New medical technology regulation The world how to do

The 2016-05-09

Source: health

The national health and family planning commission health development research center Zhao Kun xiaoye

New health technology, especially for drugs and devices and therapy treatment, the clinical application of management has become a concern of many governments. Such as the United States, Australia, and Japan's research shows that: the new technology for medical expenses increase "contribution" in 40% ~ 50%, far more than structure adjustment factors such as aging and disease. Health technology itself, meanwhile, there is a big uncertainty, according to the international research results of evidence-based medicine research center, 48% lack of evidence in the use of clinical medicine technology, application effect of uncertainty, only 13% of the medical technology is proven effective, and 6% of invalid technology and 3% of harmful. Countries attaches great importance to the health field, therefore, the application of new technology and management, new technology application, even by laws and regulations.

In the 1970 s, Health Technology Assessment (Health Technology Assessment, the HTA) appeared officially in the United States, then gradually popularized in the world. Through the scientific evaluation of health technology security, effectiveness and economy, suitability, equity and other effects, clinical access to medical technology, application management, pricing for reimbursement of provides the basis for decision making, this is a kind of important evidence-based health decision-making analysis tools. At present, most developed countries and some developing countries established by health technology assessment to support evidence-based health decision-making mechanism, improve the medical service system performance, improve the level of residents' health. In 2014, the world health organization in the world health assembly passed a resolution that calls for countries to promote the establishment and perfection of health technology assessment system, in order to help to achieve the goal of universal coverage of health.

For emerging medical technology regulation, most countries take use of the HTA clinical suitability evaluation of new technology, cost effectiveness and ethics, fairness, to judge whether the technology is suitable for the introduction of the national health service system. Many countries are in a state or province as the unit management new medical technology, such as Canada, Sweden, Australia and other countries, the provincial government level build system of HTA, technically assist policymakers access to technology and its application.

In the vast majority of the organisation for economic co-operation and development (OECD) countries, North America and South American countries government, using the HTA as the main tool of whole life cycle of clinical technology management, at the national level to establish a formal technology assessment mechanism, some countries even at the state or province level set up a similar mechanism. There are 34 countries and regions set up formal HTA system and mechanism, including the HTA state funded specialized institutions, and support its long-term and "rapid spike" research; Establish key clinical technology selection mechanism; Unified the HTA implementation procedure and other technical requirements; Channels and the mechanism of evaluation results into policy, etc. The many mechanism with the legislative protection, ensure the HTA result is used for clinical decision making and related health policy making.

Most Asian countries, such as Thailand, Malaysia, South Korea, Singapore, etc., are the HTA as improve medical and health policies and improve the performance of the overall system operation, hoping to solve the limited medical resources and the contradiction between the unlimited growth of medical demand. As a result, not only established the HTA functional organization and working mechanism, led by the health department also promoting the application of the HTA findings and spread.

Asian countries the HTA professional organizations main characteristics can be summarized as the following: generally belongs to the department of health or have closely relationship with the health sector; As an independent nonprofit organization exists, or all of the main funds from the government; Organization structure generally take the ministries responsible for led, the HTA institution specific organizational activities and supervise, rely on groups such as medicine or universities and research institutions to carry out specific technical force the HTA activity; By conducting "short term rapid assessment" meet the demand of health policy makers, and according to the comprehensive assessment of the need for large projects; Attaches great importance to the communication and communication, through the evaluation results on a variety of forms, promote the popularization and application, at the same time to carry out training and exchange activities, guide the social from all walks of life to the attention of the HTA.

Through experience, found that some will HTA findings only as the basis of clinical decision making, development of clinical guidelines or drug formularies; Others will formalise the HTA mechanism and institutionalization, as the basis of medicine and health care decisions, extensive use of cost-effectiveness analysis, strengthening the drugs, devices and clinical application technology such as market operation, public health policy measures such as the effect of supervision and evaluation.