Implementation of Compulsory Licensing of Pharmaceuticals in Thailand

Abstract

Intellectual property rights (IPRs) play an important role in creating incentives for innovations. To strengthen and harmonise global standards of IPRs, the WTO members established the international agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and provided flexibilities for governments to safeguard social benefits of their countries. Compulsory licensing (CL) is one of the flexibilities under TRIPS that enables a government authority to use the licenses of patented medicines without patent-holders’ permission. However, policy makers in many countries are reluctant to use CL to promote access to essential medicines. One explanation is that most countries are worried about the potential implications of using the policy, and they are uncertain about which implementation strategies might help avoid negative consequences. The aim of this PhD thesis is to propose a framework to aid decision-making and implementation of drug policy, focusing on CL under the condition of public non-commercial use and government use of license. This framework is designed to be used as a tool for policy makers in the Thai Ministry of Public Health, suggesting a list of policy elements to help them consider related elements for policy action in making a decision and implementing CL policy in order to minimise negative consequences of the CL. Mixed methods were employed to develop the framework. This study began by developing a preliminary framework based on generic elements of CL policy suggested by inter-governmental organisations. The preliminary framework was strengthened by incorporating lessons learnt from experiences of the former government of Thailand. The implications of CL policy decisions on certain drugs were evaluated in terms of lifetime cost savings compared across different drug types. This allowed the identification of key factors to be included in criteria for drug selection. In addition, the performance of the Thai government in policy implementation was evaluated in order to prioritise areas for improvement. Finally, the contents of the preliminary framework were assessed in terms of applicability to the Thai context. Any additional elements derived from experiences of the former government were used to strengthen the framework. The findings of this study suggest key elements, which should be included in the framework to aid decision-making and implementation of drug policy, focusing on CL policy. 32 elements were identified to be included in the framework. This study also suggests strategies for the decision-making process. Three additional factors are suggested to be incorporated in the drug selection criteria, in order to help policy makers to select the drugs that potentially create the greatest benefits from CL implementation. In addition, this study suggests strategies for the implementation process. The findings help prioritise four implementation areas, which should receive more attention within current CL implementation. This study closes with policy recommendations for the Thai government about the current and future use of CL policy to improve its performance, and also for other countries having the similar context to learn from the Thai experiences.