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[e-drug] South Africa, AIDS emergency, compulsory licensing

E-DRUG: South Africa, AIDS emergency, compulsory licensing
[The South African Sunday Times frontpage starts with the news that the SA 
government is considering issuing a declaration of (public health)
due to AIDS. See http://www.suntimes.co.za/2001/03/11/news/news01.htm

If this is done by President Mbeki on wednesday, this will mean that the
Government can apply for compulsory licenses using the existing Patents
Act for non-commercial government use of anti-retrovirals and other
essential but patented drugs.

Please note that the compulsory licensing procedures in the Patents Act are
being challenged by the drug companies; they are challenging parallel
using the Medicines Control Amendment Act.

A declaration of emergency is a valid reason under TRIPS for issuing a 
license. Kenya was last week also considering issuing a declaration of

Please note the article incorrectly states that Brazil has been issuing
licenses for their ARV production. Brazil had a different pre-TRIPS Patent
which made it possible for generic companies to copy ARVs.

South Africa does not have such a possibility: the only way to produce or
generic ARVs in South Africa would be the issue of a compulsory license.

The Sunday Times also carries an editorial on the new AIDS drug
See:  http://www.suntimes.co.za/2001/03/11/insight/in09.htm

Copied as fair use. NN]

Sunday Times, 11 March 2001 (frontpage)


Mbeki investigates declaring a national emergency on HIV/AIDS to secure
cheap drugs


The government is investigating declaring a national emergency to fight
AIDS. This could 
speed up access to anti-AIDS drugs as the government battles pharmaceutical
over cheap medicines. 

This week in the Pretoria High Court, the government faced up to 39 of the
world's biggest 
drug producers as they fought to protect drug patents that health officials
say are stopping 
lifesaving drugs reaching the ill. 

Then, on Friday, the director-general of Health, Ayanda Ntsaluba, told the
Sunday Times 
that the government was considering declaring an emergency. 

Ntsaluba said this would be discussed in Parliament on Wednesday, adding:
"The President's 
legal team are looking at it and preparing themselves." 

South African law allows several ways for an emergency to be declared - a
move for which 
AIDS activists have been pushing. 

Democratic Alliance leader Tony Leon added his voice to those calls this
week, saying the 
government should declare a public health emergency for AIDS. 

The declaration of an emergency would allow the government to: 

- Issue compulsory licences - as in Brazil - to local drug manufacturers
authorising them to replicate 
patented anti-AIDS drugs cheaply; 

- Import cheaper generic drugs; and 

- Copy the drugs without breaching international trade agreements because
such a move would be 
accepted by the World Trade Organisation. 

"It would have to come from the President and one would have to look at it
carefully. It might not be 
as straightforward as just standing up and saying it's a national
emergency," Ntsaluba said. 

He said it was generally agreed that issuing compulsory licences would be
much easier to justify 
"in an environment where a national emergency has been declared". 

President Thabo Mbeki's spokesman Bheki Khumalo confirmed that the
President would address 
the issue in Parliament on Wednesday during question time. 

"The President has taken a personal interest in this question of HIV/AIDS,
and we should not discount 
anything. We will have to wait and see what he will say on Wednesday,"
Khumalo said. 

AIDS activists welcomed Ntsaluba's comments but cautioned it might be a
gambit by Pretoria to 
force the drug companies to lower their prices or face having their
products copied. 

The head of the Treatment Action Campaign, Zackie Achmat, said: "We hope
this is not a bad 
chess game between the opposition, the drug companies and the government.
It would be to the 
advantage of all people if the government did handle this as an emergency."

Ellen 't Hoen, a campaigner with Médecins Sans Frontières, said that by
declaring an emergency 
South Africa would lead the world in the quest for better access to
anti-AIDS medicines. She said 
that at least two other countries were seriously considering issuing
compulsory licences for cheap drugs. 

Cosatu has also called on the government to issue compulsory licences. 

But Mirryena Deeb, the chief executive of the Pharmaceutical Manufacturers'
Association of South Africa, 
which is contesting the government in court, said there was no need to
declare an emergency. 

"If you declare a state of emergency then you can ignore your laws. Why are
they so reluctant to use 
existing law? What are they so scared of?" Deeb asked. 

Leon said the Agreement on Trade-Related Aspects of International Property
Rights allowed patent rights 
to be bypassed in emergencies. "We call on the government to proceed with
the steps required . . . to 
open up the market for HIV drugs," he said in The Star newspaper. 

While acknowledging that AIDS appeared to constitute an emergency, legal
experts said an emergency 
declaration should be a last resort. 

Professor Karthy Govender, a constitutional law expert at the University of
Natal, said: "To prove it was 
valid you would have to show to the court that all other methods of
resolving the crisis have been tried and failed." 

The government's aggressive signals come as it gains support
internationally for its stand on cheaper medicines. 

In the past week there has been: 

- A price war between competing drug companies, resulting in the price of a
cocktail of three anti-retroviral 
medicines being offered to Pretoria at $350 (about R2 770) a patient a

- A counter-offer from the local manufacturer Aspen Pharmacare to produce a
similar cocktail for $347 
(about R2 670); and 

- Support for South Africa's stand on cheap AIDS drugs from the US, the
European Union and the World Health 
Organisation, and 

- International protest against the multinational pharmaceutical companies'
court action in South Africa. 

[editorial Sunday Times; 

Sunday Times editorial

United against AIDS profits

SOUTH Africa's warring AIDS interest groups found common ground on the
steps of the Pretoria High Court 
this week. 

As she strode into the court building, Health Minister Manto
Tshabalala-Msimang was cheered by activists 
who had camped outside the court since the night before. 

It was a rare moment. The AIDS lobby despises the minister, whom it sees as
the personification of the 
government's questionable and highly unpopular policy of not giving
anti-retroviral drugs to people living 
with HIV/AIDS. 

Exactly a year ago, Tshabalala-Msimang was booed out of the National
Conference for People Living 
with HIV/AIDS. 

But on Tuesday she was the rallying figure in the war against the
pharmaceutical industry. 

The issue that had united the government and the AIDS lobby was an aversion
to the drug companies' 
refusal to let their consciences interfere with their bottom lines. 

Under serious pressure at the international AIDS conference in Durban last
year to respond to the lobby 
groups' demands for treatment, Tshabalala-Msimang and her top officials
repeatedly referred to the 
outstanding court case, claiming that they were held hostage by it. 

Once the court made a ruling, it would provide a way out. 

And indeed it has. The South African government this week stood tall as it
took on 41 pharmaceutical 
companies who are determined to protect the industry's patent rights. 

The industry's gripe centres on Section 15C of the Medicines and Related
Substances Control 
Amendment Act (No 90 of 1997), which - according to the Pharmaceutical
Manufacturers' Association - 
allows for the "abrogation of all patent rights for any pharmaceutical upon
ministerial discretion". 

The pharmaceutical companies charge that it costs billions of US dollars to
research and develop drugs 
and that cheapskate generics will run them out of business. 

Their face-saving response has been to offer piecemeal discount drugs which
are still unaffordable to 
most people on this continent and in the rest of the Third World. 

While the issue has yet to be ruled on, the case has seen not only local
lobby groups but the entire 
international AIDS community unite behind the South African government to
secure the rights to 
produce and acquire generic drugs. 

After weathering a year of condemnation for toying with the deadly
pandemic, Tshabalala-Msimang's 
department is in desperate need of a vote of confidence. 

The fierce lobbying is starting to bear fruit and the government has
clearly woken up to the fact that the 
time for action is now. 

Funding for AIDS and health in general was given a shot in the arm in this
year's budget. 

>From next month, the government will offer pregnant women in Durban and
Pietermaritzburg who are 
HIV-positive the anti-retroviral drug Nevirapine for free to prevent them
from transmitting the virus to 
their babies. 

And it was announced this week that South African scientists have completed
their laboratory research 
on a potential HIV vaccine. The country's first human trials involving up
to 20 people are expected 
to begin later this year. 

The outcome of the court case will not only influence government policy on
AIDS treatment but will 
serve as an important test case internationally. 

The battle between developing nations and AIDS activists on the one side
and multinational drug 
companies on the other will continue for years to come as there is no
reconciling the missions of the 
two sectors. 

But of prime importance to the people of this country and continent is the
development of a common 
goal - to stop the spread of the disease and provide treatment to those who
are in desperate need of it. 

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