You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

June 24, 2024

Thailand Regulatory Change Paves Way for Psilocybin and Opiate Clinical Trials

Subscribe to Updates

Thailand’s Minister of Public Health recently promulgated the Ministerial Notification Re: Category 5 Narcotics Which Are Not Cannabis or Hemp Extract and Whose Consumption is Permitted for Treatment of Disease or for Research Purposes (2024). The notification took effect on April 23, 2024.

The substances whose regulatory controls are affected by this new notification are psilocybin mushroom (Psilocybe cubensis (Earle) Singer), opium poppy (Papaver somniferum L. and Papaver bracteatum Lindl.), and other plants in these genera from which opium, opium alkaloids, psilocybin, or psilocin may be derived. As a result of this notification, these substances are now classified as category 5 narcotics that can be applied in medical treatment. Without the implementation of this notification, patients could not access newly developed medicines containing these substances, as Thailand’s Narcotic Code prohibits the possession and use of category 5 narcotics.

Nonetheless, this does not mean that psilocybin mushrooms and opium can be used without any conditions. There is still a long process to go through before these substances can be used in medical treatment or clinical studies. Under the new notification, the FDA must first approve any medicinal drug formulation containing any of the above substances, and subsequently, the production must be approved for medical use or research purposes. The importation of medicinal drug formulations containing psilocybin mushrooms or opium is not allowed.

This seemingly small regulatory change addresses the previous legal obstacle to the research and development of such medicines. According to the previous regulation, a physician or researcher could apply to the Thai FDA for a license to produce or possess medicines containing the aforementioned narcotics. However, production and consumption are considered different activities, and consuming a narcotic-containing medicine, even if it was produced under a valid license, is prohibited by the Narcotics Code and is punishable by imprisonment, a fine, or both. Therefore, subjects in a clinical trial would not have been able to consume such medicines without falling afoul of the Narcotics Code.

In this new notification, the minister invoked his authority under sections 58 and 104 of the Narcotics Code to permit consumption, thereby exempting the patients in trials from legal liability if the narcotic-containing formulation has been produced under a valid license. Accordingly, clinical trials for such formulations are now legal in Thailand.

According to public databases, there is no report of such a clinical trial having been conducted in Thailand. Under the new regulatory landscape, however, Thailand is now ready to host this type of clinical trial—examples include studies of opium’s painkilling effects [1,2], psilocybin’s antidepressant properties [3], psilocybin’s therapeutic potential for alcohol addiction [4,5] and tobacco addiction [4,6], and psilocybin’s potential use as a tranquilizer and for toothaches [7,8].

Apart from the new drug development and access to drugs derived from psilocybin mushrooms and opium enabled by this notification, Thailand’s Department of Intellectual Property will likely react to this change by no longer viewing medical use of these narcotics as contrary to public order or morality, thereby making inventions containing these formulations patentable.

Because it clears legal obstacles impeding pharmaceutical research into derivatives of psilocybin mushroom and opium, this notification is an important step forward for the development of drugs that use category 5 narcotics in Thailand.

 

References

[1] Vadhel A, Bashir S, et al. Opium alkaloids, biosynthesis, pharmacology and association with cancer occurrence. Open Biol. 2023 May; 13(5): 220355.

[2] Kaye A, Patel N, Bueno FR, et al. 2014. Effect of opiates, anesthetic techniques, and other perioperative factors on surgical cancer patients. Ochsner J. 2014 Summer; 14(2): 216-28.

[3] Carhart-Harris R, Giribaldi B, Rosalind Watts, et al. Trial of Psilocybin versus Escitalopram for Depression. N Eng J Med. 2021;384(15):1402-11.

[4] Ziff S, Stern B, Lewis G, et al. Analysis of Psilocybin-Assisted Therapy in Medicine: A Narrative Review. Cureus. 2022; 14(2):e21944.

[5] Bogenschutz MP, Forcehimes AA, Pommy JA, et al. Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. J Psychopharmacol. 2015;29:289–99.

[6] Johnson MW, Garcia-Romeu A, Cosimano MP, et al. Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction. J Psychopharmacol. 2014;28:983–92.

[7] Butnariu M, Quispe C, Herrera-Bravo J, et al. Papaver Plants: Current Insights on Phytochemical and Nutritional Composition Along with Biotechnological Applications. Oxid Med Cell Longev. 2022;2022:2041769.

[8] Pieroni A., Quave C. L. Traditional pharmacopoeias and medicines among Albanians and Italians in southern Italy: a comparison. J Ethnopharmacol. 2005;101:258–70.

Related Professionals

Industries

Life Sciences

Location

RELATED INSIGHTS​ 

February 21, 2023
On December 28, 2022, the Ministry of Health of Laos issued Decision No. 3789/MOH on the Control of Hemp for Medication and Products (the “Decision”). The Decision approves the regulated cultivation, extraction, production, processing, storage, distribution, utilization, import-export, and transport of hemp. The Decision also authorizes the use of hemp and hemp-related products by the general population, although use of certain products is limited to those with medical prescriptions. Background In 2019, the Lao government established an ad hoc committee to consider the legalization of cannabis, as reported previously. The government permitted certain local companies to grow cannabis in specific zones under pilot programs, although it continued to strictly prohibit the use and commercialization, as well as consumption, of cannabis-related products, regardless of the level of psychoactive tetrahydrocannabinol (THC) in the products. Overview of the Decision The Decision was issued by the Ministry of Health (which led the ad hoc committee) and permits authorized companies to engage in certain activities involving the use of hemp and the consumption of hemp and hemp-related products. The Decision defines hemp (“porkeo” in Lao) as a “plant that belongs to the same family as ganja and bears the scientific name Cannabis Sativa L. (Cannabis sativa L. subsp. sativa var. sativa) which is a subspecies of ganja (Cannabis Sativa L.).” This definition aims at differentiating hemp from the general definition of ganja or marijuana, which continues to be listed as a prohibited narcotic in Laos. The Law on Narcotics (2007) and the Penal Code (2017) still prohibit the production, trade and use of all types of cannabis. These laws will need to be amended to ensure that they are aligned with changes set out in the Decision.  Authorized Hemp Activities The Decision allows approved companies to engage in the cultivation, extraction, production, processing, storage,
Read More
February 9, 2023
Vietnam’s Ministry of Finance is drafting a circular on determining the origin of imported and exported goods. This circular, a draft version of which has been released for public comment (“Draft Circular”), consolidates prevailing regulations and guidelines on determining the origin of imported and exported goods that are stipulated in the following legal documents, which the Draft Circular would replace when it comes into effect: Circular No. 38/2018/TT-BTC dated April 20, 2018, of the Ministry of Finance regulating the determination of origin of imported and exported goods, as amended by Circular No. 62/2019/TT-BTC dated September 5, 2019, of the Ministry of Finance; Circular No. 47/2020/TT-BTC dated May 27, 2020, regulating the time to submit documents proving the origin of goods and form of the documents proving the origin of imported goods applied during the Covid-19 pandemic; and Circular No. 07/2021/TT-BTC dated January 25, 2021, regulating the time to submit documents proving the origin of imported goods under the EU-Vietnam Free Trade Agreement (EVFTA). Generally speaking, the Draft Circular does not increase the administrative procedures for importers and exporters, but rather seeks to codify the recent practices implemented by the customs authorities. The Draft Circular focuses on providing comprehensive guidance for importing/exporting companies when carrying out administrative procedures to certify the origins of imported and exported goods to be in line with current trade practices and international commitments under new-generation free trade agreements. In particular, the Draft Circular supplements guidelines on declaring origins and submitting Certificates of Origin (C/Os) of imported goods under the EVFTA and the Regional Comprehensive Economic Partnership Agreement (RCEP). The Draft Circular also provides some new guidelines to facilitate exports (and imports) and overcome some obstacles and issues when implementing the prevailing regulations. For example, the submission of C/Os online, which was only applicable during the
Read More
January 27, 2023
The opening weeks of 2023 have already seen a sharp increase in enforcement against violations of product labeling and advertising rules in Cambodia, in line with a notice issued by the country’s Directorate-General for Consumer Protection, Competition, and Fraud Repression (CCF) last year. Since the Law on Consumer Protection was adopted in 2019, a major legislative push has been seen, with general rules coming out focusing on providing consumers with sufficient information on products and services, for example via product labeling or advertising rules. Then, more detailed regulations were adopted for specific product categories, for example for food products and cosmetics. Khmer language requirements have been a key feature of the recently adopted rules on advertising and labeling. Despite the Khmer language mandates in consumer protection laws and regulations, enforcement and compliance was low. Most products on the market—especially imports—did not comply with the language requirement. In line with the revamped regulatory framework, the CCF has increased its enforcement, enabled by recent substantial budget increases. They have adopted clear implementing regulations for their officers to enforce in a practical yet effective manner, and they have been issuing notices reminding companies to comply with the new rules. A September 2022 notice announced that increased CCF enforcement of product labeling rules would start on January 1, 2023. As noted above, this has already proven to be true, and enforcement is now proceeding in earnest. Companies should take heed of this notice and ensure compliance with the Khmer language requirements (detailed below), as the CCF has shown that it readily acts against violators, from small retailers to large conglomerates. Khmer Language Requirement A sub-decree issued November 4, 2022 requires all commercial advertising of products and services—by any channel—to use Khmer as the primary language. If foreign-language text is used in advertisements, it
Read More
January 10, 2023
On January 9, 2023, Vietnam’s National Assembly voted to approve a draft resolution on the continued implementation of policies for the prevention and control of the Covid-19 pandemic. Under this resolution, marketing authorizations (MAs) for the following drugs and medicinal ingredients will be extended to December 31, 2024, allowing continued use in Vietnam: Drugs and medicinal ingredients whose MAs expire from January 1, 2023, to December 12, 2024, and whose extension dossiers have been submitted but have not yet been approved in accordance with the Law on Pharmacy; and Drugs and medicinal ingredients whose MAs have been extended as per Resolution No. 12/2021/UBTVQH15 and have not been extended in accordance with the Law on Pharmacy. The extension does not apply to the following cases: Drugs and medicinal ingredients that have been recalled by the Law on Pharmacy; Drugs with signs of being unsafe for users that have been suspended from circulation/use and sealed for preservation in accordance with the Law on Pharmacy; and Drugs with MAs having a validity term of three years in accordance with the Law on Pharmacy. The Ministry of Health will announce the list of drugs and medicinal ingredients whose MAs are subject to be extended as described above.
Read More