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Good Policy Process

for Blood Safety

and Availability

for National Health Policy Makers Checklist
Ensuring the safety and availability of blood and blood products is an essential Prerequisites
public health responsibility. Measures to ensure blood safety also play a major ‰ Endorsement of government
role in preventing the transmission of HIV, hepatitis viruses and other commitment and support
bloodborne pathogens in health-care settings.
‰ National blood programme
The safety and availability of blood and blood products continue to be of ‰ National blood commission/authority
major concern, particularly in the developing world, where blood shortages and ‰ National blood policy and plan
unsafe transfusion contribute significantly to the global burden of disease,
especially among women and children, the most vulnerable populations. Through ‰ Legislative and regulatory frameworks
successive World Health Assembly Resolutions, national health authorities have ‰ Adequate funding
expressed their commitment to ensuring equitable access to safe blood ‰ National blood transfusion service with
transfusion for patients who depend on it for their survival and well-being. The responsibility for the provision of blood
public health importance of blood safety issues necessitates that each country and blood products and liaison with
should establish a sustainable national blood programme with a well-formulated clinical services
national blood policy and plan, a national blood transfusion service, legislative
and regulatory mechanisms, and a structured process for policy making. Principles of good policy process
National blood policies should address all issues that could affect the quality,
‰ Decisions based on scientific, medical
and epidemiological evidence
safety, availability and accessibility of blood and blood products and should be
reviewed regularly, particularly when new issues emerge that have implications ‰ Consideration of economic, ethical and
for the national blood programme. The adoption of a set of principles that social dimensions
define a good policy process and a structured approach to policy formulation ‰ Efficiency and cost-effectiveness
enhances the effectiveness of national decision-making by health policy makers. ‰ Partnership and active participation by
Since the issues affecting blood safety and availability – and the policy decisions relevant stakeholders
to manage them – have ramifications across national borders, these should be ‰ Transparency
addressed through an international framework of decision-making, with the
following considerations:
‰ Effective communication
„ Enhanced commitment and support of national policy makers to the Structured policy-making process
principles of good policy process for blood safety and availability ‰ Situation analysis, definition of problem
„ Structured process of decision-making in accordance with national and risk identification
policies, the level of development of national blood programmes and ‰ Identification of policy alternatives
available resources
„ Improved quality of international communication and consultation on
‰ Risk assessment and analysis
blood policy making as an ongoing, dynamic and interactive process. ‰ Identification of preferred policy option
and policy formulation
While many countries may be confronted with similar, often complex, policy ‰ Communication of policy decisions and
decisions, the available policy options, priorities for intervention and the optimal risks
allocation of resources will vary. Good policy process assists national health
authorities to address known and emerging threats to blood safety and ‰ Policy implementation
availability while ensuring the flexibility to address these issues according to ‰ Monitoring and evaluation
varying national contexts, needs and resources. Additionally, a common ‰ Risk management
framework for communicating the basis of national blood policy decisions
improves the quality of international dialogue and collaboration on issues of Assessing policies
common concern. The integration of scientific, economic, ethical and social ‰ Impact on health outcomes
considerations into public health policies is fundamental to good policy process. ‰ Access and fairness of policies
Surveillance procedures and haemovigilance systems are needed to monitor ‰ Cost and value for money
adverse events and known threats to blood safety and availability and to enable ‰ Scientific evidence to back policy
informed policy decisions to be taken in response to new challenges, threats and
opportunities. Such policy decisions may include:
‰ Operational capacity of institutions
„ Restructuring of a national blood transfusion service
‰ Legal issues and international
„ Introduction or modification of criteria for donor selection and deferral
„ Introduction of a new strategy and/or technology to enhance the safety,
quality, supply or use of blood and blood products.
‰ Risks, public health and safety

Developed by WHO/Blood Transfusion Safety with the support of the Global Collaboration for Blood Safety, a WHO-hosted network.
© 2008 World Health Organization. All rights reserved. WHO/EHT/08.02. Printed January 2008.
Key elements
Principles of good policy process
Policy decisions for blood safety and availability bloodborne pathogens and the cross- „ Participation and partnership: involve-
should be based on up-to-date scientific, cutting role of blood transfusion in ment of relevant stakeholders in the
medical and epidemiological evidence, with underpinning programmes of major public policy process, under the umbrella of the
due consideration of economic, ethical and health importance, including maternal and national blood commission/authority,
social factors. Decisions should be made in the child health, medical and surgical to ensure the legitimacy and effectiveness
interests of public health and promote procedures, and in emergency and disaster of policy; stakeholders include ministry
optimal use of available resources. Desired situations. of health, national blood transfusion
outcomes and goals should be clearly The establishment and endorsement of a service, regulatory agency, experts in blood
identified. Authority, responsibility and good policy-making process is based on the transfusion, clinicians, blood donor
accountability for the implementation of following principles: organizations, nongovernmental
policy decisions, including structural and „ Evidence-based: maximization of health organizations, patient associations and
functional relationships, should be clearly outcomes when decision-making is the media
defined. based on robust evidence „ Transparency: clear and open policy
Measures to ensure the safety, availability and „ Efficiency and cost-effectiveness: process to help ensure the legitimacy and
accessibility of blood transfusion should be prioritization of resource allocation in effectiveness of blood policy
given a high priority within the health care the context of overall public health and „ Proactive communication: to ensure public
system given the importance of preventing the prudent use of human, technical and awareness of the needs, benefits and risks
the transmission of HIV, hepatitis and other financial resources associated with blood policy issues.

Key questions for policy makers „ Commitment to ethical principles, Policy implementation
and stakeholders including accountability and
transparency Policy implementation should use appropriate
Policy making should be a structured, mechanisms to ensure maximum compliance
„ Access to relevant information by
stepwise, cyclical process. Policy makers and with the policy. Government may choose to
relevant stakeholders and their inputs
stakeholders should address the following collaborate with, or entrust policy implem-
into the identification and review of
questions: entation entirely to, partners in civil society
policy alternatives
„ What is the problem to be solved? and the private sector.
„ Formal analysis of policy options,
„ What is the proposed intervention?
including: Assessing policies
„ What are the known and likely positive – Risk assessment, analysis and risk–
and negative effects of the intervention? benefit ratio A policy can be systematically assessed using
„ Do the positive effects outweigh the – Cost-effectiveness and cost-benefit a range of methods to determine its impact,
negative effects? analysis value and feasibility. The following issues
„ What is the cost of the proposed – Feasibility: technical, administrative could be used in assessing policies on blood
intervention? and political safety and availability:
„ What is required to make the – Education and training requirements „ Impact on health outcomes and public
intervention work? – Sustainability health: assessing improvements in the
„ How can equity and sustainability be quality, safety and availability of blood
– Timeliness of options
assured? and blood products
„ Evaluation of strategies to avoid or „ Access and fairness: assessing the effects
„ What options are lost if the intervention reduce risks.
is adopted? on access to safe blood and blood
products and the impact on individuals
„ How often and by what criteria will the Preferred policy option
and groups (e.g. region, gender, ethnic,
intervention be reviewed? and policy formulation
Situation analysis and The selection of the preferred policy option „ Cost and value for money: assessing cost-
problem definition and policy formulation should be based on effectiveness and correlation with impact
the formal analysis of alternative inter- „ Scientific evidence: assessing if credible
Objective situation analysis is required at ventions as well as consideration of social scientific evidence supports the policy
regular intervals. This should include: and political factors, including the likely „ Operational capacity: assessing the
„ Definition of the problem and its causes effects on public confidence. operational capacity of the institutions
„ Review of existing policy to identify involved and their compatibility with the
limitations Communication requirements of the new policy
„ Assessment of strengths, weaknesses, „ Legal issues and international agreements:
The effective communication of the e.g. on the movement of blood and
opportunities and threats decision requires a systemic strategy that
„ Review of scientific and medical evidence
blood products across borders
cuts through the entire policy process. In „ Risk, public health and safety: assessing
and epidemiological data order to retain public confidence, a clear implications for the public, including
„ Identification of actual and potential risks. statement is required of the scientific, vulnerable groups and the environment,
economic, social and political rationale for in relation to the provision and use of
Assessment of potential the decision and the benefits and risks
interventions blood and blood products, infection
associated with the policy. control in health-care settings and
The identification and assessment of The opportunities and actions required by management of biohazardous clinical
potential interventions should include: different stakeholders should be highlighted. waste.

Blood Transfusion Safety

Department of Essential Health Technologies
World Health Organization
1211 Geneva 27, Switzerland
Fax: +41 22 791 4836 E-mail: bloodsafety@who.int www.who.int/bloodsafety