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Medicinal use of cannabis makes progress

Medical Innovation Bill and cannabis

..sent to clients 18 Dec… Dr Narend Singh who took over the tabling of the Private Members’ Medical Innovation Bill from the late Dr Mario Ambrosini, said that he was so impressed by the progress of the Department of Health (DHA) in their support of the use of cannabis for medical purposes that he could see the possibility arising where he could withdraw his Members’ Bill in favour of broader legislation tabled by the Minister of Health.

He said “there was light at the end of the tunnel” and he himself was on a “high” to learn from Dr Joey Gouws, in charge of regulatory and legislative enforcement at DHA, that regulations on the growing of cannabis, manufacture, dispensing and medical use for medicinal purposes could be in place by the end of 2017 including registration processes and classification systems.

Holistic approach

Dr Gouws was briefing the Parliamentary Portfolio on Health on progress towards the commencement of such a programme and which not only covered the medical use of cannabis as proposed in the Medical Innovation Bill but covered research, registration, manufacture and the scheduling of substances.    Separate legislation would be in parallel amending such Acts as the Drugs and Drugs Trafficking Act.

Regulations were a draft form stage in authorising permits for use by practitioners, analysts, researchers or veterinarians.      In fact, said the DHA team presenting the update to parliamentarians, it might be possible to see certain herbal products with limited THC levels available within three months.

 Worldwide

Dr Gouws said that in the United Kingdom similar legislation, to be enacted, provided for innovation in medical treatment and allowed medical doctors to depart from medical treatments for a condition but the UK Bill did not specially address the use of cannabis. In South Africa, it will be allowed for under specific prescribed conditions for the treatment of certain medical conditions and for education, research and analysis.  Similar legislation in Australia and Canada had been studied.

Patients that are proposed for eligibility are those with severe pain, nausea, vomiting or wasting arising from cancer and HIV/AIDS, including treatment. Muscle spasms and severe pain associated with multiple sclerosis and seizures from epilepsy where other treatment options have failed or have intolerable side effects. Severe chronic pain is included as part of the proposals for indications.

Crop trials completed

The Department of Agriculture, the DHA team said, has justMedicines Control South Africa forwarded the outcome of cultivation trials at four agricultural research facilities jointly overseen by both departments. This would now be disseminated and assessed, which results would form part of the ongoing research by the Medical Research Council and other academic research centres involved in the future clinical use of cannabis.

Currently, cannabis is listed as a Schedule 7 prohibited substance but regulations will shift this towards Schedules 3-6 which are prescription-only medicines with authorised prescribers.   Scheduling decisions involve levels of toxicity and safety; the proposed indication for a substance; the need for medical diagnosis before prescribing; the potential for dependence, abuse and misuse and access disciplines.

Certain cannabis products are prescribed at present but unregulated illegal herbal cannabis, Dr Gouws said, which is grown incorrectly and bought from the black market will have unknown concentrations of THC’s and cannabinoid concentrations combined with potentially harmful ingredients.   Cannabinoid drugs currently used are Dronabinal for loss of appetite during severe illnesses, Nabilone for nausea under similar conditions and Sativex for spasticity.

Conditions of use

If legalised, it will be proposed that objective evidence to support the proposed use of cannabinoids in whatever regulated form must be provided; the manner and duration of treatment provided; a patient must be monitored to ensure efficacy; the treatment outcome reported upon; the physician involved must be a specialist and informed consent by the patient or legal representative obtained.

In questioning the DHA, parliamentarians were particularly concerned that appropriate measures amending the Drugs and Drugs Trafficking Act, the criminal Procedure Act and the Medicines and Related Substances Act were undertaken. One MP remarked that there must be no question of unintended consequences with law enforcement processes in order that criminal procedures under certain circumstances involving cultivation, marketing, administering and research can be clearly separated and easily understood by the South African Police Service.

Dr Joey Gouws said that this matter had already been investigated and the issues involved were with the State Law Advisor at this very moment. It appeared that they were satisfied. The framework for medical use and research had also been submitted, which also included the licensing of growers using controlled cultivation methods for medical, scientific and research purposes. There were various cultivars of cannabis which had different medicinal properties, she said.

Quality controls

The framework being worked to by DHA also includes reaching a standardised, quality assured product for medical use indications, bearing in mind that clinical decision-making in terms of Section 22A(9)(ii) and Section 21 of the Medicines Act must be made to the scheduling of products, Dr Gouws said.

For a while, Dr Joey Gouws said, cannabis as a medicinal drug for pain may remain as a Section 21 drug as things exist until all regulations were in place and registration and classification complete, so that the use could have a controlled start.  Herbal classifications may be allowed far earlier.

ends

 

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Parliament puts use of cannabis on hold

Evidence on cannabis needed…

cannabis drinksFor the moment at least, the possibility of the legal medical use of cannabis by injection or oral dose, the medical manner in which drugs are used to reduce pain and suffering, is out of the question.    This was decided at parliamentary portfolio committee level recently, the matter not going for vote or recommended for passage to the National Assembly.

Nevertheless this does not mean, in the long term, that the matter has been totally rejected by Parliament. IFP member, Dr. Narend Singh, in the last meeting of the portfolio committee on health before the recent short recess, introduced a Private Members Bill known as the Medical Innovation Bill.

Despite the Bill at this stage having been rejected at this stage by the committee, many tributes were paid to the late Dr. Mario Oriani-Ambrosini, IFP, who had tabled the idea in the last Parliament and formulated the original wording.

Basics first

Parliament, after debate at committee level, has suggested that more international opinion on the subject is garnered and the results of any further medical research is considered before parliamentarians are asked to consider laws on the subject.   They concluded that regulations, following such a law, would be difficult to enforce; that more work had to be done on broad legal considerations and that decisions, which would be difficult, must not be based upon emotion but empirical evidence.

Considerably more public and professional opinion locally had to be sought as well, they said, but the door was not closed on the issue. Most MPs referred to the possible unintended consequences of such a law where the legal use of such powerful drugs entering into the crime world and general abuse by habitual drug users was a distinct possibility.

Implementation of a change in government health policy towards cannabis, commonly referred to as marijuana, is allowed by the proposed Bill with a change at law to the approach in the treatment of cancer and other incurable diseases suggested.

Best practice guides

Existing treatments alongside such “innovative complementary therapies” were recommended to be administered only at “nominated medical treatment research centres”. The Bill, amongst its objectives, proposed to “codify existing best-practices to allow decisions by medical practitioners to innovate in cases where evidence-based treatment or management is not optimal or appropriate or because the available evidence is insufficient or uncertain.”

The Bill also seeks to “deter reckless, illogical and unreasonable departure from standard practice and legalise and regulate the use of cannabinoids for medical purposes and for beneficial commercial and industrial uses.”

Underworld the enemy 

The DA opposition stance on the issue was that despite the possible treatment properties for cancer, any such drug when ingested as a food into the stomach could lead to severe addiction and therefore much criminal abuse if such a manner of formulation became accessible via the underworld to the wider public.

Dr W James (DA) said the Bill was really about innovative approaches to cure and treat and consequently any parliamentary debate had to be about medical innovation as such.   Referring obviously to cancer he said, “in terms of molecular cell biology, a cure had to prevent the problem from re-occurring.  Unfortunately, science in terms of finding a cure as such had not advanced in the case of cancer.”  Therefore treatment, he said, was a completely different subject for consideration, especially in the case of cancer.

Consensus across party lines indicated that whilst the proposals would legitimise the intended purpose of alleviating the pain and suffering of patients, with such a change would also come the import or local manufacture of cannabis for medical purposes in terms of commerce, with a consequent difficult accompanying regulatory process.

Input needed

Bearing in mind the unintended consequences of such a proposal, MPs generally felt there had to be a lot more professional opinion on the subject. Parliament was not the forum for such a debate, at least not without more input from science-based research and advice on the subject of how to regulate, it was decided.

Finally, it was felt that the medical profession should be the final arbiters on scientific exactitudes and whether such an innovation should be adopted and how. Only then should the proposals be considered by Parliament. One ANC member remarked that “as South Africa was a highly opinionated nation such a matter should be opened up much more for more public consultation and advice.”

Dr. Narend Singh, when asked if he was dissapointed that the Bill had been rejected at this stage, replied that the tabling of the Bill had been part of a process. “The matter is now on the backburner”, he said, “I am very happy that  this should be the case. I would have be most surprised if matters had gone further at this stage. We will hear more though in due course, now that we have laid a foundation”.

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Sugar tax possibilities

Once again, a tax on sweet drinks and beverages arises….

sugar_caneProfessor Melvyn Freeman, head of non-communicable diseases, department of health (DoH), says the department is re-looking at the issue of introducing a sugar tax to encourage South Africans to consume less sugar.

His comment comes as a result of the publication of the World Health Organisation’s Global Cancer Report 2014, which reports that tobacco, alcohol and sweet drinks are driving a rapid growth in preventable cancers.

More than 30% of cancer deaths could be prevented by modifying or avoiding key risk factors, says the fact sheet, and these include tobacco use; being overweight or obese; unhealthy diet with low fruit and vegetable intake; lack of physical activity; alcohol use; sexually transmitted HIV-infection; urban air pollution and indoor smoke from household use of solid fuels.

Poor countries worst hit

More than 60% of world’s total new annual cases occur in Africa, Asia and Central and South America. These regions account for 70% of the world’s cancer deaths. It is expected that annual cancer cases, WHO says, will rise from 14 million in 2012 to 22 within the next two decades. Obesity, particularly with schoolchildren, is considered a problem by DoH locally, according to an earlier report to Parliament by minister of health, Dr Aaron Motsoaledi.

Analysts say, while it is important for governments to encourage people to take responsibility for their own health and make changes to their diet and lifestyle, regulators should consider controlling alcohol and sugar consumption in the same way as tobacco products.

“There is no final decision on a sugar tax as yet, but it is an option that is being considered and we are assessing all relevant factors around this,” says Prof. Freeman. The R12bn South African sugar industry is cost-competitive, consistently ranking in the top 15 out of approximately 120 sugar producing countries worldwide.

Also the sugar industry provides employment in job starved regions often in deep rural areas where there is little other economic activity or employment opportunity. Opportunities for this industry lie ahead and include biomass for renewable energy. In addition, the SA sugar industry has transferred 21% of freehold land under cane from white to black owners since 1994 off a base of 5%.

Sweet story

The South African sugar industry generates an annual estimated average direct income of over R12 billion. Sugar is manufactured by six milling companies with 14 sugar mills operating in the cane-growing regions.  The industry produces an average of 2,2 million tons of sugar per season.  About 75% of this sugar on average is marketed in the Southern African Customs Union (SACU). The remainder is exported to markets in Africa, Asia and the USA.

University of the Witwatersrand School of Public Health director Karen Hofman said it was not clear if a tax on beverages would be feasible, but even if it were, it should not be seen as a silver bullet. “Any regulatory effort will only ever be part of the solution. People should be free to eat and drink what they like, but they need to have a full understanding of what they are consuming,” says Hofman.

She adds that she is unaware of a specific tax on sugar anywhere in the world. “We do know that taxes have been successfully introduced in several countries, including France and Mexico,” says Hofman. Such taxes have been introduced on those who use sugar in some form of manufacturing or food and beverage supplies.

Obesity and SSBs

In the USA, the term sugar-sweetened beverages, or SSBs, is used – which are drinks sweetened with sugar, high-fructose corn syrup, or other caloric sweeteners. They are a significant source of nutrition-less or “empty” calories in the American diet, say some, and a significant contributor to the current obesity epidemic there. In the USA, researchers say that if the taxes are large enough they could reduce consumption and the revenue from these taxes to be used on obesity prevention.

Here in South Africa, Discovery health representatives has publicly cautioned against placing too much emphasis on the link between sugar consumption and preventable cancers.  Their Derek Yach says, “Tobacco remains by far the most powerful single determinant of cancer, accounting for 90% of the lung cancer cases and about a third of all cancer deaths.” He calls for all resources to focus on this area.

In a country like South Africa, with limited financial resources, he says, “a focus on taxes on sugar to reduce cancer is a misplaced policy which will have little impact on cancer incidences and distract people from the major diet issues – which are to increase healthy food intake.”
Previous articles in this category or as background
http://parlyreportsa.co.za//cabinetpresidential/sa-health-welfare-starts-in-small-way/

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