Medical Innovation Bill: Department of Health input

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Health

23 November 2016
Chairperson: Ms M Dunjwa (ANC)
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Meeting Summary

The Portfolio Committee was briefed by the Department of Health on the Medical Innovation Bill of 2014. This Bill, which originated from the private Member's Bill by the late Dr Oriano-Ambrosini, provides for innovation in medical treatment, legalising the use of cannabinoids for medical purposes and legalising commercial and industrial use of cannabis. It will allow medical practitioners to depart from traditional treatment regimens, when existing evidence-based treatments are no longer supportive of patients, and include other alternative such as cannabis. However, the Bill is also carefully worded to prevent reckless, illogical and unreasonable departure from standard practices. The Bill further states that when cannabis is used for treatment or commercial and industrial medical use, the users will not be held liable or guilty of any offence for growing, processing, distributing, using, prescribing, advertising, dealing with or promoting cannabis.

Under section 22 A(9)(a)(i) of the Medicines and Related Substances Act, which was amended in 2015, no person may acquire, use, possess, manufacture or supply cannabis, as the whole plant or any portion or product thereof, and this includes synthetic derivatives. The Act provides for the scheduling of all substances and cannabis is listed as a Schedule 7 substance. However, the Director-General of the Department of Health may issue a permit authorising a medical practitioner, analyst, researcher or veterinarian to use cannabis on specific prescribed conditions, for the treatment or prevention of a medical condition in a particular patients and for the purposes of education, analysis or research.

Scheduled substances are defined as “any medicine or substance prescribed by the Minister under Section 22A”. All medicines are subject to a scheduling process on the basis of the substances they contain (active pharmaceutical ingredients/.substance). Section 22 A(2) schedules are approved by the Minister on the recommendation of the Medicines Control Council (MCC). Under the criteria for scheduling, the primary emphasis is on evidence of safety and requirements for intervention and or supervision of use. Scheduling decisions involve the consideration of a number of factors, including evidence around the toxicity of the substance and the safety in use, the proposed indication for the substance, the need for medical diagnosis, the potential for dependence, abuse and misuse and the need for access to the substance.

The substances classified under Schedule 7 are banned substances not recognised for clinical use. They have extremely high potential for abuse and dependence. The possession and use of these is prohibited. The Director General may issue special permits for them, on the recommendation of the MCC.

The whole plant or any portion of product thereof of cannabis may be separately specified in Schedule 6 (access through prescription), but cannabis may be used as hemp fibre, in which case it may not contain more than 0.1% THC or whole seeds. That means that it may not be in a form for ingestion, smoking or inhaling purposes.

Patients who are in a position of both a prescription and permit from the Director-General can source the product through a number of ways; namely as pharmaceutical cannabis products registered by the MCC, unregulated illegal herbal cannabis, which may be grown or bought from the black market and generally has unknown concentrations of cannabinoids and potentially harmful contaminants.

Access in terms of the Medicines and Related Substances Act 1965, under Section 21, provides for specified conditions. These relate to patients suffering from a serious illness where a clinical need can be demonstrated and where evidence exists to support the request. A mechanism for continued access to medicines is provided to patients following completion of a clinical trial. Objective evidence to support the proposed use must be provided. The dosage, route of administration and duration of treatment must be provided. Appropriate monitoring of the patient during and after treatment must be in place in order to assess efficacy and adverse events. Informed consent by the patient or legal representative is required.

The Department of Health will regulate the proposed growers of medicinal cannabis by issuing a permit to allow for the controlled cultivation of cannabis for medicinal use.

Members were pleased with the progress made on this Bill, although there were still some concerns about the consequences of using cannabis and the reasons why consent of patients was required. It was noted that the Medicines and Related Substances Act had already been signed into force in 2015, and Members asked about the timeframes for putting both that Act and this Bill (which must be read together) into force. They asked what regulatory and compliance measures will be put in place and if the enforcement authorities were briefed and prepared, so that they would not arrest those who were authorised to grow and/or possess cannabis. They asked who was likely to be licensed to grow, how long this was likely to take, and how the position would be regulated, including in the rural areas, and asked that the Department commit to a timeframe so that poor people might have access to cannabis products for medicinal purposes. Members were told a little more about the Cannabis Working Group at the Medicines Control Council,  and it was stressed that part of the framework will comprise research. They cautioned against allowing black market input.

Meeting report

Medical Innovation Bill: Department of Health (NDOH) briefing
Dr Joey Gouws, Registrar, Medical Control Council (Department of Health), presented the input of the Department of Health (NDOH or the Department) on the Medical Innovation Bill. She noted that the Medical Innovation Bill of 2014 provides for innovation in medical treatment, legalising the use of cannabinoids for medical purposes and legalising commercial and industrial use of cannabis.

The purpose of the Bill is to allow innovation in medical treatment by allowing medical practitioners to depart from traditional treatment regimens when existing evidence-based treatments are no longer supportive of patients. It is to prevent reckless, illogical and unreasonable departure from standard practice.

When Cannabis is used for treatment or commercial and industrial use, the persons using it will not be held liable or guilty of any offence for growing, processing, distributing, using, prescribing, advertising, dealing with or promoting cannabis.

Internationally there had been some developments in the UK with the Saachi Bill of 2015. The UK Bill provides for the same arguments as the proposed Bill in RSA. The Saachi Bill provides for responsible innovation in medical treatment, allows medical doctors to depart from existing and acceptable treatments for a condition, although the UK Bill did not specifically address cannabis. However, this Bill had not progressed in view of concerns raised around patient safety and protection, risks around reckless practice, the fear that it would not address quackery and could harm medical research.

RSA is a signatory to the United Nations Single Convention on Narcotic Drugs, 1961. Under this Convention, cannabis is classified under Schedules I and IV, of the 1961 making it subject to special restrictions. The International Narcotics Control Board (INCB) requires member countries to establish regulatory procedures for licensing and registration, to define control systems for hemp activation and define which cannabis varieties are authorised for cultivation.

In terms of own laws, cannabis, in South Africa, is controlled in terms of the Drugs and Drugs Trafficking Act 140 of 1992, the Medicines and Related Substances Act 101 of 1965, and the Criminal Procedure Act 51 of 1977.

Under section 22A (9)(a)(i) of the Medicines and Related Substances Act, no person may acquire, use, possess, manufacture or supply cannabis, either as the whole plant or any portion or product thereof, and this includes synthetic derivatives. Section 22 provides for the scheduling of all substances. Cannabis is listed as a Schedule 7 substance. The Director-General (DG) of the NDOH may issue a permit authorising a medical practitioner, analyst, researcher or veterinarian to use cannabis on specific prescribed conditions, for the treatment or prevention of a medical condition in a particular patient, and for the purposes of education, analysis or research.

Scheduled substances are defined as “any medicine or substance prescribed by the Minister under Section 22A”. All medicines are subject to a scheduling process on the basis of the substances they contain (active pharmaceutical ingredients/.substance). Section 22 A (2) schedules are approved by the Minister on the recommendation of the MCC. In relation to the criteria for scheduling, the primary emphasis is on evidence of safety and requirements intervention and or supervision of use. Scheduling decisions involve the consideration of a number of factors, including evidence for the toxicity of the substance and the safety in use, the proposed indication for the substance, the need for medical diagnosis, the potential for dependence, abuse and misuse and the need for access to the substance.

The substances classified under Schedule 7 are banned substances not recognised for clinical use. They have extremely high potential for abuse and dependence. The possession and use is prohibited. The DG issues special permits on the recommendation of the MCC for these.

The whole plant, or any portion of the product of cannabis may be separately specified in Schedule 6 (access through prescription). Cannabis may be used as hemp fibre but then may not contain more than 0.1% THC or whole seeds. That means that it may not be in a form for ingestion, smoking or inhaling purposes.

Patients that are in a position of both a prescription and permit from DG can source the product in several ways – namely, as pharmaceutical cannabis products registered by the MCC, or unregulated illegal herbal cannabis, which may be grown or bought from the black market and generally has unknown concentrations of cannabinoids and potentially harmful contaminants.

Access in terms of the Medicines and Related Substances Act 1965 under Section 21 provides for specified conditions. These are patients suffering from a serious illness where a clinical need can be demonstrated and where evidence exists to support the request. A mechanism for continued access to medicines is provided to patients following completion of a clinical trial. Objective evidence to support the proposed use must be provided. The dosage, route of administration and duration of treatment must be provided. Appropriate monitoring of the patient during and after treatment must be in place in order to assess efficacy and adverse events. Informed consent by the patient or legal representative is required.

The DG of the NDOH will regulate the proposed growers of medicinal cannabis by issuing a permit to allow for the controlled cultivation of cannabis for medicinal use.

In conclusion, Dr Gouws noted that there are mechanisms in place to enable controlled access to cannabis for medical use and clinical research already exists within the current legal framework of the Medicines and Related Substances Act. More work or research is needed on causality and strength of association of some adverse effects. More research is needed on age-related cognitive effects. A better understanding needs to be gained of the benefit or risk of cannabis for each indication considered.

Discussion
Mr H Volmink (DA) said this is an important subject and has a range of implications. On one hand the NDOH must protect the public from harm but on the other, ensure individual liberties are protected. There seems to be a benefit to the product. He asked if the Department of Health would agree that the current framework needs to be reformed to allow prescription of cannabis to be more easily accessible for patients and medical practitioners. His second question was on the regulation of the harvesters of cannabis, and he asked how long the process will take?

Ms D Senokoanyane (ANC) said this looked like a mammoth task. She asked what was the reasoning behind insisting that the patients or their legal representatives give informed consent and whether that was related to the potential dangers. She also noted that leeway could be provided to growers and asked how the Department would select them.

Mr D Khosa (ANC) said one issue is the bureaucratic processes for the implementation, and particularly the issuing of licences. He wanted to know if that had been considered, especially when looking at the rural and urban areas.

Mr N Singh (IFP) said that he felt very encouraged by this presentation which finally seemed to be showing some light at the end of the tunnel. He knew that it had been three years since the late Dr Oriani-Ambrosini had first proposed the Bill, but he agreed that it was better to err on the side of caution. He said the bureaucracy was such that it makes it difficult for people to access these medicines. He felt that it was a step in the right direction for this to be regulated in the way now being proposed. He asked if there is a particular timeframe that the Department could give to the Committee, in order that the Committee might assess how to move forward.

Mr A Mahlalela (ANC) sought clarity, believing that some of the principles had been agreed to some time ago and wondered what the particular difficulties were in the Department of Health and what was the engagement with the Presidency around having the legislation from 2015 put into force. He asked, on average, how many applications were made to the Director General in a year? He wanted to gain more understanding of the position and asked if the process was easy, or if there were challenges. He asked if any requests had been received for trials or research, and whether the Department had engaged at all with the Medicines Control Council. Finally, he wanted to know how long the research in the Department of Agriculture was likely to take, and whether there was a framework? He referred to page 7, noting that the NDOH and MCC are in the process of introducing guidelines, and he asked how long the process was going to take.

The Chairperson asked if the Department was working together with relevant stakeholders in relation to the proposals around cultivation of medicinal cannabis, and how the Department was likely to deal with compliance issues. She also wanted to know how the Department was going to monitor this in the rural areas. She wondered when are the law enforcement agencies were going to be taken through training and whether there would be people who would be specialising in this, and who had been properly empowered, to ensure that there was strict monitoring.

Dr Gouws responded that indeed there are two pieces of legislation. The President signed the Medicines and Related Substances Amendment Act in 2015, and it was necessary to read both of these in conjunction with each other.

She explained that cannabis will be a Scheduled substance. When the Department looks at cannabis going forward it will no longer be looking at it for manufacturing purposes only, but for medical treatment too. A patient and / or medical practitioner will need to apply to the DG, for use for medicinal purposes. She said a guideline document will specify how a person may be a grower and there is an application to be submitted in that regard. The criteria are therefore specific, relating to a qualification of person, and the grower will have to be a person with a scientific background. The Department will look at the safety and security aspects, among other things. A Cannabis Working Group has been established,  and Dr Shabir Banoo of the MCC  is part of it. NDOH also has an enforcement group. The inspectors go to the site, look at the security measures in place and work with the police to make sure that product will not disappear. NDOH exercises compliance oversight.

Dr Shabir Banoo, Council Member, Medicines Control Council, . The department has a compliance oversight.

Mr S Banoo said that the cannabis working group is to define the framework. In terms of the framework there needs to be some evidence that the applicant is able to comply with the strict requirements of cultivation. Another component for this framework is that it enables research. There have already been applications from researchers. He agreed that the concerns regarding the framework and the bureaucratic processes have limited access.  He said that his feeling is that the guidelines regarding cultivation will be published by the end of January.

Dr W James (DA) asked how the country would actually reach the desired outcomes. He commented that the NDOH seemed to be headed in the right direction. Section 21 falls away as soon as it becomes a prescribed drug, and that process will be triggered by the MCC requesting a scheduling change.

Ms Senokoanyane said that in order to legalise the use of cannabis it would be necessary to look at the Criminal Procedure Act and Drug and Trafficking Act, and wondered whether there was some sort of parallel process in line with the Medicines and Related Substances Act.

Dr P Maesela (ANC) said it looks like the Department is tying up the all the loose ends and hopefully, by the end of the year, the product would be available to those who needed it.

Mr Singh commented that the black market is a dangerous market because it was impossible to know or monitor the quality of the product produced. He said the rich can gain access to these products, while the poor would need it also. He appealed that the Department should do everything in its power to expedite these processes so that the people who needed the product would be able to access it. He asked what the timeframe was likely to be.

Dr Banoo said that one point not yet in place was the licensing of local cultivators, although this possibly could be in place within the next three months. The NDOH can provide access to other regulatory bodies like the Netherlands.

The Chairperson concluded by saying that the Committee would prefer the NDOH to exercise due caution, and think matters through properly, to be “better safe than sorry”. She commented that this was an important legacy for this Committee to leave behind. She  thanked the IFP for being so patient around the Bill being brought to fruition.

The meeting was adjourned.

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