Tobacco Products Control Amendment Bill: adoption; HIV/Aids related research, treatment & care issues: briefing by HIV/AIDS Clinicians

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Health

16 June 2008
Chairperson: Mr V Ngculu (ANC)
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Meeting Summary

The Committee undertook clause by clause deliberations once again of the Tobacco Products Control Amendment Bill. Due consideration was given to the clause that involved the use of the internet for the sale of tobacco. It was understood that although tobacco was not illegal nor was a license required to sell it, the internet was hard to monitor and would open loopholes and create opportunities for underage buyers of tobacco. Another clause was inserted to clarify commercial communication. The Committee voted to adopt the Bill, with amendments. The Democratic Alliance Members indicated that his party may wish to have a debate.

The Southern African HIV Clinicians Society presented to the Committee on their mission statement, what the Society did, their major outputs, latest developments, their branches and membership. The research and guidelines the society either initiated or participated in was also discussed. The Southern African Journal of HIV Medicine was detailed. The association with the private sector and government was also set out. It was also highlighted that although the Society would like to collaborate with government, they had yet to establish a working relationship with them but wished to hold the doors open The Society also felt that direct communication would eliminate the possibility of confusing messages such as the messages spread by the Minister of Health, which had contributed to people being fearful of ARVs and waiting too long to get treatment. They also expressed the view that testing should become normalised and that treatment should be offered at an early stage. It was suggested that rather than requiring a CD4 count of 200, as was the policy in South Africa, a CD count of 350 should be the requirement for commencement of treatment. Members questions touched upon several issues of clarification, and on ARV treatment for babies, options for expectant mothers, and relationships with other bodies

Meeting report

Tobacco Products Control Amendment Bill (The Bill): Final deliberations and adoption
The Committee attended to their final clause by clause deliberations on the Tobacco Products Control Amendment Bill.

Clause 1
The Committee agreed on the proposal that Section 1(a) of the Act was replaced by the proposal suggested by the legal advisors in the document.

Mr Thamsanga Mseleku, Director-General: Department of Health(DOH), suggested adding to Section 1(d)(a)(iii), so that it would read: “A manufacturer or importer of a tobacco product may make a charitable commercial contribution or sponsorship, provided that such contribution or sponsorship was not for the purpose of advertisement or designed to promote tobacco use.”

Clause 2
The Committee proposed amendments to Section 3(1) of the Act. It was suggested that the current formulation of 3(1)(a) and (b) be deleted and replaced.
 
The new Section 3(1)(a) would read “No person shall
advertise or promote, or cause any other person to advertise or promote, a tobacco product through any direct or indirect means, including through sponsorship of any organisation, event, service, physical establishment, programme, project, bursary, scholarship or any other method.” 

The Committee proposed a new Section 3(1)(b) which would read as follows: “...a commercial communication between a tobacco manufacturer or importer must contain no other information except for factual information about the tobacco product, its characteristics, its availability or price and the only pictorial representation that are permitted their component parts and their packaging.”

Dr R Rabinowitz (IFP) mentioned that there were words missing. 

The Chairperson suggested that the principle was clear. The Committee agreed to the amended wording and asked the drafters to insert the necessary words to the last line.

Clause 4
Mr M Waters (DA) had an issue with Section 4(5) and mentioned that adults should be allowed to buy cigarettes over the internet. He noted that Ms Dudley had suggested the Committee should look at the Gambling Act to check if there was some way to ensure that there were checks and balances.

Ms C Dudley (ACDP) mentioned that it was too complicated. Brazil and the state of Vermont banned the sale of tobacco over the internet.

The Chairperson suggested that the Committee could add a qualifier that only the wholesale dealers could buy over the internet, but questioned if there were any loopholes.

Mr Waters responded that it was down to adults’ own choices. It was a legal product and adults should have a right to purchase it within parameters.

Ms Rabinowitz responded that after all the effort to close loopholes it would be impossible to control the internet sales.

Mr Neetesh Ramjee, Corporate Manager: Philip Morris,  added that this would allow companies to communicate with the tobacco traders. If there were adequate age and tax checks over the Internet then perhaps it would be possible. He pointed out that Philip Morris did not sell to consumers over the internet.

The Chairperson did not want to allow people to sell over the internet with carte blanche. 

Mr Mseleku added that the problem with the internet sales was that there was no need for licenses. Anyone could be selling over the internet. Therefore it was impossible for DOH to do what the Gambling Act was trying to do. He suggested that the Committee should keep the prohibition in Section 5 and accept the amendment along with it. 

The Chairperson proposed that the Committee retain Section 5 and add a new Section 5(b) that read: “..does not apply to commercial communication and shareholders.” In that way the Committee would both maintain its stance and align with comments of Philip Morris.

The Chairperson read out the motion of desirability, which was agreed to by Members.

Members, having agreed to each clause as amended, voted to adopt the Bill, with amendments.

The Chairperson asked if there was any party that was likely to vote against the Bill in the House.

Mr Waters responded that he would have to go back to his party.

The Chairperson asked if the DA was likely to want a debate on the Bill.

Mr Waters responded that the DA whips might call for a debate as it was an important piece of legislation.

HIV Aids related research, treatment and care issues: Southern African HIV Clinicians Society (SAHIVSOC) presentation
Ms Fatima Shaik, General Manager: SAHIVSOC began the presentation by explaining the mission statement of the society. The Society was a special interest group in South African Medical Association (SAMA). She gave a brief explanation of their history, elected executive committee and president, size and composition, membership and black economic empowerment. Their major outputs were the journal that was published four times a years. What were fairly new were the clinical management guidelines that included adult Antiretroviral (ARV) treatment guidelines. Their branches were all over Southern Africa, including Zimbabwe and Botswana, and were constantly increasing, as was their membership.

Prof Mark Cotton, Executive Committee: SAHIVSOC, explained that researchers were linked to universities. Ethics committees approved all the research. All structured trials received permission from the Medical Control Council. There was also cooperation with the provincial Departments of Health. The majority of the research was investigator initiated. All Universities’ medical schools were linked to research and he listed the projects. There was outside research but Prof Cotton was fully informed about them. There was a research project that linked the Universities of Witwatersrand, Cape Town and Stellenbosch, and which was funded through the United States of America. The outcomes of processes resulted in the change of treatment guidelines for children on anti-retroviral medication. USA committees and experts had adopted these guidelines, the World Health Organisation (WHO) had just adopted the guidelines and they were currently working with the South African DoH.

Dr Linda Gail Bekker, Editor: Southern African Journal of HIV Medicine: SAHIVSOC, gave a brief description of the Southern African Journal of HIV Medicine. It covered a wide range of subjects. It was a vehicle for guidelines and descriptions for best practices. It was peer reviewed and listed with local and international review boards. There were 14 000 copies printed each quarter. Their readership included practitioners and HIV health care workers in South Africa, Africa and beyond. There were frequent clinical meetings and society branch meetings to update on research findings. The meetings were aimed at standardising practices and maintaining a high standard of care. The conferences attended, capacity building among practitioners, as well as support and services around the country all helped in the skills building.

Dr Lulamile Jam Jam, Executive Committee: SAHIVSOC, provided some background information. HIV therapeutics was costly, life long and complex at times. It was, however, dynamic and involved evolving science. There was also an additional burden to Health Care Services. The government’s responsibilities included access, affordability and alignment with other departmental programmes. The government and the HIV Clinicians society should seek to ensure that the best affordable treatment was made available to all South Africans. It was also suggested that there should be the modification of some international guidelines, when to initiate ARV treatment and many others. There should constant monitoring of the programme to identify issues that were preventing access to treatment and care, to evaluate of the cost of follow up care, and to access and learn from the programme. Partnerships would ensure that there was ongoing scientific rationale to justify current therapeutic programmes.

Dr Eric Hefer, Executive Committee: SAHIVSOC, presented on the private sector portion of the presentation. HIV gave South Africa a disproportionate representation in the international pharmaceutical industry by having the world’s largest treatment programme. South Africa had initially enjoyed a coveted position for HIV research but would have to reclaim that position. There were opportunities for international and local recognition at the International AIDS Conference 2009 and the Durban HIV Conference 2009. The society requested direct communication to avoid public, exploitable and confusing exchanges and messages related to HIV. It wished to work in a collaborative and positive manner to support the national government’s policies and programmes. The way forward included the Society offering access to their collective resources and expertise to cooperate with government programmes.

Discussion
Ms S Matsemela (ANC) asked what was the difference between a clinician and a physician.

Prof Cotton replied that a clinician looked after patients. A physician was a specialist in diseases in adults, whereas a paediatrician was a specialist in diseases of children. A clinician was any doctor that dealt with patients.

Ms Matsemela asked who were the funders of the Society.

Ms Shaik replied that Atlantic Philanthropies funded the Society for a portion of their work. They also generated funds from the pharmaceutical companies who placed advertising in the journal or sponsored a branch meeting. They also generated funds from their members; those who worked in the private sector paid a fee of R250 and those that worked in the public sector paid a fee of R100. They had seven staff members and the executive committee who were non-paid members. 

Ms Matsemela asked what, if any, relationship there was between the SAHIVSOC and the Medical Research Council (MRC). She asked whether it was related to the research that they were doing.

Prof Cotton replied that the MRC was a funder. Members of the society as well as non-members applied for funds.

Ms Matsemela asked if they accessed the palliative and home-based caregivers.

Dr Bekker replied that palliative and home-based care was an integral part of the team. The Society had noted that HIV had to be analysed from the point of testing right up until there was nothing that could be done for the patient. They believed that there was an active process of palliation. They had put out guidelines around palliative care and gave input on best practises of palliative care. Perhaps there had not been enough put into the education of field workers and home-based carers and councillors. Many of their best practises indicated that, particularly in the HIV pandemic, the medical team was critical, and it was not just about doctors.

Ms Matsemela asked what were their views on the institutionalisation of African traditional medicine and healers.

Dr Hefer replied that they had a sub-committee that specifically started looking at the overlap between clinicians or people registered with the Health Professions Council and the traditional healers. There were an estimated 700 000 traditional healers that could contribute to care giving. The next topic at the Johannesburg branch meeting was the role of traditional healers in HIV. They were addressing the topic and inviting experts to address them to find common areas. Some of the first guidelines they addressed were those on nutrition.

Mr S Dithebe (ANC) noted that it was a lucid presentation. He was interested in the Society’s working relationship with organisations such as the Human Sciences Research Council (HSRC) because of the social sciences role they had played in understanding the social impact of the HIV/AIDS.

Dr Bekker replied that it was important to note that there was huge overlap in the country. There were fewer experts than organisations and many of them belong to several organisations. They transected the private and public sector. The Society felt that it was important to move guidelines along as the world changed. The Society had looked at the adult guidelines twice since the initial roll out plan was implemented. They saw their strategy as putting the best practice forward for both the public and private sectors. They recognised that there might be implementation issues within the public sector and would like to assist.

Mr Dithebe asked for comments about the probable patterns of decline within the ages of 18 and 25, given the disproportionate amount of work that was done in reference to the roll out of ARVs.

Dr Bekker replied that it was hoped that the pandemic was changing. There had been some evidence that suggested that, and if so then the Society hoped to work on that.

Dr Jam Jam added that sustainability also had to be assessed. It was pointless changing something if it was not sustainable. They needed to critically look at those issues jointly with the Department of Health.

Mr Dithebe asked about the guidelines that had been presented to the Department, and if the Society had received any comment from the Department.

Mr M Waters (DA) asked what was the process when adopting guidelines and what was the delay that caused the Department not to adopt the guidelines. He asked this because of the dual therapy guidelines that were shown in November 2003, yet four years later had not been fully implemented.

Prof Cotton replied that results were released asynchronously and it took time to go from a research finding to a guideline. Implications also needed to be considered. The timing for this one was illustrative. The South African Guideline Group started meeting in 2006 already to revise the guidelines that were first done in 2004. The guidelines were a pragmatic approach to facilitate the treatment of infants and children. It was not easy to decide who needed to be treated more, in the presence of a treatment deficit and lack of resources.  Their results were released in July 2007. The Department was informed of this and looked at the guidelines. The Essential Drug List Committee of South Africa and the Paediatric Group had heard the presentation. The Essential Drug List Committee had accepted the guidelines as being reasonable. The guidelines stated that there should be treatment of all children less than 12 months of age regardless of any tests, provided they were HIV positive. The American group had reacted to the research findings since they were public domain at the conference in Sydney. The World Health Organisation (WHO) was aware of the findings and recently met and got a group of sixty people throughout the world to assess the guidelines. The South Africa Department of Health were informed of the developments and essentially were part of the process. There was a huge fear because when treating infants there were programmatic issues that needed to be addressed. The international responses would help. Implementing the guidelines would not be easy. Another major issue was that ARVs needed to be given. It was not an easy task to train a mother, who had recently heard that she was HIV positive, and her child. Infrastructure was needed as well as a change in the way counselling was done, better testing, and tracking of mothers all added to logistical issues. It was a roadmap of where they had to go.

Dr Jam Jam added that when new guidelines had to be implemented the logistic implications had to be assessed. 

Mr Waters noted that the presentation had mentioned direct communication to avoid confusing messages. He noted that confusing messages had been coming from the Minister of Health, and asked how that had had a negative impact on the government programme of roll out of ARVs.

Dr Hefer replied that was exactly the problem. The Society’s frustration had been that people were fearful of ARVs until it was too late. South Africa had the second lowest point of access to the CD4 count in the world, because people were so apprehensive that they required so much more motivation by either their care-givers or families before they could access the treatment. He was not saying that the treatment was not without side effects. However, there should be a realistic scientific message about it, as it remained life saving treatment. If the Society could get out a coherent sustainable message more people would come on to treatment and there would be a much bigger impact through the decline on the mortality rates.

Ms M Madumise (ANC) asked what was meant by the Black Economic Empowerment (BEE) accreditation.

Ms Shaik replied that being BEE accredited was a requirement by many funders.

Ms Madumise asked for clarification on a point in the presentation that compared nurses and doctors.

Dr Bekker replied that the nurses’ care was equivalent to doctors’ care. It was a relevant question because nurses would become the frontline in terms of managing HIV and ARVs in the future. The research was a way to provide evidence that this would not cause less optimal care. The Society was currently waiting for the research.

Ms Madumise asked what the clinicians thought was the best time to start the treatment of ARVs, because South Africa waited until the CD4 count was below 200.

Ms Rabinowitz also mentioned that there have been claims that the CD4 count was too low and asked for the Society’s views.

Dr Bekker replied that currently the National programme was based on a CD4 count of 200. This meant that there was an advanced level of HIV before starting ARVs. In their guidelines the Clinicians had put forward a CD4 count of 350 as an optimal starting point. This was because of the co-epidemic of TB that happened multiple times as people became more ill. The remit was that if it was possible to get people on to ARVs earlier and raise the CD4, so could there be a reduction in the TB infection. The premise was that people would be tested so that access could be granted. There needed to be a normalising of HIV testing within the country. The reality was that many people only accessed the ARVs when their CD4 was under 100.

Ms Rabinowitz commented that the journal was good, and she was surprised that she had not seen it before.

Ms Rabinowitz thought that the guidelines were “for the ideal world” as opposed to being practical. For instance there seemed to be no urgency to get the partnership with the traditional healers in place. and that was where the masses of people were going for treatment. She asked if the Society had direct communication with the Department.

Dr Bekker replied that the Society was less of a bio-medical model. They did have a need to align themselves with what was happening in the country.

Ms Rabinowitz asked what was their association with organisations such as the Treatment Action Campaign (TAC) and with National AIDS Council (SANEC) that was supposed be doing research at the local level.

Prof Cotton replied that TAC was a different kind of a society. They were an activist group and the Society was not activist in the same sense. If there were issues that TAC were pushing for, and the Society believed in, they would support TAC.

Dr Bekker replied that SANEC’s responsibility was to prioritise research then to facilitate some of the research.

Ms Rabinowitz asked for the presenters’ views on the fact that TAC had gone to the courts to ensure that foreigners in South Africa also received treatment, at a time when South Africa was already struggling to get resources.

Ms Rabinowitz asked if there were legislative obstructions to nurses and traditional healers doing AIDS testing.

Ms Shaik replied that their National Strategic Plan was a document that dictated their agenda.

Ms Rabinowitz asked if there was a fee when the Society was accredited on PubMed.

Dr Bekker replied that PubMed accreditation meant that anybody could access the PubMed website and that all of the articles in the Journal would be available. It was also important to note that there was no cost to download the articles from the Journal.

Ms Rabinowitz asked if the society could send a one-page newsletter to the Committee each month.

Dr Hefer thanked the Committee for the recommendation and would take it back to the executives.

Ms R Mashigo (ANC) asked what were the consequences of using ARV as a recreational drug.

Prof Cotton replied that it was a concern. He was not sure of the effect on people with HIV, he was not sure if it was absorbed that way and they might develop resistance to the drug.

Ms Mashigo asked about the babies that were on treatment regardless of their status, and asked what would happen if those children were infected

Prof Cotton replied that the Society was advocating treating babies that were HIV positive with ARVs. It was important to confirm their status. The ARVs did have side effects. Many of the babies treated successfully would survive into their 60s or 70s as productive people. In the short term the Society was seeing that the medication was not as toxic nor as harmful as untreated HIV to babies.

Ms Mashigo asked about the mission statement and asked if the government was not doing their job.

Ms Mashigo asked about the prisoner guidelines, and if they were interlinked with the Department of Correctional Services.

Dr Jam Jam replied that they tried as much as possible to be included in all South African programmes. It was discussed in their executive meeting. The sub-committee took cognisance of the issue.

Ms Matsemela asked where were the actual problems since the Department also had programmes in place.

Ms Shaik replied that the Society would work with anyone who would want to work with them. It was unfortunate that they had not worked with the Department of Health for a number of reasons. It had sometimes become personal.

Ms Rabinowitz asked about the PEPI-Malawi study that suggested that only AZT, and not dual-therapy, was sufficient.

Prof Cotton replied that the PEPI-Malawi study was an interesting new development that tried to protect babies whose mothers had to breastfeed. As paediatricians the clinicians would always advocate breastfeeding. It was of tremendous concern to discover that HIV was spread through breast milk. The study showed that giving treatment to babies for the first fourteen weeks helped a lot. They used various strategies in the trial. It did not have anything to do with TAC, and was thought out by the investigators by Malawi. It was a study funded through the United States. Competitive funding was funding for any good idea.

Ms Rabinowitz asked if the opt-out approach was the best approach.

Dr Hefer replied that the opt-out approach was the best way to go in South Africa.

Ms Rabinowitz responded that it might be a contradiction if there was voluntary counselling and testing because people could refuse to be tested.

Dr Hefer replied that opt-out meant that it was part of the ante-natal workup. After counselling, the mother would make a decision whether or not to have the test.

Ms Shaik replied that they agreed to disagree.

The Chairperson thanked the presenters. There were many things that the Committee would like to pursue further with the Society. He underscored that they had established a particular relationship. They had attempted to have meetings for some time. They would continue as legislators and would try to ensure that they dealt with the issue surrounding of health. They would not distance themselves from a particular challenge. In the next period perhaps the society could advise them to home in on certain issues. They dealt with all legislation and would not be guided by political affiliations.

The Chairperson adjourned the meeting.

 

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