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HEALTH PORTFOLIO COMMITTEE
25 September 02
Processing of Medicines and Related Substances Control Amendment Bill (B40-2002)
Chair: Lincoln Ngculu
Summary: With particular reference to recent public hearings on the Medicines and Related Substances Control Amendment Bill (B40-2002), the Committee flagged items of concern in the legislation to be addressed when amendments are debated on October 15; the bill will be debated in the National Assembly the following week. The Committee was briefed by the Chief Parliamentary Legal Advisor and the State Law Advisor. Dr Manto Tshabalala-Msimang, Minister of Health, and Mr Ayanda Ntsaluba, Director-General of Health, as well as officials from the Department of Health (DOH) and Medicines Control Council (MCC), were present for the proceedings
Mr Palmer, the Chief Parliamentary Legal Advisor, addressed the issue of classification of B40-2002. He reminded the Committee that each bill is assigned one of four classifications under the Constitution. If a bill is not passed through the correct procedure, it could be ruled unconstitutional. B40-2002 amends the Medicines and Related Substances Control Act of 1965 (the Principal Act), which predated the classification system, but is assumed by the Office of the Chief Parliamentary Legal Advisor to be a Section 75 bill, dealing with intellectual property and not the delivery of health services. A Section 76 bill dealing specifically with health services, such as clinics.
The Pharmaceutical Manufactuers Association (PMA) has expressed concern that, since Act 90 of 1997 was a Section 76 bill and B40-2002 is a Section 75 bill, in constitutional terms, one is incorrect and the other is correct, leaving the incorrect legislation vulnerable to a constitutional challenge. Mr Palmer expressed his opinion that the PMA's stance is overly simplistic; for example, a levy bill related to health must be introduced under the Section 77 process, regardless of its relevance to the health sphere. Bills are classified on the basis of substance, not title. It is the conclusion of the Chief Parliamentary Legal Advisor that B40-2002 is a Section 75 bill. The Joint Tagging Mechanism concurs.
Representatives of the State Law Advisor supported this conclusion.
Mr Gauss (NNP) asked what impact regulations would have on classification of the bill. B40-2002 appears to be a Section 75 bill, but there may be a provincial element to the regulations.
Mr Palmer (CPLA) responded that subordinate legislation is created after a bill is passed into law. The simple answer, therefore, is no.
Mr Ngculu (ANC) proposed that the Committee pursue an informal process to take into account the public hearings of the previous week. He noted that the transcription of recordings from those hearings had taken longer than expected. Mr Ngculu invited members to examine the text of the bill beginning on the first page.
Mr Gauss noted that there was a strong argument that the definitions in the bill should be brought in line with WHO standards.
Ms Kalyan (DP) flagged the definition of "medical devices" in particular.
Mr Ngculu noted that several definitions had prompted long discussions at the hearings, especially "generics" and "medical devices" (which was removed from the Principal Act in B40-2002).
Ms Rajbelly (MF) inquired as to whether the pharmaceutical industry has a voice in the amendment process.
Mr Ngculu noted that pharmaceutical companies had presented at the public hearings.
Mr Gauss remarked on clause 4. The marketing committee described therein has no power to enforce its code of conduct on the industry. The section detailing the committee should be changed to provide enforcement powers.
Ms Dudley noted that qualifications for ministerial appointments to the Medicines Control Council (MCC) are not specified. Qualifications may need to be written into the legislation.
Ms Luthuli (ANC) commented that the Minister would create regulations enabling the marketing committee to enforce its code of conduct.
Mr Ngculu reiterated his concerns around the exclusion of "medical devices" from the legislation, noting that the Department of Health (DOH) intended to include this area in the broad framework of the National Health Bill.
Noting that the Director-General has many responsibilities, Ms Kalyan asked to whom does power devolve when the DG is unavailable.
Mr Ngculu explained that there is always someone acting in the DG's stead when the DG is unavailable, and suggested that it would be superfluous to specify this in the legislation.
Mr Ntsaluba (DOH) noted that an acting DG is delegated certain powers in terms of the Public Service Act, and that the Principal Act empowers the Minister to perform the DG's functions under certain circumstances.
Mr Gauss noted the question around licensing of dispensing doctors that has arisen from section 6. A conflict has developed between the Health Professions Council (HPC) and the Pharmacy Council over which regulator should manage this process. Mr Gauss contended that there is a strong case for the HPC to oversee dispensing doctors.
He added that the "package deals" enabling poorer rural patients to access diagnosis and medication for one rate warrant special consideration, and that licensing of dispensing doctors must not be based on need, which is very subjective.
Ms Luthuli suggested that package deals benefit not only rural patients, but also poorer people in urban townships.
Ms Rabinovitch stated that, in light of the submissions from the public hearings, it might be worthwhile to hear the DG's opinion about duplication of oversight and licensing on the basis of need versus objective criteria. She expressed her position that there should be clear, objective standards for licensing and that this process should be overseen by HPC.
Mr Ngculu noted the proposal that HPC regulate dispensing doctors after consultation with the Pharmacy Council.
Ms Rabinovitch suggested that "objective criteria" be added to the section in the legislation concerning licensing, in order to eliminate licensing on the basis of need, which there is no capacity to determine.
Mr Jassat (ANC) expressed his support for statements by Mr Gauss and Ms Rabinovitch.
Mr Gauss suggested that the Committee should create a new definition for "package deals." He will propose an amendment on October 15.
Ms Kalyan suggested that, in the section requiring pharmacists to inform the public about the benefit of generic substitution, it should be stipulated that pharmacists consult with prescribing doctors whenever generic substitution has been recommended.
Mr Ngculu flagged issues around the pricing committee and the single exit-price raised during the public hearings.
Mr Gauss flagged the position of wholesalers.
Ms Luthuli flagged the issue of transparency with respect to wholesalers.
Ms Rabinovitch suggested it might be important to examine the issue of transparency along the entire supply chain, provisions for bulk sales, and the establishment of a maximum price (rather than a fixed price).
Mr Gauss noted that, in the appeals process, it would be important to include a provision for appeals to the judiciary.
Mr Ngculu stated that concerns had also been raised regarding the number of inspectors available for enforcement.
Ms Luthuli suggested that the concerns expressed were in relation to the adequacy of inspectors, and that it may not be feasible to specify a certain number of inspectors.
Mr Gauss argued for the inclusion of the words "documents, books, records" in the legislation with regards to enforcement, so that cases do not collapse due to lack of evidence.
Ms Kalyan asked about the status of evidence. Can seized evidence be used in successful prosecution?
Ms Luthuli explained that there are two types of inspection: routine and law enforcement.
Ms Kalyan stated that she had been referring to the law enforcement type.
Mr Ngculu acknowledged that there was not much time to reference issues from the public hearings, but stated that the important issues had now been flagged. Members will be able to review the transcripts of the public hearings prior to the October 15 meeting.
Ms Kalyan requested copies of the draft regulations for all Committee members.