location: nan, 'Thailand 
year: 2002 source: HSRI 
title: Methodological development for health impact assessment : A case study from TRIPs agreement in drug Patent 
abstract:Rationale: Drugs are essential for patients. International trade agreements might affect accessibility to essential drugs for many patients.   Some would finally die because they do not have enough money to buy expensive drugs. One of the major international trade agreements is  the “Trade Related Intellectual Properties or TRIPs” . Intellectual properties include “patent” and “copy right”.  A patent is granted to inventors for any branches of industrial inventions. A copy right is granted to the owners of writings, musical composure, art works, movies and trade marks.  Protected intellectual property rights encourage innovations and innovators are fairly rewarded. It is believed that intellectual property right protection will be economically and socially beneficial to the world in the long run. Intellectual property right related to health policy is “drug patent”. There are two subgroups for drug patent i.e. one is related to “product patent” , another is related to “production process patent”. In Thailand, Patent Act has been enacted since 1979. Under this act, the protection of  “product patent” right for drugs is excluded but “process patent”.  The rationale for the exclusion is based on human health and livelihood. Unreasonably expensive drugs are the major concerns. The country’s drug industry might also be affected if the right is granted. 	 During 1984-1999, the US government put pressure on the Thai government to amend the “Patent Act” and “Copy Right Act”. The US government required that “product patent” must be included otherwise Thailand will be punished by abolishing the “GSP” granted to Thailand. The “GSP” is granted to allow some developing countries to be able to export commodities to The US with low tariff rates. It was estimated Thailand will lose $US 165 millions or  4,125 million Baht (in 1983). Other measures will simultaneously be implemented if Thailand refuse to amend the Act.  Finally, Thailand has amended the Act in 1992.	Major amendments are as follows:  	1. Extend the protection to other items including food product, beverage, drugs and drug ingredients, agricultural machinery. Extend protection period from 15 years to 20 years effective from the date of submission for patent. Compulsory licensing must be done according to the Uruguay round on trade agreements.  For instance, compulsory licensing can be used only if the owner of the patent unrightfully performed by unreasonably not producing or not selling the products.  If compulsory licensing is implemented, the owner of the patent can make an appeal to the court.Clauses related to drug patent as well as other regulations related to pricing and anti-dumping must be amended according to the Uruguay round on trade agreement.   Later in 1999, more amendments were done. The committee on “Drug Patent” was abolished.  A system of petty patent was implemented. The study aims at studying the scopes of the health impacts arising from the amendments of the Patent Acts.Study Methods: Literature reviews, In-depth interviews with government officials who have duties on the related issues, group discussions with stakeholders to outline the scopes of the impacts of the amendments to be assessed in the future.  Results of the study:	The scopes of the impacts on Thailand drug systems because of  TRIPs were found in these three areas:  1.    Rising costs of drugs and inaccessibility  to drugs especially those with AIDS Hindering the development of home drug industry	CASE STUDY: Anti-retroviral drugs for AIDSDrug manufacturers purchase license from various research institutions. They then manufacture drugs to be sell in the markets around the world under their own brand names.  For example, Bristol Meyer Squipp bought license to produce an anti-retroviral drug called “Didanosine” (ddI) from the National Institute of Health who has discovered the drug. The company has modified the ingredients of the drug by adding antacid components in order to make it acid tolerable and not being destroyed in stomach. The company submitted for new drug patent in Thailand. and		Moreover, the company was also submitting for new drug patent for the combined formula, for example,    “Indinavir” combined with “Efavirenz”  or  “AZT” combined with “3TC”. 	The company was granted protection even though it has not discovered any new drugs at all. This enables the company to extend its right for longer period of time and hinder local drug companies to produce the drugs. The progress of new drug development in Thailand is slow, although there is claims that the “Patent Act” will encourage innovations.  Since 1996 – 2000, most of the new drug patent in Thailand were granted to foreign drug companies.   	     	3.  No real technology transfer  Multinational drug companies always claim that granting drug patent is beneficial to the countries in terms of technology transfer. Because the formula of new drugs were provided therefore countries can further develop new drugs.   The former director of the Research and Development Institute of the Government Pharmaceutical Organization once said it is unlikely that Thailand will benefit from the drug patent in terms of technology transfer. Three reasons for her argument were 1) there are insufficient information in the submitted document 2) the drug companies deliberately keep essential information secret and 3) the inventions were so complicated.   In addition, the capabilities and infrastructures of Thai institutions are lacking in order to be able to check whether the submissions were really new inventions.   Conclusions and suggestions: The health impacts due to TRIPs are inevitable if applied.  Serious public health problems still remain endemic in Thailand, for example, AIDS, Tuberculosis, Malaria etc.. Drugs are essential for the patients with these diseases. Trade agreements need to be revised and reconsidered with concerns of health values, benefits and well being of all Thais.