- Medicine Access and Rational Use > Financing
- Traditional Medicine > Traditional, Complementary and Herbal Medicine
(2001; 88 pages)
6.4 Questions and dilemmas
Protection or disclosure?
The choice between disclosure and (patent) protection is more complex than may be obvious from the previous two paragraphs, since not only does disclosure facilitate promotion and use of traditional medicine, while protection creates opportunities for profits and benefit sharing - but if those profits go to (large) foreign enterprises, would the protection accorded then provide perverse incentives for biopiracy? Furthermore, one of the important conditions for granting a patent is disclosure of the invention. But while patent laws are national laws, disclosure -especially in an increasingly globalized, interconnected world- is absolute, or 'international'; once disclosed, the invention is accessible to all, thus opening up opportunities for third parties to commercialize the invention, and maybe even patent derived products, outside the national borders29. This adds yet another dimension to the dilemma, since, ultimately -and paradoxically- protection is disclosure.
29 Commercialization of the invention by third parties can be prevented only in countries where a patent is obtained. However, while it would not be possible for parties other than the original, initial patent holder to obtain foreign patents on the same invention, depending on the national IPR law of the foreign country concerned, patenting of derived products may be possible.
There are a number of other suggestions and proposals for potential modifications of the conventional IPR system; however, expert opinion differs with regard to their desirability and their impact on traditional medicine. These differences of opinion can be explained, at least in part, by differing concepts and priorities, and by different views with regard to the importance of knowledge in the public domain. Suggestions have been made regarding:
• Standards of patentability: Requiring higher -or stricter- standards of novelty and/or inventiveness could at least ensure that the failure of IPR law to adequately protect traditional knowledge is not compounded by the ability of third parties to obtain patents for inventions closely derived from such knowledge. This proposal however directly conflicts with suggestions to facilitate patenting of traditional knowledge in order to provide incentives for its (continued) development.
• Definition of novelty and/or prior art: The definition of novelty and/or the interpretation of prior art could be adapted, in order to (i) exclude from patentability any knowledge which is already in the public domain anywhere in the world, whether through publication or through use, and (ii) explicitly exclude from patentability existing traditional knowledge, as well as products and processes which are essentially derived from such knowledge. This proposal too may interfere with efforts to encourage patenting of traditional (medicinal) know-how. Another complicating factor is that, to be really effective in preventing misappropriation, definitions of novelty/prior art in overseas laws ought to be changed as well - which is per definition beyond the purview of national authorities.
• Innovation patent system: Innovation patents can be considered as an intermediate form of protection between conventional or 'real' patents and petty patents. Innovation patents don't require absolute novelty, but just require that some innovation, some improvement has been made. Innovation patents should be granted quickly, allow only limited claims, and have limited validity (e.g. 8-10 years)30. While contradicting the previous two proposals, an innovation patent system could be designed in order to be relatively accessible to traditional healers and innovators; yet at the same time, there would seem to be considerable potential for misuse of such a system by (large) companies trying to 'evergreen' their inventions. The drawback, therefore, could be a reduction in access to 'modern' pharmaceuticals.
30 An innovation-patent system exists for example in Australia. Since there are no international rules or standards for innovation patents, these would have to be specified in the national legislation
• Patentability of uses: Traditional medicine is usually not eligible for patent protection, since neither the product nor the processes involved are new. However, some countries31 permit the issuing of patents for new uses of a known product and/or of a substance existing in nature; under TRIPS, countries seem free to decide whether or not to allow this. Since most 'biopiracy patents' relate to the new use of an existing, natural product for a certain indication, excluding the patentability of uses of known products and substances may help to curb biopiracy; impact however will be limited, due to the territoriality of the patent system. Moreover, by deduction it follows that legitimate patents for traditional medicine, if any, would most likely fall in the category of 'use patents' as well; excluding 'new use' from patentability would therefore at the same time be an obstacle for genuine protection of traditional medicine. Finally, it should be borne in mind that, in the context of safeguarding access to 'modern' drugs, developing countries' interest seems to lay in not allowing the patenting of a 'new use'32.
31 For example the US and Europe.
32 See "The TRIPS Agreement and Pharmaceuticals", report of an ASEAN Workshop on the TRIPS Agreement and its Impact on Pharmaceuticals, Jakarta, 2-4 May 2000, paragraph 3.2.
These latter two points illustrate that there is not just some contradiction between increasing protection of and increasing access to traditional medicine, and a confusion as to whether increasing protection may eventually increase access, but that strategies to increase protection of traditional medicine also interfere, to some extent at least, with strategies to safeguard access to 'modern' pharmaceuticals.
However, before making decisions on these and other dilemmas and modalities, there are some more fundamental questions to be addressed:
• How necessary is IPR protection really for the further development of traditional medicine and TM-based industries? In the case of pharmaceuticals, most industrialized countries introduced IPR protection for drugs only after their pharmaceutical industry was well-established. Similarly, a number of developing countries have seen the rise of a local pharmaceutical industry during a period of limited IPR protection, or even in the absence of IPR protection, for drugs. Likewise, in the software sector, the so-called open source software33 is quite successful without IPR protection.
33 The program code of 'open source' software is made public, thus allowing any programmer to modify it according to users needs, or to solve problems as and when they arise, instead of creating dependency on a software's original developer by hiding this code and/or protecting it under IPR laws.
• Even if the answer to the previous question is positive, do the potential benefits outweigh the anticipated disadvantages? Especially the impact on access to traditional medicines should be carefully assessed, in view of their important role in health care, notably for the poor and for those living in remote areas; moreover, the relevance of traditional medicines for addressing health care needs may increase, due to anticipated price increases of modern medicines34.
34 The TRIPS Agreement makes it obligatory for all WTO Member States to introduce product patents for pharmaceuticals. It is widely anticipated that this will cause (steep) price increases, notably in developing countries, many of which did, previously, either not recognize such patents, or strictly limited the exclusive rights granted.
• Is the IPR system the best mechanism to encourage the development of contemporary traditional-knowledge-based innovations? Important aspects of the discussion on the desirability of IPR protection for traditional medicine relate to the impact on indigenous communities; on one hand, the establishment of IPR protection could increase the recognition for traditional healers and their communities, but there may also be some danger of distortion of indigenous systems.
• To what extend would intellectual property protection achieve the intended objectives? Are there other (better) ways to achieve those objectives?
• What exactly is being protected, and why? Is it the knowledge? Is it the indigenous and/or local culture? The biological resources? Is it all of these, and maybe more? At times, it seems that the debate is being driven by the issues of access and benefit sharing. Thus, the focus appears to be primarily on economic aspects of traditional medicine and traditional knowledge, then on the biological aspects and only lastly on the cultural aspects. One might question this order; maybe the emphasis should shift: maybe increasing the protection of and respect for the values and cultures of indigenous peoples and strengthening their customary laws should be the overarching aim - and because of the close interconnection between cultural diversity and biodiversity, as well as the importance of indigenous peoples' cultures and values for sustaining -and further developing-traditional medicinal knowledge, perhaps this would be key to achieving some of the other objectives.