The Medicines Control Council (MCC) gave a briefing on its mandate, functioning and processes. It was mandated to undertake the registration of medicines, both human and veterinary, based on quality, efficiency and safety. Stock medicines were still regulated by the Department of Agriculture. The Council was also to approve clinical trials, monitor safety, respond to signals, licence manufacturers, wholesalers and distributors and provide information and timely access to medicines. The legislative responsibilities were described, and the structure and functioning of the Council was set out. It was noted that the Council had 24 members, from various sectors and areas of expertise, and the functioning of the four directorates was described. There were 138 staff in all. The duties of the inspectorate were briefly outlined. It was noted that the Council did not have its own strategic plan as it participated in the overall strategy of the Department of Health, and was not separately audited. The budget for 2008/09 would be R36.5 million, and this would take account of the need for increased staff and inspections. The programmes undertaken, and how they fitted into the Department’s framework, were detailed.
Members expressed some concern that the Members of the Council were not present, and that only the Registrar was at the meeting, particularly in view of the wide ranging questions that were asked. It was noted that the Council was to undergo restructuring and several questions related to this, the time lines for it, and the results. Further questions related to the meaning of the CE marking, the international agreements, fast tracking of medicines, the political role of the Minister in the fast track process and the laws on parallel imports and compulsory licensing. Members were concerned about generic drugs and the pricing structure was explained. A number of questions were asked around the work of the Complementary Medicines Committee and the African Traditional Medicines Committee, and their functioning. Members were concerned about the inspections, the capacity, and raised several issues around the backlogs of registration. Further questions were asked about the Roth matter and the liabilities and responsibilities of the Department and the Council, how the Council controlled the time taken for evaluations and benchmarked it, security for traditional leaders and what the Department was doing about the intellectual property issues, and fast tracking of certain types of medicine. The Committee would need to speak to the Council again.
The Committee then noted that it had placed advertisements calling for submissions on the Medicines and Controlled Substances legislative amendments, which it hoped to be able to deal with, since this was the first bill presented to the Committee. A Member warned that the Committee should not find itself short of time to deal with the matter, and it was decided that the Committee would decide on the best course of action once it had received the submissions.
Medicines Control Council (MCC) Strategic Plan and budget 2008/09 briefing
Ms Mandisa Hela, Registrar, Medicines Control Council (MCC) gave a briefing on the mandate, functioning and processes of the Medicines Control Council, also setting out their strategic plans and budget for the coming financial year.
She noted that the MCC was mandated to undertake the registration of medicines, both human and veterinary, based on quality, efficiency and safety. It was also to approve clinical trials, monitor safety, respond to signals, licence manufacturers, wholesalers and distributors and provide information and timely access to medicines. The legislative responsibilities of the Minister and the Director General of the Department of Health in relation to the MCC were described, as well as the functions of the MCC, the Registrar of Medicines and the inspectors. Ms Hela noted that the MCC regulated human and veterinary medicines but stock remedies were still regulated under an Act administered by the Department of Agriculture. She described the way in which the Council functioned, pointing out that it was obliged to meet on a bi-monthly basis, and that all decisions were taken by majority vote. Executive committees were empowered to exercise the powers of the Council between meetings, but any actions taken would have to be ratified.
The MCC consisted of 24 members with defined expertise and skills and there were 10 technical expert committees, which varied in the number of members. There were currently 145 members of the Council, and they had a wide range of backgrounds and were drawn from a variety of institutions country-wide. She tabled a diagrammatic representation of the work of the Council.
Ms Hela then noted the existence of the Medicines Regulatory Affairs (MRA) Cluster, which provided the secretariat to the MCC, and consisted of employees of the Department of Health (DOH), under four directorates of evaluation and research, clinical evaluations and trials, inspectorate and law enforcement, and Administration. Each directorate supported one or more expert committees. There were 138 staff in all. The functions of the Inspectorate were outlined, noting that they aimed to promote good manufacturing practice, good clinical practice, and good laboratory practice, through a system that was peer-reviewed. The inspectorate examined licensing manufacturers, manufacturing sites, and attended to law enforcement, including permits and liaison with the International Narcotics Board. The analytical laboratories were outsourced.
Ms Hela outlined the process of evaluation and detailed the fees payable and timelines for different types of applications. She then outlined the workload trends, and the numbers of clinical trials since 2004.
Ms Hela indicated that the MCC did not really have its own strategic plan, although it participated in an overall strategy, as it was part of the DOH plans. Its budget allocation for 2007/08 was R30 554 million, with the MRA receiving the bulk of that budget at R28.1 million. The budget for 2008/09 was R36.5 million. The increase would be put to appointing extra staff, and inspections would account for about R4.5 million. The rates paid to the Chairperson, Vice Chair and Members of the Committee were set out, and the details of the expenditure in the 2007/08 financial year were given.
Finally Ms Hela tabled a document which gave an indication of the programmes undertaken, noting the priorities over the period 2004 to 2009 and the targets and indicators for each of the programmes.
The Chairperson asked why the Council members of the MCC were not present at the meeting.
Mr Thami Mseleku, Director General, Department of Health, said his understanding was that the MCC Council itself had not been required to attend, but that the Portfolio Committee simply wished to be briefed on the activities of the MCC. He cited the reason for this as the fact that the committees were elected from time to time.
The Chairperson asked however if there was a Chair of the MCC.
Mr Mseleku said there was, but that he was not invited.
The Chairperson noted that the invitation was for a presentation by the MCC to the Portfolio Committee.
Ms M Matsemela (ANC) noted that the Committee had been awaiting the presented information for quite some time. She asked Ms Hela as to whether she was speaking about the current or restructured entity.
Ms Hela replied that she was not speaking from a restructuring point of view, but talking about the MCC as it was at present.
Mr Mseleku said that the Bill in front of the Committee introduced the restructuring that Ms Matsemela had referred to, but this would only be undertaken if indeed the Bill was passed. He reiterated that what had been presented reflected the current position of the MCC.
Dr R Rabinowitz (IFP) asked why very little of the information presented was on the MCC’s website.
Dr Rabinowitz asked what the CE mark represented.
Ms Hela said that this was an European Union (EU) standard that referred to the quality and safety of medical devices.
Dr Rabinowitz asked what the situation was in terms of compulsory licensing and parallel importation.
Ms Hela said that the MCC had not yet invoked it yet. She said that this was the last step taken if the owner of the technology was intransigent. She said so far the MCC had managed to engage with owners of technology to grant voluntary licenses before the term of a patent expired, so that they could continue to be players. She said that this process was undertaken with more than one generic company so that there was more competition within the market, bringing down prices.
Dr Rabinowitz asked about the fast tracking of TB medicines, asking also if there was any support from the World Health Organisation (WHO) bodies who gave support for the urgent acquisition for TB medicines. The Committee had been told previously that this was not necessary, but she would now like an update.
Dr Rabinowitz asked what the political role of the minister was, and whether the Minister had ever called for medicines to be fast tracked, and who did decide which medicines were to go for fast tracking.
Ms Hela noted that all TB medicines used within the country were part of the Essential Drug List (EDL). She said that what the MCC did not have was new technology and that this was in the hands of researchers and the developers of medicines, but that the MCC did fast track medicines. She said that most of the fast tracking of medicines occurred through a delegated authority. The Minister would delegate to a body with whom she or he would be comfortable on fast tracking. She added that anything on the EDL, which would take care of 90% of the conditions that were prevalent in the country, formed part of the fast tracking. Calamity of any form also forms parted of this fast tracking. There was an essential drugs committee that weighed these cases and not the regulatory body alone.
Dr Rabinowitz asked about the change of the law with regard to parallel importation and compulsory licensing, and if this had affected the amount of counterfeited medicines entering the country.
Ms Hela responded that there had not been a problem with the counterfeiting of medicines even thought it was a global problem. She said the reason was that one of the strong points of the country was the fact that medicines were usually brought in by air, in particular through OR Tambo International Airport. There were only really four ports of entry, which was manageable. She said the bulk of the imports came in through containers and that the MCC worked very closely with port officials. She added that nothing entered the country by road because that would be too difficult to control.
Dr Rabinowitz asked how many people were in the inspectorate and how many medicines had they seized. She asked that if the information was not readily available at present this could be made available at a later stage.
Ms Hela noted that she did not know how many inspectors the MCC had.
Dr Rabinowitz asked what the Complementary Medicines Committee and the African Traditional Medicines Committee had been doing, if they had not been registering or approving medicines, and on what basis they would evaluate medicines.
Ms Hela responded that the Complementary Medicines Committee had a period during which it was not acting, but was dormant for a couple of years. However, it had now been resuscitated with vigour, and hence the regulations were almost ready. She said the African Traditional Medicines Committee was relatively new and because of this it was not functioning up to optimum levels, but that there hade been a couple of meetings. She said the MCC had developed certain guidelines specific to certain quotas, in terms of evaluating the efficacy and safety, and there were clinical trial guidelines that had been developed, but that these were in the early phases.
Dr Rabinowitz asked how the MCC was coping with round-tripping as this had been mentioned as a problem, and whether it was related to compulsory licensing or parallel importation legislation.
Ms Hela noted that the MCC was coping quite well as they had cooperation of other law enforcement arms and that as soon as something presented itself they would engage the other countries involved. So far there had been excellent cooperation.
Dr Rabinowitz asked how the MCC coped with the 180 manufacturing sites abroad, who would go to visit these and what standards were applied.
Ms Hela said that it was the GMP and GCP inspectors who went overseas and that it would not be less than two inspectors at a time, so that they were not unduly influenced. She said that not all 180 were being inspected annually; the inspections were done every three years, except for the new institutions, who were inspected when they were newly registered.
Dr Rabinowitz also asked what standards were applied to generics in terms of bio equivalents because there were complaints that generics did not achieve the same standards as conventional medicines, and yet they were being fast tracked. She asked what levels of equivalents the MCC accepted as bio equivalents. She also asked that the numbering of generics be explained and how these related to their price advantage.
Ms Hela said the standards used on generics were international, like the International Convention on Harmonization and the WTO guidelines, and that these were not sub-standard. She said that when the first generic came in, it would be priced much lower than the originator. When the second generic was registered there was a drop and after the third generic was registered there was a drop of 40% to 60%. After the third generic was registered there was a marginal decrease as they were competing at the margin and that this resulted in not much of a price advantage.
Ms S Kalyan (DA) asked what the backlog of registration was in each of the categories mentioned in the presentation. She said the committee had been given timeframes but she wanted to know specifically the backlog for Complementary, African Traditional, and alopathic Medicines and asked if the backlog was due to the process, or a lack of human resources.
Ms Kalyan asked that the information relating to slide 10 – clinical trials - be made available so that she could ask questions on it.
Ms Kalyan asked about the fact that only
Ms Hela referred to the timeframe problem as being one related to human resources. She said that the MCC did not have people available to it everyday as they worked on applications when they could. She said that clinical trials at the University of Free State was not the only one helping with research but that it helped with the quality of vaccines before these go out in terms of their sterility and quality.
Mr M Waters (DA) said that complementary medicines were registered in the past, and that he had sent the Chairperson a list of medicines that had been registered according to the same procedures as conventional medicines. He asked why the registration of complementary medicines had been stopped. He said in his view most complementary medicines were harmless but that there were some that purported to cure diabetes, for instance. Many diabetic people may in these cases stop their orthodox medicines. He further queried the backlog of these complementary medicines on the market. He asked how the process was going to be undertaken, when would the MCC start registering them and what time frame the MCC was giving itself.
Ms Hela said the MCC had never ever registered complementary medicines. She said it had received a call some years ago to test what was available in the country. This fact was being used incorrectly because every time the MCC received anything it must assign that application a file number. The file numbers had mischievously been touted around as registration numbers. The MCC would only start registering complementary medicines when it had certain regulations in place.
Ms Hela said the backlog for registration in 2003, being the numbers received but not registered in that year, amounted to 28%. Those not registered for 2004 were 31%, not registered for 2005 were 53%, not registered for 2006 were 80% and not registered for 2007 were 98%. She said that there was an increase in the number of applications. The reason for the backlog was because the MCC was functioning as it was in 1965.
Mr Waters asked what this meant.
Ms Hela said that she meant that the numbers of evaluators and committee members was still at 1965 levels.
Mr Mseleku added that it must be emphasized that the MCC worked on the technical work done by MRA through committees, and this would be fed into another committee which sat every two months to evaluate dossiers that had been finalised and their recommendations. He stated it had been working like this since 1965. The people who evaluated these dossiers determined the pace at which these applications would be registered. He said this process depended on the time available to the evaluators to look at dossiers, and this could take four or six weeks. He said that, together with previous backlogs, there were a number of new applications, which impacted on the time taken to register all the new applications. He said that irrespective of whether a dossier had been sitting for one and half years, it still would take up to four weeks or more for it to be looked at, and that this added to the timeframe for applications to get through the system. Because the evaluators were also attending to other consultancy work it was not possible to make these a priority. Hence the need for restructuring, which would create a body which relied on its own capacity so that it could made timelines and stick to them.
Mr Waters noted that it was the MCC who gave permission for clinical trials. He wanted to know, in the case of Dr Roth conducting trials without the MCC’s permission, whether the MCC did not bear some responsibility if it had the authority to stop the cases, and if so, why it had not taken action if the trials were being publicly undertaken.
Mr Mseleku said that the issue of Dr Roth was a complicated matter. The Court would still determine what the MCC and Department should have done. He said the DOH was still in the process of studying this very carefully. There were a number of issues. Firstly, for Dr Roth to have been declared as running clinical trials there would need to be the agreement that he was using medicines and not complementary medicines in his clinical trials. The preliminary assessments of the Department had established that the vita cells that Roth was using had been initially determined as food substances, and thus declared as complementary medicine and not conventional medicine. He said the MCC had initially looked into the matter and asked for evidence from Dr Roth so that it could determine whether he had been exceeding the levels at which the vita cells could be seen as merely vitamins.
Mr Mseleku added that Dr Roth was asked to stop his advertisements that his preparations cured HIV. He had ceased that. However, the debate was ongoing on the content of the preparations. The MCC was in the process of determining, in its own right, as to what was involved in the preparations when the matter went to Court. He said the Court had found that the MCC was supposed to have acted, and that indeed Roth was running clinical trials. The Court had found that the 15 milligram level that was adjudged to be fit for human consumption by way of vitamins had been doubled, and therefore that the law enforcement or the inspectorate sections of the Department of Health should have acted. The Court stated that the Department should have put a stop to the clinical trials undertaken by Dr Roth. The Department was still studying the implications of the judgment because there were many complementary medicines being advertised, over and above those of Dr Roth, particularly in The Sowetan. He said that the enforcement of complementary medicines would be given particular attention, and would be dealt with by the Regulations on Complementary Medicines.
Ms Hela added that the Dr Roth issue had been a standing item on the agenda pending the court action.
Ms Matsemela said she had been hoping the MCC would speak on the restructuring as the Committee had been told about the restructuring for a long time. She said that it was also included in the restructuring plan for the DOH. There had been a statement that the MCC was the largest source of revenue for the Department of Health. She wanted to know if the MCC would ever be independent. From time to time the Department may try to interfere in what the MCC was doing. She wanted to know for how long the MCC would be inter-dependent with the Department as even its budget came from the Department.
Ms Matsemela also wanted to know what the intention of the restructuring was, if indeed there were no problems with the MCC.
Ms Hela said one of the intentions of the restructuring was the improvement of the website. She said the whole registration process would be web-enabled when MCC moved to the electronic system. She said it would be stratified on two levels; one at the level of providers (doctors, pharmacists and professionals using the medicine) and the second level at information directed at the public. She said there would also be an improvement on safety alerts, so that there would be more information on this. She said the new regulatory authority would have timelines in place detailing when reports must be provided so there was more information on the website. She admitted that the site was at present not user friendly.
Mr A Madella (ANC) asked what the MCC could do to improve the timelines. The MCC had mentioned that in
Dr Rabinowitz asked about the MCC’s accountability. She noted that it received a large amount from the Department of Health and it seemed if it had spent exactly double that amount. She asked why there was not a qualified audit of the MCC.
Mr Mseleku said that in terms of budget issues and accountability, any income collected by any part of state had to be posted with the National Treasury. The income that came from the registration of medicines did not sit with the Department of Health but went straight to national coffers. He said the budget did not reflect that as part of income into the MRA or MCC. He said that with specific regard to the MRA, its budget was a slice of the bigger budget of the Department of Health, and it was not treated as a separate entity. He said that because of this those that were under-spending within the Department could then help those overspending. He said that this was why there was not an audit that had reported that the MCC had over spent. The spending was seen within the overall context of the Department of Health. He said it was a factor of a whole range of things, and may mean the Department of Health overall was not adequately budgeted, but that at the moment this was balanced out.
Dr Rabinowitz noted that the MCC had measured the timeline of some committees, which was why there had been so many concerns; clearly this had been tested and shown to not work. She asked who measured the amount of time those workers were spending, or if it was purely based on trust and if they logged the information themselves.
Ms Hela noted that the measuring was done simply by benchmarking one evaluator against another. She said if a particular type of evaluation took 25 hours for one person and 40 hours for another the MCC would look into the matter. It had no other means to regulate this process.
Dr Rabinowitz asked what security of information did traditional healers have on the basis of intellectual property. She said the country had never had an indigenous wisdom bill. She said that until there was a secure Intellectual Property Bill, or something similar, traditional medicines would go on being exploited. She cited that this was even written up in the Health Systems Trust report; and that there had been loss of traditional plants, and that if this was not seen to the country would lose the potential advantage it had.
Mr Mseleku said, on the issue of African Traditional Medicines, that what the Department was doing first on was creating a policy to be published for public comment within the next week or so. He said that on the basis of this policy, legislation would be drafted. He said it looked at all the issues, including Intellectual Property (IP). He said that IP as understood in the Western sense referred to an active ingredient but that in African Traditional Medicine it could not be so restricted. He said the Department was looking at legal ways to protect people, but that it was difficult when the understanding of IP was not fully defined. He said the regulation of traditional medicines would be much stricter once the policy was in place. He said that there had been policy debate and acceptance about how the matter would be regulated.
Mr S Dithebe (ANC) noted that in relation to African Traditional Medicines there was a Convention on Biodiversity, that would then govern the approach the MCC was contemplating taking, as against that of the WTO on Intellectual Property rights, which was much stricter and did not take into account the uniqueness of African Medicines. He asked what the Department was going to be doing in the next few weeks, and what the Committee could expect in terms of the restrictions already in place in terms of the Indigenous Knowledge Systems (IKS) Unit and Department of Science and Technology (DST) policy framework on indigenous knowledge. He asked if the consultation the Department had already done was watertight so it could provide results.
Mr Mseleku said that in terms of the Technology and Human Resources for Industry Programme (THRIPS) and biodiversity convention, the Department was looking at both. He said that in the management of traditional medicines and sources it was necessary to go to the Biodiversity convention, in which there were all sorts of protected plants. However in the registration process there might not be an active ingredient identified. Here, the combination was important. The Committee therefore would look at that possibility. He said that the Department felt it would need to engage with the international community around this issue, because
Ms Kalyan asked a follow up question on the backlog. She said that the MCC could not hinge progress on the fact it was awaiting a specific piece of legislation to be passed before it dealt with its backlog. She said the fact of the matter was that it was not registering 98% of medicines, as at 2007. She asked what the MCC was going to do to address this matter as one of urgency. She understood the comment about the part-time staff, but this was not a good enough reason. She noted the restructuring may take two years and that the statistics were already unbelievable.
Ms Matsemela also asked a follow up questions with regard to the backlog of medicines. She wanted information on which areas actually had a backlog, as she said right now there were medicines which could treat HIV and Aids, as well as Prevention of Mother to Child Transmission, dual therapy and others that the Department had just implemented. She spoke about the section in the Health Act that the President had not yet promulgated and wondered whether it would not impede the Council.
Ms Hela said that MCC was working under very strained circumstances that were influenced by what budget was made available to it. Over and above this the large backlog also had resulted from the previous inefficiency of the system. She said that if there were only six meetings a year, instead of as and when needed, then there was going to be a backlog. The MCC had to maintain a fine balance in its negotiations with the people who evaluated for it because these people were doing the work in their spare time, and could be lost if too much pressure was exerted. The MCC had found was that there were many duplicate applications of generics under different names. That was part of the problem of differential pricing, and the different names would be registered so that the manufacturers could direct different products to different markets. She said the MCC had asked the industry to make this clear, so that only one application needed to be evaluated, and the rest would be administrative. The MCC was introducing a process of checking as to which evaluator had done the original work, and then sending the rest of the applications there. The MCC would have to increase its capacity to do the evaluations in terms of numbers and skills, and would prefer these to be done in house as there could then be better regulation of timelines. The amount paid to evaluators was too little to entice them, so that most of the evaluators were mature people doing the work out of interest or wishing to assist
Ms Hela noted that the medicines mentioned specifically were fast tracked and that these were not in the backlog situation. The MCC would deal with them within nine to fifteen months. She said this would apply for all the priority conditions and this included medicines for HIV and Aids.
Ms Matsemela asked for clarity on page 8 in terms of the Section 21 exemption.
Mr Mseleku said that the Certificate of Need was not likely to impact on the restructuring. He said it was more about the establishment of health facilities and related matters determining need and it would not impact on the processes of registering medicines in the country. He said that those would be impacted upon by other legislation that the Department would be implementing. He said that the Department could not wait for legislation, that industry knew this and that the Department was aware of the problem.
The Chairperson commented that in view of the number of questions he would have liked to have the remaining MCC members present.
The Chairperson was concerned that the process of registering was manual, and that restructuring seemed to be minor. He noted that another concern was the number of evaluators.
The Chairperson noted that on 29 July the Committee would be getting briefings on the Medicines and Related Substances legislation, which was designed to strengthen these weaknesses. He said that in his view the report that was presented did not cover a range of issues and was not of substantial use to the Committee. It had not addressed a number of fundamental challenges that the MCC was facing. He said that the two bodies would find time to interact and that the MCC should came back before the Committee.
The Chairperson noted that the Committee had to deal with both the Medicines and Related Substances and the Medical Schemes Amendment Bill by the end of the year. He felt this perhaps not feasible, because both bills were quite involved. He asked that for the present the Committee should concentrate on the Medicines and Related Substances matter, as this had been tabled first. He suggested that the Committee agree to place adverts and call for submissions, and that a briefing should be held on the bill on 29 July 2008.
Dr Rabinowitz agreed but said that this was a good warning; noting that this Committee had previously been faced with a situation in which it found itself extremely short of time to finalise legislation, and had ended up trying to deal with a Bill of which the finalised version was not available. She warned that the Committee should ensure that it would be able to complete the process within the given time before embarking on it.
The Chairperson accepted these concerns, and suggested that in that case perhaps the Committee should call for submissions, but once these had been received the Committee should take a decision on how best to the issue further in the light of what was before it. .
Ms Kalyan asked if the advertisement had already been prepared, when it would go out, and when the closing date for submissions would be.
The Chairperson replied that the advertisement would go out this week and submissions must be received by 12:00 on Friday 18 July 2008. He added that the date for public hearings would be set for 5 and 6 August 2008, and copies of the Bill could be obtained on the Parliamentary website.
The meeting was adjourned.
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