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With the most recent change in the law, the AMNOG, pharmaceutical companies were obliged to demonstrate the benefits of this product compared to the existing one when introducing a new product, so that the G-BA can decide whether this product justifies the high price of an innovative product. This means that the question of quality is firmly anchored for pharmaceutical companies for the first time and is made the decisive benchmark for payment. The G-BA decision is only the beginning of price negotiations between the health insurance companies and the pharmaceutical company; in principle, the health insurance companies as well as the companies are also able to restart the negotiations if new findings arise.
Quality is therefore increasingly becoming the benchmark for evaluating services and also for paying for services. So far, this does not correspond to the reality of acquiring knowledge about the quality of health care. The universities at which health services research can be carried out are just as dependent on third-party funding, i.e. payments from sources other than the universities themselves, as are private research institutes. There is no doubt that a lot has happened in recent years; the Federal Ministry of Research has significantly increased funding for health services research. In 2010, the ministry's corresponding funding pot was endowed with 54 million euros.
The pharmaceutical industry has not yet seen itself affected by health services research. Ultimately, the effects of care structures and processes under everyday conditions are examined, i.e. complex ways of caring for patients are the focus of interest, not the specific use of a means. However, the pharmaceutical industry examines the effect of a product under clinical conditions; it does not feel responsible for researching its use under specific everyday conditions (apart from the required pharmacovigilance reports).
And the proponents of health services research? Look with suspicion at the potential involvement of the pharmaceutical industry; after all, there is enough reason to be suspicious; such research could once again be interest-driven with the aim of presenting the use of a product as indispensable.
But the current quality assessment of the effectiveness of medicines as a starting point for determining their value for health insurance companies (and patients) may be the reason for the pharmaceutical industry to change its stance. Not by using health care research for the dossier that it will have to submit in the future for price setting, because that is not possible in purely practical terms because health care research, by its very nature, cannot be used for products that have just been approved. But the industry has an opportunity here to provide evidence of the benefits of a newly used product under everyday conditions through serious participation in appropriate research projects and thus also to demonstrate this in future supply operations.
This will not help in obtaining a higher price. But it will help address distrust of an industry that is increasingly seen as developing new products only by making small changes to the molecular structure to meet the requirements of a new and therefore more expensive product. And it will help to back up the industry's claim that it is serious about improving care with hard evidence. And this will be one way in which the pharmaceutical industry can improve its permanently damaged reputation. The pharmaceutical industry is now increasingly trying to get involved in comprehensive supply projects. It seeks real collaboration with the healthcare players, who are no longer just KOLs for marketing new products in specialist circles. She can demonstrate the seriousness of such collaborations through appropriate accompanying independent research and thus once again help to eliminate the prevailing reservations about such collaborations (and also about the pharmaceutical industry).
The prerequisite for this is that the research is not carried out on behalf of, but rather supported by, industry. To do this, the industry would have to set up a foundation or something similar, which would be managed and controlled by a board in which all the groups involved in the healthcare system are represented and which would decide which projects would be funded. This could also be a starting point for health insurance companies to systematically promote healthcare research; any necessary changes to the law will then certainly be easily achievable. Health Minister Rösler has repeatedly emphasized how important he believes health care research is.
Such a pharmaceutical industry research fund will not once and for all put healthcare research on golden financial ground. That's not what this is about. But rather concrete proof that the pharmaceutical industry is seriously interested in finding out about the reality of care when using its products. In this way, insights would be gained into how new products actually change and (hopefully) improve medical care, as well as insights into what may need to be changed in the care process in order to achieve a positive effect. The financial commitment to such research will pay off for the pharmaceutical industry in an improved reputation, both because it is committed to something that brings it no concrete financial benefit and because it has the courage to gain knowledge even if it does in individual cases will not always be positive for you. <<