Medical Innovation Bill [PMB1-2014]: Central Drug Authority opinion

Meeting report

Mr David Bayever, Deputy Chairperson: Central Drug Authority (CDA), said the CDA’s purpose was to provide its opinion on the Medical Innovation Bill (MIB) and to explain that within its mandate, there were certain responsibilities, the most important ones being intervention, early intervention, integration and after-care services, which spoke to the current debate. It would also provide guidance on policy and programming in the field of substance abuse and drug trafficking, which was part of its mandate. It recommended to Parliament that the drug master plan be reviewed every five years.  Included in the discussions were issues around harm reduction and substance abuse in general.

The CDA understood that the purpose of the MIB was to make provision for the innovation of cannabinoids in medical treatment and also to legalise their use for medical purposes, as well as for commercial and industrial use. It was very concerned that the two issues should be separated. If one was talking about the provision of cannabinoids for the innovation of medical treatment, then clearly one was talking about marijuana the drug as opposed to the legalisation of the use of cannabinoids for medical use and official commercial and industrial use, which was marijuana, the plant.

From the CDA’s perspective, there was a need to separate the two issues and deal with the substantive one which, as far as it was concerned, was for medical treatment. In order to do that, the CDA had held a roundtable discussion where it had invited a number of people to give representations from the grassroots level, right up to the academic level, to debate on the safety and the dangers of cannabis use in South Africa. More importantly, it provided an opportunity to investigate the medical use of cannabis, as opposed to its recreational use, which was something for a separate debate. He re-emphasised the CDA’s perspective that the two had to be dealt with separately.

The actual theme of the debate was to shed light on the properties of the chemicals residing in cannabis, with which all of the Committee Members were familiar with by now. At the same time, the CDA wanted to use this roundtable debate to help it formulate a position paper on cannabis to present to Parliament and to present to the Minister. Mr Bayever said that he would go through some of the most important and salient points which had come out of the discussion and been highlighted in the presentation. These were issues that had come up during the debate, together with some of the findings.

When he was here previously, he recalled that the Medical Control Council (MCC) had spoken about the fact that cannabis could be used, and that there were facilities for a section 21 application to be granted in order for it to be used for medicinal purposes. Cannabis could be used for research and medicinal purposes, and this had been emphasised in Dr Naidoo’s presentation on 12 July, where he had explained that there was provision for it to be used for medicinal purposes and to have research done.

There was a need to strengthen community education and awareness on cannabis for medicinal use. This was being borne out by the message that was going out, particularly to the youth. In other parts of the world, the decriminalisation or legalisation, or the allowing of cannabis for medicinal use, was sending a message to the youth in particular that this was a soft drug, and that therefore one should be dealing with it similarly in South Africa. The context in SA was very different to what it was in other parts of the world. The message going out to the youth at the moment required it to focus on the awareness and education in the context of its medicinal use. Parenting was key for modeling and shaping of the behaviour of young people who were vulnerable to cannabis use and/or abuse, and this was fuelled by what was happening in other parts of the world.

Scientific investigation needed to be conducted to develop medication using cannabis without Tetrahydrocannabinol (THC), or if it was going to use THC, there was evidence to show that there needed to be a combination of both Cannabidiol (CBD) and THC in order for the drug to be highly effective, or more effective. The concentration of the CBD as opposed to the concentration of the THC needed to be adjusted as well, and for that, there was a need for more investigation to take place. Cannabis was an integral part of some religious, cultural and traditional practices, which one also needed to be sensitive to, and that had been brought out in the roundtable discussions.

Currently, no comprehensive cost analysis had been conducted in SA on the economic implications of cannabis use, and this was something that the CDA had also recognised at the roundtable as being an issue that needed to be looked at in the South African context, and to determine the extent to which this was admissible or not. It was critical to measure the effectiveness of existing cannabis-related treatment programmes. One of the issues identified was that unfortunately there were not enough facilities for the harm reduction programme that had been discussed. This referred to the issue of how to deal with those people who, according to the genetic predisposition that they might have, experienced problems associated with cannabis use. That was where critical analysis needed to be done as well.

There was a need to consider alternative uses of cannabis and how this could contribute to the economy, recognising that there was a lot of research to show that there were certain varieties that could be used, other than smoking, for recreational or medicinal use, which would have other implications and this also should be looked at. Accurate information about the medicinal use of cannabis should be disseminated through various media platforms. There was well articulated and divergent news on the criminalization and legalization of cannabis, and that was clearly brought out during the course of the roundtable as well.

Looking at a general summary from the roundtable that took place, there was a need for more discussion and understanding of the divergent views, and that meant that a lot more debate needed to happen before a final decision could be taken. There were strong views about the medicinal use and the legalisation of cannabis use for recreational, cultural and religious purposes, and this debate still needed to take place. However, the use of marijuana the plant must be separated from the use of marijuana the drug for treatment, and this must be kept separate from the debate around recreational and other issues. The roundtable discussions provided a platform for further engagement among different stakeholders on cannabis, and the CDA thought that this was important because it was not a decision that it could make on its own without having the views put forward by all stakeholders in order to be informed on the policy that needed to be put forward.

In SA, cannabis was the most common illicit substance among young people and children, and it was the youth that the CDA was most concerned about. The THC potency in the South African plant was higher than in other parts of the world, which was why there was a need to consider this in the South African context. On average, 6.3% of the South African population uses cannabis, as opposed to the world average of 3.8%.

Currently, Dronabinol could be used for therapeutic purposes. It was available as a Schedule seven medicine and could be obtained using a Section 21 application with the correct motivation, which the MCC had already informed the Committee about. What the majority of peer reviewed studies showed was that, in about a third of the studies, no benefit or harm was caused by the use of medicinal marijuana. However, it was the benefits that had to be investigated. The principle that the CDA had worked on was that, “he who asserts, must prove” that this was what they were using it for.
 
Dependence, lung problems, memory impairment, psychosocial developmental problems, mental health problems and poorer cognitive performance were associated with early initiation to cannabis use. This highlights the CDA’s concerns about the impact of cannabis use on the youth and future generations. Increased potency leads to increased health consequences, and one could see that this was what was happening with ‘skunk’ and many other innovative drugs that were being brought forward, such as designer drugs that were being used in other parts of the world, and which were leading to increased health consequences.

Touching on the issue of the smoking of the plant, he said there were warnings on all cigarette packs, stating that smoking causes cancer. If one looked at the content of cannabis as opposed to ordinary tobacco, there was 50% more tar in cannabis plants than there was in tobacco, which compounded the problem. Considering this as a precursor to cancer from smoking, the benzopyrine was 75% higher in marijuana than it was in tobacco smoke, and that was because tobacco had gone through a process where it had been cured. This was not the case with smoked cannabis at the present moment, and this was the point made in slide 12 of the presentation.

Mr Bayever said the issue of dosing needed to be researched. Reliable delivery systems were needed, and a lot of research was being done at the Wits Faculty of Health Sciences, of which he was a member, into developing delivery systems for drugs, such as anti-retrovirals.

The effects of cannabis use on the brains of young people who had not used it before was going to be much stronger than the effects on the brains of older people who had been using it for some time. Was there enough evidence for physicians to be able to make an informed decision? No information was available regarding the composition, dose, side effects and therapeutic targets, and yet the Bill was asking physicians to be the “gatekeeper” in allowing people to use marijuana. Dose-response exhibited a biphasic effect, where lower doses relieved symptoms but higher doses exacerbated them. The Global Burden of Disease Study of 2010 showed that both cocaine and cannabis were recognised as impacting on diseases. There was an absence of CBD reported in cannabis from SA and three regions of Mexico, reinforced the point made earlier about needing to look at the content of marijuana in the South African context. Results indicated that illicit substances such as cannabis had a manifold increased risk of psychopathology with adjustments for age and gender, so one needed to consider this again in terms of the youth.   

The interplay between cannabis and psychopathology was another concern in terms of youth. A study that had appeared in the Lancet, which was recognized as being one of the most reputable journals for medicine, had discussed the adverse health effects of non-medical cannabis use. One had to be sure that the two issues were separated. One of the issues regarding addiction was that a person’s normal mood state dropped as a result of cannabis use.

Any drop in price would lead to increased initiation. An economic consideration had been tax returns from retail cannabis sales weighted against the cost of prevention and health care. Worldwide markets continued to expand, and an increase in the abuse of cannabis would lead to an increase in related public health costs. This needed to be measured, as there already was a high prevalence of tuberculosis and lung conditions in SA, to assess to what extent this would have an impact.

Mr Bayever said substitution effects learnt from Portugal were that referrals had increased from 47% in 2001 to 65% in 2005. While he could not give a figure for 2015, he said that we could certainly see that with the relaxation, there had been more people looking for treatment. Was SA in a position to be able to accept the need for rehabilitation and treatment for these patients? Tax revenue from retail cannabis sales may provide revenue, offset by the need to regulate the new industry, so what would be gained on the one hand would be lost on the other. These were issues to be considered.

Possession charges could be expected to decrease, but control over cultivation, sale and distribution would require routine monitoring. Was SA in a position to monitor even alcohol at the present moment? Convicted users were more likely to experience adverse employment consequences, relapses, relationship problems and accommodation difficulties – all issues which should be looked into.

The Colorado Department of Health had stated that only 2% of users had reported cancer, and less than 1% reported HIV/AIDS, as their reason for using cannabis. 94% had reported severe pain as their reason for usage. The question that needed to be asked was whether this was because pain could not be measured -- it was something that was subjective. 

The reason it was said that cannabis was safer than alcohol and many other substances, and did not have many recognisable effects, was because the onset of problems associated with cannabis was not seen immediately. A person imbibing alcohol was immediately seen to be under the influence. Unfortunately with cannabis, this was a long term effect which developed only after a period of time, and therefore the damage that was being seen would be recognized only in the long term. That was why the CDA was saying that one needs to be careful about saying cannabis was safer.

The smoking of cannabis was linked to cardiovascular and respiratory disorders, cognitive impairment, mental disorders and associated neural spasticity, which could not be cured. High potent cannabis represented a significant public health problem, and it was a fact that the THC content in SA was much higher. Acute marijuana use was associated with increased motor vehicle accidents and fatal crashes, and the carnage already on SA’s roads was well known.
 
Discussion
Mr I Mosala (ANC) asked what the CDA’s honest view was as an organisation with regard to the Medical Innovations Bill, as proposed, in relation to the issues raised in the roundtable discussions, and the way forward.

Mr H Volmink (DA) commented that Mr Bayever had emphasized the need to separate the medicinal and non-medicinal uses of marijuana. However, there were actually three layers. Apart from the medicinal and non-medicinal layers, there was also a third layer of innovations that could occur for potentially chronic, life-threatening conditions. He thought it was important to separate that third layer from the other two. In the presentation, the CDA had imparted a lot of information about the link between cannabis use and psychopathology, but had not mentioned anything about the carcinogenic effects of cannabis. He asked if inhaled cannabis smoke was more carcinogenic than tobacco smoke, and what the health risks associated with that were, with regard to cancer.

Ms L James (DA) said that the Committee had heard a lot about the health risks, but she wanted to know if there were any benefits that might outweigh the risks.

Mr A Mahlalela (ANC) understood that there was a need for research around the use of marijuana. He asked if research could be conducted in the current environment.

Mr N Singh (IFP) said the presentation talked about innovation, evidence-based approaches, and further research. He thought the purpose of the Bill, when it was first introduced, was that there was no legal mechanism for any research institution, be it the Medical Research Council or any other institution, to use marijuana for research, because it was a banned substance. He asked what the CDA’s view was in that regard -- of piloting health centres to conduct this kind of evidence-based research -- because international studies in many countries around the world had shown that medical marijuana was being used for palliative care.

Ms S Nkomo (IFP) said she felt that if cannabis was to be treated as being for medicinal use, there should be more debate on the issue, as well as further research.

Mr Bayever responded to the question about the carcinogenic effect of cannabis as opposed to any of the other effects. If one looked at a person who was using cannabis for recreational purposes, one of the first telltale signs that would be picked up was what was called the ‘hash throat’, which was one of the reasons why people had started using “hubbly bubblies” and hooka pipes. Smoking cannabis did have carcinogenic problems associated with it, as the active ingredient in tobacco, which was the prescursor to cancer, was a substance called benzopyrine --and there was benzopyrine in cannabis as well. The problem was that it was in a much higher concentration.

However, there were many other problems associated with it as well. For example, if one was promoting the use of cannabis for people who were HIV positive in order to improve their appetite, one of the things research had shown was that it actually destroyed the immune system over a long period of time. This was the point made earlier, that one could not recognise a lot of the effects in the short term, as they would be obvious only after a period of time. Treating a person for a problem with a substance which was going to exacerbate the underlying problem, was problematic in itself. One needed to look at a system whereby one could extract the active ingredient which had a true therapeutic value, and that had been done. However, the question was, why had it been accepted? There were people that were using those particular drugs --Dronabinol and Nabilone – already. There was new research that had shown that if one extracted the therapeutic CBD, which had the therapeutic benefit associated with it, on its own, it did not have the same effect as when it worked synergistically with the THC. The research the CDA was proposing therefore needed to look at why it was that Dronabinol and Nabilone on their own, which were commercially available as tablets that could be swallowed, were not having as great an impact on the problem as they should have, if that was really where the answer lay. The answer was that only one active ingredient had been extracted, which might relate to others, and there were 85 different cannabinols in every sample of cannabis. The one that was missing was the THC, which was the psychoactive part of it, and which needed to be there as well in order for the CBD to have its true therapeutic effect. There had to be a review of what was being talked about in using this particular compound for medicinal purposes and the type of research that was being proposed. This was happening in other parts of the world already, and that was where the emphasis was now moving to.

The issue on the carcinogenic effect on the throat promoted the argument against using it in a smoke form. How did one measure the dose, when a doctor prescribed cannabis? Was he going to say, “take three puffs every four hours and hold your breath for ten seconds to get the right therapeutic value?” What was needed was to find a way of extracting the active ingredients and putting them into a delivery system where one could measure and assess the true value of the content that a patient would be receiving. That would give the prescriber the confidence to be able to use the drug, knowing exactly what the patient was getting, and whether that was what the patient needed. It would be a moral injustice to deny patients the benefit that could be derived from a therapeutically advanced product, which they were being denied at the moment, but that required that more research must be done.

Mr Bayever responded to the question of whether there was the capacity to do the research, and whether it was allowed. His understanding of the Medicines Control Act (MCA), as well as Dr Naidoo’s, was that permission could be granted for research to be done and provision was made in the MCA for that to take place. It had to be done with the permission of the Director General of the Department of Health, and under those circumstances, there was no reason why research could not be conducted. This was something that CDA would certainly not deny the public the privilege of getting, and it would support any research that needed to take place in order to come up with a conclusive standpoint as to whether it was beneficial or not.

There were issues associated with palliative care, particularly with pain control. The problem, again, was the neurospasticity that was created by using cannabis for recreational purposes, and reinforces the point that one needs to separate the two debates very clearly. One could not, on a moral basis, deny the public the right to a medicinal product that could benefit society, based on evidence-based research, as had been done with every other drug that had been brought to the table, but this needed to be balanced in terms of the true therapeutic value of what was actively involved in the cannabinoids which may be of benefit. One should see if one could rather come up with an improved version, as opposed to what was available in the past as a Section 21 application, but had not found favour in practice.

It was known that there were benefits associated with cannabis, and that from a palliative care perspective that it could be used, and should be used, if a delivery system could be devised that ensured one could measure the required dose according to the needs of the patient, as opposed to allowing the patient to be under the influence and then not recognising to what extent they were benefiting from the drug, which was very often the case.

Dr W James (DA) said the use of medical marijuana was already provided for through the Section 21 process, and what could be done was to make it easier by lifting some of the restrictions and barriers in the way of its legal use. However, that did not actually tackle the issue of using it for cancer treatment, which was completely different. It was not a cure for cancer -- there was no cure for cancer. If the country wanted to invest in a treatment for cancer that affected its population, given its genetic make-up, that was a different matter. It was expensive. In the United States, they had the Mayo Clinic, which specialized in cancer. South Africa could have a similar, dedicated cancer centre, but that would be very expensive. It may be worthwhile to invest in it, but the Medical Innovations Bill was not about that. It had both aspects in it, and was confusing as a consequence. What it needed, in his view, was to be simplified and directed where it could be effective. Was the MIB simply to deal with medical marijuana, and making it easier to access? Was this what the CDA was suggesting?

Mr Bayever replied, “absolutely correct!”

Dr P Maesela (ANC) commented that it would be ironic to say that one was combating cancer while using carcinogens to treat it. It was being said that marijuana should not be banned for medical use, and the law said one could apply to use it. Not everybody was going to be given a carcinogen to deal with pain, as that was unethical. Every country had rules and regulations regarding research that could be done. The fact that South Africa allowed a carcinogen, meant that there would already be safeguards in place. Research using cannabis was covered by legislation. He thanked the CDA for adding to the small body of knowledge that the Committee had about this.

Mr Singh asked what the CDA had meant when it said that the Section 21 application had not found favour in practice.

Mr Bayever responded to Dr James’s comments about cancer research, saying that there were three universities -- Wits, Stellenbosch and Cape Town -- that have just opened centres for cancer research. If money had already been allocated for cancer research to be conducted, then an issue that they should also be looking at was to what extent patients could benefit from using the properties that were contained in this plant. One needed to ensure that the research was going to take place. They should be looking at the possible benefits of cannabis.

The CDA wanted to isolate what was beneficial and extract it for use, where its benefit would outweigh the risk. It needed to remove the dangers. Any drug that did not have side-effects was not worth taking, as it was not doing anything. However, the drugs that were available were not having the same effect as smoking marijuana. Therefore, the synergistic effect between the different chemicals needed to be researched.

Regarding Section 21 applications, he said that there was a particular company that specialised in getting Section 21 drugs.

The Chairperson thanked the CDA for their presentation. If there were any further questions, Members could send them to the CDA in writing.

Barcelona Declaration issue
The Chairperson referred to an issue related to there being no agenda item for discussion on the TB conference in Barcelona at the last meeting. Dr James had said he had sent a letter to which she had not replied. She thought that it would be important to dispense with this matter, as the request had been in the minutes.

The Minister had written to two presiding officers, the Speaker of the National Assembly and the Chairperson of the National Council of Provinces, requesting that the matter be put to Parliament. Her view was that the Minister was not only talking about putting it to Members of the Portfolio Committee, but to parliamentarians as a whole.

Mr S Jafta (AIC) said he had unfortunately not been at the meeting, but seeing that it was problematic for the Committee to engage in the issue, he suggested that Dr James and the Chairperson should meet together so he could advise her what he intended to present to the Committee, and maybe it could be included in the agenda for the next meeting.

Dr James replied that the item was on the agenda. He recalled writing a letter to the Chairperson’s office, and he would find the e-mail and share it with the Committee. He had gone to London on private business, to see an organisation regarding the Barcelona Declaration, which was a worthy effort to give voice to eradicating tuberculosis. When he returned, as a member of the Democratic Alliance, he got all of the MPs to sign. All he wanted to do was to come to the Committee and ask his colleagues to do the same. He repeated his request to Members to sign on to this declaration.

Mr Mosala said that he had made an input to the effect that the matter should be noted, and that he still made that particular input.

Mr Mahlalela said that the Committee knew that the matter was before Parliament. The relevant Minister had been given the responsibility, because he was the co-founder of this campaign and it had been communicated in no uncertain terms that the process must follow the proper parliamentary procedures. The parliamentary procedure was exactly what the Minister had followed, and the Committee must allow the process to take its course.

The Chairperson said that she checked her e-mails every day, and the last letter that she had received from Dr James was regarding HIV testing. He knew for a fact that she responded to his correspondence. She answered any correspondence from any Member regarding requests for any process. She requested that the Committee we close the matter on that note, and then it would be able to move forward.

The meeting was adjourned.