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Portfolio Committee Health
15 October 2002
Occupational Diseases in Mines & Works Amendment Bill: hearing; Medicines & Related Substances Amendment Bill: deliberations
Chair: Lincoln Ngculu
The Committee pursued two separate orders of business: (1) public hearings on the Occupational Diseases in Mines and Works Amendment (ODMWA) Bill, at which NUM/COSATU provided the sole briefing; and (2) processing of the Medicines and Related Substances Amendment Bill. The NUM/COSATU presentation was generally supportive of the ODMWA Bill as constituted, recommending two significant alterations (extension of the period within which the Director of the Medical Bureau for Occupational Diseases may refuse the application for medical examination by an ex-miner, and a parliamentary review of the policy and legislative framework on occupational health in mines). Processing of the Medicines and Related Substances Amendment Bill focused on definitions in the amendment and the issue of licensing of dispensing doctors, and completion of processing was deferred to a later date.
Briefing by NUM/COSATU
Mr Fred Gona of the National Union of Mineworkers (NUM) made a presentation on behalf of NUM and the Congress of South African Trade Unions (COSATU). Mr Gona acknowledged that the ODMWA Bill represented a significant step towards rectifying the systematic limitations imposed by the original act. He noted that the negative effect of the migrant labour system under apartheid has been felt by black workers and their families through the inadequate and mostly cost-driven legislative provisions on compensation for occupational diseases.
NUM and COSATU proposed the following changes to the Bill:
Extension of the 24-month period during which the Director of the Medical Bureau for Occupational Diseases (MBOD) may refuse the application for medical examination by an ex-miner to 36 months, in Section 32 of Act 78 of 1973 subsection (3). This was based on the fact that the latency period of these occupational diseases is long, some manifesting themselves after a staggering ten years of exposure or even longer after the worker has left the industry.
Linking of the term "reasonable costs" to "proven costs" in Section 36A of Act 78 of 1973 subsection (1). Currently the Act does not set out uniform, minimum standards that give meaning to "reasonable costs," which in practice has led to this being interpreted subjectively. Individual mining companies have the discretion to determine what is "reasonable" on an ad hoc basis, which creates much uncertainty (and consequently hardship) for mine workers. Mining companies may also use this subjectively to deny workers their reimbursement despite the legitimacy of the claims. Therefore, the payments of costs must be based on proven expenditure incurred, which may for example be based on the submissions of receipts and invoices. Further, NUM proposed that these proven costs payable by the owners be extended to cover expenses related to traveling, accommodation, and food necessitated by such occupational diseases.
NUM also stated that the principal Act does not make adequate provision requiring corporates to take full responsibility for compliance with World Health Organization guidelines and International Labour Organization Standards. Neither is provision made to ensure that health surveillance is undertaken on a life-long basis. Nor is industry required to invest in research for the purposes of finding mechanisms to prevent the contraction of related occupational diseases, for example, investigating the substitution of hazardous substances or finding an engineering solution that will eliminate the exposure of workers to these hazardous substances. Accordingly, NUM called on the Committee to initiate a process directed at investigating and reviewing the current legislative and policy framework applicable to occupational health in mines. The emphasis must be placed on ensuring that the industry takes full responsibility, which includes making of financial and material contributions that are commensurate with the nature of the range of diseases that are in many instances severe and life threatening.
Questions and Discussion
Mr Jassat (ANC) expressed his satisfaction with the fact that NUM/COSATU had pointed to "other costs associated with accessing" medical examinations. He noted that ex-miners cannot always travel on their own, and suggested that accompaniment be added.
Ms Luthuli (ANC) thanked NUM/COSATU for their useful input. Regarding costs, she stated that the specification of "reasonable" may exclude a great deal. She agreed that there was much exploitation of, and embezzlement from workers by unscrupulous people. She also noted that the diseases concerned are incurable, debilitating and chronic. Ms Luthuli asked what was NUM doing about prevention.
Ms Rajbelly (MF) asked if there were substantive and preventive measures being pursued by the industry. She also enquired as to whether diseases were on the increase or were declining?
Mr Gous (NNP) noted that no mention had been made in the presentation of HIV/AIDS, and described the close relationship between AIDS and tuberculosis (TB), an often cited occupational disease. He asked if it was possible that the government was compensating people for contracting HIV/AIDS via its support for ex-miners suffering from TB.
Mr Gona (NUM) noted that his union had been at the forefront of prioritizing health and occupational safety in the industry. There were structures within the union to address these issues. Attention to occupational diseases has been insufficient, and in NUM's view, not enough preventive action was taken. Ultimately, the responsibility under law for prevention and treatment rested with employers.
A COSATU representative added that NUM/COSATU's proposal called for a holistic approach to the long-term problem of occupational diseases among ex-miners. As to the HIV/AIDS link, he noted that the link between TB and mining was unquestionable. There was strong scientific evidence to support this link, and it was clear that the mining industry's profits were being subsidized through South Africa's social security and health systems.
A NUM representative expressed his opinion that Mr Gous' implication that the state was paying for people contracting HIV/AIDS was deeply troubling. According to NUM statistics, among 100 miner deaths, only 3 were related to HIV/AIDS. An integrated approach, with legislation and operational aspects of the mining houses was urgently needed. Some mining companies were hiding behind HIV/AIDS, using it as an excuse not to move forward on the prevention and treatment of TB.
Ms Malumise (ANC) commended NUM/COSATU for its agreement with the Department of Health (DOH).
Mr Cachalia (ANC) asked as to whether longer shifts were detrimental to the health of miners.
Mr Gona agreed that long shifts were detrimental to worker health, and noted that NUM has worked with the Department of Labour to look at the number of hours of work per week. The Department has also pursued this objective in its bilateral agreements with mining houses. Hours worked were often correlated to income level, since poorer workers were prepared to work longer, sometimes up to 18 hours overtime.
Ms Rabinowitz (IFP) observed that mine benefits have become less effective since the introduction of new legislation. She suggested that engagement with the government was necessary to determine how the support could be improved.
A NUM representative responded by describing how the mining industry no longer regarded health provision as its responsibility, but rather, something that belonged to the domain of the state. This was relevant to the discussion around HIV/AIDS: AIDS was part of the occupational problem. The mining industry was looking to restrict, rather than broaden, occupational health provision.
Mr Ngculu (ANC) thanked NUM/COSATU for their briefing.
Processing of the Medicines and Related Substances Amendment Bill
Ms Rabinowitz (IFP) recalled that the process culminating in this bill has been ongoing: seeking to amend Act 90 of 1997, a process interrupted by Constitutional Court rulings. It cannot be rushed. She requested a copy of Act 90 of 1997. She also drew attention to the usefulness of a document provided at the public hearings by the Pharmaceutical Manufacturers Association (PMA) that color schemed the original act, Act 90 of 1997, and the current amendments.
Ms Kalyan (DP) stated that seven of the presenters at the hearings expressed the opinion that much had been left out of Act 90 of 1997 and the current amendments. She suggested that, in addition to copies of Act 90, copies of the regulations were also necessary.
Ms Rajbally (MF) agreed with Ms Rabinowitz and Ms Kalyan that the process should not be rushed, and suggested that a workshop be convened to reexamine the bill in detail.
Ms Kalyan noted that not all members had received the PMA comparative study. Was it sent to the committee secretary?
Mr Ngculu (ANC) observed that the Department of Health (DOH) had made presentations to the Committee, that a number of interests had submitted briefings at the public hearings, and that members had been able to ask questions. It had been agreed that the Committee would pronounce itself today. The PMA's submission was available to everyone, though not necessarily the comparative study.
Mr Ngculu noted that the original act, Act 101 of 1965, had been amended in Act 90 of 1997, elements of which were subsequently struck down, leading to the current amendments. Mr Ngculu chastised MPs for not acquiring the relevant documents themselves. He stated that it could not be argued that the process was being rushed.
Ms Rabinowitz suggested that, in order for the Committee to properly fulfill its mandate, it must work beyond the current amendments (B40-2002). Its purview must encompass Act 90 of 1997 and Act 101 of 1965.
Mr Ngculu argued that members cannot use the opportunity of the proposed amendments to go back and review legislation not specifically involved. Doing so would be profoundly counterproductive.
Ms Rabinowitz asked if there would be an opportunity for preparatory questions. For example, where are complementary medicines in the new amendments? Due to the extensive hearings held on this issue, she had assumed it would be included in the legislation.
Mr Ngculu proposed a 15 minute break, so that the secretary could provide copies of Act 90 of 1995. He recessed the meeting. Upon reconvening, Mr Ngculu suggested that members could analyze the document page by page, and invited comments on page one.
Ms Baloyi proposed that the line in Section 1(a) designating "justice officers" be deleted, since as written it included doctors, priests, and even bank officials, and as such was too broad. She suggested that the text should be narrowed to include only magistrates.
Ms Rabinowitz noted a problem with the constitutionality of the clause. Can the Committee be certain that there will not be similar problems arising from the clause as amended? The Court decision said that the powers delegated to magistrates were too broad and violated privacy.
The State Law Advisor flagged this issue for discussion at the next meeting, admitting that he needed to research it and advise the Committee.
With respect to Section 1(c), Ms Baloyi recommended that the definition of medical devices be removed, since the definition already appeared in Act 101 of 1965.
Ms Rabinowitz inquired as to whether the original act contained many references to medical devices.
Mr Jassat (ANC) read the definition of medical devices from the original act.
Mr Gous (NNP) advocated for the extension of the definitions in the bill by including World Health Organization (WHO) definitions of terms such as bioequivalence, bioavailability, pharmaceutical equivalence, etc.
Ms Rabinowitz supported this suggestion.
Mr Jassat expressed his concern with the fact that these terms were not used in the text of the bill, and thus seemed not to require definition.
Mr Gous countered that, if the bill is taken before the Constitutional Court, the government will require these definitions in order to interpret it.
Ms Kalyan suggested it was also important to include definitions of "wholesaler," "distributor," and "pharmaceutical industry," in the context of the bill.
Ms Mnumzana (ANC) agreed, but reiterated the concern that these terms are not in the bill. How should issues not raised in the bill be addressed?
Mr Ngculu noted that "wholesaler," "manufacturer," and "pharmaceutical industry" were used in the bill and should be defined.
Mr Gous added that the term "generic" is used in the bill, and that the terms he suggested for inclusion are themselves definitions of "generic." Must the regulations define "generic?"
Mr Jassat requested assistance from the State Law Advisor.
The State Law Advisor stated that a definition in the clauses concerned would suffice.
Ms Matsuso, Registrar of the Medicines Control Council (MCC), stated that a context had already been provided in the language of the bill. She noted that the WHO definitions split "multisource" and "interchangeable." Definitions of "bioequivalence" and "pharmaceutical equivalence" should be included. To miss out any definitions in the bill would be a serious omission.
Mr Gous noted that, although a product can be interchangeable, bioavailability might not be the same. Great caution is required when dealing with definitions. An alternative may be to stipulate that definitions must be established in the regulations.
Mr Ngculu suggested that the WHO definitions could be referenced in the legislation.
Ms Rabinowitz proposed the language: "taking into consideration the WHO definition."
With reference to Ms Kalyan's initial proposal, Mr Jassat noted that the generally accepted definition of "pharmaceutical industry" embraces the entire supply chain from manufacturer to distributor.
Ms Kalyan expressed her desire to see lay terminology defined in the bill.
The State Law Advisor asked if Ms Kalyan had any definitions in mind other than the ordinary dictionary definitions.
Ms Kalyan replied that she would submit definitions at the next meeting of the Committee.
Ms Matsuso agreed with the State Law Advisor. There are standard dictionary definitions for the terms concerned and it is not necessary to include these in the legislation.
Mr Ngculu invited the Committee to proceed.
Ms Kalyan called attention to the qualifications for appointments to the MCC under Section 2.
Mr Ngculu asked the Committee whether qualifications should be specified.
Mr Jassat suggested there was no need to specify qualifications. Act 90 of 1995 is sufficient.
Ms Dudley (ACDP) agreed that it was sufficient to refer to the aforementioned section.
Mr Cachalia (ANC) proposed that Section 4(c) be left unamended.
The Committee agreed.
Mr Jassat noted that in Section 6(b), lines 54 and 56, there had been an initial decision to exclude medical devices, but that this should now be reinserted.
The Committee agreed.
With respect to Section 6(b)(2), Mr Gous argued that the licensing of dispensing doctors should fall under the purview of the Health Professions Council (HPC). Legislation should not create a gray area in which a different board is responsible for medical practitioners. The Pharmacy Council can be involved, but final control must lie with the HPC.
Mr Ngculu expressed his opinion that the HPC could not be permitted to police itself on the issue of dispensing.
Mr Gous noted that doctors have been in the position of dispensing because, in the past, few pharmacists have been available. Doctors go through a dispensing course in medical school. If a doctor administers an injection, he or she is, in essence, dispensing. Already, the HPC has a mechanism to register dispensing doctors. Doctors cannot be told that an activity that has long been integral to their work now falls under the Pharmacy Council.
Mr Ngculu asked if the language in the text should require the HPC to register dispensing doctors "after" consultation with the Pharmacy Council.
Ms Rabinowitz opposed this proposal, stating that it would create a dual authority between the HPC and the MCC, which will also register, on the basis of need. The issue of duplication is significant.
Mr Ngculu noted that Mr Gous' proposal was widely endorsed by members.
Ms Kalyan observed that there was a conflict in the current language. She stated that licensing on the basis of need is not the way to go.
Mr Gous pointed out that licensing on the basis of need is not in the legislation, and suggested that the Committee should not express an opinion on that which is not included in the existing text.
Ms Rabinowitz appealed to the Department of Health for clarity. Subsection 2 seems to concern who sets exams, whereas Subsection 1 appears to suggest licensing on the basis of need.
Mr Zokufa (DOH) described the Department's reading of the bill. A course will be made available, and the Pharmacy Council will be asked to facilitate it. Once the course is available, the curriculum can be taught by any accredited institution. The bill does not specify who will license dispensing doctors.
Ms Rabinowitz asked if Section 1(a) empowers the Director-General to license dispensing doctors.
Mr Zokufa responded that it does empower the DG to do so.
Ms Rabinowitz stated that medical doctors who pass an exam should be able to dispense. Why must they apply to the DG for a permit to do so, when they have already been licensed by the HPC?
Ms Rabinowitz asked if it would be possible to delete Section 22(c)(1)(a), unless a reason could be presented for its continued inclusion.
Mr Gous suggested that the Committee was again anticipating regulations. Someone must grant licenses to dispensing doctors. The intention of the bill is that the DOH via the DG will issue licenses. Ms Rabinowitz would apparently prefer the HPC to do so.
Mr Jassat stated that the Pharmacy Council should determine the requirements, but that the final say should rest with the separate professional boards.
Ms Dudley agreed that there is no real problem. She proposed that the Pharmacy Council establish the context of a course for dispensing doctors "in" consultation with other professional boards.
Ms Rabinowitz agreed, but stated that Section 6(a) is important and must be addressed. It is not important who sets the exam, but rather, who grants licenses. If a doctor is able to pass the exam, they should be licensed by their own professional board. Why is the DG involved?
Mr Gous noted that this process has been going on for years. There are some 8000 dispensing doctors in South Africa, who have performed an important service, mainly for rural and poor people. Mr Gous expressed his concern that changing the legislation would take away a vital service. He noted that doctors are taught cold chains and other aspects of dispensing in medical school. The DG could "require further information to be furnished" such as the demography of a dispensing doctor's catchment area, which would be unduly burdensome.
Mr Ngculu asked if the Committee could agree to a need for a license.
The Committee agreed.
Mr Ngculu asked if it could be agreed that this license should be determined by the Pharmacy Council in consultation with professional boards.
The Committee agreed.
Mr Ngculu asked if there was a problem if licenses were issued by the DG.
The Committee agreed that this was not a problem.
Mr Ngculu acknowledged that concerns remained around the text that enabled the DG to request further information from dispensing doctors.
Ms Tshabalala-Msimang (Minister of Health) expressed her opinion that the Committee should not consider matters that the bill does not seek to amend.
Ms Dudley acknowledged that, while it might be critical to do so, the issues on the table are of critical importance to the country.
Mr Gous noted that it is the Committee's prerogative to amend anything it sees fit to examine if the members are in agreement.
Ms Kalyan stated that there is bound to be a ripple effect on other sections in the same clause.
Mr Ngculu asked where in the text is it stated that licensing will be determined on the basis of need.
Ms Rabinowitz asked the DG if it will be written into the regulations over which the Committee has no control.
Mr Ntsaluba (Director-General of Health) expressed his puzzlement at the proceedings. From the policy perspective, there are other issues of importance beyond whether a dispensing doctor can simply pass an exam. Those considerations are the topic of discussions between DOH and various parties, including dispensing doctors. If need will be a basis for licensing, must the legislation be crafted to specify that? At the time the legislation was drafted, there were concerns that a lot was wrong with the practice of dispensing by doctors. Mr Ntsaluba also noted that, in the Pharmacy Act, many functions are attached to the Pharmacy Council.
According to Mr Ntsaluba, the heart of the debate is: Do doctors have the automatic right to dispense if a test is passed? DOH believes this is not the case, and that dispensing by doctors should serve other policy objectives. If the answer to the question is yes, however, there is no need for the DG to license.
Mr Ngculu suggested that, on Section 6(b), the Committee was in agreement: that the Pharmacy Council should make the determination in consultation with professional boards.
Mr Gous noted that there is also a lot wrong with what pharmacists have been doing. In terms of policy, it is subjective and open to abuse.
Ms Kalyan observed that the DG had made a compelling argument, but that territoriality remains a problem. This could potentially harm the relationship between GPs and pharmacists.
Mr Zokufa asked if there was a provision for deadlock built in to the language "in consultation with."
Ms Dudley observed that, regardless of the language, there will be attendant problems.
Mr Ngculu asked if the Committee could retain the language "after."
The Committee agreed.
Mr Ngculu proposed that the meeting continue at the next session of the Committee.
The meeting was adjourned.
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