Thailand Pharmaceutical Industry: Data Exclusivity and Trade Secrets
By Edward J Kelly and Edward Madden
This is a time of relative uncertainty for many pharmaceutical companies operating in Thailand. The industry has many concerns about issues related to data exclusivity, registration of generic drugs with the Food & Drug Administration (FDA), outright counterfeiting of medicinal products and possible compulsory licensing of patented life-saving drugs by the Government Pharmaceutical Organization (GPO). At the outset, it must be highlighted that while there is a comprehensive body of laws and regulations relating to drugs, including protection under the law of patents, a number of uncertainties exist. It seems from the legislation (and practice) that Thai law confers generic drug manufacturers with the ability to engage in various preparatory activities with a view to seeking regulatory approval before a patent for a particular protected drug has expired. To this extent, we have seen instances where generic manufacturers may (it appears on a case by case basis) submit applications for regulatory approval before the expiration of the patent.
The primary source of uncertainties that exist relate to so called “data exclusivity” of trade secret (clinical data) information which an R&D based drug manufacturer may have on file with the FDA. The extent to which a generic drug manufacturer can rely on previously filed data in order to support the application for marketing and sales approval for a generic version of the drug is still quite unclear under Thai law and regulations, primarily because no implementing ministerial regulations have yet been enacted in respect to the Trade Secrets Act of 2002. These ministerial regulations would add necessary meaning to what may and what may not be protected under the Trade Secret Act.
Law/Regulations Applicable to Drugs in Thailand
There are two main bodies of law applicable to drugs in Thailand. The first, the law of patents, relates to the intellectual property protection of new drugs, while the second body of law, principally codified in the Drug Act 1967 (BE 2510) and subsequent amendments, sets out a regulatory regime for the supervision of drug production, importation, sale and marketing of drugs in Thailand.
At present there is no ability to extend the 20 year term of a patent for time lost due to regulatory hurdles and procedures that must be adhered to before a drug can released to the market. This is a subject of negotiation in the current Free Trade Agreement discussions occurring between the Thai and US governments.
The sale of drugs and medicines in Thailand is supervised by FDA, one of the departments under the Ministry of Public Health. Part of the FDA’s mandate is to supervise drugs in accordance with the regime under the Drug Act. The licensing of the manufacture, importation and sale of drugs is required by law and applications for permission and licenses are granted in accordance with the various rules and supplementary ministerial regulations promulgated to govern the FDA approval process. New drugs must be registered and approved before being sold on the open market. In fact the drug registration process has been declared necessary to ensure efficacy, safety and effectiveness for the drugs sold in Thailand. A drug developer who has successfully patented the drug in Thailand, must proceed to obtain approval from the FDA before the drug can enter the Thai market. Approval must also be obtained for generic versions of drugs bas proof of bio-equivalence. The Trade Secrets Act also will come into play when there implementing regulations that deal specifically with confidential clinical safety data that has been submitted to the FDA during the regulatory approval process. The issue of data exclusivity arises in the context of how generics try to prove bioequivalence- do they prove it with their own clinical safety data or do they simply refer to the data submitted by an R&D based company. This policy issue is a very murky area for the pharmaceutical industry at the present time.
US-Thailand and Japan-Thailand FTAs
Currently there are ongoing negotiations between the Thai Government and its largest foreign trading partners for FTAs. Following from experience in the recent US-Singapore FTA (concluded last year) it is widely expected that numerous intellectual property reforms will be required of Thailand.
In particular, it is anticipated that one key area of these reforms will be the increased protection of R&D based pharmaceutical products. One of the key requirements of the US-Singapore FTA was the right of pharmaceutical patent owners to increase the term of protection for their patented drugs (by up to five years), where a delay has resulted in bringing the patented product to the market due to regulatory approval. Additionally, the US-Singapore FTA introduces a form of data exclusivity: where undisclosed information concerning the safety or efficacy of a pharmaceutical or agricultural chemical product to grant a marketing approval, it shall not permit third parties to market the same or similar products for at least 5 years from the date of approval for a pharmaceutical product.
Indications exist flowing from the various preparatory activities that were conducted ahead of the forthcoming negotiations that similar provisions will be included in the US-Thai FTA.
It must be kept in mind that the Thai Government is concerned with ensuring that necessary life saving medications are available in an affordable manner to all citizens throughout the Kingdom. In this respect it is anticipated that the ability of generic manufacturers to compete with branded pharmaceuticals (upon expiration of the patent) would probably receive some support by the Thai Government as it is quite a populist policy. Big PHARMA needs to lobby now and lobby hard to assure that its R&D based business model, requiring huge investments of time and resources, is protected from unfair competition from generics by implementing patent term extensions and data exclusivity controls.