WEDNESDAY, 5 APRIL 2000 _____

                PROCEEDINGS OF THE NATIONAL ASSEMBLY
                                _____

The House met at 15:05.

The Speaker took the Chair and requested members to observe a moment of silence for prayers or meditation.

ANNOUNCEMENTS, TABLINGS AND COMMITTEE REPORTS - see col 000.

QUESTIONS AND REPLIES - see that book.

                          NOTICES OF MOTION

Ms T R MODISE: Madam Speaker, I give notice that on the next sitting day of the House I shall move on behalf of the ANC:

That the House -

(1) notes with grave concern reports that SA National Defence Force equipment worth more than R7 million has been stolen or is unaccounted for;

(2) believes that effective management controls are an essential element of military effectiveness and good governance;

(3) calls upon the accounting officers to give a clear account of the missing equipment and how this situation came about;

(4) requests the SANDF to institute appropriate disciplinary measures to deal with those responsible for the missing equipment; and

(5) requests the SANDF to ensure that effective controls and systems of management of equipment are put in place.

[Applause.]

Mr I O DAVIDSON: Madam Speaker, I give notice that on the next sitting day of the House I shall move on behalf of the DP:

That the House -

(1) notes -

   (a)  the increase in the petrol price today by 27c per litre to a
       record level of 322c per litre;


   (b)  the inevitable inflationary effect of such an increase and the
       hardships that will bring; and


   (c)  Opec's decision to increase production by 7%, which will result
       in the lowering of crude oil prices in the short term; and

(2) calls on the Government to alleviate the harmful short-term effects of the current fuel price increase by absorbing such increase through temporarily reducing the fuel levy and utilising any residual amount in the Equalisation Fund until such time as Opec’s increase in production has an impact on the South African fuel price.

Mr V B NDLOVU: Madam Speaker, I give notice that on the next sitting day of the House I will move on behalf of the IFP:

That the House -

(1) congratulates the SAPS on their tough action against drugs dealers in the Northern Cape, KwaZulu-Natal and Gauteng;

(2) notes, however, that such sterling work by the SAPS is undermined by the corruption that is rife at certain police stations; and

(3) calls on the Minister to take action, in consultation with the MEC in KwaZulu-Natal, to stamp out such corruption and, as a first step, to ensure the closure of the Chatsworth police station in KwaZulu-Natal where allegations of corruption abound.

Mr D A A OLIFANT: Madam Speaker, I give notice that at the next sitting of the House I shall move on behalf of the ANC:

That the House -

(1) notes that the Cabinet has established an emergency reconstruction committee to oversee the speedy reconstruction of the flood damage of an estimated R2,2 billion caused to the country’s physical, social and economic infrastructure;

(2) recognises that the committee will formulate an integrated strategy for the needs in the immediate, short, medium and long term; and

(3) commends the Cabinet for taking this bold step to deal speedily with the damage caused by the recent floods.

Mev M E OLCKERS: Mevrou die Speaker, ek hiermee kennis dat ek op die volgende sittingsdag van die Huis namens die Nuwe NP sal voorstel:

Dat die Huis -

(1) sy ernstige kommer en afkeur uitspreek oor -

   (a)  die verkragting van twee Belgiese vrouetoeriste in die Oos-Kaap
       twee dae gelede; en


   (b)  die diefstal van persoonlike besittings van toeriste uit
       hotelkamers in 'n gesogte hotel in die Wes-Kaap;

(2) die hoop uitspreek dat die skuldiges met die volle geweld van die reg hanteer sal word; en

(3) van mening is dat -

   (a)  toerisme van die grootste belang vir die Republiek van Suid-
       Afrika is en dat die negatiewe invloed wat hierdie twee gevalle
       in die buiteland gehad het onaanvaarbaar is;


     b) die persepsie dat die regte van kriminele in Suid-Afrika groter
        beskerming geniet as dié van slagoffers, onmeetbare skade
        veroorsaak het aan die vertroue wat die mense van Suid-Afrika
        in die Regering het en ook aan die land se internasionale beeld
        as 'n gesogte toerismebestemming. (Translation of notice of motion follows.)

[Mrs M E OLCKERS: Madam Speaker, I herby give notice that on the next sitting day of the House I shall move on behalf of the New NP:

That the House -

(1) expresses its serious concern and censure regarding -

   (a)  the rape of two female Belgian tourists in the Eastern Cape two
       days ago; and

   (b)  the theft of personal belongings of tourists from hotel rooms in
       a sought-after hotel in the Western Cape;

(2) expresses the hope that the guilty parties will be dealt with using the full force of the law; and

(3) is of the opinion that -

   (a)  tourism is of the utmost importance to the Republic of South
       Africa and that the negative effect that these two incidents had
       abroad is unacceptable; and


   (b)  the perception that the rights of criminals in South Africa
       enjoy greater protection than those of victims,  is causing
       immeasurable harm to the confidence which the people of South
       Africa have in the Government and also to the country's image as
       a sought-after tourist destination.]

Dr G W KOORNHOF: Madam Speaker, I give notice that at the next sitting of the House I will move on behalf of the UDM:

That the House -

(1) notes with dismay the reported reinstatement of Mr James Nkambule, the axed provincial ANC Youth League secretary, just three weeks after being dismissed by the Premier of Mpumalanga, Mr Ndaweni Mahlangu;

(2) further notes that since 1 April 2000 Mr Nkambule has been holding a senior post in Mpumalanga’s local government department;

(3) also notes that Mr Nkambule has publicly admitted to committing fraud by siphoning state funds into the ANC coffers for use, amongst others, in political campaigning and to fund ANC promotional material; and

(4) expresses its strongest dissatisfaction with the premier’s inability to resolve the issue.

Mr R S NDOU: Madam Speaker, I give notice that on the next sitting day of the House I shall move on behalf of the ANC:

That the House -

(1) notes Deputy President Jacob Zuma’s call, at the International Confederation of Free Trade Unions’ congress in Durban, for trade unions of developed countries to concern themselves with ending protectionist practices in the economies of developed countries;

(2) reminds the developed world that free trade that only opens the markets of developing countries to developed countries is no free trade at all;

(3) acknowledges that this practice allows rich countries to exploit poor countries and defeats the confederation’s objective of globalising social justice; and

(4) calls on trade unions, business and governments from the developed world to end their protectionism in order to fight international poverty.

[Applause.]

Rev K R J MESHOE: Madam Speaker, I give notice that on the next sitting day of the House I shall move on behalf of the ACDP:

That the House -

(1) notes with shock that the IBA has refused to renew the licence of Link FM in East London;

(2) notes with great disappointment that the IBA did not have the decency even to provide Link FM with reasons why its application was turned down or to inform them whether they have any right to appeal against the decision;

(3) strongly objects to the IBA’s bias against community broadcasting services that are used by Christians and churches; and

(4) notes with great concern that the IBA seem to favour radio stations that do not have a Christian content thus giving credibility to suspicions that the IBA’s subtle ultimate goal is to remove all Christian programmes not run by the state or their agents from the air; and

therefore calls on the IBA to review its decision and to ensure that adequate appeals procedures are in place to allow the aggrieved community radio station sufficient time to appeal.

Mr I S MFUNDISI: Madam Speaker, I give notice that on the next sitting day of the House I shall move on behalf of the UCDP:

That the House -

(1) notes the unbecoming conduct of students at the Phatsima College of Education in Kimberley who boycotted classes and littered the administration block of the college yesterday, 4 April 2000;

(2) notes that it costs the taxpayer a fortune to keep these undeserving students in class while deserving ones are roaming the streets for lack of admission;

(3) further notes that the upgrading of teachers’ qualifications and that of colleges to award degrees in education cannot, and shall not, be delayed or even stopped by such people; and

(4) calls on the education authorities in the Northern Cape to mount a full-scale investigation into the matter and, where possible and applicable, to set a good example to indicate that this nation is on course for a better life.

Ms N N MAPISA-NQAKULA: Madam Speaker, I give notice that on the next sitting day of the House I shall move on behalf of the ANC:

That the House -

(1) notes the wild and false allegations made by the DP about their offices being bugged;

(2) recognises that the impression they were creating was part of their mischievous agenda to attack the credibility of the ANC-led Government;

(3) further notes that Attorney-General Frank Kahn dismissed the DP’s claims and refused to prosecute as no evidence could be found to substantiate the DP’s irresponsible claims; and

(4) calls on the DP to stop behaving like spoilt brats.

[Applause.]

Mr N J CLELLAND: Madam Speaker, I hereby give notice that on the next sitting day of the House I shall move on behalf of the DP:

That the House -

(1) notes -

   (a)  that the Zimbabwe Congress of Trade Unions, under the leadership
       of Morgan Tsvangerai, is leading opposition against the misrule
       of Zimbabwe by President Robert Mugabe;


   (b)  that members of Tsvangerai's Movement for Democratic Change
       participated in a peaceful and lawful demonstration against the
       invasion of white-owned farms by Zanu-PF supporters;


   (c)  that the demonstrators were violently assaulted by armed Zanu-PF
       supporters while Zimbabwean police did not intervene to stop the
       violence; and


   (d)  with concern that Cosatu has been surprisingly silent on this
       matter; and

(2) calls on Cosatu to -

   (a)  voice its solidarity with the Zimbabwe Congress of Trade Unions;
   (b)  speak out against the violation of the rule of law and human
       rights in Zimbabwe; and


   (c)  bring pressure to bear on its alliance partner in Government to
       do likewise.

[Applause.]

Dr K RAJOO: Madam Speaker, I give notice that on the next sitting day of the House I will move on behalf of the IFP: That the House is of the opinion that -

(1) the interest rate on mortgages is exorbitantly high in this country;

(2) this nation has a vested interest in seeing to it that the bank rates for first-time home owners are low enough to motivate the homeless to put an affordable roof over their heads;

(3) an interest rate ceiling of 10% for first-time, sub-economic home seekers should be protected by Government;

(4) banks, insurance companies and the Government, in the quest to build a stable economy and to provide people with shelter, should endeavour to and encourage people to build homes, thereby releasing an economic spin-off that will improve the economy;

(5) it is interesting and encouraging that the World Bank Corporation is investing in the home loan securities company SA Home Loans in order to keep interest rates at an affordable level; and

(6) the Minister of Finance should encourage home buyers by allowing mortgage payments as a beneficial write-off in respect of taxation.

Mr M I SCOTT: Madam Speaker, I give notice that on the next sitting day of the House I shall move on behalf of the ANC:

That the House -

(1) notes the success of the anti-crime initiative Operation Crackdown in the Western Cape, which has resulted in more than 1 000 arrests, with 893 arrests for serious crimes; (2) commends the SAPS, the SANDF and the Ministers of the safety and security cluster for their effective implementation of the National Crime Prevention Strategy, which is being used with success to tackle the scourge of crime in our country; and

(3) calls upon all political parties represented in the House to come out in full support of this initiative.

Dr P J RABIE: Mr Chairman, I hereby give notice that on the next sitting day of the House I shall move on behalf of the New NP:

That the House -

(1) notes that African and European leaders have expressed concern regarding Africa’s external debt of US $350 billion at the summit being held in Cairo;

(2) recognises that this spiral of debt has left many poor African countries with no option but to spend more on the repayment of loans than on health and education combined;

(3) calls on all role-players to caution poor countries about the negative consequences of reckless spending and borrowing; and

(4) calls on the affluent European countries to cancel the debt of the poorest African countries, provided that the recipient countries take sound measures against corruption, uphold the principles of democracy and respect and enforce human rights.

Miss O N MNDENDE: Chairperson, I give notice that on the next sitting day of the House I shall move on behalf of the UDM:

That the House -

(1) expresses its serious concern about several complaints concerning deliberate and insensitive displays, both at the SA Natural History Museum and the SA Cultural History Museum;

(2) expresses disbelief and dismay at the implication that black people are subhuman since their cultures are displayed with animals and dinosaurs in the SA Natural History Museum, while European and Eastern cultures are displayed at the SA Cultural History Museum;

(3) strongly condemns the apparent acceptance, even after six years of liberation, by museum bosses of the colonial label that indigenous Africans are primitive and closer to animals; and

(4) calls on Government to ensure that human cultures, black and white, are put together in one museum as soon as possible.

[Applause.]

Mr D V BLOEM: Chairperson, I give notice that on the next sitting day of the House I shall move on behalf of the ANC:

That the House -

(1) notes that the PAC will finally this week have its national congress, which was postponed earlier owing to the disarray that the party was in and continues to be in; (2) recognises the PAC’s lack of leadership, absence of sensible policies, organisational incapacity and virtually nonexistent support; and

(3) calls on the PAC’s members and supporters not to waste their time and energy further, but to join forces with the country’s only organisation that has the policies, leadership, organisational strength and voter support to effectively tackle poverty, namely the ANC.

[Interjections.] [Applause.]

Dr J T DELPORT: Voorsitter, ek gee kennis dat ek op die volgende sittingsdag namens die DP sal voorstel:

Dat die Huis -

(1) met skok daarvan kennis neem dat die Kantoor van die Meester van die Hof in Grahamstad alle uitgaande telefoonoproepe en uitgaande pos gestaak het weens ‘n gebrek aan fondse;

(2) daarop wys dat ‘n doeltreffende diens aan die publiek daarmee drasties ingekort en selfs vernietig word; en

 3) 'n dringende beroep doen op die Minister vir Justisie en
    Staatkundige Ontwikkeling om in te gryp en hierdie wantoestand te
    beëindig. (Translation of Afrikaans notice of motion follows.)

[Dr J T DELPORT: Chairperson, I give notice that I will move at the next sitting day on behalf of the DP:

That the House -

(1) notes with shock that the Master’s Office Grahamstown, has stopped all outgoing telephone calls and outgoing mail owing to a lack of funds;

(2) points out that because of this an effective service to the public is being drastically curtailed and even destroyed; and

(3) urgently requests the Minister for Justice and Constitutional Development to intervene and put an end to these shocking conditions.]

                        MOTION OF CONDOLENCE

                       (The late King Lebone)

The CHIEF WHIP OF THE MAJORITY PARTY: Madam Speaker, I move without notice:

That the House -

(1) notes the untimely passing of King Lebone of the Bafokeng people;

(2) recognises the central role played by King Lebone in the development of the Bafokeng people and his unconditional support for the transformation processes in our country; and

(3) expresses its condolences with and joins the King’s family and the Bafokeng people in mourning the death of a fine and noble leader.

Agreed to.

              PEACEFUL CHANGE OF GOVERNMENT IN SENEGAL
                         (Draft Resolution)

Mr M J ELLIS: Madam Speaker, I move without notice:

That the House notes with appreciation the wonderful example set by the people and politicians of Senegal in that the peaceful and democratic change of government was handled graciously by the retiring President Diouf and with magnanimity by the new President Wade.

Agreed to.

                        MOTION OF CONDOLENCE

                      (The late Gen D T Masuku)

The MINISTER OF DEFENCE: Madam Speaker, I move without notice:

That the House -

(1) notes the death of the Surgeon-General, Davidson Themba Masuku;

(2) recognises Gen Masuku’s significant contribution to the democratisation of the Republic of South Africa and his ground- breaking participation in the setting up of the South African National Defence Force;

(3) regrets his untimely passing away; and

(4) expresses its deepest sympathy to the family and friends and directs that this resolution be communicated to his loved ones.

Agreed to.

                    ALLOCATION OF SPEAKING TIMES

                         (Draft Resolution)

The CHIEF WHIP OF THE MAJORITY PARTY: Mr Chairperson, I move the draft resolution printed in my name on the Order Paper, as follows:

That, notwithstanding the provisions of Rule 106, the following times be allocated to parties for comment on today’s statement by the Minister of Health: Minister: 15 minutes; African National Congress: 5 minutes; Democratic Party: 4 minutes; Inkatha Freedom Party: 4 minutes; New National Party: 3 minutes; United Democratic Movement: 3 minutes; all other parties: 2 minutes each.

Agreed to.

                           NEVIRAPINE DRUG

                             (Statement)

The MINISTER OF HEALTH: Mr Chairperson, in recent years, and especially since the advent of the HIV/Aids epidemic, there has been a proliferation of clinical drug trials amongst human subjects. Many of these are taking place in South Africa. The reason for this is that South Africans are what is known as drug naive''. In other words, they have not been treated with medication for HIV/Aids, and are therefore attractive, as subjects for the testing of new drugs. By contrast, most people in Europe and America have received previous medication and are therefore lesspure’’ for testing purposes.

The problem with the proliferation of clinical trials in South Africa has become so acute that articles have been published in international literature suggesting that South Africa is an ``easy location’’ for conducting clinical trials. Under normal circumstances, it is justified to test drugs on human subjects because the long-term gain will be positive, not only for the subjects, but also for others with the particular disease or infection, if the medication proves to be effective. But this is not true in the South African scenario because it is highly unlikely that all but a few South Africans will ever derive any benefits from the drugs that are tested here, since once they have been patented and registered, they are marketed at prices that are unaffordable to us.

Having become aware of this, the Ministry of Health has established a clinical trials committee within the Medicines Control Council to review clinical trials of both registered and nonregistered drugs, and to ensure that the mechanisms for the review of clinical trials are well developed and carefully structured. This newly established committee has already introduced some carefully designed standard operation procedures, check lists and guidelines to achieve its aims. One of the drugs that is currently undergoing clinical trials in South Africa is nevirapine, a drug that is thought to be useful as a first-line therapy in the treatment of people with HIV, including pregnant women. Studies on the safety and efficacy of nevirapine for mother-to-child transmission in HIV-infected pregnant women have already been conducted in Uganda. These studies have not yet been concluded with respect to long-term safety.

In South Africa, a study known as Saint is currently comparing nevaripine with short-term AZT and 3TC for safety and efficacy for mother-to-child transmission. We have been told by the scientists concerned that the results of this study will not be available until June or July this year. The Medicines Control Council has not yet registered nevirapine in South Africa for paediatric use. Before we can reach a policy decision on the issue of nevirapine, we require the medicine to be registered, as well as the results of the same study.

It would be immoral and unethical for Government, despite the numerous requests that we are receiving and the demonstrations that have been staged, to attempt to make policy decisions regarding the use of nevirapine in our country until the full results of the clinical trials of the drug are available. This is true for any country in the world, and I am at a loss to understand why South Africa should proceed with any less caution than any other country does.

In a World Health Organisation report on developing resistance to nevirapine in mother-to-child transmission trials, published on 24 March 2000, it is stated:

There is currently insufficient information to recommend widescale implementation of neviparine for mother-to-child-transmission prevention.

And now, recent developments have underscored the need for caution, even in the face of the overwhelming challenges presented by HIV/Aids. I have recently learned that five South African women have died during the course of an ongoing clinical trial involving nevirapine. As Government, we sincerely regret these deaths, and offer our condolences to the families concerned. The trial in question is called the FTC 302 Trial, and is being conducted by Quintiles Clindepham on behalf of an American company, Triangle Pharmaceuticals. On hearing of these deaths I immediately requested the MCC to supply me with a full report of the circumstances in which the deaths occurred. I received this report five days ago. It appears from the report that 510 patients have been recruited. The trial aims to compare FTC with lamivirudine in a triple-combination regimen in people who are HIV-positive or who have not yet taken any antiretroviral drugs.

The trial has two arms or groups. One group receives FTC and the other receives lamivirudine. Within each arm there are three strata or subgroups of patients. The patients in strata one and two receive nevirapine as part of their drug cocktail, while the stratum three patients do not.

According to the MCC report, which is based on their review meetings with the drug companies involved, Triangle Pharmaceuticals and Quintiles, two of the deaths were due to hepatitis. The report further cites the causal association between nevirapine and the deaths as ``probable’’ in three of the five cases. This means that, based on what has happened in the trial so far, there is a death rate of 1% and a liver toxicity profile of 11%. These findings are serious indeed. As a result, the MCC has halted any further recruitment of study subjects while full reports are being compiled on all the serious adverse events, including the five deaths. Also, the MCC has made contact with the Food and Drug Administration of the USA and they concur with the MCC’s concern about the trial and the further conducting of it.

Yesterday I sent a further request to the MCC for more detailed information on, amongst other things, all 16 study sites, including those in which the deaths occurred; all the adverse effects of the drugs, not just those associated with liver toxicity; consent of the patients, and whether indeed the consent was fully informed and in a language that was understandable; the ethics committees that approved the study; the names and CVs of all investigators in the trial; the protocols and case record forms; the screening procedures; and the treatment of patients for trial-drug-related complications, and who paid for such treatment.

In addition, I have asked for a comprehensive report on all HIV/Aids- related clinical trials approved by the MCC that are currently running in South Africa, or that have been completed in the past five years. If these reports are sufficiently comprehensive, I shall have at my disposal full details of the drugs that have been investigated, the therapeutic outcome, the numbers of deaths, and any other serious adverse events.

Finally, I am pleased to be able to say to hon members today that even with these tragic deaths, which sadden us deeply, there is nevertheless a positive outcome. My department has just completed the task of preparing proposals for the establishment of a national health research ethics council. We have discussed our proposal extensively with the provinces and it will be submitted for discussion and, hopefully, approval at the Minmec in May this year. This will afford significant protection to our people, especially those suffering from HIV and Aids who are particularly vulnerable because of the hope offered to them by various drug companies through the promise of participation in clinical trials. [Applause.]

Mrs S V KALYAN: Chair, hon members, the official statistics for HIV/Aids for the year 1999 compiled by the Directorate of Aids have for some inexplicable reason been withheld by the Minister, despite their being finalised in October 1999. However, I have it on good authority that one in five pregnant women are HIV positive. Also, while the infection rate in 1991 stood at 2%, 10 years down the track it stands at 20% to 25%, that is 1 600 new infections per day. From these statistics it is clear that the Government has no coherent strategy in place to arrest the epidemic. It is indeed quite unfortunate that the drug, despite well-documented evidence to the contrary, is still being questioned as potentially dangerous to Aids sufferers. Nevirapine or Viramune is more effective than AZT in vertical transmission reduction, at one tenth of the cost. It is administered by giving one dose to the mother when she is in labour and one dose to the baby within 72 hours of birth.

There are many advantages in using the drug. It is easy to administer. A client can do it …

The DEPUTY CHAIRPERSON OF COMMITTEES: Order! Hon members, allow the member at the podium a chance to say anything she wants to, even if it is controversial. Please continue, hon member. [Interjections.]

Mrs S V KALYAN: As I said, the drug is so easy to administer that clients can do it themselves. There is no need for a hospital setting and compliance is easy. Best of all, the drug is cheap at R25 a dose. It is estimated that 60 000 babies are infected at present, and what it does is to reduce transmission in early infancy.

I would like the Minister to tell us what is immoral about giving hope. A mother that is HIV-positive has a death sentence, and if she and her baby could be given nevirapine to reduce the possibility of infection, there is nothing immoral about that. She is being given a chance at life. [Interjections.]

The DEPUTY CHAIRPERSON OF COMMITTEES: Order!

Mrs S V KALYAN: Yes, there are side effects, but they are minimal and according to the World Health Organisation, it is not dangerous enough to warrant not giving the drug. The benefits far outweigh the risks. The risk is far greater if we let the child become HIV-positive. Those persons who have died did so from complications. The package insert states quite correctly that it should not be given to persons with liver conditions.

We are waiting for the outcome of the same study. Of course, it is going to be very, very appropriate. The results are going to be appropriately announced at the launch of the Aids 2000 Conference. One wonders whether it is not just a political strategy at the expense of human life.

This waiting game conflicts with the urgency of what is happening in terms of infections. The Ugandan model has been successful, because it moved the national HIV/Aids control programme out of Health and formed the Ugandan Aids Commission. The DP acknowledges that the Government must drive the programme, but here politicians have taken it upon themselves to divert this programme and we now have a political campaign at the expense of human lives.

South Africa has wasted too much time on an incomprehensible approach to the HIV/Aids epidemic. Let us stop wasting time. We need antiretroviral therapy, not intellect therapy. [Applause.]

Dr R RABINOWITZ: Mr Chairperson, the most positive aspect to this debate about nevirapine is that it reminds us that there are more than 13 drugs available from nine different companies in South Africa to treat HIV and Aids. They are produced by companies from the UK, Switzerland, France, Germany and the USA. Therefore the narrow focus on AZT in relation to Aids is irrational. It also reminds us that we must work untiringly with these countries and companies to cope with the Aids crisis.

The Minister has taken steps to combat the Aids menace and we congratulate her on these. However, a more concerted effort is needed if we are to save our nation from a terrible fate, as all that we have gained will be wiped out if we lose this war. Treatment of mothers, to reduce by 50% the spread of HIV to infants, is an important issue. It is an issue of cost, practicality and ethics.

If we cannot treat everyone, then whom do we treat? Surely pregnant women, rape victims and health workers are the most deserving. If we reduce the number of infants born to die of Aids from 150 000 to 75 000 at the cost of R18 million to the state - which is R25 per patient - with the use of nevirapine, it seems inexcusable not to do so. However, we must then be prepared for the orphans, and we can only do so if we are sure of their safety.

This particular issue is being well handled by the Department of Health, as evidenced by the Minister’s statement, but let us show the same clarity and will with regard to the rest of the war. The issues to be tackled are vast. They include education about the cause of Aids, tackling the morality of the youth, lifestyle education, parenting education, developing a vaccine, treatment of mothers, infants, school children and assisting families of the Aids-ill.

None of this can be handled effectively unless we stop denying essential aspects of the disease. If we had a neutron bomb threat - which would wipe out all the people and leave only the buildings - we would roll out billions in defence, but with Aids we cannot even get our financing in order.

For the provinces the entire epidemic is an unfunded mandate. Funds voted nationally are tied up in a complex world of bureaucracy and cannot flow to those who should use them. Provinces have no money to train counsellors and community educators let alone treat mothers and patients. Let us create an Aids emergency fund and distribute it via the provinces.

In keeping with IFP principles, let us give the provinces autonomy and make them financially accountable. Let them train health educators and Aids counsellors. Let them offer group pretest counselling and advise every individual who attends a clinic or hospital to have an HIV test and know his or her results. By giving them the right to refuse to be tested, the focus will change from vague fear to clear knowledge. Let us now vigorously embrace partnerships with all international donors and manufacturers willing to fund ethical pilot trials.

As for the myths surrounding the virus, let us put them behind us. Like all viruses, HIV consists of particles of DNA and RNA. They have been isolated and seen. Prof Van Rensburg of the medical and virology department in Stellenbosch has offered to show the MPs HIV in her laboratory. Let us go, together with the Minister and the President, and see it with our own eyes. It is a cunning virus. Although it has been replicated, it cannot be used to produce infection in animals, but related viruses do. Who would like to see us try to test the virus on humans?

Since the Minister is concerned with ethics and legality, I am interested to know why misoprostol, which has never been registered for use in abortion but is registered for use for ulcers, is used as the Government’s mainstay in the treatment of abortion. [Time expired.]

Dr S J GOUS: Mr Chair, my first remark would be that the name of the drug is spelt wrongly on the Order Paper. Secondly, I would agree totally with the Minister of Health regarding her approach to and remarks on the clinical trials, and the Republic of South Africa in terms of toxicity and drugs. It is essential that one must be extra careful and proceed with utmost caution. Therefore I would support the Minister’s remarks on those grounds. [Interjections.]

I also welcome the establishment of a national health research ethics council. I think that would stabilise an unsatisfactory position in the country. There is a problem though. I see the Minister refers to a trial. In this trial that she refers to, nevirapine is only used as part of a cocktail. In other words, it is not the drug on its own. Therefore, it would be very difficult to isolate the drug nevirapine as the one causing the damage. Also, it is very different to the trials that we are really interested in, that is the mother-to-child-transmission trials, where there is only a low single dosage given. In this case it is an ongoing treatment for Aids and amounts to big doses for many days.

First of all, there is a big difference in dosage. Secondly, it is in a cocktail mixture, and it is very difficult to predict what will happen under those circumstances. Thirdly, liver toxicity is well known in most antiretroviruses and could have been predicted anyway. Even the pamphlet insert says: ``A doctor should monitor liver function.’’ It is part of the precautions that a doctor should take when he works with this drug.

All drugs have side effects, some more serious than others. The probable advantages must always be weighed up against the side effects. For instance, one would accept the much more serious side effects in the treatment of cancer than in the treatment of a headache. At the same time, even a simple headache tablet has a whole list of complications and side effects, but this does not mean that we should take all headache tablets off the market. It certainly does not.

Now, the problem is that with regard to Aids, we are at war and if, in fact, the Minister’s remarks meant that all trials in terms of mother-to- child transmission are going to be stopped, we are very disappointed, because I think this is not the same thing we are talking about here. We are not comparing apples to apples.

The New NP has always supported any measure that will prevent the transfer of the HIV virus between mother and child, and between any two people, for that matter. Therefore we have always supported the use of even antiretrovirals. We perceive this resistance to the use of antiretrovirals in the prevention of mother-to-child transmission as a planned resistance which we do not quite understand, but there might be an ultimate agenda of compulsory licensing and parallel imports behind it. The feeling is that this statement is going to be a smoke screen or excuse not to use nevirapine in the future.

The DEPUTY CHAIRPERSON OF COMMITTEES: Order! The hon member’s time has expired. Order! This is a very important debate that affects the total population of this country, and every one of you should be interested. Your Minister has introduced it in this Parliament, and I think that every one of you owe it to yourselves and your constituencies to listen. Leave your chitchat and listen to the debate or leave the Chamber.

Mr S NAIDOO: Chairperson, and hon members, health is one of the most important aspects of South African society, and the UDM believes in preventative measures. It is also our view that, through timely and effective treatment, one can prevent excessive suffering and hardship.

The introduction of a new drug is always welcomed, but of concern is the cost of the drug and its availability. Therefore, those affected may never have access to such drugs. Of importance is the initiative by our Government, by launching Aids Awareness Day, to undertake precautionary measures in the spread of the epidemic throughout Africa.

The question of whether South Africa approves of nevirapine or not can only be considered within the context of the HIV/Aids situation in South Africa. It is thus impossible to avoid a discussion on the current confusion reigning in Government’s Aids policy. Two years ago, the hon the President, Thabo Mbeki, then still Deputy President, launched an extensive Aids awareness campaign. However, in the last few months, the hon the President as well as members of his Cabinet have made statements that have thrown the South African debate into disarray. In addition to this, the SA National Aids Council has been composed in such a way that many of the most important role-players are sidelined. Furthermore, Government has consistently insisted on cheaper drugs. This in spite of Glaxo Wellcome’s 75% discount offer on AZT and Pfizer’s announcement that a certain specialised Aids drug treatment will be provided at no cost to poor South Africans.

Clearly, judging by the cautionary statement by the hon the Minister, we cannot rejoice at the availability of nevirapine when it and other drugs are not supplied by Government due to the complaints about price. People wonder why, after millions of rands were lost in the Sarafina 2 debacle, Government refuses to spend an equivalent amount on these types of drugs. Nevirapine, like other treatments, is only successful if combined with at least two other drugs. This is due to the high rate of mutation of the virus.

We need a clear and unambiguous policy statement from Government with regard to its role and strategy in respect of HIV/Aids, since many role- players now feel that they are battling Government instead of working with it to fight the dreaded disease. We note that important stakeholders have threatened to boycott the forthcoming summit in Durban, and therefore call on Government to avert such action as it will have a bearing on the public and, more so, the Government because many people out there would like to see a well-considered strategy. [Time expired.] [Applause.]

Mrs C DUDLEY: Chairman, the ACDP is sorry to hear of the deaths of the women mentioned, and we pray that the families concerned will be comforted by our Lord Jesus Christ. [Interjections.]

The ACDP is also saddened by the Minister’s statement because studies show strong evidence that nevirapine reduces the transmission of HIV from mother to child. Medical researchers say the beauty of nevirapine is that it has a long halflife, and can be given to all mothers in high-risk areas as a matter of course, without their having to submit to Aids tests and counselling.

Only a single dose is necessary, given before and after birth. Most importantly, the treatment costs less than R30. Nevirapine can only be given once, however, as resistance develops quickly, and outside of mother- to-child transmission usefulness has clearly not been shown.

The original use of Nevirapine was to prevent further cells from infection. It does not kill the disease and is therefore used in conjunction with other drugs when treating rape victims. Nevirapine on its own therefore does not help rape victims. Government may argue that there is a very small risk in the case of rape victims, yet we know HIV is transmitted sexually; therefore the victim must be given the benefit of the doubt, and AZT and 3TC must be an option.

For ethical reasons it will never be possible to get scientific results regarding treatment of rape victims, as human study on rape victims cannot carry clinical approval, but AZT has already been given by Government to health workers and the drug has proven to be 80% effective in preventing HIV transmission in needlestick injuries. These patients can be monitored and the information is therefore reliable.

In conclusion, the ACDP believes it is commendable that such emphasis has been placed on antiretrovirals, but we believe we should also focus on fighting opportunistic disease infections. Drugs against TB, meningitis, thrush, shingles and herpes should also be on the essential drugs list and available free of charge to patients. Although the results of the AZT and nevirapine trials being conducted in Durban, Pretoria and Johannesburg have not yet been released, researchers to date did not see this as a major problem, as so far known results seem satisfactory. We hope these are not just delaying tactics in view of Government’s policy on the murder of unborn children. [Time expired.]

Mr G E BALOI: Chairperson, we are a nation at work. We are very concerned about the monsters that ravage the lives of our youth on a weekly basis. We know that the hon the Minister of Health also cannot sleep at night, and therefore she has requested us to comment on this issue of nevirapine. Nevirapine is the nth anti-HIV drug HIV/Aids patients can try, and was first approved only within the past six months.

In Washington, the United States Food and Drug Administration authority approved this new class of HIV/Aids medicine, gearing patients to start adding the drug nevirapine to the treatment combination. Nevaripine is a new class of drug especially developed to fight reverse transcriptive enzymes differently by blocking the receptor where the enzymes seem to do their job, much as a key fits into a lock. Adding nevirapine to older drugs such as AZT and DDI is mostly done to try to boost the patient’s ability to lower HIV floating in the bloodstream and to strengthen the immune system. However, nevirapine cannot be used alone. The HI-virus rapidly develops resistance to nevirapine. The drug is, in fact, not administered to cure HIV, but to reduce the load of HIV in the body.

Mrs P DE LILLE: Chairperson, it cannot be a coincidence that the Minister is making this statement today, because last week I actually got involved in the same investigation myself. I can confirm to this House that there are about six contract research organisations, seven academic research institutions and fifteen pharmaceutical companies in South Africa doing trials on people. In Gauteng alone more than 300 such trials have been conducted, and this has been confirmed by the chairperson of the ethics committee, Dr Falcken.

With regard to the specific trial that the Minister referred to, I have received complaints and I visited two of the patients at Kalofong Hospital last week. These are the complaints. The first complaint was that the consent form of more than eight pages has never been explained to them in the language of their choice. They signed something that they did not understand.

Secondly, they were promised money. They were told that they were going to die in any case. They are paid R40 for every treatment that they receive, and the side effects are vicious. The other thing is that they are given a phone number that they can call whenever they need to talk to the ethics committee. I phoned the ethics committee and the only answer I got was a fax machine - no other answer. There is no recourse for the patient.

I just want to call on Government today to stop and suspend all these trials until we have proper controls in the country, because our people are dying. We need to protect the human rights of our people. These drug companies are exploiting our people, and the worst thing is that they are not testing these drugs in their own countries. They are coming here and using our people as guinea pigs, and this is unacceptable. [Interjections.]

I just want to say that I have also been informed that the Minister has established a committee. That is to be welcomed because we need some control. However, is the Minister aware that the committee is going to meet for the first time on 31 May 2000? What are we doing in the meantime about our people who are dying? What are we doing to stop these companies? They must be stopped. They must go and test their drugs in their own countries and not in South Africa. [Applause.]

Dr A I VAN NIEKERK: Mr Chairperson, I readily agree with what the hon Patricia de Lille said with regard to the sufferers of Aids. I think that the ordeal of people who are suffering from the Aids virus will never be fully understood by people who do not have that virus. It is by means of research and the development of new drugs that the plight of the sufferers of Aids can be alleviated. Such action has to be supported.

The main problem with Aids-related medicine is the cost involved in developing and selling the product at affordable levels. In many cases it is too expensive for ordinary people to use. On the other hand, development and research to make such drugs available and safe are expensive. If the developer, on the one hand, is to be deprived of the profit incentives, then no new medicines will ever see the light. It is, therefore, essential that a solution be found to allow the industry its reasonable profit and experimentation. The social health structures of Government on the other hand must make such medicines available in an equitable and sustainable way to as many Aids sufferers as possible, even if this should mean an affordable subsidy by the taxpayers.

Dit is egter ook nodig om te waarsku teen valse gerugte en verwagtings wat weens voorlopige proewe ontstaan. In dié verband is die agb Minister se waarskuwing en verklaring tydig, en ek steun dit. [It is, however, also necessary to warn against false rumours and expectations which arise as a result of preliminary trials. In this regard the hon the Minister’s warning and statement are timely, and I support them.]

Dr A S NKOMO: Chairperson, we are like people who are mourning at a vigil. We have heard announcements of the deaths of five mothers and for us it is a time of mourning, a time of sadness. We are sad, therefore, that there are people who use this opportunity to dance on the victims’ graves, which is exactly what happened when the hon Sandy Kalyan was addressing us here. I would also like, with the permission of the chairperson, to pass over the speech of the Minister with reference to what the World Health Organisation has said on this matter of nevirapine in paediatric use. We will pass over that.

South African law, until recently, did not regulate clinical trials. The first democratic Government of South Africa addressed this issue by passing the Medicines and Related Substances Control Act of 1997. Unfortunately, the implementation of this Act has been arrested. It is sitting in the Transvaal Division of the Supreme Court of South Africa, having been taken there by the PMA, which is an ally of a party which is present here, and which I shall not mention. [Interjections.]

We support the setting up of the MCC clinical trials committee. Clinical trials need to be regulated, and we need the full force of law behind this regulation. Clinical trials occur when the pharmaceutical industry needs to test new drugs in order to establish the safety and efficacy of the new medicines. Great care needs to be taken when new drugs are first introduced to humans to ensure that people are not at risk and not exploited in the process, which is what Patricia de Lille has been talking about.

Governments the world over have legislation to protect their constituents from abuse in clinical trials, but the pharmaceutical industry in South Africa does not want us to do so. Members should ask themselves why. I would like to congratulate the Minister on taking decisive action on this matter. I would also like to say that the ANC will be ever vigilant to ensure that the standards of protection of our people are at one with the best in the world.

It is wrong that our people are used as subjects in clinical trials to produce scientific data, but do not benefit from the results thereof. When the trials stop they find that the drug is unaffordable. We need to ensure that only medicines that will benefit South Africans will be tested on our people. We need to ensure that all clinical studies are performed to the highest ethical standards. All ethics committees that review these studies must be transparent - and the Minister must ask for their names and CVs - and properly constituted with community representation.

Pharmaceutical companies talk about their rights to intellectual property, but there must be responsibilities. These companies that own rights to the drugs should carry the full cost of the study. If state facilities are used then a cost will arise. Appropriate reimbursement to the state should occur.

If a patient in a clinical trial has a bad reaction to the drug, then the pharmaceutical company should reimburse the state for all the medical expenses that arise. Most importantly, the pharmaceutical company should have appropriate product-liability insurance. Should a patient be so unfortunate as to die in a clinical trial, as we have heard from the Minister does happen, then the pharmaceutical industry has the responsibility of ensuring that the family is not financially disadvantaged by this loss.

It is also important that the care of patients is not disadvantaged by the trial. For example, if a patient living with Aids enters a three-month clinical trial, what happens at the end of the three months? It is unacceptable to us that all treatment for the patient is stopped when the trial stops. Medicines should always be provided free of charge to patients in clinical trials. Patients should never be made to pay for the study, nor should doctors receive payments or benefits of any kind that would in any way induce them to encourage certain outcomes.

Let me state categorically, however, for the benefit of this House, that the ANC is not against the pharmaceutical industry performing clinical trials in South Africa. We recognise that clinical trials are essential for drugs and the development of drugs, if they are available and beneficial to health. However, there must be a North-South divide on the way these trials are performed.

The DEPUTY CHAIRPERSON OF COMMITTEES: Order!

Dr A S NKOMO: If they are performed here in South Africa, they must be performed to the highest …

The DEPUTY CHAIRPERSON OF COMMITTEES: Order! Hon member, your speaking time has expired.

Dr S A NKOMO: … ethical standards because what we do not want is the development …

The DEPUTY CHAIRPERSON OF COMMITTEES: Order!

Dr A S NKOMO: I am finishing. What we do not want, is the development of the syndrome of the poor African guinea pig … [Interjections.]

The DEPUTY CHAIRPERSON OF COMMITTEES: Order!

Dr A S NKOMO: … and the ANC’S health plan, on page 53, dealt with this matter as early as 1994. [Applause.]

Debate concluded.

The House adjourned at 18:05. ____

            ANNOUNCEMENTS, TABLINGS AND COMMITTEE REPORTS

ANNOUNCEMENTS:

National Assembly and National Council of Provinces:

1. The Speaker and the Chairperson:

 (1)    The Joint Tagging Mechanism (JTM) on 5 April 2000 in terms of
     Joint Rule 160(6), classified the following Bill as a section 76
     Bill:


     (i)     National House of Traditional Leaders Amendment Bill [B 15
          - 2000] (National Assembly - sec 76) - (Portfolio Committee on
          Provincial and Local Government - National Assembly). TABLINGS:

National Assembly and National Council of Provinces:

Papers:

1. The Speaker and the Chairperson:

 Report of the Auditor-General on the Financial Statements of the Human
 Resources Fund for 1998-99 [RP 55-2000].

1. The Minister of Trade and Industry:

 Reports of the Board on Tariffs and Trade on the -

 (1)    Increase in the rate of duty on other pigments and preparations
     based on titanium dioxide, Report No 3889;

 (2)    Increase in the rate of duty on alkyd resins, Report No 3894.

National Assembly:

1. The Speaker:

 The President of the Republic submitted the following letter, dated 28
 March 2000, to the Speaker of the National Assembly, informing
 Parliament, in terms of section 201(2) of the Constitution, 1996, of
 the employment of the South African National Defence Force in terms of
 section 201(2)(c) of the Constitution, 1996.

 REPORT IN TERMS OF SECTION 201(2) OF THE CONSTITUTION OF THE REPUBLIC
 OF SOUTH AFRICA, 1996 (ACT 108 OF 1996), ON THE EMPLOYMENT OF THE SOUTH
 AFRICAN NATIONAL DEFENCE FORCE IN TERMS OF SECTION 201(2)(c) OF THE
 CONSTITUTION, 1996, IN THE FULFILLMENT OF AN INTERNATIONAL OBLIGATION
 IN THE REPUBLIC OF MOZAMBIQUE


 1.     This serves to inform the National Council of Provinces that I
     authorised the extension of the employment of the South African
     National Defence Force (SANDF) personnel and aircraft, in the
     Republic of Mozambique, in fulfillment of an international
     obligation. This employment was authorised in accordance with the
     provisions of Section 82(4)(b)(ii) read with Section 227(1)(b) of
     the Constitution of the Republic of South Africa, 1993 (Act No 200
     of 1993), [which sections continue to be in force in terms of Item
     24(1) of Schedule 6 of the Constitution of the Republic of South
     Africa, 1996 (Act No 108 of 1996)], read with Section 3(2)(a)(iv)
     of the Defence Act, 1957 (Act No 44 of 1957).

 2.     This employment is in compliance with the Republic of South
     Africa's regional support, to the Government of the People's
     Republic of Mozambique, for humanitarian assistance in the
     preservation of life, health, and property, resulting from the
     current widespread rains having caused extensive and serious
     flooding in Mozambique. Due to the necessity for the continued
     support and distribution of aid to Mozambican citizens adversely
     affected by the severe flooding, and due to the deterioration of
     the situation, an extension of the deployment was requested.

 3.     The deployment has been extended from 17 March 2000 to 07 April
     2000.


 4.     The deployment will consist of 60 personnel, three Orynx
     helicopters, two BK 117 helicopters, two Casa-212 transport
     aircraft and two light aircraft.

 5.     The estimated total cost for the extended period is R6 077 232 -
     00.

 6.     I will communicate this report to the Members of the National
     Council of Provinces and wish to request that you bring it to the
     notice of the Members of the National Assembly.


 Regards
 TM MBEKI