The origins of
traditional Chinese medicine can be traced to Shen Nong Shi, a mythological
figure from about 5,000 years ago, who sampled hundreds of herbs for use as
medicines. The formal history of TCM starts about 2,500 years ago with the
Yellow Emperor's Inner Classic, the first written account of its
practice.
TCM views a
patient's condition as a reflection of the interaction of five elements of
nature: wood, fire, earth, metal and water. The goal is to treat each patient
holistically, with prescriptions tailored to the individual patient's
condition.
Chinese consumers
generally perceive TCM as more effective for disease and chronic illness
prevention, and they view Western medicine as being more effective for acute and
serious illnesses.
Another major
difference between TCM and Western medicine is that, until recently, TCM has
relied on patient experience, not clinical trials, for proof of
effectiveness.
TCM combines raw
materials, principally herbs, to treat disease. Historically, the formulation
incorporated as many as 10,000 ingredients, 90 percent extracted from herbs and
10 percent from animal byproducts and minerals.
Today, practitioners
of TCM regularly use around 300 ingredients in their widely available
formulations. Any given formulation requires four to eight ingredients on
average.
The principle used
for combining ingredients has its origins in the framework of imperial
ministerial-assistant-servant, which was documented 5,000 years ago in the Shen
Nong Herbal Encyclopedia.
The framework calls
for an imperial herb, the chief herb or main ingredient of a formula; the
ministerial herb, ancillary to the imperial herb, which augments and promotes
the action of the main ingredient; the assistant herb, which reduces side
effects of the imperial herb; and the servant herb, which harmonizes or
coordinates the actions of the other herbs.
Although only 10
percent of China's 2 million physicians are trained exclusively in TCM, most
medical school students receive some training in the discipline. They can
prescribe TCM medicines that have earned State Food and Drug Administration
approval.
Products and
protection
I. Patent protection
covers special ingredients, quality standards, processing techniques, dosages,
formulations, and design, and is valid for 10 to 20 years. For example, Tasley's
Fufang Danshen Diwan, which works to improve circulation and kill pain, has
patent protection for its ratio of raw materials and special processing
techniques.
II. The
innovative-drug protection mechanism covers formulations and dosage forms for
two to five years. The protection mechanism applies to TCM and Western
medicines.
III. Protected TCM
was introduced in 1992 to limit excessive competition. For each protected
formulation and form of dosage, there can be no more than 10 manufacturers.
Companies typically apply for Protected TCM status when their innovative-drug
protection is about to expire. This protection is valid for seven to 30
years.
IV. Heritage secret
recipe offers exclusive protection for trade secrets, formulations and
processes. This mechanism lasts five to 20 years, but obtaining approval is very
difficult. Fewer than 200 traditional drugs are protected under this category,
and many of them - for example, Yunnan Baiyao, used to slow internal bleeding,
and Pian Zai Huang, used to treat mouth ulcers and bee stings, were first
introduced more than 100 years ago.