[Pharm-policy] Re: legality of parallel imports

[Andy Gray]

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