HIV/AIDS: hearings

Meeting report

HEALTH PORTFOLIO COMMITTEE
16 May 2000
HIV/AIDS HEARINGS

Relevant submissions:
SA Red Cross Society
Chamber of Mines
Aids Law Project
Pharmaceutical Manufacturers Association
National Council of Trade Unions
Department of Health
[email [email protected] for submissions that are not online]

SA Red Cross Society
Sister Jacobs presented an overview of their Home Based Care Project with regard to HIV/AIDS and TB. She said that the infection rate in South Africa has increased dramatically over the past 5 years. A holistic approach to controlling and managing the epidemic is required. This calls for a partnership between Government and the NGO sector.

Their HIV/AIDS home awareness project was started in 1993 together with drug awareness programs in schools and factories. SA Red Cross formed part of a Task Team to evaluate the future needs of HIV/AIDS patients as hospitals would be unable to take care of the increasing numbers. SA Red Cross Society had been conducting Home Based Care for geriatrics at the same time. The Society was asked to set up a home based care project for HIV/AIDS and agreed on condition that it was funded. In 1994 the Mayoress raised R250 000 for the pilot project with provinces committing to subsidise the program.

Sister Jacobs outlined the main resources necessary for Home Based Care to succeed. Skills, time, energy and funds from communities and governments were necessary. Her presentation further outlined the twelve key principles associated with home based care: Holistic, Person centred, Comprehensive and interdepartmental, Empowering, Support services, Cover total life-span, Sustainable and cost effective, Quality and safety in the services being supplied, Allow choice of all participants, Recognise diversity, Promote and protect human rights, Efficient and effective.

Sister Jacobs gave details on how the project was set-up and what research was conducted. The research phase was completed in 1995 and documented. Running the project involves 3 stages: Referrals come to the manager's office; Patients are allocated to a sister in their residential area; A sister conducts an assessment through a home visit. On the basis of this assessment, patients are categorised according to their mobility and stage of illness and the applicable services are given. Supervision was required from the Home Carer and the Nursing sister. In the terminal stages of illness daily visits from the Sister were required. The Manager's role was to oversee and interact between various hospitals and staff teams to assess problems. Close work is required with the Provincial Department of Health and Welfare. As the AIDS epidemic increases Home care will play a major role in the community.

Discussion
Dr Rabinowitz (IFP) asked the following questions:
How were patients tested?
Patients were referred from the HIV clinics where testing had already taken place. Therefore no testing took place.

Why were people more open?
This depended on the attitudes of the doctors and nurses towards the patients. This spread by word of mouth and patients indicated a preference to go to certain clinics as opposed to others.

How were home carers identified?
(A) Home carers were recruited from the Red Cross. They are however very migrant and do not stay for long periods. The Society trains 300 volunteers per year. The volunteers have an interest in HIV and come to receive basic training. They have sick relatives and need information and training.

How were the home carers paid?
(A) Home carers were not paid any remuneration. Only bus fare was paid. Those working at Nazareth house with the HIV/AIDS babies were paid R5.00 per hour and bus fare.

Had the Society approached funding organisations?
(A) The Red Cross was battling financially. They needed to meet organisations more regularly with regard to funding.

Patricia de Lille (PAC) commended the Red Cross Society on the sterling work they were doing and the services that they were offering. She asked:
How do they find participants for the programs?
(A) Recruiting was by word of mouth and voluntary. There were special referrals from the HIV clinics as well. Students are accepted from matric onwards. Students in this category conducted home care visits. Medical students also accompanied the home carers to conduct care counselling. The Accreditation Board accredited training. Three levels to the basic home-based care course are offered.

Was home care inclusive or exclusive of drugs? How does the RCS acquire drugs?
(A) There was no supply of HIV drugs. Medication was supplied by the referring hospital. Hospitals included all necessary medication. Somerset Hospital was conducting trials under supervision.

On special referral from the HIV Clinics. Clinics supplied drugs including Antiretrovirals that were donated from the companies. Antiretrovirals were not freely available. A basic home kit was provided for home carers. This comprised ointments, gloves, a protective apron and a uniform for those carers working with HIV/AIDS babies.

Did they have access to Antiretrovirals drugs and when did these become available?
(A) These drugs were donated and there was not open access to this class of drugs.

Ms Baloi (ANC) commended the Red Cross on the wonderful work they were doing. She commented that Health Services could not cater for all patients and joint initiatives were important. She asked if discussions had been held on partnerships with the Provinces?
(A) Yes, discussions had been held with all the Provinces. All the day hospitals had been visited where the project had been introduced. A problem arose when the patient only wanted treatment and not support / care services.

What were various organisations doing with regard to home based care?
(A) The new Minister of Health had donated R50 000 for a twelve-month period.

The Chairperson, Dr Nkomo, complimented the Red Cross on their services, and asked if the Red Cross had been in contact with WHO and the Department of Health?
(A) There was close co-operation with regard to the various departments. The doctor in charge arranged transport in certain instances. An area where the system was functioning well was the Boland.

Continued Professional Development points were awarded to doctors for ongoing education? If these points were awarded in rural areas and to doctors, would this motivate doctors to conduct voluntary community services?
(A) Yes, these were available to nursing staff. This would contribute and form part of the training. There were still problems to overcome. Patients did not like certain locals as there was a judgmental attitude from the workers. There was a certain amount of fear of the disease from the workers. This had to be overcome.

In Khayetlitsha there was a special HIV clinic. The same staff manned this and patients preferred this. They received better treatment and understanding. With the result that they requested to attend this clinic as opposed to other clinics. There was a long-standing association between the Society and this clinic.

Chamber of Mines
Dr Le Grange introduced her presentation with comment on the measures the Chamber of Mines was implementing to prevent the spread of HIV. She then dealt with the legal implications surrounding HIV/AIDS testing.

The prohibition of HIV testing is governed by section 7(2) of the Employment Equity Act. The Parliamentary Portfolio Committee on Labour inserted the clause at the last minute after a very brief debate. The negative consequences of this piece of legislation were not considered. A blanket prohibition has serious ramifications for the industry and the control of HIV/AIDS.

The wording of the legislation is as follows: "All testing, even with consent, is prohibited". This implies that even with the employee's consent testing is prohibited. Legal experts argue that this could not have been the intention of the legislator, and consequently such testing is not prohibited. The wording is not clear and employers will not act against the legislation due to the sensitive nature of the issue. Therefore testing under the following conditions is not taking place.
- Voluntary testing/counselling at health care services provided by the employer at on site clinics. Under the current wording of the legislation no testing can take place even where a doctor-patient relationship exists and the employee requests this.
- Medical diagnostic testing. Many conditions exist which would require a patient (i.e. the employee) to be tested for HIV in accordance with good medical practice to make an accurate diagnosis This testing cannot take place at the employer sites.
- Testing for research purposes. This is also not allowed even where researchers wish to determine the prevalence of HIV.

Dr Le Grange then argued for testing in the workplace. Her main points were:
Controlled testing in the workplace is in the interests of the employee to establish HIV status. Necessary precautions and preventative measures can be implemented. These pertain to opportunistic infections and infection from TB. Patients need to be tested for HIV as preventive medicine can be administered to reduce the chance of TB infection.

Accidental exposure to HIV in the workplace is a serious threat. This requires immediate HIV testing to determine the status for compensation purposes. Treatment for occupational exposure requires treatment to start within 24 hours. Testing is required for a further 6 months to monitor sero-conversion.

Follow up to accidental exposure is also problematic. The woman cannot be informed when the miner returns home. The partner has a moral right to know the status of her partner. She argued that surely a partner has a right to know. While all people have a right to privacy, the right to life supersedes all other rights.

HIV must be made a notifiable disease. Allocating this status to HIV will allow follow up, especially in the rural areas

Dr Le Grange proceeded to interpret the meaning the legislation incorporated in the EEA. If the sections in question were included to prevent unfair discrimination against the employee or an applicant for employment, on the basis of his/her HIV status in the workplace, section 7(1) suffices to deal with all other comparative serious life threatening conditions, it should also suffice for HIV/AIDS.

The implication of the current wording suggests that any and all information pertaining to HIV status of an employee be prohibited. This is irrespective of whether the status is positive or negative.

Dr Le Grange had the following recommendations for the sub-clauses:
Preferred option
Repeal section 7(2) but specify HIV section in 7 (1)

7 (1) Medical testing, including testing for HIV, is prohibited, unless
- Legislation permits or requires the testing: or
- It is justifiable in the light of medical facts, employment conditions, social policy, the fair distribution of employee benefits or the inherent requirements of the job.

Alternative option:
Replacement of section 7(2) of the Employment Equity Act:

7(2) Testing of an employee at the request of an employer to determine that employee's HIV status is prohibited unless:
- The employee gives informed consent to such testing.
- The employer treats the information as confidential
- The results are not used to unfairly discriminate, directly or indirectly, against the employee; or
The Labour Court, in terms of section 50.4 determines such testing to be justifiable; or
Legislation permits or requires the testing; or
The testing is done in terms of a collective agreement entered into between the employer and a representative trade union.

Informed consent for purposes of section 7 (2) means that the employee understands and agrees to an HIV test and that the employee understands what the test is, why it is necessary and the benefits, risks, alternatives and possible social implications of the outcome.

Discussion
Dr Jassat (ANC) - The incidence of HIV on the mines has not increased. There is also a good control of TB on the mines. His question: Can the mines provide comprehensive antiretroviral drugs, are these provided?
(A) The cost of Antiretrovirals is prohibitive. Even if it was supplied monitoring and follow-up are costly. As regards the supply or AZT, not monitored this can be toxic. If the drug is taken for 2 years it becomes useless. Fifty percent of patients on AZT do not benefit. Triple therapy only benefits 50% of other patients and is very expensive. It is more beneficial to treat opportunistic infections such as TB. Affordable drugs are available. Avenues of treatment have to be explored and affordable drugs used. The Mines acknowledge the value of home carers.

Dr Gous (NP) - There are clear problems associated with testing. Why should a person with HIV/AIDS have human rights above those of other people? How do you understand this issue?
(A) There is an ethical dilemma. There is the risk of unemployment; it is a decision that the larger society has to make.

Dr Rabinowitz - On the privacy issue. The right to privacy versus the right to human life. The real issue is the government is not providing testing. Government should provide all testing and all people should have a test, thus eliminating discrimination.
(A) Testing of HIV has to clarified by government. The sudden increase in HIV infection is because of the misguided belief that "it will not happen to me".

Dr Twala ANC - If testing is prohibited then voluntary testing should be allowed?
(A) Voluntary testing on site (employer's work place) is not permitted under the current legislation. Therefore more clarification of Section 7(2) is needed.

Dr Khumalo - We have heard the general views of highly knowledgeable people. What is the attitude in the rural areas?
(A) They are under the impression that the disease is curable. More risk taking behaviour is seen, as they believe there is a cure.

Patricia de Lille PAC - Large mining companies should screen all workers. HIV positive workers came from Namibia to SA to find work. SADC and counterpart countries should monitor HIV status and control the movement of migrant people. Major migrant patterns should be stopped. Families should be brought closer to migrant workers to decrease infection.
(A) Dr Le Grange said there was SADC interaction between Namibia and SA. In 1994 the World Bank started an initiative on the issue of a migrant labour force. They found migrancy to be extremely high. Half the migrant labour force came from Namibia. At present there was spare capacity in the single sex hostels. These hostels would be able to accommodate families in the future.

Ms Baloi ANC - How will wives know the status of husbands who are HIV positive if there is no follow through and follow up care.
(A) Follow-up and counselling have to take place on site on the mine property. STD's are monitored but there are few follow-up sites. On site there is care. Once off site the miners are discharged and there is no care.

Aids Law Project
Mr Mark Heywood's presentation was an argument for an expanded access plan to encompass all aspects of HIV/AIDS care and treatment.

Mr Heywood commented that the Chamber of Mines presenter had misquoted facts. According to his sources TB was on the increase in the mines as was the infection from HIV. He argued that the Chamber of Mines had "mistaken strategies."

He commenced his presentation with the reasoning for the expanded access plan from a social, political and human rights perspective:
- Recently Justice Albie Sachs had described the right to human dignity as "foundational and animating our Constitution". The same can surely be said for equality. Yet AIDS reveals the inequalities under which we still labour.
- In 1996, Anglo American Director Clem Sunter wrote in The High Road: Where are we Now?
"We accept that a richer person can have a better car or a better life, but there's something less acceptable about the rich being able to purchase more years of life."
- His comment was made at a time when effective treatments for HIV and AIDS were little more than a dawning possibility. Four years later, however, it is a prediction that has been borne out. Rich people, people on certain medical aids, now have access to effective drugs. Poor people die.
- Statistics point to decreases in deaths from AIDS in the US, but an exponential increase in Africa. These figures could be seen as catastrophic.
- A definition of the term "access to treatment" has been over-simplified in the public debate. The main issue is accessibility to drugs. Other contributing needs are: Expanded access to HIV testing and counselling; Improved health care infrastructure; Access to prophylactic and anti-retroviral treatment;
- Treatment is ineffective if only available to small numbers of people, even if these small numbers include poor people. Infrastructure systems need to be set up. Inadequate infrastructure is no reason to deny accessibility to drugs. Access programs could be offered through existing tertiary hospitals and health care centres in South Africa.

He stated that drugs are the key issue to controlling the disease. The creation of openness about HIV will be less effective unless treatment is available. In the words of Justice Cameron, access to treatment changes people's perceptions of the disease: "Access to treatment changes people's perceptions of the person living with HIV. They no longer see a person who will be dead in a few years time." Treatment access contributes to breaking the stigma associated with HIV. In the long run, the provision of treatment would therefore diminish the need for treatment.

The continuing focus on the "cost" of treatment is fully justifiable. In 1997 the Public Protector investigated the Minister of Health (instigated by the PMA) found that medicines were too highly priced in South Africa. A reduction in prices was necessary.

Government's argument, that providing treatment for people with HIV will erode the health care of "other" people and diminish the constitutional right of these "other" people to have access to health care services is not valid and should be rejected. Instead of being fixated solely on the cost of drugs, the cost of not providing treatment in South Africa should be studied.

Not treating people with HIV creates avoidable costs. Mother to child transmission is a clear example. Not providing AZT to reduce the risk of mother to child transmission doubles the numbers of infected infants. Roughly 20 000 infant infections are occurring that could have been avoided. Not providing effective prophylactics and ARVs to parents leads to an increasingly rapid increase in the number of orphans. Surely there is a social obligation the Government has to keep parents alive longer.

Two obstacles exist to the delivery of treatment:
- The cost of essential drugs
- Stigma and discrimination

He commented on the recent offer by pharmaceutical companies for donations and price reductions, specifically the Pfizer offer. Government should urgently establish an expert team to negotiate price reductions directly with the pharmaceutical companies. These negotiations need to be pursued aggressively and within clear time frames. However, bona fide negotiations around cost cannot take place as long as producers of essential medicines will not provide information on a drug-by-drug basis of :
- the actual costs of research and development
- active ingredients,
- legitimate marketing costs

Should negotiations fail between the various parties and the pharmaceutical companies are shown to have been acting in bad faith, then the legal basis will be set for the use of compulsory licences and /or parallel imports.

The high cost of essential drugs is unjustified and there is a legal obligation on government to use its powers under the 1975 Patents Act to make public health available. AIDS Law Project recommends to the government that it act on its constitutional duty to facilitate compulsory licencing, should negotiations fail.

The South African government needs to use South Africa's moral legitimacy to challenge the pricing practices of pharmaceutical companies - and the economic policies of industrialised countries that have contributed to the collapse of almost all public health facilities in the vast majority of African countries.

Government also needs to reassess its use of available resources. Huge sums of money are spent on submarines despite the massive need for HIV testing and treatment. 50% of people in the worst affected parts of South Africa cannot even access HIV testing.

Finally he accused the PMA of the following: " Since 1998 the PMA has used its unlimited resources and ability to command some of the best lawyers in the country, to prevent the implementation of an Act that aims to improve access and affordability of medicines and strengthen the power of government to fulfil it's constitutional obligation to expand access to health care services. It has done this on the basis of its members' rights - all incidentally multi-national companies - to intellectual property. The human right to health is being held hostage to the private right to property. This is clearly wrong."

He challenged President Mbeki to challenge the pharmaceutical companies.

Discussion
Dr Gous (NP) - Mr. Heywood's statement that drugs were more expensive here than the rest of the world was very sweeping. The reference to the Public Protectors report needed to be clarified. At the time of the report selected pricing studies were conducted on selective drugs. Could he support his statement by defining costs in the private and public sector?

Mr Heywood replied that there was plenty of evidence in the Public Protector's report that the cost of drugs needed to be scrutinized more closely. Essential life saving drugs were the main issue. There was documented evidenced with regard to mother to child transmissions. Where studies had been conducted at Chris Hani Baragwanath hospital, the response had been phenomenal.

Dr Nkomo introducing the Pharmaceutical Manufacturers Association stated that clinical trials are important, but require regulation. Further comments were: The committee respected intellectual property rights nor were they opposing patents. Transparency was necessary regarding drug treatments. The cost of active ingredients should also be made available.

Pharmaceutical Manufacturers Association
Dr Nkomo thanked the PMA for returning to answer questions and issues from the previous day. Ms Deeb of the PMA made a formal announcement of the decision by five research-based multinational pharmaceutical companies to supply necessary drugs at significantly reduced prices to developing countries.

The PMA presentation covered in detail all aspects of clinical trials with explanations to various queries that had been raised the previous day (see document).

Discussion
Dr Twala - Why do delays in the approval of clinical trials occur in South Africa? What happens in other countries?
(A) Dr Johan Botha from SmithKline Beecham said that countries of great concern were the US, Canada, Western Europe and the UK. From the time the regulatory authority received the final documents took 92 days. The draft for the trial for application to the MCC requires final documentation. If there are errors or omissions then the whole process of commencing the clinical trial will halt. In South Africa at present it takes 90 days and more for this process to occur. Research on any international trial commences on the same date around the world with participating countries. If the documentation is incorrect or not complete the country will not be allowed to participate in the trial. All participating countries are notified of a start date and a close-up date. The country not ready will be withdrawn from the said trial and cannot participate at all.

He said that the area of international clinical trials is becoming extremely competitive. Countries (mostly in Eastern Europe) who could previously not participate are now able to due to changed political policies. This resulted in new competitors who are fast and keen and meet the necessary criteria and deadlines speedily. Countries Dr Johan Botha named are Czech Republic, Bulgaria and Yugoslavia. They are price competitive in relation to South African charges.

Dr Rabinowitz - How does PMA see its social responsibility in South Africa?
This question would be responded to in another written submission
Will PMA and drug companies fund homeopathic and unorthodox research. For example the Russian Box that is being used in treatments?
(A) The answer given by Mrs Deeb was yes. Provided there was a basis of scientific evidence to support the findings and conclusive results could be achieved.

Dr Nkomo ANC -In South Africa the issue surrounding the trials is that situations exist where people do not know enough about the trial or the name of the drug being tested. Specific issues relating to South African clinical trials need to be investigated. Why are clinical trials conducted here?

(A) South Africa has had a reputation for conducting high quality international studies. Scientists and researchers are respected. Clinical trials amount to around R400m per annum in direct foreign investment, money brought into South Africa by foreign multinational research based companies, some of which spend 5 to 20% of their total clinical trial research budgets in SA. The figure is disproportionately higher than the income generated by these companies from sales in SA (approximately 0.5% -1%).

What are the conditions that must prevail for trials to be conducted?
(A) The area of infection relating to the specific trial must prevail. An example given was the seasonal movement of the flu virus. When winter in Europe then trials would be conducted there, when the seasons reversed then trials would be conducted here. Malaria was another example of why clinical trials are conducted here. The disease affects the population and the drugs can be tested in the regions where the disease is prevalent.

Concern was raised that South Africa was an easy target to conduct trials. In response Dr Botha replied that for a drug to be tested here in a clinical trial, the drug had to be registered overseas first with FDA or EU or both. It was important to remember that any irregularity found by the bodies in regard to trials would sabotage the complete trial. In money terms this was a huge loss.

In response to a question regarding South Africa being a cheap destination, Dr Botha replied that South Africa was not cheaper than other countries. He did not recall the exact costs. However in the EU and US the companies only paid for all the costs relating to the actual trial itself and not sundry costs. In the EU and US standard therapy costs were born by those governments respectively.

In South Africa the company paid for every single cost related to conducting the complete clinical trial. I.e. hospital charges and standard therapy charges. South Africa was a very expensive place to conduct clinical trials.

Ms Deeb responded to a question on what the international drug offer encompassed, saying that there are no pre-conditions to the offer. If a country does not have adequate intellectual property protection, they would not be excluded from the offer of access to medicine. The offer was a global industry initiative at government level. UNAIDS would act as a mediator between the companies and governments. The international organisations involved in the offer include the World Bank, the WHO and public health organisations.

National Council of Trade Unions (NACTU)
Mr Tumediso Modise, NACTU HIV/AIDS National Programme co-ordinator, presented NACTU'S main areas of concern:

Workplace testing for HIV
NACTU's current policy is that there should be no compulsory pre or post workplace testing for HIV. Voluntary testing conducted by suitably qualified health care workers could be undertaken with both pre and post-counselling available. Pre-counselling should assist the person with their decision.

Strict legal confidentiality should be kept as regards the person's HIV status. The written consent of the person concerned should be obtained regarding disclosure of information. HIV status should not effect job status, promotion or transfer.

Relationship between HIV and AIDS
NACTU found the Government's attitude to the causes of HIV /AIDS incomprehensible. That the Government could spend R2 million as alleged on a conference to debate the relationship between HIV/AIDS was not acceptable. Evidence in the fact that thousands upon thousands were dying was enough proof. He referred to the dissident's arguments and rebutted these.

Reduction of prices on essential drugs
Prices would remain a negotiable issue as created through TAC and NACTU.

SANAC representative
NACTU had not received an invitation to participate in SANAC. If COSATU is represented then NACTU is omitted. NACTU wishes to operate independently from COSATU. NACTU questioned the governments under-utilisation of its budget of R40 million and wanted to know where the money was.

Organized Labour - an appropriate vehicle to reach the seemingly unreachable.
Organised labour is well placed because there are members structures already in place. Targeting people through trade union-based education one is sure that they will pass on the information and ideas to the broader community.

In conclusion he pleaded with the government whom they had elected to assist organised labour by financially supporting trade union-initiated education and training programmes.

Department of Health
The Department of Health's feedback was provided by Dr Harm Pretorius and Dr Simelela standing in for Dr Ntsaluba who was attending a meeting in Geneva with the Minister of Health. The questions asked of the department the previous day were not answered. Dr Simelela stated that as these hearings formed part of the consultative process, the DOH would have to evaluate the issues* raised and incorporate them in new policies and strategies being formulated by the DOH. Dr Pretorius said that all resources would have to be mobilised. The debate had been useful and informative. The Southern African Development Community would require a collective effort to combat the disease. Best practice for clinical trials should be established. Campaigns and home based care would have to be supported by the DOH. More equipment, planning and infrastructure resources would need to be made available. A way forward had to be found.
The DOH would have to evaluate all these issues and return with suitable responses. A task team should be formed to evaluate all the information obtained from the hearings. Continuous discussion was required between all parties.

Dr Nkomo requested that the DOH and the PMA make written responses to all the questions not fully answered from all the sessions.

[* Issues raised during the hearings were:
Attitude change of workers in the public sector and clinics
Access to drugs
Home based care initiatives
The new offers made by the Pharmaceutical companies
The allocation of the SANAC funds
Offering laboratory support as suggested by the AIDS Law Project.
Conduct cross border negotiations with SADC countries and create a multi-tasking force for the management of HIV/AIDS - as recommended by the Chamber of Mines]

Report provided by Locunda Karam