African Standards for African Traditional Medicine, role of the TBT Programme

Posted on: March 24, 2015


The 2013 WHO Report on Traditional Medicine defines it as “the sum total of the knowledge, skill, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness”. Also this Report also states that the number of African countries with national Traditional and Complementary Medicine (T&CM) policies increased from eight in 1999/2000 to 39 in 2010, and those with national T&CM strategic plans rose from zero to 18. Country regulatory frameworks increased from one in 1999/2000 to 28 in 2010, including various instruments such as the code of ethics and the legal framework for T&CM practitioners.

In recognition of the wide use and hence the importance of integrating traditional medicine into their national health systems, the Heads of States and Governments in their meeting in Lusaka, Zambia in July 2001 declared the Decade of African Traditional Medicine from 2001-2010 in order to create an enabling environment for optimising its contribution (AUC 2007).

In order to implement the Lusaka Decision of the Heads of States and Governments (AHG/DEC. 164 (XXXVII)) (AUC, 2001), 2nd ordinary Session of the Conference of African Ministers of Health (CAMH2) meeting in Gaborone, Botswana from 10th – 14th October 2005 approved the Plan of Action on the AU Decade of African Traditional Medicine 2001-2010 (AUC, 2005).

The Progress Report on Decade of African Traditional Medicine in the African Region (WHO-AFRO, 2011) indicates that during the Decade countries popularized traditional medicine, established and strengthened their institutional capacity and developed national policies and regulatory frameworks for the practice of traditional medicine. Countries also made progress in establishing national programmes and expert committees for the development of traditional medicine in their ministries of health.

By 2010, 22 countries (Benin, Burkina Faso, Burundi, Cameroon, Cote d’Ivoire, DR Congo, Ethiopia, Ghana, Guinea, Kenya, Madagascar, Mali, Mozambique, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Togo, Uganda, Zambia and Zimbabwe) were conducting research on traditional medicines for malaria, HIV/AIDS, sickle-cell anaemia, diabetes and hypertension using WHO guidelines. Subsequently four countries (Burkina Faso, Cameroon, Democratic Republic of Congo and Madagascar) included traditional medicines in their National Essential Medicines Lists (NEMLs). The number of countries that included traditional medicine in their NEMLs has increased from only one (Mali) in 1999/2000 to five countries. Examples of traditional medicines in the NEMLs include Saye‖ and N’dribala‖ used for malaria treatment in Burkina Faso and Madeglucyl‖ for treatment of uncomplicated diabetes in Madagascar.

Twelve countries (Burkina Faso, Cameroon, Democratic Republic of Congo, Ghana, Madagascar, Mali, Mauritania, Niger, Nigeria, Rwanda, Sao Tome Principe, Senegal, Seychelles, South Africa and Zimbabwe) issued marketing authorizations for traditional medicines, ranging from three in Cameroon and Congo to over 1000 in Ghana and Nigeria, as compared to only Mali at the time of the baseline survey. In 1999/2000, 16 countries (Burkina Faso, Cameroon, Democratic Republic of Congo, Ghana, Madagascar, Mali, Mauritania, Niger, Nigeria, Rwanda, Sao Tome Principe, Senegal, Seychelles, South Africa and Zimbabwe) produced traditional medicines locally on a small-scale.

By 2010 six countries (Botswana, Cameroon, Chad, Ghana, Nigeria and South Africa) had national tools for protection of IPRs and TMK as compared to zero in 1999/2000. Eight countries (Benin, Cameroon, Democratic Republic of Congo, Ghana, Guinea, Mali, Senegal and South Africa) established databases on traditional medicine practitioners, TMK and access to biological resources. Democratic Republic of Congo, Ghana and Nigeria developed national herbal pharmacopoeias. Cameroon, Chad, Cote d’Ivoire and Seychelles carried out national inventories of medicinal plants.

These statistics show the value of traditional Medicine. The Chairperson of the ARSO Technical Harmonisation on African Traditional Medicine, Ms Amanda Gcabashe (left in the picture accompanied by the THC 13 Secretary Ms. Rahba Muhammed of SSMO, Sudan) of South African Bureau of Standards (SABS, 2013) indicated, at the launching of the ARSO THC 13, that global trade in traditional medicine was

estimated at US$ 83 billion dominated mainly by western herbal medicine, Traditional Chinese Medicine (TCM) and Ayurveda with the African share being insignificant. Gcabashe (2013) further explained that African Traditional Medicine (ATM) is our common heritage and is a reality in regional trade.

For many Africans, Traditional healers are often the first and last line of defence against the most contagious and debilitating diseases that plague their lives. The World Health Organization (WHO) estimates that 80 per cent of people in Africa regularly seek their services. This can be attributed to easy access. It is a fact that access to medication is a big issue in Africa. WHO-AFRO (2010) explains that traditional medicine is popular because it is generally available, affordable, and commonly used in large parts of Africa, Asia, and Latin America.

However the issue goes beyond access, Traditional healing is linked to wider belief systems and remains integral to the lives of most Africans. Herbal medicines have the advantage of reconciling health with traditions. Doctors trained in the Western sciences largely focus on the biomedical causes of disease, while traditional beliefs take a more holistic approach. In Africa, traditional healers are reputed to divine the cause of a person’s illness or social problems. Many have in-depth knowledge of plant materials and their various curative powers. They use leaves, seeds, stems, bark or roots to treat symptoms. Animal parts and minerals are also employed, but to a lesser extent. Most traditional healers are both herbalists and diviners.

Prohibitive medical costs also make it impossible for the poor to get medical attention. People are opting for traditional healers, who do not always demand cash up front and who far outnumber doctors. People consult traditional healers whether or not they can afford medical services.

It is important to note that Traditional healers, with a vast knowledge of herbs, are already a trusted source of health information and treatment even if they are not mainstreamed in the national healthcare systems.

The concern for many professional doctors, including the Doctors for Life is that most of the medicines used by traditional practitioners have not been validated scientifically. There is a belief that many people suffer because of the serious complications that arise due to the use of traditional medicines. To avoid such complications professionals are urging that remedies be thoroughly researched before approval. However many agree that traditional doctors can been valuable when it comes to developing new medications, reporting new cases of contagious diseases and finding ways to ensure that patients stick to their prescribed treatments.

To an extent, an informal system of referral already exists between traditional practitioners and doctors. But traditional healers complain that information largely flows in only one direction. Dr. James Hartzell, a professor at South Africa’s University of KwaZulu/Natal medical school attests to this and confirms that Traditional healers already send referral letters to clinics mostly inquiring about prescriptions given.

Ms. Nora Groce and Ms. Mary Reeve, medical anthropologists, argue that open lines of communication between traditional healers and the medical community could tremendously improve surveillance (Itai Madamombe, 2006). They maintain that Health officials must include traditional healers in their educational outreach to doctors and must be trained to know what information they should request from healers. They note that Traditional healers must be taught why, what, when and how to report unusual symptoms in their patients to local officials, maintaining that checklists or pictorial guides to symptoms, diseases and modes of transmission could facilitate communication between healers and officials.

While reporting that several African countries and Regional Economic Communities (RECs) were having initiatives to incorporate ATM in their healthcare systems, WHO-AFRO (2010) recognizes that there is need for building capacity of countries in order to ensure sustainability, Good Agricultural, Collection and Conservation Practices of medicinal plants and Good Manufacturing and quality control practices of traditional medicines.

WHO-AFRO (2010) explains that in order to boost the role of traditional medicine in national health systems, the Summit of Heads State and Government in their meeting in July 2003 in Maputo endorsed the observation of the African Traditional Medicine Day on 31st August of every year.

WHO advocates incorporating safe and effective traditional medicine into primary health-care systems. In 2002, the organization issued its first comprehensive guidelines to help countries develop policies to regulate traditional medicine.

All these debate and initiatives indicate that African population tends to use more and more traditional and complementary medicine for their primary health and thus represent an important economic pillar provided that countries adopt the right standards.

The economic science distinguishes one major role of standards as promoting the increasing demand for complementary goods and raising elasticity of substitution in demand between versions of similar products as well as enhancing product reputation, consumer confident and safety and providing for lesser market risks for companies introducing products to the market.

In this context, the work undertaken by the African Standardization Organization (ARSO) in general and in the T&CM sector in particular, through the ARSO Technical Harmonization Committee (THC) on Traditional Medicine No. 13 (ARSO THC 13), is crucial for the continent. Adopting the appropriate standards will not only encourage trade and economic growth, help develop good agricultural practice, create jobs but will also make safe and quality herbal products available to the people at large. African Experts for the ARSO THC 13 meeting in Nairobi in December 2014.

The ARSO THC 13 harmonises terminologies and technical terms to facilitate exchange of information among stakeholders involved in African Traditional Medicine and create a common platform for understanding concepts, theories and technical aspects. The initiative will assist in setting national standards for ATM in countries with health systems that are evolving national ATM regulatory systems.

ARSO/THC 013 aims to contribute to the maintenance of health and improvements of health care through the use of Traditional Medicine; to support the quality, safety and effectiveness of products; support good manufacturing practices, good agricultural and collection practices and to assist in the trade and commerce of related goods and services. More important, this initiative is promoting the visibility, viability, applicability and modern favourable attitudes to ATM among professionals in African populations.

In order to accelerate the work of the THC on Traditional Medicine, ARSO, with the support of the TBT Programme, launched in December 2014, activities related to the harmonization of standards in African traditional medicine. From Tuesday, 2nd of December 2014 to Friday, 5th of December 2014 the African Experts for African Traditional Medicine under the ARSO THC 13 held its first meeting in Nairobi, Kenya, to launch the first activities related to standards’ harmonization, for which the preparatory work had started in July 2014 with the development of draft harmonized standards.

This meeting was the first of the two, to take place within the framework of the ACP-EU-TBT Programme Project “Harmonization of African standards – Traditional Medicine, the first being held in Kenya on 2nd – 5th December 2014 while the second being held on 2nd – 6th March 2015 in Mauritius.

During the four days launching meeting in Nairobi, more than twenty delegates from all over Africa, including the Project Team Leader Prof. Ameenah Gurib Fakim, discussed working drafts of seven standards on African traditional medicine, which were produced by the project and submitted for consultation to ARSO member states prior to the workshop.

The Mauritius meeting was also graced by the Acting Director of Mauritius Bureau of Standards, Mrs. Mrs R Nanhuck, ARSO Secretary General, Dr. Hermogene Nsengimana and Valentin Gerold of BKP Development Research & Consulting GmbH Jutastr, Germany. 

During the Mauritius Meeting, the Experts also had the opportunity to discuss the ARSO Policy documents on General Technical Regulations Framework for African Countries, General National Quality Policy for African Countries and Criteria for Classification and Identification of NTBs.  It is noted that Good Regulatory Practice can contribute to the improved and effective implementation of the substantive obligations under the TBT Agreement.  Effective implementation through best practices is seen as an important means of avoiding unnecessary obstacles to trade.  Institutionalizing the various mechanisms, processes and procedures of Good Regulatory Practice through laws, regulations and guidance, as well as through the creation and designation of institutions within Member governments to oversee regulatory processes, is seen as a means of giving effect to Good Regulatory Practice.

The standards (FD ARS 950-2014, African Traditional Medicine — Glossary, FD ARS 951-2014, African Traditional Medicine — GMP for herbal medicines, FD -ARS 952-2014, African Traditional Medicine — Guidelines on good agricultural and collection practices for medicinal plants, FD -ARS 953-2014, Traditional African Medicine — Certification scheme for medicinal plant produce, FD -ARS 954-2014, Minimum requirements of registration of herbal medicines

(vi) FD -ARS 955-2014, Technical guidelines for safety, efficacy and quality of raw materials and herbal medicines) being developed by ARSO with the support of the TBT Programme will ensure that these standards are acceptable to ARSO member countries and eventually across the continent. There is a greater emphasis on the use of Good Regulatory Practice (GRP) and the WTO TBT Agreement Code of Good Practice for the Preparation, Adoption and Application of Standards, which outlines for the general principles for development and application of voluntary standards. The Development of the ATM Standards stresses the importance of ensuring the effective application of the Code of Good Practice following the full application of the six principles set out.

The Mauritius meeting also provided the opportunity for training the Experts on the WTO TBT/SPS Issues. The WTO Agreement on Technical Barriers to Trade (TBT) sometimes referred to as the Standards Code 1979 aims to reduce impediments to trade resulting from differences between national regulations, standards, and conformity assessment procedures. It obliges Members to ensure that technical regulations, voluntary standards, and conformity assessment procedures do not create unnecessary obstacles to trade, and it is one of the least understood Agreements amongst many trade players in Africa. The TBT Agreement applies in principle to all products, both agricultural and industrial, while the scope of the SPS Agreement is more limited, as it covers only products related to issues of human and animal health.

The results of the deliberations in Nairobi and Mauritius meetings, supported by the ACP-EU-TBT Programme are now being considered as Final Draft Standards to be recommended for adoption in accordance with the African Standards Harmonisation Model (ASHAM), Good Regulatory Practice and Code of Good Practice.

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