VMDA says framework for monitoring and oversight in cannabis research needed

The Vanuatu Medical and Dental Association (VMDA) has recommended for the Government to suspend the human research into medicinal cannabis as treatment for diabetes in Vanuatu until a proper system covering pertinent areas such as legal, ethical, justice, cultural, religious and health are in place to provide independent monitoring and oversight of the research.

The VMDA made this recommendation in a submission to the Parliamentary Social Policy Committee on June 5.

It also recommended for Medicinal cannabis not to be included in the national health system (serving majority of the population) until a clear framework is set in place to monitor the product, its prescribing practices and use.

The third recommendation by VMDA was for no changes to be made to the Dangerous Drug Act in relation to medicinal cannabis until the above recommendations are fulfilled.

In the submission signed by President, Dr Basil Leodoro, VMDA stated that the term ‘medicinal cannabis’ being referred to here is cannabis used for medicinal purposes to cure or relieve symptoms of specific medical conditions and so this distinguishes it from cannabis used as food, recreational drug or other products.

“Although research is expanding in the area of medicinal cannabis, scientific knowledge about how it affects the body is relatively recent and incomplete for some medical conditions. Studies that have been cited in support of its efficacy often rely on research (case reports and very small cohort studies) that lack rigor in methodology and controls.

“This indicates the need for high quality studies to be undertaken to support some of the claims, anecdotes and aspirations for the efficacy of medicinal cannabis.

“There is a body of scientific knowledge that supports treatment of specific medical conditions with medicinal cannabis, like severe pain from cancer, HIV or AIDS for example.

“But there is still research being done into the other medical conditions, like Diabetes Type 2.

“We are of the understanding that a clinical trial of medicinal cannabis for the treatment of Diabetes is to be conducted in Vanuatu.

“According to our knowledge, research into medicinal cannabis as a treatment for diabetes is still ongoing,” the VMDA stated in its submission.

The VMDA stated that at this point, Vanuatu is not yet ready to be conducting human research such as clinical trials for the following reasons:

Firstly, Vanuatu does not yet have a robust system in place to engage in human research: In other countries, clinical trials are registered, made transparent and regulated by laws and codes of conduct that aim to protect participants and integrity of the research.

There are stringent guidelines and controlled protocols that must be carefully adhered to, including reporting back to various government agencies and scientific meetings with reports. Therefore, a whole system aimed at providing independent monitoring and oversight has to be in place before a clinical trial is conducted.

Second is related to ethical reasons: Researchers need approval from a local Research and Ethics Committee that act as an independent body safeguarding the interests, autonomy, and culture of the participants.

Such a body ensures the accountability of the researchers to their participants and the research.

VMDA told the Parliamentary Social Policy Committee that the Ministry of Health is in the process of reviving its research and ethics committee and until then a research should not commence without an approval of such a committee.

The Association also stated that prescribing and monitoring of the use of medicinal cannabis is also important.

It should be noted that the decision as to which patient can be prescribed medicinal cannabis is always a medical decision to be made by a registered medical practitioner.

“Should the government bring in medicinal cannabis, how and for what medical conditions should it be prescribed for, and who should be given authority to prescribe?

“There has to be a regulatory body that ensures that medicinal cannabis imported into the country are approved by recognized drug bodies, like the Food and Drug Administration (FDA) and also the National Drug and Therapeutic Committee (NDTC).

“While we understand that there are other economical benefits of cannabis farming, as an association, it is our duty to protect the integrity and wellbeing of our people thus this submission highlighting our major concerns regarding medicinal cannabis and human research in this area,” VMDA stated in its submission signed by President Dr Leodoro.

Last week on Friday when officially opening the First Ordinary Session of Parliament for 2019, President Obed Tallis, said the people of Vanuatu must be consulted first before a law is drafted for the cannabis industry.

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