Key Takeaways
- Nothing has changed yet. The drug reimbursement criteria are in draft and under consultation. The Department will announce them by official circular once they are settled.
- Co-payment would be targeted, not universal. In its statement of 15 September 2026, the Department said a patient may have to pay part of the cost of an originator drug only where a generic or biosimilar registered with the Thai FDA, of proven quality and equivalence, is available and the hospital's price exceeds the Department's reimbursement rate. Later reports describe the conditions differently, and the final criteria may differ.
- The dispensing periods reported in the media are not final. The Department says any limit is aimed mainly at newly started medicines.
- There is no rule on lost medicine. The Department says documentation for lost medicine is still under discussion.
- A separate draft Royal Decree is moving. Public consultation on amending the medical welfare Royal Decree closed on 8 August 2026. The Department said in July that it would then submit the draft to the Cabinet; no submission has been reported.
1. What the Comptroller General's Department Has Actually Said
Relevant to: originator and generic manufacturers, importers and distributors supplying state hospitals.
On 15 September 2026, Mrs. Patricia Mongkolwanich, Director-General of the Comptroller General's Department, responded to the social media reports. She said the criteria were still being drafted, that no official start date had been fixed, and that the Department would issue a formal circular once the rules were concluded. She described the claim that patients must co-pay for every originator drug as incorrect. In that statement, co-payment would arise only where a generic or biosimilar registered with the Thai Food and Drug Administration, of proven quality and equivalence, is available and the hospital charges more than the Department's reimbursement rate. Some later reports present these as alternative conditions, so the point will be settled only by the final text.
On 20 September the Department added that civil servant patients are not barred from originator drugs. Where there is a medical need, or the treating doctor seeks approval, an originator can still be prescribed through the normal process, and drugs outside the National List of Essential Medicines remain claimable where medically justified. On dispensing periods, the Department said the figures in circulation are not final, that the limit is intended to let doctors monitor patients starting a new medicine, and that arrangements for stable chronic patients will be considered with hospitals and the professional councils. On lost medicine, it said the matter is still under discussion and is not yet a rule.
2. Draft Amendment to the Medical Welfare Royal Decree
Relevant to: companies selling to state and private hospitals that bill the CSMBS directly.
On a separate track, the Department consulted the public from 10 July to 8 August 2026 on a draft amendment to the Royal Decree on Medical Treatment Welfare Benefits B.E. 2553 (2010), as amended. As reported, the draft would require hospitals to register with the Ministry of Finance to use the electronic direct billing system, make beneficiaries responsible for the conduct of family members who use their benefits, allow beneficiaries to choose or suspend the family members covered, and require hospitals to adopt good governance measures. The Department has linked the reform to cost control and to abuse such as obtaining the same medicine from several hospitals in a short period.
After the consultation, the Director-General said most respondents supported the changes. She also said the revised draft would give civil servants a voluntary choice between the CSMBS and the Universal Coverage Scheme, a point that was not among the proposals put out for consultation. None of these changes applies until the amended Royal Decree is enacted, published in the Royal Gazette and in force on the date it sets.
3. What This Means for Pharmaceutical Companies
Relevant to: commercial, market access and legal teams.
For originator companies, the exposure lies in products that face an equivalent generic or biosimilar registered in Thailand and are priced to hospitals above the CSMBS reimbursement rate. Those are the products most likely to see patients asked to pay a difference, and hospitals switching volume to the cheaper alternative. If the final criteria apply either condition on its own, the exposure would be wider. A portfolio review now, product by product, will show where the gaps exist and how large they are.
For generic and biosimilar manufacturers, the Department's description links co-payment to FDA registration and proven equivalence, so a product's registration status and bioequivalence or comparability data are likely to matter commercially. Supply reliability will matter too, since hospitals that move volume quickly will need stock to follow. Distributors should check whether their hospital supply agreements allow prices or quantities to be adjusted if the reimbursement rules change mid-contract.
Any patient support or co-payment assistance programme designed in response should be reviewed against Thai drug advertising rules and the applicable industry code of practice before launch.
Already Made: Thai Traditional Medicines and Topical Pain Relief
A Ministry of Finance circular signed by the Director-General on 21 August 2026, reported as effective from 1 October 2026, limits reimbursement of Thai traditional medicines to products used to treat illness, excluding health promotion, herbal cosmetic and food-like products. It also caps topical pain and anti-inflammatory products, including topical NSAIDs, at one package unit per month, with no more than three months per prescription.
How Dej-Udom & Associates Can Assist
- Corporate & Commercial: review of hospital supply and distribution agreements, pricing and change-in-law clauses, and patient support programme structures.
- Intellectual Property: patent and data protection positions for originators facing generic or biosimilar entry, and freedom-to-operate reviews for generic manufacturers.
For further information, please contact us at +66 (0)2 233 0055 or [email protected].
Source: statements of the Comptroller General's Department reported by Hfocus, The Coverage, The Thaiger, Matichon, Thai PBS The Active and Krungthep Turakij (July to September 2026). The Department's drug reimbursement circular has not been issued, and its text should be confirmed before any reliance is placed on this summary.
Disclaimer: This publication is intended for general informational purposes only and does not constitute legal advice. The information contained herein should not be relied upon as a substitute for specific legal counsel. For advice tailored to your circumstances, please contact Dej-Udom & Associates directly.