>> To put it bluntly: If one euro had flowed into the German healthcare system for every public mention of the specter of the “transparent patient”, we would no longer have to worry about its financing. Pseudonymization and security of the data used are undoubtedly a basic requirement for responsible research. However, both must not be misused as a deadlock argument against systematic data collection and analysis.
Federal Health Minister Jens Spahn has always opposed this very German way of looking at digitalization. “Collecting data is not an end in itself, but rather serves to better help sick patients or prevent illnesses,” said Spahn in May 2015, long before his appointment as minister. The book “App from the Doctor”, published in 2016, in which Spahn was involved as an author, has the subtitle “Better health through digital medicine”.
So you really can't accuse the Federal Minister of being hostile to progress. Mr. Spahn knows about the opportunities that digitalization creates for doctors and patients. And he wants to use it. In this sense, the new law is expressly to be welcomed.
However, the DVG falls short in one crucial point. It squanders the opportunities that modern data processing offers for research and development of new therapies. This is a major disadvantage for Germany as a pharmaceutical location, for research and development in this country and, last but not least, for patients and doctors.
On the occasion of the bill, the Federal Minister emphasized again: “The medicine of the future is dependent on data.” As the managing director of a pharmaceutical company that works based on knowledge, I can only agree with him. Medical progress needs data. For us at Janssen, the responsible exchange of data has long been part of our responsibility towards patients, relatives, doctors, nursing staff and all other people who use our medicines and services. We were the first company to enter into a cooperation with Yale University in 2014. Since then, scientists from all over the world have had access to all data from our clinical studies as part of the YODA project (YODA = Yale Open Data Access Project). It goes without saying that protecting confidential patient data has top priority.
The institutions that use data to contribute to medical progress are numerous. The DVG lists them in detail in connection with the “research data center” in paragraph 303e. Mentioned include health insurance companies, health care research institutions, universities, IQWiG, the G-BA, medical associations and many other deserving institutions. However, an important group that has made a comparable contribution to medical progress over the past decades is not on the list of “beneficiaries”: pharmaceutical companies.
Research-based drug manufacturers employ around 17,000 excellently trained researchers and developers in Germany alone. According to vfa, companies' pipeline investments in this country amounted to more than 6 billion euros.
The result is impressive: In 2018, research-based pharmaceutical companies in Germany brought 36 new drugs onto the market (excluding biosimilars), including twelve against cancer and ten against metabolic diseases.
Achieving such successes requires high scientific standards, significant financial resources and – of paramount importance – comprehensive data sets. The ministry itself is aware of their importance and writes on the occasion of the draft law: “We ensure that the billing data available to the health insurance companies is summarized pseudonymously in a research data center and that anonymized results are sent to research upon request.” Here the question must be permitted: why pharmaceutical companies are not granted the opportunity to make such an application. Are we not part of the research? Here, medical progress is being blocked against our better judgment.
Great Britain shows that things can be done differently. Here too, digitalization is creating a treasure trove of patient data. Unlike in Germany, however, these can also be used by companies for the purposes of research and development. A focus of the regulations is on the anonymization of data and strict rules for its use by everyone involved - including pharmaceutical companies. Data security is guaranteed.
The British approach is characterized by a “common sense” that one would also like to have in Germany. It is then accepted that health care institutions pursue different objectives. This is perceived as good and sensible as long as the interests of companies result in medical benefits for doctors, patients and other stakeholders. What is important is the individual and social benefit of new therapies, not who provides them.
In Germany, as of today, this opportunity is unfortunately being missed. Users of patient data that are important for medical progress are excluded from access. Speculating about the reasons is pointless. It's not just the companies themselves that are disadvantaged. The partners in the medical and academic environment who are so important for research and development are also affected - and even more than anyone else, the patients. For them, access to new therapies is delayed or denied.
It remains to be hoped that this will change. The researchers and developers of the pharmaceutical companies – and I too – are happy to be available to politicians as discussion partners. <<
