The life sciences industry in Thailand continues to show promising growth and remains welcoming to foreign investment. A recent Cortellis report shows that the market is expected to grow to USD6.3 billion by 2021, and USD8.4 billion by 2026.

Trade liberalisation, largely driven by Thailand's participation in the Association of Southeast Nations (ASEAN) Economic Community, is taking place across various life sciences industries. The adoption of the ASEAN guidelines (such as the ASEAN Guideline on Stability of Drug Product, Mutual Recognition Arrangement for Good Manufacturing Practice Inspection of Manufacturers of Medicinal Products), as well as Thailand joining the member of the Pharmaceutical Inspection Co-operation Scheme, has streamlined the otherwise complex navigation of pharmaceutical regulation in Thailand with other ASEAN member states and globally. This will facilitate further domestic R&D and production, as well as the export of finished products. The elimination in tariffs on medicinal products originating from ASEAN countries as well as the harmonisation of regulations and the relaxation of the restrictions on investors from ASEAN countries with a wholly owned or majority interest subsidiary in Thailand are further key factors promoting the Thai pharmaceutical industry.

The COVID-19 pandemic was a catalyst in promoting self-reliance in the Thai pharmaceutical industry. Several leading universities in Thailand have collaborated with start-ups and small- and medium-sized enterprises in developing healthcare products including vaccines, new chemical entities and medical devices. The pandemic also accelerated public interest in digital health, and the Thai Government has been supporting this by updating regulatory guidance. The 2019 National Cyber Security Act and the EU General Data Protection Regulation-aligned 2019 Personal Data Protection Act (PDPA) (effective on 1 June 2022), deal with important issues arising from digital health and telemedicine such as personal data protection, consent to use and to transfer personal data, and privacy.

Non-traditional life science industries are also expanding into this area. For example, a Thai national oil and gas conglomerate has expanded its life science business not only in Thailand but also to acquire pharmaceutical companies in other Asian countries.

The legalisation of cannabis and its trade liberalisation has also significantly driven the cannabis market in Thailand. The use of cannabis is not limited to medical treatment, but is also permissible in other industries including food and beverages, cosmetics and herbal products.

The majority of drug manufacturers in Thailand are final-stage producers of finished generic drugs. According to data from Cortellis Generics Intelligence, 86 dose manufacturers are currently producing finished dose formulations, whereas active pharmaceutical ingredients (APIs) are produced by only three manufacturers with corporate headquarters based in Thailand. Instead, APIs are typically imported for further mixing and production into drug dosage forms. Following proof of bioequivalence against a patented/originator drug, a drug can obtain marketing authorisation from the Thai Food and Drug Administration (FDA).

Since Thailand imports almost all APIs for the production of drug products, most Thai pharmaceutical industries do not receive government investment or funding support. However, some start-up companies working with vaccines and biological products have received financial support and grants from the government. The Thailand Centre of Excellence for Life Sciences (TCELS), a public organisation, aims to build up Thailand competitiveness, and has been working with life sciences start-ups since 2017. A qualified start-up can obtain capital investment and/or other support from TCELS, including in relation to intellectual property strategy, protection, management and commercialisation.

There are three main schemes in the health care system in Thailand.

Social Security Scheme (SSS). This is administered by the Social Security Office and covers employers with one or more employees. However, this scheme is not applicable to:

Civil Servant Medical Benefit Scheme (CSMBS). This is administered by the Comptroller Department, Ministry of Finance, and covers government officials and their dependents (parents and up to three children).

National Health Insurance. Also known as the "THB30 scheme" or "Universal Coverage Scheme", this is administered by the National Health Security Office (NHSO) under the supervision of the Ministry of Public Health (MOPH) and covers the remaining population not covered under either the SSS or the CSMBS.

The structure of the national health care system is also being developed in relation to digital health. The Ministry of Public Health has been developing a ten-year plan for the development of e-government services, which is well underway at many Thai hospitals. In 2019, three government agencies collaborated to connect the health care services provided by 116 government hospitals by an IT system and mobile phone application. This project has facilitated long-distance study in the medical sciences as well as medical consultations in teleradiology, telecardiology and telepathology.

State agencies such as public hospitals are the most important purchasers of drug products, and purchasing takes place through the national health care system. Therefore, state agencies play an important role in determining how Thailand's market develops. About 80% of the total domestic market for drug products is distributed through hospitals, while the NHSO and the SSS also have a special access scheme for orphan drugs such as for high-cost rare disease drugs and antidotes. In case of emergencies such as the COVID-19 pandemic, there are regulations for managing, procuring and distributing drugs affordably. Besides direct procurement by hospitals, there is also collaboration between drug and vaccine distributers to control outbreaks and save the lives of Thai nationals under the health care schemes and through government hospitals. Therefore, the drug procurement and distribution system is the connecting point where the life sciences industry and health care system interact. This connection is critical to ensure that patients have access to essential life-saving treatments.

Prices of medicinal products are regulated when they are sold to government hospitals. The National Drug Development System Committee establishes median drug prices, which are the maximum public hospitals will pay to purchase the medicinal products. Typically, drugs to be purchased are listed in the National List of Essential Drugs (NLED), a selected list of essential medicines from which government hospitals are expected to select their individual hospital formulary. The prices of the drugs on this list are subject to the median price policy.

In addition, in relation to persons under the CSMBS only, the Comptroller Department of the Ministry of Finance has implemented notifications that set:

Medicines are reimbursed by the state if the drugs are listed in the NLED. However, this list is only available to government hospitals.

Government hospitals generally provide drugs from the NLED to civil servants under the CSMBS, and to all other persons under the THB30 scheme. In such cases, the patient pays nothing to the hospital (in the past they paid a maximum of THB30, which is why it is known as the THB30 scheme). The hospital is reimbursed completely by the government. Medical devices are not listed on the NLED. However, in 2005 the Ministry of Finance began allowing the reimbursement of some medical therapy equipment and artificial organs for civil servants.

For persons under the SSS, reimbursement is partially covered if the medicinal product was administered by a doctor in a government hospital. Persons under the SSS may also acquire private health insurance to cover the remainder of the cost.

The health care scheme in Thailand does not engage pharmacies as service providers. Patients who visit pharmacies pay out-of-pocket costs for drug products, which are not reimbursable. However, since 1 October 2019, certain patients can bring prescriptions received from physicians at public hospitals to a certified pharmacy to get prescribed drugs free of charge. Such pharmacies must register patients in order to ensure they dispense to patients who live nearby. This aims to reduce congestion at public hospitals. Four groups of patients are eligible, including those with diabetes, high-blood pressure, asthma or mental illness. The drugs collected at a pharmacy are the same as would be received from the hospital. A pharmacy enrolling in this programme must meet the Good Pharmacy Practice (GPP) standard of the FDA. The pharmacy receives THB70 per prescription.

Under the Drug Act BE 2510 (1967), as amended (Drug Act), "modern drug" is defined as a drug intended for use in the practice of modern medicine or healing arts, or the cure of an animal disease (as distinct from traditional and herbal medicines). The channel of distribution for a modern drug depends on its category. Modern drugs are divided into four categories:

Marketing pharmaceutical products online, by e-mail and/or by mail order is not permitted, as these activities are considered to be the advertisement of drugs (which requires FDA permission). According to the FDA, most advertisements (more than 85%) on the internet are being run without FDA permission. The FDA has prioritised the solving of this problem.

Under the Drug Act, a wholesale distributer can only sell directly to:

The wholesale of modern drugs requires a licence from the FDA. The FDA will issue the licence if the applicant:

The wholesaler must also comply with GPP. The GPP inspection is carried out by accredited bodies. The government fee for GPP inspection is THB2,000.

The Drug Control Division of the FDA supervises the distribution of drugs. The Drug Act and its bye-laws encompass many aspects of drug control in addition to drug distribution, including the:

Companies established in Thailand intending to import and place a drug on the market must:

The FDA review of a marketing approval application can take at least nine months, depending on the type of drug, with different timelines for new drugs and generic drugs. The review can take up to two years for a new drug for which a marketing licence has never been applied for in Thailand. The timeline also depends on the credibility and comprehensiveness of the information submitted with the application.

Once the review has been passed, new drugs must undergo a two-year safety monitoring period, during which the product can only be prescribed in hospitals and clinics. Safety reports must then be submitted to the authorities for consideration as to whether general marketing will be permitted.

Parallel imports are not regulated in general in Thailand because the exhaustion of rights principle is recognised by most intellectual property laws in Thailand. However, in contrast with other commodities/goods, parallel imports of medical products are indirectly prohibited. This is because importers must register the product with the FDA before importation.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, see Life Sciences Regulation in Thailand: overview.

In Thailand, the main pieces of legislation governing the advertisement of pharmaceutical products are:

In addition, pharmaceutical companies that are members of Code of Sales and Marketing Practices issued by the Pharmaceutical Research and Manufacturers Association (PReMA) must comply with the PReMA Code (PReMA Code). Although the PReMA Code is not considered to be law, and the FDA does not have the authority to enforce it, a violation of the PReMA Code can be reviewed by the PReMA Committee, which can sanction its members.

The Drug Act does not provide a specific definition of "advertisement". However, the FDA considers any activities undertaken, organised or sponsored by a pharmaceutical company with the objective of encouraging the prescription, supply, administration or consumption of its pharmaceutical product(s) through all methods of communication (including the internet) to be an advertisement.

Under the FDA Advertisement Regulation, advertising is classified into two main categories:

See Question 5.

Companies are not legally required to have internal procedures for reviewing and approving the advertisement of drug products. However, promoting or advertising a pharmaceutical product for use other than for the purpose approved by the FDA is restricted under the Drug Act and FDA Advertisement Regulation. In addition, the Drug Act states that an advertisement for the sale of a pharmaceutical product must not falsely or exaggeratedly show its therapeutic properties. Therefore, it is a good practice for a company to set up an operating procedure for reviewing and co-ordinating its advertising and promotional activities.

Advertisements targeted at the general public are only permissible for household remedy drugs. Non-household remedy drugs (pre-packed drugs, dangerous drugs and specially controlled drugs) (see Question 5) cannot be advertised to the general public. Direct-to-consumer marketing activities for non-household remedy drugs is limited to activities that help create disease awareness, patient education and basic healthcare education.

All drug advertising materials (whether directed at the general public or health care professionals) must be submitted for prior authorisation by the FDA before dissemination. An advertisement licence is valid for five years and is not renewable.

Comparative advertising is prohibited for all types of goods and services in Thailand, and this is particularly true of highly regulated goods such as pharmaceuticals. The FDA Advertisement Regulation prohibits:

No pharmaceutical products or medicines can be promoted for commercial purposes until marketing authorisation of the product has been obtained from the FDA. Promoting or advertising a pharmaceutical product for use other than for the purpose approved by the FDA is prohibited under the Drug Act and Advertisement Regulation. However, these provisions do not prevent pharmaceutical companies from sharing or exchanging scientific information on unauthorised medicines or unauthorised indications with health care professionals. Materials that contain only scientific information and that are scientific or educational in nature (that is, they do not include any references to product brands or companies) are not deemed to be an advertisement under the Drug Act and therefore do not need to obtain pre-approval from the FDA.

It is acceptable for an academic researcher to provide information for academic purposes on unauthorised medicines or unauthorised indications. However, the provision of such information without a request from health care professionals, or at a company-sponsored event, should be avoided. Such information should be provided or discussed only when there is a request from health care professionals. To mitigate risk, it is advisable to:

Only household remedy drugs can be advertised through social media, as this is accessible by general public (see Question 12). Advertising for medicines classified as non-household remedy drugs is not allowed on social media.

Websites with advertisements or other information only intended for health care professionals must include access restrictions that allow only the intended target audience to view the information.

The Drug Act sets out penalties or measures that regulators can impose for violations of the medicine advertising and inducement rules. The Secretary-General of the FDA can issue a written order to cease any advertising deemed to be contrary to the Drug Act. If it is determined that an advertisement misled the public, the FDA can order the violator to issue a corrective advertisement.

Violation of the Drug Act's marketing provisions is subject to a fine of up to THB100,000. Calculation of the fine depends on the amount of time it takes the advertiser to act after receiving a warning or notice of violation, as well as the number of individual violations. For example, if a promotional booth uses three posters and two gifts that were not submitted for FDA approval, the violator could be fined for a combination of the five offences.

For PReMA members, if a complaint regarding a breach of the PReMA Code is filed by another PReMA member, the complaint will be administered by the PReMA chief executive officer and the organisation's Code of Conduct Committee (CCC) which can sanction PReMA members. On the decision of the CCC, the PReMA CEO may order one or more of the following actions:

Advertisements targeted at the general public are only permissible for household remedy drugs. Non-household remedy drugs (pre-packed drugs, dangerous drugs and specially controlled drugs) cannot be advertised to the general public. Most drugs are classified as dangerous drugs under Thai law (see Question 5).

All advertising is subject to FDA review and approval before dissemination. Advertising must not:

(Section 88, Drug Act.)

In addition, advertisements must not:

(FDA Internal Rules 2002.)

Advertisements must also meet the FDA information requirements (for example, contain the drug name, ingredients and manufacturing source).

No sale of drugs can be advertised by a gift or lottery (section 90, Drug Act). The FDA has adopted a broad interpretation of this section, and has determined that free samples or "buy-one-get-one-free" offers are equivalent to advertising by giving a gift.

Providing free samples is considered to be the sale of the drug under the Drug Act. Only drugs classified as a household remedy (see Question 5) can be provided as free samples to public.

The Drug Act, its bye-laws and the PReMA Code do not restrict interactions between pharmaceutical companies and patients or patient organisations.

When working with patient organisations, companies must ensure that the nature of their involvement is clear from the outset. Companies can provide financial support for patient organisation meetings as long as the primary purpose of the meeting is educational or scientific, or otherwise supports the mission of the patient organisation.

If companies provide financial support or in-kind contributions to a patient organisation, it is advisable to have written documentation setting out the nature of the support and the purpose of funding the activity.

Under the PReMA Code, a "health care professional" means any member of the medical, dental, pharmacy or nursing professions or any other person who in the course of their professional activities can prescribe, recommend, purchase, supply or administer a pharmaceutical product, including government officers who review and approve pharmaceutical products.

"Health care organisation" means an entity that provides health care that is not an individual health care professional but that may be a group of healthcare professionals. Examples include:

The PReMA Code prohibits advertisements that persuade health care professionals to prescribe or dispense a drug persistently and unnecessarily, or that make consumers misunderstand that it is appropriate to take the drug regularly. Information on unauthorised medicines or indications must not be presented to health care organisations. Pharmaceutical companies can only send such information on receiving a written request from the health care organisation.

The Drug Act does not specifically restrict marketing practices in relation to health care establishments or individual medical practitioners. However, under the general bribery provisions of Thai law, a state official (which includes health care practitioners employed in public hospitals and clinics) can only receive property or any other benefit from any person (other than a relative) if the value of the benefit received from each person, and on each occasion, does not exceed THB3,000 (section 103, Organic Act 1999 (as amended) and Notification of the National Counter Corruption Commission Concerning the Provisions on the Acceptance of Property or Any Other Benefit on an Ethical Basis by State Officials B.E. 2543 (2000)). This applies to gifts, entertainment, services, training and so on.

Marketing to health care practitioners such as pharmacists who are not employed by the government is regulated by the PReMA Code (see Question 9). The PReMA Code provides detailed marketing restrictions, including the following:

In addition, the Ministry of Public Health Circular dated 2 March 2018 expressly prohibits the exchange of benefits relating to the procurement of drugs, and is aimed at preventing corruption in the purchasing of drugs and medical devices under the CSMBS. The Circular is aligned with the Cabinet's resolution on Thailand's National Anti-Corruption Strategy. According to the Circular, no discounts or free samples can be provided to hospitals' welfare funds. Instead, the government's payment will be of the net price for the drug that hospitals are to procure.

There are no requirements to disclose sponsorship and transfers of value to health care professionals or health care organisations.

The FDA can issue administrative orders to a pharmaceutical company to cease any non-compliance in its marketing to health care professionals. If the non-compliance includes the violation of drug advertisement rules, the violator is subject to a fine of up to THB100,000.

The usual criteria to obtain a patent are:

Generally, the following can be patented if they are novel, non-obvious and useful:

Pharmaceutical patents are treated the same as inventions in other fields. A claim for a pharmaceutical innovation must meet the usual criteria of novelty, non-obviousness and industrial applicability.

The following subject matters are not patentable:

(Section 9, Patent Act.)

These exclusions from patent protection are absolute. The most problematic issues for the pharmaceutical sector relate to biologics, diagnostic methods and methods of treatment.

Until 30 September 2013, there were no specific examination guidelines for pharmaceuticals. To try to clear the longstanding backlog of patent applications for pharmaceutical and chemical inventions, the Department of Intellectual Property issued patent examination guidelines for these sectors.

One of the most debated issues is the acceptance of "use claims". There is now guidance that a claim indicating a process or method that results in an actual/concrete outcome is considered to be a patentable process under the Patent Act 1999, as long as use is not directed to a method of treatment of human or animal disease under section 9(4), which is not patentable.

In addition, in the past, a "Swiss-type claim" was readily acceptable. However, under the new examination guidelines this is not the case, and the Department of Intellectual Property will consider whether the specification sufficiently disclosed the claimed subject matter.

Patent applications are made to the Patent Office of the Department of Intellectual Property, which is part of the Ministry of Commerce. Guidance on the application procedure and fees are provided on the Ministry of Commerce website (in both Thai and English).

Thailand is a signatory to the Patent Cooperation Treaty (PCT). Since 24 December 2009, international patent applications can be submitted through the PCT system.

Government fees for filing a patent in Thailand depend on the type of patent (invention patent, petty patent or design patent). In general, the government filing fees are minimal. Once the patent is granted, various maintenance fees apply from the fifth year onwards.

To apply for an invention patent, the applicant must first prepare a patent specification, including a detailed description of the invention, abstract, drawings and claims. The application must be filed with the Patent Office. The Patent Office then conducts a preliminary (formality) examination and publishes the patent application in the official Patent Journal in Thai.

Oppositions can be filed within 90 days of the publication of the application. Grounds for opposition include that the:

A substantive review of the invention is then undertaken. The entire process for issuance of an invention patent can take from three to five years, or even longer in the case of advanced technology or complicated inventions. For pharmaceutical patents, the process can take five to ten years, and sometimes up to 15 years. The problems caused by delayed processes are often raised by foreign pharmaceutical companies and foreign governments. The Patent Office has recently increased the number of patent examiners to reduce the examination backlog.

In the emerging field of digital health, any technical solution in the form of a product or a process that is novel, inventive, or possible for industrial application can be patented in Thailand. However, methods of diagnosis, treatment or cure are excluded from patent protection.

A patent for an invention is valid for 20 years from the date of filing (section 35, Patent Act). No extensions or renewals are allowed.

Once the patent expires, the patentee's monopoly rights under the patent cannot be extended by other means such as supplementary protection certificates or data exclusivity periods, as these are not available in Thailand.

The specific rights of patentees are set out in section 36 of the Patent Act. Patentees have the exclusive right to produce, use, sell, possess for sale, offer for sale and import in Thailand the patented products or articles made by the patented process. In addition, patentees can grant a licence for their patent to another person. The patentees and licensee must make the patent licence agreement in writing and register it with the Patent Office.

If the patentees hold a patent for a product design, the patentee has the exclusive right to use the patented design on a product. The patent owners also have the right to sell, possess for sale, offer for sale or import into Thailand items incorporating the patented design.

Patent owners can choose to send a warning or notice letter to alleged infringers before commencing civil or criminal actions.

Patentees can enforce their patent rights through civil actions in the IP & IT Court, which can issue injunctive remedies, search and seizure orders, damages and criminal penalties (including fines and/or imprisonment).

In the case of a criminal infringement, a patent owner also has the option of lodging a complaint with the police authorities or the Department of Special Investigation. A patentee can bring criminal charges against anyone who produces, uses, sells, possesses for sale, offers for sale or imports any of their patented products or any products resulting from their patented process.

Any person who violates the patentee's exclusive rights is subject to infringement liability, except where a statutory exemption applies.

Research exemption. The Patent Act sets out a statutory exemption from patent infringement for an act for the purpose of study, research, experimentation or analysis (Bolar exemption).

IP exhaustion. The Patent Act sets out a statutory exemption from patent infringement for any act concerning an application for drug registration where the applicant intends to produce, distribute, or import the patented pharmaceutical product after the expiration of the patent term.

Other exemptions. A defendant can raise non-infringement and/or patent invalidity as a defence.

In addition, the statutory exemptions from patent infringement under the Patent Act include any manufacturing of a patented product or application of a patented process by a person who, in good faith, manufactured the product or acquired the equipment before the date of filing of the patent application in Thailand.

Thailand entered into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) in 1995 and has enacted several laws to comply with global standards of intellectual property protection including the:

Thailand officially became a member of the Paris Convention for the Protection of Industrial Property in 2008 and enforced the PCT in the same year. There have been dramatic changes in the number of foreign patent applications since the PCT came into force, with most of the patent applications coming from abroad.

In 2017, Thailand enacted the Madrid Agreement Concerning the International Registration of Marks, becoming the 99th member of the Madrid System.

Both registered and unregistered trade marks are protected in Thailand. Registered trade marks are mainly protected under the Trade Mark Act 1991, as amended (Trade Mark Act), which is the key legislation governing registered trade marks. Section 44 of the Trade Mark Act provides that the owner of a registered trade mark has the exclusive right to its use for the goods or services in respect of which registration has been granted. Therefore, any unauthorised use of a registered trade mark in connection with the goods or services for which it has been registered constitutes a trade mark infringement that is actionable by the owner of the trade mark.

Registered trade marks receive considerably broader and stronger protection than unregistered marks, which are merely protected against passing-off through various provisions of the Thai Penal, Civil and Commercial Codes.

Under the Trade Mark Act, a trade mark is registrable if it is:

A medicinal product brand can be registered as a trade mark under the Trade Mark Act.

Cannabis is an ingredient in a number of Thai traditional medicine recipes. Currently, trade mark applications that include goods or services relating to medical cannabis are registrable. However, cannabis and its chemical derivatives were still on the list of Category-5 Narcotics until very recently. On 9 June 2022, the growth, sale and purchase of cannabis with a tetrahydrocannabinol (THC) content of 0.2% or less became legal in Thailand. There is still uncertainty about how this development will affect cannabis trade marking.

The Trade Mark Act was last amended in 2016. According to the 2016 amendments, the registration of trade marks through the Madrid system now applies in Thailand. In addition:

There is no special register of pharmaceutical trade marks. Applicants for drug marketing approval are not required to obtain prior approval from the drug regulatory authorities for trade mark use.

Notification No 5 of the Ministry of Commerce prohibits the registration of a mark that is similar or identical to an international non-proprietary name (INN). This notification has been in effect since 2000.

Applications are made to the Trade Mark Office of the Department of Intellectual Property, Ministry of Commerce (Trade Mark Office).

Multiple-class applications are allowed.

After filing an application with the Trade Mark Office, it takes around nine to 12 months for the registrar to examine an application. After the examination, if the application is accepted for registration, it is published in the Trade Mark Gazette. If no objections are filed within 90 days after publication, registration is granted, dated as at the application filing date. The registrar then issues a notification requesting payment of the registration fee. The certificate of trade mark registration is issued within two months after the registration fee has been paid. Barring any problems, it normally takes about 12 to 18 months for a trade mark to be registered in Thailand. Trade mark protection starts once registration is granted and lasts for ten years from the filing date.

The main body of competition law is in the Trade Competition Act 2017 (2017 Act), which repealed and replaced the first competition law in Thailand, the Trade Competition Act 1999 (1999 Act).

The 2017 Act prohibits or otherwise limits practices that potentially restrict competition, including:

The 2017 Act applies to all business operators, including the pharmaceutical sector.

The 2017 Act established the Trade Competition Commission (TCC) and the Office of Trade Competition Commission (OTCC). The TCC is an independent state agency autonomous in matters of personnel, budget and administration. The TCC has promulgated a number of notices and regulations addressing competition law matters, while the OTCC handles administrative work.

In October 2021, the OTCC published the TCC's decision on an important case against a COVID-19 vaccine importer. The defendants were accused of anti-competitive behaviour for allegedly restricting the supply of COVID-19 vaccines from 4 million doses to 1.6 million doses. The TCC ultimately found that the defendants' failure to deliver 4 million vaccines was not due to behaviours prohibited by the 2017 Act, as the vaccines were to be delivered as requested by the purchasers.

The Thai Central Commission on Prices of Goods and Services (CCP) is also a relevant competition authority, as section 24 of the Prices of Goods and Services Act BE 2542 (1999) grants the CCP authority to issue notifications designating any goods or services as "controlled goods or services". When classified as a controlled good or service, the government is entitled to prevent the fixation of selling prices or distribution prices, or unfair conditions and trade practices, in relation to the good or service by:

Thailand recognises the international exhaustion of rights doctrine as it applies to intellectual property rights in Thailand. Parallel imports of pharmaceuticals have not raised intellectual property and competition law issues in Thailand.

A patent licence agreement for a registered patent in Thailand (as well as an assignment of a Thai registered patent) must be registered with the Department of Intellectual Property (section 41, Patent Act).

Under section 39 of the Patent Act and corresponding ministerial regulations, in particular Ministerial Regulations No 25 1999 (BE 2542), a patent licence agreement must not contain any provisions that unfairly restrict competition. On receipt of an application for registration, the Patent Registrar will examine the licence agreement to ensure that it does not contain any anti-competitive provisions. Anti-competitive provisions will effectively bar the agreement from registration, meaning that the licence will be legally void.

Short-form patent licence agreements based on a main technology licence agreement are acceptable. Generally, the Patent Registrar takes around six months to complete a patent licence agreement review for registration.

The Ministerial Regulations No 25 expands further on the various prohibited restrictions. There is no concept of a block/category exception under Thai law. However, there are:

The Director General of the Department of Intellectual Property's analysis of the agreement may determine that there is a grey list restrictive provision. The Director General will then consider "the object or intent of the parties" as to whether they intended to cause unfair practice, including the result which may occur. Therefore, there is scope for a type of "rule of reason" approach to activities on the grey list. The grey list generally includes the following prohibited activities:

Black list clauses are per se anti-competitive and automatically cause registration of a licence to be refused. The Director General cannot apply a rule of reason type analysis to these clauses. They include:

There are no restrictions on licensing or transferring patents to foreign parties. However, a patent licence agreement concerning a registered patent in Thailand must be made in writing and be registered with the Department of Intellectual Property at the Ministry of Commerce, or with a Provincial Commercial Office. Failure to comply with the registration requirement renders the patent licence void and therefore unenforceable under Thai law. Similarly, for a transfer of patent rights, the Thai Patent Act stipulates that the assignment of the patent rights must be in writing and be registered with the Department of Intellectual Property.

There is no requirement for a patent or trade mark licence agreement and payment of royalties under it to a foreign licensor to be approved or accepted by a government or regulatory body. However, a patent and a trade mark licence agreement must be registered with the Department of Intellectual Property to be enforceable under Thai law.

For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, see Life Sciences Regulation in Thailand: overview.

The key regulator is the Drug Control Division of the FDA. It directly regulates and monitors all pharmaceutical products in Thailand, and has the authority to recall products and impose penalties for non-compliance.

Thailand has adopted the following laws to specifically address product liability.

The Unsafe Goods Liability Act 2008 imposes a strict liability standard. A business "operator" can be liable regardless of whether it was negligent in making or selling the product. Injured parties only have to prove that they were injured or suffered damage from the defective product while using the product in the way it was intended to be used. There is no need to prove fault or negligence.

Potentially liable "operators" include:

In the pharmaceutical context, the following persons can be liable if the product is found defective and/or has resulted in damage to a consumer:

Product liability cannot be waived or limited by contract or by any waiver or limitation of liability statement given by a business operator.

The Unsafe Goods Liability Act provides several defences for a defendant operator. For instance, an operator is not liable if it can prove either the:

The Unsafe Goods Liability Act also provides defences for producers of custom-made products and component producers, who are generally not liable if they can show that the defect was due to the specifications or design of the final product provided to them by the outsourcer or producer.

The right to claim damages expires after three years from the date that the injured person was aware of both the injury and the identity of the business operator liable for the loss or damage, or after ten years from the date of sale of the product.

If the injury occurred to life, body or health as a result of substances accumulated in the body of the injured person, or if it takes time to show symptoms, the injured party (or the person with a right to file a legal action on behalf of the injured party) must bring the claim within three years of knowing of the injury and being able to identify the responsible business operator. However, this must not exceed ten years from the date on which the injury was discovered.

Thailand has not historically allowed for class actions but this changed following the National Legislative Assembly's amendment of the Civil Procedure Code to allow these, which came into force in December 2015. Under the amended provisions:

To date, only very few actions have been certified as class actions and none of these have been for pharmaceutical product liability.

Damages under the Unsafe Goods Liability Act consist of two components:

A court can award punitive damages on top of actual damages if it can be shown that the defendant either:

In these cases, the court can award punitive damages in an amount that the court deems appropriate (with a maximum limit of no more than twice the amount of the actual damages).