The Blood Test – Overview and Consequences

(Status: October 2020)

At a press conference held in February 2019, researchers at the Women’s Hospital of Heidelberg University Hospital (UKHD) announced the development of a marketable procedure for detecting breast cancer with the aid of a blood test. For this purpose, companies bearing the name of HeiScreen GmbH and HeiScreen NKY GmbH (for the Chinese market) were founded by the UKHD subsidiary called technologie transfer Heidelberg GmbH (tth GmbH) with the participation of investors.

In the following weeks it became clear that this announcement was premature and that the processes and structures of the University Hospital with regard to the transfer of technology and the spin-offs of its subsidiaries had not been adequately defined. In order to clear up the events involving the HeiScreen GmbH and HeiScreen NKY GmbH and to prevent such events from happening again, the following measures were taken:

• With a resolution dated April 5, 2019, the Supervisory Board deployed an independent, external investigative commission headed by Prof. Dr. Matthias Kleiner (President of the Leibnitz Association and former president of the German Research Foundation (DFG)) and retired Federal Constitutional Court Judge Dr. Christine Hohmann-Dennhardt. This commission has worked intensively in the past months; a final report on the clarification of the facts is now available. On the basis of the final report, the commission formulated recommendations regarding structures and processes for the transfer of technology. UKHD and the Faculty of Medicine have already implemented most of the recommendations.
• To ensure good academic practice and to handle misconduct in science, Prof. Dr. Bernhard Eitel, Rector of the Heidelberg University has entrusted the Senate Commission, under the leadership of the former Vice-Rector for Research and Transfer, Prof. Dr. Stephen Hashmi, with the review of all academic aspects in connection with the blood test for diagnosing breast cancer. The final report of the Senate Commission has been handed over to the Rector.
• In the area of transfers, experienced physicians at the Heidelberg Medical Faculty examined the scientific quality of the research work and the utilization processes by order of the Dean under the leadership of Prof. Dr. Walter Emil Haefeli and Prof. Dr. Magnus von Knebel Doeberitz. Results and evaluations were provided to the external investigative commission and the university Senate Commission (see above) for their work.
• An investigation by the Mannheim Public Prosecutor’s Office in connection with the publication of the blood test was discontinued on March 3, 2020. The extensive investigations conducted by the State Criminal Investigation Department of Baden-Württemberg did not disclose any indications for any criminally relevant grants of benefits or agreements that do not comply with the law in relation to the aforementioned blood test. Furthermore, the investigations did not disclose any indications of criminally relevant behavior. Heidelberg University Hospital had itself filed a criminal complaint against persons unknown in April 2019.

Staff consequences

The events related to HeiScreen GmbH have led to staff consequences on the Management Board level: The Dean of the Heidelberg Medical Faculty, Prof. Dr. Andreas Draguhn, resigned from office and from all related functions with effect from July 24, 2019.

The Chair of the Management Board and Chief Medical Director of the Heidelberg University Hospital Dr. Annette Grüters-Kieslich made room for a successor as of October 31, 2019. Commercial Director Dipl.-Volkswirtin Irmtraut Gürkan resigned on July 31, 2019. An amicable settlement was reached with Markus Jones, the former Deputy Commercial Director, in late January 2020.

New organizational and administrative features

These events were taken as the occasion to revise and update the by-laws of the UKHD. The new by-laws will represent a further development of the existing version from the year 2007 and will regulate more clearly, for example, the lines of responsibility and reporting obligations of the individual Management Board members. Moreover, the allocation of duties was reformulated, by putting the areas of responsibility of the five members of the Management Board into writing.

Changes in the transfer of technology

Heidelberg University has terminated the utilization agreements which it had signed with tth GmbH on behalf of the Medical Faculty at Heidelberg. In the future, the ScienceValue Heidelberg (SVH) is responsible for the transfer of technology and patent management of the Medical Faculty. Employees of tth GmbH were offered jobs in the new GmbH, which is wholly owned by the University.