One of the arguments for seeking IPRs protection in the area is TRM is, as mentioned above, the desire to promote the development of a TRM-based industry, particularly by stimulating investments to undertake the tests necessary to validate TRM-based products.
However, traditional medicines are not subject, in many cases, to regulatory controls, or are subject to specific regulations that are less stringent than those applicable to modern medicines171. From a public health perspective, the past use (even if ancestral) of a medicine, may not be sufficient reason to obviate pre-clinical and clinical tests needed to establish toxicity and safety. The WHO has warned that, though, in general, prolonged use of a traditional medicine offers testimony of its safety, in a few instances
“investigation of the potential toxicity of naturally occurring substances widely used as ingredients in these preparations has revealed previously unsuspected potential for systematic toxicity, carcinogenicity and teratogenicity” (WHO, 1996, p. 180).
171 See, e.g., Jayasuriya and Jayasuriya, 2002, p. 200.
The need for clinical trials under standard scientific procedures is the same as in the case of modern medicines. However, the regulatory authorities of many countries - including India - and the WHO have accepted much shorter preclinical animal tests for traditional medicines.172 According to WHO, if adequate study of the published literature demonstrates lack of harmful effects of a herbal remedy, clinical evaluation can be undertaken without previous animal toxicology studies (WHO, 1996).
172 See, e.g., Chaudhury and Chaudhury, 2002, p. 213.
The development of appropriate formulations may require some investment, more or less significant depending on the product’s characteristics and the targeted form of presentation,173 but generally the size of investment required would not be high.
173 TRM may also be used to investigate possible new therapeutic products or treatments, though this is rare for the plant medicines industry (ten Kate and Laird, p. 93).
The granting of exclusive rights under IPRs and other schemes174 may contribute to encourage investment in scientific validation and development of pharmaceutically acceptable formulations of traditional medicines, but important questions arise as to the justification of such rights for this purpose. The investments required are relative small - as compared to those necessary for the development of new drugs - and public support may be more easily available.175 Exclusive rights restrain competition and reduce access to the protected medicines. Should the promotion of investment be desirable, States have many options (such as tax breaks) outside the IPRs system to provide the needed incentives without negatively affecting public health.
174 One possibility would be, for instance, to confer a limited period of exclusivity (shorter than patents) as applied under “orphan drug” legislation in the U.S. and other countries. The goal of this legislation is to provide incentives to pharmaceutical companies to invest in diseases where the small number of patients and, thus, total market expectations, are too small to warrant investing in the costly R&D process. An attractive feature of the orphan drug act is that it combines “push” and “pull” incentives (Kettler, 2002).
175 Some countries have established extensive public supported programs to undertake clinical trials of traditional medicines. For instance, the Indian Council for Medical Research set up a network of more than 25 clinical research centres to carry out controlled clinical trials (Chaudhury and Chaudhury, 2002, p. 2120-221). In China the government began establishing in the late 1950s research institutes to establish the value of TCM and develop it further (Xie, 2002, p. 129).