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[e-drug] CPT on CIPLA CL request to the South Africa Dept of Trade & Industry

E-drug: CPT on CIPLA CL request to the South Africa Dept of Trade & Industry
On March 7, CIPLA formally requested the South Africa Department of
Trade and Industry issue compulsory licenses to patents on the following
HIV drugs:  nevirapine, lamivudine, zidovudine, stavudine, didanosine,
efavirenz, indinavir and abacavir.  The CIPLA letter is attached below.
Here is the CPT Statement:

James Love, CPT Director said:
"The South Africa government should quickly approve the CIPLA request
for compulsory licenses to patents under section 56 of the South Africa
patents act.  The basis for the approval is as stated in the request, to
increase competition and drive down prices for antiretrovials in South
Africa, where more than 98 percent of HIV infected persons do not have
access to medicines.  Moreover, we call upon the South Africa 
government to issue additional compulsory licenses to Ranbaxy, Hetero 
Drugs Ltd. and generic producers from South Africa, Brazil, Thailand, 
Canada and other countries."
"Any delay in issuance of compulsory licenses will harm the health of
South Africa AIDS patients."

"The South Africa PMA has spent the past two weeks stating the South
Africa government should issue compulsory licenses to patents on HIV
drugs under the provisions of the existing South Africa patents act.
While the PMA said this to undermine the South Africa government's use
of 15c in the Medicines Act, it is also true that the government has a
legal way to issue the licenses.   Now that there is request for a
compulsory license, the government should act quickly, this is an urgent

For comment
James Love mobile 1.202.361.3040
(I will be traveling and out of voice mail contact from 4pm South Africa
Time until 7 am US Eastern time on the 8th).  People can also contact
Robert Weissman in the USA, at 1.202.387.8030, rob@essential.org

CIPLA's March 7, 2001 compulsory licensing request
7th March 2001

Mr McDonald Netshitenzhe
Registrar of Patents
Department of Trade and Industry
Private Bag X400
Pretoria 0001
South Africa

Dear Mr. McDonald Netshitenzhe:

The following is a request for compulsory licenses under Article 56 of
the South Africa Patents Act.  Specifically, we request licenses for the
patents that are relevant to the following HIV drugs.
and combinations of the above drugs.

We are requesting a non-exclusive compulsory licenses under 56(c), on
the grounds that there is an abuse of patent rights because:

         "the demand for the patented article
         in the Republic is not being met to an
         adequate extent and on reasonable terms;"

According to the Department of Health, there are from 4 to 5 million HIV
infected persons in South Africa, and less than 2 percent are receiving
antiretroviral treatment.  Any result that leaves more than 98 percent
of a population untreated and subject to painful death is not adequate.
Submissions of the Treatment Access Campaign in the current litigation
over the Medicines Act indicate the price of drugs is a significant
barrier for access to health care.  If the Department permits
competition for these drugs, prices will fall, and more people will
receive drugs, saving lives and reducing suffering.

Experience in Brazil and other countries demonstrates the following
important factors:

1.      Competition reduces prices.
2.      The benefits of price competition increase over time.
3.      The decision by Brazil to purchase anti-retroviral products from
generic suppliers created a large enough market in the competitive
sector to achieve significant economics of scale in the raw materials
markets, ultimately lowering the prices of drugs globally.

This is an urgent request.  According to Department of Health officials,
there are now about 20,000 deaths from AID every month, and this 
number is expected to grow to as many as 33,000 in the next two 
years.  Delays in lowering the price of drugs result in death and 

CIPLA seeks to create additional competition for antiretroviral drugs,
and has sought voluntary licenses from the brand name companies that
market each of these products, offering to pay a royalty of up to 5
percent on net sales to patent owners.  It is well known that
competition drives down the prices of drugs.  CIPLA does not seek an
exclusive license, and indeed, CIPLA encourages the Department to issues
licenses to all bona-fide competitors for any or all of these products.

It is our opinion that South African citizens would benefit greatly from
a more competitive market for antiretroviral drugs, and more important,
that South Africa can only maximize access to medicines by pursuing a
strategy that embraces the competitive sector, rather than dealing with
monopolistic and cartel like suppliers.

Please advise us on the procedures to follow to obtain the licenses.

With kind regards,

Yours sincerely,
Dr Y K Hamied
Cipla Ltd.

from James Love <love@cptech.org>
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