FDA light touch on medical devices for patient self monitoring

Senate inquiry barriers to patient access to medicinal cannabis

The Department of Health (DoH) recently released a report that reviewed and reported on barriers encountered by patients when trying to access to medicinal cannabis in Australia. There are many contributors who will understandably focus on the patient side, but few will identify the points of interest for medicinal cannabis manufacturers and distributors and how this review might impact their business plan, capabilities and resourcing requirements.

Here are my main takeaways:

1. There is a potential to leverage off the Pharmaceutical Benefits Scheme

The Pharmaceutical Benefits Scheme (PBS) is essentially a list of all the prescription medicines that are subsidised by the government. For a medicine to be added to the PBS list:

  1. The sponsor of the product (usually the manufacturer) submits a Common Technical Document (CTD) and dossier of evidence detailing the clinical efficacy, safety and manufacturing quality of the product
  2. The TGA evaluates the product and it can then be registered on the ARTG,
  3. The manufacturer may then apply for PBS listing
  4. The Pharmaceutical Benefits Advisory Committee (PBAC) reviews submission, and considers the effectiveness and cost of the medicine, including against that of alternative treatments.

But the Government has no power to compel a sponsor follow this route and, since it is an extended and costly process, much of the current access for cannabis proceeds via Authorised Prescriber or the Special Access Scheme – Category B.

However, this may be a short-sighted stance on the manufacturer’s part since addition to the ARTG would permit health practitioners to prescribe the product without additional paperwork, dramatically increase patient access and also exposure of products to the wider market.

Given the strict current standard for medicinal cannabis products (i.e. compliance to TGO 93 and GMP), manufacturers have already completed some of the hard work.

However, setting up clinical trials is a challenging, costly and time-consuming process, so each business must determine for itself whether the costs outweigh the potential gains.

2. Acceptable sources for import

The TGA requires imported medicinal cannabis finished product to be manufactured to an acceptable manufacturing standard. The report has directly indicated that the countries that demonstrate compliance to this principle include: Canada, Germany, the Netherlands, Switzerland and Israel.

While bulk biomass may end up coming from other sources, it generally doesn’t have to meet this manufacturing requirement (even if it needs to meet GACP). However, regardless of whether it is finished product or raw material, both products must comply with the TGO 93 testing regimen.

3. Legal markets for potential export

There are 53 countries which enable access to medicinal cannabis in some capacity as of October 2019, so for those thinking about potential legal export supply chains, you could consider the following:

Region Countries
Europe Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Luxembourg, Malta, Netherlands, North Macedonia, Norway, Poland, Portugal, Romania, San Marino, Slovenia, Spain, Sweden, Switzerland, and the UK.
Asia South Korea, Sri Lanka and Thailand
Middle East Israel and Turkey
Americas Argentina, Brazil, Bermuda, Canada, Chile, Colombia, Costa Rica, Jamaica, Mexico, Peru and Uruguay
Africa Lesotho, South Africa and Zimbabwe
Oceania New Zealand,  Vanuatu, and us (Australia).

Note that the import/export requirements for each country varies widely and in-depth understanding (or the employment of appropriate consulting services) of the local regulatory framework is a must.

4. Internal conflicts

The report states that the cultivation and manufacture scheme for medicinal cannabis in Australia aims to:

  • address Australia’s commitments under the Single Convention
  • minimise the risk of diversion of cannabis to illegal uses and
  • provide a product of high and consistent composition and quality suitable for use as a prescription medicine.

The last point is particularly pertinent, and a clear statement is made that the “Australian Government did not consider that personal cultivation of cannabis was appropriate for medicinal purposes.”

This conflicts directly with the Drugs of Dependence (Personal Cannabis Use) Amendment Bill 2018 that was recently released last year in the ACT and broadly welcomed as the first “legal recreational” bill for Australia.

While I admire the optimism, it would be remiss of me to point out that if you can still be arrested for possession (of above 50g) then it’s not technically legalisation; supplementary notes issued alongside the original legislation also indicate a greater focus on decriminalisation and enhancement of personal liberties.

Interestingly the bill’s introduction was intended to address the limited availability of cannabis medicines, however, as this current report by the TGA has highlighted, the “depiction of the situation as a “shortage” is not accurate.

Whether or not this will have any impact on local legal cultivators and manufacturers remains to be seen.

5. Rescheduling by the WHO:

The WHO Expert Committee on Drug Dependence has been conducting its own review and has made a recommendation to ease the international restrictions on preparations containing THC by down scheduling it from:

  • Schedule I (high potential for abuse, no accepted medical use in treatment, lack of accepted safety for use under medical supervision)


  • Schedule III (less potential for abuse than those in Schedules I and II, have a currently accepted medical use in treatment, abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence).

This is being done under the Under ICND Article 3, #4: “If the World Health Organization finds that a preparation because of the substances which it contains is not liable to abuse and cannot produce ill effects…and that the drug therein is not readily recoverable, the Commission may, in accordance with the recommendation of the World Health Organization, add that preparation to Schedule III.”

However, the WHO scheduling has been delayed and “physical dependence” has already been identified by the TGA for nabiximols: “while nabiximols has an established therapeutic value at therapeutic dosage levels, it is recognised to produce dependency and has a potential for misuse, abuse or illicit use….. therefore the loss of regulatory controls over prescribing for those with a drug dependency issue would seem premature.”

Hopefully additional evidence emerges out of other clinical trials that will positively sway their decision making so the control requirements can be relaxed.

6. Potential rescheduling of CBD in Australia

Of high significance to the market is the report’s disclosure that the TGA is currently undertaking a safety review of CBD at lower doses, based on the outcome of the (admittedly limited) studies. It is possible that the scheduling status of low dose CBD (which might permit ‘over the counter’ sales and mirror the wide consumer market seen in the UK) could be relaxed in 2020.

Again note: CBD would still be deemed a complementary medicine and require compliance with TGO 93 and GMP. As the regulatory environment shifts, it will be interesting to watch other avenues for the marketing of CBD products – perhaps the concerns raised in a previous blog (CBD cosmetics – a cautionary tale) would be rendered null and void.

Should this down-scheduling occur, it would be useful for manufacturers if the TGA were to indicate what they consider acceptable doses (and acceptable products) so that any confusion is avoided.

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