[Pharm-policy] Re: legality of parallel imports

[James Love]

The US and Japan both have legal traditions of international exhaustion
of patent rights, and parallel import issues for pharmaceuticals in most
developed countries are issues of health and saftey regulation, not
patent law.  Of course, the South African medicines act 15(c) would
permit parallel imports in SA, if it survives the court challenge, but
even if it doesn`t, SA could just pass another law.   There is nothing
special about international exhaustion of patent rights, most countries
already have international exhaustion.  What parallel imports get a
country is the ability to buy at the cheapest price, for the same
product by the same manufacturere.  I think the objectives of the Brazil
WHA proposal is to do a little more -- to make it easier to market low
cost generic products worldwide.   Jamie
 

On Fri, 19 May 2000, Andy Gray wrote:

> Hi all
> 
> In terms of Jamie's clarification:
> > The US restrictions on parallel imports of pharmaceuticals have a basis 
> > in US FDA statutes, but not in US patent law.
> 
> In South Africa, there was an attempt to provide for parallel 
> importation in the Medicines Act. This was challenged by the 
> manufacturers, as it was considered to give the Minister of Health 
> excessive powers to over-rule patents law. Is it therefore necessary 
> to have complementary provisions in both laws - such as specific 
> mention of exhaustion of rights in the Patents Act (within a region, 
> such as the EU, or wider), and then specific mention in the 
> Medicines Act about the registration of such parallel traded goods 
> (e.g. considering goods from the same manufacturers to have the 
> same level of quality as those manufactured inside the country, 
> registered with the regulatory body, and made in inspected 
> facilities OR alternatively a fast-track mechanism just to consider 
> GMP provisions for the foreign plant)?
> 
> How would that affect a country's ability to procure medicines by 
> international competitive bidding (or by using the sort of database 
> proposed by the Brazilian amendment at the WHA)?
> 
> regards
> Andy 
> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
> Andy Gray
> Discipline Chair: Pharmacy Practice
> School of Pharmacy and Pharmacology
> University of Durban-Westville
> email: andy@healthlink.org.za
> Tel: +27 31 2044358 Fax: +27 31 2044792
> 
> 
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James Love, Consumer Project on Technology    
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