of Countries in the WHO Eastern Mediterranean Region. Glob J Transfus Med 2019;4:6-15
|How to cite this URL:|
Sibinga CT, Abdella YE, Konings F. Review of existing legislative instruments for blood systems of Countries in the WHO Eastern Mediterranean Region. Glob J Transfus Med [serial online] 2019 [cited 2019 Jul 23];4:6-15. Available from: http://www.gjtmonline.com/text.asp?2019/4/1/6/256774
| Introduction|| |
Each year millions of lives are saved through supportive blood transfusions. However, the same life-saving intervention is also a potential source of infections and other adverse events.
In low- and middle-income countries, patients still die as a result of unavailability or shortage of blood and blood products while many more are at risk of being infected through blood transfusions. The lack of public awareness, combined with the high prevalence of infectious agents, leads to high prevalence rates of infections in donated blood, for example, not only hepatitis B and C viruses, HIV, syphilis but also malaria, HTLV I/II, and Chagas.
The HIV/AIDS pandemic focused major attention on the importance of preventing the transmission by transfusion, in particular in countries with a high incidence and prevalence of the disease. However, particularly in low- and middle-income countries, HIV continues to be transmitted through the transfusion of infected blood and blood products. In addition, the availability of safe supplies cannot be achieved without costs. However, 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 and blood and blood products have been included since 2013 in the WHO Model List of Essential Medicines. Hence, the organization of blood systems should be an integral part of the national health policy and health-care infrastructure. The structure of the national blood system (NBS) will depend on the organization and level of development of the health-care system. However, all critical activities within an NBS 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, regulatory framework, and strategic plan; defining the roles, responsibilities, and accountability of institutions; setting national standards for blood and blood products, services, processes, and systems; defining requirements for the registration, licensing, and operation.
The WHO  and other international organizations, including the EU,,,,, have successfully attempted to improve blood transfusion legislation and regulations at national and international levels. These efforts have included the development of strategic instruments such as adequate norms and ethics, standards, recommendations, and guidelines. However, despite these efforts, a relatively small number of countries in the world, largely belonging to the high-income countries  have a well-developed blood system based on an adequate and appropriate legislative and regulatory framework.
| Approach|| |
Existing legislative instruments of Member States of the WHO Eastern Mediterranean Region (EMR) were collected and analyzed for relevance and appropriateness for the preparation and use of blood and blood products as well as the use of associated substances and relevant medical devices. A literature search in PubMed and Index Medicus for the WHO EMR was done on matching combinations of the MESH terms “regulatory system,” “regulatory framework,” “legislation,” “regulation,” with the production and use of blood and blood products (components). The WHO recommendations ,,, and the EU Directives ,,,, were used as a reference.
| Findings|| |
The search resulted in almost exclusively references with respect to national and international legislation.
Of 22 countries in the EMR, nine responded having legislative and/or regulatory instruments, namely Egypt, Iran, Jordan, Lebanon, Morocco, Pakistan (all provinces and territories), Saudi Arabia, Tunisia and the United Arab Emirates. These instruments were put into force by their Governments between 1960 (Egypt) and 2017 (Pakistan – Sindh). Most are detailed descriptions of the regulatory authority (RA) and technical details and specific requirements of operational establishments. The contextual findings of the existing instruments of these nine countries in alphabetical order are as follows:
1. Egypt - Law No. 178 of 1960 Regulating the Collection, Storage, and Distribution of Blood and its Products, and a series of 28 Ministerial Decisions (3 from 1954) regulating various technical aspects as mentioned e.g. amending article 6 – collection, storage, distribution of blood and components; the party that shall test donors; blood transfusion procedure; conditions for donors; prices of blood and components in the Southern Region. There is no preamble, no principles, no definitions and no indication of a national organization or structure.
The contents of this Law reads in 11 articles –
- Art. 1 – regulates the need for a licence.
- Art. 2 and 3 – regulate application requirements and payment.
- Art. 4 – deals with responsibilities of licensed physicians.
- Art. 5 – handles need for a donor register to be send to Central Administration, Cairo. Ministry of Public Health approves the procedure, Central Administration shall prevent duplication of donor-cards.
- Art. 6 – establishment for Southern Region of a Blood Processing Control Council with a ToR.
- Art. 7 - Council is given power to draft its own bylaw and regulations to be approved by the Minister.
- Art. 8 – regulation of collection, storage, distribution and products. Establishing of a 'competent entity in charge of licensing, donor screening blood transfusion procedures and requirements, donor eligibility remuneration for donors, and prices of blood and its products'.
- Art. 9 – deals with Non-public or private entities to be licensed retrospectively.
- Art. 10 – violations, penalties.
- Art. 11 – publication, entry into force.
In 1999 Law no. 427 regarding establishments of specified blood transfusion centres for blood transfusion services development became in force to which the Law 178 of 1960 applies.
2. Iran - Articles of Association - Iranian Blood Transfusion Organization (IBTO) May 23, 1984. These Articles of Association have no preamble or chapters, no principles, and no definitions. They were preceded by the 1968 Iranian fourth development program allowing NGOs to recruit donors, and 1979 Directive No. 104879 transferring the managerial and operational responsibilities of the then Iranian National Blood Transfusion Organization to the Iranian Ministry of Health.
Act concerning the establishment of IBTO, October 7, 1982, with 18 articles:
- Art. 1 and 2 – Tasks, responsibilities, authorities, and accountabilities as well as IBTO structure being the sole national organization responsible
- Art. 6 – Supreme Council and Managing Director
- Art. 7 – Role and duties of the Supreme Council including the codification of regulation
- Art. 11 and 12 – Regulatory affairs
- Art. 13–17 – Human resources and financial affairs
There are 4 regulations in force: 1990 – How to handle gifts and donations granted to IBTO; 2015 – Pricing framework for IBTO services; 2015 – based on art. 7 section F: Activities of blood banks and hospital departments, with 39 articles; 2016 – Creating a Council on Ethics of Donation and Transfusion assuring the rights of donors and patients through a Code of Ethics.
3. Jordan – Blood Transfusion Services Regulation No. 83 of 2014 issued pursuant to Article 72/H of Public Health Law No. 47 of 2008. Regulation is based on the Public Health Law No. 47 of 2008 and contains 19 articles, no preamble and no anchoring of the blood transfusion principles other than a mentioning of some in specific articles, for example, article 5A and article 8. Besides detailed description in articles 3 (National Blood Transfusion Services Committee), articles 4–7 deal in relative detail with the description of the process of blood collection, separation and testing, storage and distribution. Articles 8–13 deal with aspects of clinical use of blood and blood products. Articles 14–15 describe documentation and confidentiality of data. Article 16 handles the collection of platelets in private hospitals, article 17 deals with costing; article 18 deals with violations and penalties in line with the Public Health Law. Article 19 spells out issuing of 4 ministerial instructions to enforce the Regulation.
Attached is an undated document “Requirements for Blood Transfusion Services” signed by the then Minister of Health, describing in nine articles a number of procedures related to clinical use of blood and clinical interface, ending with a list of available blood products. Both Regulation and Requirements have been published in the Official Gazette.
4. Lebanon – Decree No 4336 of 26 October 2000 Law on Creation, Regulation, and Control of Blood Transfusion Centers.
Regulation No 527/1 of 29 July 2002: Mandatory tests for biological qualification of labile blood products.
Regulation No 891/1 of 17 November 2007: Establishing conditions for hygiene and technical criteria for creating a blood center.
The 2000 Law has 4 chapters and 23 articles. No preamble or anchoring of the principles in the Law.
- Chap. I – Definition of blood transfusion center: Detailing operational functions and provisions
- Chap. II – Blood transfusion center licensing: Which includes licensing physicians. The validity date of the licenses granted not mentioned
- Chap. III – Requirements for blood donors, collection, storage, and classification: Spells out technical requirements
- Chap. IV – General Provisions: Some further authorities and responsibilities; violation penalties and prohibits commercial activities (selling and trafficking of blood).
Regulation No 527/1: 6 articles on mandatory testing and instructions in case of seropositivity.
Regulation No 891/1: 4 articles on:
- Construction criteria
- Technical requirements for light, finishing of floors, walls and ceilings, climate control, power supply, sizes of workbenches and doors, and the presence of UPS
- Requirements for hygiene and personnel safety
- Organization of labor
- List of basic materials and equipment for a blood transfusion center.
Regulation No 1873/1 of 20 November 2012 on Mandatory tests, safety measures and flat-rate for blood products.
5. Morocco – Law No 03-94 of 18 July 1995 regarding donation, processing and use of human blood. There are 3 chapters and 17 articles. No preamble and no definitions. Some principles are spelled out in articles (e.g., art. 1 – voluntary blood donation; art. 3 – anonymity of donor and recipient; art. 4 – confidentiality). Details of processes and procedures are described in formal regulations.
- Chap. I – Collection and processing of blood: 9 articles describing principles of blood donation, testing (detailed in a regulation), apheresis, autologous donation
- Chap. II – Use of blood: 4 articles, describing processing and clinical use, medical prescription, hemovigilance, fractionation of plasma, and import and export of blood and blood products
- Chap. III – Penalties: 4 articles describing penalties on violations.
Law No 23-04 of 05 December 2005 modifies article 11 of 03-94 law regulating hemovigilance in new articles 11-1 and 11-2.
6. Pakistan – The Islamic Republic of Pakistan is a Federal Republic with five Provinces (Balochistan, Punjab, Sindh, Khyber Pakhtunkhwa and Gilgit Baltistan [GB]), and two territories (Islamabad Capital Territory [ICT] and Azad Jammu and Kashmir [AJK]). No single federal legislation on blood supply and transfusion, instead there are separate provincial and regional legislations. Pakistan has a National Blood Policy (NBP) and Strategic Framework 2014–2020 endorsed by Ministry of National Health Services, Regulations and Coordination which indicates in Cluster 1: Governance under objective 6 “to implement regulatory framework through Blood Transfusion Authorities (BTAs).”
During 1997–2017, all Provinces passed their respective legislations on blood safety. First blood law approved and implemented was from Province of Sindh in 1997, followed by similar legislations passed by Provinces of Punjab and Khyber Pakhtunkhwa in 1999. The Islamabad Blood Safety Ordinance for the federal capital and federally administered tribal and northern areas (FATA, FANA) was enacted in 2002, whereas Balochistan approved its law in 2004. Since the establishment of the Safe Blood Transfusion Programme (SBTP) in 2010, these blood safety legislations have begun to be implemented, especially in the federal capital. It is important to note that GB region (earlier called FANA) became a Province in 2011 and currently does not have a blood safety legislation, its blood safety bill is under process in the Parliament at the time of the review. All provincial laws indicate in their title concern for blood safety, raising an expectation, but do not anchor and secure ethics and principles that form the foundation for safe blood transfusion and protection of the community from unsafe, unjustified, and malpractices.
A recent review showed no uniformity in Provincial legislations, although they all do focus on the establishment of a BTA, and BTA Secretary is responsible for inspection and licensing. There are a number of limitations including omission of hemovigilance, quality management, sector diversity, clinical interface, functional separation, and considerable latitude in financial penalties and physical imprisonment. SBTP from the federal level in Islamabad coordinates with provincial counterparts and has developed a dozen technical documents for the new blood transfusion system to guide and steer the reform agenda toward more uniformity.
SBTP, through the German GIZ support, has developed a design of a model Blood Transfusion Safety Act (Template 2015). Unlike the existing legislation, the template includes a comprehensive list of definitions and outlines the role and responsibilities of BTAs. It also separates the operational functions of “blood banks” into production (Regional Blood Centres) and utilization (Hospital Blood Banks) activities. The template has been followed and approved by KP, Punjab and Sindh. Balochistan, ICT and AJK, which have agreed to use the template and intend to amend their existing Act. The GB is in the process of approval of their first ever legislation based on the 2015 template.
7. Saudi Arabia – The Food and Drug Authority Law of 24 February 2007.
Four forms (15, 16, 17 and 18), dealing with:
15 – Minimum requirements for location, equipment, and staffing of general laboratories as well as authorized testing.
16 – Minimum requirements for location, equipment, and staffing of specialist laboratories as well as authorized testing.
17 – Minimum requirements for location, equipment, and staffing of hospital laboratories as well as authorized testing.
18 – Minimum requirements for location, equipment, and staffing of X-ray laboratories.
The law exclusively describes in 25 articles in detail existence, tasks, authorities, responsibilities, and accountability of the Food and Drug Authority.
Blood derivatives are captured under “biopharmaceutical.”
The four requirements (15, 16, 17, 18) spell out technical details of different types of laboratories. A blood establishment (manufacturing laboratory) or hospital blood bank (patient-oriented pre- and post-transfusion laboratory) is not captured.
8. Tunisia – Law No 82-26 of 17 March 1982 on Organization of blood collection for transfusion;
- Decree No 82-757 of 05 May 1982 (amending Decree 81-793) on Organization of a central administration (Min. Public Health)
- Decree No 83-967 of 20 October 1983 on Establishing acceptance criteria for blood transfusion organizations, their authorities, administrative organization and operations; establishing a centralized Tunisian Blood Transfusion organization
- Decree No 88-734 of 08 April 1988 on a National Blood Donor Day
- Decree No 92-116 of 13 January 1992 on Changing Decree No 83-967 (article 9, part 2)
- Decree No 94-1476 of 04 July 1994 on Special Diploma for blood donors
- Decree No 98-18 of 5 January 1998 on Establishing acceptance criteria for blood transfusion organizations, their authorities, administrative organization, and operations
- Decree No 99-742 of 05 April 1999 on a Presidential blood donor award
- Order of 05 August 1993 on composition and tasks of a National Blood Transfusion Committee
- Order of 28 September 1999 on role and tasks of a Hemobiology Committee
- Order of 02 October 1999 on approval of a Manual of Procedures
- Order of 11 October 2005 on Technical conditions for routine operations
- Circular 24 of 2007 on Hemovigilance
- Circular 49 of 13 June 2005 amended by Circular 32/2015 on Transfusion Safety.
In contextual detail, the Law and the two most relevant Decrees read -
Law No 82-26: No preamble, no definitions or fundamental principles, no chapters.
There are 11 articles spelling out responsibilities (Ministry of Health and the medical profession), some requirements are included (VNRD, processing – products and plasma, clinical use free of charge), storage and distribution, the creation of a National Blood Transfusion Committee, collaboration between military and civil blood establishments, financing and penalties. References to Ministerial decisions/regulations.
Decree No 83-967: 5 chapters and 30 articles. No preamble, no principles anchored, and no definitions.
- Chap. I – Criteria for establishing blood transfusion establishments: 5 articles on types of blood centers, qualified personnel and technical requirements (detailed in regulations)
- Chap. II – Tasks and authorities of blood establishments: 3 articles on tasks and authorities of the different blood centers
- Chap. III – Organization of the Blood Establishments: 2 sections and 10 articles describing the organization of
Section I – Blood establishments of the Ministry of Health: (a) Director and personnel, selection and appointment, tasks and responsibilities of director, classifications of personnel; (b) Advisory boards of National and Regional blood establishments;
Section II – Blood establishments of the Tunisian Red Crescent: authorization by Minister of Health.
- Chap. IV – Finances: Seven articles on finances, budgets, and accountability
- Chap. V – Miscellaneous: Four articles on the property of belongings, dissolving of blood establishments and transition.
Decree No 92-116: Two articles changing article 9 part 2 of Decree No 83-967 on selection, and nomination of the Director of National Transfusion Service.
Decree No 98-18: Revision of Decree No 83-967, with 5 chapters and 27 articles.
Preamble with reference to relevant laws and decrees, no definitions or fundamental principles. No quality system/management, no hemovigilance.
Art. 1 – Purpose.
- Chap. I – Licence conditions: Six articles on operational conditions and structure including the Tunisian Red Crescent Society and Universities (regional blood centers and hospital blood banks). Creation of a Technical Hematology Committee
- Chap. II – Tasks and authorities: Three articles on operational tasks of regional blood centers (procurement and provision) and hospital blood banks. The National and University attached regional blood centers are charged with research and development and coordinate emergency situations. National Blood Center is charged with overall coordination including the collection of plasma for fractionation
- Chap. III – Administrative organization: Two sections and 6 articles.
Section 1 – Administrative functions: Title, authorities, and appointment (by decree) of heads of National, regional centers and hospital blood banks.
Section 2 – Advisory Council: Composition (13 members, Director General presides); tasks and meetings of Advisory Council.
- Chap. IV – Financial organization: Autonomous budget attached to State budget, expenses and income based on cost-recovery
- Chap. V – Various measures: Termination of National Centre, reference to Decree No 83-967 of 20 October 1983.
9. United Arab Emirates – Blood Transfusion Law of 06 July 2008.
The document which has been given the status of law describes in two sections in detail the flow and its elements of provision and clinical use of blood. The outline follows basics of a manual, rather than a law. No preamble, no principles, no definitions other than a blood transfusion services center.
Section 1 – Administrative systems related to technical aspects of blood transfusion services centers; three chapters:
- Chap. 1 – Detailed functions and tasks of different types of blood centers such as blood donation centers, hospital-based blood banks, and mobile blood donation units
- Chap. 2 – Details of blood, main blood components, and reasons for best use, preservation fluids, storage times, testing, compatibility issues, and infectious disease testing
- Chap. 3 – Basics of handling blood and blood components, describing issues such as sterility, gamma irradiation, whole blood and components, plasma derivatives and frozen red cells. Also immunohematology testing, alloantibodies and labeling, storage and transport with a schematic tabular overview for all blood products, record keeping and product QC based on information provided by the Council of Europe Guide.
Section 2 – Safety of patient receiving blood and blood components; four chapters:
- Chap. 1 – Responsibilities of blood banks
- Chap. 2 – Responsibilities of treating doctor requesting blood transfusion
- Chap. 3 – Responsibilities of the doctor supervising blood and blood component transfusion
- Chap. 4 – Rules and controls regulating the work of blood transfusion services including a description of a hospital transfusion committee.
The literature search done on matching combinations of regulatory system, regulatory framework, legislation, regulation, with production and use of blood and blood products (components), resulted in a few references with respect to national and international legislation. The WHO recommendations and the EU Directives were analyzed as a reference cadre.
| Discussion|| |
Based on the nine countries in the WHO EMR which responded to our request, there is a variety of formal legislative and regulatory documents issued and put in force by Governments between 1960 (Egypt) and 2017 (Pakistan – Sindh). These largely provide detailed descriptions of the RA and detailed technical and specific requirements for operational establishments. However, none complies with the WHO recommended format and contents (WHO 2012 Assessment Criteria for National Blood Regulatory Systems; recent Review on “Existing and recommended legislative framework for a national blood transfusion policy”) and do not seem to be based on an established NBP (WHO Aide Mémoire for the National Health Policy Makers on Global Policy Process for Blood Safety and Availability).
There are universal principles and ethical norms related to a blood transfusion system , with which all specifics of legislative instruments must be consistent. The most elementary principles and ethical norms are listed in [Table 1]a and [Table 1]b.
Blood is a potential source of infection but also a major beneficial component of supportive treatment. Since the WHA Resolution 28.72 in 1975, blood safety has been accorded a high priority by the WHO and is an issue of concern to all WHO Member States.
Despite the efforts to achieving Universal Health Coverage (UHC), ensuring availability of safe blood is still recognized as a neglected health-care area in many countries. Work is required not only in setting standards, but more importantly in system development and governance, the creation of partnerships between different interests involved, and legislative instruments to support proper development of the National Blood System (NBS) within the cadre of accepted international ethics and principles.
Evidence from all over the world indicates that poor organization and lack of coordination of blood systems, as well as poor donor selection practices and unnecessary clinical use, are equally important factors to unsafe transfusion., To promote the provision of safe and adequate supplies of blood and reduce risks associated with transfusion, WHO has developed an integrated strategy  [Table 2].
Effective implementation of this strategy requires a systematic approach to the organization of the NBS  [Table 3].
Legislative instruments give expression to public policy and provide governance and support to those who are charged with authority and responsibility to implement the policy. Whatever its merit, without law no public policy could be effectively implemented, and sustained. Appropriate blood legislation and adequate regulatory system is a public health priority because of control of transmission of diseases by blood products and the threat of malpractice.
The process of regulating the blood transfusion chain encompasses various activities that aim to ensure that nationally coordinated blood supply and transfusion system under the final responsibility of Minister of Health is established and maintained; adequately financed to ensure the sustainability and affordability of the blood supply and transfusion systems on a cost recovery basis. The legislation also aims to improve the safety, quality, and efficacy of the blood system as an integral part of the health-care system. The ultimate goal is to promote and protect public health, in particular, to protect and promote the health of blood donors and recipients. After all blood and blood products are essential health products.
The law has a specific role to play in blood transfusion due to the distinct nature of blood (transplant tissue). The law should recognize blood as a precious and unique biological material donated altruistically by volunteers. Thus, blood shall be regarded as a national resource, not as commerce. Governments should take full responsibility for legislative and regulatory instruments to control the vein-to-vein spectrum of blood supply and transfusion process, including principles of “product liability” (procurement) and “consumer rights protection” (clinical consumption). Experience has shown that the development of a blood supply and transfusion legislative framework has occurred in successive phases, gradually and stepwise. Factors such as the level of development (Human Development Index ), availability of educated and trained human resources, infrastructure and financial resources influence the type of legislative and regulatory functions, as well as size and sophistication of the RA. Evolutions show that improvements in quality and efficacy of blood legislation have often occurred in response to serious blood transfusion events and resulting public pressure exerted on decision-makers.
The legislative framework and instruments shall be in accord with national policies, the degree of regulation that governments consider desirable and practicable to exercise, and level of development in the blood supply. It should be based on key elements of providing adequate, safe and clinically effective blood and blood products to all patients within principles of UHC. In particular, blood legislation should be sufficiently comprehensive and flexible to meet objectives of the NBTS and government. Flexibility can be achieved by promulgating a basic framework-law on blood spelling out and anchoring ethical principles. The Ministry of Health formulates and updates detailed regulations to satisfy requirements relative to these principles and necessary quality system: Organization, governance, and structure, donors, technical and quality standards, quality control and testing, inspection and audit, clinical use and patient blood management, and oversight through appropriate monitoring and evaluation (bio-hemovigilance). RA needs to be operational to establish and maintain an appropriate and effective system for inspection, licensing, audit, and accreditation and to provide periodic reports on all relevant issues to its governing body, the National Blood Committee/Forum or equivalent.
What is effective varies from country to country. Thus, the delineation between law and regulation will vary according to the health-care and legal system, infrastructure, state of development, and tradition. However, in all countries, the law must include the following themes [Table 4].
These essential and fundamental requirements then need to be documented in the managerial and operational blueprint [Table 5].
|Table 5: Managerial and operational blueprint of a national blood supply system|
Click here to view
Regulations pertaining to the NBS shall spell out details of policies and laws to which Parliament has given statutory approval. Regulations cannot be made without special authorization from Parliament and cannot be contrary to primary legislation. Regulations are the basis on which management and operations of the blood system (centralized, regionalized, or fragmented; public, NGO or private) are based and indicate how the system should function to implement relevant policies, strategies, goals, and objectives. The principal aims of regulations are:
Organization and structure
To ensure compliance with all related national legislation and to establish efficient systems for cost-effective operational and financial management and control of the system.
Standards and guidelines
To ensure that sufficient and safe blood products are available to all patients within the scope of UHC through a system of standards for collection of blood, platelet, and plasma donations from voluntary nonremunerated blood donors (low-risk groups) who meet specified criteria for donor selection; to develop and promote effective implementation of national guidelines through education and training of all clinical and blood bank staff involved.
To establish a national quality system and management that will ensure appropriate quality and operational standards for the NBS and ensure that there is appropriate education and training of personnel and corrective action instituted if defects in the system or noncompliances are observed during an audit or inspection; To develop and implement a suitable and affordable information system to enable the NBS to establish and maintain a database that would form the basis for measuring outcomes of all policies, strategies and operational programs.
Provide continuing education and training for all personnel including hospital staff who may have multidisciplinary responsibilities.
To establish and maintain an appropriate monitoring and evaluation system including a hemovigilance (surveillance) system and ensure that cases of severe deviations from standards, adverse events, or errors are documented, periodically reviewed and appropriate corrective and preventive action is instituted.
In addition, attention should be focused on how to develop, document, and implement optimal standards of care for all donors; to establish a program for education, motivation, and retention of voluntary nonremunerated loyal and safe blood donors; to develop, document and implement a national strategy for testing of all donations (transfusion-transmissible infections) using the most appropriate and effective tests in accordance with good laboratory practice and to establish quality systems to ensure high standards for blood group serology, compatibility testing, and preparation of blood products.
Equally important, regulatory aspects are to establish and maintain a national cold chain for storage and transportation of blood and blood products and to promote and contribute to research and development in relation to relevant transfusion medicine and blood safety issues of health sciences.
| Conclusion|| |
A variety of formal legislative and regulatory documents exist in the WHO EMR. So far these have been issued and put in force by Governments of only nine countries between 1960 and 2017 covering more or less detailed descriptions of the RA, the operational establishments and specific requirements. However, none of these legislative documents complies with the WHO and EU recommended formats and contents.,,,, These 9 do not seem to be based on an established NBP.
Blood transfusion is an integral part of healthcare and needs for its day-to-day practice 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 any government to protect citizens against flaws and deviations from the universal human rights (United Nations, 1948). To achieve the goal, a proper legislative framework is needed in which 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.
The WHO has developed global assessment criteria for developing and/or strengthening of national blood regulatory systems. EMR (22 countries) endorsed a resolution on a strategic framework for action for blood safety and availability 2016–2025 which starts with priority interventions including strengthening of existing legislation. In 2018, in Resolution EM/RC65/R.1 the EMR Member States are urged to take action to update the organization of their NBS and establish appropriate regulatory systems for the management of blood and blood products as EMs. These initiatives and the presence of a sample or model legislation could support countries seeking such enforcement of the governance of their health-care and blood transfusion system and allowing a better oversight and control.
The authors wish to express their sincere gratitude to national blood program managers or focal persons from Egypt (Nehad Mohamed), Iran (Fariba Seighali), Jordan (Asia Adwan), Lebanon (Rita Feghali), Morocco (Khadija Lahjouji), Pakistan (Hasan Abbas Zaheer), Saudi Arabia (Adel Al Harf), Tunisia (Slama Hmida), United Arab Emirates (May Raouf) for their supportive cooperation and collaboration in providing the relevant legislative and regulatory documents and in reviewing the manuscript.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
WHO Technical Report. Series No. 1004:67. Annex 3. Guidelines on Management of Blood and Blood Components as Essential Medicines; 2017.
Commission Directive 2004/33/EC of 22 March 2004 Implementing Directive 2002/98/EC of the European Parliament and of the Council as Regards Certain Technical Requirements for Blood and Blood Components. Official Journal of the European Union; 2004. p. 25-39.
Commission Directive 2005/61/EC of 30 September 2005 Implementing Directive 2002/98/EC of the European Parliament and of the Council as Regards Traceability Requirements and Notification of Serious Adverse Reactions and Events. Official Journal of the European Union; 2005. p. 32-40.
Commission Directive 2005/62/EC of 30 September 2005 Implementing Directive 2002/98/EC of the European Parliament and of the Council as Regards Community Standards and Specifications Relating to a Quality System for Blood establishments. Official Journal of the European Union; 2005. p. 41-8.
Commission Directive 2009/135/EC of 3 November 2009 Allowing Temporary Derogations to Certain Eligibility Criteria for Whole Blood and Blood Components Donors Laid Down in Annex III to Directive 2004/33/EC in the Context of a Risk of Shortage Caused by the Influenza A (H1N1) Pandemic. Official Journal of the European Union; 2009. p. 7-9.
Commission Implementing Directive 2011/38/EU of 11 April 2011 Amending Annex V to Directive 2004/33/EC with Regards to Maximum pH Values for Platelets Concentrates at the End of the Shelf Life. Official Journal of the European Union; 2011. p. 28-9.
Smit Sibinga CT. Existing and recommended legislative framework for a national blood transfusion policy. Glob J Transfus Med 2017;2:89-96. [Full text]
Petrini C. Evaluation of EU legislation on blood: A bioethical point of view. J Blood Med 2017;8:193-8.
Directive 2002/98/EC of the European Parliament and the Council of 27 January 2003, Setting Standards of Quality and Safety for the Collection, Testing, Processing, Storage and Distribution of Human Blood and Blood Components and Amending Directive 2001/83/EC. Official Journal of the European Union; 2003. p. 30-40.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]