Regulatory, Pricing and Reimbursement Overview
Regulatory, pricing and reimbursement overview in Thailand – a comprehensive legal overview. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for USD 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
In Thailand, drugs, biologics, and medical devices are regulated by the Thai Food and Drug Administration (Thai FDA), under the supervision of the Ministry of Public Health (MOPH).
More precisely, the Drug Division of the Thai FDA is the main regulatory body controlling pre-marketing and post-marketing of Drugs and Biologics in the Kingdom; while the Medical Device Control Division of the Thai FDA is the main regulatory body controlling pre-marketing and post-marketing of medical devices in the Kingdom.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
The Drug Act, B.E. 2510 (1967), as amended, provides the regulatory framework for the marketing authorization and post-marketing surveillance of drugs and biologics in Thailand. The Medical Device Act, B.E. 2551 (2008), as amended, provides legislation governing the marketing authorization and post-marketing surveillance of medical devices in Thailand. In general, there are no specific regulations related to pricing for drugs and medical devices. The prices of medicinal products are only controlled when they are listed in the National List of Essential Drugs (NLED), a list of medications used by public hospitals and public health services. Under the control of the Ministry of Commerce, drugs on the NLED are subject to a median price policy. However, these pricing regulations only apply to drugs that are listed on the NLED and are prescribed in public hospitals. Private hospitals and drug stores are free to set their own prices for the drugs they sell, but the price must not exceed the sticker price—the maximum price set by the distributor.
The cost of drugs and medical devices on the NLED can be reimbursed by the government. Government hospitals generally provide drugs and medical devices from the NLED to civil servants and other persons under the universal coverage (THB 30 Scheme). Civil servants are not required to pay anything to the hospital, and patients under the THB 30 Scheme will pay a maximum of THB 30 (approximately USD 1). Public hospitals will be reimbursed in full by the government for the cost of the drugs and medical devices used in these cases. Another reimbursement scheme available to Thais is the Social Security Scheme, which is available to employees of private companies. For more information on reimbursements, please see the answer to question 10 below.
Classification of Pharmaceutical Products
Chemical drugs are classified into three categories:
(i) New Drug
A new drug is a drug formulation that has not been registered in Thailand before. New drugs include products of a new chemical entity (NCE), a new combination, a new dosage form, a new drug delivery system, a new indication, a new strength, or a new route of administration.
(ii) New Generic Drug
A new generic drug is a drug formulation that has the same active pharmaceutical ingredient(s), dosage form, indication(s), route of administration, and strength as a reference drug that had previously been approved by the Thai FDA after B.E. 2534 (1991).
(iii) Generic Drugs
A generic drug is a drug formulation that has the same active pharmaceutical ingredient(s), dosage form, indication(s), route of administration, and strength as a reference drug that had previously been approved by the Thai FDA before B.E. 2534 (1991).
Classification of Medical Devices
Medical Devices are classified into three classes based on the results of a risk analysis that specifically consider the context in Thailand.
(i) Licensed Medical Device
The most strictly controlled class, Licensed Medical Devices require a specific license before they can be manufactured in or imported into Thailand. Examples of these licensed medical devices include condoms, contact lenses, COVID-19 diagnostic test kits, HIV diagnostic test kits, and prosthetic silicone breast implants, among others.
(ii) Detailed Notification Medical Device
Detailed Notification Medical Devices are subject to a less intensive review procedure than Licensed Medical Devices; though pre-market approval is also required for devices under this category. Examples of Detailed Notification Medical Devices include, among others, alcohol detectors, methamphetamine diagnostic test kits, and rehabilitation/ physical therapy devices.
(iii) Notified (or General) Medical Device
Devices that do not fall under the scope of the first two categories will be classified as Notified (or General) Medical Devices. Currently, the majority of medical devices in Thailand are regulated under this class. Only imported devices require an approval certificate prior to importation; devices manufactured locally do not need pre-market approval. In the future, local medical device manufacturers will be required to register Notified Medical Devices prior to marketing the products.
Thailand is a member state of the Association of Southeast Asian Nations (ASEAN), and all member states have ratified the ASEAN Medical Device Directive (AMDD). The Thai FDA is currently working on full implementation of the risk classification rules laid out in the AMDD, which will include four classifications for medical devices:
- Class 1 (low-risk devices, equivalent to Notified Medical Devices);
- Class 2 (low- to moderate-risk devices, equivalent to Detailed Notification Medical Devices);
- Class 3 (moderate- to high-risk devices, equivalent to Detailed Notification Medical Devices);
- Class 4 (high-risk devices, equivalent to Licensed Medical Devices)
3. What are the steps to obtaining authorization to develop, test, and market a product?
Generally, there are three steps to obtaining market authorization. First, an established company in Thailand must obtain either a drug manufacturing license or a drug importation license from the Thai FDA. After obtaining one of these licenses, the company can submit a request to manufacture or import samples for various purposes (e.g., clinical trials, research and development, etc.). For research purposes, the clinical trial protocol must be approved by the relevant ethics committee of the applicable investigation site. Once those first two steps are complete, the company can apply for marketing authorization of the particular drug product.
For imported drug products, importers are also required to submit a GMP clearance application for each drug product in order to ensure that the overseas manufacturing site meets PIC/S GMP standards. The GMP clearance approval granted by the Thai FDA will have the same validity as the GMP certificate issued by the regulatory authority in the country of manufacturing. Thailand is a member of PIC/S GMP.
There are two steps to obtaining market authorization for medical devices. First, an established company in Thailand must obtain either a medical device manufacturing license or a medical device importation license from the Thai FDA. Once that is complete, the company can then apply for marketing authorization of the particular medical device.
4. What are the approximate fees for each authorization?
According to the Ministerial Notification: Official Fees for Drug Products published on 4 Aug 2017 and Ministerial Notification: Official Fees for Medical Devices published on 4 Aug 2017, the official fees assessed will not exceed the maximum values provided in the table below. This new fee schedule is designed to facilitate the government for levying fees by defining the actual cost for each type of registration.
|(1) Modern Drug Manufacturing Licenses||THB 8,500||Per license|
|(2) Modern Drug Selling Licenses (Retail)||THB 2,500||Per license|
|(3) Modern Drug Selling Licenses (Wholesale)||THB 2,00||Per license|
|(4) Modern Drugs Import License||THB 38,000-88,000||Per license|
|(5) Technical Document Evaluation for New Drug Registration||THB 155,000 – 395,000||Per product|
|(6) Technical Document Evaluation for Generic Drug Registration||THB 39,000 – 59,000||Per product|
The fees for Nos. 5-6 do not include (i) application fee, which will be between THB 1,000 – THB 2,500, and (ii) license fee, which will be THB 2,000.Remarks:
|(1) Medical Device Manufacturing Licenses||THB 33,100||Per license|
|(2) Medical Device Import License||THB 13,100||Per license|
|(3) Medical Device Sale License||THB 13,100||Per license|
|(4) Technical Document Evaluation for Licensed and detailed Medical Device Registration||THB 38,000-88,000||Per license|
|(5) Technical Document Evaluation for Notified (General) Medical Device Registration|| THB 1,000
| 1-10 products
More than 10 products
– Fee No. 4 does not include (i) application fee in the amount of THB 100, and (ii) license fee, which will be between THB 5,000 – THB 20,000.
– Fee No. 5 does not include the; application fee in the amount of THB 100.
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
The modern drug manufacturing and modern drug import license are both valid for a period of one year (from January 1 to December 31). Each type of license must be renewed before December 31 each year in order to be carried over to the following year.
According to Amendment No. 6 of the Drug Act, marketing authorization drug licenses that received approval after October 13, 2019, will have a validity of seven years, and are renewable.
The medical device manufacturing and medical device importing license are both valid for a period of five calendar years. Each type of license must be renewed before December 31 of the fifth year.
The medical device selling license is valid for a period of one calendar year (from January 1 to December 31) and must be renewed before December 31 each year.
According to the Medical Device Act, as amended, market authorization licenses of Licensed Medical Devices and Detailed Notification Medical Devices are valid for a period of five years, and are renewable. For Notified (General) Medical Devices e.g., low-risk medical devices, the market authorization certificate will have the same validity as the certificate of free sale, with a maximum of five years, and is non-renewable.
6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
There are no significant differences between local and foreign-owned manufacturers. Both types of companies are required to apply for marketing authorization licenses for each drug product they wish to manufacture.
There are, however, major differences between original and generic product registration. Original drugs (or patented drugs) are classified as new drugs, meaning the registration dossier must include both non-clinical and clinical documentation. To register an oral-solid dosage form (i.e., tablet or capsule) generic product which is oral-solid dosage forms i.e. tablet, capsule, companies can merely submit the bioequivalence study to prove pharmaceutical equivalence with the original product.
Further, after obtaining a market authorization license, new drugs (original products) must undergo a mandatory Safety Monitoring Program (SMP). During the SMP, new drugs can only be dispensed in hospitals. The company manufacturing the original drug must provide periodic safety updates to the Thai FDA for the first two years. After the committee evaluates these reports over the two-year period, the drug can be released from the SMP and re-classified. SMPs are not required for generic drugs.
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
If the drug combination is new, the Thai FDA will classify it as a new drug.
For a combination between a drug and medical device, the classification will be based on the products intended use; therefore, it requires an evaluation by both the Drug Division and the Medical Device Control Division. However, the final classification decision will be at the Thai FDA’s discretion.
For example, drugs available in prefilled syringes are classified as drugs. However, if the main function of the combinationacts like a medical device, such combination will be classified as a medical devices (i.e., drug eluting stent, condom with spermicide, Heparin-coated catheters, etc.)
As of today, combination products that fall within the scope of medical devices are classified as Notified (General) Medical Devices. Oncethe Thai FDA officially implements the risk classifications according to the AMDD, said combination product will be reclassified as Licensed Medical Devices (Class 4).
8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
Thailand’s regulatory regime is comparable to that in the U.S. because it is governed by a centralized process through the Thai FDA, and specific subdivisions of the Thai FDA, namely the Drug Division and the Medical Device Control Division, are responsible for supervising drugs and medical devices, respectively.
In order to comply with the Thailand’s regulatory regime, pharmaceutical companies must follow the provisions laid out in the Drug Act, as amended, and medical device companies must follow the provisions laid out in the Medical Device Act, as amended.
In order to monitor pharmaceutical and medical device companies and ensure that there are no adverse effects regarding the safety or efficacy of drugs, the Thai FDA conducts consistent pre- and post-marketing inspections. These inspections can come in a variety of forms, including on-site inspections for GMP compliance, on-site inspections to explore any aspect of the manufacturing process, and general on-site visits on a yearly basis.
9. What is the potential range of penalties for noncompliance?
Under the Drug Act and the Medical Device Act, penalties for noncompliance by a licensee include suspension of import licenses, revocation of the marketing authorization licenses, a financial penalty, and imprisonment.
10. Is there a national healthcare system? If so, how is it administered and funded?
The national healthcare system is divided into three main schemes:
- The Social Security Scheme (SSS): This scheme is administered by the Social Security Office and financed by tripartite contributions from the government, employers, and employees. It covers employees, and employers with one or more employees. This scheme is not applicable to those covered by the Civil Servant Medical Benefit Scheme (below) or to employees of foreign entities.
- The Civil Servant Medical Benefit Scheme (CSMBS): This scheme is administered by the Social Security Office and provides health care benefits to government officials and their dependents (spouse, parents, and up to three children).
- The Universal Health Coverage Scheme (UCS): This scheme is administered by the MOPH and covers the remaining population not covered under either the SSS or the CSMBS.
11. How does the government (or public) healthcare system function with private sector healthcare?
In general, private sector healthcare companies are not subsidized by the government. However, some private sector healthcare companies may be partially subsidized by the government if they cooperate with the SSS. Subsequently, these private hospitals are able to provide healthcare services for patients who are registered at their hospital under the SSS.
12. Are prices of drugs and devices regulated and, if so, how?
The prices of medicinal products are only controlled when they are listed in the National List of Essential Drugs (NLED), a list of medications used by public hospitals and public health services. Under the control of the Ministry of Commerce, drugs on the NLED are subject to a median price policy. However, these pricing regulations only apply to drugs that are listed on the NLED and are prescribed in public hospitals. Information about median pricing can be found on (http://ndi.fda.moph.go.th/drug_value). Private hospitals and drug stores are free to set their own prices, but the price must not exceed the sticker price—the maximum price set by the distributor.
In May 2019, the Department of Internal Trade issued Notification No. 52 on the Price Reporting of Drugs, Devices, and Healthcare Services, which requires distributors to report the price of drugs sold to private hospitals. Further the private hospitals must also report the selling price of medicinal products and medical devices they purchase
13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?
Reimbursement of drugs and devices is only available for those listed on the NLED, and prescribed at public hospitals (or private hospitals that cooperate with the SSS). Therefore, the government will ultimately bear the cost (beyond THB 30) of NLED-listed drugs and devices at all public hospitals and a select number of private hospitals. For all other drugs and devices, including those prescribed by private hospitals that do not cooperate with the SSS, the patient will be solely responsible for the total cost.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
Licensed practitioners, such as doctors and dentists, are authorized to prescribe the drugs and medical devices to patients. Following prescription for a licensed practitioner, a licensed pharmacist will dispense the prescribed drugs or medical devices to patients.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
Only licensed practitioners such as doctors and dentists are authorized to prescribe drugs in Thailand, after which such drugs will be dispensed by a licensed pharmacist. Generally speak, most drugs are available at the hospital and at the pharmacy stores. Unlike the case for drugs, there are no dispensing requirements for medical devices.
Only doctors holding a medical license from the Medical Council of Thailand can practice the medical profession in Thailand, which includes the diagnosing, treating, and preventing diseases. Likewise, only pharmacists holding a pharmacy license from the Pharmacy Council of Thailand can dispense drugs to patients.
Medical professionals who work in hospitals may have additional responsibilities such as investigating a patient’s drug allergies, and monitoring drug levels.