I INTRODUCTION

Established by a policy of the Ministry of Public Health (MOPH), the Food and Drug Administration (FDA) is the principal government regulatory authority for drugs, medical devices, foods, cosmetics, hazardous substances, narcotics and psychotropic substances in Thailand. The FDA controls these products through the following divisions: Bureau of Drug Control, Medical Device Control Division; Bureau of Foods, Cosmetic and Hazardous Substance Control Division; and Narcotics Control Division.2

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 in the form of specific Acts for each product category. The Acts generally follow a common format and cover the following matters: definitions, specialised committees, officers' responsibilities, licences, obligations on the licence holder, product classification, advertisement, licence suspension and revocation, penalties and government fees. Under each Act, notifications are issued by the relevant committees or ministers that provide additional guidelines and requirements for operators. These notifications usually provide details of 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, which will be discussed in Section II.

The relevant laws also demand that certain issues are decided by committees whose members (experts in their respective fields) will be appointed by the Minister of Public Health. At present, there are seven committees: drugs, medical devices, foods, cosmetics, hazardous substances, narcotics, and psychotropic substances.

II THE REGULATORY REGIME

i Classification

There are seven Acts that govern specific products, in particular, drugs, medical devices, foods, cosmetics, hazardous substances, narcotics and psychotropic substances. The products (and their variations) governed by each specific Act are laid out in the introductory section of each Act.

The Acts provide for definitions and classifications of products. For example, the Drug Act provides 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 that are excluded under the Drug Act), there are then further subclassifications (such as modern drugs and herbal drugs).

For medical devices, the Medical Device Act provides clear definitions for medical devices and the main focus for product classification is on the manufacturer's intended use, which must be clearly declared by statements made on the product label or leaflet issued by the manufacturer.

ii Non-clinical studies and animal testing

The Institute of Animals for Scientific Purpose Development, an agency of the National Research Council of Thailand, is the body responsible for the use of animals for scientific purposes. Non-clinical testing on animals is regulated by the Animals for Scientific Purposes Act, BE 2558 (2015).

In addition to the Act, the National Research Council of Thailand has issued Ethical Principles and Guidelines for the Use of Animals.3 The Guidelines set standards for animal care and management of animal health, and only allow techniques that minimise the stress and pain endured by animals during testing.

iii Clinical trials

There is no specific Thai law governing human clinical trials. However, in practice, 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.

To facilitate clinical trials, the FDA has issued a Notification4 that deals with the importation of drugs for clinical trial purposes. The Notification outlines the requirements for an Ethics Committee to consider requests for importing 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 commercially sell or distribute the drug in Thailand.

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 (EC), which is under the purview of the MOPH. The EC has put in place Guidelines and Procedure for Research on Human Subjects; however, these are not enforced by law and most research institutions have their own sets of guidelines and procedures.

The requirement for informed consent is 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.5 Informed consent is not limited to a one-off signature on a piece of paper, but is a continuing process.

iv Named-patient and compassionate-use procedures

Unlike some countries, there is no specific legislation or regulation that deals with named-patient production or importation. Neither are there any specific exceptions on product registration for the purposes of named-patient usage stipulated in the Drug Act.

v Pre-market clearance

Drugs

Pre-marketing control covers product registration and related licences and permits (such as manufacturing facilities, product quality assurance and advertising).

The pre-marketing control of drugs by the FDA is divided into two main steps. The first step is that the Drug Act requires that those who wish to import, manufacture or sell drugs in Thailand must obtain an appropriate licence.6

The second step is for the applicant to apply for the relevant product (formula) registration licence.

The application file is then reviewed in detail by the FDA to check the quality, efficacy and safety of the drug. If the application file is complete, it requires 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 eCTD (electronic Common Technical Dossier) only.7 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 (SMP).8 Reports from the SMP 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.

The dossier requirements for drug applications must follow the Association of Southeast Asian Nations (ASEAN) Harmonisation rules that came into effect on 1 January 2009. This means that under the new rules of the ASEAN Harmonisation on Pharmaceutical Registration, 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.

Medical devices

Medical devices are categorised into three subcategories (see Section II.xi for product classifications) and each category has its own specific pre-marketing procedures.

As a general first step, a local manufacturing facility requires a manufacturing licence and an importer requires an import licence.

vi Regulatory incentives

Thailand does not have specific laws on data exclusivity for the protection of an originator's drug registration data from other companies submitting applications to the FDA to register generic versions of the drug in question. There is a Trade Secrets Act of general application under which the MOPH has issued a Regulation. However, this Regulation is of limited use as it does not prevent the FDA from referring to and relying upon an originator's registration data when considering a subsequent generic application. The scope of this Regulation is limited to pharmacopoeia registration information related to modern drugs that use new kinds of chemical substances that have not ever been approved for registration in Thailand.9

The purpose of the Regulation is to allow an applicant who submits the pharmacopoeia registration information, as part of the drug registration process, to also submit an application requesting that the FDA keep the trade secrets of the pharmacopoeia registration information confidential. If the confidentiality application is approved under the Regulation, the FDA is required to keep the information confidential for five years from the approval date.10 It is important to note that the protection granted under this regulation is limited to the maintenance and safe-keeping of the pharmacopoeia registration information as a trade secret.

Thailand has no special provisions to encourage the development of products for rare diseases and no 'orphan drug' programme.

vii Post-approval controls

Post-marketing controls aim to monitor manufacturing facilities and product quality and safety after approval has been granted. The objective is to ensure there is continuing 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 uses research and epidemiological data, which includes technical information on adverse events.

Manufacturing facilities that have previously been approved are inspected to ensure continuing compliance with the good manufacturing practices (GMP) certification and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an extension of the Pharmaceutical Inspection Convention.

Currently there are no laws or regulations regarding the transfer of ownership of medical device licences and a transferee would have to apply for a new licence.

Post-marketing controls on medical devices involve surveillance of the medical devices to prevent injury that are on the market, and the development of regulatory standards and product improvement. Various sources of information are used for post-marketing surveillance (PMS).

To ensure that Thailand's PMS procedures and requirements meet ASEAN standards, the MOPH has issued a notification on the procedures for the submission of a Device Defect Report or Adverse Event Report and the ensuing Field Safety Corrective Action Report, which came into effect on 4 November 2016.11

As an ASEAN Member State, Thailand has applied and harmonised its standards in compliance with the ASEAN Consultative Committee for Standards and Quality-Medical Device Product Working Group, which has set up a Post-Marketing Alert System to keep track of medical devices on the market that are unsafe.

viii Manufacturing controls

An entity that intends to manufacture drugs in Thailand must apply for a manufacturing licence from the FDA.12 A factory licence from the Ministry of Industry will have to 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.13 All manufacturers are required to have GMP certification that complies with the standards of PIC/S.

An entity that intends to manufacture any category of medical device in Thailand must have its business premises inspected and registered with the FDA and obtain a manufacturing licence.14 Additionally, procedures to register or notify each type of medical device is required.

ix Advertising and promotion

Each category of drugs and medical devices 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.15 Several medical devices can only be advertised to healthcare professionals, while other medical devices can be advertised to the general public.16 The specific requirements regarding advertising and promotion are prescribed by the FDA.

There are two fundamental requirements for advertising drugs and medical devices.

  1. First, both drugs and medical devices must meet pre-approval requirements for advertising. Before advertising any drug or medical device by any means, the content and wording that will be used in the advertisement must be submitted to the FDA for approval.17
  2. Second, the content of advertisements must comply with the conditions set by the FDA and must not contain information that is false, exaggerated, misleading or different from the details as registered with the FDA. An advertisement must not use information that cannot be proven. In the approval process, supporting evidence such as scientific or academic information must be provided.18

In addition to the main requirements set out in the Drugs Act and the Medical Device Act there are several other laws and regulations of relevance, including the Consumer Protection Act, BE 2522, the Direct Sales and Direct Marketing Act, BE 2545, the Medical Professionals Act, BE 2525, and the ASEAN Harmonisation Guidelines covering topics such as labelling requirements and interaction with medical professionals.

x Distributors and wholesalers

Drugs

To sell drugs, a selling licence relevant to the type of business in question is required from the FDA; this may be a wholesale licence, a retail licence or a pharmacy licence. The main condition is that the seller must have such facilities as are prescribed by the ministerial regulations. A pharmacist must be in attendance during business hours to dispense drugs and to monitor activities.

A selling licence is also required for the sale of certain types of medical devices.

xi Classification of products

The Drug Act generally categorises drugs as modern, traditional, dangerous, specially controlled, household, packaged (other than those categorised as dangerous or specially controlled) and herbal.19 The Minister of the MOPH, on the advice of the Drugs Committee, has the authority to classify drugs into one of these categories by making an announcement in the Royal Gazette.20

However, in practice, for licensing purposes, the FDA classifies drugs into seven main categories: new, new generic, modern, traditional; herbal, household and orphan. Each category of drugs has different restrictions and requirements.

As is the case with a number of other South East Asian countries, the incidence of self-medication in Thailand is generally more prevalent than in some Western countries. For example, what would commonly be regarded as prescription-only items in certain other jurisdictions are available for purchase in retail pharmacies in Thailand without the need for a doctor's prescription. Generic substitution is accepted practice.

The Medical Device Act classifies medical devices into three categories, each with different restrictions and requirements. The Minister of the MOPH, on the advice of the Medical Devices Committee, has the authority to classify medical devices based on risk and safety to consumers,21 and the classifications are subject to change as announced.

xii Imports and exports

An entity that intends to import drugs into Thailand must obtain an import licence from the FDA.22

An entity that intends to import any category of medical device must have its business premises registered with the FDA.23

Under the Drugs Act and the Medical Device Act, there is no requirement for a licence to export drugs or medical devices. However, an export certificate (similar to a free sale certificate) may be required by Thai Customs.

A business in Thailand that wishes to manufacture medical devices in accordance with the quality standards, labelling standards or other details specified by an overseas purchaser, and to export those devices without selling them in Thailand, can apply for a manufacturing-for-export licence that will expedite the application process and make it faster than a normal manufacturing licence application process. The procedures and conditions for obtaining a manufacturing-for-export licence are as prescribed by the FDA.24

xiii Controlled substances

Narcotics and psychotropics are listed under various categories and are either restricted or subject to strict licensing requirements.

xiv Enforcement

Owing to personnel limitations, the enforcement phase is initiated when spot checks in the market reveal that products are not up to standard, or when a complaint is made to the FDA about concerns regarding drugs or medical devices. Some follow-up questions might be asked and proof requested from the complainant to determine the legitimacy of the complaint. The FDA will then take over and begin by gathering preliminary information about the product and the responsible person. The product in question will then be analysed and the results will be 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 infractions are provided in the relevant legislation. Additional enforcement actions required for medical devices are covered above in the post-marketing subsections.

III PRICING AND REIMBURSEMENT

In Thailand, drug reimbursement can be made through three programmes: the Civil Service Welfare System for civil servants and their families, social security for private employees, and the Universal Coverage scheme (UC), which is theoretically available to all other Thai nationals who have identification cards.25 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 Department26 of the Ministry of Finance. For social security, payments are funded by the Social Security Office27 and the UC is funded by the National Health Security Office.28 Each programme also uses a different payment system, namely fee-for-service, Diagnosis Related Groups and capitation.29 However, in all three programmes, the only drugs that can be reimbursed are those included on the National List of Essential Medicines (NLEM). The NLEM is developed by the National Drug System Development Committee, which includes a number of experts, the majority of whom are selected by the FDA. Drugs outside the NLEM can only be reimbursed when a doctor prescribes such drugs as necessary and required to cure the patient of the sickness.

The Health Intervention and Technology Assessment Program (HITAP) under the MOPH is responsible for conducting economic evaluations to develop the Thai health system and policies (including the drug reimbursement policy), to be more effective through using methods such as pharmaeconomics and surveys of relevant stakeholders, such as healthcare providers, academics and patients.30 Apart from HITAP, the Health Systems Research Institute (HSRI), which is also an agency under the MOPH, is developing academic information on health policy to develop cost-effective drug reimbursement, among other issues.31

There is also a median drug price for public hospital drug procurement prescribed by the National Drug System Development Committee.32 This median price is one of the mechanisms used to control drug expenditure so that public hospitals can purchase drugs at an appropriate price.33 The criteria of median price of the supplies to be purchased by government agencies, including the median price for the purchase of drugs by the public hospitals, is also subject to the criteria and requirements under the Public Procurement and Management of Supplies Act, BE 2560 (2017), which became effective on 23 August 2017.34 The Government Pharmaceutical Organization also plays a role in controlling drug prices.35

IV ADMINISTRATIVE AND JUDICIAL REMEDIES

The Drug Act and the Medical Device Act provide mechanisms for internal review of administrative decisions. Under the Drug Act, if the FDA declines to issue or renew a licence, the applicant is entitled to submit a letter seeking an administrative review by the Minister of the MOPH within 30 days of the date of the letter declining the application.36 The Drug Act provides the same mechanism for someone whose licence is suspended or revoked.37

Similar to the administrative review mechanism provided under the Drug Act, the Medical Device Act provides that if the FDA declines to issue or renew a licence, the applicant is entitled to submit a letter seeking an administrative review by the health minister within 30 days of the date of the letter declining the application.38 A person whose licence is suspended or revoked is also entitled to the same administrative review mechanism.39 The Medical Device Act also provides that after receiving a letter requesting an administrative review, the Minister of the MOPH must render a decision within 120 days.40

According to both the Drug Act and the Medical Device Act, the Minister of MOPH's judgment is considered to be final,41 and this will be the end of the appeal under the internal administrative review system. If the petitioner is still not satisfied with the Minister of the MOPH's judgment, the next step is to bring the dispute to an administrative court, which has the function of addressing disputes caused by acts of the government and its agencies, including the FDA.42

The Administrative Court Act provides:

If the law provides for the process or procedure for the redress of the grievance or injury in any particular matter, the filing of an administrative case with respect to such matter may be made only after action has been taken in accordance with such process and procedure and an order has also been given thereunder or no order has been given within a reasonable period of time or within such time as prescribed by law.43

Since there is a specific appeal process provided by the Drug Act and the Medical Device Act, the entity will have to complete the appeal process before filing a dispute with an administrative court.

According to the Administrative Court Act, any person who is aggrieved or injured, or who may be aggrieved or injured in consequence of an act by the government and its agencies, can file a case with an administrative court.44 This means that competitors and consumers who are affected by an FDA decision can also file a case with an administrative court.

In addition to the aforementioned mechanisms provided by the law, in practice, a number of disputes relating to non-critical issues are resolved through an informal internal dispute resolution process conducted by an FDA officer. In practice, for non-critical issues, after the submission of the licence application, or before the suspension of each existing licence, the FDA's official will review the application and related facts and let the business entity know of any issues that may lead to the rejection of the application or suspension of the existing licence, before making any decision. The official will inform the business entity of the problem and ask it to resolve those issues internally.

For critical issues, where criteria cannot be negotiated or resolved, the FDA official will render a decision directly. An entity that wishes to challenge or appeal the decision will then submit a letter seeking an administrative review by the Minister of the MOPH. The classification of critical issues and non-critical issues are listed internally by the FDA official and are subject to the discretion of the official involved.

V FINANCIAL RELATIONSHIPS WITH PRESCRIBERS AND PAYERS

Generally, there should not be any financial relationships between prescribers and payers or product suppliers. The procurement of products must be done with hospitals and not through prescribers. In Thailand, most healthcare facilities are government hospitals or hospitals that belong to medical schools that are mostly required to abide by the same set of procurement rules as used by government hospitals.45

Doctors and healthcare professionals who work in government hospitals are deemed to be 'officials' under and subject to the Penal Code and the Act Supplementing the Constitution Relating to Prevention and Suppression of Corruption, BE 2561 (2018). Generally, the types of procurement methods that are used in government hospitals are e-market and e-bidding under the general invitation method, the selection method and the specific method. The e-market applies to the procurement of supplies costing in excess of 500,000 baht that do not have specific or complex features, and where the specification of such supplies is provided in the government's e-catalogue system, while the e-bidding applies to the procurement of supplies costing in excess of 500,000 baht, where specification of such supplies is not provided in the government's e-catalogue system. The relevant processes must be in accordance with the method specified by the Comptroller General's Department.46 The selection method requires at least three entrepreneurs who have qualifications as specified by the government agency, all of whom must submit a proposal, unless there are fewer than three entrepreneurs who meet the requirements.47 This method is often used by public hospitals when there are special circumstances or conditions, for example when the article being procured must be a brand name owing to the nature of its use or its technical specifications.48 The specific method applies primarily when supplies are procured that are manufactured, distributed, constructed or serviced in general, the cost is within the financial limit specified by ministerial regulations for single procurement (not exceeding 500,000 baht)49 and there is only one entrepreneur who possesses the qualifications specified by a government agency.50

It is common practice that certain discount schemes are required as part of the procurement process adopted by government hospitals. Currently, discounts of this nature are considered to be acceptable within the industry as long as the discount and the payment of the discount in question is made in a transparent manner. Nevertheless, the National Anti-Corruption Commission (NACC) has issued a guidance letter to the secretary general of the Cabinet as a proposal for the Cabinet to consider. One of the criteria is to prohibit government agencies that procure any medical or healthcare supplies from seeking any income (to be payable to a hospital welfare fund) in any form that might be considered a quid pro quo from pharmaceutical companies.51 The Cabinet had a conference on 12 September 2017 acknowledging the proposed measures under the NACC guidance letter, and requested that the MOPH be the main agency, alongside the Ministry of Finance and other related agencies, to consider proceeding with the relevant matter. The MOPH also agrees with the NACC guidance letter.52 Failure to comply with these requirements may lead to accusations of non-compliance with government corruption prevention measures and disciplinary sanctions for the government agency.

VI SPECIAL LIABILITY OR COMPENSATION SYSTEMS

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

VII TRANSACTIONAL AND COMPETITION ISSUES

i Competition law

Thailand does not have any specific rules or laws that provide for any settlement or arrangements where there is a patent dispute between the originator and generic manufacturers.

ii Transactional issues

There is no specific law or rules governing commercial arrangements between importers or manufacturers and other business operators in the industry. Any licensing and strategic collaborations, joint ventures or mergers and acquisitions in the life sciences industry will be subject to national laws on the subject matter that apply to other industries or products.

VIII CURRENT DEVELOPMENTS

On 13 November 2018, the Cabinet approved in principle the draft amendment of the Drug Act (the Bill), as proposed by the Ministry of Public Health. The Bill will be sent to the National Legislative Assembly for further review and enactment. Among other matters, the key amendments to the Drug Act as proposed under the Bill include:

    1. allowing experts (in the form of external organisations, government agencies, or private entities, both in Thailand and overseas) that meet the required qualifications to enrol with the FDA to evaluate academic documents, conduct product analyses and audit business premises on behalf of the FDA. The aim of this is to facilitate and accelerate the drug approval process by lessening the workload of the FDA;
    2. allowing the FDA to use the official fees collected from the experts' enrolment and the drug approval process for its own operations (including the development of the required systems related to the drug approval process and consumer protection activities), without first having to return the fees to the government treasury;
    3. requiring the applicant to provide a document showing the patent or petty patent for a drug product that has a patent or petty patent in accordance with the applicable patent laws, or the right to data related to Thai traditional medicinal wisdom for Thai traditional drug products, when applying for a drug registration licence; and
    4. specifying the period of validity of drug registration licences to be five years from the issue date (instead of having no expiration date). Drug registration licences issued before the Bill becomes effective will remain valid for between five and seven years (depending on the year the drug registration licences were issued).

Footnotes

1 Peerapan Tungsuwan is a partner and Praween Chantanakomes is an associate at Baker McKenzie.

2 Food and Drug Administration, 'Organization structure of Thai FDA' (2016) – www.fda.moph.go.th/sites/FDA_EN/SitePages/Organization.aspx, accessed 5 January 2017; Ministerial Regulation regarding the divisions of the Food and Drug Administration under the Ministry of Public Health BE 2552 (2009).

3 National Research Council of Thailand, 'Principles and Guidelines for the Use of Animals', 1999.

4 The Notification of the Food and Drug Administration Re: the Requirement on the Import of Drug into the Kingdom for Clinical Trial, dated 17 September 2561 (2018).

5 Section 9 National Health Act, BE 2550 (2007).

6 Section 12 Drug Act, BE 2510 (1967).

7 Thai Government, 'Drug Formula Registration for New Drugs' – www.fda.moph.go.th/sites/drug/SitePages/Zone_manual.aspx?Name=%E0%B8%A2%E0%B8%B2.

8 The Notification of the Food and Drug Administration Re: the Criteria on the Risk-Based Approach Safety Monitoring Program, dated 9 October 2560 (2017).

9 Article 3 Ministry of Public Health Regulation governing the Keeping of Trade Secrets of Pharmacopoeia Registration Information, BE 2550 (2007).

10 Article 19 Ministry of Public Health Regulation governing the Keeping of Trade Secrets of Pharmacopoeia Registration Information, BE 2550 (2007).

11 Ministry of Public Health notification on rules, procedures and conditions for the submission of Device Defect Report or Adverse Event Report and the ensuing Field Safety Corrective Action Report, dated 22 March 2559 (2016).

12 Section 12 Drug Act, BE 2510 (1967).

13 Section 20 Drug Act, BE 2510 (1967).

14 Section 15 Medical Device Act, BE 2551 (2008).

15 Section 88(6) Drug Act, BE 2510 (1967).

16 Section 4.5 Notification on Guidelines, Procedures and Restrictions on Medical Device Advertising, BE 2553 (2010).

17 Section 88 bis Drug Act, BE 2510 (1967), and Section 57 Medical Device Act, BE 2551 (2008).

18 Section 88 Drug Act, BE 2510 (1967), and Section 59 Medical Device Act, BE 2551 (2008).

19 Section 4 Drug Act, BE 2510 (1967).

20 Sections 76 and 78 Drug Act, BE 2510 (1967).

21 Section 6 Medical Device Act, BE 2551 (2008).

22 Section 12 Drug Act, BE 2510 (1967).

23 Section 15 Medical Device Act, BE 2551 (2008).

24 Section 34 Medical Device Act, BE 2551 (2008).

25 National Health Security Office, 'The Ministry of Public Health, National Health Security Office Annual Report 2015' (2015), pp. 8–9.

26 Comptroller General's Department, 'Guideline for Civil Service Welfare System for civil servants'.

27 Social Security Act, BE 2533 (1990).

28 National Health Security Act, BE 2545 (2002).

29 S Ngorsuraches, 'Drug Reimbursement Decision-Making in Thailand, China, and South Korea' [2012] Elsevier 120, 125.

30 Health Intervention and Technology Assessment Program, 'Organization History' – www.hitap.net/abouthitap/background, accessed 5 January 2017.

31 Health Systems Research Institute Act, BE 2535 (1992); Health Systems Research Institute, 'About HSRI' – www.hsri.or.th/people/about/strategic, accessed 5 January 2017.

32 National Drug System Development Committee Notification regarding median drug price, BE 2561 (2018).

34 Government Gazette Book No. 134, Section 24 Gor, dated 24 February 2017.

35 Government Pharmaceutical Organization, 'About us' – www.gpo.or.th/Default.aspx?tabid=56, accessed 5 January 2017.

36 Section 18 Drug Act, BE 2510 (1967).

37 Section 99 Drug Act, BE 2510 (1967).

38 Section 74 Medical Device Act, BE 2551 (2008).

39 Section 75 Medical Device Act, BE 2551 (2008).

40 Section 76 Medical Device Act, BE 2551 (2008).

41 Section 18 Drug Act, BE 2510 (1967) and Sections 74 and 75 Medical Device Act, BE 2551 (2008).

42 Section 9 Act on Establishment of the Administrative Court and Administrative Court Procedures, BE 2542 (1999).

43 Section 42 Act on Establishment of the Administrative Court and Administrative Court Procedures, BE 2542 (1999).

44 ibid.

45 Public Procurement and Management of Supplies Act, BE 2560 (2017).

46 Comptroller General's Department Regulation on Public Procurement and Management of Supplies Act, BE 2560 (2017).

47 Section 55(2) the Public Procurement and Management of Supplies Act, BE 2560 (2017).

48 Section 56(1)(d) the Public Procurement and Management of Supplies Act, BE 2560 (2017).

49 Section 56(2)(b) the Public Procurement and Management of Supplies Act, BE 2560 (2017) and Section 1 the Minister of Finance Regulation Specifying the Budget for Procurement of Supplies by the Specific Method, the Budget for Procurement of Supplies that a Written Agreement is not required, and the Budget for Procurement of Supplies in appointing the Procurement of Supplies Inspector, BE 2560 (2017).

50 Section 55(3) the Public Procurement and Management of Supplies Act, BE 2560 (2017).

51 The NACC Guidance Letter No. PorChor. 0003/0133, dated 28 June 2017.

52 The Secretariat of the Cabinet Letter No. NorRor 0505/Wor(Lor) 30342, dated 15 September 2017, and the MOPH Letter No. 0217/3382, dated 9 August 2017.