Medical Innovation Bill: Medicines Control Council briefing, in presence of Deputy Minister

Meeting report

Medical Innovation Bill: Department of Health briefing

Professor Shabir Banoo, Member, Medicines Control Council, Department of Health, presented the Medical Innovations Bill (the Bill) to the Committee. He informed the Committee that under the current legal framework there was a mechanism to enable controlled access to cannabis and other drugs for medical use, provided the Director General of the Department of Health (DoH or the Department) had granted the medical practitioner a permit to prescribe the unregistered drug for a seriously ill patient.

He took the Committee through the legal framework. Section 22A of the Medicines and Related Substances Act (Act 101 of 1965, as amended) governed the sale, supply and use of a medicine or scheduled substances in South Africa. The Public Health Regulatory Mandate looked at protecting patients against harmful or ineffective medicines, serving a gatekeeper function, with the obligation to apply stringent standards of assessment and to restrict availability of certain substances where deemed necessary. It also protected patients against the consequences of untreated diseases by enabling drug development to ensure that patients had access, as early as possible, to safe and effective drugs.

The legal framework states that all medicines are subject to a scheduling process on the basis of the substances they contain. Section 22A (2) states that Schedules are approved by the Minister on the recommendations of the Medicines Control Council (MCC). Section 37A provides for amendments to the Schedules. Schedules are published in the Gazette or amended by a subsequent notice in the Gazette.

The primary consideration of scheduling was safety, in relation to therapeutic indications for its use. Substances may be listed in one of eight schedules and also in more than one schedule based on the indication, dosage form, route of administration, strength, duration, or a combination of these factors. The Schedules are classified as follows:

• Schedule 0 – available through general sales outlets
• Schedule 1 – pharmacy over the counter (OTC) products
• Schedule 2 – pharmacist-prescription products
• Schedule 3-6 – prescription-only medicines; authorised prescribers
• Schedule 7 – prohibited substances
• Schedule 8 – limited use; special permits by DoH required

Prof Banoo noted that in respect of substances which may be abused or misused, this scheduling ensures appropriate levels of control consistent with international drug control conventions, and also ensures timely implementation of policies and resolutions of the International Narcotics Control Board.

He noted that scheduling decisions involve the consideration of a number of factors:

• 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
• the need for access to the substance

Prof Banoo went on to discuss the legal status of cannabis in South Africa. Presently, it is controlled in line with the 1961 Single Convention, and is listed as a banned substance in Schedule 7. He explained that section 22A(9)(a)(i) of the Medicines and Related Substances Act provides that no person may acquire, use, posses, manufacture or supply cannabis, as the whole plant or any portion or product thereof, and this includes synthetic derivatives. This section also provides for the Director General (DG) of the DoH to issue a permit authorising a medical practitioner, analyst, researcher or veterinarian to use cannabis, on the prescribed conditions, for the treatment or prevention of a medical condition in a particular patient, or for the purposes of education, analysis or research.

It was possible to access cannabis legally. Section 22A(9)(a)(i) of the Medicines and Related Substances Act enables acquisition, possession, manufacture and use of a Schedule 7 substance, if the DG has issued a permit for that substance, under specified conditions. Section 21 of this Act also enables the use of an unregistered drug under specified conditions. These may include: 

• patients suffering from a serious illness where a clinical need can be demonstrated and where evidence exists to support the request
• mechanism for continued access to medicines provided to patients following completion of a clinical trial
• provision of objective evidence to support the proposed use
• appropriate monitoring of the patient during and after treatment must be in place, in order to assess efficacy and adverse effects
• the treating physician must be a specialist in the field
• informed consent by the patient or legal representative is required

He noted that there were several potential therapeutic uses of cannabis, for

• Glaucoma
• Chemotherapy-induced nausea and vomiting
• HIV/Aids-associated loss of appetite and weight loss
• Chronic pain syndromes
• Multiple sclerosis
• Epilepsy in children

He also pointed out the adverse effects of cannabis use in the short term, which may include

• impaired short-term memory and attention
• impaired motor co-ordination and reaction times
• altered skilled activities
• anxiety and panic reactions
• visual illusions and pseudo-hallucinatory responses
• dissociative states such as de-personalisation and de-realisation

Long-term adverse effects of cannabis use could include:

• poor educational outcomes
• addiction to those who began using it in adolescence
• cognitive impairment
• respiratory and reproductive system effects
• increased risk of schizophrenia, de-personalisation disorder, bipolar disorders, and major depression

Professor Banoo repeated that mechanisms to enable controlled access to cannabis for medical use do exist within the current legal framework already. He expressed the opinion that more work is needed on causality and strength of association of some adverse effects. More research is needed on age-related cognitive decline and on THC-related effects, based on emerging evidence that the THC content or potency of marijuana has been steadily increasing. Finally, a better understanding was needed of the benefit or risk ratio of cannabis for each indication considered.

Discussion

Mr I Mosala (ANC) wanted to know what the situation is regarding research and cure for cancer. He further asked why, under the current legislation, medical practitioners cannot have permits to prescribe illegal drugs to patients for medicinal use.

Dr Anban Pillay, Deputy Director-General, Department of Health, stated that there is a research institution conducting research on cancer and it briefed the Medical Committee about its progress once a year. He also noted there were a number of trials taking place around the country, specifically looking into the short and long-term effects of THC. If a doctor wished to prescribe an illegal drug, then it was the responsibility of that health worker to submit an application and a motivation letter to the DG regarding the use of the unregistered drug for medicinal purposes.

Mr A Shaik Emam (NFP) asked why the legislation was not encouraging the use of cannabis, if it has been proven to cure ailments or alleviate pains.

Professor Banoo explained that this Bill took, as its starting point, the assertion that there were no answers as yet. The Department was reflecting that there was in fact a framework in place, which he added was working, regarding the use of cannabis and other drugs.

Dr W James (DA) commented that the Medical Innovation Bill should concentrate on the research facility for curing diseases like cancer, especially the type of cancer that is prevalent in South Africa, and not focus on cannabis only.

Ms C Ndaba (ANC) remarked she did not believe that cannabis can cure cancer. If it has been proven to cure it, then she wondered why the former Member of the Committee, Dr Mario Oriani-Ambrosini, had not used it. She noted that she was not seeking to be insensitive in any way, but was emphasising her lack of conviction that cannabis could cure cancer. But if it was said it relieved pain, then she would see no harm in using it for that purpose.

Ms S Nkomo (IFP) commented that the objectives of the Bill did not make any statement that cannabis cures cancer. She went on to say the Bill itself stated that more research was needed, and this then suggested the need to address the issue of the research institution, because it was clear there was still more work to be done.

The Chairperson asked the Department to convince the Committee there was legislation that allowed medical practitioners to ask for permission to use unregistered drugs on seriously ill patients for medicinal purposes only. For a long time, the general public had been under the impression that there was in fact no such legislation.

Prof Banoo stated it was possible there had been a lack of communication in making health workers aware that they could make applications and motivate to access these unregistered drugs for medicinal use. The lack of communication may have meant that they were not aware of the new framework in place. He mentioned that section 21 of the Act should make medical practitioners aware of the possibility of controlled access to unregistered drugs, and this is something they should consider when treating seriously ill patients.

Mr A Mahlalela (ANC) commented that South African had many research institutions that were conducting research on medicines. If there was a gap in their work, the Department should identify weaknesses so as to strengthen their capacities in doing research rather than simply creating parallel structures. He suggested the Committee should call upon the Medical Research Council (MRC) to update the Committee on the research capacity of the country. If it indicated that such capacity is poor or insufficient, then it might be the time to think of a new research institute.

The Chairperson was pleased to know there was legislation that governed the prescription of unregistered drugs for medicinal use, but the shortcoming was that few people were aware of that.

The Chairperson noted the concurrence of Members to invite the MRC to brief the Committee.

Mr Mosala suggested the Central Drug Authority and Medical Control Council to be invited as well.

Mr Joe Phaahla, Deputy Minister: Department of Health, pointed out in his concluding remarks that the issues that Members raised featured prominently in the Bill. One major consideration was the desire to increase capacity for research, and that was why, within the Department, there was a body that coordinated all the research, including information shared or exchanged by the scientists of the Department on international forums. The Department was focusing on what can be or needs to be improved.

The meeting was adjourned.