INTELLECTUAL PROPERTY: WHO-WIPO-WTO BOOK
Chapter 2: The policy context for action on innovation and access
D. Traditional knowledge and traditional medicine
Traditional medicine has long been used as a mainstay of health care for many populations. This section reviews a number of issues concerning traditional medical systems with respect to IP, regulatory systems and trade.
1. Traditional medicine knowledge systems
Traditional medicine is the sum total of the knowledge, skills 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 to prevent, diagnose, improve or treat physical and mental illnesses (WHO, 2000b).1 It is used as a comprehensive term to refer both to traditional medicine systems such as Traditional Chinese Medicine (TCM), Ayurvedic medicine and Unani medicine, and to various forms of indigenous medicine being practised traditionally. It is thus best understood as a set of distinct systems of knowledge that include different therapeutic philosophies, products and practices. Traditional medicine that has been adopted by other populations (outside its indigenous culture) is often termed “complementary and alternative medicine” (CAM) (WHO, 2002b).
Traditional medicines can be of different composition, including herbs, herbal materials and preparations, and finished herbal products (herbal medicines). They may also use animal materials or mineral materials. Their active ingredients are therefore substances derived from
plants, animals or minerals.2 Traditional medicine is used widely throughout the world, but especially in developing countries. In some Asian and African countries, 80 per cent of the population depend on traditional medicine for primary health care. In many developed countries, up to 80 per cent of the population has used some form of CAM, such as acupuncture.3
Herbal treatments stand out as the most popular form of traditional medicine. International trade in traditional medicines is growing, with the China Chamber of Commerce for Import and Export of Medicines and Health Products reporting exports of US$ 1.8 billion in 2010. 4 Traditional medicines are increasingly being used outside the confines of traditional cultures and far beyond traditional geographical areas without proper knowledge of their use and the underlying principles. They are also being used in different doses, extracted in different ways and used for non-traditional indications (WHO, 2004a).
The WHO, in cooperation with its member states, promotes the rational use of traditional medicine for health care.5 The WHO monitors the status of traditional medicine around the world and has published a worldwide review on how traditional medicines and CAM are recognized and regulated at a national level. This work aims to facilitate the development of legal frameworks and the sharing of experiences between countries (WHO, 2001b). The WHO has also published a report on a WHO global survey on national policy on traditional medicine and regulation of herbal medicines (WHO, 2005b).
The WHO is currently updating its traditional medicine strategy and, for this purpose, is undertaking a second global survey. The WHA has also adopted a number of resolutions relating to traditional medicine:
- In 1988, referring to the Chiang Mai Declaration, the WHA resolution on medicinal plants placed medicinal plants, their rational and sustainable use, and their conservation, firmly in the arena of public health policy and concern.6
- In 2003, a WHA resolution on traditional medicine, referring to the WHO traditional medicine strategy, requested the WHO to collaborate with other organizations in the UN system and NGOs in various areas related to traditional medicine, including research, protection of traditional medical knowledge and conservation of medicinal plants resources.7
- Regarding the GSPA-PHI, the WHO identified traditional medicine as one of the areas to be addressed in its Quick Start programme. The programme aims “to support research and development and to promote standard-setting for Traditional Medicine products in developing countries”.8
- In 2009, a resolution on traditional medicine referred to the Beijing Declaration, which urges national governments: to respect, preserve and widely communicate traditional medicine knowledge while formulating national policies and regulations to promote appropriate, safe and effective use; to further develop traditional medicine based on research and innovation; and to consider the inclusion of traditional medicine in their national health systems.9
2. Traditional medical knowledge in international health and IP policy
In international debates, the term “traditional knowledge” (TK) has been used in a broad sense in many contexts, notably in policy discussions on the environment and biodiversity, health, human rights and the IP system. The term itself has no agreed international legal definition (WIPO, 2001).10 In this study, “traditional medical knowledge” is used in a specific context, referring to the content or substance of TK, skills and learning, with specific application to human health, wellness and healing. It may apply to traditional medicines as such, or to knowledge systems relating to medical treatment (such as healing massage or yoga postures).
Traditional medicine systems can be categorized as follows:11
- Codified systems which have been disclosed in writing in ancient scriptures and are fully in the public domain. These include the Ayurvedic system of medicine, the Siddha system and the Unani Tibb tradition. TCM, which is disclosed in ancient Chinese medical texts, is another example of a codified system.
- Non-codified traditional medicinal knowledge which has not been fixed in writing often remains undisclosed by TK holders and is passed on in oral traditions from generation to generation.
The past decade has seen greater attention paid to traditional medical knowledge in several international policy contexts. For example, the United Nations Declaration on the Rights of Indigenous Peoples,12 which was adopted in 2007, states: “Indigenous peoples have the right to their traditional medicines and to maintain their health practices, including the conservation of their vital medicinal plants, animals and minerals”. It also cites medicines within the context of the “right to maintain, control, protect and develop their cultural heritage, TK and traditional cultural expressions, as well as the manifestations of their sciences, technologies and cultures”.
3. Traditional medicines regulation
The high prevalence of traditional medicines throughout the world, coupled with efforts to integrate traditional medicines in modern national health systems, has increased the demand for information on the safety, efficacy and quality of these medicines. As with other medicines for human use, traditional medicines should be covered by regulatory frameworks to ensure that they conform to required standards of safety, quality and efficacy, according to the status and position of traditional medicine in the country’s national health policy and health system. The regulation of traditional medicines takes many different forms around the world. Depending on the national legislative and regulatory framework, they can be sold as prescription or non- prescription medicines, dietary supplements, health foods or functional foods.
Additionally, the regulatory status of a particular product may differ in different countries. The same herbal product can be considered differently if it is traded between two countries which have different regulatory approaches and requirements. Herbal products which are categorized as something other than medicines and foods are becoming increasingly popular, and there is potential for adverse reactions due to lack of regulation, weaker quality control systems and loose distribution channels (including mail order and Internet sales) (WHO, 2004a).
In 2006, the International Regulatory Cooperation for Herbal Medicines (IRCH), a global network of regulatory authorities responsible for the regulation of herbal medicines which operates in conjunction with the WHO, was established. Its mission is to protect and promote public health and safety through improved regulation of herbal medicines.13
Currently, over 120 WHO member states regulate herbal medicines. To support the efforts of member states in establishing and implementing effective regulation of herbal medicines, the WHO has published key global technical guidelines, in terms of their quality, safety and efficacy and sustainable use. Several other sets of guidelines are in development, including guidelines on the assessment of herbal medicines, the methodology for research and evaluation of traditional medicine, good manufacturing practices (GMPs) for herbal medicines as well as conservation and sustainable use of medicinal plants, such as good agricultural and collection practices (GACP) for medicinal plants.14
In addition, the WHO has developed a series of volumes of WHO monographs on selected medicinal plants, which aim to provide scientific information on the safety, efficacy and quality control of widely used medicinal plants. The WHO provides models to assist member states in developing their own monographs or formularies for these and other herbal medicines, and it also facilitates information exchange among member states.15
Growth in international trade in traditional medical products has sparked discussions on the trade impact of regulations. In recent years, WTO members have notified the WTO Committee on Technical Barriers to Trade (TBT Committee) in relation to a range of regulations that have a direct bearing on traditional herbal medicines. Such regulations include: GMPs for the production of herbal remedies (Mexico); regulation of herbal medicines for the protection of public health (Peru); inspection of herbal medicines for the protection of consumers and the promotion of public health (Republic of Korea); and regulations on the preparation of herbal medicine for human consumption (Kenya).16 Reflecting the TBT Agreement principle that countries are encouraged to apply international standards, a number of these notifications refer to various WHO guidelines on herbal medicines.17
The trade interest of countries such as China, Ecuador and India in in traditional medicines has been apparent in the continuing TBT Committee discussions on the impact on these countries’ exports to the European Union. The Directive 2004/24/EC on traditional herbal medicinal products18 provides a simplified regulatory approval process for traditional herbal medicines through a single approval which has effect across the European Union.
4. Concerns about misappropriation of traditional medicines
Research is continuing on traditional medicines and traditional medical knowledge in various different areas, each generating a multitude of policy issues:
- 0Traditional health practitioners develop their expertise through observation, building on empirical understanding about the use of traditional formulations. Many countries increasingly seek to preserve and promote traditional medicine systems.
- Research efforts are being made to scientifically and clinically validate traditional medicines, to integrate them into countries’ health systems.
- Traditional medicine and medical knowledge provide leads for the development of new treatments. Many existing modern medicines are originally based on herbal products. For example, oseltamivir, used to treat various influenza infections, is based on shikimic acid, which is isolated from Chinese star anise, a cooking spice used in TCM.19 Current malaria treatments contain synthetic derivatives of artemisinin, which is derived from a plant, sweet wormwood, or Artemisia annua. This is an ancient Chinese medicine still used in modern practice that was used to treat malaria- stricken soldiers during the Viet Nam War and was developed through international partnership into a widely used pharmaceutical product for malaria treatment (Rietveld, 2008).
- Reflecting the clinical significance of traditional medicine, some programmes undertake an “integrative” approach, looking for synergies between “traditional” and “conventional” medical research. One such example is a research programme on good practice in TCM Research in the post-genomic era (Uzuner et al., 2012) and initiatives to integrate traditional and contemporary cancer care in the Middle East (Ben- Ayre et al., 2012).
The use of genetic resources (GR) and associated TK is primarily regulated by the Convention on Biological Diversity (CBD) and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (Nagoya Protocol). National biodiversity policies frequently reference traditional medicines and medical research. Many other national policies seek to create medical R&D programmes on the basis of their heritage of GR and associated TK.
The essential effect of the CBD and the Nagoya Protocol is to confirm national sovereignty over GR and to establish a right of prior informed consent (PIC), approval and involvement, over the access to, and use of, associated TK. Many of the issues highlighted in this debate concern genetic materials used as the basis for medical research, and traditional medical knowledge that is either used directly to produce new products or is used as a lead in researching new treatments. The principal shift in focus has been to recognize that: (i) the custodians and practitioners of traditional medical knowledge may have legitimate rights; (ii) their knowledge cannot be assumed to be in the public domain, free for anyone to use; and (iii) as financial and non-financial benefits from R&D are shared along the product development pipeline, an equitable portion should also be provided to the origin or source of the material used in research. The Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) has called for benefits derived from TK to be shared with the respective communities (WHO, 2006b).
How to apply PIC and equitable benefit sharing (EBS) has sparked a wide-ranging debate.20 With regard to IP, however, the policy issues can be distilled into two broad themes:
- First, whether patents and other IPRs can and should be obtained over inventions derived from TK and GR. In particular, what mechanisms, if any, should be put in place to ensure that patents are not erroneously granted over TK and GR and that patent holders comply with the principles of PIC and EBS. Strategies to ensure that third parties do not gain illegitimate or unfounded IPRs over TK subject matter and related GR are known as “defensive protection”, such as measures to pre-empt or to invalidate patents that claim pre-existing TK as inventions.
- Second, how to recognize and give legal and practical effect to positive IPRs that owners or custodians of TK and GR may have, whether through the existing IP system or through sui generis rights. This is referred to as “positive protection”. Positive protection involves preventing unauthorized use of TK by third parties as well as active exploitation of TK by the originating community itself.
Concerns about improving patent examination in the TK area, in order to avoid erroneous patents on traditional medicines in particular, have led to initiatives at international and national levels. A leading example is the Traditional Knowledge Digital Library (TKDL), a collaborative project in India between the Council of Scientific and Industrial Research (CSIR), the Ministry of Science and Technology, and the Ministry of Health and Family Welfare. An interdisciplinary team of Indian medicine experts, patent examiners, information technology experts, scientists and technical officers have created a digitized system enabling consultation of existing literature in the public domain relating to Ayurveda, Unani, Siddha and Yoga. Such literature is generally available in traditional languages and formats. The TKDL therefore provides information on traditional medical knowledge in five international languages and formats which are understandable by patent examiners at international patent offices. The aim is to prevent the grant of erroneous patents,21 while at the same time not newly publishing TK in a way that would facilitate its misappropriation. The WHO GSPA-PHI urges governments and concerned communities to facilitate access to traditional medicinal knowledge information for use as prior art22 in the patent examination procedures, where appropriate, through the inclusion of such information in digital libraries (Element 5.1f). The WTO TRIPS Council has discussed how to preclude erroneous patents using GRs and associated TK through the use of databases. This included a submission by Japan that had been previously submitted to the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC).23
5. New approaches to IP protection of traditional medical knowledge
Parties to the CBD, WIPO and the WTO have considered the concept of a disclosure requirement in the patent system, put forward by its proponents as a means of ensuring that patents on inventions derived from TK and GR are consonant with the principles of PIC and EBS. The proposals and the debate are diverse and cover areas other than medicine, although patents in the medical area have been the major focus of the debate. The essential thrust of the proposal to implement a disclosure requirement in the patent system would be to require the patent applicant to notify the source or origin of TK/GR used in claimed inventions and to document compliance with PIC and EBS requirements. A number of countries have implemented such provisions in their national laws, but there is no agreed international standard. An alliance of developing countries has proposed a revision to the TRIPS Agreement to make such provisions mandatory,24 but other countries continue to question the usefulness and effectiveness of this kind of disclosure mechanism.25
The cultural, scientific, environmental and economic importance of TK has led to calls for it to be preserved (safeguarded against loss or dissipation) and protected (safeguarded against inappropriate or unauthorized use by others), and there are many programmes under way at national, regional and international levels to preserve, promote and protect different aspects of TK. Such measures include: first, preserving the living cultural and social context of TK, and maintaining the customary framework for developing, passing on and governing access to TK; and second, preserving TK in a fixed form, such as when it is documented or recorded.
WIPO is primarily concerned with “protection” in the IP sense (i.e. the protection against copying, adaptation and use by unauthorized parties). The objective, in short, is to ensure that the materials are not used wrongly. Two forms of protection – positive protection and defensive protection – have been developed and applied, as outlined above.
The IGC is working on the development of an international legal instrument for the effective protection of TK. It is also working on ways to address IP aspects of access to, and benefit-sharing of, genetic resources. The WTO TRIPS Council has also extensively debated the protection of TK,26 including an African Group proposal for a formal decision to establish a system of TK protection, but this discussion has not led to any conclusions. The IGC work on TK27 is concentrating on positive protection and the IP aspect of protection – the recognition and exercise of rights to preclude others from illegitimate or unauthorised use of TK. As WIPO member states are continuing efforts to negotiate on these issues, no final agreement has been reached. The text of an international legal instrument for the effective protection of TK is, therefore, in flux and new drafts continue to become available on a regular basis. The information set out below seeks to provide a broad and informal description of the nature of the discussions under way in the WIPO negotiations.
(a) Why protect traditional knowledge?
The IGC has considered the policy objectives for international protection,28 including to:
- recognize the holistic nature of TK and its intrinsic value
- promote respect
- meet the actual needs of TK holders and empower TK holders
- promote conservation and preservation of TK
- support customary practices and community cooperation
- contribute to safeguarding TK
- repress unfair and inequitable uses and preclude unauthorized IPRs
- promote innovation and creativity, community development and legitimate trading activities
- ensure that PIC and exchanges are based on mutually agreed terms, and promote EBS.
(b) What is to be protected, and for whose benefit?
There is as yet no accepted definition of TK at the international level. In principle, TK refers to knowledge as such, in particular knowledge resulting from intellectual activity in a traditional context, and includes know- how, practices, skills and innovations. It is generally accepted that protection should principally benefit TK holders themselves, including indigenous peoples and local communities. However, there is no agreement on whether families, nations, individuals and others (such as the state itself) could be beneficiaries. While TK is generally regarded as collectively generated, preserved and transmitted, so that any rights and interests should vest in indigenous peoples and local communities, in some instances beneficiaries may also include recognized individuals within communities, such as certain traditional health practitioners (with a specific reference to traditional medical knowledge). Some countries do not use the term indigenous peoples or local communities and consider that individuals or families maintain TK.
(c) What is it to be protected from?
One problem confronting TK holders is the commercial exploitation of their knowledge by others, which raises questions of legal protection of TK against unauthorized use, the role of PIC and the need for EBS. TK holders also report lack of respect and appreciation for such knowledge. For example, when a traditional healer provides a mixture of herbs to cure a sickness, the healer may not isolate and describe certain chemical compounds and describe their effect on the body in the terms of modern biochemistry, but the healer has, in effect, based this medical treatment on generations of clinical experiments undertaken by healers in the past, and on a solid understanding of the interaction between the mixture and human physiology.
(d)How to protect traditional knowledge?
The diversity of TK means that no “one-size-fits-all” solution could suit all countries and communities. It is also a significant challenge to establish how protection under a national system could be enforced regionally and internationally.
Existing IPRs have been successfully used to protect against some forms of misuse and misappropriation of aspects of TK. Several countries have adapted existing IP systems to the needs of TK holders, including through specific rules or procedures to protect TK. For example, the Chinese State Intellectual Property Office has a team of patent examiners specializing in TCM. Other countries have developed new, stand-alone sui generis systems to protect TK. Thailand’s Act on Protection and Promotion of Traditional Thai Medicinal Intelligence, B.E. 2542 (1999)29 protects “formulas” of traditional Thai drugs and “texts on traditional Thai medicine”. It defines “traditional Thai medicinal intelligence” as “the basic knowledge and capability concerned with traditional Thai medicine”. The Act confers on the right holder – “those who have registered their IP rights on traditional Thai medical intelligence under the Act” – “the sole ownership on the production of the drug and research and development”. Peruvian Law No. 27811 of 24 July 2002, Introducing a Protection Regime for the Collective Knowledge of Indigenous Peoples Derived from Biological Resources,30 is a sui generis regime for the protection of collective knowledge of indigenous peoples that is connected with biological resources. The Swakopmund Protocol on the Protection of Traditional Knowledge and Expressions of Folklore, within the Framework of the African Regional Intellectual Property Organization (ARIPO), adopted by ARIPO member states in August 2010,31 aims: “(a) to protect traditional knowledge holders against any infringement of their rights as recognized by this Protocol; and (b) to protect expressions of folklore against misappropriation, misuse and unlawful exploitation beyond their traditional context”. The international legal instrument for the effective protection of TK, which is being negotiated in the IGC, is a sui generis system. Other options are also available, such as contract laws, biodiversity-related laws, and customary and indigenous laws and protocols.
Documentation is especially important because it is often the means by which people beyond the traditional circle get access to TK. It does not ensure legal protection for TK, which means that it does not prevent third parties from using TK. Depending on how the documentation process is carried out, it can either promote or damage a community’s interests. IPRs may be lost or strengthened when TK is documented. WIPO has developed the World Intellectual Property Organization (WIPO) Traditional Knowledge Documentation Toolkit to help holders of TK, in particular indigenous peoples and local communities, protect their interests should they decide to document their TK.32 This toolkit focuses on management of IP concerns during the documentation process, and also takes the documentation process as a starting point for more beneficial management of TK as a community’s intellectual and cultural asset.
4. China Daily, "TCM Exports Set to Rise at a Healthy Clip", 10 February 2012, available at www.china.org.cn/ business/2012-02/10/content_24601720.htm. back to text
6. WHA, Resolution: WHA41.19: Traditional medicine and medicinal plants. back to text
7. WHA, Resolution: WHA56.31: Traditional medicine. back to text
8. WHA, Resolution: WHA61.21: Global strategy and plan of action on public health, innovation and intellectual property. back to text
9. WHA, Resolution: WHA62.13: Traditional medicine. back to text
10. See also WIPO documents WIPO/GRTKF/IC/3/9 and WIPO/GRTKF/IC/17/INF/9. back to text
11. WIPO document WIPO/GRTKF/IC/3/6. back to text
12. UN document A/RES/61/295. back to text
13. See www.who.int/medicines/areas/traditional/irch/en/index.html. As of August 2009, member states include Armenia, Australia, Brazil, Canada, China, Ghana, Hungary, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, the Republic of Korea, the Kingdom of Saudi Arabia, Singapore, the United Arab Emirates, the United Kingdom and the United States. The three regional/sub-regional bodies are the Association of Southeast Asian Nations (ASEAN), the European Medicines Agency (EMA) and the Latin American Parliament (PARLATINO). back to text
14. Guidelines and other relevant documents can be found at http://apps.who.int/medicinedocs/en/cl/CL10.1.3/clmd,50.html#hlCL10_1_3. back to text
15. WHO Monographs can be found at http://apps.who.int/medicinedocs/en/cl/CL10.1.4.3/clmd,50.html#|hlCL10_1_4_3. back to text
17. Guidelines and other relevant documents can be found at http://apps.who.int/medicinedocs/en/cl/CL10.1.3/clmd,50.html#hlCL10_1_3. back to text
18. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. back to text
20. For the political debate on access and benefit-sharing aspects regarding the sharing of viruses, see Chapter III, Section E. back to text
22. For more information on prior art, see Endnote 67 above. back to text
23. WTO document IP/C/W/472. Japan has submitted this proposal originally to the IGC as WIPO document WIPO/ GRTKF/IC/9/13. See also WIPO documents WIPO/GRTKF/ IC/20/INF/9 and WIPO/GRTKF/IC/20/INF/11. back to text
24. See WTO document IP/C/W/474 and addenda. back to text
25. See WTO documents IP/C/W/368/Rev.1 and Corr.1, IP/C/W/370/Rev.1. Discussions are ongoing in the TRIPS Council. They are regularly reported in the minutes of the meetings. For the latest report, see WTO document IP/C/M/70. back to text
26. WTO documents IP/C/W/368/Rev.1 and IP/C/W/370/ Rev.1. back to text