The Department of Health briefed the Committee on the Medicines and Related Substances Amendment Bill. They informed Members that the Bill provided for the creation of the SA Health Products Regulatory Authority that would replace the Medicines Control Council provided for in the principal Act 101 of 1965. The Authority would be subject to the Public Finance Management Act and would carry out the same functions as the Council had done, such as the registration of products, the authorisation of unregistered products and the issuing of licenses.
The Department discussed the Minister’s appointment of the CEO of the Authority, and the appeal process against the decision of the Authority.
The Committee asked the Department to elaborate more on the Bill, as the presentation had been too short. It was also suggested that the changes effected by the Portfolio Committee, together with the reasons for those changes, should be before the Committee. The Department explained that it had wanted to replace the Council with the Authority because they needed full time workers to deal with regulatory issues. The Committee suggested that the Department present the rationale behind these amendments at the next meeting. Members also asked the Department to elaborate further on the structure of the Authority, which the Department had wished to leave to the Ministers to decide upon. The Committee also questioned the roles of the Minister of Health and Minister of Public Service and Administration, disqualifications for appointment as the Chief Executive Officer of the Authority, the Chief Executive Officer’s role in the appeals process, the Authority’s relationship with the Public Finance Management Act, the concept of “bonusing”, the sale of unregistered products and penalties, and the cost implications of the Bill. It was resolved that the Members would examine the Bill in more depth and would then direct further questions to the Department.
The Committee then adopted its minutes from the meetings held on 24 June, 9 September and 23 September 2008.
Chairperson’s Opening Remarks
The Chairperson congratulated the new Minister and Deputy Minister of Health on their appointments in the Ministry.
The Chairperson informed the Committee that her Office had received a letter from the Treatment Action Campaign (TAC). She asked Members to read through the document that TAC had prepared. The Committee would give the TAC the opportunity to present on the document at the meeting scheduled for 21 October 2008 but the Committee would not engage them on the document.
Medicines and Related Substances Amendment Bill (the Bill): Department of Health (DoH) briefing
Mr Sello Ramasala, Head of Legal Services, Department of Health briefed Members on the Medicines and Related Substances Amendment Bill. He informed the Committee that the Medicines and Related Substances Act 101 of 1965 (the principal Act) had provided for the control of medicines and medical devices. It also provided for the establishment of the Medicines Control Council (MCC), which looked at the registration of medicines and medical devices. MCC members served part time and only met every six weeks.
The Medicines and Related Substances Amendment Bill now provided for the control of medicines, medical devices as well as foodstuffs and cosmetics that contain scheduled substances. The Bill also provided for the establishment of the South African Health Products Regulatory Authority (SAHPRA or Authority) in place of the MCC. This Authority would be subject to the Public Finance Management Act (PFMA) and would register medical products. The Minister would appoint the Authority’s Chief Executive Officer (CEO). The Authority’s functions would be the same as those of the MCC. This included the registration of products, cancellation of registration, authorisation of sales of unregistered products, issuing of licenses and declaration of products as undesirable products. The MCC would cease to exist one day before the new Bill was to come into operation as an Act.
It was noted that persons would be disqualified from being appointed as the CEO of the Authority if they were insolvent, were mentally unfit or had previous convictions. The CEO could be removed from office for serious misconduct, incapacity and engaging in activities that undermined the integrity of the Authority.
The Department then discussed appeals against the decision of the Authority. A person aggrieved by the decision of the Authority would have to have to have the matter resolved by the CEO if the problem was of an administrative nature. If the matter could not be so resolved, an Appeal Committee consisting of the Chairperson and four other persons would be created to resolve the matter.
The Chairperson asked if Members the Department to elaborate on the Bill, clause by clause.
Mr B Tolo (ANC, Mpumalanga) stated that he had expected a longer presentation, given that the Bill itself was lengthy. He suggested that the Department give the Committee a brief overview of the Bill.
The Chairperson agreed, saying that the Department should elaborate on the Bill more.
Mr M Thetjeng (DA, Limpopo) thought that the Committee should look at the Bill so that Members could come back the following week with questions for the Department to answer.
Ms Mandisa Hela, Registrar of the Medicines Control Council (MCC) and the Chief Director of the Policy Section of Medicines Control, stated that the MCC structure that was currently being used dealt with the registration of medicines on the basis of efficacy, safety and quality. Over time, the MCC and its nine or ten committees found it difficult to deal with the increasing number of products that had to be registered efficiently and timeously, as most of the people working at the Council were doing so on a part time basis and had other full time jobs. The Department therefore needed a different structure that would employ full-time workers to deal with regulatory issues. There was furthermore a need to employ people who could be held accountable for their actions. The Department also wanted to attract younger people to the committees, but they were not interested in joining the structure that currently existed as they would be earning too little. For these reasons, the Department decided to put another Authority in place of the MCC, to ensure market related remuneration and accountability. The Bill was then designed to seek more efficiency and accountability for the public’s benefit.
Mr Ramasala reiterated that the Bill introduced the Authority instead of the MCC. The Department had to amend almost every section of the existing legislation but the principle behind the legislation had remained much the same.
Ms Ntombe Mnyikiso, Senior State Law Adviser, Office of the Chief State Law Adviser, stated that it would help Members to understand the Bill if they understood why the amendments were made by the National Assembly. The Bill was introduced by the Minister and taken to the National Assembly. The Bill had been almost completely redrafted by the Portfolio Committee on Health.
Mr Tolo suggested that the Department show the Committee the rationale behind these amendments at the next meeting.
Ms H Lamoela (DA, Western Cape) still did not understand the structure of the new Authority. She asked the Department to elaborate on it. She also wanted to know if having an Authority would mean that more scientists would be needed.
Mr Ramasala informed the Committee that the Department had neglected to provide for a structure for the Authority in the legislation, as it would provide too many challenges. It was left to the Minister of Health and the Minister of Public Service and Administration to decide. The Department wanted to give the two Ministers flexibility in deciding what the structure should be. However, the Department welcomed the Committee’s suggestions.
Ms Mnyikiso stated that there was nothing constitutionally or legally wrong with the clause concerning the structure of the Authority.
Ms Hela stated that finding new scientists would be a challenge, but the Department also had scientists that it trained. However, experience showed that these trainees tended then to migrate to the private sector because better salaries were offered there. Government could never match the private sector’s salaries but it could try to narrow the gap.
Mr Tolo stated that if Clause 3 said that only one Minister made the decision. All the Minister of Health had to do was consult with the Minister of Public Service and Administration, and then the Minister of Health could make the final decision. He stated that Parliament could not give one Minister that much power.
Mr Thetjeng stated that this was a very unusual system of decision-making and it would have problems. He urged the Department to think about the structure of the Authority.
Ms Mnyikiso suggested that the Department could change the wording of Clause 3 to “in consultation”, , to make it clear that both Ministers had to make the decisions.
Mr M Sulliman (ANC, Northern Cape) noted that the Bill had cost implications. It was very worrying that there was no structure for the Authority, as it was necessary for Members also to think about the cost implications.
Mr Ramasala stated that the Department was moving from having a Council to having a full time entity in the form of the Authority. The Department was still trying to find out how to provide for the number of employees in the Authority. This was up to the person who would establish the Authority. The Committee had to look at the number of divisions needed in the Authority.
Ms Hela stated that the Department had benchmarked the number of people that would be needed for the Authority against other countries’ regulatory authorities. Adding the amount of expertise that would be needed would result in the necessity for additional expenditure.
Mr Tolo wanted more information on Clause 3(2)(c), which stated that those who had committed crimes before the Interim Constitution of the Republic of South Africa came into effect in 1993 could still be considered for appointment as the Chief Executive Officer (CEO) of the Authority. He did not understand this. He also did not understand why the CEO was given so much power in the appeals process. He also wondered what the relationship was between the Authority and the Public Finance Management Act (PFMA).
Mr Ramasala stated that Clause 3(2)(c) was inserted in to the Bill to cater for those people who were wrongly accused of or unfairly prosecuted for crimes such as political crimes. Such a person would first have to be pardoned in order to be eligible for appointment. However, if the Committee did not approve of this clause, it could be removed.
Mr Tolo complained that the clause was very general and that as currently worded it seemed to apply to all people who committed crimes before 1993, and not just to those who committed political crimes before 1993.
Mr Ramasala stated that the Department would await the Committee’s instructions regarding Clause 3(2)(c).
Mr Ramasala stated, in regard to comments made about the Appeal Committee, that both the CEO and the appellant would appoint two members each to sit on the Appeal Committee and the CEO would also be included in this Committee. The Department believed that this would suffice.
Mr Ramasala then addressed the matter of the Authority’s relationship with the PFMA. He stated that the Authority would be subject to the PFMA, so that the Department could ensure that there were proper financial controls within the PFMA as well as accountability.
Mr Thetjeng asked the Department to elaborate on the concept of “bonusing” in the Bill. He was confused about Clause 19, where authorisation could be given to the sale of unregistered products. The Member wanted to know why there were no penalties included in the Bill for misrepresentation of medicinal products and devices.
Mr Ramasala answered that Section 30 of the principal Act (Clause 36 of the Bill) dealt with penalties.
Mr Anban Pillay, Chief Director: Strategic Planning, DoH added that there was a rationale behind controlling bonuses. Most often, the patients did not have access to information about what the best medicines or medical devices were. They would then have to rely on help of professionals. Suppliers could approach the professionals with certain deals that would incentivise the professional to sell the suppliers’ products to patients, even if they were not appropriate, so that they could make some more money.
Ms Hela stated that the sale of unregistered medicines could only be done with a permit and suppliers had to satisfy certain requirements. The sale of unregistered medicines would only be done for clinical trials when testing for efficacy, safety and quality.
Mr Tolo suggested that the Committee deliberate on the Bill and come back to the Department with concrete proposals.
The Chairperson reminded Members that this was the first briefing from the Department. She thanked the Department for its time and informed them that Members would deliberate on the Bill.
Committee business: Adoption of Minutes
Members adopted the minutes of the meetings of 24 June, 9 September and 23 September 2008.
- We don't have attendance info for this committee meeting
Download as PDF
You can download this page as a PDF using your browser's print functionality. Click on the "Print" button below and select the "PDF" option under destinations/printers.
See detailed instructions for your browser here.