on protection of traditional medicinal knowledge
traditional knowledge (hereinafter referred to as “tk”) and indigenous knowledge has been the focus of recent international debates—whether or not to define an explicit connotation of tk, and if possible, how to confirm an internationally recognized definition, and how to seek an effective way to protect it, etc—due to its increasing significance in vital areas such as medicine security, the development of agriculture and medical treatment. while it is true that enormous efforts have been contributed to the introduction of international legal instruments in terms of folklore, plant genetic resources for food and agriculture, no world-wide consensus on legal protection of traditional medicinal knowledge (hereinafter referred to as “tmk”) has been reached, in particular on traditional chinese medicine, resulting in the damage of interests of tmk holders and paralyzing the development thereof. principal rationales for the importance of protecting tmk and some possible strategies are listed in the following part. before considering how tmk can be protected in the intellectual property (hereinafter referred to as “ip”) system, we’ll take a look at the need for tmk protection and the international definition of the core concepts, though a singular definition may not be necessary at times.
the wide use of tm, especially in poor countries, and its rapidly growing medical and economic value have riveted global attention on its significance.
in africa up to 80% of the population use tm to help meet their health care needs, in asia and latin america, populations continue to use tm as a result of historical circumstances and cultural beliefs. in china, tm accounts for around 40% of all health care delivered, which can be demonstrated in the well-developed system of practices at public hospitals and official education at university level covering tm for doctors, pharmacists and nurses. apparently, the broad use of tm in developing countries is often attributable to its accessibility and affordability among the majority who are suffering poverty. of course, its high popularity is also embedded within the local beliefs.
even in developed countries, tm (or cam) has been attached increasing importance. with more concern about the adverse effects of chemical drugs, cam have its appeal to many patients that it offers gentler means of dealing with such chronic, debilitating diseases such as heart diseases, cancer, diabetes and mental disorders. meanwhile, traditional medicines appear as an alternative to the average therapies against the currently incurable diseases like aids, which may raise hope among hiv-affected individuals. according to the wto report, the percentage of the population which has used cam at least once is 48% in australia, 70% in canada, 42%in usa, 38% in belgium and 75% in france.
the aims of tmk protection can be categorized into two groups:
(a) the grant of specific intellectual property rights (hereinafter referred to as “iprs”) in relation to tmk, to persons including those indigenous peoples or communities who have inherited and originally mastered the traditional medicinal knowledge, so that they could enjoy their legitimate rights and interests;
(b) protection of tmk from being used by malicious persons or entities without authorization or being misappropriated, or without proper sharing of the benefits arising therefrom.
with legal tools, tmk can become the trigger point for new medicine development, because the low-cost herbal materials could substantially reduce the current soaring medicine price and explore new ways to combat incurable diseases. an ipr also protects tmk from misappropriation by outsiders, who without offering either compensation or reward have often taken it from its holders. indicated by statistics, until now, chinese exploiters have yielded at least 3000 patent registrations to foreign counterparts, 900 of which are traditional chinese medicines worthy of 1 billion dollars in the potential market. they lost not only the current trade revenue, but also the expected export profits in the impeding decade as a result of non-tariff distortions and impediments to international trade.
no special legal instruments on traditional medicinal knowledge are adopted in the international arena yet. but we still can make full use of several existing international bodies.
(a) the wto agreement on trade-related aspects of intellectual property rights (trips agreement). with the adoption of the trips agreement in 1994, the patenting made a major stride forward towards global recognition and enforcement (china’s legislation also referred to most of it). it defines various types of iprs, including protection of copyrights and related rights, trademarks, geographical indications, industrial designs, patents, and undisclosed protection, etc. however, article 27.3(a) explicitly grants members to exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals. indeed, nor does the trips agreement make express reference to traditional knowledge.
(b) the world intellectual property organization (wipo). again, wipo has neither erected protecting mechanisms on tmk, but it compiles databases to assist national legislative efforts to protect tk on a broad sense, and has explored a consensual definition of tk, though not adopted. indeed, it is already engaged in a very substantive program in the intergovernmental committee on genetic resources, traditional knowledge and folklore, which has yielded concrete results, including a decision to prepare a document on the elements of a sui generis system for the protection for traditional knowledge.
the major responsibility for identifying more precisely the scope of protectable traditional medicinal knowledge rests on national laws, for no one other than the relevant nation knows more and better about the details of traditional knowledge within countless domestic communities. and the nation could incorporate some unanimously agreed concepts and international practices into its own laws, and tailor its key concerns, in accordance with its policy objectives, to the legal protection of national heritages, like traditional medicines in china.
in china, no special laws are specifically prepared for traditional medicinal knowledge protection. and the governing laws likely to cover it, in terms of protection of intellectual activities, fall into the realm of ip protection: that is, copyrights in copyright law of the prc, trademarks in trademark law of the prc, and patents in patent law of the prc, as well as regulations for the implementation of those three.
the copyright law stipulates that the personal and property rights of authors, other citizens, legal entities and other organizations who create the works are protected.
under trademark law, the owner shall enjoy the exclusive right to the use of the registered trademarks, including trademarks for goods and services, collective trademarks, and certification trademarks. here, trademarks also imply “geographical indications of the goods”,
as for patent, the patent law is enacted in order to protect patent rights for inventions-creations of chinese entities or individuals to whom the patents belong. according to article 2, “’invention-creation’ means inventions, utility models and designs.”but any invention or utility model for which a patent right may be granted must possess the characteristics of novelty, inventiveness and usefulness. however, “methods for the diagnosis or for the treatment of diseases” shall be granted no patent right.
this paper suggests a general term-traditional medicinal knowledge-that is closely connected with the subject matter of the protection.
tmk encompasses knowledge of different types, which may be distinguished by the elements involved, the knowledge’s potential or actual applications, the form of expression, the way of possession, individual or collective, and its legal status.
tmk includes, for example, information, methods, natural plants and other materials for medical treatment or health care, in other words, medical processes and products that can be used in personal ways or industry, as well as medical services.
as for its forms, the context of some tmk appears codified while others are non-codified, such as “tribal” or “indigenous” medicine, which is passed down to generations through oral ways, based mostly on traditional beliefs, norms and practices accumulated through centuries of experiences within a family or a limited range of community,
tmk may be possessed by individuals, or members of a group/community, for example, knowledge on herbal-home remedies which is held by millions of women and the elder in china, in rural areas particularly.
according to the working concept of “traditional knowledge” for the purposes of the fact-finding missions in 1998-1999 by wipo secretariat, “traditional medicinal knowledge, including related medicines and remedies”, falls into a category of traditional knowledge. before we go into the depth of defining tmk, we shall possess a clear picture of what traditional knowledge is. in this report, the term “traditional knowledge” is defined as:
“tradition-based literary, artistic or scientific works; performances; inventions; scientific discoveries; designs; marks, names and symbols; undisclosed information; and all other tradition-based innovations and creations resulting from intellectual activity in the industrial, scientific, literary or artistic fields. ‘tradition-based’ refers to knowledge systems, creations, innovations and cultural expressions which: have generally been transmitted from generation to generation; are generally regarded as pertaining to a particular people or its territory; and are constantly evolving in response to a changing environment.”
however, we could easily find that the said definition is not a formal one precise and restrictive enough for protectable subject matter in the legal sense, but it provides essential elements of its scope and nature, in that much of the matter covered in the definition is already potentially eligible for the grant of protection under ip laws, such as patent law, trademark law and the law of undisclosed information.
actually, no international body or domestic legislature has worked out a definite concept of tmk other than wto. in this sphere exist traditional medicine (tm) and complementary and alternative medicine (cam) systems including traditional chinese medicine, indian ayurveda and arabic unani medicine. tm/cam therapies can be categorized as medication therapies—if they use herbal medicines, animal parts and/or minerals—or non-medication therapies—if carried out primarily without using medication, as in the case of acupuncture, manual therapies, qigong, tai ji, thermal therapy, yoga, and other physical, mental, spiritual and mind-body therapies (see table1 ). apparently, traditional medicine contains diverse and sometimes conflicting characteristics. but such a definition is far from useful.
who therefore defines tmk as “including diverse health practices, approaches, knowledge and beliefs incorporating plant, animal, and/or mineral based medicines, spiritual therapies, manual techniques and exercises applied singularly or in combination to maintain well-being, as well as to treat, diagnose or prevent illness” (excluding new plants or plant materials).
another similar definition could also be found in document who/edm/trm/2000, “[t]he 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 in the prevention diagnosis, improvement or treatment of physical and mental illnesses.”
thus, tmk can be summarized as codified and non-codified medication therapies incorporating plant, animal (including traditional chinese patent medicines, single or compound drug prescriptions), non-medication therapies (physical, mental, spiritual and mind-body therapies like acupuncture, qigong, tai ji), production or exploitation of chinese herbal materials, and diverse traditional theories, practices, and experiences about illness prevention, diagnosis, or treatment.
however, a survey of existing international standards in the field of ip illustrates that a precise definition of tk is not necessarily a crucial requisite for identifying the legal elements of a mechanism for its protection. the same approach could be applicable to tmk. therefore it’s more essential to identify the legal characteristics of protectable subject matter than a shared definition, to decide whether or not they meet the conditions of protection, such as novelty, an inventive step and industrial application for patent, and distinctiveness for trademark.
thus, to identify the concrete characteristics of traditional medicinal knowledge, we have to clarify first the nature of this concept.
(a) initially speaking, tmk, contrary to a common perception, is not necessarily old. in the same vein as the above concept “tradition-based”, tmk is a process of periodic, even daily creation, evolving from time to time, as individuals and communities pass down their knowledge from generation to generation and adapt their practices to their social and physical environment with new elements or improvements. in many ways, as a result, tmk is actually contemporary knowledge, which each community has developed and maintained in its local context.
(b) secondly, the traditional essence also gives rise to another tmk feature: non-formal or non-systematic; partly because the use of methods or medicines depends on previous experiences without any scientific tests or research, partly because tmk is passed on in an informal or cultural manner, partly because tmk may be poorly documented with some essential elements modified or not explicitly articulated. so this feature may lay a hurdle on the way of claim or description when tmk is applied for registration.
(c) another feature of tmk is concerned with the rights claimed by indigenous groups, local communities or other tmk holders. indeed, tmk also boasts the culture or geographical distinctiveness of communities or regions pertinent to the practices in discussion.
a case in point is “guangdong herbal tea”. traditionally, herbal tea is taken as folk formula for clearing up internal heat and eliminating damp, due to the typical climate natural environment in the southern china. despite the fact that some herbal-tea-based products prevail in other parts of the country since the breakup of sars, herbal tea is indisputably culturally rooted in guangdong, which helps define the region’s own identity. another example can be found in the traditional practices in some tribal groups where the shaman treats the patient with both prescription and a religious ceremony. consequently, the protection of tmk ceases to be simply a matter of pecuniary gains, but also intertwines with the cultural or geographical identification of traditional or local groups. analogously put, special protection of tmk should be granted, as if moral rights in copyright law would be entitled to an author to prohibit others from tampering.
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