Is This The End of Patents in Europe?

[Guest guest]

Hi all,

 

A new European directive (Medicinal Products Directive 65/65EEC) has been

introduced concerning the sale and use of herbs as medicine. This has

serious implications for the sale and use of herbs, especially patents and

other over the counter (OTC) products in Europe.

 

To discuss the implications of this directive, let me first set out the

definitions and quote the important extracts from it:

 

Definition of Medicine

 

Any substance or combination of substances which may be administered to

human beings or animals with a view to making a medical diagnosis or to

restoring ,correcting or modifying physiological functions in human beings

or in animals.

 

Market Authorisation License

 

All patents and OTCs products require a market authorisation license as does

any medicine entering the market.

 

Traditional Herbal Medicine Directive - Directive 2004/24/EC

 

Herbal remedies sold over the counter (OTC) must be registered. To become

registered, each product must have a market authorisation license.

 

Time Scale:

 

'A' Day - 30th April 2004 - Publication of Directive

'B' Day - 30th October 2005 - The legislation comes into force with a 7 year

transition period

'C' Day - 30th April 2011 - All herbal remedies on the market must be

registered.

 

So what does this mean for Chinese medicine in the UK?

 

Well, Chinese medicine practitioners, even if they are qualified, will NOT

be able to prescribe any patent or OTC product. The use of Chinese raw herbs

falls under the legislation laid down by Henry VIII to protect western

herbalists. Raw herbs are therefore safe and can be prescribed.

 

Is this the end of patents in Europe?

 

I hope not. Each patent and OTC will have to obtain a market authorisation

license which in effect means it will have to be tested like every other

pharmaceutical drug on the market. This costs alot of money, for example

£500,000 per product. It may be possible to have alot of this market

authorisation done in China, thereby cutting down the costs. Also, a

enterprising herb company in China may taken on the role of obtaining a

market authorisation license for each product, thereby giving them the sole

rights to sell that product in Europe. Europe is the world's largest trading

block and a tempting market to herb companies. Chinese medicine is well

known and well used in Europe. Europe also has a long history of traditional

herb use making it popular. However, traditional names of patents may need

to be changed to protect the company's market authorisation license, who

knows. But anyway, its not good news and another nail in the coffin. What

with M.D. practising acupuncture after a two day course and this, what else

could happen?

 

Warm regards,

 

Attilio D'Alberto

Doctor of (Beijing, China)

B.Sc. (Hons) T.C.M. M.A.T.C.M.

Editor in Chief

Times

07786 198900

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