UNAIDS Report on Patents on HIV Drugs in developing countries

[James Love <love@cptech.org>]

This is a report about UNAIDS new study that says few HIV/AIDS drugs are
currently protected by patent in most developing countries.  We haven't
seen the report, and look forward to receiving the data.   However, the
intellectual property issues are likely to be considerably larger than
are suggested by some who have reported the UNAIDS report.

(1) The WTO TRIPS agreement is less than 5 years old, and many countries
have yet to modify laws to comply, which means drugs developed in the
future will likely face different regimes of national legislation.  

(2) It is difficult to determine the status of patent barriers, because
claims can be made for products or processes, and in some countries,
treatment regimes.  In the Thailand case, the US government did not file
for a "use" patent for ddI, but BMS claims it has patents on the
formulations that block entry generics, for example.  In the case of
Taxol, BMS claims to a bevy of patents on processes and patent regimes,
blocking generic products in many countries.  Some countries have
exclusive marking protections under TRIPS transition rules, or other
non-patent intellectual property protections, such as the TRIPS rules for
unfair commercal use of health registration data (Article 39.3). 

(3) Patents in countries where production may be feasible will make it
problematic to obtain the product in countries where small domestic
markets make domestic production too costly.   

(4)  Some countries require drug registration in countries where patents
are likely to be in place.  For example, South Africa is an important
country for drug registration, and is more likely to have a patent claim
than many other Africa countries that rely upon the SA registration.  This
is the case, for example, for Yale's use patent for d4T.  

(5) Companies have been sued in some countries for producing, even off
shore, for sale in non-patent markets.  

All this said, the UNADIS report is a valuable addition to the study of
barriers to access to medicines, and also points to the need for AIDS
activists to work more closely with generic drug companies and national
procurement authorities to address existing opportunties to obtain cheaper
supplies of medicines not protected by patents at present.


   Jamie

---------------------------------

>From rastern@racsa.co.cr Sat Dec 11 08:09:25 1999
Date: Sat, 11 Dec 1999 05:48:51 -0500 (EST)
From: rastern@racsa.co.cr
Reply-To: healthgap@CritPath.Org
To: Multiple recipients of list <healthgap@CritPath.Org>

Developing Countries Could Produce Generic Drugs Right Now, UNAIDS Study Reveals


- Richard Stern
************************ 
In a dramatic development with significant implications for Access to Treatment,

UNAIDS has released a study which indicates that AIDS medications are not patented

in hardly any of the world's developing countries. Theoretically, the study

publicizes the fact that generic versions of the medications could be produced

in almost all developing countries in Asia, Africa, and Latin America. 

The announcement was made on Tuesday December 7th in Paris in an afternoon session

chaired by activist Eric Sawyer (US) devoted to issues related to Compulsory

Licensing and access to treatment. 

In spite of the zeal and organization of activists interested in Compulsory

Licensing, the fact emerged that Compulsory Licensing may not be necessary for

cheaper access to generic medications. 

For example, although Merck, Sharpe and Dohme's protease inhibitor indinavir

(crixivan) is patented in the United States and several European countries,

as well as Australia, New Zealand and Japan, it is not patented in any country

in Latin America. In Africa it is only patented in South Africa, and in Asia

only in Singapore. According to UNAIDS representative Joshua Perriens, Brasil

will soon be producing a generic version of Indinavir and there are no laws

which would prohibit developing countries from buying it at the Brasilian price.



Compulsory Licensing exists as a recourse within the TRIPS agreement, which

is the World Trade Organization's legal agreement related to intellectual property

rights. But the world s poorest 46 countries, almost all of them in Africa and

Latin America, have until the year 2006 to develop national legislation implementing

this agreement. And even when it is implemented Pharmaceutical companies still

have to patent each product in each country. There is no international patenting

process. All patents must be applied for on a country to country basis and few

pharmaceutical companies have bothered to patent their product in developing

countries, although they continue to insist on blocking generic access to their

products in these nations 

The UNAIDS list includes information on 24 medications used to treat AIDS, including

those for opportunistic infections as wells as anti-retrovirals. 

Representative Bernard Pecoul of Doctors Without Borders presented price comparisons

on various medications which are already being produced generically. DDI which

sells for $180 per month in the USA is being manufactured generically in Brasil

where it costs $46 per month. 

AZT costs 37 cents per tablet in Thailand, but sells for $2.08 per tablet in

the Netherlands. Fluconazole, used to treat cryptococcus prophylaxis, cost $7

per day in Thailand before July 1988 but with generic production the price has

dropped steadily and now stands at 67 cents a day. 

Francisco Mingorance of the Fondation du Present summarized the existing situation

related to both Compulsory Licensing and Parallel importing in relation to the

TRIPS agreement. 

Eric Sawyer reminded the audience that Jonathon Mann taught me that I have a

moral obligation to fight for the rights of people with AIDS in the developing

world. He called AIDS the worst plague the world has even seen and called for

businesses to wake up to the fact that human life is far more important than

profit. 

Richard Stern
HCCare Key Correspondent (Costa Rica)
Care@hivnet.ch 

*** From the Fourth International Conference on Home and Community Care for

People Living with HIV/AIDS, 5 - 8 December, Paris, France
 
 



-------------------------------
James Love 
Center for Study of Responsive Law | Consumer Project on Technology 
P.O. Box 19367, Washington, DC 20036 | http://www.cptech.org
Voice 202/387-8030 | Fax 202/234-5176 | love@cptech.org