Since the decoding of the human genome, the genomes of cancer cells, too, can be analysed ever more rapidly. This knowledge has the potential to improve treatment, which can be tailored more specifically to genetic and molecular biological causes. In-vitro diagnostics (IVDs) are an indispensable component of personalised medicine. These include diagnostic laboratory tests that make it possible to tailor therapy to the specific tumour. They are among the medical innovations from which also patients with statutory health insurance should be able to benefit as quickly as possible. However, this must not be at the expense of quality and safety and must also take into account economic aspects.
Based on the observation that there is still no legal regulation in German law that is oriented by these normative principles, the now completed project pursued the goal of finding out whether special regulations exist in other legal systems to solve the access question, and to propose reforms based on this. Every comparative law study faces a difficult initial problem, namely to focus specifically on those legal systems that promise a gain in knowledge. To address this, we took advantage of the fact that IVDs are marketed worldwide. Therefore, we started from a case study, namely the dissemination of a specific gene expression test for breast cancer, on which more detailed information is available as an application example of diagnostic laboratory tests in numerous countries. Among these countries, three European countries (France, Sweden and England as part of the United Kingdom) and three countries that are not part of the harmonised European healthcare market but have significant independent markets for IVDs (America, Japan and Australia) were selected.
The comparative legal analysis has brought to light a number of noteworthy approaches. In France, the promotion of medical innovation is considered crucial for the development of the healthcare system. In addition to the establishment of several procedures for the early financing of innovative IVDs, which include different financing mechanisms and timeframes, a special annual budget is made available for research and innovation. Sweden, too, has a number of approaches to rapidly introduce innovations into healthcare. These include a kind of government model project for complex care provision (nationellhögspecialiseradvård); in addition, patient participation in the decision-making process is strong.
England is characterised by a large number of special programs to introduce innovative services and products into the healthcare system. For IVDs in particular, there is the possibility of launching a novel test on the market relatively quickly (after 63 weeks). An intensive cost-benefit assessment of all health technologies is carried out within the framework of the Health Technology Assessment (HTA) with regular "follow-up" checks to filter out any inefficient products. For the U.S., it is mainly the aspects of access to the general market that are of particular interest. During this phase, there is a close exchange between the regulatory authority (FDA) and industry. This promotes predictability, short approval periods for tests and, consequently, the readiness of manufacturers to innovate. After the market launch of innovative IVDs, however, "Medicare" and "Medicaid" are reluctant to assume the costs.
Cost aspects also seem to limit openness to innovation in Japan. Although the Japanese government published the "Strategy of Sakigake" in 2014 with the aim of promoting innovation in the medical device sector, the instruments provided for this purpose are hardly used. The Australian access procedure is characterised by a high level of transparency and extensive participation rights. This increases acceptance, especially of decisions that are undesirable in terms of health policy. However, an Australian quality assessment is required, which on the one hand means that innovations are sometimes only accepted into the system after years, but on the other hand also reduces the risk of ineffective innovations being introduced prematurely.
This brief overview shows that there are various approaches that can be used to put the inclusion of IVDs in the German healthcare system on a regulatory footing of its own. In most cases, this does not depend on a specific institutional design corresponding to the national legal culture; moreover, individual advantageous regulations can be combined. What remains decisive, however, is a normative evaluation when it comes to answering the questions as to how much secured knowledge must already be available upon first access and how further possibilities for knowledge generation can be created through shortened examination processes in the initial phases and through subsequent control procedures.
