Government use licenses in Thailand: The power of evidence, civil movement and political leadership

This paper attempts to describe and analyse the policy processes that led to the granting and implementation of the government use licenses to enable the import and production of generic versions of medicines patented in Thailand. The decision to grant the series of government use licenses was taken despite much domestic and international controversy. The paper demonstrates that the policy processes leading to the granting of government use licenses are a successful application of the concept of "the triangle that moves the mountain". This is a well-known conceptualisation of a philosophical and strategic approach to public policy advocacy in Thailand, which propounds that the effective bridging of three powers; a.) Knowledge and evidence generated by research and analysis, b.) Civil society movements and public support, and c.) Leadership of policy makers and politicians; in a synergistic "triangle" can move "mountains", meaning the resolution of seemingly insurmountable problems. The paper provides insights into the policy context for the decision and analyses the roles of key actors, their motivations and the policy processes in the country

Government use licenses in Thailand: an assessment of the health and economic impacts

<p>Abstract</p> <p>Background</p> <p>Between 2006 and 2008, Thailand's Ministry of Public Health (MOPH) granted government use licenses for seven patented drugs in order to improve access to these essential treatments. The decision to grant the government use licenses was contentious both within and beyond the country. In particular, concerns were highlighted that the negative consequences might outweigh the expected benefits of the policy. This study conducted assessments of the health and economic implications of these government use licenses.</p> <p>Methods</p> <p>The health and health-related economic impacts were quantified in terms of i) Quality Adjusted Life Years (QALYs) gained and ii) increased productivity in US dollars (USD) as a result of the increased access to drugs. The study adopted a five-year timeframe for the assessment, commencing from the time of the grant of the government use licenses. Empirical evidence gathered from national databases was used to assess the changes in volume of exports after US Generalized System of Preferences (GSP) withdrawal and level of foreign direct investment (FDI).</p> <p>Results</p> <p>As a result of the granting of the government use licenses, an additional 84,158 patients were estimated to have received access to the seven drugs over five years. Health gains from the use of the seven drugs compared to their best alternative accounted for 12,493 QALYs gained, which translates into quantifiable incremental benefits to society of USD132.4 million. The government use license on efavirenze was found to have the greatest benefit. In respect of the country's economy, the study found that Thailand's overall exports increased overtime, although exports of the three US GSP withdrawal products to the US did decline. There was also found to be no relationship between the government use licenses and the level of foreign investment over the period 2002 to 2008.</p> <p>Conclusions</p> <p>The public health benefits of the government use licenses were generally positive. Specifically, the policy helped to increase access to patented drugs, while the impact of the US GSP withdrawal did not adversely affect the overall export status. Because the levels of benefit gained from the government use licenses varied widely between the seven drugs, depending on several factors, this study makes recommendations for the future implementation of the policy in order to maximise benefits.</p

To What Extent are Pharmaceutical Prices Determined By Patents? A Case Study of Oncology Medicines in Thailand

89-95This study seeks to assess the relative impact of patent status as a component of pharmaceutical prices while controlling other <span style="mso-ansi-language:EN-US; mso-bidi-language:TH" lang="EN-US">market and medicine characteristics on the retail prices of oncology medicines in Thailand. Ordinary Least-Squares (OLS) regression model of log prices as a function of supply and demand factors was developed and data fitted to establish the relationship and the effects for each factor. <span style="mso-ansi-language: EN-US;mso-bidi-language:TH" lang="EN-US">The main finding of the model is that patented status is associated with a price of approximately 144-206% that of an equivalent generic. Market characteristics also affect price, e.g. larger sales volumes, a more competitive market and a longer product life are associated with price around 3-30% higher. The scale of the influence of patent status over other factors confirms the view that addressing patent policy is the most effective option to bring down price, and proves support for invoking TRIPS-flexibilities such as, compulsory licensing, parallel importation or other exceptions to patentability. </span

A review of the health and economic implications of patent protection, with a specific focus on Thailand

Abstract Background Although it has been two decades since the Thai Patent Act was amended to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), there has been little emphasis given to assessing the implications of this amendment. The purpose of this review is to summarize the health and economic impact of patent protection, with a focus on the experience of Thailand. Methods A review of national and international empirical evidence on the health and economic implications of patents from 1980 to 2009 was undertaken. Results The findings illustrate the role of patent protection in four areas: price, present access, future access, and international trade and investment. Forty-three empirical studies were found, three of which were from Thai databases. Patenting does increase price, although the size of effect differs according to the methodology and country. Although weakening patent rights could increase present access, evidence suggests that strengthening patenting may benefit future access; although this is based on complex assumptions and estimations. Moreover, while patent protection appears to have a positive impact on trade flow, the implication for foreign direct investment (FDI) is equivocal. Conclusions Empirical studies in Thailand, and other similar countries, are rare, compromising the robustness and generalizability of conclusions. However, evidence does suggest that patenting presents a significant inter-temporal challenge in balancing aspects of current versus future access to technologies. This underlines the urgent need to prioritize health research resources to assess the wider implications of patent protection.</p

Maternal and child health voucher scheme in Myanmar: a review of early stage implementation

Abstract Background The Maternal and Child Health Voucher Scheme (MCHVS) was introduced in Myanmar to address the high rate of maternal and infant mortalities. It aimed to increase access to maternal and child health (MCH) services by skilled birth attendants (SBAs) and improve the health of pregnant women and their babies. A study to pilot a voucher scheme was implemented in May 2013 in Yedarshey Township. This paper provides a report on a mid-term review of the programme after 7 months of implementation to determine the outcomes of the programme and its impediments. Methods Quantitative and qualitative approaches were used. Secondary quantitative data were analysed in order to measure the coverage and utilisation of the programme. Semi-structured interviews were conducted in groups and individually with 79 key informants to explore qualitative information on voucher communication, beneficiary’s identification, voucher distribution, and challenges for beneficiaries and providers under the MCHVS. Results The results showed that 63 % of eligible pregnant women who registered to the programme received voucher booklets, while the utilisation of most of the MCH services increased over time; in particular, delivery by SBAs increased significantly (P < 0.01) after implementing MCHVS. Overall, the programme was implemented well in terms of promoting and communicating the programme to people in Yedarshey Township. Although a number of targeted poor pregnant women were included in the programme, some beneficiaries were overlooked for a variety of reasons. Nevertheless, both providers and beneficiaries who experienced the MCHVS service utilisation were satisfied with the programme. The evaluation indicated several programme challenges, i.e. external and internal programme communication, voluntary voucher distributor recruitment, incentive and support for voucher distributors, beneficiary screening criteria, and approaches to increase access of services for pregnant women living in remote areas. Conclusions Generally, the MCHVS pilot programme is a promising initiative to increase access to and utilisation of the MCH services for pregnant women and their babies in Myanmar. However, increasing coverage of the programme and overcoming the barriers should be considered as high-priority issues that need to be addressed

Additional file 1: of The influence of cost-per-DALY information in health prioritisation and desirable features for a registry: a survey of health policy experts in Vietnam, India and Bangladesh

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