Keen to learn more about regulatory reforms in Thailand? Read on! Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
The Patent Act
The Patent Act is currently under review and final revision by the Department of Intellectual Property and is expected to be passed soon. The Act’s amendments aim to update Thai patent law according to international agreements and standards. Areas for amendment include:
- Reducing the long periods of pendency for patent registration and improving the patentability and enforceability of petty patents.
- Accepting the Protocol Amending the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) regarding Thailand’s public health.
- Facilitating Thailand’s accession to the Hague Agreement regarding design protection.
The Narcotics Act
The Narcotics Act was recently amended. The major revisions were made to allow: – The use of medicinal cannabis, and government controlled production of medicinal cannabis. Private Thai companies are now allowed to partner with certain government organizations to begin development and production of medicinal cannabis facilities. Private organizations will likely be allowed to produce without government cooperation in the coming years.
- Production of hemp for industry, so long as it contains less than 1% THC by dry weight and is produced in certain designated regions of Thailand.
- Ministerial regulations regarding the specific policies have not yet been published.
Herbal Product Act 2019
The Herbal Product Act 2019 was recently enacted. However, the ministerial regulations regarding the registration of herbal medicine has not been published yet. At present, if an individual or company aims to register a herbal medicine product, they must follow the current regulations published by the Bureau of Food or Drug.
2. When are they likely to come into force?
The enactment date for amendments to the Patent Act is currently unknown. It has slowly made its way to the final stages of review and is expected to be decided on relatively soon.
The amendments to Drug Act are expected to be enacted on October 13, 2019.
The Herbal Product Act 2019 and amendments to the Narcotics Act have already been enacted and are currently waiting for bylaws to be announced and enforced.