Summary: | 碩士 === 國立政治大學 === 科技管理研究所 === 97 === Perspectives from industry, technology, medicine, management, economics and people are essential to the establishing of an innovative health technology assessment (HTA) mechanism for the purpose to placing the assessment results as a basis of public policy decision-making. The impacts of an innovative HTA mechanism were not only occurred to the government and people's needs but also to huge commercial interests and competitions, and even to the future progression of science & technology of a country. Different stakeholders might have different thoughts and standpoints and these conflicts might lead to the failure of a HTA mechanism at the end. In addition to that roles of HTA, consensus on important components for planning & executing models, capabilities of research & groundwork of science, infrastructure etc. all are influencing factors to the establishment and the successful operation of a HTA mechanism of a country.
The purposes of the study were to explore the policy possibility and the factors connected to the system planning and operation design of HTA mechanism in Taiwan. Comprehensive literature review and in-deep interviews to the experts from government, academia and industry affiliates were executed to discover the most critical points. A potential HTA mechanism in Taiwan has been projected after the considerations of global experiences and the study findings.
Study revealed that the most important issue of the HTA mechanism in Taiwan was the nervousness and the opposition from the industry. In addition to that consensus has not been reached on the roles, position, methods of assessment, criteria of judgment, and even the usage of reports of the HTA. How to establish a comprehensive planning and operation system, potential impacts of HTA to small and medium enterprises in Taiwan, lack of domestic data, insufficient person of talent, and no confidence to the HTA reports from the users etc. were all important factors exposed by this study and have to be resolved in the future.
Conclusion of the study was provided as below:
1. Aspect of the policy possibility: Although there existed different opinions on the HTA mechanism in Taiwan among industry, government and academia the necessity and essentiality of HTA mechanism were recognized and currently was a suitable time to endorse such a mechanism in Taiwan. However under current situations where consensus not reached for the roles of HTA, lack of persons with talents and experiences the most practical ways in this early beginning stage were to cultivate people and to go through learning process. By following the acceptance of HTA report and the appearance of important issues concerned by the society roles and directions of the HTA in Taiwan would be consolidated. Why and how to bridge HTA results to policy decision-making was under discussion and construction presently. Nevertheless purely scientific assessment was emphasized to maintain its entirely objective standpoint of the HTA. Otherwise bias or policy leading will happened and the accountability of the HTA in Taiwan will be lost.
2. Aspect of the regulation envirement:Whether explicit law and regulation wanted for the endorsement of HTA mechanism had debates with different thoughts and rationales. Study revealed that affecting with political order has been the most efficiency way presently. However in the long run law or regulation will be desired as the HTA environment been established and society consensus been attained. Considering the modes of legislation on matter single legislation, attended to current law, or graduated from soft guidance to consolidated law all were sufficient.
3. Aspect of the executing model: The most significant requirements to HTA executing models and HTA reports were scientific, transparency, justice and accountability. SOPs of HTA research were recommended to set up as the environment of HTA conduction in Taiwan been matured. Accreditation mechanism applied to HTA researcher and HTA institution was also suggested. Field experts to provide professional opinions were crucial owing to the limitation of scientific evidences. For the positioning of HTA experiences from experts will not be wholly replaced by the HTA mechanism, therefore by using experts committee to help for decision making will not be changed in short time.
4. Aspect of the operation planning: In front of shortage of data and expertise in Taiwan one recommendation was to retrieve data from the national health insurance database while models can be explored under different assumptions. Different levels of assessment reports may have their levels of value for references. As experience and capability increased, related database built up and as time moving forward the deficiency of data can be enhanced. In addition to that networking with research institutes domestically and internationally was essential seeing that the extension of resources. Government should lead to coordinate and to integrate related HTA organizations and to invest money for the research of the integration. Incentive scheme to related parities was not suggested right away. More important facets were the transparency and the consistence of the system. If the final consequences of the HTA in Taiwan are predictable and then the industry will have their input. And if good research can be acknowledged by the policy and the impacts on the decision-making can be recognized then the academia and related associations will have their actions. After all powers from different sources will be initialed. It was not necessary to determine self-owned HTA methodology in Taiwan but just followed the global standards because HTA methodologies have developed for a period of time and by this way the results found in Taiwan can be accepted globally. HTA assessment is resources consuming while lots of human resources, time and money required. Since resources are scare the utilization of HTA resources should has its priority setting. A mechanism to have people or basic health care workers to provide health care issues was not been developed in Taiwan. Considering the efficiency of operation whether to design a more transparency mechanism with whole society participation can be considered by the authorities according to the demands in the future. Comprehensive evaluation to the HTA results and routinely assessment to the technologies in uses were also recommended.
Plate-form of communication was suggested to construct to invite related parties for discussion and for connection. If opinions can be integrated and the susceptibility from industry can be released then a cooperation foundation can be built. To initial and to chair of the plate-form should be the responsibilities of the authorities. Comprehensive strategic planning including definition of the regulations, establishment of the guidance was critical to the authorities to avoid pieces of decision-making, surprised problems and too much uncertain room occurred. By this way the industry will have unambiguous basis with predictable outcomes to make strategic planning for their innovative medicinal products.
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