1. Medical Innovation Bill [PMB1-2014]: Medical Research Council and clinicians' submissions

Transcription

1 1. Medical Innovation Bill [PMB1-2014]: Medical Research Council and clinicians' submissions 2. Committee: Health 3. Chairperson: Ms L Dunjwa (ANC) 4. Date of Meeting: 27 May Summary Legal and medical researchers from the Medical Research Council (MRC) and three clinicians made submissions to the Committee on the Private Member's Medical Innovation Bill (the Bill). This Bill essentially proposed the legalisation of alternative treatments, specifically cannabis, for medical use. The first submission highlighted a few problems with the definitions, specifically the definitions for treatment, and medical practitioner and cure. The Bill was proposing the establishment of pilot health centres, but this would need considerable consideration into how and where to create them, and how powers and functions would align, and testing of patients. Generally speaking, the Committee would have to work closely with legal advisers to sort out the several points of ambiguity and possible constitutional implications of the Bill. All submissions recognised that the topic was complex, and said that in general there was very little empirical scientific research into the use of medicinal cannabis and cannabinoids to support the Bill and there was also some uncertainty whether the Bill wanted to propose only legalisation for medicinal use or for general use. There were concerns about the inclusion of provisions that would promote the industrial production and commercialisation of medicinal cannabis. It was also pointed out that there were numerous conditions which could be treated using cannabis and cannabinoids, and more clarity was needed on which would be legally accepted for treatment in this way. Both presenters and Members raised concerns that there could be a public perception that if medicinal cannabis was legalised, this would then open up the possibility of legalising also for recreational use. Other points raised were which medical practitioners, general or specialist, would be recognised in South Africa as allowed to prescribe the cannabis. It would be important to discuss and understand how this Bill would function in the health system, especially in relation to the mental health system, and whether other legislation would need to be amended as well. It was pointed out that South Africa was a signatory to international treaties that had to be respected, whilst many people questioned whether, given that some

2 form of special application was available already, there was actually a need for a new specialist Bill. Clinicians pointed to the effect of addiction and drugs on the mental health care system, saying that this would be added to if drug induced mental conditions were also added to the general situation. However, there were divided views on whether cannabis was necessarily addictive, whether it had a lower deleterious effect than other substances such as alcohol, whether use of cannabis necessarily led on to use of other drugs, and whether medical use of cannabis would stimulate a desire to use it recreationally. Different examples were cited of other countries who had legalised it from a medical or general perspective. Other important points raised related to the cost of the research, the cost of introducing the Bill, the cost of setting up regulatory systems, and whether this would be possible, decisions on who must regulate, and the form which the medical cannabis would take, which then also meant that how it was acquired or synthetics manufactured would need to be considered. Some Members were concerned that this Bill sought to introduce cannabis through a "Trojan Horse" approach. Some felt that it could lead to pressure for general legalisation. The motives behind the Bill were questioned, as well as noting the emergence of strong lobby groups. Through all the different views, however, there seemed to be a common concern that more research was needed in a number of areas. The MRC pushed strongly that if research was to be done, then it should be done by the MRC, who supported a number of other research methods and organisations, and was already engaged in considerable research on cancer. The social and political implications would also need careful consideration and it was pointed out that although information from other countries was useful, it was not necessarily directly translatable to the South African situation. 6. Minutes Medical Innovation Private Member's Bill: Medical Research Council submission Adv Nkosinathi Bhuka, National Head: Legislation and Compliance, Medical Research Council, noted that the Medical Research Council (MRC) was participating in this process of commenting on the Private Member's Bill within its mandate as the custodian of medical research in South Africa. The MRC had analysed the legal perspectives of the Bill against existing legal principles. The current laws made it clear that the use of cannabis and cannabinoids is illegal. She commented on the definition section of the Bill. She suggested that the definition of "treatment" was problematic and there was a need for clarity on what, overall, the Bill meant when referring to "treatment". The definition of treatment included the term curing, but the Bill does not provide a definition or clarity on what is meant by curing or cure. The normal definition of curing involved assistance with managing symptoms, but the definition here suggested the absolute of curing the illness, not the process of managing it.

3 The problem of having "cure" included in the definition of treatment was that there was room for misinterpretation and misuse. There was a need, thus, to get clarity in order to avoid ambiguity in the intended medicinal use of cannabis. She noted that the Bill spoke to the establishment of pilot health centres. The MRC had no objection to the establishment of these centres but had some suggestions about how to go about creating and managing them. The health centres would need to be mandated by the Minister to be under the guidance or direct oversight of the MRC, the Office of Health Standards Compliance and the National Ethics Research Council. This would also be aligned to the powers, functions and responsibilities of each entity as outlined in the National Health Act. There would need to be further elaboration on governance of health centres, in relation to the National Health Act. Due to the pilot nature of the centres, there needed to be protection of the patients because this would be experimentation with medicines. The information and consent of patients needed to be protected and be aligned with other legislation such as the Consumer Protection Act. She submitted that the Bill also contained a constitutional conflict, with regard to the definition of "medical practitioners". The definition for medical practitioners in the Allied Health Professions Act and the Traditional Healers Act included practitioners who used cannabinoids for healing purposes. "Medical practitioner" as it was used in the Bill would bring about issues of equality between professions, because "other practitioners" were not listed as permitted to administer cannabis and cannabinoid treatments. She suggested that more information and guidance was needed from the Parliamentary Legal Advisers on the narrow definition contained in this Bill, and the possible conflict with definitions elsewhere. It was crucial to sort this point out. She reminded the Committee that although the use of cannabis and cannabinoids is illegal in South Africa, the country is also a signatory to the United Nations International Treaty on Narcotics of If this Bill was adopted then it had to be sure that not only was it not in conflict with this treaty, but a review would be needed of all the legislation that currently prohibited use of cannabis. The Committee would have to look at these other pieces of legislation and decide whether amendments were to be made to these as well. Generally speaking, the Committee would have to work closely with legal advisers to sort out the several points of ambiguity in the Bill. Prof Parry, MRC Submission Prof Charles Parry, Director of Alcohol, Tobacco and Dry Research Unit, MRC, introduced his presentation by explaining his role at the MRC and his credentials and expertise. He had co-authored an article on the use of medical cannabis. He was introduced to the concept of medical cannabis at a conference in Germany where an Israeli scientist, Raphael Mechoulam, presented on the use of cannabis in the reduction of brain swelling after a traumatic event. This Bill was introduced by the late Mario Oriani-Ambrosini MP, as a private member s bill. Dr Oriani-Ambrosini had presented it in Parliament and the President had said

4 that Parliament would make a point of looking into the legalisation of medicinal cannabis. Prof Parry said that the MRC had no problem with the purpose of the Bill, except for the inclusion of the industrialised production and commercialisation of cannabis. The industrialised production and commercialisation would make it a normal medicine, and the MRC did not agree with that principle. The main problem with the Bill is that did not seek only to legalise the medicinal use of cannabis, but it was leaning towards the legalisation of cannabis for general use. The Bill should be clear on its purpose. One very positive element on the medicinal purpose of the Bill would be to facilitate the research on the use of medicinal cannabis and its benefits. This research, however, should be limited to the use of medicinal cannabis for the treatment of various set conditions rather than branching out into other forms of research. "Medical cannabis" refers to the use of cannabis and constituent cannabinoids such as THC and cannabidoil (CBD) as a form of therapy to treat or alleviate symptoms of certain specific medical conditions. In some countries, medicinal cannabis came in synthetic form such as cesamet and marinol, which were available for the same purpose as THC and CBS. Cannabinoids could be delivered through various mechanisms, of which the most obvious or common practice was through smoking. Smoking it was probably the most hazardous to health over the long term, because the combustion process released toxic compounds in the lungs. Smoking also makes the process of measuring dosage of cannabinoids very difficult; however smoking seems to be the fast-acting delivery of cannabinoids. Cannabinoids can be ingested orally through vaporisers (Nabidiolex), or through the use of transdermal patches and through the use of suppositories. Synthetic cannabis often comes in pill form. Delivery mechanisms of cannabis and cannabinoids can vary in cost and the ease to which you can access the different forms. In South Africa, the cheapest way to deliver cannabinoids was through smoking and this was due to how easy it was to access cannabis for smoking purposes. People also risked arrest to acquire cannabis for the mechanism of delivery through cannabinoids. Cannabis oils were also available on the black market and the recipes were available on the internet for those people seeking to make their own cannabis oil. Medical use of cannabis was now legal in a few countries: Austria, Canada, Finland, Germany, Israel, Italy, Netherlands, Portugal and Spain. In the US, more than 20 states had allowed for the use of medical cannabis, and users are not prosecuted if they adhere to the regulations of each state, as is the case in DC, Maryland. In South Africa, it was currently illegal even to be in possession of cannabis or to be trading in it. There were no medicines which contain cannabinoids such as THC and synthetic cannabinoids which had been approved by the Medicines Control Council. Cannabis had not been approved for medicinal use in FDA in the USA due to the following: lack of human clinical trials showing that the benefits outweigh risks inconsistencies in main chemical compound, especially when smoked negative health effects sometimes associated with cannabis use, particularly when smoked

5 The use of cannabis for any purposes had been prohibited for the last 60 or so years, during a time of minimal scientific research and knowledge. Cannabis clearly had medicinal properties which had been largely overlooked for a very long time, because the focus of research and society was on the recreational use of the cannabis rather than its medical benefits. Policy consideration on medical cannabis should be separated from the considerations on recreational use, except for instances when the increase in medical cannabis would result in an increase in recreational use. Before the approval of medical cannabis could happen, he suggested that evidence would have to be presented, relating to its effectiveness, safety, cost-effectiveness, supply, regulation and route of administration. This could be only be determined through thorough research into the medicinal properties and benefits of cannabis. The effectiveness of cannabis for medicinal use was usually observed in its use for symptom alleviation rather than cure. Dr Oriani-Ambrosini had referred to studies from Harvard cited in the Cannabis Position Paper presented to the Central Drug Authority (CDA) in November This study highlighted the various studies, mainly pre-clinical, but some also involving human subjects, that showed positive effects of cannabis on a variety of conditions, including Alzheimer s disease, amyotrophic lateral sclerosis, chronic pain, multiple sclerosis, diabetes mellitus, dystonia, fibromyalgia, incontinence, gastrointestinal disorders and various cancers (including lung cancer). Cannabinoids were used in symptoms-management of some forms of cancer, as palliative care. Most commonly, cannabinoids were used for pain relief in cancer patients. In experimental models of acute pain, inhaled cannabis resulted in dosedependent pain relief in patients with chronic pain. Both cannabis and cannabinoids outperformed placebo treatment, but few studies had compared cannabis or cannabinoids with conventional medicines. Cannabinoids could also be used in the management of AIDS wasting syndrome, but a Cochrane Review found that seven studies concerning wasting syndrome were biased, used a small sample size and lacked longitudinal data, so no conclusions could be drawn from the information. There had been evidence to suggest that cannabinoids could have positive effects in treating the nausea and vomiting experienced by patients during chemotherapy, but further research on this was still warranted. A German review had found 82 favourable and only nine unfavourable controlled studies assessing the potential for cannabis/cannabinoids for addressing several conditions. When researching efficacy, the research would also consider the possibility of vested interest or links to cannabis-related institutions in outcomes of research. At this stage, no meta-analysis had taken place so it was not known if there actually was a positive effect nor how homogenous the findings were, and the quality of the various studies had not been analysed. There was no systematic review - only a review of selected literature and there was no indication of whether and why any other studies may have been excluded. Two Cochrane Review on the AIDS wasting syndrome and Multiple Sclerosis had been ignored. There is, however, emerging evidence that cannabinoids may have anti-cancer effects, particularly anti-tumour effects. The evidence is based mainly pre-clinical studies, very few

6 human clinical trials had been published in this area and more trials were required to achieve certainty that cannabis or cannabinoids could be used as anti-cancer agents. The safety of medical cannabis was an important issue. The MRC research had shown associations between cannabis use and road traffic injuries and other forms of trauma, property crimes, and murder, and sexual HIV risk behaviours, but causal mechanisms were not clearly elucidated. Unpublished research conducted at the MRC Stress and Anxiety Unit at Stellenbosch University, using fmri, showed cognitive deficits associated with cannabis use, even after participants had stopped using cannabis for several weeks. Recent systematic reviews identified several adverse effects associated with cannabis use, including dependence syndrome; increased risk of motor vehicle crashes, impaired respiratory function and cardiovascular disease; adverse effects of regular use on adolescent psychosocial development and mental health. However, he stressed that this could not be over-stressed; this was not shown in all users. At community level, the harm from cannabis use was less than that associated with alcohol and tobacco use. There was a need to look at studies on side effects of medical use of cannabis, rather than the side-effects of recreational use of cannabis. Reviews of medicinal cannabis used under essentially controlled conditions indicated that frequencies of both side effects and dependence were low. There was also a need to compare the side effects of treatment by cannabis and by conventional medicines. Medical doctors and pharmacists would require further education about medical cannabis and how to instruct patients in its use, and criteria for patient selection would need to be developed. When used as cannabopioid analgesic, the risks of diversion of medicinal cannabis must be minimised, although Prof Parry made the point that significant diversion would probably not be necessary should cannabis become very easy to obtain. In the US states that had passed medical cannabis laws, no increase had been found in the use of cannabis for recreational purposes, either overall or specifically amongst adolescents. In general, having medical cannabis policies reduced cannabis consumption, although the positive effect on consumption could be offset in states that allowed open dispensing and/or home cultivation. Interestingly, when cannabis was legalised, there was a 8% to 11% drop in road fatalities linked to alcohol. Prof Parry added that there was not sufficient analysis on how to make medical cannabis cost effective. Most mechanisms used for its delivery, such as vaporisers, were very costly. Also, the cost of regulating supply of medicinal cannabis would have to be assessed. There would have to be consideration and clarity on whether the National Department of Health (NDOH) would be a supplier or whether it would be given to pharmaceutical companies to produce industrially, whether to import, or whether to licence production be strict rules and compliance requirements. In addition, the route of administering the cannabis needed to be researched. There was a need to separate out the health effects of synthetic cannabis against natural cannabis; and the effects of smoking it or ingesting it in other ways. Smoking did not provide an accurate dosage method, and was not acceptable to many patients, nor was it medically acceptable. Oral absorption could be poor, slow, unpredictable, and less

7 acceptable to patients. Vaporisation in an electrically heated vaporiser produced comparable results and was probably preferable. In conclusion, the MRC commended Parliament for bringing attention to issues of medical cannabis, but could not support the Bill in its current form, without re-working. Prof Parry stressed again that the MRC argued that the issue of medical cannabis should be separated from legalisation of cannabis or commercial cultivation. As a public health research organisation it could not support smoking of cannabis for recreational purposes, just as we it did not support tobacco smoking. The MRC acknowledged the increasing evidence of value of medical cannabis (using extracts such as oils, tablets, patches or vaporizers) in providing palliative care for various conditions. The MRC recommended that a full Cochrane Review be undertaken by the MRC, to evaluate the quality and strength of evidence for use of cannabinoids/cannabis for both palliative care and therapeutic use. It suggested that the Medicines Control Council (MCC) would need to consider the evidence before registering cannabinoids/cannabis in South Africa. The MRC should take the leading role in coordinating further research and clinical trials on the use of medical cannabis. The MRC should also monitor possible influences of medical cannabis use on non-medical use (especially among adolescents). Clinician experts' submissions: Assoc Prof Willie Pienaar Associate Prof Willie Pienaar, Addiction expert and Psychiatrist, set out the point of view of clinician experts on medical cannabis. He agreed in large part with Prof Parry's conclusions. The main point about the Bill was that it had highlighted the absence of vital information that needed to be clarified before any further deliberations on the Bill itself. He agreed that far more research into medical use of cannabis was needed. Although cannabis has been known and used for years, there were many cannabinoids which had been identified, and the receptors of cannabinoids in the brain had been identified. Cannabis can intoxicate because it also attaches to the cerebellum. The smoking of cannabis is most common and had the highest effect. Potency of cannabis over the last twenty years had increased tremendously, in agricultural terms. The use of cannabis in adolescents was the biggest concern, due to adverse effects of cannabis and the vulnerability it presented. In psychiatry, cannabis was classified as an addictive drug, although it was not as addictive as heroin and cocaine, and addiction can solicit violent behaviour in order to acquire and use more. The use of cannabis could result in psychosis, along with other side effects of addiction. The use of cannabis in adolescents could result in a lowered IQ and it could lower the cognitive functions of the brain. Cannabis was understood to be a motivational syndrome inducing drug but there was also concern that this was creating a sub culture of low engagement with school and academia in general in South Africa. Another factor particularly of concern in South Africa was the high prevalence in the country, unique in the world, of HIV and TB. HIV-positive people did not have a functioning immune system, and many forms of TB were drug-resistant. Mixing a drug culture with these

8 diseases would result in "disaster". The health impact of smoking of cannabis was similar to smoking of cigarettes, but smoking cannabis was more dangerous because it burned at a higher temperature than cigarettes. Some of the substances people smoked could produce bacterial and fungal infections. Using cannabis for medicinal purposes would not have very dangerous effects on the human brain, but this was not the case with using it recreationally. If a person started smoking cannabis at a young age, it had very devastating effects on the brain and at times also on the genetic composition of the person, which was why it was very dangerous for young people, especially teenagers. He supported the notion of well-regulated and well-administered medicinal cannabis, but could not support recreational use. He noted that people who were genetically pre-disposed to psychosis had a greater chance of becoming psychotic when they regularly used cannabis. This was also true for people who are genetically predisposed to schizophrenia, as shown through studies at Stellenbosch University, which also showed that eradication of cannabis use and thus removal of the triggers produced a dramatic decrease in the percentage of the population displaying these conditions. Similar to other drugs such as opium, cannabis affected the operations of the brain and the dopamine cycle. Cannabis was also a gate-way drug for most people, and legalisation of cannabis had not given positive outcomes where this had been done, although he stressed that it was not useful to try to make direct comparisons between South Africa and other countries, given the specific socioeconomic conditions in South Africa. Drug induced psychosis was a particular burden to the mental health facilities because there were already limited resources available to treat other mental illness. This had become a serious problem in the mental health fraternity. He wanted to clarify that although today's discussion was not about decriminalisation of cannabis, but about the medicinal use of cannabis, there were linked concerns over the inclusion of the provisions dealing with industrialised production and commercialisation of cannabis and cannabinoids. It was not clear what the commercialisation of cannabis would entail, and certainly clarity was needed on that point if it were to be included in the Bill. He wanted to highlight some important questions that came out of Prof Parry s presentation: - What form is this medicinal use going to take? - are patients going to smoke it, eat it, inhale it, use synthetic cannabis or vaporisers? - What conditions will be approved for use of cannabis and cannabinoids as a form of treatment? The number of conditions which listed cannabis as a definite treatment varied in terms of seriousness, and it would be necessary to avoid creating a window for abuse. - Who is going to prescribe the use for medicinal cannabis? and will the medicinal solution of cannabis be available for everyone? Expanding on this point, Prof Pienaar said that there were different cannabis and cannabinoils and cannabinoids, and it would be important to note which cannabinoid could

9 be used for which condition. There was also a need to know the effectiveness of all the cannabinoids and conduct more research into their use. Smoked cannabis had the highest use and was the most effective because it is was absorbed more quickly. Synthetic cannabis was also a popular alternative. The use of treatments in world literature were not obvious and not clear. For clinicians, it was very important that the Bill must be clear on which conditions the medical cannabis was to treat, to give clarity on what and how to administer it. He said that progress was needed on science, alternative treatments and particularly pain management, but a clear direction was needed to set the direction of research, and to decide what, and for what purpose, matters would be researched. He questioned if the current system would regulate manufacturing and supply, and limit it to medicinal and scientific purpose, and he also suggested that perhaps there had to be a process to assess the intended and unintended results of legalising medicinal cannabis. He cautioned that legalising it for one purpose may lead to public perceptions that it was a safe and healthy practice, and therefore increase the instance of recreational use, especially by vulnerable groups - and said that world literature did support that theory. He suggested that perhaps the first question was whether there actually had to be this Bill? This was something that the MCC and the Medical Research Ethics Council needed to be responsible for. The definition of cannabinoids wasstrict, because it referred to products of cannabis but it did not account for the fact that synthetic cannabis was not "a product". The definition would need to take account of that distinction. Another point on which clarity was needed was whether specialists, or any medical practitioner, could be responsible for administering the cannabis. Clear definitions were needed for commercialisation and industrial use, to avoid the huge potential for abuse. Clarity was also needed on who was going to do research at the pilot health services, and whether the MCC and MERC would be part of the process. Another point he raised was that "informed consent" for medical purposes was the age of 12 years, and this was a particularly vulnerable agegroup. but it burnshe added that there would need to be a definition for those who would be held responsible for the prescription, and guidelines for regulation. Prof Pienaar commented also on the Memorandum on the Objects. In the paragraph setting out the background, the reference to "legally be prevented from prescribing harmless treatments " was incorrect. It would need further elaboration. The cost of regulation was not stated, and that was problematic, for clarity was needed on whether the public health care system would need to bear the cost of the regulation of manufacturing, prescription and dispensing. In summary, Prof Pienaar said that he was in favour of the idea of the Bill but not in favour of its current form. He repeated that there needed to be more research into the use of medicinal cannabis and clarity on the problematic areas of the Bill. The Bill also needed to be very comprehensive, both on a legal and scientific front.

10 Dr Lochun Naidoo submission Dr Lochun Naidoo, Board member, National Pharmaceutical Council (NPC), pointed out that South Africa is a signatory to the UN Convention on Narcotic Drugs, and thus had adhered to the legislative requirements of this Convention. He said that his presentation would put South Africa in a global context within the debate about the legalisation of cannabis. A lobby had emerged, popular in several power circles, including the academic, political and other arenas, which was pushing for the legalisation of cannabis for both medicinal and recreational use. The UK medical innovation legislation was different from this one, because it covered rare diseases where there would never be enough people for clinical trials. He said he would support a medical innovation bill in that situation, but could not support the present one. He believed that the focus of this Bill was legalisation of cannabis in general, rather than specifically for medicinal use, and that was not in line with the UN Convention. Any cannabis control centres must be under the guidance of the UN Convention and the use of cannabinoids also needed to also be under the same guidance. Dr Naidoo said that there was a difference between hemp and cannabis and thus they should be regulated differently. Hemp was less toxic than conventional cannabis. He saw this Bill as an attempt to legalise cannabis using a "Trojan Horse" approach. He believed that legalisations for medicinal use would lead to the legalisation for recreational use. This could not be allowed to happen because cannabis was a dangerous drug and that was why it had been banned, or in some instances heavily controlled. The current Bill created conditions that would allow recreational use of cannabis to be made legal, because it was not limited to medicinal cannabis. There was no current best practice for medicinal cannabis and the American practices were illegal because they were against federal law. The legalisation of medical cannabis would put pressure on the South African health and legal system due to the level of control and regulation that would be required. The "war on drug" reference was a total misinterpretation of the Convention because it was never a legal issue but rather a health issue. When looking into medical use of cannabis, that too should be guided by the Convention. He noted that the Convention could provide guidance to any centres of research because it was comprehensive and set reasonable parameters for research into cannabis. Special topics about the control measures on cannabis and narcotics (2014 INCB Report) in the Convention outlined how the regulation of cannabis and the control of the substance in medical research could be done, and how to control it to avoid abuse and incorrect use was set out in lines He urged that in all instances, there would have to be compliance with the Convention, especially by the control councils for cannabis, as set out in lines The World Health Organisation (WHO) had set up a Board which will soon look into medicinal cannabis. One of the arguments about cannabis that was raised had to do with vulnerable populations, some of whom were in prison for possession and consumption. There had been a direct

11 investment in reducing the supply of drugs and the violence associated with that, coupled with statistics on incarceration rates. However, there was not necessarily a direct correlation. Venezuela had the highest murder rate in the world, but it did not grow drugs, and whilst the prevalence of violence can be a breeding ground for drug abuse, Venezuela also had one of the best prevention programmes in the world. Prevention was more important than drug supply reduction. He suggested that there was a need to review the Bill because it removed liability from the medical practitioners, and could allow patients to grow their own cannabis without properly citing how this should be regulated. There was also a problem with counterfeit drugs even with cannabinoids. There was a growing economy behind the legalisation for recreational use, and a huge social risk was posed by the fact that the police would not be able to distinguish legal and illegal use on the streets. The problem with addiction was that cannabis is a gateway drug and it had serious effects on the brain which the brain cannot reverse on its own without treatment. The mental health system did not have the capacity to deal with that pressure. Cannabis really impacted negatively on IQ, and learners who smoked cannabis had lower information retention, because of the effects of cannabis on the brain. The Chairperson noted at this stage that there were two other presenters, and she asked them if their presentations would set out any different information to that presented already, if they wished to present or if their matters had been covered. This process would not be rushed, and it was clearly important that all relevant information and clarity be given before the Committee proceeded with the Bill. Prof Solomon Rataemane submission Prof Solomon Rataemane, Clinician and President of African Psychiatrists Association, said that his presentation had been covered largely in the previous presentations, but he would like to add to what had already been said. Prof Rataemane did not agree with the questions posed by Prof Pienaar. He said that this process must not happen in isolation from what was happening on the rest of the Continent. He agreed that a delicate and careful process would be needed, because the current system does not have enough controls to regulate prescriptions, and that was the reality with the prescription of pain medication. There were 86 cannabinoids that had already been acknowledged but that there was still so much to be understood about these cannabinoids. He agreed with the suggestion that there needed to be more research before a Bill was even considered. He noted that the Mental Care Ward at George Mukhari Hospital had to treat many young people who had used cannabis either alone or in combination with something else. There

12 was no way to separate the good from the bad. The cannabinoid THC was the problematic one, which could lead to some of the issues of addiction and drug induced mental conditions. If the isolation of cannabinoids could be achieved then there remained the questions around who monitors the prescription and the monitoring of the people who prescribed it. Once this could be established then there would be progress. There were problems with the Bill but there was no opposition to the Bill. He noted that there was a "wheel of cannabis" that showed how cannabis affected different parts of the body and what it could do to alleviate certain conditions. This type of research would be time consuming and it would require a lot of money. His Association was not wanting to put out any positive or negative indicators to the Bill, but did want to stress the need for more research and information. Discussion Dr W James (DA) agreed with the dichotomy between medical and recreational use and said that the purpose of this meeting was to determine whether to legislate on medical cannabis, and if so, then to look at the governance of the medical cannabis production and distribution, who would be responsible for the regulation of it, and who would be responsible for the control. He agreed that there was some evidence of useful effects of cannabis in medical research, but it was clear that cannabis is not a cure for cancer. He agreed on the need for more research in solving the problem of cancer. However, he would supports the Bill as it stands but believed that research into cancer must also be tailored for the South African context. The FDA did not approve of the use of cannabis, due to the limited human subjects research, and more clarity was needed on whether there were inconsistencies and instability in the chemical compounds of cannabis. Dr H Volmink (DA) asked what the risks of substance dependence would be in those who used medical cannabis. Currently, the use of cannabis was illegal but medical practitioners could prescribe some types of cannabinoids. That raised the question of what the purpose was behind the Bill. He wondered how prevalent was Amotivational Syndrome in those who used cannabis. Mr N Singh (IFP) said that Section 21 of the Act of 1965 prohibits the use of cannabis for medical use. Therefore, even in medical research it was problematic because the use and possession of cannabis is illegal. Outside of that, he questioned whether the medical use would be possible in any way within the context of existing legislation. He agreed that there was a need to distinguish between medical and recreational use. The MRC needed to engage more in cancer research, and produce knowledge in that regard. He asked whether the MRC could give an indication of the use of plants in medicines. Mr P Maesela (ANC) said that there could not be legislation on the commercialisation of cannabis. He agreed that this process could not continue if it were only to be based on anecdotal evidence, and far more empirical evidence was needed by conducting sound research. The Department of Health did allow for people for apply for prescription of cannabinoids, on a case by case application, and he agreed that this raised questions on the

13 necessity for this Bill. He agreed that the prospect of wider treatment should not turn into a "Trojan Horse" and be a gateway for recreational use or abuse. Mr C Ndaba (ANC) agreed that cannabis cannot cure cancer but it should be considered for pain management. She did not support the commercialisation of cannabis in any shape or form. Mr A Mahlalela (ANC) said that more clarity was needed on the recommendations in Prof Parry s presentation. He accepted the process that the Bill was taking but disagreed with a lot of things in the Bill and had to ask himself whether he would agree with the Bill if things were removed. For instance, more clarity was needed on commercialisation, smoking of cannabis, as raised in the presentation. He too noted that the current legislation allowed for prescription of cannabis under certain circumstances, asked whether this was enough; and that went to the question of whether the Bill was necessary. Research centres under the MRC would need to be established. He wondered what additional capacity was required. The Chairperson noted the comments on pain management, and said that perhaps more exploration of alternatives was needed. More knowledge and understanding about medicinal cannabis had to be obtained, in her view, before the process could continue. She did not believe that cannabis could be the only solution, because of the experiences she had had with people who smoked cannabis. Mr Mahlalela said that he thought there was some contradiction in Prof Pienaar s presentation - he raised many items and questions on which clarity was required, but yet said he agreed with the process and idea of the Bill. He had not been aware of the effect of cannabis on IQ levels of youth. Dr P Maesela agreed with Prof Pienaar when he had indicated that in its present form, the Bill was " a non-starter". The most important point was whether the Bill was needed. Mr N Singh disagreed, and said that the Bill is not a "non-starter". Dr James said that Committee could not discuss the commercialisation aspect because that did not fall within the legal parameters. However, this Committee should be focussing on the medical use of cannabis and how that could be provided for in the system. Commercialisation would be the jurisdiction of the Portfolio Committees on Trade and Industry. Prof Glenda Gray, President, MRC, responded to the questions from the Members. She said that the MRC supported research into medicinal cannabis and the biological compatibility for the use of cannabis. The MRC supported the pre-clinical and clinical trials into the use of medicinal cannabis. There needed to be knowledge about how things worked, and in what order, with regard to the use of cannabis in the treatment of conditions. There needed to be well designed and well controlled clinical trials where the products used were of good quality and where the researchers knew how to use the products. There was a need for

14 pharmacovigilance during such trials, to observe the effects of the medicines used, especially the intended and unintended effects. There also needed to be an understanding of dosage versus toxicity, due to the unintended effects such as psychosis and Amotivational Syndrome. There needed to be more research into reproductive toxicity and other adverse effects. She agreed with the need for more empirical evidence and moving away from anecdotal evidence. The MRC should be the research centre, due to the multifaceted teams that it already had there, who would be able to facilitate the research. The MRC supported other research units such as Cochrane, but the evidence available was still not enough to facilitate an informed decision. Well designed trials would have to be conducted to establish the correct use and the conditions that would be appropriate for this treatment. The issue of age of consent also would need clarity, particularly since the Department of Health had strict regulations about experimenting on people under 21 years of age. One of the FDA's main issues was around cannabis dosage. Cancer research took up around 5% of the MRC's budget, and she would welcome an injection of money for research. There was not simply not yet enough information about the medicinal use. Dr Anban Pillay, Deputy Director General, Department of Health, said that the Section 21 exemption related to a particular type of patient, who had tried all treatments, but where the practitioner felt that an unregistered drug would be of great assistance to the patient. Under those conditions, an application could be made to the Minister of Health, for the use of this drug. Patients had had access to these drugs in the past, including cannabinoids for pain management. With regard to research on cannabis, he noted that this fell under the jurisdiction of the MCC, with permission and a proper proposal. The use of plants in medicines had generally been replaced with synthetics, due to the cost of continuing to use the plant, and that was why there had been creation of synthetic cannabis. Prof B Myers, Tobacco and Dry Research Unit, MRC, responded to the abuse potential of medicinal cannabis. There needed to be more research into adverse effects of cannabis medicine, because there had not been much research in that regard. With regard to pain management, there still needed to be more research but most importantly this had to be matched up against the use of opiate medicines, which tended to be more addictive than cannabis medicines. Prof Parry suggested that the research should not be done through health pilot centres but rather through the cancer research units established by the MRC, due to the resources made available through the MRC to these centres. They could look at the delivery mechanisms that could be most cost effective, making treatments available for everyone in the country, not just those who could afford it. Treatments had been expensive and there did need to be more research into treating alternatives. Prof Gray agreed with that point. She cited that her daughter had multiple sclerosis and struggles with pain, but found that she needed to import medication from USA, under section

15 21, because the Conventions did not provide sufficient alternatives at a good price for South Africa. Dr Maesela said that it was important that research address the effects of cannabis on the brain, and sufficient safeguards built in to prevent drug abuse. Ms Ndaba said that the presentation confirmed some of her suspicions about the motives behind the call to legalise cannabis. She wanted the process to be fair. The Committee should not be walking into a predetermined scenario. Dr James asked if there were indeed any examples of where legalisation for medical use had spread into legalisation for recreational use. Dr Naidoo said that California was a good example. Doctors had been unwilling to prescribe cannabis so, after recommendations, cannabis dispensaries were set up with the responsibility of giving people prescriptions, but that had ended up enabling recreational use. In the UK, there was a manufacturer, although this was not termed "medical cannabis" to avoid the perception that cannabis use in general was legalised. The UK had excellent regulatory systems. Mr Singh wanted to clarify that Dr Mario Oriani-Ambrosini was not influenced by anybody. His own research gave rise to this Bill. Dr James asked which pharmaceutical companies had commercial interests. Dr Maesela felt that was not a fair question to ask. Dr Naidoo said that opiates were not addictive, when used genuinely for pain relief. The Chairperson stressed that the mental health issues were important and must be brought squarely to the agenda. There was insufficient information about mental health and it was still stigmatised. Adoption of Minutes The Committee adopted minutes of the meeting on 20 March The meeting was adjourned