gms | German Medical Science

The structure of the legal systems in the EU countries is determined by the basic structures of the medical and health care systems themselves. We have to observe the difference between national health care systems, where the state determines the rules for accepted medical methods and products, and social insurance systems which are more or less self-governing bodies, though always within the framework of public legal regulations. However, the freedom of the agencies of social insurance varies to a large extent. A second level of differentiation relates to the local scope of decisions. In some systems, decisions have effects at national level, in other systems only at regional level. An example is Italy, where decision-making processes have been regionalised to a large extent in recent years. HTA decisions, meaning appraisal - not HTA assessment, which I would like to emphasize - are thus subject to quite different legal regulations. In Germany the law on the modernisation of statutory health insurance on 1 January 2004. This law has established the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) as "new institutions" of statutory health insurance, restructured the procedures for the assessment of health services and formulated more precise assessment criteria than hitherto provided. Within the HTA process, external scientific experts are now in charge of the collection, sorting and initial assessment of the existing information, the IQWiG is responsible for further scientific assessment and a concluding recommendation addressed to the G-BA, and the G-BA is responsible for the final assessment and decision. The G-BA decides on the basis of the criteria of diagnostic or therapeutic benefit, medical necessity and efficiency. The determination of benefit requires the concretisation of and consensus on the extent of the reference to patient-related therapy objectives, the establishment of additional benefits and risks, the required standard of scientific evidence and the consideration of part populations. The knowledge basis of all decisions remains determined by many uncertainties. Standards for clinical research as well as mandatory requirements for the subject matter of studies and methodical standards should be concretised and negative research results must be published. Medical necessity can be assumed if there is a therapeutic gap for a particular indication which may be filled with the new method. A cost/benefit assessment possibly resulting in medical treatment not being applied due to cost reasons and competing needs is not intended. With the criterion of efficiency, the G-BA claims the right to undertake a cost-benefit assessment with regard to the entirety of the insured. However, the practice of G-BA decisions as well as international comparisons have shown that the decision to exclude a therapy is generally based on lack of benefit or medical necessity. These relatively undetermined legal concepts which leave considerable scope for interpretation, and the lack of consensus on the criteria and procedures of decision-making in HTA concerning health sciences as well as practice constitute unsatisfactory empirical facts as well as a normative challenge. The partial exclusion of specific fields from HTA (pharmaceuticals) results in further deficits. A legal constitution of HTA has to guarantee the coherence of regulations in the different fields of law related to HTA (e. g. pharmaceutical law, law of medicinal products, statutory health insurance law) and the harmonisation of their effects in the process of application. The legal constitution of HTA can also be an incentive or obligation to deal with these challenges. There is a need for harmonisation between institutions concerned with HTA processes at an empirical-informational as well as a normative level. The establishment of a network of mutual information on criteria, principles of application and assessment, expertises, recommendations and decisions in the field of HTA is desirable and a first step towards harmonisation. The G-BA is the central actor and its normative practice (most recently rules of procedure) has resulted in some essential achievements. The G-BA brings together the main parties and has the administrative apparatus required to further the task of legal systematisation.

The complete lecture can be found on the website of DIMDI: http://www.dimdi.de/static/de/hta/symposien/2005/index.htm