In the context of the current legislative debate on the Medicinal Products Market Restructuring Act (known by its German initials AMNOG) and of the planned Healthcare Provision Act, the German Ethics Council’s Opinion is intended to help focus political and public attention on thorny issues of distributive justice, taking as an example the ethically disputed methods of analysis used in health economics.
The establishment of criteria for an equitable distribution of healthcare resources is a political task with medical, economic, ethical and legal aspects. In view of the complex issues involved, however, it is extremely difficult to arrive at a consensus among all interested parties. The German Ethics Council nevertheless believes that principles can be formulated as a necessary basis for the assessment of existing structures and processes.
The Ethics Council considers it urgently necessary for prioritization, rationalization and rationing in the field of healthcare to be debated openly. All forms of “covert rationing” of medical treatments and benefits must be rejected. Unavoidable decisions on rationing must not be delegated to an individual medical practitioner or nurse. However, by acknowledging the existence of the problem of how scarce healthcare resources ought to be distributed, one is of course not espousing an “economization” of decisions. An objective debate in fact calls for the involvement of medical, economic, ethical and legal expertise in a transparent process. Decisions on the extent of solidarity-financed benefits are ultimately ethical decisions, which must be taken on the basis of social discourse and through the political process.
Decisions must always be based on the principle of human dignity and on the fundamental rights involved in every citizen’s guaranteed right of access to appropriate healthcare. These rights must not be subordinated to any supposed maximization of the common good. Again, the calculated or presumed socioeconomic “value” of individuals or groups must on no account underlie decisions on distribution.
On the basis of the foregoing, the German Ethics Council has formulated twelve recommendations to be taken into account by healthcare decision-makers in the drafting of statutory instruments, with the twofold aim of optimizing the allocation of funds for healthcare while at the same time achieving equitable distribution.
If scarce resources are to be used responsibly, they must be deployed in such a way as to ensure that utility really does accrue from them under field conditions. In addition to early analysis of utility for pricing purposes, it must remain possible for the Federal Joint Committee (G‑BA) and the IQWiG (Institute for Quality and Efficiency in Health Care) to conduct a comprehensive analysis of utility at any time irrespective of cost considerations, in particular in relation to patient-related outcomes (mortality, morbidity and quality of life). In the case of important groups of indications, a systematic second stage of utility analysis should follow as a matter of course after an appropriate interval, not only for pharmaceutical products, but also for non-pharmacological interventions. It must always be possible to exclude a given treatment from the range of benefits provided owing to lack of utility where necessary for reasons of patient protection.
The Ethics Council recommends an expansion of transfer and care-related research, as well as assistance, independent of the manufacturer, for clinical studies in the practical treatment situation after a drug or medical device has been licensed. This should be linked to the systematic identification of research topics of particular relevance to healthcare provision, for instance by the G-BA. An appropriate statutory framework must be established for this purpose.
One eventual aim should be the compulsory publication of all studies, regardless of their findings, and not only of confirmatory studies conducted for licensing purposes, as well as of post-licensing clinical trials. This is the only way to guarantee access to all data relevant to the analysis of utility.
In the context of the cost-utility analysis of medical treatments, there are important ethical and justice-related reasons not to apply the principle of maximization of utility on a level higher than that of the patient group. Parliament should therefore clarify Section 35b of Social Law Code Book V (SGB V) (Analysis of the cost-utility ratio of medicinal products) accordingly. However, calculations of cost-effectiveness based on an efficiency-frontier approach, too, cannot be deemed ethically “neutral” when used as a criterion for the appropriateness of decisions on reimbursement for innovations. This is because the cost-effectiveness of the particular established therapy that offers the greatest level of utility in a given field of indications – i.e. the status quo – is based on a variety of factors which are not always coordinated with each other. The mention of international standards in health economics in sentence 5 of Section 35b(1) SGB V as currently worded is too vague.
The effects of the existing provisions on cost-utility analysis in Germany are at present substantially innocuous because an insured party’s legal entitlement to receive everything that is medically necessary is unimpaired. These provisions do not currently serve as an instrument for the distribution of scarce resources, but for pricing purposes. However, the likely future need for rationing decisions will compel the legislature to clarify the extent to which entitlements to benefits pursuant to Sections 27 and 12 SGB V may be influenced by a cost-utility analysis, and to spell out the relative roles of this analysis and of the criterion of medical need.
The Opinion can be accessed (in German) at http://www.ethikrat.org. An English version will be available in due course.