Compulsory licensing policy implementation in Thailand

Abstract

The objectives of this research were to investigate the following: 1) the reasons and needs for the compulsory licensing policy in Thailand, 2) the guidelines for implementing the policy in Thailand, 3) the factors that affect compliance with the policy in Thailand, and 4) patients’ effective access to drugs as a result of the policy in Thailand. This research involved principals and concepts about public policy, as well as concepts about drug patents and compulsory licensing. The focus was on the reasons and needs for compulsory licensing, costs of production or importation of generic drugs for sale under the policy, guidelines and results of the policy implementation, as well as factors that have affected the policy implementation in Thailand. This research relied on mixed methods-qualitative methods and quantitative methods. Qualitative data were studied to explore answers to the research questions, based on secondary data and primary data by means of in-depth face-to-face and phone interviews. The interviewees included policy makers at the Ministry of Public Health (MOPH) and policy-implementing personnel-directors from government hospitals affiliated with the the Ministry of Public Health (MOPH) and universities. Out of 45 government hospitals, twenty hospital directors (representing 44.44%) gave their consent to the interviews. Quantitative data were used to confirm the study results of the evaluation of the policy implementation; such data included the number of new patients receiving the drugs and the savings in costs from 2008 to 2010. The study results led to the conclusion that the compulsory licensing policy can definitely solve the problem of patients’ inaccessibility to drugs. From 2008 to 2010, the amount of each drug administered to new patients increased continually, and the drug costs fell steadily by approximately two billion baht. As for the policy implementation guidelines, the Ministry of Public Health (MOPH) formulated protocol guidelines as the MOPH’s Notification for each drug. However, the performance of individual hospitals depended on their characteristics, which were different in many aspects-the roles of directors in the hospital, the roles of doctors in the hospital, and characteristics of the hospital. Factors that affected the success in the policy implementation at the macro and micro levels covered the clarity of the policy, the consistency between the policy and the problem, budgets, and political changes. Factors that were related to the failure in the policy implementation included lack of communication of the policy, characteristics of respective hospitals, attitudes of practitioners, and political changes. The study on these success and failure factors reflected the drawbacks of the policy implementation at both levels. They included: 1) lack of a strict, clear drugpricing control mechanism that differentiates drugs from other commercial goods, 2) lack of knowledge about the evaluation of “innovative” drugs being applied for a patent before granting it to them, 3) the Ministry of Public Health’s lack of campaigns for boosting knowledge and understanding about patients’ rights in the public health system, the compulsory licensing policy, or generic and original drugs in terms of their efficiency, effectiveness, costs, quality and toxicology for the general public, patients, doctors and medical personnel; and its lack of surveys of government hospitals to determine how different they were with respect to preparedness, equipment, and equality in factors prior to the implementation of this policy, 4) the Ministry of Public Health’s lack of clarification about legal mechanisms available to minimize the impacts from the allegations about intellectual property infringement by people who lost some benefits from this policy, 5) unequal medical care benefits among patients in different public health care schemes, 6) the Government Pharmaceutical Organization (GPO)’s need for building the faith and confidence that its production of generic drugs meets established standards, that the importation process of generic drugs is transparent, and that the quality and effectiveness of the imported generic drugs are equivalent to those of original drugs, The Thai government and the Ministry of Public Health (MOPH) need to cope with the identified deficiencies and improve their performance in order to result in efficient policy implementation and solve the problem of patients’ inaccessibility to drugs as a whole.