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Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

During the past couple of years, the Thai Food and Drug Administration (FDA) has been working hard (in conjunction with its peers in the Association of South East Asian Nations (ASEAN)) to harmonise the regulatory framework and to reduce, as much as possible, the differences in legal and technical requirements across the region. The FDA has adopted the Good Manufacturing Standard and the Pharmaceutical Inspection Cooperation Scheme (PIC/S), and is now qualified to check compliance with PIC/S standards.

While there is currently no specific legislation governing human clinical trials, draft legislation proposed by the National Research Council of Thailand is awaiting cabinet approval.

Recently, the government issued an order to increase the efficiency of approval processes related to all healthcare products. Improvements to the approval mechanisms, which will introduce binding timeframes, will hopefully allow the public to access and choose a better range of quality healthcare products. Ultimately, such improvements will also ensure that Thailand has a modern and efficient approval system that can be a driving force for the country’s economy and increase its competitiveness in the global market. The order is also in line with Thailand’s continuing role in the ASEAN harmonisation process for healthcare products.

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The Drug Act BE 2510 (1967) is the primary legislation governing medicinal products in Thailand. The Drug Act provides for a broad definition of a ‘drug’ that covers details such as substances recognised in a pharmacopoeia approved by the minister and intended for use in the diagnosis, treatment, relief, care or prevention of human or animal disease. Once it is clear that a particular product has the characteristics of a drug (and, more importantly, that it does not have characteristics excluded under the Drug Act), then further sub-classifications come into play (eg, modern drugs and herbal drugs).

Are any legislative changes proposed or expected in the near future?

In January 2018 the Food and Drug Administration (FDA) held a public hearing concerning the possible amendment of the Drug Act. The key amendments proposed include:

  • empowering the Drug Committee to appoint a sub-committee to perform duties under the Drug Act;
  • allowing experts, special organisations and public or private agencies (both in and outside Thailand) to participate in the consideration and approval process of licences and permits; and
  • introducing the collection and payment of official fees.

The amendment of the Drug Act is still at the consultation stage and may well be changed at a later stage by the relevant authorities. There is no specific timeline provided for the implementation of these amendments.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

The FDA is the principal government regulatory authority for drugs in Thailand. The FDA controls these products through the Bureau of Drug Control.

The roles and responsibilities of the FDA can be grouped into five main areas: pre-marketing control, post-marketing control, a surveillance programme for consumers’ safety, consumer education, and technical support and cooperation with other agencies.

The FDA’s duties are conducted in accordance with national legislation (ie, the Drug Act). Under the Drug Act, notifications are issued by the relevant committees or ministers that provide additional guidelines and requirements for operators. These notifications usually provide details on what approvals are needed, the requirements to obtain those approvals, the relevant forms and the implementation date. These notifications serve as updates on changes implemented by the FDA, such as the new e-submission system.

The relevant laws also demand that certain issues be decided by the Drug Committee whose members (experts in their respective fields) will be appointed by the minister of public health.

Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?

The trade of medicinal products is similar to the trade of any other products in that is also subject to other general Thai laws (eg, competition, data protection, consumer protection).

However, there are no specific laws or regulations governing commercial arrangements between importers or manufacturers and other business operators in the industry. Furthermore, Thailand does not have any specific laws or regulations that provide for any settlement or arrangements where there is a patent dispute between the originator and generic manufacturers.

Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

The Drug Act provides that any person that produces or sells modern drugs, or imports or orders modern drugs into Thailand, must first obtain a licence from the FDA. However, exemptions exist under particular conditions, such as:

  • the production of drugs by government ministries, public bodies and departments that have a duty to prevent or treat diseases, and by the Thai Red Cross and Government Pharmaceutical Organisation (GPO);
  • the production of drugs in accordance with the prescription of medical practitioners or practitioners in the art of healing for a particular patient or in accordance with the prescription of a veterinary for a particular animal; or
  • the sale of herbal drugs that are not dangerous, the sale of common household drugs, the sale of drugs by dentists to their patients, the sale of drugs by veterinaries for the treatment or prevention of animal diseases or the sale of drugs by government ministries, public bodies and departments that have a duty to prevent or treat diseases and by the Thai Red Cross and GPO.

The Drug Act also provides exemptions on product registration requirements in particular cases – for example:

  • drugs that are pharmaceutical chemicals or semi-processed pharmaceutical chemicals that are not packaged drugs;
  • herbal drugs;
  • sample drugs that have received permission to be produced or imported into Thailand in order to apply for registration of the drugs’ formula; and
  • drugs licensed to be brought or imported into Thailand for the purpose of research, analysis, exhibition and donation for charity purposes.

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

An entity that intends to manufacture drugs in Thailand must apply for a manufacturing licence from the Food and Drug Administration (FDA). A factory licence from the Ministry of Industry must be obtained before applying for the manufacturing licence. A manufacturer of modern drugs must have at least two pharmacists to manage the operation and monitor drugs at the premises during business hours. All manufacturers are required to have Good Manufacturing Practice certification that complies with the standards of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

Upon obtaining the manufacturing licence, the manufacturer must also obtain product registration for each specific product.

What is the fee for obtaining authorisation?

The government fee for the licence to manufacture drugs in Thailand is Bt10,000.

What is the validity period for authorisation?

The manufacturing licence must remain valid until December 31 of the year of issue. A licensee that wishes to renew its licence must, before its expiration, file an application for renewal. Once the application has been filed, business may continue until the FDA issues a decision refusing to renew the licence.

How robust are the standard good manufacturing practices followed in your jurisdiction?

The FDA applies the PIC/S or the Listed Inspection Service of the Association of South East Asian Nations as the standard of good manufacturing practices to consider the granting of the relevant licences under the Drug Act BE 2510 (1967). The FDA will not grant the relevant licences to a business operator that fails to comply with these standards.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

Failure to obtain a licence to manufacture drugs will make the offender liable to imprisonment for up to five years and a fine up to Bt10,000. While the Drug Act does not specifically cover failure to follow good manufacturing practices, the FDA has broad powers to suspend or revoke any licence that fails to comply with the Drug Act or its regulations.

Distribution

How are the distribution and storage of medicinal products regulated?

     The Drug Act specifies the terms related to the distribution for sale of drugs:

  • ‘to sell’ means to retail, wholesale, sell, distribute, issue or exchange in the interest of trade, and includes possession for the purpose of selling; and
  • ‘to wholesale’ means direct sales made to drug sales licence holders, holders of drug wholesaling licences, government ministries, public bodies, government departments, the Thai Red Cross, the Government Pharmaceutical Organisation, persons licensed to operate clinics and hospitals, midwives, practitioners in the vocation of nursing and midwifery, medical practitioners and practitioners of the modern art of healing or veterinarians.

There are limitations on the sale of drugs, which vary for each type of drug. For example, dangerous drugs and specially controlled drugs can be sold only to a hospital, or to someone who holds a licence for the sale of those drugs. Household drugs can however be sold to general customers. Moreover, the sale and purchase of specially controlled drugs will also require a prescription.

The Drug Act imposes specific requirements for holders of drug manufacturing, sale or import licences. Such requirements depend on the specific licence. Generally, it includes requirements relating to the control of quality and safety within the storage area.

Import and export

How are the import and export of medicinal products regulated?

An entity that intends to import drugs into Thailand must obtain an import licence from the FDA. Under the Drugs Act, there is no requirement for a licence to export drugs. However, Customs may require an export certificate (similar to a free sale certificate).

Are parallel imports permitted in your jurisdiction?

The Drug Act contains no specific provision prohibiting the parallel importation of medicinal products into Thailand. However, an importer that wishes to import such medicinal products must still apply for its own import licence and product registration.

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

The licensed manufacturer or importer can sell the products that it manufactures or imports without the need to obtain any further licences. However, other business operators will require sales licences that depends on the type of their operations – for instance, a wholesale licence, a retail licence or a pharmacy licence. The main condition is that the seller must have such facilities as prescribed by the ministerial regulations. A pharmacist must be in attendance during business hours to dispense drugs and to monitor activities.

As noted above, the purchase of certain types of drug may be restricted – for instance, specially controlled drugs that require a prescription.

Are there any restrictions on the online sale and purchase of medicinal products?

The Drug Act prohibits the sale and purchase of medicinal products online.

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

There is no specific Thai law or regulation that deals with named patient drug production or importation. Neither are there any specific exceptions on product registration for the purposes of named patient usage stipulated in the Drug Act, except in certain instances – such as importation by government agencies.

Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

In order to facilitate clinical trials, the Food and Drug Administration (FDA) has issued a notification that deals with the importation of drugs for clinical trial purposes. The notification outlines the requirements for an ethics committee to consider requests for importation of drugs into Thailand for clinical research. If approved, these drugs are then exempted from the need for drug formula registration with the FDA, until such time as the manufacturer decides to sell or distribute the drug commercially in Thailand.

In addition, a licence to import drugs into Thailand for clinical research must be obtained, which is valid for four years. However, if the clinical trials are not completed within this period, and it is necessary to import more drugs for clinical research, the licence can be renewed by filing the application form with reference to the supporting documents previously submitted to the FDA.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

Clinical trials in Thailand should follow international codes of ethics such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and Good Clinical Practice (ICH/GCP). In 2000 the FDA translated the ICH/GCP into Thai for ease of reference and to act as guidelines.

Research participants must be volunteers and a high level of care has to be used. A research project has first to be approved by the Ethical Review Committee for Research in Human Subjects, which is under the purview of the Ministry of Public Health. The Ethical Review Committee has put in place guidelines and procedures for research on humans; however, these are not enforced by law and most research institutions have their own sets of guidelines and procedures.

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

The FDA has issued the Notification on the Requirements for Import of Drug for the Clinical Trials Research BE 2559 (2016) that imposes the reporting and disclosure requirements for the results of clinical trials. The reporting requirement consists of the submission of an annual report on the development of the clinical trial research to the FDA within October 1 and 31 of each year. Once the clinical trials are completed, a summary report must be submitted to the FDA within 60 days of the end of the clinical trials in Thailand. The FDA is empowered to inspect the clinical trials before, during and after the completion of the research project, and the researcher must afford convenience and facilitate the inspection by the FDA.

What are the informed consent obligations with respect to clinical trial subjects?

The Medical Council Regulations on Medical Ethics Preservation BE 2549 (2006) require that the medical practitioner obtain consent from the subject, and treat the subject in the same manner as a patient in a medical practice.

Informed consent is also covered by Section 9 of the National Health Act, which requires that volunteers must provide written consent before participating in any medical research. Volunteers can revoke their consent at any time. Informed consent is not limited to a one-off signature on a piece of paper, but is an ongoing process.

Insurance

What are the insurance requirements for clinical trials?

There is no specific legal obligation specifying the insurance requirements for clinical trials.

Data protection

What data protection issues should be considered when conducting clinical trials?

There is no specific law or regulation governing data protection when conducting clinical trials. However, the general principles of data protection measures should be applied to clinical trials, especially in terms of the collection and use of the trial subjects' personal data. Thus, consent must be obtained from subjects in clinical trials before or upon collection, use or disclosure of personal data. To obtain consent, the purpose of using the personal data and details of the entity that will use such data must also be stated – for example, the transfer of personal data between affiliated companies or hospitals.

Marketing authorisation

Authorisation

What is the marketing authorisation procedure for medicinal products in your jurisdiction?

The market authorisation of drugs by the Food and Drug Administration (FDA) involves two steps. The first step is that the Drug Act BE 2510 (1967) requires that those wishing to import, manufacture or sell drugs in Thailand must obtain an appropriate licence.

The second step is for the applicant to apply for the relevant product (formula) registration licence. The FDA then reviews the application file in detail to check the quality, efficacy and safety of the drug. If the application file is complete, it requires only a final signature for approval.

It takes approximately 280 working days for a drug registration licence to be granted according to the current Citizen Manual, and the application file must be submitted using the electronic Common Technical Dossier system only. The first approval of a new drug is a conditional approval only, which allows the new drug to be sold solely through hospitals and medical clinics, and is subject to at least a two-year safety monitoring programme. Reports from the safety monitoring programme during these two years will then be considered when a subsequent application is made for an unconditional approval. If granted, an unconditional approval will also allow the drug to be sold through retail pharmacies.

What criteria are considered in granting marketing authorisation?

 The dossier requirements for drug applications must follow the Harmonisation Rules on Pharmaceutical Registration of the Association of South East Asian Nations (ASEAN) that came into effect on January 1 2009. Under these rules, manufacturers wishing to sell their products in ASEAN countries are required to prepare dossiers in a common format in accordance with the ASEAN Common Technical Requirement and the ASEAN Common Technical Dossier.

What is the fee for obtaining marketing authorisation?

The government fee for licences to import, manufacture or sell drugs in Thailand for the first step of the authorisation process described in the section above range from Bt2,000 to Bt20,000, depending on the type of licence. The government fee for product (formula) registration licence for the second step of the authorisation process is Bt3,000. There are additional fees for assessing the research documents and inspecting the business premises, which vary depending on the type of drug (eg, the fee for assessing research documents of a new chemical entity or new biological entity is Bt182,500).

What is the validity period for marketing authorisation?

The relevant licence to import, manufacture or sell drugs must remain valid until December 31 of the year of issue. A licensee that wishes to renew its licence must, before its expiration, file an application for renewal. When the application has been filed, the business may be continued until the FDA refuses to renew the licence.

The product registration has no expiration date. However, the licence holders must submit an annual report concerning the manufacture or importation of drugs before March 31 of the following year. The product registration will be cancelled if the drug products under that product registration is not actually manufactured or imported for two consecutive years.

What are the consequences of failure to obtain marketing authorisation?

Failure to obtain the licence to import, manufacture or sell drugs render the offender liable to imprisonment for up to five years and a fine up to Bt10,000. In addition, any licensee that fails to proceed with the relevant product (formula) registration will be liable to imprisonment for up to three years or a fine up to Bt5,000, or both.

Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

The Food and Drug Administration (FDA) imposes the post-marketing controls to monitor manufacturing facilities and product quality and safety after approval has been granted. The objective is to ensure ongoing compliance with both previously approved requirements and current standards, legislation and notifications.

Occasionally, the FDA randomly selects and spot-checks products in the market, and tests them to ensure that the ingredients are true to the pre-approved product licence label. The surveillance programme for consumers’ safety works hand-in-hand with the operators’ required pharmacovigilance to protect consumers from dangerous products. The FDA also uses research and epidemiological data, which includes technical information on adverse events.

Manufacturing facilities that have previously been approved are inspected to ensure ongoing compliance with the Good Manufacturing Practice certification and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) – an extension of the Pharmaceutical Inspection Convention.

To ensure that Thailand’s post-market monitoring procedures and requirements meet the standards of the Association of South East Asian Nations, the Ministry of Public Health issued a notification on the procedures for the submission of Device Defect Reports or Adverse Event Reports and the ensuing Field Safety Corrective Action Reports, which came into effect on November 4 2016.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

There are no specific laws or regulations governing data protection when conducting pharmacovigilance activities. However, the general principles of data protection measures should be applied. As the pharmacovigilance activities would include reports on adverse events due to the use of medicinal products, this would include disclosure of patient information, which could violate patient confidentiality. Thus, consent must be obtained from patients before or upon the collection, use, or disclosure of personal data. To obtain consent, the purpose of using the personal data and details of the entity that will use this data must also be stated, such as the transfer of personal data between affiliated companies or hospitals.

Pricing and reimbursement

Pricing

Are there rules governing the pricing of medicinal products in your jurisdiction?

Medicinal products are one of the controlled products under the Price of Goods and Services Act BE 2542 (1999). Therefore, the Committee of the Price of Goods and Services, appointed under this act, is empowered:

  • to determine the purchase price or the distribution price of the controlled goods (including drugs), so that:
    • the buyer buys at a price not lower than the determined price; or
    • the distributor distributes at a price not higher than the determined price; or
  • to fix the price at a particular level.

In addition, the National Drug System Development Committee determines a median drug price for public hospital drug procurement. This median price is one of the mechanisms used to control drug expenditure so that public hospitals can purchase drugs at an appropriate price. The criteria used to determine the median price of supplies to be purchased by government agencies (including the purchase of drugs by the public hospitals) are set forth in the Public Procurement and Management of Supplies Act BE 2560 (2017), which became effective on August 23 2017. The Government Pharmaceutical Organisation also plays a role in controlling drug prices.

Reimbursement

What is the structure for state reimbursement of medicinal product costs?

In Thailand, three programmes exist for drug reimbursement:

  • the civil service welfare system for civil servants and their families;
  • social security for private employees; and
  • the universal coverage scheme for (theoretically) all other Thai nationals who hold identification cards.

A citizen is legally entitled to participate in only one government programme, but he or she may also have private insurance or be self-insured.

All three programmes have their own health service benefit package, payment system and funding. For the civil service welfare system, all payments are funded by the Comptroller General’s Department at the Ministry of Finance. For social security, payments are funded by the Social Security Office and the universal coverage scheme is funded by the National Health Security Office. Each programme also uses a different payment system: fee-for-service, diagnosis-related groups and capitation, respectively. However, all three programmes share a feature: the only drugs that can be reimbursed are those listed in the National List of Essential Medicines (NLEM). The NLEM is developed by the National Drug System Development Committee, which is made up of various experts, a majority of whom are selected by the FDA. Drugs outside the NLEM can be reimbursed only when the doctor specifies that such drugs are necessary and required to cure the patient.

The Health Intervention and Technology Assessment Programme under the Ministry of Public Health is responsible for conducting economic evaluations to develop the Thai health system and policies (including the drug reimbursement policy), to become more effective by using methods such as pharmaeconomics and surveys of relevant stakeholders, including healthcare providers, academics and patients. In addition, the Heath Systems Research Institute, another agency under the Ministry of Public Health, is collating health policy information in order to develop cost-effective drug reimbursement, among other issues.

Advertising and labelling

Advertising

How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?

Each category of drugs has different requirements regarding advertisement and promotion. Some products are more restricted than others when it comes to advertising. For example, specially controlled drugs and dangerous drugs cannot be advertised to the public. The specific requirements for advertising and promotion are prescribed by the Food and Drug Administration (FDA).

There are two fundamental requirements for advertising drugs under the Drug Act BE 2510 (1967).

First, the drugs must meet pre-approval requirements for advertising. Before advertising any drug by any means, the content and wording that will be used in the advertisement must be submitted to the FDA for approval. 

Second, the content of ads must comply with the conditions set by the FDA and must not contain information that is false, exaggerated, misleading or different from the details registered with the FDA. An ad must not use information that cannot be proven. In the approval process, supporting evidence such as scientific or academic information must be provided.

Several other laws and regulations apply, including:

  • the Consumer Protection Act BE 2522;
  • the Direct Sales and Direct Marketing Act BE 2545;
  • the Medical Professionals Act BE 2525; and
  • the Harmonisation Guidelines of the Association of South Asian Nations covering topics such as labelling requirements and interaction with medical professionals.

Do any special rules apply to online advertising of medicinal products?

The online advertising of medicinal products is subject to similar fundamental requirements to the advertisement of drugs under the Drug Act.

Labelling

What are the packaging and labelling requirements for medicinal products?

Pursuant to the Drug Act, manufacturers, importers or sellers of drugs must fulfil certain requirements for labels and package inserts. The main requirements are that the labelling must be in accordance with the drug's registered formula to be placed on containers or packaging of the finished product. The text of such labels and leaflets must be clearly legible and a Thai translation must be provided for any leaflet made in a foreign language. In addition, warnings and methods of administration for drugs must be given on labels and packing leaflets.

How is the promotion of off-label use regulated?

The Drug Act prohibits off-label promotion.

Relations with healthcare professionals

Gifts and incentives

What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?

A number of activities that may be construed as incentives for healthcare professionals who are deemed to be ‘officials’ should be considered with care. These activities may include, but are not limited to, the provision of gifts, entertainment, other forms of hospitality and sponsorship of the healthcare professional to attend local or overseas events such as medical congresses, symposiums or onsite visits. (Such sponsorship may cover accommodation, travel, meal and registration expenses.) The matters outlined below must be considered.

Bribery offences

Under Section 144 of Thailand’s Penal Code, a person may be guilty of a bribery offence if he or she gives, offers or agrees to give property or any other benefit to an official in order to induce the official to do or refrain from doing any act, or to delay the performance of any act, that is contrary to the official’s functions or duties.

Based on the above, an offence constituting bribery requires the existence of dishonest intent, and benefits are given to make the official perform or not perform his or her duty on a quid pro quo basis.

Section 144 does not provide any exceptions with regards to facilitation payments, nor are there any express exceptions in relation to good-faith business expenses. Nevertheless, payments made to government officials will violate Section 144 only if the payments are made with the dishonest intent to influence the government official.

The Penal Code defines a ‘government official’ as a person whom the law considers an official or who has been appointed under a law to carry out official duties, whether permanent or temporary, and whether or not receiving remuneration in return. Doctors or physicians working in state or government hospitals would be deemed to be government officials under the Penal Code. Moreover, non- government officials may also be deemed to be government officials under the Penal Code if they are appointed to certain positions on government boards or committees that have certain authorities given to them by the law.

In addition, the Act Supplementing the Constitution Relating to Prevention and Suppression of Corruption BE 2542 (1999) (the Anti-Corruption Act) has been amended to cover bribery related to state officials in Thailand, foreign countries and international organisations. The Anti-Corruption Act specifically aims to control the bribery of, and corrupt acts by, state officials, politicians and other high-ranking officials. It does not replace the offences in the Penal Code, but empowers the National Anti-Corruption Commission to investigate and file lawsuits against these particular officials, as well as those in the private sector involved in bribery. A legal person can also be subject to a fine up to twice the damages sufferred from the commission of an offence.

Receipt of properties or benefits by officials

In addition to the above, under the Anti-corruption Act and its subordinate notification, no official may receive property or any other benefits from any person, other than legitimate property or benefits derived under the law, rules, or regulations issued by virtue of the provisions of law, with the exception of the receipt of property or any other benefits on an ethical basis.

‘Ethical basis’ means that an official may receive property or any other benefits from any relative or from any person on a traditional, customary or cultural occasion, or on an occasion in which societal practice requires the giving of such items. Regardless, no official may receive any property or other benefits on a single occasion from a person who is not related to the official, with a value in excess of Bt3,000 (approximately $100). The receipt of an asset or other benefit that is given to others as a matter of general practice is acceptable.

PReMA Code

Pharmaceutical companies in Thailand that are members of the Pharmaceutical Research and Manufacturers Association (PReMA) may adopt PReMA’s Code of Sales and Marketing Practices (the PReMA Code) on a voluntary basis.

The PReMA Code outlines certain requirements and/or prohibitions in relation to the sales, marketing and promotion of the members’ products in order to ensure that such practices are conducted in an ethical manner.

The matters controlled under the PReMA Code include, but are not limited to:

  •  advertising through journals;
  •  promotional activities undertaken by sales representatives and the materials used by such sales representatives;
  •  the use of trade displays and audio-visual materials;
  •  the provision of samples;
  •  the provision of gifts or entertainment; and
  •  sponsorship of healthcare professionals to attend symposia or medical congresses.

Violation of the PReMA Code by PReMa members may lead to sanctions under the PReMA Code, which includes suspension of membership and fines.

Liability

Defect products

How can a liability claim for a defective medicinal product be brought?

Thailand does not have any special systems or laws dealing with patients who are injured by drugs. Where an injury is caused by drugs, the general principles of tort law and product liability law may apply.

Which parties can be held liable for a defective medicinal product?

Two specific laws in Thailand relate to product liability: the Act on Liability for Injuries from Unsafe Products BE 2551 (2008) (the Product Liability Act) and the Act on Court Proceedings for Consumer Cases BE 2551 (2008) (the Consumer Case Procedure Act). These two statutes provide a number of consumer-friendly procedural elements designed to give consumers advantages when taking cases to court against business operators.

The scope of the Product Liability Act is limited to injuries caused by unsafe products, whether to life, body, health, wellbeing, emotions or property, but excludes damages caused to the unsafe product itself. The term ‘product’ covers all types of movable property, including drugs.

Under the Product Liability Act, a product is deemed unsafe if it causes or is likely to cause damage. Damage, or the likelihood of damage, may arise from manufacturing defect, design defect or warning defect. In determining whether or not a product is unsafe, the court will take into account both the nature of the product and its ordinary use and storage.

If a consumer suffers damage as a result of an unsafe product, the relevant business operator may be liable to compensate the consumer. In this regard, ‘business operator’ means:

  • manufacturers or hirers for manufacture;
  • importers;
  • sellers of products, if the products do not indicate the manufacturer, hirer for manufacture or importer; and
  • persons who use a name, trademark, trade name, sign or statement that would lead to the understanding that they are the manufacturer, hirer for manufacture or importer of the product in question.

The Product Liability Act expands the concept of ‘strict liability’ under Thai law to mean that a business operator may not need to be at fault to be liable for an unsafe product under the Product Liability Act. Once a product is found to be unsafe, a business operator will be held jointly liable with other relevant business operators to compensate the injured persons, even if such business operator did not intend to cause injury or was not acting negligently.

Remedies

What remedies are available to successful claimants?

The Consumer Case Procedure Act applies to all cases arising from the consumption of goods and services, and includes cases under the Product Liability Act. The Consumer Case Procedure Act ensures that consumers are given access to cheaper, quicker and simpler proceedings. Consumers are allowed to file a complaint either orally or in writing. They are exempted from court fees, unless they lose the case. For expediency, consumer cases are guaranteed a speedy trial. The court will appoint a case administrator to assist consumers in the process.

During trial, the burden of proof regarding facts relating to the production, assembly, design or components of a product, or regarding the provision of services, rests on the business operator (the defendant), as only the defendant can know these facts. Unlike in a normal civil case, the court is empowered to call any evidence and witnesses that it deems appropriate.

With regards to damages, the Consumer Case Procedure Act provides the court with greater power than in normal civil cases: the court can award/order punitive damages, a product recall and replacement damages. Furthermore, where the defendant is a legal entity, the court can apply the doctrine of ‘piercing the corporate veil’ in order to force the defendant’s shareholders, partners or controlling persons to be jointly liable to the consumers where the court finds that:

  • the defendant has been established or operates in bad faith;
  • the defendant has committed fraudulent acts against consumers; or
  • the defendant’s assets have been transferred for the benefit of any individual, including third parties, and the remaining assets of the legal entity are insufficient to cover the damages sought by the claimant.

Exclusion and limitation

On what grounds can liability be excluded?

Under the Product Liability Act, a business operator is not liable for injury from an unsafe product when it can be proven that:

  • the product is not unsafe;
  • the injured party was fully aware that such product is unsafe; or
  • the injury arose from incorrect use or storage, which differed from that advised in the instructions for use or storage, or the warnings or information concerning the product that the business operator reasonably, correctly, and clearly provided.

In addition, a manufacturer manufacturing the product as instructed by a hirer is not liable where it can be proven that the product was unsafe due to the design that the hirer provided or as a result of compliance with the orders of the hirer – provided that the manufacturer did not foresee and could not have foreseen that the product was unsafe.

The manufacturer of a part or component of the product is not liable where it can be proven that the product was unsafe due to the design, assembly, instructions for use, storage, or destruction, warning, or information concerning the product, provided by the manufacturer of the product.

What preventive steps can be taken to limit liability?

  The Product Liability Act imposes the concept of ‘strict liability’ under Thai law. The business operator’s liability cannot be exempted or limited by an agreement with consumers. However, the courts are empowered by the Product Liability Act to award compensation for punitive damage of up to twice the actual damages suffered.

Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

The Drug Act BE 2510 (1967) specifies criminal penalties (ie, imprisonment and fine) for business operators that fail to comply with the relevant requirements.

Moreover, the Food and Drug Administration (FDA) is also empowered under the Drug Act to enforce the provisions of the Drug Act through various mechanisms, including checking products in the market.

However, personnel restrictions means that the FDA must limit its enforcement to cases where spot checks reveal that products are not up to standard, or when it receives a complaint about a specific drug. The FDA may ask some follow-up questions, and request proof from the complainant to determine the legitimacy of the complaint. The FDA will then start gathering preliminary information on the product and the responsible person. The product at issue will be analysed, and the results compared with the product licence and registrations, and any relevant legislation to determine infractions. The investigation and inspection procedures applied by the FDA vary from case to case. If necessary, the FDA may enlist the Police for assistance. The penalties for the infractions are provided in the relevant legislation.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

There is no specific mechanism to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector. Therefore, the general laws and regulations apply. They have been recently amended to be more stringent in order to combat bribery. For example, the Act Supplementing the Constitution Relating to Prevention and Suppression of Corruption BE 2542 (1999) (the Anti-Corruption Act) specifies a presumption of criminal liability on legal persons whose employees offer or receive bribes. The entity will be deemed to be committing the offence, unless it can prove that it has put in place appropriate internal controls.

Section 123/5(2) of the Anti-Corruption Act specifies that if a person who has committed bribery is related to a legal person (eg, an employee or agent) or performing for or on behalf of that legal person, and the offence is committed for the benefit of the legal person and that legal person has not put in place appropriate internal controls to prevent the commission of such an offence, that legal person will be subject to a penalty of a fine up to twice the assets received from the commission of the offence.

On December 16 2017 the Office of the National Anti-Corruption Commission issued a separate notification under the Anti Corruption Act that specifically requires companies to have appropriate internal control measures for the prevention of acts of bribery which may be undertaken by a company's connected persons for the company's benefit. Under the notification, the company's internal control measures must at least include the following eight fundamental elements:

  • strong, visible policies and support from top-level management to prevent bribery;
  • risk assessment to identify and evaluate effectively exposure to bribery;
  • enhanced and detailed measures for high-risk and vulnerable areas;
  • application of anti-bribery measures to business partners;
  • accurate books and accounting records;
  • human resource management policies complementary to anti-bribery measures;
  • communication mechanisms that encourage the reporting of suspicion of bribery; and
  • periodic review and evaluation of anti-bribery prevention measures and their effectiveness.

These key elements are considered as minimum legal requirements. However, an anti-corruption policy is only one part of what may be considered appropriate internal control measures. The notification issued by the Office of the National Anti-Corruption Commission makes it clear that the existence of such minimum internal control measures does not guarantee the company's exemption from liability. Consideration must also be given to how the measures are implemented and used by the company. It may therefore be more important to consider whether such legal person actually implements and uses all the measures required under both the notification and the Official Guidelines (in addition to merely having an anti-corruption policy).