HIV/AIDS: hearings

Meeting report

HEALTH PORTFOLIO COMMITTEE
9 May 2000
HIV/AIDS HEARINGS

Documents handed out:
Address by Pharmaceutical Manufacturers Association

SUMMARY
The purpose of the public hearings are to assess progress in respect of the campaign against HIV/AIDS. What are the successes and failures? What can be done to enhance the work already done? Presentations were made Department of Health and the Pharmaceutical Manufacturers Association.
Discussion at times was heated.

MINUTES
Department of Health
Dr Simelela, a Director in the AIDS Directorate of the Department, presented the Department's strategy and challenges:

Broad Strategic Goals
- To work towards a reduction in the number of new HIV infections.
- To work towards a reduction in the impact of the HIV epidemic on individuals and communities.

Priorities
There are four main priority areas: treatment/care/support, the protection of human rights and monitoring/research/evaluation.

Specific Objectives
There are units within the HIV/AIDS Directorate to support the above goals. Their specific objectives and strategies are as follows:
- Providing counselling, care and support.
- Providing interdepartmental support.
- Providing support to non-governmental organisations and their other partnerships.
- Creating awareness of HIV/AIDS and sexually transmitted diseases (STD's). - Educating people on HIV and TB and on barrier methods.
- Building youth awareness and skills.

Counselling
The priority is to increase access to medical and non-medical voluntary testing clinics (VTCs). There was a need to establish counsellor mentorship programmes. Criteria have been established for lay counsellors. These lay counsellors will have mentors and will focus on counselling for children -addressing their psychological needs. An integrated team is going around to inform provinces and assist them in setting up task teams.

Care and Support
The Department is still busy finalising models. Impact study tenders were awarded last year to examine whether a hospice type facility or a community model is suitable. Provinces have selected the model most suitable to them. A roll-out plan for home-based care is being put into action.
Guidelines on the treatment of opportunistic diseases and infections have been developed. These also cover paediatric and palliative care.

The Department is looking at creative ways of involving people in the Directorate's work. For instance, five sufferers have been employed in different government departments to create awareness and drive the response to the campaign. A new appointee has just taken up a post to work with business to initiate projects.

Interdepartmental support
There is a need to develop HIV plans and programmes in all national departments in order for government to plan for short and long-term recruitment, benefit plans and so forth. There is a strong interdepartmental committee currently conducting HIV impact assessments.

NGO support
The Department funds 10 national and 200 provincial NGOs. There is a strong need to build the management capacity of funded NGOs. There is also a need to build provincial capacity to fund and monitor provincial NGOs. NGOs should be encouraged to twin with other civil society groups to build capacity.

Partnerships
The trade unions are proving to be strong partners. They have become involved within their own communities in the fight against disease. Business is a strong partner and they largely fund their own initiatives and projects. The Department is making use of traditional healers - there are two in the directorate. This is an attempt at building rapport, assisting the healers and using them as a resource for the Department.

From the civil/military alliance someone has been seconded into the Directorate as a liaison. Lastly, there is a small unit working with the Law Commission providing technical assistance on necessary law reform.

HIV Public Awareness
Billboards are being used to create awareness. The focus is dealing with the language challenge and communication with the handicapped and other target groups. Disclosure and acceptance in the community is a challenge.

This year there must be at least two health care providers in a facility who know the protocol. There is also a move to examining activity in the private sector. For instance, in respect of STDs the infected male partner usually seeks treatment in the private sector and generally private physicians do not adhere to the protocol. These physicians need to be trained. The directorate is also working with miners and sex workers. Interventions in case of TB need to be strengthened and AIDS counsellors must be equipped to counsel TB sufferers. Especially amongst dual AIDS/TB sufferers there was a need to alleviate poverty and educate people on nutrition.

Research
The Directorate was collaborating with the Medical Research Council on vaccine research. Research was also being done on the prevention of mother-child infection. There are pilot projects underway. Other areas of research are on STDs and HIV / STD transmission after sexual assaults on women.

Youth Programmes
A number of youth programmes have already implemented sustainable HIV/AIDS programmes.

Life Skills Programme
R75 million has been allocated to this programme. There is meant to be an integrated life skills programme in primary and secondary schools. As part of the programme the training of teachers as lay counsellors would be piloted. Peer education would also be implemented which would allow capacity building amongst the youth themselves.

Budget 2000/20001
The national budget is R145 million. The breakdown for the different programmes in the Directorate is as follows. Nothing has been spent yet except on a number of meetings. Presently various proposals from organisations are being evaluated.

In respect of NGOs who are being funded, they have been requested to provide a database showing which organisations they fund in order to avoid duplication and over funding of certain organisations.

Dr Simelela referred to the underspending of last year's budget. By the end of 31 March 2000 the remaining funds had been committed but not used. The underspent funds have subsequently been rolled out.

Challenges facing the Department
- The area of human resources is a constant challenge. Volunteers and health care workers must be encouraged to help with support and care.
- It must be ensured that all facilities have the necessary drugs.
- Each province must have an interdepartmental committee to co-ordinate activities.
- Coordination is needed within the NGOs.
- Different media needs to be used in different areas of the country.
- Where must resources be channelled?
- How can other sectors be brought aboard?

Dr Ayanda Ntsaluba, Director General: Department of Health, highlighted a number of issues from Dr Simelela's presentation. He emphasised the need for an integrated strategy in respect of home-based care. At the last MINMEC meeting held in March Mpumalanga and Kwazulu Natal's home based care programmes came under scrutiny. It was agreed that these provinces needed to come up with an integrated strategy. It became clear that some community workers are confronted with high levels of poverty among the families they work with. Government must therefore begin to work on poverty alleviation predominantly in rural areas and households headed by women.

He also reported on the AIDS advisory panel convened by the President in order to establish recommendations around:
- Prevention: how to consolidate prevention in developing countries.
- Therapeutic interventions: are retroviral drugs helpful in improving quality and length of life or are they toxic.
The divide between the dissident group and the mainstream group is not only due to the dissidents' disbelief in the connection between the HIV virus and AIDS. They also rejected the use of anti-retroviral drugs.

The two day conference was held to identify the main issues in the initiative. Apart from the meeting's 33 participants, a number of scientists had been invited but were unable to participate. A closed internet discussion in which they will also participate will follow soon.

Dr Ntsaluba firmly stated that anyone who could give an input on AIDS must be allowed to do so and have his views challenged by scientists. His analysis of the meeting is that it was a success. The key decision announced by Dr Abdul Karriem in the media was to continue with the initiative in spite of the misunderstandings. Although the minds of the dissidents had not been changed, they now understood the essence of each other's views. Prof Mogoba had said in the media that they would try to work around and through the complexities. Therefore the present position is that they would continue to extend initiatives along the lines set out.

Pharmaceutical Manufacturers' Association (PMA)
Ms Deeb, Chief Executive of PMA, stated that advances in the treatment of AIDS are due to pharmaceutical manufacturers devoting billions of dollars to medicines and vaccine research on AIDS and AIDS-related infections. She noted that there are over 100 new AIDS medicines in the research and development pipeline, including 10 vaccines for HIV prevention.

However a favourable environment must be created for research and development. This research must not be hindered by short-term actions such as compulsory licensing and parallel trade. Some claim they are cost-saving policy initiatives but they weaken patent protection and the ultimate beneficiaries of the profits are the parallel traders. Issuing compulsory licences could lead to only a limited number of licences being issued and only a minority will benefit from the cheaper drugs. Price benefits may be minimal, while the quality of a copied version may not be equivalent to the original.

A coalition of stakeholders led by committed governments and institutions such as the World Health Organisation and the World Bank needs to encourage new drug innovations and increase adequate health care access.

Such a coalition faces the following priorities:
-stepping up educational campaigns to curb the spread of HIV;
-enhancing the capacity of health systems to deliver medical care to the people living with the disease;
-encouraging further innovation into new therapies and vaccines while improving access to existing ones in regions such as Africa.
-recognising that the problem of access to drugs for AIDS and related conditions is one aspect of the broader issue of access to adequate health care generally.

Other mechanisms to explore should include developing policy measures similar to US orphan drug legislation which includes tax credit and market exclusivity provisions. The US government proposes setting up a market-based mechanism to support vaccine development. New incentives should not be limited to vaccines only but drug treatments as well to improve the quality of life for those living with these diseases.

Individual companies are working with the private sector to deliver vaccines to needy countries at a substantially reduced price. This commitment by industry is essential. Pfizer has recently donated Diflucan to South Africans living with HIV-related cryptococcal meningitis where these patients cannot afford treatment for as long as it is needed.

The UNAIDS HIV Drug Access Initiative, a partnership with major pharmaceutical companies, seeks to improve access to needed drugs, the lack of medical infrastructure and drug distribution channels in developing countries.

In spite of these initiatives there remains some barriers to access. The distribution costs of medicines are huge. South Africa uses the two tiered pricing system. Eighty percent of the drugs in the market are purchased on the state tender system. This allows the state to secure the best world prices. Ms Deeb posed the question: why can the state not use this system to obtain the best prices for HIV drugs? She emphasised that PMA is prepared to work with government and share their expertise.

Discussion
Ms Malumise (ANC) noted that the lack of medical infrastructure and resources was usually cited as the cause for not making anti-retroviral drugs available. However such drugs were being used in hospitals like Chris Hani -Baragwanath. Ms Deeb commented that there was still a need for infrastructure. Ms Deeb said there was still a need for infrastructure projects. For the year ending 1998 R500 million had been spent on infrastructure development but more work can be done on these projects.


Dr Rabinowitz (IFP) asked if there was any potential to combine current research with research on why some HIV virus carriers take so long to display the symptoms of AIDS and on alternative methods of treating symptoms such as yoga. Ms Deeb said that in research generally, anything is considered if it has a scientific basis. A lot of research was going into other initiatives especially vaccines. Partnerships were very important.

Dr Nkomo asked the PMA representative whether there was any objective way of determining whether what the pharmaceutical companies claim about costs is true. Ms Deeb said in response that they were obliged to accept what the companies say and there was no objective mechanism. It would also be an exercise in futility since the prices of drugs fluctuate constantly.

Dr Gous (NNP) said that the public perception is the President Mbeki is unsure that the HIV virus causes AIDS. He referred to Dr Simelela's address in which she had said that the first leg of the campaign against AIDS is to attack the HIV virus. Why fight HIV if there is still uncertainty that it causes AIDS? Dr Gous asked both Dr Simelela and Dr Ntsaluba to tell the Portfolio Committee what their personal views on the link between HIV and AIDS is.

Dr Ntsaluba hesitated over the question. He said he was usually unwilling to give his personal views but in his capacity as Director General of Health he was prepared to say that he was taught and believes that the HIV virus causes AIDS. As far as what the President believes, that can only be gleaned from his statements in the media.

Dr Simelela said that personally she believes there is a virus that causes AIDS. It was worrying that the virus in our country is different. She suggested that other interventions such as traditional medicines could play a greater role.
It was necessary to respond to the epidemic as it presents itself in Sub-Saharan Africa.

Dr Jassat (ANC) commented that the amount spent by the pharmaceutical industry in developing countries is only five percent while the profit margin is as high as twenty five percent.

Ms Deeb said this figure was incorrect. Research has accounted for the substantial amount of 5 to 25% of some countries' budgets.

An ANC member referred to the recent Pfizer announcement that they would be making Diflucan freely available to HIV-cryptococcal meningitis sufferers. [Research shows that 1 of every 20 people with HIV got sick with cryptococcal meningitis but research has also found that 2 of every 5 people with HIV got sick with thrush. Diflucan can be used to treat both these infections.] This question was not answered in the response to the cluster of questions.

Dr Jassat (ANC) asked why more money was not being spent researching vaccines. Was it because the pharmaceutical companies make more profit from drugs? Ms Deeb said that the costs involved in vaccines are enormous. Currently there are eleven vaccines in the pipeline for AIDS alone. But there is a problem with financing vaccines and companies proceed with caution especially where there is uncertainty about demand. A Joint Global Vaccine Initiative has been formed recently, funded by the World Bank and other large organisations.

Ms Jacobus (ANC-Chair of the NCOP Committee on Social Services) asked how much of a pharmaceutical company's research is funded by state grants? This question was not adressed by PMA.

Mrs Kalyan (DP) asked why the AIDS Panel had not included any persons from Uganda and Senegal, where they have had more success with managing HIV/AIDS. Dr Ntsaluba said that the panel did include someone from Uganda and a second representative had been able to attend. The delegates from Thailand were unable to attend though someone from Senegal was present at the conference. He emphasised that all these scientists would be participating in the upcoming closed internet discussion.

Mrs Kalyan (DP) asked for the criteria used for the selection of the VTCs? Dr Simelela said that the VTCs were meant to provide support services, counselling and testing, to the people. The provincial AIDS managers look for sites where there is a centre for people already, then a VTC is set up.

Mrs Kalyan (DP) asked for the cost was of the recent newspaper insert on AIDS awareness. Dr Similela said not all the costs had been collated yet but it was probably R1 to R1.5 million. It was felt to be a necessity since most media coverage had been very negative so far.

Ms De Lille (PAC) asked for the real cost of the drug, Nevirapine. She asked if AZT is toxic only to persons who cannot afford it?

Dr Ntsaluba deferred this issue to the Medicines Control Council who had registered AZT. The Council's view is that there is justification for the registration of AZT. He felt that their decision should be respected. While nobody could say that AZT does not have side effects, combination therapy must be given.

Ms De Lille (PAC) noted that there were numerous drug trials happening around the country. Were people being used as guinea pigs? Is there adequate control over the trials? Why were people dying from these trials?
Dr Ntsaluba's response is that AIDS trials are a sensitive issue. In the next meeting between the Department and MECs on the 8/9 June ethical guidelines for these trials would be discussed. He wished to make it clear that South Africans are not guinea pigs. However, he did pose the question as to whether it was correct to carry on clinical trials if they will not benefit people.

Mr Mpehle (ANC) asked PMA to state exactly what these drug trials are promising? Are people informed about how these drugs must be used and what the effects are?

Dr Cowper, from PMA, attempted to answer the cluster of questions on clinical trials. She opened with a remark that it was apparent to her that there was a distinct lack of information on clinical trials amongst committee members. Dr Nkomo asked Dr Cowper to withdraw this remark immediately as it implied a lack of integrity amongst the members. There was a general assent to this among committee members. Dr Cowper immediately withdrew her comment. She responded to the questions, saying that the reason why so much money is being spent on trials is to look at the efficacy of the drugs. If this is not shown, the programme is withdrawn.

Dr Rabinowitz(IFP) followed up on her answer. She asked whether there is an international protocol on the drug trials which is applicable in South Africa. Dr Cowper said that in practice as soon as South Africa begins an initiative all participants in the trial start on the same day. An international protocol is uniformly followed.

Ms Marshoff(ANC) asked what is done when this protocol is not followed. Ms De Lille(PAC) added that in South Africa once the Medicines Control Council has approved a trial there is no monitoring body to monitor the trial.

Mrs Deeb strongly disagreed with these statements. She referred to ordering procedures and safety implications that are picked up immediately when data is sent through. She pointed out to the members that Dr Cowper had been invited to accompany the delegation because of her expertise in research on medication and was widely respected for her knowledge. Dr Nkomo said that she was not respected for her knowledge here before the Portfolio Committee or by him. He asked the PMA delegation to do research on clinical trials and report back to the Committee next week. Dr Gous (IFP) said he took offence to Dr Nkomo's remark because it had been an insult to Dr Cowper. Dr Nkomo said although he felt it was fitting in the light of Dr Cowper's remarks to the committee members and her failure to answer the questions on clinical trials he would withdraw it for the benefit of Dr Gous.

Dr Cowper added to her answer saying that she liked to think that trials are conducted according to the Helsinki Declaration and international guidelines.

Dr Nkomo asked what these rules are that she is referring to and more specifically what 'monitoring' is done? Dr Cowper said that once a trial is opened the pharmaceutical company must be present to monitor at the site. Prior to this patients would already have given their informed consent to the treatment.

Dr Nkomo asked if the patient continues to receive treatment after the trial. Dr Cowper said that in an international trial, the trial might be picked up by private companies. In South Africa the patient could be funded by a private company after the trial.

Mrs Deeb added that there is strict control by the Medicines Control Council of Phase 1, 2 and 3 trials. In respect of Phase 4 trials, that is, after the drug has been registered as safe and effective, there may be a gap in control. However, before action can be taken a complaint must be laid.

Dr Cowper said that South African patients also have the option of entering other trials or some companies offer the option of life-long medication.

Ms De Lille (PAC) commented that when President Mbeki had made the announcement about the 'FTC 302' trial the shares in the pharmaceutical company immediately plummeted. She added that she did not feel that PMA represented their members well and was disappointed with their responses. Dr Nkomo agreed, saying there were gaps and tensions on certain issues.
Mrs Deeb responded that PMA is a trade association representing individual traders. Members take responsibility for their own trials.

Mr Mpehle (ANC) asked why drugs trials are being done primarily on Black women. Mrs Deeb said this was not true, according to her knowledge. Moreover, in scientific terms, metabolism differs according to different races. Dr Cowper stated, categorically, that trials are not done on Black females only.

Mr Mpehle asked whether PMA are prepared to negotiate on the marginal costs of manufacturing drugs. Mrs Deeb said that the cost of manufacturing drugs differed from one country to another and if a government wishes to buy one of the drugs on a large scale, the company would be open to negotiation on the price.

Dr Nkomo commented that the Open Democracy Bill is currently awaiting the President's signature. Mrs Deeb retorted that she hopes intellectual property law will also be respected.

Dr Jassat (ANC) asked why the court case against South African Airways had arisen when a Cabinet decision had been made against pre-employment testing. [SAA had done pre-employment medical tests on an applicant and refused to employ him as a cabin attendant when he tested HIV positive.]

Dr Ntsaluba said the Court's ruling would probably relate to the fact that testing took place prior to the decision by Cabinet on pre-employment testing. Dr Simelela added that the Department had initially asked to testify in the trial until it was realised that the incident had occurred before the Cabinet decision was taken.

Dr Jassat (ANC) said it cost R1269 for one month's treatment of Nevirapine, which was supposed to be the cheapest on the market. Ms Deeb said this was indeed the MIMS price for Nevirapine and the important point is that he MIMS price is used as reference price in the private sector. In practice MIMS does not reflect the actual manufacturer's price or discounts and so forth. Where the State decides to purchase drugs, prices would bear no resemblance because companies are always willing to negotiate with the state, as a bulk buyer.

Ms Marshoff (ANC) asked if the different strains of HIV were being concentrated on? Will the pharmaceutical industry also change the strategy with their drug production? Would the pharmaceutical companies be able to augment intervention strategies of government? Dr Cowper said that research is directed at all strains of the virus. Ms Deeb added that there are companies who are talking with government to direct it to concentrate on the virus prevalent in Sub-Saharan Africa. A partnership with government is definitely possible because the government needs the expertise of business and industry.

Ms De Lille (PAC) asked whether PMA and the Department can say whether Nevirapine has been approved for vertical use [mother-to-child transmission of HIV] as a report was due to have been submitted to the Minister last week.
Dr Ntsaluba said the drug was not registered for mother-to-child use. The Medicine Control Council has looked at their application but will only decide after the trials have been completed. He was uncertain whether the report had been submitted to the Minister.

Dr Nkomo(ANC) asked what the status is of the Medicines and Related Substances Control Act 90 of 1997.
Ms Deeb said that Act 90 of 1997 has been suspended. There is a national crisis in this regard that would only be aggravated by the Act, which is unworkable and unconstitutional.

Ms Mnumzana (ANC) asked whether it would not be reasonable for the government to take out compulsory licenses to allow the parallel importation of cheaper medicines. Dr Rabinowitz (IFP) asked whether, if the problem with parallel importation in the Act were withdrawn, the court case currently pending would be withdrawn. [Forty companies are currently challenging the Act in ongoing litigation and the matter remains sub iudice.]

Ms Deeb's response was that even if the section on generic substitution was withdrawn, their objection is not wholly to generic medicines. She did not want to prejudge the case but believes it is riding on technical and legal certainty. She stated clearly that they wanted a negotiated settlement but the process and the law must be clear and certain.

Dr Nkomo (ANC) said that if legalities could be left aside was there not still a need to respond to national crises? Ms Deeb did not believe that patent protection stands in the way of affordable medicines. There are many loopholes in pricing. There is also a difference in pricing between the developed and the developing world. Parallel importation undermines the ability to sell at a lower price to some countries. Why should a company invest millions in employment and training in a country if it knows the government will source the drugs to someone else? The government must decide whether it wants to buy cheaper drugs at the price of not having a viable local industry. She added that compulsory licensing means that a third party is allowed to bring in a cheaper product, not having invested anything in research, training, employment and so forth. Ultimately the present government wants to implement compulsory licensing. PMA has an abhorrence to compulsory licensing.

Ms De Lille (PAC) referred to Mrs Deeb's speech where she said it would take five years to develop a vaccine for HIV - this was a long time.
Ms Deeb said all companies are competing to get the vaccine on the market first. Some companies estimated that it would take five or five to ten years. Even where some felt it could be done in less time they were applying caution. Several offers have been made to government to negotiate the impasse they were experiencing in the partnership with the manufacturers. PMA had experienced some disappointment that offers made by companies were not replied to even several months later. Ms Deeb herself had made a substantial proposal to top government officials but was still awaiting an answer.

Ms Deeb said that clinical trials are not only for the benefit of pharmaceutical companies. Although it does bring in foreign exchange and foreign investment it also focuses the company's attention on diseases prevalent to a particular area. If they can prove there is a clinical benefit to that drug, they will make it possible to use the drug in the long term.

Dr Rabinowitz (IFP) asked why parallel importation could not be withdrawn. If PMA do not keep their word and prices do not go down, then bring the provision in again.

Dr Ntsaluba responded that in 1998 there had been a meeting between PMA and the former Health Minister, Dr Zuma, at which PMA had raised their points. Dr Zuma had said that the issue of parallel importation is important because there is no evidence of significant moves among members of the pharmaceutical industry to lower prices. She was prepared to put the clause on parallel importation aside but an alternate mechanism was needed. It was felt that if PMA could demonstrate that they could lower prices they should not have to be concerned over parallel importation which would only be used where the price was not coming down.

Dr Ntsaluba responded to PMA's submission and the discussion that followed. He acknowledged that delegates usually come to the Committee at short notice. He understood that members were concerned over certain aspects of trials that do not conform to the guidelines. Perhaps some of the organisations making submissions on the following day could address these concerns. He had been in contact with the Minister of Health, Manto Tshabalala-Msimang, and she had suggested talks with PMA. After this session however, it occurred to him that perhaps this was a waste of time. He was unhappy with the insinuations made and the fact that some issues had been harped on instead of navigating forward.

The first day of public hearings on HIV/AIDS was concluded.