International Conclave on Traditional Medicine

16-17th November, 2006

New Delhi, INDIA

Organized by In Collaboration with

Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy, Ministry of Health and Family Welfare, New Delhi, India Website: www.indianmedicine.nic.in

National Institute of Science Communication and Information Resources (CSIR), New Delhi, India

Website: ww.niscair.res.in

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CHAPTER 1

Overview of the Current Scenario on Traditional Medicines

Introduction: Traditional medicine is defined by WHO as health practices, approaches,

knowledge and beliefs incorporating plant, animal and mineral based medicines,

spiritual therapies, manual techniques and exercises, applied singularly or in

combination, to treat, diagnose and prevent illnesses or maintain well-being

(WHO, 2003).

The term traditional medicine is applied due to the fact that they had their origin

in the remote past and most of these are still practiced almost in the same

manner as have been in the past, maintaining the tradition. The basic principle

involved in traditional medicine is that these are holistic in nature and rather than

treating in isolation they are believed to eradicate the root cause of the disease.

Medical knowledge systems have developed over centuries within various

communities before the era of modern medicine by the knowledge gained by trial

and error process and also by observing the behaviour of the diseased animals.

Perhaps the earliest use of plants has been documented in Vedas about 4,500 to

600 years BC. This represents the oldest repository of human knowledge, and

comprises 67 plant species. In China, Sheng-Nongs Herbal book is thought to be

one of the earliest sources of folk knowledge on the use of herbals; it comprises

365 plants, animals and minerals useful as medication from the period of Sheng-

Nong (3000 BC) (Pei 1987, 2001). Studies on Tibetan Medicine have shown that

the earliest literature on Tibetan medicine is dated eighth century AD (Yang

1988).

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The experts at W.H.O. have identified and enlisted more than 100 types of

traditional medicine practices, which are in use throughout the world. These

forms of medicine are variously known as traditional medicine (as most of these

are practiced from time immemorial), complementary medicine (as these

medicines supplement the Allopathic medicines in many-a-cases or as they differ

from the orthodox medicine), holistic medicine (most of the alternative medical

systems consider the human body as a complete being comprising of physical

mental, social and spiritual dimensions), ethno medicine (as these traditional

health care systems are closely associated with the life and culture of the

masses), natural medicine (as these methods of treatments are based on the

laws of nature and natural substances are used to treat the patients).

Some examples of the Traditional Medicine Systems practiced in different

countries include acupuncture by the Chinese; magnetic healing by the French;

Heilpraxis by the Germans; Herbalism by the Swedish; Ayurveda, Siddha, Unani

and Yoga by Indians; Shiatsu in Japan; So-wa Rig-pa in Bhutan, etc. Some of

the most popular systems of alternative medicine are Ayurveda, Unani, Siddha,

Naturopathy, Yoga, Acupuncture, Acupressure, Shiatsu, Medical herbalism,

Meditation, Hydropathy, Diet Therapy, etc.

Popularity of Traditional Medicines (TM)

Countries in Africa, Asia and Latin America chiefly use traditional medicine (TM)

to help meet some of their primary health care needs. Even industrialized

countries are turning towards TM for health care purposes. TM, thus has not only

maintained its popularity in all regions of the developing world, its use is rapidly

spreading in industrialized countries which is exemplified from the following facts:

• In China, traditional herbal preparations account for 30%-50% of the total

medicinal consumption.

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• In Ghana, Mali, Nigeria and Zambia, the first line of treatment for 60% of

children with high fever resulting from malaria is the use of herbal

medicines at home.

• WHO estimates that in several African countries traditional birth

attendants assist in the majority of births.

• In Europe, North America and other industrialized regions, over 50% of

the population have used complementary or alternative medicine at least

once.

• In San Francisco, London and South Africa, 75% of people living with

HIV/AIDS use TM/CAM (Complementary and Alternative Medicine).

• 70% of the population in Canada have used complementary medicine at

least once.

• In Germany, 90% of the population have used natural remedies at some

point in their life. Between 1995 and 2000, the number of doctors who had

undergone special training in natural medicine had almost doubled.

• In the United States, 158 million of the adult population use

complementary medicines and according to the USA Commission for

Alternative and Complementary medicines, US $17 billion were spent on

traditional remedies in 2000.

• In the United Kingdom, annual expenditure on alternative medicine is US$

230 million.

• The global market for herbal medicines currently stands at over US $ 60

billion annually and is growing steadily (WHO, 2003).

The popularity and renewed interest in the traditional systems of medicine is due

to the following reasons: (i) lesser side effects as compared to allopathic

medicines, (ii) affordability of traditional drugs by large number of people of the

third world countries, and (iii) the effectiveness of these time tested systems,

particularly for diseases which are chronic in nature or not adequately addressed

in the modern system of medicine.

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Besides the above primary reasons, there are some subsidiary or secondary

reasons of the growing popularity of the traditional medicines such as: (i) cultural

links in many rural areas to the traditional medical systems lead to easy

acceptance, and (ii) simplicity of remedies and practices attracts people.

National Policies on Traditional Medicine (TM)

The concept of national policy primarily involves three key elements, which are

firstly a definition for TM/CAM, secondly provision for the creation of laws and

regulations, and thirdly consideration of intellectual property issues. Besides

these key elements, national policies can reflect the strategies that the

Government may adopt for achieving the objectives of the policy, and may also

include laws and regulations on TM/CAM (WHO, 2005).

In a global survey carried out by WHO (WHO, 2005), wherein data was collected

from 141 Member States, 32% countries were found to have national policies on

TM/CAM, whereas 64% countries do not have a national policy and 4% countries

did not provide a satisfactory reply. However, 56% countries have indicated that

such policies are in the process of development. This study indicates that

developing of a national policy is prerequisite for further growth of TM in these

countries. It was also noticed in the study that the national policies on TM/CAM

increased significantly in the last decade. There is a growing trend in the recent

past for member states to establish national policies on TM/CAM. The trend is

likely to continue as more Member States are likely to have their national polices

shortly.

Laws and Regulations on TM/CAM

The structure and comprehensiveness of laws and regulations on TM/CAM

varies from country to country, and furthermore in Member States where no

policy exists, laws and regulations cover different areas of TM/CAM.

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A Law is the first stage of the legislative procedure and is the rule of conduct

imposed by the authority. A law establishes necessary conditions under which

TM/CAM needs to be organized in line with the national or other relevant policies.

The law may cover various areas in the TM/CAM field including education of

professionals, licensing of practitioners and manufacturers, manufacture and

trade of products used in TM/CAM, sales practices, etc. (WHO, 2005)

A Regulation is the second stage of the legislative procedure, specifically

designed to provide the legal machinery required to achieve the administrative

and technical goals of law. Many activities such as description of obligations and

responsibilities of licensed practitioners, the penal sanctions if the rules are

conravened, the obligations of incumbents on manufacturers of TM/CAM

products, etc., come under regulations (WHO, 2005).

The study carried out by WHO indicates that 38% countries have laws or

regulations whereas 60% countries do not have laws or regulations.

Countries face major challenges in the development and implementation of the

regulation of traditional medicines. These challenges are related to regulatory

status, assessment of safety and efficacy, quality, control, safety monitoring and

lack of knowledge about TM within national drug regulatory authorities.

Before manufactured drugs came into widespread use, herbal medicines played

an important role in human health. There are great differences between Member

States in the definition and categorization of herbal medicines. A single medicinal

plant may be defined as a food, a functional food, a dietary supplement or a

herbal medicine in different countries depending on the regulations applying to

foods and medicines in each country. This makes it difficult to define the concept

of herbal medicines for the purposes of national drug regulation, and also

confuses patients and consumers.

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The global survey conducted by WHO (WHO, 2005) on Regulation of herbal

medicines particularly on the regulatory status of herbal medicines, regulation

requirements, number of registered herbal medicine products and quality control

requirements such as GMP, monographs, etc. gave the following results.

Before 1988, there were only 14 Member States with regulations relating to

herbal medicines, but the figure increased to 53 Member States (37%) having

laws and regulations in 2003. Of those Member States without current laws or

regulations, 42 (49%) declared that these regulations were in the process of

being developed. Such results show that Member States are increasingly

involved in developing the regulation of herbal medicines;

The questions about the regulatory status of herbal medicines also show,

interestingly, that in most Member States (97 out of 142 respondents) herbal

medicines are sold as over-the-counter medicines, in contrast to 50 Member

States where herbal medicines are also sold as prescription medicines. Medical

claims, health claims and nutrients contents claims are the most common types

of claims with which herbal medicines may legally be sold (90 Member States

allow medical claims, 62 allow health claims and 49 allow nutrients content

claims)

The collected information about herbal medicines also shows that 86 Member

States (61%) have a registration system for herbal medicines and 17 have 1000

or more registered herbal medicines. Judging from these data, many Members

States are giving the regulation of herbal medicines careful consideration. (WHO

1995).

National Programme on TM/CAM

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This refers to any programme performed at local or national level so as to

achieve the objectives in line with national policies or legislation. The response

on this study by WHO indicates that 28% countries do have national programmes

whereas 66% countries do not have any national programme. However,

33%countries indicated that such a programme was in process of being

established (WHO, 2005).

National Offices and Expert Committees for TM/CAM

The WHO study indicates that 53% countries have national offices whereas 43%

countries do not have any national offices out of which 19 countries indicated that

such an office is being planned. Expert Committees, formed by national

governments for the purpose of reviewing and making policy and

recommendations exist in 43% of the countries.

Standardization, Quality Control and Safety of Traditional Medicines

The safety and efficacy of Traditional Medicines as well as quality control have

become important concerns for both health authorities and the public. Diverse

TM practices have been developed in different cultures and in regions, but

without a parallel development of international standards and appropriate

methods for evaluating traditional medicines.

Requirements and methods for research and evaluation of the safety and

efficacy of traditional medicines are more complex than those for conventional

pharmaceuticals. A single medicinal plant may contain hundreds of natural

constituents, and a mixed herbal medicinal product may contain several times

that number. If every active ingredient were to be isolated from every herb, the

time and resources required would be tremendous. Such an analysis may

actually be impossible in practice, particularly in the case of mixed herbal

medicines.

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The safety and efficacy of herbal medicines is closely correlated with the quality

of the source materials used in their production. The quality of source materials

is, in turn determined by intrinsic factors (genetic) and extrinsic factors

(environmental conditions, cultivation and harvesting, field collection and post

harvest/collection transport and storage). Therefore, it is very difficult to perform

quality controls on raw materials of herbal medicines. In the quality control of

finished herbal medicinal products, particularly mixed herbal products, it is more

difficult to determine whether all the plants or starting materials have been

included.

Good Manufacturing Practice (GMP) lay down many requirements for quality

control of starting materials, including correct identification of species of

medicinal plants, special storage and sanitation as well as cleaning methods for

various materials.

Adverse events arising from consumption of herbal medicines may be due to any

one of a number of factors including, the inadvertent use of the wrong species of

plant; adulteration of herbal products with other, undeclared medicines;

contamination with toxic or hazardous substances; overdose; misuse of herbal

medicines by either health care providers or consumers and use of herbal

medicines concomitantly with other medicines. Analysis of adverse events

related to the use of herbal medicines is more complicated than in the case of

conventional pharmaceuticals. Furthermore, herbal medicines are often used for

self care; thus, there is a great need to educate consumers and public in their

proper use.

The general lack of knowledge about traditional herbal medicines within national

drug authorities and the lack of appropriate evaluation methods are factors that

delay the creation or updating of national policies, laws and regulations for

traditional medicines. In order to meet these challenges, the WHO TM Strategy

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2002-2005 was developed, with four primary objectives: framing policy;

enhancing safety, efficacy and quality; ensuring access; and promoting rational

use. Resolution on Traditional Medicine was adopted at the Fifty sixth World

Health Assembly held in May 2003. The resolution requested WHO to support

Member States by providing internationally acceptable guidelines and technical

standards and also evidence based information to assist Member States in

formulating policy and regulations for the safety, efficacy and quality of

traditional medicines (WHO, 2005).

In view of the above, there is an urgent need for standardization and evaluation

of safety and efficacy for wider use of traditional medicines particularly in the

developed countries. Plant-based traditional systems of medicine have

substantial usage data spanning over centuries indicating safety and efficacy.

Some of the reasons why standardization, quality control and safety are essential

are enumerated in the following paragraphs.

Change in drugs composition

Several original codified texts with specific traditional medicinal formulae exist.

However, physicians practicing these systems of medicine have modified these

formulations according to prevailing local conditions or personalized them for

individual patients. Consequently, though the formulation name may have

remained unchanged, the formula of the original preparation has gone through

changes resulting in the same preparation having different compositions as well

as different therapeutic indications. These errors have led to confusing

nomenclature of plants, accidental substitution of herbs, etc. Even in the original

works, the means of maintaining finished product quality, safety and efficacy

mentioned were at best only subjective in the absence of objective means of

evaluation available to modern day science (Chaudhary, 2003).

Socio-economic changes

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With respect to traditional medicines, the activity of herb procurement,

preparation and dispensing was done by the physician and was a personalized

system. However, the socio-economic changes in modern times, technological

advances, commercial factors, consumer preferences, changing lifestyles, etc.

have influenced the way herbal drugs are being 'manufactured' and distributed

(Chaudhary, 2003).

Change in natural immunity and also of disease causing organisms

There has also been a remarkable change in the natural immunity towards the

disease state, the nature and severity of diseases and the dietary and social

conditions. The disease causing agents / factors might have also undergone

dramatic change due to evolution of the parasites based on the drugs being used

for the treatments. An average person's diet, lifestyle and other social habits, all

which play important roles in disease-genesis and treatment, are also changing.

This may require validation of the efficacy of formulations for the treatment

purposes (Chaudhary, 2003).

Change in plant constituents

Plant constituents are also greatly influenced due to climatic factors, intra-

species variations, ecological conditions, parasite attacks, geographical location

of their collection, cultivation, etc. The herbs and their properties described

thousands of years ago must have undergone changes in phytochemical profile

in the normal evolutionary process and due to changed environmental and

agronomic conditions. Hence, the original pharmacological claims of these

medicinal plant species need to be revalidated.

Substitutes and Adulterants

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Some traditional literature allows the substitution of herbs that were not found

easily or scarce in certain regions. In some cases the substitutes have acquired

the status of the original herb and are sometimes wrongly attributed with all the

properties of the original herb. With passage of time, the herbs that were meant

to substitute the original herb in one application start finding use in other

applications not recommended by the authors. Hence, this has also necessitated

constant clinical evaluation and validation(Chaudhary, 2003).

Natural products are used as supplements in many countries and not as the

prime candidate for treatment since there is high cost of regulatory approvals

required in placing a natural drug on the market as the main line of therapy.

Hence, safety trials coupled with efficacy trials are essential for bringing these

natural drugs as the first line of treatment.

Quality standardization for Branded Drugs

Traditional medical literature mentions specific combinations of plant, animal and

mineral resources for the given disease conditions. The efficacy and safety of

traditional formulae have been done by informal system of trials down the ages

but on the other hand it is essential that the proprietary branded drugs are also

prepared as per traditional texts, which perhaps may maintain the desired

efficacy.

Change in lifestyle

Traditional systems of medicine also recommend certain changes in lifestyle

during medication. Some of these are difficult to adhere to which may for

example include dietary restrictions, dosages, supplementary food items, etc.

Research needs also to be focused on these aspects for their therapeutic

efficacy with respect to the treatment (Chaudhary, 2003).

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Some Research needs

There is also a need to conduct systematic research on the effectiveness of

usage of medicinal plants and products on different age groups, human races,

etc. For example, the drugs which are health vitalizers/ rejuvenators often

recommended for older people are being consumed by wide age groups and also

different human races (Chaudhary, 2003).

Attracting Consumers using herbal claims

Recently, there has also been a trend of enhancing the commercial value of a

product by mentioning it as herbal product. Consumers do get attracted to such

products. These may be unjustified or have exaggerated claims. Quality control

of marketed products through regulatory legislation is the answer to the problem

of spurious and sub-standard "herbal" products with exaggerated claims at times.

Several efforts have been made in recent times to ensure the quality, safety and

standardization of drugs used in Traditional Medicine Systems. Some of these

are briefly enumerated below.

(i) The pharmacological screening of plant materials from different ecosystems

and traditional formulations from various texts is continuing. However, there is a

need to enhance these activities to a much larger scale.

(ii) Clinical trials are also being carried out on certain potentially active herbal

moleciules or isolates, candidates which are in phase I and II trials to evaluate

novel activities. This will ensure standardization of starting and finished materials

ensuring a healthy and growing market for herbal products (Chaudhary, 2003).

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(iii) Even though there has been rapid developments in screening of biological

samples through complex analytical methods, the quality control of the finished

products has been a challenge.

(iv) Clinical evaluation of branded formulations is also taking place but the efforts

need to be speeded up.

(v) The Pharmacopoeias often form the basis of quality control in the drug

industry of any country. Several countries have already made progress in the

compilation of their national Herbal Pharmacopoeias. However, this exercise

needs to be continued further with added vigor and speed.

(vi) There is also a need for providing adequate testing facilities, contract

research laboratories and other facilitating agencies to meet the needs of the

small-scale sector traditional drug manufacturers.

(vii) It has been felt that without a stringent regulatory policy on quality control of

natural products, there will never be adequate motive for private initiative in this

field. There is also a need to have adequate infrastructure to fulfill the

requirements and then to vigorously implement the existing provisions of health

regulations or to amend the existing laws (Chaudhary, 2003).

It may be pertinent to mention here that the World Health Organization launched

its first ever comprehensive traditional medicine strategy in 2002. The strategy is

designed to assist countries to:

• Develop national policies on the evaluation and regulation of TM practices;

• Create a stronger evidence base on the safety, efficacy and quality of the

TM products and practices;

• Ensure availability and affordability of TM including essential herbal

medicines;

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• Promote therapeutically sound use of TM by providers and consumers;

• Document Traditional Medicines and remedies.

While some countries have fully or partially integrated traditional medicine into

their health care systems, many countries are yet to collect and integrate

standardized evidence on this type of health care.

It is estimated that 70 countries have a national regulation on herbal medicines

but the legislative control of medicinal plants has not evolved around a structured

model. This is because medicinal products or herbs are defined differently in

different countries and diverse approaches have been adopted with regard to

licensing, dispensing, manufacturing and trading.

It has been suggested that due to limited scientific evidence about TM safety and

efficacy as well as on other considerations, the governments need to:

• Formulate national policy and regulation for the proper use of TM and its

integration into national health care systems in line with the provisions of

the WHO strategies on Traditional Medicine;

• Establish regulatory mechanisms to control the safety and quality of

products and of TM practice;

• Create awareness about safe and effective TM therapies among the

public and consumers;

• Cultivate and conserve medicinal plants to ensure their sustainable use

and prevent adulteration.

Some governments have drawn up regulations for good manufacturing practices

for traditional systems of medicine so that the industry can compete in

international markets. This step overcomes a serious shortcoming. Drug

standardisation and quality control have been identified as the most important

challenges affecting the future of the traditional Indian systems of medicine.

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The new manufacturing regulations are calculated to improve the quality and

standards of medicines being manufactured in about 9000 licensed pharmacies.

The manufacturing rules prescribe essential infrastructure, staffing, and quality

control requirements such as standard manufacturing processes and the use of

authentic raw materials free from contamination.

The Indian government apart from taking legislative measures is also

strengthening laboratories for testing traditional medicines, which is expected to

promote traditional medicines in national and international markets. Testing by

government approved laboratories and adoption of good manufacturing practices

will perhaps ensure the quality control over use of traditional medicines and may

improve the export potential.

In fact, for enhancing the export market, China and Hong Kong have braced up

to the stringent requirements of more rigorous clinical trials and modeled after

western regulatory protocols. Hong Kong is funding 18 Chinese medicine

research projects that include clinical trials, development of quality standards and

basic pharmacological studies (Basu, 2004)

Traditional Medicines in the US markets have been historically regulated as

dietary supplements under the 1994 Dietary Supplement Health and Education

Act (DSHEA). Unlike the standard used for prescription drugs, DSHEA puts the

onus on FDA to prove that a supplement poses significant or unreasonable risk

of harm rather than on the manufacturers to prove the supplement’s safety.

Elsewhere, The European Union (Brussels) regulates supplements similarly to

the US, though the process is faster because a substance’s historical use can be

used to document safety and efficacy, in the absence of scientific evidence to the

contrary.

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Manufacturers who opt to designate their products as supplements can bypass

expensive and time intensive clinical trials, thereby getting products to the

market.

The European Union has introduced a new legislation called the ‘Traditional

Herbal Medicinal Product Directive’ for fast track registration of traditional

medicinal products of plant origin. This Directive seeks from traditional medicine

makers to show evidence of safe usage in the EU member nations, for market

authorization of a product. For limited therapeutic conditions, and in the absence

of adequate clinical data, companies have the option of demonstrating safe use

of `traditional medicinal herbal products’. Canada also opened the doors of its

new Natural Health Products Directorate in January 2004. In the absence of

clinical safety data, the Directorate will now consider entry of a natural remedy if

traditional references like translated Sanskrit texts or anthropologically validated

oral traditions can prove that it has been safely used for at least 50 years. While

regulatory agencies are rethinking regulatory practices, developing countries are

inching closer to western style regulation (Basu 2004).

Thus, developing countries need to exploit and transform traditional knowledge

into new venture, and the issues mentioned above need to be addressed in a

systematic manner along with enforcement of necessary measures to protect

intellectual property.

Applications of Traditional Medicine in Drug Development Traditional Medicine knowledge has proved valuable for the discovery of novel

drugs for therapeutic purposes. Some examples are given below:

(i) Jeevani is a herbal medicine developed by the scientists of the Tropical

Botanic Garden and Research Institute (TBGRI) located in Kerala, South India.

Jeevani is based on the traditional medicinal knowledge of the Kani tribe found in

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Thiruvananthapuram district of the state of Kerala in South India. It is derived

from Arogyapaacha plant (Trichopus zeylanicus), which is a small perennial herb

found in Southern India, Sri Lanka and Malaysia. Jeevani is reported to have the

following properties:

• Activates the body’s natural defenses

• Activates delayed type hypersensitivity reaction and antibody synthesis

• Increases the number of polymorpho nuclear granulocytes

• Activates the cellular immune system

• Exhibits hepato-protective and cholorectic activities

• Has adaptogenic properties as evidenced by anti-peptic ulcer and anti-

fatigue effects.

Fruits of Arogyapaacha plant eaten by the ethnobotanical expedition to the

Western Ghats of TBGRI scientists with Kani tribals in 1987 provided anti-fatigue

properties attributed by experimental studies to the presence of glycolipids and

polysaccharides. Three patents claiming processes for preparation of herbal

drugs based on Arogyapaacha have been filed in India (Wilder, 2001).

(ii) For thousands of years, African tribesmen have eaten the Hoodia gordonii

cactus to stave off hunger and thirst on long hunting trips. The Kung bushmen,

San, who live around the Kalahari desert in Southern Africa used to cut off stems

of the cactus about the size of a cucumber and munch it. Hoodia’s appetite-

suppressing element is known as P57 and has potential to cure obesity.

(iii) TM can also have impact on infectious diseases. For example, the Chinese

herbal remedy Artemisia annua, used in China for almost 2000 years has been

found to be effective against resistant malaria and could create a breakthrough in

preventing almost one million deaths annually, most of them children, from

severe malaria.

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(iv) In South Africa, the Medical Research Council is conducting studies on the

efficacy of the plant Sutherlandia microphylla in treating AIDS patients.

Traditionally used as a tonic, this plant is expected to increase energy, appetite

and body mass in people living with HIV.

Biotech companies keenly watch the developments where traditional medicines

are being used in clinical trials and are giving desired results. The idea is to

transform local medicinal knowledge into biotech medicines. For example,

Kanglaite is an extract produced from coix seeds (Coix lacryma-jobi), which in

injectable form of the extract was approved by China’s State Drug Administration

in 1996 and is being used in China for lung, liver, breast and other forms of

cancer. The drug at present being considered for drug approval in the West

(Basu, 2004).

Similarly one more remedy is for lung cancer treatment developed by China’s

National Corporation of Traditional and Herbal Medicines. Phase-I clinical trials

have been approved by FDA for the traditional medicine developed from a rare

Chinese medicinal plant.

Clinical validation of certain Ayurveda formulations has also been initiated. An

R&D company known as Avestha Gengraine Technologies, Bangalore targets

obesity and diabetes using Ayurveda drugs which are at the preclinical stage of

development.

Reverse Pharmacology: A route for Novel Drug Development Reverse pharmacology correlates traditional drug action, say for example

Ayurveda. This approach has attracted sizeable attention, nationally and

internationally. The golden triangle approach, wherein Traditional Drugs, modern

science and modern medicine will be used synergistically for new drug discovery

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and development has been initiated in India using Traditional Drugs from

Ayurveda.

Reverse pharmacology comprises of three stages—experiential, exploratory and

experimental. Possessed with a pluralistic healthcare, India offers a goldmine for

robust documentation of clinical observations of bio-dynamic effects of

standardised traditional drugs. The exploratory studies would cover dose-activity

in ambulant patients and in selected in-vitro and in-vivo models to evaluate the

key target. These exploratory leads are evaluated critically for resource allocation

and state-of-the-art experimental studies. The experimental stage involving

relevant basic and clinical science would be employed to study the plant or a

molecule at different levels of biological organization. This would define the

safety, efficacy, preventive or therapeutic dimensions of the new or natural drug.

The reverse approach in pharmacology has been quite successfully applied in

the past. The drawback was that the long time lag from the observational

therapeutics to a new drug. For example, Rauvolfia serpentina was convincingly

demonstrated to be an anti-hypertensive in 1931. But a drug reserpine, emerged

only after 20 years. This happened because the path of reverse pharmacology

was random and quite discontinuous. Currently, Council of Scientific and

Industrial Research (CSIR), India, through the New Millennium Indian Leadership

Initiative (NMITLI) has adopted the path of reverse pharmacology. The NMITLI

team in the last four years has networked for R&D in a multi-institutional, multi-

disciplinary endeavour to develop natural drugs for treating diabetes, arthritis and

hepatitis. The results have been remarkable as to the hits and leads obtained

(Wilder, 2001).

Reverse pharmacology was only sporadically applied to new drug development.

It is the need of the time to document unknown, unintended and desirable, novel,

prophylactic and therapeutic effects in observational therapeutics. Several new

classes of drugs have accidentally emerged by this path.

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Protection of Traditional Medicine

Traditional Medicine Knowledge which has evolved over several years of

observations and experimentations is a valuable knowledge with the

communities possessing this knowledge. In fact, the livelihood of many people in

these regions is dependent on the use of the traditional medicine knowledge

existing in these communities.

Protection of this TM knowledge has become important due to the rapid

misappropriation particularly by the developed countries. The codified traditional

knowledge has also become an open treasure for misappropriation.

Some of the examples of misappropriation of traditional knowledge are given

below:

Turmeric (Curcuma longa )

In 1995, a US patent (no.5,401,504) was granted on the use of turmeric in wound

healing. The Indian Council of Scientific & Industrial Research (CSIR) filed a re-

examination case with the US PTO challenging the patent on the grounds of prior

art. CSIR argued that turmeric has been used for thousands of years for healing

wounds and rashes and therefore its medicinal use was not a novel invention.

Their claim was supported by 32 documentary evidence of traditional knowledge.

USPTO upheld the CSIR objections and cancelled the patent. The turmeric case

was a landmark judgment case as it was for the first time that a patent based on

the traditional knowledge of a developing country was successfully challenged.

The US Patent Office revoked this patent in 1997, after ascertaining that there

was no novelty; the findings by innovators having been known in India for

centuries.

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Neem (Azadirachta indica)

In 1994, European Patent Office (EPO) granted a patent (EPO patent

No.436257) to the US Corporation W.R. Grace Company and US Department of

Agriculture for a method for controlling fungi on plants by the aid of hydrophobic

extracted neem oil. In 1995, a group of international NGOs and representatives

of Indian farmers filed legal opposition against the patent. Evidence was

submitted that the fungicidal effect of extracts of neem seeds had been known

and used for centuries in Indian agriculture to protect crops, and thus was a prior

art and unpatentable. In 1999, the EPO determined that according to the

evidence all features of the present claim have been disclosed to the public prior

to the patent application and the patent was not considered to involve an

inventive step. The patent granted on was neem was revoked by the EPO in May

2000, which was challenged by United States Ministry of Agriculture in 2001. However, in March, 2005 EPO upheld the decision to withdraw the patent.

(iii) Hoodia (Hoodia gordonii)

For thousands of years, African tribesmen have eaten the Hoodia cactus to stave

off hunger and thirst on long hunting trips. In 1995, South African Council of

Scientific & Industrial Research (CSIR) patented Hoodia’s appetite-suppressing

element (P57) and hence, its potential cure for obesity. In 1997 they licensed

P57 to British Biotech Company, Phytopharm. In 1998, Pfizer acquired the rights

to develop and market P57 as a potential slimming drug and cure for obesity.

The San people eventually learned of this exploitation of their traditional

knowledge, and in June 2001, launched legal action against South African CSIR

and the pharmaceutical industry on grounds of bio-piracy. They claimed that their

traditional knowledge has been stolen, and the South African CSIR had failed to

comply with the rules of the Convention on Biodiversity, which requires the prior

informed consent of all stakeholders, including the original discoverers and

users.

22

The two sides entered into negotiations for a benefit-sharing agreement, despite

complications regarding who should be compensated: the person who originally

shared the information, their descendants, the tribe, or the entire country.

However, in March 2002, a decision was reached in which the San will receive a

share of royalties. The settlement will not directly affect Phytopharm or Pfizer

since the San would be paid out of the CSIR’s royalties, as South African CSIR is

the patent holder.

(iv) Study by the Traditional Knowledge Digital Library (TKDL) Task Force

TKDL Task Force studied randomly selected 762 US patents, which were

granted under A61K 35/78 and other International Patent Classification (IPC)

classes, having a direct relationship with medicinal plants in terms of their full

text. Out of these 762 patents, 374 (49%) patents were found to be based on

traditional knowledge. 408 patents were granted by USPTO during March 2000

itself on several medicinal plants. A further study by a team of experts of TKDL

studied the USPTO, EPO and UKPO patent databases in respect of medicinal

plants (with respect to Unani system of medicine) in April, 2003 and found more

than 15,000 patent references against 4896 references found in 2000, clearly

demonstrating three-fold increase. However, as per the study carried out in

December 2005 at EPO, UKPTO, USPTO, the number of patents filed in these

offices on medicinal plants have increased to 35,567. The possible number of

patents taken on the Indian System of medicine each year is approx. 2000.

Reasons for Grant of Bad Patents on codified TM

Patent examiners, in the international patent offices, when considering the

patentability of any claimed subject matter, use available resources for searching

the appropriate non-patent literature sources. Patent literature, however, is

23

usually wholly contained in several distinctive databases and can be more easily

searched and retrieved whereas non-patent literature prior art may be buried

somewhere in the many and diverse sources. Hence, the patent examiners

neither have the TM information with them and even if they have this information

are unable to understand it due to the language and format barriers.

Creation of Traditional Knowledge Digital Library

TKDL has been created to prevent grant of wrong Traditional Knowledge patents

at international level by making the database available in multiple languages

such as English, French, German, Spanish and Japanese and in patent

application format.

TKDL is being created on the codified traditional knowledge on Indian Systems of

medicine, which are Ayurveda, Unani, Siddha and Yoga. Information on

traditional drug formulations from 148 texts having 230 volumes are being

transcribed. So far 1,65,000 formulations from texts in Sanskrit, Urdu, Arabic,

Persian, Tamil, etc. have been transcribed and the database size that has been

created is more than 20 million A4 sized pages.

Traditional Knowledge Resource Classification (TKRC)

Traditional Knowledge documentation lacked a classification system.

Therefore, a modern classification based on the structure of International Patent

Classification (IPC) was evolved. The objective of creation of TKRC is not only to

give a structured classification to Indian Traditional Medicine but also to use it as

a tool for data entry and retrieval of data. Approximately 25,000 subgroups have

been created for Ayurveda, Unani, Siddha and Yoga.

The evolution of TKRC also has had international connotations. WIPO

constituted a Task Force comprising United States Patent Office, European

24

Patent Office, China, Japan and India to address the issue of the existence of a

single subgroup on medicinal plants and linking IPC with TKRC. Subsequently,

the Task Force recognised the need of having more detailed level of

classifications relating to medicinal plants and has included about 200 sub-

groups under A61K 36/00 instead of single sub-group on medicinal plants A61K

35/78. Also the Task Force has approved linking of TKRC developed by India

with IPC at the 35th IPC Union Meeting held in October, 2004.

Specifications and Standards

TKDL has been able to set international specifications and standards for setting

up of TK databases and registries based on TKDL specifications. This was

presented at the at the 4th Session of Intergovernmental Committee (IGC) of

WIPO on Intellectual Property and Genetic Resources, Traditional Knowledge

and expression of folklore. The technical standards were adopted by the

Committee in the fifth session of the IGC held in 2003.

International Coverage

TKDL has widely covered in the international and national media as is evident

from the high coverage in newspapers. In December 2005 itself TKDL found

coverage in as many as 76 newspapers — 68 international (50 from USA and

eight national). Recently, TKDL was covered extensively in Nature (27th July,

2006) which is a science journal of international repute and also in Time Asia

magazine (7th to 14th August, 2006 issue). A number of international TV networks

such as CNN, United States PBS, etc. video clipped TKDL project and telecast

stories on TKDL in their channels.

TKDL as a model for defensive protection of TK by other Countries

25

TKDL has thus become a model for defensive protection of TK by other

countries. Several countries and organizations such as South Africa, Nigeria,

Mongolia, Thailand, African Regional Industrial Property Organization (ARIPO),

SAARC Member States have shown interest in protecting their own TK from

misappropriation. In fact a two day workshop was organized at New Delhi in

December, 2004 on Creation of TKDL for SAARC Countries.

Legal and Policy framework on TK protection

The diverse nature of TK systems and their close association with the cultural

identity of diverse communities have been some of the major practical

considerations while dealing with protection of TK. It id therefore not possible to

evolve a common template or solution that is likely to suit all countries and legal

environments. TK protection is also closely linked to access and benefit sharing

measures. Prior informed consent is another aspect that needs to be given due

consideration while drafting laws to protect TK. This would ensure that TK held

by the traditional community should not be accessed, recorded or used or

commercialized without the consent of the TK holders.

The debate revolving around TK and the IP system has highlighted the limitations

of existing IP laws to meet all the needs and expectations of TK holders. Yet,

existing IP laws have been used successfully to protect against misappropriation

of TK, including through laws of patents, trademarks, geographical indications,

industrial designs and trade secrets. However, modifications to IP law are

essential to make it work better considering the substantial differences in nature

of TK and other forms of IP. The holistic quality of TK and its close relationship to

TCEs or expressions of folklore have led many countries to draft laws protecting

both TK and TCEs together. Some of the issues of why Traditional Medicines

cannot fit into the existing IPR system are enumerated below.

26

Issues regarding the inapplicability of existing IPR with respect to TM

Seeking patent rights for inventions on Traditional Medicines have three

constraints. First, most traditional knowledge including traditional medical

knowledge is ancient and does not meet the requirements of novelty and

inventive step. Second, traditional knowledge is held collective, there is not a

single individual or discrete group of individuals that can be identified as an

“inventor” in whose name the application may be filed. Some thought has been

given to customary law, which could interface with patent laws to influence a

determination of “inventorship”. Third, the complexity and cost of drafting and

prosecuting patent applications is outside financial capacity of the knowledge

holders and may not be able to afford (Wilder, 2001).

The definition of novelty for patent purposes depends on the national or regional

law under which a patent is granted. Thus, some national laws define oral

disclosures as a part of the “prior art” which will defeat “novelty” only if they are

made within their national borders.

A traditional healer who has identified the Traditional Medicine ingredient is the

inventor. A determination of inventorship is essential and must be determined in

accordance with the relevant national or regional laws.

Traditional medical practitioners have identified the high costs of filing patent

applications as the biggest bottleneck to the acquisition of the patents by

practitioners of traditional medicine. Suggestions have been made, however, that

are specific to holders of traditional knowledge, including requests for financial

and legal assistance to traditional healers’ organizations for filing of patent

applications by traditional healers associations on behalf of individuals or groups

of informal innovators. This would allow holders of traditional knowledge to share

transaction costs for acquiring and exercising patent rights (Wilder 2001).

27

Sui Generis Protection of TK

Because of the inadequacy of the current forms of IPR to fit TM requirements,

there have been suggestions for the establishment of sui generis system for the

protection for the protection of TK. Given the present state of understanding of

TK and the applicability of IP to its protection, it is perhaps appropriate to

proceed with negotiations on an international sui generis system for protection of

TK.

Experts have suggested that a sui generis system separate from the existing IPR

system should be designed to protect the knowledge, innovations and practices

associated with biological resources. However, the parameters, elements and

modalities of a sui generis system are still in the drafting stage.

In the first instance, not only the applicability of IP protection, but also the

“parameters, elements and modalities” in respect of sui generis protection

systems needs to be worked out at the national level. Some countries have

introduced specialized legislation that seeks to protect the rights of holders of TK-

including TM (WIPO, 2004). Examples of countries or inter-draft legislation or

laws include Brazil, Panama, Thailand, the Philippines, and the Organization of

African Unity. Inter Governmental Organizations have taken up the question of

sui generis protection for TK. Non-Governmental Organizations have also made

proposals for model legislation in the field.

The subject matter protectable under these laws varies-from artistic designs, to

traditional nowledge associated with biodiversity, to only TK of indigenous

peoples not associated with biodiversity. In addition, the method for obtaining

rights varies under these laws –from those requiring no formalities to those

requiring an application and examination. Moreover, some laws provide for an

independent right of action to enforce rights in TK, others simply provide that

28

rights in TK may be exercised to prevent others from obtaining industrial property

(in particular, patent) rights. There is also variation as to the term of protection.

A comparison of the sui generis rights to protect TK number by different countries

such as Peru, Portugal and Thailand is given below.

The sui generis regime of Peru was established by law in 2002, which affords

protection to collective knowledge of indigenous peoples which is associated with

biodiversity. This knowledge is protected irrespective of whether it is registered in

national/local registers provided for under the law. The law grants indigenous

peoples right to consent to the use of TK associated with biological resources.

The law also envisages the payment of equitable compensation into a national

fund or directly to the beneficiaries or TK holders. The law also recognizes the

customary laws and provides for dispute settlement through them.

The Portugal sui generis legislation for the protection of TK again focuses on

plant genetic resources and TK associated with them. The policy objectives are

to maintain the knowledge, innovations and practices of farmers and local

communities and promote their conservation. The law protects all TK associated

with utilization of local varieties developed by local populations against

commercial or industrial reproduction and/or use.

Thailand endeavours to protect its traditional knowledge through two laws: Act on

Protection and Promotion of Traditional Medicinal Intelligence and Plant Varieties

Protection Act. The idea is since TK often cannot be patented due to lack of

novelty, there needs to be an alternative means to protect traditional herbal

medicine for primary health care and developing herbal medicine for economic

benefit.

Among the regional frameworks there is the SAARC framework for the protection

of TK. The objective of this framework is to prevent misappropriation of TK,

regulate access to TK and to ensure fair and equitable sharing of benefits arising

29

from the use of TK. TK in this context includes any result of intellectual activity in

a traditional context such as Ayurveda, Unani, Siddha systems of health care. It

is not limited to any technical field, and may include agricultural, environmental,

health care and medicinal knowledge, knowledge associated with genetic

resources, etc.

But these are national laws or regional frameworks for protecting TCEs and TK,

which are limited to the given jurisdiction and protection beyond national

boundaries is lacking.

In 1998 and 1999, WIPO consulted a wide range of stakeholders, such as

indigenous peoples and local communities, NGOs, governmental

representatives, academics and the private sector, to identify the IP needs and

expectations of the holders of TK and cultural expressions. The WIPO

Intergovernmental Committee on Intellectual Property and Genetic Resources,

Traditional Knowledge and Folklore (the IGC) was established by the WIPO

General Assembly in October 2000 as an international forum for debate and

dialogue concerning the interplay between intellectual property (IP), and

traditional knowledge (TK), genetic resources (GR), and traditional cultural

expressions/ expressions of folklore (TCE (folklore)). Currently, the IGC which

met for the first time in 2001, is discussing the enhanced protection of TK and

traditional cultural expressions against misappropriation and misuse.

The IGC has extensively reviewed documentation and analyzed the wide

ranging experiences of legal protection of TK through existing IP rights as well as

sui generis measures. The Conference of Parties of CBD itself has stated that

the most appropriate means of protecting TK is based on a combination of

approaches including the use of existing IP mechanisms, sui generis systems,

customary law, the use of contractual agreements, registers of traditional

knowledge and guidelines and codes of practice.

30

Several options in the form of form of basic policy tools are suggested for use to

develop protection measures for TK. A basic element of numerous IP systems is

the grant of exclusive property rights. These may be applied to TK by using

conventional forms of IP rights, amending existing forms of IP rights or tailor

made sui generis systems. For example, geographical indications have been

used to protect products with traditional technologies, China granted several

patents for traditional Chinese medicine, copyright has been used to protect

expressions ion fixed form, etc. Recognition of customary laws is also important.

Keeping the above experiences and existing gaps in mind, the IGC is presently

debating a protection regime at the international level and has proposed some

draft objectives and principles which are under discussion the IGC for the

protection of TK. The drafts have not been adopted or endorsed by the IGC and

may be developed further. While these draft objectives and principles have no

formal status, nevertheless, they provide guiding principles in this area and

possibly suggest frameworks for protection of TK against misappropriation and

misuse (WIPO, 2006).

There is a set of draft objectives and principles proposed for TK which is given

below.

Protection of TK The substantive provisions fundamentally aim at protection against

misappropriation. Suggested mode of protection is a sui generis law or

adaptation of existing laws on IP, unfair competition, etc keeping in mind the

need of the holders of TK. Access and benefit sharing issues are clearly

addressed along with prior informed consent involving appropriate national

authorities (WIPO, 2006).

Duration of protection of TK may be infinite as long as they fulfill the defined

criteria.

31

Draft Legal Instrument for SAARC Countries on protection of traditional knowledge A two-day workshop on ‘Creation of TKDL for SAARC Countries’ was held at

New Delhi in December 2004 and was attended by eleven delegates from

SAARC member countries, viz., Bangladesh, Bhutan, India, Maldives, Nepal and

Sri Lanka. During this workshop draft recommendations on legal framework for

protection of TK for SAARC countries were finalized, the salient features of which

is given below. Details on this recommendation is at Annex. 1.

(i) The preamble of the legal instrument on protection of TK brings out the

needs of protection of Traditional Knowledge in the SAARC region.

(ii) The SAARC member states have agreed for the different aspects of

protection of traditional knowledge, which have been covered under 14

articles.

(iii) The objectives of this legal instrument, given in Article 1, are to repress

the misappropriation of traditional knowledge, to regulate access to

traditional knowledge, and to ensure the fair and equitable sharing of

benefits arising from the use of traditional knowledge.

(iv) The second article identifies the scope of the protected subject matter,

wherein not only that traditional systems of medicines have been

included but also other areas of TK protection such as the Agricultural,

Environmental, Healthcare, Knowledge Associated with Genetic

Resources and Components of Biodiversity, Traditional Architecture

and Construction Technologies.

(v) The third article deals with the access to the traditional knowledge,

which includes the prior informed consent from the knowledge holders.

(vi) The fourth article covers the criteria for eligibility of protection which

includes the protection of knowledge which is generated, preserved

32

and transmitted, and the knowledge with the tribal community or the

people and the codified traditional knowledge systems.

(vii) The nature of rights has been dealt in article five wherein it has been

suggested that member states are free to implement their obligations

under this instrument through a special law on TK and other laws

which are impinging on the protection of TK.

(viii) The conditions of protection have been listed out in the article six.

(ix) The article seven briefly covers the scope, rights and exceptions.

Protection against misappropriation has been dealt as a part of this

article. The different methods of misappropriation of the TK have been

identified and those which are prohibited have been enlisted.

(x) Under sub-article for right of compensation, the users of traditional

knowledge for commercial benefits have been identified to provide

equitable compensation. However, where TK is used for non

commercial purposes, a suitable benefit sharing for such users has

been suggested.

(xi) Within the scope of exceptions, it has been suggested that application

and implementation of TK should not affect the continued availability of

TK for customary purposes, practices, exchange, use and transmission

by TK holders or for use for non commercial or help purposes.

(xii) In article eight the right holders and the beneficiaries have been

identified. The protection, in particular, must benefit the traditional and

tribal communities. The benefits must take into account the customary

protocols, laws and practices of these communities and peoples.

(xiii) The article nine deals with the acquisition of rights i.e. the protection of

TK against misappropriation and other acts of unfair competitions.

(xiv) The article ten covers the expiration and the loss of rights.

(xv) The exercise and enforcement of rights are dealt in the Article eleven

wherein, the responsibilities have been identified where it has been

suggested to appoint an appropriate competent authority appointed by

the member states with responsibilities that have been identified.

33

(xvi) The registration mechanism and other procedures are covered in

article twelve where further responsibilities of the appropriate

competent authority appointed by the member states have been

enlisted.

(xvii) The defensive protection of TK has been covered in Article thirteen

wherein the member states have been given the responsibility of

establishing registries, digital libraries, databases and other records on

TK as defensive protection measures.

(xviii) The defensive protection measures have been further elaborated in

Article fourteen wherein it has been suggested 10 that the equitable

sharing of benefits may be guided with respect to the customary

practices, norms, laws and understanding of the holders.

Access and Benefit Sharing

This is an important issue which needs to be addressed along with protection of

TK as with genetic resources. The international trade in genetic resources, often

referred to as biotrade, involves high economic stakes today. Traditional

knowledge of local and indigenous communities plays an important role in

identifying genetic resources and biodiversity products and services that have a

commercial use. To reduce research costs, pharmaceutical, biotechnology and

personal care companies sometimes focus their research on plants and animals

used by indigenous people for their beneficial qualities. The Convention on

Biological Diversity (CBD) was adopted in 1992, in response to the alarming rate

that countries have been losing their biodiversity. The survival and livelihoods of

all human societies – especially the poorest – are closely dependent on

biological diversity. Most of the richest ecosystems host human populations

which have lived in harmony with nature for centuries. These populations are

now among the poorest in the world and depend entirely on the natural resources

that surround them. It was therefore, to ensure that industries and scientific

34

communities that access genetic resources share the benefits arising from

research and development with the populations that maintain and use them.

One of the basic objectives of the Convention on Biological Diversity, as set out

in its Article 1, is the fair and equitable sharing of the benefits arising out of the

utilization of genetic resources. A framework for the implementation of this

objective of the Convention with regard to access to genetic resources and

benefit-sharing (ABS) is also provided in Article 15 of the Convention which

recognizes the sovereign rights of States over their natural resources and

provides for national legislation relating to ABS.

To deal with issues relating to ABS, an Ad Hoc Open-ended Working Group was

established by the Conference of Parties, with the mandate to develop guidelines

and other approaches and to assist Parties and stakeholders in addressing the

elements, such as terms for prior informed consent and mutually agreed terms,

mechanisms for benefit-sharing, for example through technology transfer and

joint research and development, etc.

The Working Group meeting held in 2001, contributed to the development of draft

guidelines on access and benefit-sharing meant to assist Parties and

stakeholders with the implementation of the access and benefit-sharing

provisions of the Convention. The adoption of Bonn guidelines on access to

genetic resources and the fair and equitable sharing of the benefits arising from

their utilization was one of the major achievements.

At the third meeting of the Working Group held in February 2005 and

subsequently at its fourth meeting in February 2006. At these meetings, the

Working Group, began negotiations for an international regime on access to

genetic resources. It also addressed other approaches including consideration of

an international certificate of origin/source/legal provenance; and, measures,

including consideration of their feasibility, practicality and costs, to support

compliance with prior informed consent of the Contracting Party providing such

35

resources and mutually agreed terms on which access was granted in

Contracting Parties with users of genetic resources under their jurisdiction. This

regime is expected to be negotiated before the end of 2010.

Two Indian legislations, which deal with ABS system are the Protection of Plant

Varieties and Farmers’ Rights Act (PPVFR Act), 2001 and the Biological Diversity

Act (BD Act), 2002. The PPVFR Act was enacted to make India TRIPS compliant

with respect to grant of intellectual property protection on plant varieties7. The

BD Act seeks to establish national sovereignty over the bio-resources and

associated traditional knowledge existing within legal territorial bounds, including

the economic zone in sea, in pursuance of the CBD and to provide regulation for

its conservation, sustainable use and access of its components and ensuring fair

and equitable sharing of benefits arising out of its use.

Conclusion

The use of Traditional Medicine Systems has been increasing both in the

Developing Countries as well as in the Developed Countries due to the fact that

these are gentler compared to the modern systems of treatment, are time tested

and have proved their effectiveness for centuries, are holistic in their method of

treatment and are affordable by a large section of people.

However, there are a number of issues, which need to be addressed for

enhancing potential for exports and to ensure that the effectiveness of these

drugs. Some of these issues include (i) Standardization, Quality Control and

Safety of TM, (ii) Regulatory and Clinical Aspects, (iii) Access and Benefit

Sharing, (iv) Legal and Policy framework for TK protection, etc.

TThhee aabboovvee iissssuueess hhaavvee bbeeccoommee iimmppoorrttaanntt ccoonncceerrnnss ffoorr bbootthh hheeaalltthh aauutthhoorriittiieess

aanndd tthhee ppuubblliicc.. GGoooodd MMaannuuffaaccttuurriinngg PPrraaccttiiccee ((GGMMPP)) rreeqquuiirreemmeennttss ffoorr qquuaalliittyy

ccoonnttrrooll aallssoo nneeeeddss ttoo ggeett aaddoopptteedd bbyy mmaannuuffaaccttuurreerrss ooff TTrraaddiittiioonnaall DDrruuggss ffoorr

36

pprroovviiddiinngg eeffffiiccaacciioouuss aanndd ssaaffee ddrruuggss.. TThhee ddeevveellooppmmeenntt aanndd iimmpplleemmeennttaattiioonn ooff

tthhee rreegguullaattiioonn ooff ttrraaddiittiioonnaall mmeeddiicciinneess aarree ccoommpplleexx iissssuueess tthhaatt aallssoo nneeeeddss ttoo bbee

aaddddrreesssseedd.. FFooccuuss aallssoo nneeeeddss ttoo bbee oonn ccrreeaattiinngg aa ssuuii ggeenneerriiss ffrraammeewwoorrkk ffoorr

pprrootteeccttiioonn ooff TTMM ssiinnccee the provisions in the existing IPR system for protection of

TK are inadequate. AAcccceessss aanndd BBeenneeffiitt SShhaarriinngg iissssuuee aallssoo nneeeeddss ttoo bbee

aaddddrreesssseedd aalloonngg wwiitthh pprrootteeccttiioonn ooff TTKK aass wwiitthh ggeenneettiicc rreessoouurrcceess....

IInn sshhoorrtt,, tthhee IInntteerrnnaattiioonnaall CCoonnccllaavvee ffooccuusseess oonn tthhee mmaajjoorr ccoonncceerrnnss oonn ttrraaddiittiioonnaall

mmeeddiicciinneess aatt iinntteerrnnaattiioonnaall lleevveell ssoo tthhaatt tthhee bbeenneeffiittss ooff TTMM mmaayy rreeaacchh eevveerryy ppaarrtt

ooff tthhee wwoorrlldd..

References (i) Basu, Paroma 2004. Trading on traditional medicines. Nature

Biotechnology, 22 (3): 263-265.

(ii) Chaudhary, Jayesh 2003. Standardization and Evaluation of Traditional

Medicine. Pharmabiz.com, http://www. pharmabiz.com/article/detnews.asp

?articleid=16962&sectionid=46.

(iii) Pei, Sheng-ji 1987. Medicinal plants in tropical areas of China. Proceedings

of the Symposium 5-35, the 14th International Botanical Congress, Berlin.

Wageningen, Netherlands.

(iv) Pei, Sheng-ji 2001. Ethnobotanical approaches of traditional medicine

studies: Some experiences from Asia. Pharmaceutical Biology, 39, Suppl.:

74-79.

(v) WHO, 2003. http://www.who.int/mediacentre/factsheets/fs134/en

(vi) WHO, 2005. National Policy on Traditional Medicine and Regulation of

Herbal Medicines, Report of a Global Survey. World Health Organization,

Geneva.

(vii) Wilder, R. 2001. Protection of Traditional Medicine. CMH Working Paper

Series, Paper No. WG 4:4.

37

(viii) WIPO, 2004. Intellectual Property and Traditional Knowledge. Booklet No.

2. WIPO Publication No. 920(E), World Intellectual Property Organization,

Geneva

(ix) WIPO, 2006. Intellectual Property and Genetic Resources, Traditional

Knowledge and Traditional Cultural Expressions/Folklore.

WIPO/GRTKF/INF/1, World Intellectual Property Organization, Geneva.

(x) Yang, Jing-Sheng 1988. A review on the derivation of Xizang (Tibetan)

drugs and the advanceof its research. Acta Bot. Yunnanic Adit., China.

38

Annex. 1

DRAFT LEGAL INSTRUMENT FOR SAARC COUNTRIES ON PROTECTION OF TRADITIONAL KNOWLEDGE

The Member States of the South Asian Association for Regional Cooperation (SAARC), Convinced of the need to promote respect, preservation, wider application, networking and development of traditional knowledge and associated genetic resources; Recognizing the need to evolve mechanisms for scientifically re-validating the traditional knowledge, wherever possible; Determined to prevent misappropriation and misuse of traditional knowledge and associated genetic resources; Recognizing the need to create an appropriate system for access to traditional knowledge; Desirous to ensure fair and equitable sharing with traditional knowledge holders of benefits arising from the use of traditional knowledge; Recognizing the need to provide mechanisms for the enforcement of rights of traditional knowledge holders; Wishing to enhance scientific capacity of all stakeholders, including traditional knowledge holders, at the regional, national and community levels; Recognizing the need to promote the transfer of technologies whichare involved in or make use of traditional knowledge and traditional cultural expressions; and Appreciating the need to promote and recognize innovation based on traditional knowledge; Seeking to utilize traditional knowledge for wealth creation and social development for society at large and communities in particular; Hereby agree as follows:

39

Article 1

Objectives 1. The objectives of this instrument are to repress the misappropriation of traditional knowledge, to regulate access to traditional knowledge, and to ensure the fair and equitable sharing of benefits arising from the use of traditional knowledge.

Article 2

Scope of protected subject matter 1. “Traditional knowledge” refers to the content or substance of knowledge that is the result of intellectual activity and insight in a traditional context, and includes the know-how, skills, innovations, practices and learning that form part of traditional knowledge systems, and knowledge that is embodied in the traditional lifestyle of a community or people, or is contained in codified knowledge systems passed between generations, such as Ayurveda, Unani, Siddha systems of health care. It is not limited to any specific technical field, and may include agricultural, environmental, health care and medicinal knowledge, knowledge associated with genetic resources or other components of biological diversity, and know-how of traditional architecture and construction technologies. 2. This instrument concerns the protection of traditional knowledge, including when compiled in registries, digital libraries or databases, against misappropriation and misuse beyond its traditional context and should not be interpreted as limiting or seeking to define the diverse and holistic conceptions of knowledge within the traditional context.

Article 3

Access to Traditional Knowledge

1. The principle of prior informed consent shall govern any direct access or acquisition of traditional knowledge from its traditional holders, subject to the provisions of this Article and Article 9, and relevant national laws. 2. The holder of traditional knowledge shall be entitled to grant prior informed consent for access to traditional knowledge, or to approve the grant of such consent by an appropriate national authority, as provided by applicable national legislation.

40

3. Member States shall set up legal systems or mechanisms for granting prior informed consent, which should ensure legal certainty and clarity; should not create burdens for traditional holders and legitimate and honest users of traditional knowledge; should ensure that restrictions on access to traditional knowledge are transparent and based on legal grounds; and should provide for mutually agreed terms for the equitable sharing of benefits arising from the industrial and commercial use of that knowledge. 4. Member States may exclude from the principle of prior informed consent access to and use of traditional knowledge which is already readily available to the general public, provided they require that users of that traditional knowledge to provide equitable compensation for industrial and commercial uses of such traditional knowledge, in accordance with Article 7bis. 5. If traditional knowledge is associated with genetic resources, access to such genetic resource is governed by the relevant national legislation(s), and prior informed consent granting access to such knowledge does not imply prior informed consent for access to such resource, and vice versa.

Article 4

Criteria for eligibility for protection 1. Member States shall extend protection at least to that traditional knowledge which is:

(i) generated, preserved and transmitted in a traditional and intergenerational context, or through recognized courses of study of traditional medicine;

(ii) distinctively associated with a traditional or tribal community or people which preserves and transmits it between generations; and

(iii) integral to the cultural identity of a traditional or tribal community or people which is recognized as holding the knowledge through a form of custodianship, guardianship, collective ownership or cultural responsibility, such as a sense of obligation to preserve, use and transmit the knowledge appropriately, or a sense that to permit misappropriation or demeaning usage would be harmful or offensive;

(iv) integral to systems of traditional knowledge, in particular systems of traditional medicine, which are codified in ancient written scriptures and are passed on between generations on the basis of these scriptures or through recognized courses of study of traditional medicine, subject to national legislation.

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Article 5

Nature of the Rights 1. Member States shall be free to implement their obligations under this instrument through a special law on traditional knowledge; the laws on intellectual property, including unfair competition law and the law of unjust enrichment; the law of torts, liability or civil obligations; criminal law; laws concerning the interests of traditional and tribal peoples, and biological diversity; regimes governing access and benefit-sharing; or any other law or a combination of any of those laws. 2. The form of protection need not be through exclusive property rights, although Member States may make such rights available for the holders of traditional knowledge, as appropriate, including through existing or adapted intellectual property rights systems, in accordance with the needs and the choices of the holders of the knowledge, national laws and policies, and international obligations.

Article 6

Conditions of Protection 1. Protection of traditional knowledge against misappropriation and other acts of unfair competition shall not be subject to any formalities.

Article 7

Scope of Rights and Exceptions 1. The Member States shall be bound to assure nationals of other Member States effective protection against the misappropriation of traditional knowledge. 2. Any acquisition or appropriation of traditional knowledge by unfair or illicit means constitutes an act of misappropriation. Misappropriation also includes deriving commercial benefit from the acquisition or appropriation of traditional knowledge when the person using that knowledge knows, or is grossly negligent in failing to know, that it was acquired or appropriated by unfair means; and other activities contrary to honest practices that gain inequitable commercial benefit from traditional knowledge. 3. The following, in particular, shall be prohibited:

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(a) acquisition of traditional knowledge by theft, bribery, coercion, fraud, trespass, breach or inducement of breach of contract, breach or inducement of breach of confidence or confidentiality, breach of fiduciary obligations or other relations of trust, deception, misrepresentation, the provision of incomplete or misleading information when obtaining prior informed consent for access to traditional knowledge, or other unfair or dishonest means;

(b) acquisition of traditional knowledge or exercising control over it in violation of the prior informed consent requirements in accordance with Article 3, and use of traditional knowledge that violates terms that were mutually agreed as a condition of prior informed consent concerning access to traditional knowledge;

(c) false claims or assertions of ownership or control over traditional knowledge, including acquiring, claiming or asserting intellectual property rights over traditional knowledge-related subject matter when those intellectual property rights are not validly held in the light of that traditional knowledge and any conditions relating to its access; and

(d) commercial or industrial use of traditional knowledge without just and appropriate compensation, when such use has gainful intent and confers a technological or commercial advantage on its user, and when compensation would be required in accordance with Article 7bis.

Article 7bis

Right of Compensation 1. If the traditional knowledge is used with gainful intent for commercial or industrial purposes, and if that traditional knowledge confers a technology-based advantage in commerce or industry, the user of that traditional knowledge shall be liable to provide equitable compensation for such uses

(a) to the recognized holder of that knowledge if that holder is identifiable and if that holder has declared in accordance with Article 9 that the knowledge shall be subject to the provisions of this Article;

(b) to the Competent Authority if the holder of that traditional knowledge is

not identifiable.

2. Use of traditional knowledge for non-commercial purposes need not incur an obligation for compensation, but suitable benefit-sharing from such uses should be encouraged, including access to research outcomes and involvement of the source community in research and educational activities.

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Article 7ter

Scope of Exceptions 1. The application and implementation of protection of traditional knowledge should not adversely affect:

(i) the continued availability of traditional knowledge for the customary practice, exchange, use and transmission of traditional knowledge by traditional knowledge holders;

(ii) the use of traditional medicine for household purposes, use in government hospitals, or for other non-commercial public health purposes.

Article 8

Right holders and beneficiaries 1. Protection of traditional knowledge should be for the principal benefit of the holders of that knowledge in accordance with the relationship described under Article 4(ii) and (iii). Protection should in particular benefit the traditional and tribal communities and peoples that develop, maintain and identify culturally with traditional knowledge and seek to pass it on between generations, as well as recognized individuals within these communities and peoples. 2. Entitlement to the benefits of protection should, as far as possible and appropriate, take account of the customary protocols, understandings, laws and practices of these communities and peoples. Benefits from protection should be appropriate to the cultural and social context, and the needs and aspirations, of the beneficiaries of protection

Article 9

Acquisition of rights 1. In the exercise of his right under Article 3 to grant prior informed consent for access to his undisclosed traditional knowledge, a holder of undisclosed traditional knowledge may file a written declaration to the Competent Authority stating that that knowledge shall be subject to the provisions of Article 7bis. Following the registration of the written declaration by the Competent Authority, that traditional knowledge shall be subject to the provisions of Article 7bis and shall no longer be subject to the provisions of Article 3. That written declaration shall include a sufficiently clear and complete description of the traditional knowledge, so as to enable a person with average skill in the art to practice that

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traditional knowledge. Member States may require that that declaration and description be included in the registries referred to in Article 12.

Article 10

Expiration and loss of rights 1. Protection of traditional knowledge against misappropriation shall last as long as the traditional knowledge fulfills the criteria for eligibility of protection, as set out in Article 4 above. 2. In case of commercial and industrial use, the term of the right to equitable compensation under Article 7bis shall last no more than [X] years counted from the filing date of the declaration. 3. Possible additional protection against other acts, which may be made available by relevant national laws or measures, shall specify the duration of protection under those laws or measures.

Article 11

Exercise and enforcement of rights 1. Member States should appoint an appropriate Competent Authority, or Authorities, which should be competent for:

(i) determining whether an act pertaining to traditional knowledge constitutes an act of misappropriation of, or an other act of unfair competition in relation to, that knowledge;

(ii) determining whether prior informed consent for access to and use of traditional knowledge has been granted;

(iii) granting licenses for industrial and commercial uses of traditional knowledge;

(iv) administer a Fund for Traditional Knowledge through which the compensation can be channeled;

(v) determining equitable compensation; determining whether a user of traditional knowledge is liable to pay equitable compensation; and, if the user is liable, as appropriate, facilitate and administer the payment and use of equitable compensation;

(vi) determining whether a right in traditional knowledge has been acquired, maintained, or infringed, and for determining remedies;

(vii) assisting, where possible and appropriate, holders of traditional knowledge to acquire, use, exercise and enforce their rights over their traditional knowledge.

(viii) Distributing information about traditional knowledge protection and conducting public awareness and advertising campaigns to inform traditional

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knowledge holders and other stakeholders about the availability, scope, use and enforcement of traditional knowledge protection;

Subject to national policies and procedures, these competencies may be exercised by different competent authorities respectively. 2. Measures and procedures developed by the Competent Authority, or Authorities, to give effect to protection in accordance with this instrument should be fair and equitable, should be accessible, appropriate and not burdensome for holders of traditional knowledge, and should provide safeguards for legitimate third party interests and the interests of the general public

Article 12

Registration mechanisms and other procedures 1. Member States may establish relevant registration procedures as a means of facilitating protection of, and equitable compensation for uses of, traditional knowledge. 2. Member States may maintain registers, digital libraries, databases or other records of traditional knowledge, where appropriate and subject to relevant policies, laws and procedures, and the needs and aspirations of traditional knowledge holders. Such registers may be associated with specific forms of protection, and should not compromise the status of hitherto undisclosed traditional knowledge or the interests of traditional knowledge holders in relation to undisclosed elements of their knowledge. 3. Disclosed traditional knowledge may be registered in the SAARC Traditional Knowledge Digital Library or other regional or international registries, which may be established, in order to facilitate defensive and positive protection in and beyond the Member States. 4. The purposes of the register or digital library shall be to preserve and safeguard the collective knowledge of indigenous peoples and their rights therein and to provide the Competent Authority, or Authorities, with such information as enables it to defend the interests of traditional knowledge holders where their collective knowledge is concerned. 5. Traditional knowledge holders shall be permitted to register their knowledge in such registries, which could either be manual or digital. Registration may be subjected to opposition procedures, as are commonly applicable before the grant of intellectual property titles.

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6. Registration of traditional knowledge in the Traditional Knowledge Digital Library or other registries shall not form a requirement of protection. However, registration through those mechanisms shall constitute prima facie evidence in the context of exercise, maintenance, administrative revocation and inter partes procedures and enforcement of rights, as well as settlement of disputes. Rules under this instrument shall provide guidance on matters such as procedures for registration of traditional knowledge through those mechanisms. 7. The registration procedures will facilitate the apportionment of rights in case of multiplicity of custodianship or ownership and will assist in resolving disputes regarding the custodianship or ownership of registered traditional knowledge. Registration will also enable the holder of the traditional knowledge to license the uses of his knowledge to the prospective users in accordance with Article 7bis. 8. The internationally agreed data specification for databases and registries of traditional knowledge and associated biological/genetic resources (Annex of document WIPO/GRTKF/IC/4/14) shall be applicable to traditional knowledge registries.

Article 13

Defensive protection 1. With a view to opposing pending patent applications, disputing granted patents or otherwise intervening in the grant of patents for products or processes invented or developed on the basis of traditional knowledge, the Competent Authority shall send the information entered in the Traditional Knowledge Digital Library to the main patent offices of the world in order that it may be treated as prior art in the examination of the novelty and inventiveness of patent applications. 2. When conducting search and examination for the grant of existing industrial property titles, industrial property offices of Member States shall endeavor to discover as much of the relevant disclosed traditional knowledge as the registers, digital libraries, databases or other records of disclosed traditional knowledge which are available to those offices permit, and shall in any case consult the disclosed traditional knowledge contained in those registries, digital libraries, databases or other records which other Member States have established.

Article 14

Customary Laws and Protocols

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1. The application, interpretation and enforcement of protection against misappropriation of traditional knowledge under this instrument, including determination of equitable sharing and distribution of benefits, should be guided, as far as possible and appropriate, by respect for the customary practices, norms, laws and understandings of the holder of the knowledge, including the spiritual, sacred or ceremonial characteristics of the traditional origin of the knowledge.

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