Dr. Gerard Bodeker University of Oxford Medical School

1. POLICY DEVELOPMENT IN TRADITIONAL AND COMPLEMENTARY MEDICINE:LEARNING FROM THE DEVELOPING WORLD’S EXPERIENCE Dr. Gerard Bodeker University of Oxford Medical School & Chair, Global Initiative For Traditional Systems (GIFTS) of Health

2. Consumer Demand Drives Policy Increase in demand for traditional and complementary medicine • Governments working to develop sound policies, regulations and trade standards. Key issues: • Public access to healthcare system of choice • Public safety

3. ASIA •Asia has seen the most progress in incorporating its traditional health systems into national health policy: •  China - Late 1950's •   India - 1970

10. India and China are the world’s largest producers of medicinal plants & herbal medicines.

12. Safety As traditional medicine exports become a major foreign exchange earner for China, pressure on biodiversity is one challenge. Another is the quality of the medicines produced for the export market. Recent studies in the UK have found that there has been adulteration with steroids of some traditional Chinese dermatological preparations. In an analysis of Chinese herbal creams prescribed for dermatological conditions, Keane et al.4 (1999) found that eight of eleven creams analysed contained steroids.

13. New WHO Policy – May 2002 • 3 Year Plan • Policy, Safety, Access, Rational Use • Priority on Integration • Building knowledge base • Guidance on regulatory & quality assurance standards • Evidence base for tackling priority disease: e.g. HIV, Malaria.

14. A POLICY FRAMEWORKfor TRADITIONAL MEDICINE International policy experience can be organised as: 1.Equity. 2.Ethics. 3.Governance. 4.Financing. 5.Knowledge production. 6.Knowledge Management & Utilisation. 7.Capacity Development. 8.Research Environment.

15. EQUITY – INDIA • India has World Bank funds for development of rural traditional medical services, targeted at poorer sectors of society • Indian government has added 10 medicines from the Ayurvedic and Unani systems into its national family welfare program.

16. Project on reproductive and child health in 7 Indian states for Ayurveda; Unani medicines are being introduced in 4 cities. • Traditional herbal formulations for: anaemia, oedema during pregnancy, post-partum problems such as pain, uterine and abdominal complications, lactation-related problems, nutritional deficiencies and childhood diarrhoea. Massage oils for babies and mothers.

20. ETHICS • Clinical Research • Helsinki Declaration: governs the use of human subjects in research. Informed consent is a key. Human subjects committees.

21. ETHICS Other ethical issues include • the need to protect intellectual property rights • obtaining informed consent from the community • devising ways to share benefits, and return findings to the community

22. Intellectual Property Rights & Traditional Knowledge The Convention on Biological Diversity (CBD) Article 8(j) assigns ownership of biodiversity to indigenous communities and individuals and asserts their right to protect this knowledge. Trade Related Aspects of Intellectual Property Systems (TRIPS) of the World Trade Organization makes no reference to theprotection of traditional knowledge and does not acknowledge or distinguish between indigenous, community-based knowledge and that of industry.

24. TURMERIC • March 1995: Patent on therapeutic use, granted by US Patent & Trademark Office - “Use of Turmeric in Wound Healing” - to the University of Mississippi Medical Center.   • Government of India appealed the patent and sought revocation based on prior art. Turmeric powder is a traditional remedy in India and had been applied to the scrapes and cuts of generations of children. • 14 August 1997, US Patent & Trademark Office invalidated the patent.  

25. The Doha Declaration and the Harmonization of CBD and TRIPSIn November 2001 the declaration of the Fourth Ministerial Conference in Doha, Qatar, mandated a review of TRIPS provisions and called for a harmonization between the CBD and TRIPS (www.wto.org)

26. 3. GOVERNANCE • Self-regulation by traditional health practitioners is central to the establishment and maintenance of standards of best practice. • New Zealand: registration of more than 600 Maori traditional healers who provide services within the wider health system. The government reimburses their services under health insurance schemes.

27. CHINA • State Administration of TCM comprises eight departments   Government investment in the sector has more than quadrupled over a 15 year period (State Administration of TCM, 1997) World Bank funding for TCM since 1980

28. 4. FINANCING INSURANCE • Potential conflict: if traditional healthcare services are made available under medical insurance schemes, those who can afford to pay for insurance will be the greatest beneficiaries of traditional medicine.   • The poor may be relegated to purchasing unregulated drugs from unlicensed street vendors. Traditional medicine is no longer the first and last resort for available healthcare for the poor.

29. INSURANCE Conversely, health insurance coverage can lead to a substantial increase in the use of traditional medical services. Korean immigrant population in Los Angeles use of traditional health practitioners: • 24% of the uninsured • 59% of persons with Medicaid only • 71% of those with other types of insurance including Medicare and Medigap coverage.

30. In China, although traditional health services are covered by health insurance, only about 12% of the population has comprehensive medical insurance that covers the cost of hospitalization and the proportion of uninsured people may be as high as 50%.

31. In hospital settings, insured patients are more likely to receive traditional Chinese medicine. Due to the fact that one of the primary sources of a hospital ward’s profit, under the market model of healthcare is the 15-25% markup for prescribed medications. So the changed incentive system has become associated with increased polypharmacy.

32. In Japan, Kampo medicine, plays an important role in healthcare. Kampo medicine represents a $1 billion segment of annual drug sales in Japan. In a recent survey, about of 76% of responding physicians indicated that they prescribe Kampo prescriptions. Japan's Ministry of Health and Welfare approves 148 Kampo prescription drugs for reimbursement under the national health insurance.

33. 5. KNOWLEDGE PRODUCTION Comparative research should be promoted, where modern and traditional approaches to managing the same conditions are compared in terms of clinical outcomes and cost. Clinical research should follow national and international health priorities - e.g. cancer, cardiovascular disease, diabetes, TB, malaria, HIV/AIDS, etc., and mainstream research funds should encourage a component of research into traditional means for treating specific conditions.

34. 6. Knowledge Management & Utilisation. Currently, no central resource on policy, trade, training, safety, evidence-based treatment modalities, sustainable use of medicinal plant biodiversity, intellectual property rights and models of benefit sharing with customary knowledge holders. Such a resource is clearly needed.

35. GLOBAL INFORMATION RESOURCE ON INTEGRATED MEDICINE • At the request of the Health Ministers of the 54 Commonwealth countries, the Commonwealth Working Group on Traditional & Complementary Health worked with the Government of Malaysia and other countries to establish such a global information resource, which Malaysia has now undertaken to host and fund.

36. . • A widely available web-based resource on complementary & traditional medicine will make safety and efficacy information easily accessible. • Policy makers, consumers and industry will have access to accurate and current evidence-based information to develop the sector.

37. 7. CAPACITY DEVELOPMENT Capacity of the traditional sector must be strengthened in the following areas: • Investment • Regulation & training • Safety, efficacy, standardisation, current utilisation, • Cost-effectiveness, customer satisfaction • Priority diseases (cancer, cardiovascular disease, diabetes, TB, malaria, AIDS, etc.) • Prevention • Conservation & sustainable production of herbs

38. INDIA • New regulations were introduced in India in July 2000 to improve the standard and quality of Indian herbal medicines.   • The new regulations outline requirements for infrastructure, manpower, quality control and raw material authenticity and absence of contamination. • Of the 9,000 licensed manufacturers of traditional medicines, those who qualify can immediately seek GMP certification. The remainder have two years to come into compliance with the regulations and to obtain certification.

39. The Indian government is also setting up ten new drug testing laboratories this year for ISM and upgrading existing ones to provide high quality evidence to licensing authorities of the safety and quality of herbal medicines.

40. CHINA •       Integration & development of TCM through • centralised national planning • Science-based approach to TCM education • Emphasis on research into TCM •      Substantial organisational infrastructure

41. Traditional medicine hospitals in China (number of hospitals)

42. Number of staff and ward beds in traditional medicine hospitals in China

45. 8. RESEARCH ENVIRONMENT • Safety • Consumer evaluation • Special populations • Basic research • Prevention • Meaning & clinical outcome • Comparative studies

49. PREVENTION Retrospective study of 2,836 health insurance enrolees: effects of meditation (TM) on health insurance claims. Before meditation: yearly payments for TM group & control same After meditation: TM group's mean payments declined 1-2% p.a.; control group's mean payments increased up to 12% p.a. over 6 years. Mean annual difference between the two groups of about 13%. Estimated savings on insurance payments as much as $300 million p.a. for provincial government's health insurance company.

50. FUTURE Way forward in policy development is via: *  consultation with all relevant stakeholder groups * exchange of information & experience with international partners * integrated training and educational program for both traditional and conventional medicine.