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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. 

WRITTEN BY

Tilleke & Gibbins
For further information, please contact:

Atthachai Homhuan – Director, Regulatory Affairs, Tilleke & Gibbins
atthachai.h@tilleke.com

Dr. Atthachai Homhuan is the director of the regulatory affairs department at Tilleke & Gibbins. Atthachai assists chemical, life sciences, pharmaceutical, and biotechnology companies with regard to the preparation and submission of the healthcare product dossiers for registration, including biological products and vaccines, biosimilar products, new chemical entities, medical devices, food and herbal products, cannabis and hemp, cosmetics, and household chemicals. He assists international companies in developing market entry strategies for countries in Southeast Asia. His broad experience allows him to evaluate the feasibility of product registrations, conduct pharmaceutical and medical device plant audits/due diligence, and coordinate pre-clinical and clinical trials in accordance with international guidelines and standards. Atthachai also reviews healthcare product labeling/claims/advertisements for food products, cosmetics, medical devices, cannabis and hemp, and drug products in Thailand and other Southeast Asian countries.

In addition, he also assists the life sciences industry to draft and review their patent claims and specifications. He advises patent agents on amending claims and providing responses to office actions. Atthachai frequently drafts counterstatements against opposing parties in trademark and patent applications. His practice also includes advising on pre-litigation and litigation matters involving the life sciences, medical devices, and pharmaceuticals. He has presented before the IP&IT Court as a witness in chemistry and life sciences patent litigation.

Prior to joining the firm, Atthachai was a postdoctoral researcher in Japan and Taiwan, focusing on stem cell therapies and vaccine development. He applied his technical expertise to the industry when he became a project manager for a Thai vaccine manufacturing company, where he led the firm’s R&D efforts. His industry background also includes serving as a formulation manager at the subsidiary of a well-known American pharmaceutical innovator, where he was the group leader in charge of the company’s R&D and production functions.

Atthachai holds a PhD in Pharmaceutical Technology from Thailand’s Mahidol University, and he frequently lectures on pharmaceutical and chemical patents at universities across Thailand. He has completed the FICPI South East Asian Drafting Training Course, enabling him to prepare patent applications and claims.

EXPERIENCE

  • Assisted pharmaceutical companies in drafting sale and purchasing agreements and held discussions with the Ministry of Public Health with regard to the purchasing agreements of COVID-19 drug products.
  • Advised pharmaceutical companies about the Thailand Emergency Use Authorization (EUA) approval requirements of COVID-19 drug products and vaccines.
  • Revised guidelines for Thai patent officers examining chemical and pharmaceutical patents.
  • Implemented a quality-control system and addressed GMP-related topics for the manufacturing of vaccines. This involved working closely with the Department of Medical Sciences of the Thai FDA with regard to biohazard manufacturing and audits, in order to obtain approval.
  • Worked with companies in the agricultural and chemicals industries with regard to complaints on substandard products raised by the Ministry of Agriculture.
  • Reviewed clinical trial agreements and bioequivalence studies for new drugs and conventional products, and ensured that the trials/studies and protocols were in accordance with Good Regulatory Practices and Good Clinical Practices.
  • Assisted life sciences and chemical companies to draft a variety of complex patents involving the manufacturing process for creating polymers from waste gas and patents related to biological vaccines, among others.
  • Audited leading pharmaceutical companies to ensure that their product registration dossiers and advertising campaigns comply with Thai legislation.
  • Registered new biological product dossiers at the Thai FDA and received approvals within 1.5 years—a relatively short period of time to obtain approval for a new drug in Thailand.
  • Registered medical devices, food products, and cosmetics with the Thai FDA for domestic and international companies.
  • Worked with the firm’s litigation team and won a disputed patent litigation case for a chemical glass company, in which the opposing party claimed damages exceeding THB 50 million.

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