Legislation and Regulations
The primary legislation governing pharmaceuticals in Thailand is the Drug Act, B.E. 2510 (1967), along with its amendments and ministerial regulations and notifications, which encompass specific regulations and requirements (collectively referred to as the "Drug Law"). Similarly, the primary legislation governing medical devices in Thailand is the Medical Devices Act, B.E. 2551 (2008), along with its amendments and ministerial regulations and notifications, which encompass specific regulations and requirements (collectively referred to as the "Medical Devices Law"). These acts provide regulatory frameworks for pre-market and post-market controls for pharmaceuticals and medical devices in Thailand, respectively.
The Thai Food and Drug Administration (the "Thai FDA"), which falls under the Ministry of Public Health (MOPH), serves as the primary government administrative and regulatory body overseeing pharmaceuticals and medical devices in Thailand. The Drug Control Division of the Thai FDA is the primary regulatory body responsible for drug regulation, including pre-market control, post-market control, and development of standards and regulations. Similarly, the Medical Device Control Division of the Thai FDA is the main regulatory body for medical device control in Thailand.
Under the Drug Law, if the licensing authority refuses to grant or renew a licence, the applicant has the right to appeal against that decision to the MOPH within 30 days of receiving notice of the decision. Failure to appeal within the designated timeframe will result in licence revocation. While the Drug Law does not specify a timeframe for appeal consideration, the period for appeal consideration will follow the Administrative Procedure Act, B.E. 2539 (1996), which is 30 days from the date of receiving the appeal.
Regarding medical devices, if the authority fails to issue an establishment licence, licence, or specifications declaration receipt, or does not renew an establishment licence, the applicant has the right to appeal that decision to the MOPH within 30 days of receiving notice of the non-issuance. According to the Medical Devices Law, the MOPH must complete the appeal process within 120 days of receiving the appeal. If, due to extenuating circumstances, the consideration cannot be completed within the specified period, a written notice must be sent to the appellant before the expiration of the period. The appeal consideration period may be extended for up to 120 days beyond the initial 120-day consideration period.
Under the Drug Law and the Medical Devices Law, the decision of the Minister of Public Health shall be final. However, if the appellant is dissatisfied with the MOPH՚s decision, they have the right to file a case before the Administrative Court.
Under the Drug Law, pharmaceuticals are categorised into the following categories:
Under the Medical Devices Law, medical devices are categorised into three main categories as follows:
In addition, the Notification of the MOPH Regarding Medical Device Classification According to Risk Level B.E. 2562 (2019) (the “MOPH Notification 2019”) further classifies medical devices based on the degree of risk as listed below in order to align with the Association of Southeast Asian Nations Medical Device Directives (AMDD);
Therefore, according to the Medical Devices Law and the MOPH Notification 2019, medical devices are classified as follows:
There is no specific law governing clinical trials in Thailand. Furthermore, there is no requirement that clinical trials must be conducted locally in order to obtain marketing authorisation in Thailand. However, the informed consent process is indirectly governed by the following:
In addition, there are many regulations that govern health professionals conducting clinical trials including:
Any research institute that wishes to undertake a clinical trial must establish a research ethics committee to review and approve research projects involving clinical trials. The committee must be certified by either the NRCT (under the National Ethics Committee Accreditation System of Thailand (NECAST)) or The Strategic Initiative for Developing Capacity of Ethical Review/Forum for Ethical Review Committee in Asia-Pacific (SIDCER/FERCAP).
If a clinical trial is conducted for a pharmaceutical, the above committee must be approved by the Thai FDA. In addition, the pharmaceutical must be used only in research projects approved by the Thai FDA.
In general, the research institute undertaking clinical trials usually publishes annual reports of the clinical trial on its website. These reports contain only an overview and progress of the clinical trials undertaken in such research institutes without disclosing results of the trials. While these reports must be submitted to the Thai FDA, the authority does not currently provide a publicly accessible database of the reports.
There are no laws or regulations that restrict the use of online tools to support clinical trials, provided that such tools comply with the PDPA.
There is no specific law or regulation that categorises data obtained from clinical trials as personal or sensitive data. However, resulting data from the clinical trials may be deemed personal or sensitive data under the PDPA, depending on the information in such data.
Under the PDPA, personal data is defined as any information relating to a natural person, which enables the identification of such person, whether directly or indirectly, but not including information of deceased persons. Although, the PDPA does not provide an explicit definition of sensitive data, the PDPA does list several categories of personal data that are subject to greater protection, including health data. The PDPA requires that the processing of sensitive personal data must meet a higher standard of consent and security measures than non-sensitive data.
Under the PDPA, such resulting data from the clinical trials may be transferred to a third party or an affiliate after receiving explicit consent from persons involved in the clinical trials. Additionally, all data management activities, including the transfer of such resulting data, must comply with provisions stipulated in the PDPA.
The creation of a database containing personal or sensitive data obtained from clinical trials would not be subject to any requirements beyond those proscribed in the PDPA.
The term “pharmaceutical” under the Drug Law refers to substances intended for use in the diagnosis, treatment, relief, cure or prevention of human or animal disease or illness. It also includes substances which are pharmaceutical chemicals or semi-processed pharmaceutical chemicals, as well as substances intended to affect the health, structure or function of the human or animal body. However, this term does not include substances intended for use as food for humans, sport devices, medical apparatus, cosmetics or devices for use in the practice of healing arts or practice of medicine or components thereof, or those intended for use in a science laboratory for research, analysis or verification of diseases that are not directly related to the human body.
The term “medical device” under the Medical Devices Law refers to an instrument, tool, mechanical device or object that is used for insertion into a human or animal body, fluid for laboratory examination, product, software or any other object specifically intended by the manufacturer for specific uses (such as therapy, medical practice, dental practice, diagnosis, prevention, monitoring, treatment, relief or cure of human or animal disease or injury) either solely or as a constituent or accessory of any other object. It also includes equipment or a constituent of an instrument, tool, mechanical device product or object thereof. However, the accomplishment of the above purposes, which occurs within a human or animal body, must not be the result of a pharmacological, immunological or metabolic process.
For a combination product that includes both a drug and a device, its classification as either a drug or medical device will be based on its intended use. The Thai FDA will make a final decision to classify such a combination product at its discretion, where it cannot be clearly distinguished. However, the Division of Innovative Health Products and Services under the Thai FDA provides an online consultation service regarding this.
There are no specific requirements for biologic medicinal products, including biosimilars, to receive a marketing authorisation. Importantly, the marketing authorisation procedures for new, generic, biologic, and biosimilar drugs do not differ.
For marketing authorisations, pharmaceuticals are classified into three categories as follows:
Under the Drug Law, the marketing authorisation of a drug formula must be renewed every seven years. An application for renewal must be submitted before the expiration date.
Under certain conditions, the marketing authorisations of a drug formula can be revoked in cases where:
As mentioned in 1.3 Different Categories of Pharmaceuticals and Medical Devices, medical devices are classified as follows:
All classifications of medical devices are valid for a period of five calendar years and renewable.
Marketing authorisations of medical devices may be revoked in certain conditions including:
Individuals or juristic persons must obtain a licence from the Thai FDA to manufacture, sell or import drugs.
The manufacturer or importer must file an application for manufacturing or importing drug samples as appropriate, to request a marketing authorisation. For imported drugs, a certificate of Good Manufacturing Practice (GMP) of the overseas manufacturer must also be provided. The amount of the drug to be manufactured or imported for the marketing authorisation are subjected to the Notification of Drug Control Division.
The manufacturer or importer must file a marketing approval application, along with drug samples, certificate of such drugs including product characteristics, technical and safety information and data concerning the results of clinical trials, and other pertinent data to the Thai FDA in order to obtain marketing authorisation.
Individuals or juristic persons must obtain an establishment licence from the Thai FDA to manufacture or import medical devices.
The manufacturer or importer must file a marketing approval application to the Thai FDA in order to obtain marketing authorisation. The Note for Licence and Detailed Notification Medical Devices, Common Submission Dossier Template (CSDT) according to the AMDD must be applied.
To amend a marketing authorisation for pharmaceuticals and medical devices, such as therapeutic indication, formulation, packaging or labelling, the marketing authorisation holder must submit a request for the amendment, along with supporting documents, to the Thai FDA.
Transfer of Marketing Authorisation
According to the Drug Law, it is possible for a marketing authorisation holder to transfer its licence to another holder under certain conditions. A marketing authorisation holder can transfer its licence to another holder with the approval of the Thai FDA. The transfer must be made in writing and must include the reasons for the transfer, as well as the details of the transferee. Both the transferor and the transferee must be licensed by the Thai FDA to manufacture or import drugs. The transferee must also have the technical capability to manufacture or import the drug covered by the licence.
The Thai FDA will evaluate the application for the transfer of the licence based on the information provided by the transferor and the transferee. If the transfer is approved, the transferee will become the new marketing authorisation holder and will be responsible for complying with all applicable regulations and guidelines.
However, the Medical Device Law in Thailand does not provide regulations for the transfer of licences from marketing authorisation holders to another holder.
The Drug Law and Medical Device Law do not explicitly outline compassionate-use programmes.
However, pharmaceuticals manufactured and imported for the following purposes will not be subject to a marketing authorisation, if they comply with the requirements outlined in the Notification of the MOPH:
In addition, only the following entities are authorised to produce and import pharmaceuticals without possessing a licence:
The Medical Device Law requires licence holders to prepare and maintain a record of the manufacturing, importation and sale of their medical devices for a specific period of time. Moreover, there are notifications issued by MOPH and the Thai FDA that regulate licence holders to report the device malfunction and/or adverse event.
For pharmaceuticals, the Safety Monitoring Programme (SMP) of new drugs has been in place in Thailand since 1991 and has been updated periodically. In 2017, the Thai FDA issued a notification on the risk-based approach of the SMP. The Health Product Safety Surveillance Centre (HPVC), an organisation under the Strategy and Planning Division of the Thai FDA, has also made a publicly available adverse event reporting website. The HPVC is responsible for collecting reports and managing the adverse event database of health products, including drugs, food, cosmetics, medical devices, herbs and more.
In general, third parties are not allowed to access pending applications for marketing authorisations for pharmaceuticals and medical devices in Thailand as the Thai FDA considers these applications as confidential information. However, there may be some circumstances under which third parties could access information in pending applications, such as in cases where the information is required for legal proceedings or public health and safety reasons. In these circumstances, the third party would need to obtain special permission from the Thai FDA or other relevant authorities to access the information.
Both the Drug Law and the Medical Devices Law prescribe criminal penalties for any illegal acts regarding the production, import, marketing and/or distribution of pharmaceutical products and medical devices, including but not limited to:
In Thailand, there is a customs recordal system to tackle counterfeit products at the borders. Trade mark or copyright owners (or their representatives) may file an application specifying any preliminary information that customs officers may use to verify the authenticity of goods being exported, imported or transited through Thailand on the spot. The application must be filed with the Customs Department, not the Department of Intellectual Property (DIP) as previously done. The customs recordal will be valid for three years and is renewable. Rights holders who have previously filed a customs recordal with the DIP need to re-file the customs recordal with Customs Department.
If the rights holders proceed with customs recordal, the Customs Department may look out for suspected counterfeit products, including but not limited to, pharmaceuticals and medical devices and proceed with their ex-officio action against suspected counterfeit products.
Generally, manufacturers of pharmaceuticals and medical devices are subject to an authorisation for manufacturing from the Thai FDA.
To obtain a licence for pharmaceutical manufacturing, a manufacturer must apply for the licence along with necessary documents to the Thai FDA. A licence will be granted if the applicant՚s facility is qualified under the Pharmaceutical Inspection Co-operation Scheme (PIC/S), Good Manufacturing Practices (GMP), and all necessary documents are satisfactory. Once a licence is granted, it will be valid up until 31 December of the year in which the licence is issued. An application for renewal must be submitted before expiration of the current licence.
To obtain a licence for medical device manufacturing, a manufacturer must apply for the licence along with necessary documents to the Medical Device Control Division of the Thai FDA. The Thai FDA will grant a licence if the applicant՚s facility is qualified with the GMP and all necessary documents are satisfactory. Once a licence is granted, it will be valid up until 31 December of the fifth year from the year in which the licence was issued. An application for renewal must be submitted before expiration of the current licence.
Wholesale of Pharmaceuticals
The wholesale of pharmaceuticals is subject to the authorisation of the Thai FDA. To obtain a wholesale licence, an application must be submitted to the Thai FDA, and the applicant must meet qualifications outlined in the ministerial regulations. The wholesale licence is valid until 31 December of the year in which it is issued, after which an application for renewal must be submitted before the current licence expires.
In addition, under the Drug Law, a person who obtains a manufacturing licence or import licence is also licensed to engage in the wholesale of pharmaceuticals.
Wholesale of Medical Devices
The wholesale of medical devices also requires authorisation of the Thai FDA. An application for a sale licence must be submitted to the Thai FDA, and the applicant must meet the qualifications outlined in the ministerial regulations. The wholesale licence is valid until 31 December of the year in which it is issued.
See 1.3 Different Categories of Pharmaceuticals and Medical Devices.
The importation and exportation of pharmaceutical and medical devices are mainly governed by the following laws and government authorities:
The importation of pharmaceuticals requires a licence from the Thai FDA prior to importation into Thailand. The manufacturer or importer must obtain a local drug registration for that drug prior to the importing, manufacturing, marketing or selling of the said drug. It should be noted that registration requirements of the drugs differ for each type of drug.
To import medical devices, importers must first obtain an importing establishment licence and subsequently an import licence. Depending on the type of medical device, importers of medical devices could either be subject to a licensing, notification or listing requirements according to the Thai FDA’s classification of medical devices. Please note that requirements for the importer to comply with the Thai FDA differ for each type of medical device.
The exportation of pharmaceuticals and medical devices are not subject to additional licences. Manufacturers of pharmaceutical and medical devices, as holders of a manufacturing licence, must report regarding its exportation activities as well as submit the required information to the Thai FDA to obtain certificates required for the customs clearance process.
Only the entity that has been granted licences by the Thai FDA for the importation of pharmaceuticals and medical devices in Thailand can act as the importer of record for such products.
The importation of pharmaceuticals and medical devices into Thailand requires prior licensing and local product registration (market authorisation), notification or listing as regulated by the Thai FDA.
The importation of pharmaceuticals into Thailand is subject to a licence from the Thai FDA prior to importation. Moreover, the manufacturer or importer must obtain a local drug registration for that drug before importing, manufacturing, marketing or selling it. Please note that the registration requirements of drugs vary for each type of drug.
Importing medical devices into Thailand requires importers to first acquire an importing establishment licence, followed by an import licence. Depending on the type of medical device, the importer may be required to comply with licensing, notification or listing requirement based on the Thai FDA’s classification of medical devices. Please note that requirements for importers vary for each type of medical device.
Importation of pharmaceuticals and medical devices into Thailand is governed by a licensing and market authorisation system as stipulated by the Thai FDA.
In general, the Thai FDA and other relevant agencies in Thailand have the authority to restrict importation and exportation of certain products that may harm consumers or be contrary to public order or good morals. For example, under the Export and Import of Goods Act, the Minister of Commerce has the authority to stipulate goods that are subject to importation and exportation restrictions.
Thailand has been a member of WTO since 1995, and ASEAN since 1967. Additionally, Thailand has signed 14 free trade agreements with 18 countries, including but not limited to, China, Japan and USA.
In Thailand, there are no specific laws and regulations that govern pricing of pharmaceuticals and medical devices. The pricing of medicinal products is subject to control only if they are listed in the National List of Essential Medicines (NLEM), which is announced by the NLEM’s Drug System Development Committee. Medicinal products listed on the NLEM are usually prescribed and dispensed in public hospitals and public health services. Public hospitals purchase medicinal products at a price not exceeding the median price indicated on the NLEM. However, private hospitals and drug stores can set their own prices for the medicinal products they sell at their establishments.
Generally, price levels of pharmaceuticals or medical device do not depend on or are not influenced by the prices of the same products in other countries. However, the prices of pharmaceuticals for the same products in other countries may be a factor for the determination of pricing decisions for drugs listed in the NLEM.
In Thailand, the costs of pharmaceuticals and medical devices are reimbursed from public funds to varying extents, depending on the type of product, the patient's health insurance coverage and the healthcare setting. There are three main schemes for public health coverage as set out below.
It is worth noting that all three schemes use the NLEM as a basis for reimbursable medicinal products. The medicinal products outside of the NLEM can also be reimbursed, only with a prescription by medical professionals in charge stating it is necessary to cure the patient of a sickness. Reimbursement is subject to the conditions set by the Thai National Health Security Office (NHSO) or other relevant authorities.
In Thailand, health technology assessments (HTAs) are used in determining what price should be paid and reimbursed for pharmaceuticals and medical devices.
The NHSO is responsible for the HTA healthcare interventions. The NHSO՚ HTA process involves a comprehensive analysis of the clinical effectiveness, safety and economic value of a product.
The results of the HTA are used to inform pricing negotiations with pharmaceutical companies and to determine the reimbursement status of a product. Products that are deemed to be cost effective and have a favourable budget impact may be listed in the NLEM, which is used as a basis for reimbursement decisions by government healthcare insurance schemes.
Generally, there are no specific regulations for pharmaceutical prescriptions and dispensing by pharmacies in Thailand.
Specially controlled drugs (see 1.3 Different Categories of Pharmaceuticals and Medical Devices) can be dispensed to patients by a licensed pharmacist with a prescription from a licensed medical practitioner.
Pre-packed drugs and dangerous drugs can be dispensed to patients by a licensed pharmacist, without a prescription.
Household medicines (OTC drugs) are not required to be prescribed by medical practitioners or to be dispensed by a pharmacist. Common household drugs can be sold to consumers by anyone, for example, supermarkets or convenience stores.
Software is included under the definition of a “medical device” under the Medical Devices Law. Depending on the function of the software, the app could be subject to regulation as a medical device.
The Thai FDA has issued example guidelines of its assessment of software subject to regulation as a medical device, as set out below.
Software which is not considered a medical device:
Software which is considered a medical device:
It is worth noting that this is not an exhaustive list and the Thai FDA may classify software differently based on its function and intended use.
Telemedicine services are regulated under the MOPH Notification Regarding Standards of Service of Medical Facility via the Telemedicine System B.E. 2564 (2021) (the “MOPH Telemedicine Notification”) and the Medical Council of Thailand Notification No 54/2563 (2020) Regarding Guideline for Telemedicine (the “Medical Council Telemedicine Guideline”).
According to the MOPH Telemedicine Notification, medical facilities that wish to provide telemedicine service must apply for an additional service from the MOPH. In addition, medical facilities providing telemedicine services are subject to additional criteria under the MOPH Telemedicine Notification, namely ensuring there is no effect to the main service provided on-site at the medical facility, ensuring a secure telemedicine system, and being liable for any consequence arising from the provision of its telemedicine service. Physicians are also required to only provide a telemedicine service through a medical facility, according to the Medical Council Telemedicine Guideline. In this case, a medical facility refers to a medical facility which is licensed to operate a medical facility under the Medical Facilities Act B.E. 2541(1998).
The Medical Council Telemedicine Guideline also prescribes additional rules for physicians to follow professional codes of conduct, understand the limitations of technology in telemedicine, assess whether a condition or disease is suitable for treatment via the telemedicine system, and more.
Advertising medicines and medical devices require prior approval from the Thai FDA, regardless of whether the dissemination will be through online or offline media channels. The entity wishing to advertise a drug or medical device must submit the image, text and sound that makes up the advertisement to the Thai FDA for review and approval. The criteria for approval are prescribed under the Drug Law and the Medical Device Law. The criteria differ depending on the type of drug or medical device and whether the advertising is targeted at the general public or healthcare professionals. For example, drugs categorised as “dangerous drugs” and “specially controlled drugs” are only allowed to be advertised directly to healthcare professionals and not to the general public.
For medical devices, the entity wishing to advertise a medical device is required to obtain an advertising licence for medical devices and approval prior to dissemination. However, if the advertising will be targeted directly at healthcare professionals meeting criteria prescribed by the Thai FDA, an advertising licence would not be required.
Online prescriptions of medicine by pharmacists are permitted under the Pharmacy Council of Thailand Notification No 56/2563 (2020) Regarding Prescription of Standards and Procedures for Providing Telepharmacy (the “Telepharmacy Regulation”). However, any prescriptions that do not comply with the Telepharmacy Regulation would be considered prohibited as per the Drug Law, which prohibits the sale of drugs outside of the specified location mentioned in the seller’s drug sale licence.
Online sales of medicine are permitted under the Telepharmacy Regulation. However, any sales of medicine that do not comply with the requirements stated in the Telepharmacy Regulation are currently prohibited as the Drug Law, which restricts the sale of drugs outside of the location specified in the seller’s drug sale license.
Electronic health records are not specifically regulated in Thailand, but they must comply with the PDPA (please refer to 2.5 Use of Resulting Data From the Clinical Trials).
There is no specific prohibition for processing data on cloud platforms. However, if personal data is processed via cloud platforms, it must comply with the PDPA requirements regarding security standards and the transfer of data to locations outside of Thailand.
In Thailand, the primary legislation governing patents is the Patent Act B.E. 2522 (1979) along with its amendments and relevant regulations (collectively referred to as the “Patent Law”). Pharmaceutical and medical device products may encounter several issues under the Patent Law, including meeting standard criteria including novelty, inventive step and industrial applicability) as well as complying with disclosure requirements. Additionally, determining the patentability of subject matter can also be an issue.
Regarding the inventive step, subsequent pharmaceutical patents that modify existing active pharmaceutical ingredients (also known as “evergreening patents”) can be controversial, as the changes made to the original invention may not constitute a substantial improvement to justify the grant of a new patent.
In terms of patentability of subject matter, the Patent Law imposes certain restrictions on patent-eligible subject matter, which includes:
Furthermore, it is important to note that the Thai Patent Examination Guideline provides extensive guidance and instructions to patent examiners on how to assess patent applications. The guideline includes examples of inventions that would not qualify as patent-eligible subject matter, such as a genetically-edited microorganism that mimics naturally occurring variants and a subsequent medical use that involves a method of administration or dosage regime (please refer to 9.2 Second and Subsequent Medical Uses).
In general, second and subsequent medical uses of a known product (such as a known chemical substance) in the form of a "Swiss-type claim" (eg, use of substance X in the preparation of a medication for the treatment of disease Y) can be patented in Thailand. However, if a Swiss-type claim involves a method of administration or dosage regime, which is considered a method of treatment claim, it will not be patentable. Additionally, the Swiss-type claim must be sufficiently supported by the patent specification.
There are currently no mechanisms for patent term extension in Thailand under the Thai Patent Law.
According to the Patent Law, the patent holder has the following exclusive rights:
Any person who violates the exclusive rights of the patent holder without the consent or permission of the patent holder will be in infringement of the patent unless an exemption applies.
It is worth noting that the mere act of applying for marketing authorisation for pharmaceuticals is not considered patent infringement in Thailand. There is a patent infringement exemption allowing a person to seek regulatory approval for a product even when there is a valid patent for the product.
However, it is important to note that only actual infringement is actionable under the Thai Patent Law. The threat of infringement, without actual infringement, is not actionable. Additionally, there is no requirement of “imminent” infringement. The patent holder must show its ownership of the infringed patent as well as prima facie evidence of infringement when filing a complaint against an infringer.
Specific defences to patent infringement in relation to pharmaceuticals and medical devices include:
In addition, any ground such as lack of novelty and/or inventive step, or non-patentable subject matter which may invalidate or revoke the patent, can be considered as a ground of defence to patent infringement.
According to the Patent Law, any person can submit a request for a compulsory licence of a patent at any time after three years from the grant of a patent or four years from the filing date of an application, whichever is later, subject to the following conditions:
Moreover, a person who submits a request for a compulsory licence must demonstrate that they have made efforts to obtain a licence from the patent holder by proposing reasonable conditions and remuneration but failed to reach an agreement within a reasonable time period.
A patent holder including its authorised attorneys can bring proceedings for patent infringement before the court and claim for remedies or damages. However, only actual provable damages will be awarded. There are no punitive or statutory damages for patent infringement. A patent holder may calculate requested damages based on reasonable royalties or loss of profits and any other provable monetary damages and would have to prove that such damages were incurred directly from the infringing actions. If the judgment is ultimately in favour of the plaintiff, the court will consider the evidence from both the plaintiff and the defendant to determine appropriate damages.
In Thailand, both criminal and civil actions are available for patent infringement. Brief general procedures of each action are as follows.
A patent holder may initiate a civil case by filing a written complaint directly with Central Intellectual Property and International Trade Court (the “IP Court”). The complaint must describe which patent and which of the claims are being infringed. After the complaint has been filed, the IP Court will serve the complaint on the defendant, providing the defendant an opportunity to file a defence to the complaint. A settlement of issues hearing will be held following the filing of the defence. At that hearing, the IP Court will schedule the trial dates. A full trial will follow, and a decision will then be rendered by the IP Court. Any party that is dissatisfied with the IP Court’s decision may file an appeal directly to the Specialised Court of Appeal and then to the Supreme Court.
There are two types of criminal action, state criminal action and private criminal action.
For a state criminal action, a patent holder can lodge a complaint directly with the police officer so that the officer may request a search warrant from the Court and conduct a search of the alleged infringer’s premises. If infringing products including materials relevant to the case are found, they will be seized as evidence and the alleged infringer will be arrested.
Once the officer finds there is sufficient grounds to prosecute the case, and if the public prosecutor agrees with the officer’s conclusion, the public prosecutor will prosecute the case before the IP Court. The Court will schedule the trial and a decision will be rendered by the Court. At any time before the Court issues its decision on the case, a patent holder may file an application requesting permission from the Court to join as a co-plaintiff, to assist the public prosecutor and preserve its right to appeal. Any party dissatisfied with the Court’s decision may file an appeal directly to the Specialised Court of Appeal and then to the Supreme Court.
For a private criminal action, a patent holder may initiate a criminal case by filing a criminal complaint directly with the Court. However, for this case, the Court will set a Preliminary Examination Hearing to examine the merits of the case before it is accepted for trial. If the Court rules that it will accept the case, a trial will follow, and a decision will be rendered by the Court. As mentioned, the Court’s decision may be appealed directly to the Specialised Court of Appeal and then to the Supreme Court.
In addition, patent invalidity is available as a defence patent infringement and can be invoked at pleadings stage of proceeding. Also, a counterclaim for patent invalidity can also be filed by the defence.
Under the Drug Law, a new drug applicant in Thailand is required to submit documents showing patent/petty patent rights or rights related to traditional Thai medicinal wisdom for regulatory approval of a drug.
However, there is currently no patent linkage system or mechanisms in place for a potential generic entrant during the process of marketing approval. Currently, submitted documents relating to patent/petty patent rights are not considered by the Thai FDA in the marketing approval process.
The main legislation related to counterfeiting of pharmaceuticals and medical devices can be summarised as follows:
The available procedures/actions against counterfeiting of pharmaceuticals and medical devices include, among others:
There is no specific restriction on trade marks used for pharmaceuticals and medical devices.
Although parallel import is not deemed trade mark infringement under the Trademark Act, parallel import may be subject to certain other offences (ie, tax) in Thailand.
Thailand does not have specific provisions on trade dress. As such, trade dress may be subject to relevant laws (ie, Trademark Act, Copyright Act, Penal Code, Civil and Commercial Code) depending on the facts and surrounding circumstances of each case.
The design of pharmaceuticals and medical devices can be protected as a design patent under the Patent Law and may receive a protection term of ten years from the application filing date.
A design patent must be novel and capable of industrial application. A novel design means:
Thailand currently does not have specific provisions on data exclusivity for pharmaceuticals and medical devices.
However, the Trade Secrets Act B.E. 2545 (2002), along with its amendments and relevant regulations, (the “Trade Secret Law”) provides protection of trade secrets and other confidential information against unauthorised use and/or disclosure of such information to be an actionable offence, subjected to both civil and criminal penalties.
Since data submitted to the Thai FDA to obtain marketing authorisation may contain trade secrets in the form of clinical trials data, testing results and/or preparation methods, the Trade Secrets Act and the MOPH’s Ministerial Regulation Regarding Trade Secrets allow the information holder, such as drug originator seeking marketing authorisation, the right to request the Thai FDA to keep such submitted data confidential. Upon approval of the request, the Thai FDA must maintain the confidentiality of such data for five years.
During the COVID-19 pandemic, various regulations provided different levels of exemption depending on the specific categories were issued. For instance, the Thai FDA allowed importers, without an establishment licence, to distribute listed medical devices such as surgical face masks, personal protective equipment (PPE), and products relevant to COVID-19 antigen testing. However, there was no exemption on imports for pharmaceuticals for commercialisation. Instead, with the collaboration between the MOPH and the MOC, import tariffs were temporarily waived.
It is worth noting that as of October 2022, the Thai government declared COVID-19 as endemic, and the above-mentioned exemptions were revoked.
No special regulations were issued in relation to ongoing clinical trials for COVID-19 treatments or vaccines. However, in May 2020, the Thai FDA issued the guideline for conducting clinical trials during the periods of widespread COVID-19 in accordance with Good Clinical Practice. The guideline provided recommendations for alternative methods of obtaining informed consent, such as by telephone or video conference, and for remote monitoring of trial participants. They also allowed for the use of home delivery of medication and for telemedicine visits, where appropriate. It should be noted that the guideline has been applied to clinical trials for any treatments or vaccines, not only for COVID-19.
According to the Thai FDA’s Notification Regarding Conditional Approval for Emergency Use of Medicinal Products B.E. 2563 (2020), which mainly focuses on new efficient drugs and vaccines, modern drugs as defined by the Drug Law can be processed under the conditional registration scheme for the purpose of diagnosing, treating, relieving, curing or preventing COVID-19. This scheme permits licensed pharmaceutical producers or importers to apply for emergency use of pharmaceuticals in accordance with guidelines and ASEAN Common Technical Dossier (ACTD) or Common Technical Document by the International Council on Harmonisation (ICH-CTD) by providing details of the product, research, status of overseas approval and other relevant information.
However, in October 2022, the Thai government declared the COVID-19 pandemic had become endemic and cancelled many relevant regulations. As of March 2023, the FDA has approved six COVID-19 vaccines, and any regulation related to emergency approval or import has been revoked.
Pharmaceutical manufacturers must meet the standard of PIC/S and obtain a GMP licence, which is renewed annually. As of August 2022, due to the difficulty of on-site inspections and loosened documentary requirements, the Notification of the Thai FDA extended the validity of GMP certificates for domestic and overseas pharmaceutical manufacturers which expired before 31 December 2023 until 31 December 2023.
The authorised importer may submit the GMP certificate without notarisation/legalisation to the Thai FDA if they have not received the notarised/legalised overseas manufacturer GMP certificate. Nevertheless, the fully notarised or legalised GMP certificate must be submitted to the Thai FDA within 180 days from the issue date of the GMP certificate.
Since 2020, the Thai FDA has introduced several import flexibilities in its procedures to increase the supply of COVID-19-related vaccines, drugs and medical equipment in Thailand. These measures include reducing the period of obtaining import licences for devices that the Thai FDA considers to be immediately necessary, such as surgical masks and PPE. Additionally, the Thai FDA has issued the conditional approval procedure for manufacturing or importation of certain drugs for emergency use. Furthermore, the Thai FDA has issued a notification to temporarily allowing alcohol sanitiser gels to follow the approval process as a "cosmetic" product instead of as a "medical device". This change in classification reduces the approval process and restrictions.
In Thailand, the telemedicine regulations as prescribed by the MOPH and various professional councils, such as the Medical Council of Thailand, Thailand Nursing and Midwifery Council, and Thai Traditional Medical Council, are among the most significant measures implemented to promote digital healthcare and digital transformation in response to COVID-19.
To promote the digital transformation of Thailand’s national healthcare system, several long-term initiatives following the e-health strategy and digital health strategy of the MOPH are currently underway. These include the development of health information standards, data interoperability, and the national health information platform, which enables health information to be exchanged among related parties in the healthcare service chain. In implementing these strategic goals, the MOPH collaborates with other governmental agencies, including the Ministry of Digital Economy and Society, the Electronic Transactions Development Agency under the MDES, and the National Broadcasting and Telecommunications Commission.
As of March 2023, there has been no announcement from the Thai government regarding the issuance of compulsory licences for COVID-19-related treatments or vaccines.
There has been debate regarding a proposed royal decree to exempt medical personnel from liabilities resulting from COVID-19 treatment, including the use of vaccines and their effects. However, the draft decree did not pass the parliamentary process.
As of March 2023, the only relevant law that exempts medical personnel from being sued by an injured person is the Act on Tortious Liability of Officials B.E. 2539 (1996), which applies to medical personnel who act in good faith while performing their duties.
As of March 2023, there are no existing or new provisions allowing the use of or requisition or conversion of manufacturing sites due to COVID-19 or any intention to issue any such provisions.
At the outset of the pandemic, the Public Procurement and Supplies Administration Ruling Committee issued guidelines for public procurement of supplies relating to prevention, control or treatment of COVID-19. The guidelines waived several regulations related to procurement costs and imposed procedures. The guidelines provided temporary permission for responsible authorities to proceed with the procurement of supplies related to the prevention, control or treatment of COVID-19 before reporting to the chief of each administration. Such report would be considered as proof of acceptance, mutatis mutandis.
Cannabis Legislation in Thailand
In 2018, Thailand began the process of legalising cannabis by amending the Narcotics Act B.E. 2522 (1979) and issuing several ministry regulations and notifications that allowed for the medical use of cannabis. In November 2021, the Thai government enacted the Use of the Narcotics Code B.E. 2564 (2021) (the "Narcotics Code"), which came into force on 9 December 2021. This Narcotics Code revoked previous legislation, including the Narcotics Act and its amendments, as well as related ministry regulations and notifications. The Narcotics Code categorises narcotics into five categories (Category 1 to Category 5), with cannabis being classified as Category 5.
On 8 February 2022, the Ministry of Public Health (MOPH) issued the Notification Regarding Prescribing the List of Narcotics Under Category 5 (the “MOPH Notification"). The MOPH Notification came into effect on 9 June 2022 and delisted cannabis and hemp from Category 5. According to the MOPH Notification, only extracts obtained from any parts of cannabis or hemp plants that belong to the cannabis genus are considered narcotics with the exception of:
Following the legalisation of cannabis and hemp on 9 June 2022, possessing, cultivating, distributing, consuming, and selling any part of cannabis and/or hemp (excluding the extracts mentioned above) is legal without the need for a licence. Moreover, recreational use of cannabis or hemp products is also legal. Despite the fact that the usage of cannabis products is still governed by the Narcotics Code, the absence of comprehensive and secure regulations for controlling such products after legalisation has sparked numerous concerns. Numerous notifications have been released by various government authorities to address these concerns, including the following.
Despite the existence of regulations, restrictions and licensing requirements, there are still legal loopholes that, for example, allow young people to use cannabis in private areas. Furthermore, there have been occasional reports of patients being hospitalised due to cannabis use since legalisation. To address these issues, a draft cannabis and hemp act has been proposed, but it is currently suspended due to an upcoming election in Thailand.
Software as Medical Devices
In November 2022, the Thai Food and Drug Administration (the "Thai FDA") issued guidelines outlining its determination criteria for software as medical devices. The guidelines issued by the Thai FDA outline criteria for determining whether 11 types of software qualify as medical devices, which include both embedded and standalone software that are subject to risk classification for medical devices. These software types include those related to vital signs monitoring, sleep monitoring, fall detection and risk assessment. For each type of software, the guidelines provide examples of both software that is not considered a medical device as well as software that is considered a medical device. Additionally, the guidelines offer examples of risk-based medical device categories for the latter case.
The Thai FDA guidelines also provide examples of software that do not qualify as a medical device under the Medical Devices Act. These include the following:
On the other hand, examples of software that are considered a medical device under the Medical Devices Act include:
Since 2020, telemedicine services have been permitted in Thailand and their growth has been accelerated by the COVID-19 pandemic. In October 2022, the National Health Security Office (NHSO) launched a telemedicine pilot programme starting initially in Bangkok, which began providing remote care services in December 2022.
To provide remote care services to patients for this pilot programme, the NHSO partnered with four private digital health service platforms, namely Good Doctor Technology, Clicknic, Mordee and Saluber MD, to offer remote care to patients. Currently, the telemedicine pilot programme covers 42 general diseases and/or symptoms, including red eyes, conjunctivitis, osteoarthritis, food poisoning, sinusitis, headache, stomach ache, sore throat, back pain and the flu. To use the telemedicine programme, patients are required to verify their identities and consult with healthcare consultants, which typically takes between 10 and 15 minutes. Medicines are delivered to patients within 24 hours following the consultation.
Target Patent Fast-Track Programme For Medical Inventions
Efficient treatments, such as pharmaceuticals, vaccines and medical devices, play a crucial role in enhancing people՚s health, particularly during the COVID-19 pandemic. In May 2022, the Department of Intellectual Property (DIP) released a notification announcing the Target Patent Fast-Track programme (referred to as “Patent Fast-Track”), which is aimed at expediting the grant of invention and petty patents that could aid in the development of medical treatments including those for COVID-19.
To participate in the Patent Fast-Track, applicants must meet certain requirements and file a request with the DIP, as set out below.
Moreover, applicants must submit an explanation of (i) the invention՚s potential contribution to public health benefits, and (ii) its commercialisation potential, including production, commercialisation and/or licensing plans.
If an application is selected for the Patent Fast-Track, the DIP will expedite the examination process thereof. For invention patents, a final office action will be issued within 12 months from the selected date, and for petty patents, within 6 months.
As of February 2023, seven invention patent applications and eight petty patent applications have been selected to participate in the Patent Fast-Track.
Personal Data Protection Act B.E. 2562 (2019)
Prior to the enactment of Thailand’s Personal Data Protection Act B.E. 2562 (2019) (PDPA), several legal protections existed for health data. Specifically, the National Health Act B.E. 2550 (2007) protected health information from unauthorised disclosure, and the unauthorised disclosure of health information by health professionals was expressly prohibited as a criminal offense under the Thai Penal Code. Such an act would also constitute a violation of the ethical code for certain healthcare professionals, such as the Medical Council of Thailand՚s Regulation on Medical Ethics.
The PDPA was enacted in response to the increasing number of privacy violations in Thailand. It was enacted on 27 May 2019, and was initially scheduled to take full effect on 27 May 2020. However, due to the COVID-19 pandemic, the full implementation of the PDPA was postponed twice, and it finally came into effect on 1 June 2022.
The PDPA imposes additional requirements and prohibitions on the collection, use and disclosure of personal data, and recognises the rights of data subjects, which entities subject to the PDPA must comply with. The PDPA applies to entities located in Thailand and may extraterritorially apply to entities processing personal data of data subjects located in Thailand, as per the prescribed criteria. Both private and public entities may be subject to the PDPA, unless they fall within the exemptions provided in the PDPA. For example, foundations, associations, religious organisations which are non-profit organisations are exempt from certain data processing requirements under the PDPA.
The obligations under the PDPA would differ between personal data categorised as "general personal data" and "sensitive personal data". Health data is classified as "sensitive personal data" under the PDPA, and any processing of it would be subject to stricter requirements regarding its collection and disclosure. For instance, the legal basis for processing sensitive data is more limited than general personal data. If no other legal basis is available, explicit consent would be required to process health data.
The PDPA establishes a complaint filing mechanism and grants certain authority to the Expert Committee (also established by the PDPA) and competent officials to issue orders and exercise authority for the protection of personal data and the rights of data subjects.
The PDPA provisions are intended to serve as a general data protection law for Thailand. Consequently, where there is a sector-specific law or regulation regarding personal data protection applicable to an entity, the provisions of the PDPA and penalties will apply in addition to those sector-specific laws or regulations. Where the sector-specific law does not provide a complaint filing process and officials’ authority with respect to personal data protection, or where such mechanism and authority exist but the protection is not equal to that of the PDPA, the provisions of the PDPA would be applicable.
The Thailand Research and Innovation Utilisation Promotion Act B.E. 2564 (2021)
According to Thailand 4.0, an economic model and national strategy developed by the Thai government to transform Thailand into a high-income country driven by innovation, technology and creativity, the government has identified medical tourism as one of the "S-Curve" industries, with the aim of positioning Thailand as a leading medical hub in Asia. As part of this initiative, the Thai government is promoting the development of new technologies and industries, improving the country՚s competitiveness, and enhancing the quality of life for Thai citizens through research and innovation activities. To support this goal, the Thailand Research and Innovation Utilisation Promotion Act B.E. 2564 (2021) was enacted and came into effect on 7 May 2022 in order to establish a comprehensive system that encourages and supports research and innovation activities in both the public and private sectors in Thailand. The Act, along with relevant regulations subsequently released (collectively referred to as the “TRIUP Law”), plays a critical role in driving the development of the medical hub under Thailand 4.0. It creates a supportive environment for the development of new medical technologies and treatments by providing incentives for researchers and private sector organisations to invest in research and development.
Under the TRIUP Law, inventors and researchers at universities, research institutes and business entities (“Scholarship Recipient”) that receive government funding for their research projects will be entitled to own and manage innovations or research results (“Work”) including intellectual property pertaining thereto. It is worth noting that Work includes any discoveries or results arising from innovation creations, research, experiments, investigations or studies, as well as any knowledge and know-how, regardless of whether it is protectable under intellectual property laws.
The conditions under which a Scholarship Recipient will gain ownership of their Work are that they will have to disclose the Work, along with its utilisation plan to the Scholarship Provider, which is usually a government agency, within a specified timeframe. If the Scholarship Recipient does not wish to obtain ownership or fails to disclose their Work within the designated time period, the researchers involved in the Work will subsequently be entitled to request ownership using the same process.
After receiving the disclosure and utilisation plan, the Scholarship Provider will have to promptly issue a confirmatory statement of ownership to the Scholarship Recipients. Then, the Scholarship Recipient or researchers will have to utilise the Work according to the disclosed utilisation plan within two years, otherwise all rights over the Work will revert to the Scholarship Provider. Nevertheless, the two-year period may be extended upon request including submission of evidence showing the Scholarship Recipient and/or researcher’s efforts to utilise the Work.
The TRIUP Law also prescribes a profit-sharing principle to oblige funding recipients to provide incentives to researchers involved in their research and innovation work, if there are revenues earned from the commercialisation or utilisation of the research and innovation work.
Similar to the Thai Patent Law, the TRIUP Law outlines a principle regarding compulsory licenses, which enables the Science, Research, and Innovation Promotion Committee (the "Committee") to grant a licence to any person who wishes to license the Work but fails to reach an agreement with the holder of the intellectual property rights, while proposing reasonable remuneration to the holder. Any licence granted by the Committee is considered a licence under the relevant intellectual property law.
Furthermore, the Prime Minister, with approval from the cabinet, has the authority to issue compulsory licenses for public interest in situations of national emergency to utilise and exploit the Work.
After three years of the COVID-19 pandemic, the Thai government declared the COVID-19 pandemic to be endemic. The MOPH issued a notification on 1 October 2022, reclassifying COVID-19 from a "dangerous communicable disease" to a "communicable disease under surveillance".
The mandatory face mask policy has been relaxed, meaning that wearing a face mask outdoors is now voluntary. However, the government highly recommends wearing a face mask in crowded areas, such as public transport, exhibitions or concert venues. Furthermore, many exemptions and regulations related to the COVID-19 pandemic have been revoked, including regulations on the commercialisation or distribution of medicines and medical devices, as well as regulations on the conditional approval for the emergency use of medicinal products.
In addition, in response to the declaration of COVID-19 as an endemic, MOPH issued two notifications in March and October 2022 to update the criteria, methods and conditions for determining expenses related to operations for critically ill emergency patients. In brief, these notifications outline the reimbursement scheme for medical facilities that provide treatment to COVID-19 patients in a critically ill state, whereas the previous reimbursement scheme during the pandemic had applied to medical facilities treating COVID-19 patients in an emergency state. These notifications were issued under Universal Coverage for Emergency Patients (UCEP) programme, which provides free-of-charge emergency medical services to all patients, regardless of their ability to pay or insurance coverage. The UCEP programme was launched in 2002 as part of Thailand’s Universal Coverage Scheme (UCS).
Furthermore, in November 2022, the NHSO has partnered with the National Drug System Development Committee to expand the National List of Essential Medicines (NLEM) to include COVID-19 treatment medications including nirmatrelvir and ritonavir, remdesivir, favipiravir and molnupiravir. Their inclusion in the NLEM enables COVID-19 patients with varying degrees of severity of the disease to access these medications under Thailand՚s National Health Security System, reducing the financial burden associated with acquiring COVID-19 treatments.
The marginalisation of HIV-positive individuals has been an ongoing issue for several decades. For instance, requiring a blood test as a prerequisite for employment or education has been common practice. Testing positive for HIV is often cited as grounds for rejection, despite violating fundamental human rights. In an effort to combat stigmatisation and discrimination against individuals living with HIV, MOPH and its affiliated networks have been actively supporting the development and passage of the draft Act on the Elimination of Discrimination Against Individuals. The draft Act was open for public hearing on the parliament website from 31 January to 19 August 2022, and aims to reduce social exclusion not only for HIV-positive individuals, but for all marginalised groups.