Legal Frameworks

  • Burkhard SträterEmail author


Understanding the legal obligations of pharmaceutical companies and regulatory authorities in relation to medicines information in any given jurisdiction is vital for appropriate preparation of medicinal product-related communication. Likewise, any evaluation of a communication intervention a posteriori needs to check if content and timing have been compliant with these obligations in place for consumer and patient protection. In particular, the right of patients to receive compensation in the case harm occurs due to the pharmaceutical company being non-compliant or negligent, i.e. the marketing authorisation holder’s liability, impacts on communication requirements. This chapter presents legal principles of global value, including the precautionary principle, with the historical but still fundamental case of the thalidomide disaster, and looks to challenging legal questions of the future.



After graduating, the author was a judge in Berlin for 5 years and then head of the legal department of the German Federal Health Agency for 5 years. He then established the Sträter law firm and is partner of this law firm which advises pharmaceutical companies and medical device manufacturers, as well as physicians, pharmacies, hospitals and universities. He co-founded the Master’s Programme in Drug Regulatory Affairs (MDRA) at the University of Bonn 20 years ago and has headed its examination board for 10 years. Within the study programme, he leads one of the twelve modules, namely the “Pharma law” module, which addresses the balancing act between scientific evaluation and legal framework conditions for risk minimisation and other measures, i.e. also the legal framework described here for information to physicians, pharmacists and patients.


  1. Angelmar R (2006) The rise and fall of Baycol/Lipobay. J Med Market 7(1):77–88CrossRefGoogle Scholar
  2. Council for International Organizations of Medical Sciences (CIOMS) (1998) Guidelines for preparing core clinical-safety information on drugs (Report of CIOMS Working Group III & V), 2nd edn. CIOMS, GenevaGoogle Scholar
  3. Council of European Communities (1998) Commission communication on the Community marketing authorisation procedures for medicinal products, Ref. 98/C 229/03, 22.07.1998Google Scholar
  4. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human useGoogle Scholar
  5. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human useGoogle Scholar
  6. Encyclopaedia Britannica (2020) Hammurabi: King of Babylonia.
  7. European Commission Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use, Revision 1, 12 January 2009,
  8. European Commission Notice to Applicants Volume 2A Procedures for marketing authorisations, Chapter 1, December 2016, 2.8 Concept of “applicant” and “marketing authorisation holder”Google Scholar
  9. European Medicines Agency and Heads of Medicines Agencies (2012) Guideline on Good Pharmacovigilance Practices (GVP). London/Amsterdam: European Medicines Agency, since 2012Google Scholar
  10. FDA Arthritis Advisory Committee (February 8, 2001) “VIOXX Gastrointestinal Outcomes Research Trial (VIGOR)”, Bonnie Goldmann, slide 39, “Conclusions” slide 49Google Scholar
  11. FDA (2006) Guidance document: adverse reactions section of labelling for human prescription drug and biological products — content and format. FDA, Rockville, MD, United States,
  12. Froese N (2018) Aristoteles: Logik und Methodik in der Antike,
  13. Kloesel/Cyran Arzneimittelrecht Kommentar E1 (2019) (Contergan-Entscheidung und A 1.0 Anmerkungen 12, 25, 26, 27, 29 zu § 5 AMG – Definition der Bedenklichkeit eines Arzneimittels)Google Scholar
  14. Mezher M (2017) European Commission recommends changes to SmPCs, package leaflets. Regulatory Focus,™/news-articles/2017/3/european-commission-recommends-changes-to-smpc,-package-leaflets
  15. ODDB (2002) Summary of product characteristics for Vioxx, section on “Clinical Efficacy”, 5th paragraph,
  16. Popper K (1934) Epistemology and philosophy of science in “The Logic of Scientific Discovery”,
  17. Regional Court of Aachen in the Thalidomide decision, see remark 1, and very instructively the Administrative Court of Cologne on risk measures of the Federal Institute for Drugs and Medical Devices (BfArM) in PharmR 9/2014, page 410 ffGoogle Scholar
  18. Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines AgencyGoogle Scholar
  19. Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/ECGoogle Scholar
  20. Rühl U (2005) Ist Rechtswissenschaft überhaupt eine Wissenschaft?, with further notes on the antique understanding of science and on the tense relationship between natural science and humanities, with further notes on the significance of categorising sciences according to Aristotle,
  21. Science Museum (2017) Brought to life – exploring the history of medicine: Thalidomide. London: Science Museum [webpage]. Accessed: 2 July 2017Google Scholar
  22. Uhlmann G (2016) Ringvorlesung: 2400 Jahre Aristoteles und Aristotelismen. Freie Universität Berlin,
  23. Wikipedia (2020) Vorsorgeprinzip,

Copyright information

© Springer Nature Singapore Pte Ltd. 2020

Authors and Affiliations

  1. 1.Rheinische Friedrich-Wilhelms-Universität Bonn, Master Study Course Regulatory Affairs – MDRABonnGermany

Personalised recommendations