Artikler: Om retssagen i SA

South Africa's Commitment Against HIV-AIDS

Washington Post (04.15.01)
- Monday, April 16, 2001

Sheila Sisulu, SA Ambassador to the US.
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The author, South Africa's ambassador to the United States, responded to William Raspberry's March 26 op-ed piece "Overreach on AIDS." She worried that it may have led some readers "to doubt the depth of South Africa's commitment to addressing the HIV-AIDS epidemic because of its decision not to declare a "'national state of emergency'" to obtain expensive AIDS drugs.

Sisulu writes that, according to the South African constitution, a "national state of emergency" is a highly complex decision that is reached "only when 'the declaration is necessary to restore peace and order.'" "Such a measure also curtails the provision of South Africa's bill of rights and has other complex consequences." It can remain in effect for only 21 days, unless parliament decides to extend it, and then it can last for a maximum of three months at a time.

With respect to tariffs, Sisulu says that they are not meant to discourage assistance to South Africa. "It is entirely reasonable to expect all parties who wish to make donations to South Africa on humanitarian ground to comply with the law and established import regulations in order to prevent fraud. This is standard international practice and not intended to frustrate charitable efforts."

South Africa's commitment to the HIV-AIDS epidemic is deep, according to the author. "In 1998 it implemented a strategy involving all sectors of society, focusing on prevention, care and support of HIV-infected persons...." In 1997 it passed the Medicines Control Amendment Act, which is being challenged by a lawsuit filed by 39 "of the world's most profitable pharmaceutical companies. Implementing this law would enable South Africa to meet the need for affordable drugs in a sustainable manner."

Drug giants back down

The government has won its fight with pharmaceutical companies over parallel importation and other methods to reduce drug costs

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BELINDA BERESFORD April 20, 2001
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At the 13th hour the pharmaceutical industry backed down. The law it fought for three years to prevent being enacted will go ahead, unchanged.
And the ramifications go far beyond South Africa's borders. By withdrawing their objections to South Africa's legislation the drug companies have opened the way for other developing countries to enact similar laws.

The court case has also focused on the issue of patent rights, and highlighted the concerns of many NGOs and governments that international treaties and trade agreements are skewed towards the developed world. It has also graphically emphasised that major multinational industries can be affected by social pressures.

In was a complete climb-down on Thursday when the Pharmaceutical Manufacturers Association (PMA) and 39 of its members dropped their court action to have the Medical Schemes Control Amendment Act declared unconstitutional

As Judge Bernard Ngoepe turned to leave after dismissing the case, his courtroom erupted with the noise of victorious lawyers, government official and activists. Not to mention the thunder of the media pack hurdling benches - and each other - to get responses. Cameras, forbidden from the courtroom while it was in session, miraculously appeared to record the bloody nose for one of the most powerful industries in the world. Minister of Health Manto Tshablala-Msimang was given a fake gold victory statuette.

PMA executive Mirryena Deeb said: "The negotiated settlement which enabled the PMA and its members to withdraw the court case follows government's commitment to adhere to its international obligations."

The government has always argued that its legislation and intentions fulfilled international patent obligations.

The law that the PMA has now accepted is the same as the one signed by then president Nelson Mandela three years ago.

Tshablala-Msimang said: "We are pleased that the pharmaceutical industy has finally recognised both the legitimacy of our struggle ... for affordable heatlth care, and the genuineness of our respect for the international trade treaties we are party to.

"It is a pity the pharmaceutical company could not be persuaded to take this view three years ago ... The industry's response at the time was to take us to court in a costly and ultimately fruitless exercise."

The backdown came after late-night negotiations within the PMA and its members and was announced at the start of what was due to be the second day in court with the government. President Thabo Mbeki can promulgate the suspended Act as soon as he wishes.

Government had known that its opponents did not have the stomach for continuing this particular battle. In February, Mbeki was told by the secretary general of the United Nations, Koffi Annan, that five of the world's biggest drug companies would like to find a way of settling the dispute out of court.

The issue had turned into a public relations disaster for the drug companies, especially when the activist group the Treatment Action Campaign (TAC) won the right to add its voice to the proceedings as a friend of the court.

Intellectual property protection ranks far down on the emotive scale - and consequent shareholder activisim - compared to the sight of thousands of people dying because the drugs to save them are too expensive.

The government's confidence was obvious on Wednesday, when the court case was supposed to start. Department of Health Director General Ayanda Ntsaluba was smiling confidently as he waved towards the benches where the PMA's lawyers would sit. "The ball is in their court. We will just wait," he said. The government had drawn a line: it would not rewrite the disputed areas of the legislation.

Although the government had been in discussions with the pharmaceutical companies, it was the infighting within the PMA that was delaying the withdrawal of the case.

An extra legal team and spin doctors (some with British or transatlantic accents) had been hired by the drug companies to sort out the debacle. The decision to pull out had been made, it just remained to round up all parties - and to decide who was going to pay the bills.

But even while the champagne (or a cheap generic, as one Oxfam representative joked) was being cracked in celebration, all sides were gathering themselves for fresh conflict.

In a sense the ending of the PMA's court battle has simply removed the fight from one very symbolic battle, and opened up a variety of legal and political fronts.

The government, even while it was basking in the joy of victory, and magnanimously praising the pharmaceutical industry for its grace, integrity and dignity, was aware that now the ball is very firmly in its court.

It now has the tools it has claimed it needed to implement major improvements in the health care system, especially for people living with HIV/Aids. Now the world will see whether there is any truth in the pharmaceutical company arguments that high prices have simply been an excuse for lack of action by a government that in reality lacked the capacity or political will.

The trade-off for the pharmaceutical industry was that it would be invited to provide input into the regulations that are needed to implement some of the provisions of the Act. Draft regulations have already been drawn up by the goverement.

The drug companies say the ending of the court action will not affect the offers for free and reduced drugs that they have made to developing countries and that they intend to work more closely with government and civil society to help the poor get access to medicines.

The TAC, which has spearheaded most of the public awareness of the court case and the issue of access to essential medicines first at home and then tying into international aid agencies, sees this as another area where the fight will continue.

TAC chair Zackie Achmat said: "Every South African can be proud we stood firm against the most powerful lobby in the world, the drug companies. But now another struggle begins."

-- The Mail&Guardian, April 20, 2001.

Victory over pharmaceuticals companies may force government from its chosen AIDS path

20 Apr 01 Vol.16/08»
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The apparent victory over the pharmaceuticals companies at the supreme Court in Pretoria this week may have outcomes the government will regret. The High drama and world-wide mobilisation round the issue of patent rights may Force the government further down the road to buying anti-retroviral drugs for treatment and away from its preferred option of prevention in the battle
against AIDS. This will lead to a diversion of SA's slender resources or a reliance on international aid, funds for which are uncertain.

Second, the case has mobilised the labour movement and non governmental organisations against the government's macro economic neo-liberal
policies, on the eve of important privatisation decisions (SouthScan v16/05). In addition it has focused the public's attention on the arms procurement deal, with its accompanying sleaze, when the issue of available resources has become key.

The government may therefore come to see the climbdown by the Pharmaceutical majors as a poisoned chalice and not the outstanding victory it claims.

On the other hand, on the world stage, SA has again taken on the mantle of spokesman for the world's poor and oppressed, a mantle that has been slipping of late. In a series of important official overseas visits this year President Thabo Mbeki will seek to make the most of this, and
especially use it to push SA's case for a seat on the UN security council, which has now finally taken on the AIDS battle as its legitimate concern

Government action expected

AIDS campaigners now expect action to convince them that the government Has bitten the bullet of treatment and does not remain solely oriented to prevention programmes. One prominent campaigner commented, "Let's hope the government is not terrified when it wins".

It will have to fulfil some high expectations - first by buying the cheaper anti-retroviral drugs, or by showing it is moving to manufacture them
itself.

SA can now substitute triple-therapy treatment drugs imported from India (or from Bristol-Myers Squibb) at a cost as low as $350 a year instead of
current offerings from Western drug firms at more than $1,200 a year (SouthScan v16/06). However, this could still add up to a $1.5bn annual
bill - well over SA's budgeted resources, much of this devoted to upgrading the health system and operating prevention programmes.

The government is expected therefore turn to the global funds now being talked about. It is uncertain when these will kick in, or how much the
developed countries will in the end contribute. Foreign Minister Nkozasana Dlamini-Zuma said this week in Washington that the battle against AIDS had been held back because of the court case, but HIV sufferers may again be asked for patience.

Denying treatment

The drugs companies, having decided to take the government to court over a poorly drafted law, discovered too late the level of mass mobilisation against them, and found they could not withdraw. Earlier they attempted to do a deal with the government; each time they were rebuffed.

Earlier this month the opposition Democratic Alliance accused the health minister of having misled parliament by denying that the offers had been
made. DA leader Tony Leon said he believed the minister's misrepresentation of the facts was "part of a broader, unstated policy of denying treatment to HIV-positive South Africans".

Supporting this view is the fact that the World Trade Organisation rules allow countries to take over patents in cases of national emergency -
which the AIDS catastrophe in SA clearly is. The reason SA has not done so (and why Mbeki last month said he would not declare a state of emergency on the issue) may relate to SA's dogged attempt to present a clean bill of economic health. Ministers hold to the belief that with this they can increase involvement by outside business, on which their growth plan rests. But at the same time SA has kept clear of the grants being made by the drugs companies to SA and other SADC countries. (Earlier this month Bristol-Myers Squibb donated US$729,000 towards the Lesotho's battle against HIV-AIDS. The grants were part of the company's $100-million initiative in the region.)

AIDS activists believe these attitudes display an official lack of Interest in the treatment of patients with HIV.

Firms off the hook

While ministers wrestle with their new opportunities, the belief is being voiced in anti-AIDS circles that the manufacturers, apparently
humiliated, may have made little more than a tactical retreat and can expect to gain in African markets later.

The losers in the battle have, by pulling out, now avoided having to
Answer point by point questions in court about their businesses, including how They calculate their research costs, and reach their final pricing.

The main companies involved, Bristol Myers-Squibb, Merck, GlaxoSmithKline, Roche and Boehringer Ingelheim, had sought assurances from the government that it would redraft the legislation to be compliant with international law (though there was no indication that a deal had been done along these lines). Pretoria has, however, been keen to reassure potential investors that their intellectual property will not be hijacked.

On April 5 six big drug companies (Merck pulled out at last moment) met With UN secretary general Kofi Annan in an Amsterdam hotel to discuss whether And how prices on HIV drugs could be lowered. Annan wanted prices to be Brought down to "cost". However, it appears that the drug majors will retain the power to decide what is "cost" in neediest parts of the South, especially Africa. There was already broad agreement on the need for tiered pricing, with wealthier customers and countries paying more (SouthScan v15/22).

There was no breakthrough at this meeting, despite Annan's attempts to Make it appear the drugs companies had agreed to lower prices as far as possible.

The companies had been trying to do a deal with the SA government to avoid the court case, but Pretoria decided the deal was not good enough.
Shortly before the April 5 Amsterdam meeting there again were rumours that the Case might be dropped, but that did not happen.

The companies are finally out of the court case - a miscalculation of their own making - but retain the ability to determine the cost of their
production of the medicines. With more global financial initiatives opening up, they are likely to sell their medicines in more African countries
than they would previously have had access to, and even at 'cost' plus a small percentage they would be making money they would not previously have had.

In addition the African market is small compared to their US sales and those in the rest of the developed world. By keeping their internal accounting and their real research costs untransparent they have protected these markets.

Recent initiatives at US universities, where the drugs have been researched and developed, reveal that they were in the main paid for by the US taxpayer, through the US state, leaving the companies with little cost to be "recouped" through sales.

A Bristol-Myers Squibb anti-retroviral drug, one of the drugs needed in South Africa, was developed at Yale and mostly funded by the US
government. Yale then granted an exclusive licence to BMS for the drug, which has now generated over $2 billion in sales out of which Yale has directly received over $120 million in profits over the past six years (SouthScan v16/06)

The generalised issue of intellectual property remains, however, a key one for the 'new economy' on which the developed world economies are being built. This is why there is confidence in Washington that the new US government will support pharmaceuticals firms and others engaged in
patent battles abroad. SA is sensitive to these concerns and Foreign Minister Dlamini-Zuma, who was in Washington this week to see senior US officials, repeated that, as a member of the World Trade Organisation, SA respected patent law, but it had an obligation to supply affordable medicine to its people. SA is concerned not to drive potential investors away through fears that it will hi-jack their intellectual property.
Global funding effort

Meanwhile the run-up has begun towards the massive funding needed to combat the AIDS pandemic. Annan will finally bring the UN into the fight at the Organisation of African Unity summit to be held in Nigeria later this
month.
He will call for a "major mobilisation of political will and resources
commensurate with the enormity of the Aids crisis", according to a UN official. The UN is to hold a special session on HIV/AIDS on June 25-27
in New York. (Annan may also use the AIDS issue as a vehicle for his re-election campaign, after the disasters of his peace-keeping regime,
say UN watchers.) This week, too, Harvard University economist Jeffrey Sachs told a UN meeting on that a global fund was needed to combat not just AIDS in Africa but infectious diseases such as malaria and tuberculosis. (SouthScan v16/07).

Sachs placed the blame largely on industrialised nations for ignoring the problem since the AIDS epidemic began in the continent two decades ago. Assistance to the 49 Sub-Saharan African nations totalled US$856 million In 1999 or about $1.30 per African.

At least $10-$20 billion a year is needed to control the epidemics, the team of health experts said. They recommended that developed nations pool their resources to set up a global fund and fight the problem in a co-ordinated way.

Money is needed to buy drugs from major international pharmaceutical companies, the experts said.

Blood replacement deal

Meanwhile, and as the pharmaceuticals case was running, South Africa's Medicines Control Council became the first medical regulator to approve the use of a ground-breaking product which can replace blood transfusions. A deal has quietly been agreed with no challenge to the patent-holder and based on preferential pricing to the public sector.

The product, Hemopure, an oxygen-carrying solution, can be used for the treatment of acute anaemia and used instead of red blood cell
transfusions in adult surgery patients.

As HIV spreads SA is likely to face shortages of useable blood and this product may replace it. It can also be kept in stock by military
hospitals at room temperature.

Manufacturers, the Biopure Corporation, contracted Netcare and black empowerment company Community Healthcare to distribute and market the product in Africa for the next five years. Biopure have guaranteed South Africa a significant supply of its product.

Plant rights sold off

SA has reportedly sold the patent rights to its plant wealth to a US company, it was revealed earlier this month. The opposition has called
on Environmental Affairs Minister Valli Moosa to explain how the rights were "sold off" by the National Botanical Institute (NBI) in exchange for
royalties for 20 years.

The deal with giant US multi-national Ball Horticultural was apparently struck with the NBI two years ago "behind closed doors". The rights are
reportedly worth millions of dollars on the world horticultural market, and include plants such as the Namaqualand and Barberton daisies.

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