Position Papers and Statements

The TMF issues position papers, statements and expert opinions to comment on national and European policy making processes on a regular basis. These papers are coordinated and agreed upon by a broad range of stakeholders within health research and the wider health care community, depending on the issue under discussion.

As many of the statements refer to national legislation, a good deal of them is only available in German. Therefore, the complete list is available on the German webpages:

1. Position Papers and Comments on the German part of the TMF website

Issues that have been commented on by TMF and partners (some of the initiatives led by partners) include:

1. Data protection
   1. Comment on draft versions of the European General Data Protection regulation [PDF | 576 kb], July 2014; first assessment of the version after the 9th Trilogue Meeting provided to the wider TMF community, December 2015; assessment of the final version, April 2016
2. E-Health
   1. Comment on the draft of a new German E-health legislation, February 2015
3. IT infrastructure / Medical informatics
   1. Annual report on it infrastructure in patient-oriented medical research, since 2013
   2. Key issues paper: GCP-compliant digital archiving of paper-based patient records of clinical trial subjects, 2013
4. Biobanking
   1. Comments on WMA Declaration on Ethical Considerations regarding Health Databases and Biobanks, June 2015 [PDF | 158 kb]
   2. Comment on proposed Biobanking legislation in Germany, November 2011
   3. Short statement on the Comment of the German Ethics Council's Comment on Biobanking, June 2010
   4. Comment on OECD draft guidelines for Human Biobanks, 2008
5. Molecular Medicine
   1. Comment on a draft of the German Act of Gene Diagnostics, July 2008
6. Health Care Research / Secondary use of healthcare data for research
   1. Comment on a draft of the German regulation on data transparency, July 2012
   2. Comment on a draft of early cancer diagnosis and cancer registry legislation, December 2012
   3. Comment on a draft of SHI legislation to strengthen healthcare in Germany, November 2014
7. Zoonoses / Infectious diseases
   1. Position Paper: One Health approach in infectious disease research, February 2014
   2. Comment on Dual Use Research of Concern, June 2014
8. Clinical research
   1. Comment on a draft of new medicines legislation, May 2016
   2. Comment on a draft of new medicines legislation, January 2016
   3. Comment on a draft of new radiation protection regulation, October 2014