Like its predecessor, the Thai FTA will likely have a provision which grants data exclusivity for five years. Due to the huge expense in gathering clinical data, this provision will hamper the efforts of generic drug companies seeking to approve drugs based on data previously submitted by pharmaceutical innovators, and will also present another obstacle for the Thai government when seeking to make use of compulsory licenses. [FN56]

It is likely that the U.S. negotiators will also push for a provision like that in the Australian agreement (described above), which grants data exclusivity in all FTA jurisdictions once the data has been approved by a regulatory authority in another country--even if that country is not a signatory of the FTA. Thus in Thailand, generic manufacturers will not be allowed for a certain amount of time to rely on the clinical data submitted to a foreign regulator when seeking regulatory or marketing approval for its generic drug in Thailand. [FN57]

5. Implications

Because many of the issues above are not addressed in detail, if at all, under current Thai law, the above predicted provisions will have a number of effects in Thailand with regards to pharmaceutical drugs. First, the above provisions will likely hamper the availability of generic drugs. The agreement will likely reduce the amount of generic drugs that come to market and will also likely lengthen the amount of time it takes for generics to get to market. Additionally, the added protections given to pharmaceutical patents and clinical data will increase costs to local generic manufacturers due to the added burden of obtaining regulatory and marketing approval. This in turn will raise costs of generic medicines. These higher costs will likely lead to the prescribing of older, off-patent drugs, by government physicians because the older, off-patent drugs are less expensive, and thus are more likely to be approved for use under the national health plan.

B. Patent Law: Plants

A fifth issue, also related to patent law, is the patenting of life forms and, specifically, plants. Those that support life form patenting maintain that granting patents motivates researchers to develop more healthy and productive forms of plants and animals. Patented life forms include pesticide-resistant crops, larger, meatier livestock, etc. Those that oppose the patenting of life forms fear that "big business" will oust local farmers and lay claim to the natural resources of developing countries. Both the Singaporean and the Chilean agreements include no general exclusions of plants and animals from patentability. [FN58] The Australian agreement allows exclusions of life form patents only for "moral, health, or safety reasons." [FN59]

All recent U.S. FTAs have included provisions allowing for patenting of life forms, especially plants, and it is more than likely that a similar provision will be included in the Thai agreement. This is one of the most highly debated areas within the Thai agreement negotiations due to the fact that plants are not protected under the current regime [FN60] and due to the argument that such a provision would have a detrimental impact on Thailand's jasmine rice industry. The National Human Rights Commission of Thailand contends that such a provision "would allow the American plant genetic researchers and companies to patent over any new variety of rice developed from Thai jasmine rise." [FN61] The Commission believes that this provision will greatly damage the agricultural industry in Thailand. [FN62] However, others maintain that such a provision will not greatly alter the jasmine rice industry in Thailand nor be overtaken by foreign competitors. [FN63] Proponents of life form patents maintain that patenting new types of rice will not prevent local farmers from growing the original strain of rice.

C. Copyright Law

Patent law is not the only sector of IP to be affected by FTAs. The copyright provisions of the U.S.-Thai agreement will likely also reflect the trend of increasing IPR protection. Many of the provisions relating to copyright have been standard since the Singapore FTA, and it is unlikely that the U.S. negotiators will vary from those provisions. For example, beginning with the Singaporean agreement and onward, FTA provisions on the term of copyright protection have been virtually identical--life of the author plus seventy years, or if the term is decided on the basis on something other than the author's life, seventy years from the publication or creation of the work. [FN64] Consequently, the Thai agreement will likely mimic the provisions in the Singapore FTA, bringing Thai copyright terms into conformity with the majority of the developed world. Currently, Thailand's term for copyright protection is fifty years. [FN65] Thus, this new provision will substantially alter the copyright regime in Thailand and will also have a substantial impact on the issue of works falling into the public domain.

Another example of copyright protection standardization in U.S. FTAs is illustrated by the technological protection measures given to copyrighted works. [FN66] Again, beginning with the Singaporean agreement and moving forward, the provisions on this matter are virtually identical, stating that countries must provide "adequate legal protection and effective remedies" against acts or devices that circumvent technological protection measures, with exemptions given to certain institutions (e.g., libraries and educational institutions). [FN67] As in previous FTAs, the Thai FTA will likely state that Thailand must provide adequate protections and remedies against actions or devices that circumvent technological protection measures.

Thai law has not kept up with evolving technology and the FTA provisions will add much in this area. For example, currently computer programs are not given defined protection under copyright law in Thailand. Needless to say, the issue of technological protection measures also has not been addressed. Thus, the FTA provisions, while modernizing Thailand's copyright protection regime, will at the same time be taking away many of the "rights" Thai IP users are accustomed to having under the current regime.

Conclusion

Thailand has much to gain from a FTA with the U.S. The U.S. is Thailand's largest export market with sales of a variety of goods and commodities climbing sixteen percent last year to almost eighteen-billion dollars. [FN68] Additionally, according to a study conducted by the Thailand Development Research Institute in Bangkok, the U.S.-Thailand FTA is projected to boost trade between the two countries by a full five percent. [FN69]

It is likely that the U.S.-Thailand FTA will contain IP provisions similar to those found in previous U.S. FTAs, which will require a number of broad changes to occur in Thailand. First, many of Thailand's IP laws will need to be re-written, or entirely new laws will need to be passed, in order to comply with the FTA. Additionally, as enforcement of IPRs in Thailand remains a consistent problem, the U.S. will undoubtedly place a heavier emphasis on this issue in the months and years following the signing of the agreement.

While the FTA provisions will perhaps harm certain sectors of the Thai economy like generic drug manufacturing in the short term, the FTA will prove to be a driving force in the development and growth of the Thai economy as a whole. Trade will increase with the U.S. as a result of the FTA, and foreign investors will be less apprehensive about making IP investments into the country if Thailand increases IP protection.

[FN56]. Fink and Reichenmiller, supra note 48 at 2.

[FN57]. "In other words, test data exclusivity applies automatically in all FTA jurisdictions, once a company submits test data to a drug regulator in one territory--even outside the FTA area." See id. at 3.

[FN58]. Singapore FTA, supra note 34, art. 16.7.1; Chile FTA, supra note 35, art. 17.9.2.

[FN59]. Australia FTA, supra note 36, art. 17.9.2.a.

[FN60]. See supra note 29.

[FN61]. National Human Rights Commission of Thailand, Official Statement of Concern over Ongoing Negotiations on the Thai-US Free Trade Agreement (Aug. 14, 2005), unofficial translation available at http:// www.bilaterals.org/article.php3?id_article=2485.

[FN62]. Id.

[FN63]. Pichit Likitkijsomboon, Of Rice and Men, Tech Cent. Station, July 8, 2005, http://www.techcentralstation.com/070805PL.html.

[FN64]. See, e.g., Singapore FTA, supra note 34, art. 16.4.4; Chile FTA, supra note 35, art. 17.5.4; Australia FTA, supra note 36, art. 17.4.4.

[FN65]. See Thailand Copyright Act B.E. 2521 (A.D. 1978) and Thailand Copyright Act B.E. 2537 (A.D. 1994).

[FN66]. Technological protection measures are devices and software developed to prevent unauthorized copying of digital works. Fink and Reichenmiller, supra note 48, at 4.

[FN67]. Singapore FTA, supra note 34, art. 16.4.7. See, e.g., Chile FTA, supra note 35, art. 17.7.5; Australia FTA, supra note 36, art. 17.4.7.

[FN68]. Benefits of US, Thai Free Trade Agreement Examined, CalTrade Rep., July 18, 2005, http://www.bilaterals.org/article.php3?id_article=2315.

[FN69]. Id.