Safety of blood transfusion at the international level. The role of WHO]

Blood safety is an international public health challenge, particularly since the emergence of HIV AIDS. Recognizing the gross disparities between countries in the adequacy of national blood supplies and the risks arising from poorly organized services, particularly in developing countries, the World Health Organization has developed a global strategy for blood safety and availability. Dr N. Dhingra, coordinator, blood transfusion safety, WHO Headquarters, and Dr V. Hafner, focal point for blood safety in the WHO regional office for Europe, present the main features of this strategy: well-organized, nationally coordinated blood transfusion services with quality systems in all areas; the collection of blood only from voluntary non-remunerated blood donors from low-risk populations; the quality-assured testing of all donated blood; the safe and appropriate use of blood and blood products; and global collaboration for blood safety. WHO's programs, some difficulties encountered and outcomes are also described in this article.     

Plasma fractionation in Asia–Pacific: challenges and perspectives

Patients in every country should have access to quality blood products. National health authorities play a critical role in ensuring that patients’ needs are met with safe and cost-effective products. Fractionated plasma products, as other blood products, are essential therapeutics used in the prevention, management, and treatment of life-threatening conditions resulting from trauma, metabolic congenital deficiencies, immunological disorders or infections. A few high development index (HDI) countries in the region have sufficient access to a broad portfolio of plasma products (coagulation factors, immunoglobulin, albumin) through domestic (e.g. Australia, Japan, Korea) or contract (e.g. Singapore, New Zealand) plasma fractionation programmes. China is gradually establishing a modern plasma fractionation industry. Other countries face plasma product shortages leading to inappropriate clinical use of plasma for transfusion and of non-virally inactivated cryoprecipitate, and ultimately to inappropriate treatment of patients. The volume of plasma fractionated in the region is too low to meet the needs. The volume (about 6 million l) represents 20% of the total volume fractionated worldwide for 60% of the world population. There is a rationale to encourage plasma contract fractionation programmes or operation of domestic facilities (when justified) to use local resources. However, many challenges are being faced as national plasma fractionation programmes require a mature blood collection infrastructure. Unfortunately, several LDI countries lack a mature national blood programme and a legislative framework on national policies and legislation on blood donations. They lack a safe blood donor base and a well-organized, nationally coordinated blood transfusion services; their blood collection system is scattered among different entities, resulting in non-uniform screening and testing procedures. Financial and human resources are lacking. Still, a few countries (e.g. Hong Kong, Malaysia, Singapore, Taiwan) have strengthened the national blood programmes, national blood policies have been implemented and the management of the blood transfusion service improved, allowing to implement contract plasma fractionation programme with established fractionators. Others are considering initiating (Indonesia and Malaysia) or enhancing (Thailand) domestic fractionation. Plasma fractionation programmes require good awareness and understanding by national regulatory authorities on quality criteria of plasma products. Local plasma product market and potential trends should be evaluated to determine plasma needs and the capacity to implement collection of plasma by apheresis from volunteer dedicated donors to supplement recovered plasma as a source material for fractionation. Appropriate choice of a contract fractionation partner should be made and contract terms discussed carefully. The fractionation technology and product portfolio should be evaluated to make sure that intended products can meet domestic needs (e.g. range, potency and formulation). A reimbursement policy (in particular for IVIG) for a range of proven indications should be established, as approved in the marketing authorization dossier. Confidence of clinicians and patients in the quality and safety of domestic vs. imported products should be built. With the economical development of the region and the ageing population trends, the needs for plasma products are expected to increase, justifying efforts to fractionate domestic plasma (e.g. initially through contract fractionation) and increase guarantee of supply in quality plasma products.     

Mise en place de l’hémovigilance en Afrique subsaharienne

Purpose of the studyHemovigilance being an essential part of blood transfusion safety, many countries have set legislation for its organization and its establishment. In Sub-Saharan Africa, where transfusion practice is facing many challenges, hemovigilance does not always appear as a priority. Nevertheless, in 2000, Burkina Faso decided to reorganize its blood transfusion system according to the World Health Organisation recommendations and other international standards. A national blood transfusion center and regional blood transfusion centers were created. From 2005 to 2009, a hemovigilance pilot project was conducted by the regional blood transfusion center of Bobo-Dioulasso.MethodsThe implementation of this hemovigilance project included the following steps: training of medical and paramedical personnel of the health facilities provided with blood and blood products by the regional blood transfusion center, distribution of post transfusion and hemovigilance forms, and the creation of a hemovigilance and transfusion committee.ResultsDuring the period 2005–2009, 34,729 blood products were distributed for 23,478 patients. The return rate of the post-transfusion and hemovigilance forms (number of files completed partially or completely and returned to the regional blood transfusion center compared to the number of units distributed) raised from 83.1 to 94.8%, the rate of traceability (rate of forms returned to the regional blood transfusion center and totally completed) raised from 71.6 to 91.6%, and the concordance between the patient for which the blood was delivered and the patient transfused moved from 92.9 to 98.0%. The notification rate of transfusion incidents raised from 1.1 to 16.1 per 1000 units transfused during that period.ConclusionThe implementation of a hemovigilance system is possible in the Sub-Sahara African countries. This constitutes a major element in the improvement of different steps of transfusion safety. The implementation of a hemovigilance system requires negotiations between transfusion centers and the hospital personnel, and should be facilitated by the official regulation on blood transfusion practices.     

Towards equitable and sustainable availability of blood products in Zimbabwe: An analysis of strengths,weaknesses, opportunities and challenges

Blood transfusion can be a lifesaving intervention in a number of medical emergencies. To attain sustainable and equitable availability of blood products, it is important to understand the strengths, weaknesses, opportunities, and challenges of the national blood services programme. We, therefore, with this letter to the editor, discuss some of the strengths, weaknesses, opportunities and threats to the Zimbabwean programme since its inception. Despite several strengths and opportunities that the national blood services of Zimbabwe (NBSZ) leverages on, we argue that among other challenges, donor shortages and an upsurge of transfusion transmittable infections in the eligible donor population continue to be the biggest threats to the achievement of the programme objectives. These can be addressed through expanding the blood donor base and the catchment area. Additionally, improving the level of knowledge and attitude towards blood donation in the communities is critical for driving the sustainable and equitable distribution of safe blood products to the population.     

International collaboration for blood safety: The French—African experience

Blood safety is a non-negotiable issue worldwide, specifies the World Health Organization (WHO). Africa is both an entity and a multiplicity of situations within and cross-borders. Indeed, most African countries have recent borders and political organizations, after gaining independence in the 60's. Many such countries have maintained various types of links and cooperation programs with former European countries of influence, e.g. France and Belgium among others, which is the case for several countries from the francophone Central and West Africa. Besides, borders do not delineate ethnic groups as many of them migrate, with spread North to South and East to West across several countries, each having representations, ethnologically speaking. Transfusion is an essential supportive healthcare that requires medicine, technicity and logistics. Cooperation can be provided to Francophone Africa though at the expense of recruiting donors upon criteria that do not completely overlap with e.g. those put forward in France and other high-income countries, despite WHO claims for the universal model of Voluntary Non-Remunerated Blood Donation system. Next, the patient profile in intertropical Africa—of which the various francophone African countries—stringently differs from the profile now seen in France, with its younger (but strongly social network-connected) populations and the importance of anemia of all causes but frequently infectious in nature. The frequency of antigens defining blood groups also significantly differs from that in France and the rest of Europa. Last, the carriage of blood transmissible infectious pathogens in sick but also apparently healthy populations seriously complicates the build up of suitable blood component inventory. In the present review, we discuss the universality of blood donation, the specificities of inter-continent cooperation and report on experiences of such cooperation. The French Blood Establishment EFS has taken over earlier initiatives of regional blood services and provides technology and scientific transfer and support to many countries for several decades; the National Institute for Blood transfusion, an education and research institute, has set up collaborative research in several domains but mostly in the domain of blood transmissible infections. We next also present a theoretical view of support named ALEASE, that can be pursued, based on collaborative experiences carried out in the Mediterranean Northern and Eastern areas. ALEASE promotes benchmark between participants. If there is general agreement that cooperation between economically wealthy countries and low-income, developing, countries in the domain of blood and blood transfusion safety, promotion of blood donation, blood component manufacturing, transfusion technology, hemovigilance, etc., tools to achieve this goal can be periodically reviewed based on specific needs for countries and professionals. That also comprise of adapted, sometimes specific, education programs.     

Ethics in transfusion medicine: Are the intricate layers of ethics all universal? A global view

Ethical principles have been considered, and in several respects regulated, along the entire blood procurement chain from donor motivation to transfusion to the patient. Consent of donors and voluntary non-remunerated donation are fields which have been addressed by codes of ethics and legislation. Caring for donor health is an area of further development of ethical standards. In part, blood products have also become a market, where commercial principles may synergize, but also creating issues in equality and maintaining human dignity that challenge societal solutions. At the bedside, the main global challenge remains to procure enough blood products for each patient in medical need. Allocation of rare blood, ethical evaluation of transfusion triggers, attitudes towards refusing blood transfusion and provision of blood products to remote settings are areas which should receive consideration.     

Transfusion and sickle cell anemia in Africa

Sickle cell anemia (SCA) is the commonest life-threatening genetic disorder in tropical regions, particularly in sub-Saharan Africa. It has been estimated that between 50–90% of SCA children will die in Africa before the age of 5, corresponding to a number of 150,000–300,000 annual SCA child deaths, which represents 5–10% of total child mortality. Transfusion support remains an essential component in the management of patients with SCA and has made a significant contribution to improving patient morbidity and mortality. In Africa where the majority of patients with SCA reside, many blood transfusion challenges remains, including shortage of blood supplies, risks related to infectious and immunologic potential side effects and limitation on the diagnosis and management of post-transfusion iron overload. The proportion of transfused SCA patients varies from different studies, between 30% and 90%. This variation can be related to environmental factors, disease genetic factors and other factors including the low availability of blood, difficulties in accessing to health care and inadequacies of the transfusion system. Because blood transfusion therapy is an integral component of the management of SCA, improved efforts and strategies to overcome these challenges and optimize blood transfusion practices are needed in African countries.     

Developing haemovigilance in Latin American countries

Haemovigilance is seen nowadays as a potent tool to improve quality and safety in blood transfusion. It needs to be integrated into the quality systems of the institutions active along the blood chain (blood establishments - producers of blood and blood components, hospitals - users of blood transfusions). Not many details are known about haemovigilance systems and activities in countries of Central and South America. A short survey has been undertaken in order to gain a general synoptic overview of haemovigilance in Latin American countries. The results obtained are encouraging, but show at the same time that gaps and weaknesses in the national systems need to overcome. It is obvious that a more detailed and structured study is necessary to assess the actual situation and differences and to consider measures to strengthen haemovigilance in the different national systems.     

Institutionalization of African traditional medicine in health care systems in Africa

In recent times, the phrase " traditional medicine" has become a catchword among the peoples in all countries in Africa. This has been due partly because the use of herbal remedies has gained popularity worldwide and the exploitation of these remedies has become a multimillion industry. The term "African traditional medicine" is not synonymous with "Alternative and complimentary medicine" which is a misnomer which is sometimes used. African traditional medicine is the African indigenous system of health care and therefore cannot be an alternative. In Africa, there is an important reason why African traditional medicine has become increasingly popular. The high cost of allopathic medical health care and the expensive pharmaceutical products have become unavailable to a majority of people. Naturally, the many centuries-old alternative sources of health care have become handy, often in desperate situations. In fact, the frequently quoted statement that 85 per cent of the people in Africa use traditional medicine, is an understatement because this figure is much higher and continues to increase. At the Alma Atta Declaration of 1978, it was resolved that traditional medicine had to be incorporated in the health care systems in developing countries if the objective of the "Health for All by the Year 2000" was to be realized. Notwithstanding this strategy, African countries did not come near the objective at the end of the 20th century. Therefore, the Member States of the WHO African Region adopted a resolution in 2000 called "Promoting the role of traditional medicine in health care systems: A strategy for the African Region". This strategy provides for the institutionalization of traditional medicine in health care systems of the member states of the WHO African Region. Furthermore, the OAU (African Union) Heads of State and Government declared the period 2000 - 2010 as the African Decade on African Traditional Medicine. In addition, the Director General of the World Health Organization also declared 31st August every year as African Traditional Medicine Day. All these declarations signify the importance and the approval by Governments and international institutions of the need to institutionalize African traditional medicine in health care. Therefore the mechanisms for institutionalization have to be developed to make these resolutions a reality. In view of the complexity and heterogeneity of African traditional medicine, a system of incorporation in the current health care systems has to be developed. During the last four years the WHO Regional Director for Africa and his Secretariat took up the challenge and have developed model guidelines that the Member States can adapt or adopt as may be appropriate in the respective Member States. Some of the relevant guidelines include the following: 1. Guidelines for the formulation, implementation, monitoring and evaluation of a National Traditional Medicine Policy 2. Model legal framework for the practice of traditional medicine: The Traditional Health Practitioners Bill; 3. Model Codes of Ethics for Traditional Health Practitioners 4. A Regional framework for the registration of traditional medicines in the WHO African Region; 5. A regulatory framework for the protection of intellectual property rights (IPR) and indigenous knowledge of traditional medicines in the WHO African Region. These guidelines and others provide a basis for the incorporation of African traditional medicine in a manner that would best suit a particular country. The WHO Regional Director for Africa also appointed a Regional Expert Committee on Traditional Medicine which assists in the development of these guidelines. It is important to emphasize that as more and more people use this traditional health care facility, there is an urgent need for the appropriate systems of quality control in the practice as well as in the production and use of the medicines. Such systems will protect the public and also ensure that the best practices and the most useful medicines are made available in the most affordable manner. Every country in the African region would be expected to adopt a method of incorporation that would be suitable: integrative, inclusive, or tolerant, as the case may be. It is an undeniable fact that we cannot afford to sit on the fence. All the stakeholders stand to gain a great deal in the development and promotion of African traditional medicine. In particular, all the practitioners in the present allopathic health care system will gain professionally as well as economically as they will have access to an additional culture-friendly system with which to provide services to the people. All the stakeholders must join hands in the effort to institutionalize the appropriate African traditional medicine in the health care systems in order to provide the health services that are urgently needed in the communities.     

Culture media for clinical bacteriology in low- and middle-income countries: challenges,best practices for preparation and recommendations for improved access

BackgroundCulture media are fundamental in clinical microbiology. In laboratories in low- and middle-income countries (LMICs), they are mostly prepared in-house, which is challenging.ObjectivesThis narrative review describes challenges related to culture media in LMICs, compiles best practices for in-house media preparation, gives recommendations to improve access to quality-assured culture media products in LMICs and formulates outstanding questions for further research.SourcesScientific literature was searched using PubMed and predefined MeSH terms. In addition, grey literature was screened, including manufacturer's websites and manuals as well as microbiology textbooks.ContentBacteriology laboratories in LMICs often face challenges at multiple levels: lack of clean water and uninterrupted power supply, high environmental temperatures and humidity, dust, inexperienced and poorly trained staff, and a variable supply of consumables (often of poor quality). To deal with this at a base level, one should be very careful in selecting culture media. It is recommended to look for products supported by the national reference laboratory that are being distributed by an in-country supplier. Correct storage is key, as is appropriate preparation and waste management. Centralized media acquisition has been advocated for LMICs, a role that can be taken up by the national reference laboratories, next to guidance and support of the local laboratories. In addition, there is an important role in tropicalization and customization of culture media formulations for private in vitro diagnostic manufacturers, who are often still unfamiliar with the LMIC market and the plethora of bacteriology products.ImplicationThe present narrative review will assist clinical microbiology laboratories in LMICs to establish best practices for handling culture media by defining quality, regulatory and research paths.     

Blood donation patterns and challenges in Southern Africa

Introduction:  Developing countries face significant challenges in collecting sufficient blood to meet the demands from patients. Southern African countries have implemented many initiatives to recruit and retain sufficient voluntary blood donors and the success has been varied in different countries. Objective:  To analyse blood donor patterns and challenges in the 14 Southern African countries and assess progress made in attaining a 100% voluntary donor base as well as collecting sufficient blood as per the WHO recommendations for developing countries. Results:  A literature review showed that between 2004 and 2008 very little progress has been made with regard to improving the number of blood donations per 1000 population and increasing the number of voluntary non-remunerated blood donors. When factors such as age, disease burden and poverty are factored in, the donor potential in these countries is low. Discussion:  Collecting sufficient, safe blood from voluntary blood donors continues to be a major challenge for many developing countries and co-ordinated efforts, with assistance from external organizations, is required.     

Training, skill and competences' follow-up]

Blood transfusion safety is a public health requirement, which is claimed by public health authorities and blood users too. In order to comply with transfusion safety, available national regulatory requirements must be strictly followed (or applied) by blood transfusion workers, caring nurses and physicians. Transfusion's good practices are based on knowledge of the process and the skill in blood transfusion fields. Quality systems, risks management, audits, inspections and certification programs implemented by blood establishments and patients' care services should lead to efficiency. All professionals involved in blood banking and transfusion processes (blood donation, preparation and storage of blood products, transfusion therapy...) must be qualified. They have to follow a program of continued training education. Their competence or ability must also be periodically assessed and documented to let continue and perform tasks safely.     

International challenges of self-sufficiency in blood products

To face known and emerging threats to public health, all countries have to overcome the challenges of providing sufficient supplies of blood and blood products of the highest quality and safety. Unfortunately, self-sufficiency is not yet a reality in many countries. In 2011, experts from WHO addressed the urgent need to establish strategies and mechanisms for achieving this goal. A summary of these recommendations is further discussed.     

Towards a safe and sufficient blood supply in Sub‐Saharan Africa

Most countries in Sub‐Saharan Africa (SSA) are either low‐income or low‐middle income countries, that is countries whose gross national income per capita is $995 (USD) or less or $996–3895, respectively. Added to this, they have very few health care professionals specifically trained in transfusion medicine and are the countries whose populations have a high prevalence of transfusion‐transmissible agents (especially HIV, hepatitis B and malaria) and whose patients (women haemorrhaging at birth, men in motor vehicle or motorcycle accidents, children with malaria or sickle cell anaemia) are often in urgent need of blood transfusion. This combination of few resources, both financial and human, combined with many potential donors at risk of transmitting infection and patients with urgent transfusion requirements renders the provision of a safe and adequate blood supply in SSA extremely challenging. In this review, we will discuss the current literature addressing how these challenges are being met and present one example of a SSA national blood transfusion service, the Uganda Blood Transfusion Service.     

Intérêt de la base de données régionale d’hémovigilance pour le serveur d’identités de la plate-forme régionale de dossier médical partagé

The French Health Products Safety Agency coordinates the national initiative of computerization of blood products traceability within regional blood banks and public and private hospitals. The Auvergne-Loire Regional French Blood Service, based in Saint-Étienne, together with a number of public hospitals set up a transfusion data network named EDITAL. After four years of progressive implementation and experimentation, a software enabling standardized data exchange has built up a regional nominative database, endorsed by the Traceability Computerization National Committee in 2004. This database now provides secured web access to a regional transfusion history enabling biologists and all hospital and family practitioners to take in charge the patient follow-up. By running independently from the softwares of its partners, EDITAL database provides reference for the regional identity server.     

Transfusion safety in the Maghreb region

The Maghreb region comprises five countries: Algeria Libya, Morocco, Mauritania, and Tunisia. This is a review aiming at providing an update on the situation of transfusion in the five countries. Three countries have developed regulations covering all transfusion-related activities including policy development. All the countries are running blood safety activities using a National Blood Service as the main entity. Except for Mauritania and Lybia, all the blood safety activities are centralized and conducted regularly. The blood safety indicators are globally better compared to those of sub-Saharan Africa. Despite the efforts of the states of the Maghreb region, and the progress made in the field of transfusion in these countries, shortcomings persist and concern virtually all the key elements of a national blood supply system mainly in the quality management system.     

Transposing the E. E. U. Blood Directive into national law. Perspective of Slovenia.

Transposing the Directive (2002/98/CE) into the national legislation of EU Member States represents the basis for an equal minimal safe blood transfusion and a demanding job for each of these countries. In order to do this Slovenia will need to somewhat change and supplement the legislation adopted in 2000. In Slovenia, the introduction of the quality assurance system brought on the need for changes in the field of transfusion medicine some years ago. The Directive (2002/98/CE) above all signifies obligatory supplements in the field of organization of the transfusion services and especially organization on a national level. In the field of blood donations the development of the profession itself dictates changes. If and when the Directive (2002/98/CE) refers to clinical work, it will be easier to assert the demands for a more rational use of blood, its traceability and follow-ups of adverse events of a blood transfusion. An obligation to take into account the demands and standards of the Directive (2002/98/CE) will accelerate the fulfillment of numerous tasks which we have set for ourselves in the past in order to increase the safety of blood transfusion.     

Changing educational paradigms in transfusion medicine

Over the past decades, the fields of activity and knowledge in transfusion medicine have evolved into an array of diverse areas and sub-specialities including immunohaematology, blood component production, haemapheresis, pathogen detection, methods of cell and tissue collection and manipulation, cell conservation and banking, transplant immunology and haemostaseology. Physicians in most clinical disciplines require basic or more advanced knowledge in these fields to meet the requirements of modern medicine. Specialist physicians in transfusion medicine are valuable and competent partners for these related disciplines when it comes to safe, effective and tailored haemotherapy. Transfusion medicine is thus an important qualification at the interfaces of analytical laboratory medicine, pharmaceutical production and clinical disciplines such as internal medicine, anaesthesiology or surgery. In the past, blood transmittable diseases like HIV and hepatitis and adverse reactions to blood and cellular products have led to a complex system of regulatory and technical requirements. Good laboratory practice (GLP), good manufacturing practice (GMP), quality management systems and quality control on the pharmaceutical manufacturer’s level are only a few examples of the standards in today’s blood banking. European directives in the field of blood products, stem cell preparations and tissue have harmonized national regulation and led to higher uniform quality standards for biological preparations in a unified Europe, which is the desired outcome, but which also increases the complexity of this field. By contrast, directives 93/16/EEC, 2001/19/ EC, and 2005/36/EC, the directives of the European Parliament and of the Council on the mutual recognition of professional qualifications of European doctors currently in force, do not include transfusion medicine, blood transfusion or immune haematology at all. Other medical specialities, which like our field, are not common to all member states of the European Union, are listed in the above mentioned directives with the minimum length of training and minimal requirements for the qualifications. Bearing in mind the regional particularities of the medical speciality of transfusion medicine – caused by historical developments, rigidified by national legislations and the urgent need for quality standards also on the educatory level – we support a levelled approach in transfusion medicine education. Irrespective of the required day-to-day responsibilities in the blood field, which may range from basic level experience in haemotherapy, over specific knowledge of immunohaematology and clinical haemopathology, as needed for local blood bank management, up to the highest skill level required to direct a complex transfusion service and/or blood bank at an academic medical centre, transparent service quality requires defined minimum educational standards, which could then be adapted to fit specific national requirements. A long-term objective might be to introduce the transfusion medicine specialisation into the above-mentioned EC directives in order to guarantee quality and facilitate mutual recognition of transfusion medicine qualifications throughout Europe.     

Laboratory diagnosis of tuberculosis in resource-poor countries: challenges and opportunities

With an estimated 9.4 million new cases globally, tuberculosis (TB) continues to be a major public health concern. Eighty percent of all cases worldwide occur in 22 high-burden, mainly resource-poor settings. This devastating impact of tuberculosis on vulnerable populations is also driven by its deadly synergy with HIV. Therefore, building capacity and enhancing universal access to rapid and accurate laboratory diagnostics are necessary to control TB and HIV-TB coinfections in resource-limited countries. The present review describes several new and established methods as well as the issues and challenges associated with implementing quality tuberculosis laboratory services in such countries. Recently, the WHO has endorsed some of these novel methods, and they have been made available at discounted prices for procurement by the public health sector of high-burden countries. In addition, international and national laboratory partners and donors are currently evaluating other new diagnostics that will allow further and more rapid testing in point-of-care settings. While some techniques are simple, others have complex requirements, and therefore, it is important to carefully determine how to link these new tests and incorporate them within a country's national diagnostic algorithm. Finally, the successful implementation of these methods is dependent on key partnerships in the international laboratory community and ensuring that adequate quality assurance programs are inherent in each country's laboratory network.     

Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products

Regulatory approaches for allergen immunotherapy (AIT) products and the availability of high‐quality AIT products are inherently linked to each other. While allergen products are available in many countries across the globe, their regulation is very heterogeneous. First, we describe the regulatory systems applicable for AIT products in the European Union (EU) and in the United States (US). For Europe, a depiction of the different types of relevant procedures, as well as the committees involved, is provided and the fundamental role of national agencies of the EU member states in this complex and unique network is highlighted. Furthermore, the regulatory agencies from Australia, Canada, Japan, Russia, and Switzerland provided information on the system implemented in their countries for the regulation of allergen products. While AIT products are commonly classified as biological medicinal products, they are made available by varying types of procedures, most commonly either by obtaining a marketing authorization or by being distributed as named patient products. Exemptions from marketing authorizations in exceptional cases, as well as import of allergen products from other countries, are additional tools applied by countries to ensure availability of needed AIT products. Several challenges for AIT products are apparent from this analysis and will require further consideration.