Accessible Unlicensed Requires Authentication Published by De Gruyter August 31, 2013

The Missed and Missing Benefits to Africa in the Absence of Harmonized International Regulation of Traditional Medicinal Knowledge

Senai W. Andemariam

Abstract

The WHO estimates that traditional medicine(s) (TM) are used in every country around the world in some capacity and that in much of the developing world 70–95% of the population relies on these TM for primary care. It is estimated that at least 25% of all modern medicines are derived, either directly or indirectly, from medicinal plants and that in the case of certain classes of pharmaceuticals, this percentage may be as high as 60%. Some sources claim that that nearly a quarter of all pharmaceutical products worldwide are derived from plant sources. There is a global increase in interest in the use of TM and with it the global expenditure on TM. In 2005, for instance, the global market for traditional medicines was estimated at US$ 60 billion, reached US$ 83 billion in 2008 and is expected to reach US$ 114 billion by 2015.

Africa prides itself as one of the most important pools for this globally important resource. Experience has, however, shown that both at national and at international levels, the continent has not yet been able to benefit from the international trade of TM. The regulation of TM is yet to become comprehensive at international and national levels. Yet, traditional medicinal knowledge has hitherto attracted only a fragmented regulatory attention by international organizations such as the WTO which focus on the various interests that TM represents. Although the harmonized regulation of the environmental, health, intellectual property, trade, cultural heritage, human rights, development and other interests on TM can be a complicated assignment, this article will attempt to show how the rules of international economic law, in tandem with other relevant international instruments, can bring benefit to the African continent by setting rules for sustainable exploitation of TM.

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  1. 1

    WHO, The World Medicines Situation 2011, Traditional Medicines: Global Situation, Issues and Challenges (WHO/EMP/MIE/2011.2.3), p. 1, available at: <http://www.who.int/nha/docs/world_medicine_situation.pdf>, accessed 20 November 2012. A 2011 WHO report survey shows that 90% of the population in Ethiopia, 75% in Mali, 70% in Myanmar, 70% in Rwanda, and 60% in Tanzania and Uganda use TM as for primary care, whereas 80% of the population in Germany, 70% in Canada, 49% in France, 48% in Australia and 42% in the United States have used complementary and alternative medicine at least once. (See p. 3). Another WHO report states:

    In many Asian countries, TM continues to be widely used, even though allopathic medicine is often readily available. In Japan, 60–70% of allopathic doctors prescribe kampo medicines for their patients. In Malaysia, traditional forms of Malay, Chinese and Indian medicine are used extensively. In China, traditional medicine accounts for around 40% of all health care delivered and is used to treat roughly 200 million patients annually. For Latin America, the WHO Regional Office for the Americas (AMRO/PAHO) reports that 71% of the population in Chile and 40% of the population in Colombia has used traditional medicine… A survey of 610 Swiss doctors showed that 46% had used some form of complementary and alternative medicine, mainly homeopathy and acupuncture… In the United Kingdom, almost 40% of all general allopathic practitioners offer some form of complementary and alternative medicine referral or access… WHO, WHO Traditional Medicine Strategy 2002–2005, p. 11, available at: <libdoc.who.int/hq/2002/WHO_EDM_TRM_2002.1.pdf>,accessed 20 November 2012. See also, Traditional Medicine, available at: <http://www.who.int/mediacentre/factsheets/fs134/en/>,accessed 17 November 2012.

    A UNESCO report also states that:

    [i]n the United States of America 158 million of the adult population use alternative medicinal products and, according to the Commission for Alternative and Complementary Medicines, people in the United States of America spent US $17 billion on traditional remedies in 2000. In the United Kingdom, $230 million are spent yearly on alternative medicine. UNESCO, Draft Preliminary Report on Traditional Medicine and its Ethical Implications (SHS/EST/CIB-17/10/CONF.501/3, 2010), pp. 3-4. See also, WHO, WHO Traditional Medicine Strategy 2002–2005, pp. 9-13; “Traditional Medicine”, available at: <http://www.who.int/mediacentre/factsheets/fs134/en/>, accessed 19 November 2012.

  2. 2

    WHO, The World Medicines Situation 2011, Ibid, p. 2.

  3. 3

    To give a quantitative description of the staggering sales of the pharmaceutical industry, and thereby to appreciate how, comprising 25% of the source of global pharmaceutical products, TMK is such a rich asset, see the following citation:

    The pharmaceutical industry has undergone tremendous change in the last two decades. World production in pharmaceuticals grew from US$ 70 billion in 1975 to US$ 150 billion in 1990 and to more than US$ 300 billion in 2000. Sales of prescription pharmaceutical drugs world-wide grew from US$ 40 billion in 1972 to about US$ 420 billion in 2002 and are expected to rise to US$ 700 billion in 2008. pharmaceutical research and development (R&D) expenditures in the largest industrial blocs – the United States, the European Union and Japan – more than tripled to between 1990 (€18 billion) and 1997 (€55 billion). J. con Braun and M.P. Pugatch, The Changing Face of the Pharmaceutical Industry and Intellectual Property Rights, 8 The Journal of World Intellectual Property, no. 5 (2005), 599

    .

  4. 4

    Bulletin of the Medicinal Plants and Drug Discovery Research Center of the University of Asmara (2005), p. 2.

  5. 5

    WHO, WHO Traditional Medicine Strategy 2002–2005, supra note 1, p. 12.

  6. 6

    WHO, The World Medicines Situation 2011, supra note 1.

  7. 7

    Global Traditional Medicine Market to Reach US$114 Billion by 2015, available at: <http://www.sfgate.com/business/article/Global-Traditional-Medicine-Market-to-Reach-2455084.php>, accessed 20 August 2012.

  8. 8

    WHO, The World Medicines Situation 2011, supra note 1. The 2011 WHO survey showed that in 50 countries TM are used as prescription medicines, in 97 countries as over-the-counter medicines, in 47 countries as dietary supplements and in 40 countries as self-medication only.

  9. 9

    WHO, Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A World Wide Review (2001), pp. 1-2.

  10. 10

    WIPO, Intellectual Property Needs and Expectations of Traditional Knowledge Holders, WIPO Report on Fact Finding Missions on Intellectual Property and Traditional Knowledge (1998–1999), p. 25.

  11. 11

    CBD, Article 8(j). This clause has been used as the de facto definition for defining traditional knowledge in the CBD Secretariat documents. CBD Secretariat, Handbook of the Convention on Biological Diversity Including Its Cartagena Protocol on Biodiversity (hereinafter “CBD Handbook”) (3rd ed., Montreal: CBD Secretariat, 2005), p. 786 (Decision VI/10 784, in the realm of preservation); p. 625 (Decision IV/9 521 and Decision V/16, in the realm of IP). See the CBD’s health-inclusive working definition for TK at Secretariat of the CBD, Traditional Knowledge and the Convention on Biological Diversity, available at: <http://www.cbd.int/doc/publications/8j-brochure-en.pdf>, accessed 15 November 2012. See also, Article 8(j): Traditional Knowledge, Innovations and Practices, p. 1, available at: <www.hreoc.gov.au/social_justice/international_docs/pdf/art_8j_convention_biological_diversity.pdf>, accessed 15 November 2012.

  12. 12

    Read the following for summary on the story: G. Bodeker, Traditional Medical Knowledge, Intellectual Property Rights & Benefit Sharing, 11 Cardozo Journal of International and Comparative Law, no. 785 (2003), 788; S. Ragavan, Protection of Traditional Knowledge, 2 Minnesota Intellectual Property Law Review, no. 2 (2001), 11; and Olufunmilayo B. Arewa, TRIPS and Traditional Knowledge: Local Communities, Local Knowledge, and Global Intellectual Property Frameworks, 10 Marquette Intellectual Property Law Review, no. 2 (2006), 172.

  13. 13

    Ragavan Ibid, p. 12; Arewa Ibid, pp. 170-171.

  14. 14

    Ragavan Ibid, p. 61, f.n. 269; Arewa, ibid, pp. 171-172.

  15. 15

    Bodeker (2003), supra note 12, pp. 797-798; See also WIPO Document WIPO/GRTKF/IC/5/13, Patent Referring to Lepidium meyenii (Maca) and Responses of Peru (Document submitted by the Delegation of Peru).

  16. 16

    Bodecker Ibid, pp. 795-796; Arewa (2006), supra note 12, p. 174.

  17. 17

    See WIPO, Intellectual Property and Traditional Knowledge, Booklet No. 2, p. 7, available at: <www.wipo.int/freepublications/en/tk/920/wipo_pub_920.pdf>, accessed 21 November 2012; See also, Arewa (2006), supra note 12, pp. 172-173.

  18. 18

    WIPO, Ibid, p. 9.

  19. 19

    Arewa (2006), supra note 12, p. 173.

  20. 20

    More interesting set of cases involving abuse of TK of local communities available at Ibid, pp. 175-176.

  21. 21

    See Daniel J. Gervais, Spiritual but not Intellectual? The Protection of Sacred Intangible Traditional Knowledge, 11 Cardozo Journal of International and Comparative Law, no. 478 (2003), f.n. 58-59. See also, Ragavan (2001), supra note 12, pp. 33-35 for more on the Draft Declaration. In September 2007, the UN General Assembly adopted the UN Declaration on the Rights of Indigenous Peoples and in 2008 the UN Development Group (UNDG) issued the UNDG Guidelines on Indigenous Peoples’ Issues. See also Report of the UN Department of Economic and Social Affairs, Division for Social Policy and Development, Secretariat of the Permanent Forum on Indigenous Issues, Report of the International Workshop on Traditional Knowledge held in Panama City, 2123 September 2005, PFII/2005/WS.TK/10, p. 3.

  22. 22

    For works of WIPO on the protection of TK (inclusive of TM), see the following WIPO documents: WIPO/GRTKF/IC/6/11, pp. 2-3, WIPO Document WO/GA/26/6, pp. 5-7; <http://www.wipo.int/tk/en/igc/gap-analyses.html.http://www.wipo.int/export/sites/www/tk/en/documents/pdf/decision_assemblies_2011.pdf>; <http://www.wipo.int/meetings/en/topic.jsp?group_id=110; WIPO IGC Document WIPO/GRTKF/IC/7/6/Annex 1; WIPO IGC Document WIPO/GRTKF/IC/9/5 and its annexes.

  23. 23

    The TRIPs Council has been very active in organizing debates and gathering documents to identify the most appropriate took for the protection of TK. See the following: WTO Document IP/C/W/370/Rev.1, pp. 13-17; WTO Document IP/C/W/404, pp. 7-9; Ragavan (2001), supra note 12, p. 13, at 22-27; Daniel J. Gervais, Traditional Knowledge & Intellectual Property: A TRIPS Compatible Approach, Michigan State Law Review (spring 2005), pp. 140-141, at 149-163.

  24. 24

    For works of the CBD on the protection of TK (inclusive of TM) see the following: CBD Handbook supra note 11, pp. 899-905 (on the development of the Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising out of Their Utilization) and p. 139 (on the establishment of the Article 8(j) Working Group).

  25. 25

    WIPO-UNEP Study on the Role of Intellectual Property Rights in the Sharing of Benefits Arising from the Use of Biological Resources and Associated Traditional Knowledge, available at: <www.wipo.int/tk/en/publications/769e_unep_tk.pdf>, accessed 10 December 2012.

  26. 26

    The WHO has made tremendous effort in assisting its Members in developing national policy and regulatory frameworks and enhancing safety, efficacy and quality standards for traditional medicines, as well as establishing effective access mechanisms and the rational use of traditional medicines. Moreover, the WHO has produced two important documents – the WHO Guidelines for Assessment of Herbal Medicines and the three-volume WHO Monographs on Selected Medicinal Plants. The three volumes are available at: <http://www.who.int/medicinedocs/pdf/s2200e/s2200e.pdf>; <http://www.who.int/medicinedocs/pdf/s4927e/s4927e.pdf>; and <http://www.who.int/medicinedocs/index/assoc/s14213e/s14213e.pdf>. See the following references for additional information: WHO, WHO Traditional Medicine Strategy 2002–2005, supra note 1 and WHO, WHO Medicines Strategy: Countries at Core (2004–2007), available at: <libdoc.who.int/hq/2004/WHO_EDM_2004.5.pdf>; <http://www.who.int/medicines/areas/traditional/e n/;http://www.who.int/medicines/areas/traditional/TRM_BeijingDeclarationEN.pdf>, all accessed 10 December 2012.

  27. 27

    The following can briefly describe the works of UNESCO on TK: UNESCO, Traditional Knowledge, available at: <http://www.unesco.org/bpi/pdf/memobpi48_tradknowledge_en.pdf>; UNESCO, Intangible Heritage List, available at: <http://www.unesco.org/culture/ich/index.php?pg=00011>, all accessed 15 December 2012; Universal Declaration on Bioethics and Human Rights, Article 17, available at: <http://unesdoc.unesco.org/images/0014/001461/146180E.pdf>; Report of the Meeting of the UNESCO’s IBC Working Group on Traditional Medicine and Its Ethical Implications (WGTMEI), SHS/EST/10/CIB/WG-3/3, (2010), pp. 1-2, available at: <http://unesdoc.unesco.org/images/0018/001891/189196e.pdf>; UNESCO’s IBC, Work Programme for 2012–2013, available at: <http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/international-bioethics-committee/work-programme-for-2012-2013/>, accessed 15 December 2012.

  28. 28

    The ILO adopted the Convention Concerning Indigenous and Tribal Peoples in Independent Countries (Convention No. 169) on 27 June 1989, a convention which built upon the 1957 Indigenous and Tribal Peoples Convention (Convention No. 107). Available at: <http://www.ilo.org/ilolex/cgi-lex/convde.pl?C169">. For a more detailed analysis, see Ragavan (2001), supra note 12, pp. 30-32.

  29. 29

    In 2004, UNCTAD produced a 400-page document called Protecting and Promoting Traditional Knowledge: Systems, National Experiences and International Dimensions which explains importance of TK in health and agriculture, the modes of preservation and protection of TK, and means of harnessing TK for the benefit of the holders of the knowledge through trade and development. The document is available at http://www.unctad.org/en/docs/ditcted10_en.pdf.

  30. 30

    WHO, WHO Traditional Medicine Strategy 2002–2005, supra note 1, p. 38.

  31. 31

    See Paragraphs 17–19 of the 14 November 2001 Doha Ministerial Declaration, available at:<http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_e.htm>, accessed 8 December 2012.

  32. 32

    WTO, TRIPS: Reviews, Article 27.3(B) and Related Issues: Background and the current situation, available at: <http://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm>, accessed 13 January 2013.

  33. 33

    See the following: The [CBD] Secretariat also cooperates with other UN agencies, such as the Food and Agriculture Organization, World Intellectual Property Organization, World Trade Organization, UN Forum on Forests, Commission on Human Rights Working Group on Indigenous Populations, and the UN Conference on Trade and Development. This collaboration ensures that issues concerning the protection and application of traditional knowledge, innovations and practices, and the involvement of indigenous and local communities in biodiversity-related activities, are given the widest possible focus (emphasis added). CBD Secretariat, Article 8(j): Traditional Knowledge, Innovations and Practices, supra note 11, p. 3.

  34. 34

    See U. Beyerlin, Bridging the North-South Divide in International Environmental Law, ZaöRV 66 (2006), 259-296, available at: <http://www.zaoerv.de/66_2006/66_2006_2_a_259_296.pdf>, accessed 11 January 2013. See also, WTO, TRIPS: Reviews, Article 27.3(B) and Related Issues: Background and the Current Situation, available at: <http://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm>.

  35. 35

    See the compendium Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A World Wide Review (2001) prepared by the WHO.

  36. 36

    For a brief presentation of some of these legislations, see S. W. Andemariam, Legislative Regulation of Traditional Medicinal Knowledge in Eritrea vis-à-vis Eritrea’s Commitments under the Convention on Biological Diversity: Issues and Alternatives, 6 Law, Environment and Development Journal, no. 2 (2010), 152-153.

  37. 37

    This section has been copied from an article that the author is publishing with the Environmental Law and Practice Review (Vol. II, 2013).

  38. 38

    Report of the meeting of the IBC’s Working Group on Traditional Medicine and its Ethical Implications SHS/EST/10/CIB/WG-3/3 (2010), paras. 4 and 11.

  39. 39

    WHO, WIPO and WTO, Promoting Access to Medical Technologies and Innovation: Intersections between Public Health, Intellectual Property and Trade, pp. 89-94, available at: <http://www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf>, accessed 8 March 2013.

  40. 40

    Scores of countries have issued legislations on TM or complementary and alternative medicines (CAM). A WHO survey showed that as of 2003, out of the then 141 Member States of the WHO, 54 countries had legislation on TM/CAM and that 42 countries indicated that they were in the process of developing such policies. WHO, National Policy on Traditional Medicine and Complementary/Alternative Medicine (2005), pp. 12-14, available at: <http://apps.who.int/medicinedocs/pdf/s7916e/s7916e.pdf>, accessed 7 January 2012. See also, WHO, Regulatory Situation of Herbal Medicines: A Worldwide Review, WHO/TRM/98.1, available at: <http://apps.who.int/medicinedocs/pdf/whozip57e/whozip57e.pdf>, accessed 13 December 2013.

  41. 41

    A survey of the WHO showed that as of 2003, out of the then 141 Member States 45 countries had a national policy on TM/CAM and that 51 countries indicated that they were in the process of developing such policies. WHO, National Policy on Traditional Medicine and Complementary/Alternative Medicine, Ibid, pp. 11-12.

  42. 42

    For the purpose of the survey mentioned in ibid, the WHO defined a program as any program performed at local or national level by the Ministry of Health, other ministries or local bodies, whose mandate is to take specific action in order to achieve objectives in line with national policy or legislation. The survey showed that 40 countries had a national program on TM/CAM and that 31 countries indicated that they were in the process of developing such programs. Ibid, pp. 16-17.

  43. 43

    WHO, WHO Traditional Medicine Strategy 2002–2005, supra note 1, pp. 29-34.

  44. 44

    As published in Andemariam (2010), supra note 36, pp. 119-136.

  45. 45

    Prepared by reference to draft policy instruments such as those prepared by WIPO, the WHO and similar national policies of countries such as Nigeria and the Republic of Guinea.

  46. 46

    Summarized from Andemariam (2010), supra note 36, pp. 159-161.

  47. 47

    It has long been believed that “A sui generis system appears to be the most appropriate scheme for the protection of traditional medicine and other treatments.” O.C. Koon, Intellectual Property Protection of Traditional Medicine and Treatments in Malaysia, in M. Blakeney (ed.), Perspectives on Intellectual Property: Intellectual Property Aspects of Ethnobiology (London: Sweet & Maxwell, 1999), p. 153, at 172.

  48. 48

    If we take the Thai Act on Protection and Promotion of Thai Medicinal Intelligence as a reference, these include the right to ownership on the production of the drug; right over the research, distribution, improvement or development of formulae on TM; IP rights on the TM and the texts on its production; right to permit (license) one’s rights under the legislation and pass them to inheritors, etc.

Published Online: 2013-08-31

©2013 by Walter de Gruyter Berlin / Boston