Bolar Roche

[James Love <love@cptech.org>]

Can anyone help the South African Health Ministry out with this one?
Jamie


Subject: E-DRUG: Bolar Roche provision?
     Date: Wed, 11 Feb 1998 09:41:27 -0500 (EST)
    From: Bada Pharasi <hall032@hltrsa.pwv.gov.za>
 Reply-To: e-drug@usa.healthnet.org

E-drug: Bolar Roche provision?
--------------------------------------------

Further to a previous E-drug message I have received information that 
current patent laws in South Africa do not allow help generic 
companies to prepare their generics before the date of patent expiry, 
as apparently it is not allowed for them to:
- import raw material
- compound such a product
- perform stability studies
- conduct bio-equivalence studies
This basically would mean it would take them another 2-3 years from day
of 
patent expiry to enter the market, unless they register a generic 
product that they import ready made from outside South Africa.

It seems, however, that in USA and Canada this is different, and 
generic companies there are allowed to do all the above and even 
produce stocks to sell the day after the patent expires. Apparently 
it is called the "Bolar Roche" provision.

Can anybody give us more background on this "Bolar Roche" provision?

Are there other countries besides USA and Canada where generic 
companies can prepare their products ahead of patent expiry?

Thanks for your feedback!

Bada Pharasi
Chief Director
Dept of Health
South Africa
Fax +27-12-3244525
Email hall032@hltrsa.pwv.gov.za
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