„With all due respect for consumer protection, this really leaves one speechless!“

Interview with MCRA Managing Director Alexander Kristen.

There is currently a great stir about the planned adaptation of the Narcotic Substances Act. How do you explain this commotion and the protest against the planned changes?
These reactions are overblown and result from many companies and producers seeing their hopes dashed. Because what many have successfully ignored until now, the Ministry of Health has now stated more precisely: Yes, even a CBD extract which contains THC is subject to the Narcotic Substances Act. This was already true in the past, but for reasons of sales and profits, many simply ignored it. But CBD products without THC can continue to be sold in shops and apart from pharmacies.

Critics of the current change claim that the patients are the ones who will suffer the most from the consequences of this regulation. Is this true?
No, because the topic of medicinal cannabis remains untouched by this regulation – anything else is simply wrong. Business interests are affected by the consequences of this regulation, but those of patients are not. Why? Industrial hemp may in the future only be cultivated for horticultural and commercial uses, and the permissible THC level in production is being lowered from 0.3 to 0.2 percent. This is entirely irrelevant for patients. However: Preparations intended for medicinal uses are subject to the regulations of the Medicinal Products Act and in the future belong only in the pharmacy. This is an advantage for patients, because it is connected to a quality control by pharmacists. And what was the case up till now? Often the CBD extracts that were sold did not contain the active ingredient composition they were labelled with – although horrendous prices were paid for them.

How did this regulation come about, which is still under appraisal and will soon take effect without a necessary vote by the National Council?
I can only conjecture about it, but I assume that the sale of CBD buds had gotten out of hand and that the quality monitoring of many CBD products had fallen by the wayside. The AGES (Austrian Agency for Health and Food Safety) has been pointing out this problem for years, and I assume that the lawyers in the Ministry of Health and the Ministry of Justice have now recognised a need for action.

Does the current draft offer any positive aspects for you?
Positive is that a stop is being put to promised cures and medical advertising, and that the topics of quality inspection and consumer protection are coming to the fore. Because the call for CBD is justified, and the patients have a right to safe and high-quality products. But some central issues have remained unsolved and unanswered. We need large-scale change and not just patching of an already outdated paragraph. We need the legalisation of medicinal cannabis according to the example of the German or Canadian legal situation, and we need the end of the AGES monopoly on cultivating medicinal cannabis. There would also be an urgent need to de-criminalise recreational users.

Which issues have remained unsolved?
Who will oversee the planned changes? We don’t know. Is CBD now a recognised active ingredient and subject to the Medicinal Products Act, or does CBD rank as Novel Food? We don’t know, because a classification did not take place. In principle, no THC should be contained in a CBD extract or CBD product. The 0.3 percent THC was always just considered a reference value for production. It is unclear how much THC may now be contained in the various products. The European Food Safety Authority has provided the information that a daily intake of 0.07 milligrammes of THC for an adult is associated with zero risk. For an intoxicating effect, at least 2.5 mg of THC would be necessary. So why should just Austria no longer allow any THC at all in CBD preparations? With all due respect for consumer protection, this is really absurd! What we need here is a unified European regulation and a workable solution which is viable for the producers.

To what extent is MCRA affected by the planned regulation?
We do not sell or produce any CBD extracts or CBD products, so in that sense we are not directly affected by it at all. We are striving to develop and produce special CBD strains for medicinal production, but the requirements are still very unclear for this as well. In principle, no one really knows what’s what at the moment, and the current Narcotic Substances Act and the AGES monopoly on cannabis production for the medical field are hampering the entire development.

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