The impact of the new EU Clinical Trial Regulation on Switzerland

 

New EU Regulation Blog

 

This article describes the CTR and discusses possible outcomes for the Swiss clinical trial regulations. Moreover, the article raises important questions which soon have to be addressed by Swiss politicians.

Why a new clinical trial regulation?

The old Directive 2001/20/EC of 4th April 2001 originally aimed to introduce good clinical practice within clinical trials in the EU. Unfortunately, this approach failed because of time and costs. The following reasons were crucial factors for this unsuccessful project.

  • An increase in insurance fees
  • An increase in demand for staff for the authorization process
  • An increase in administrative costs for non-commercial sponsors
  • The delay for launching a clinical trial increased

The very disappointing result was a decline in clinical trial application in the last years, which did not just hamper the reputation of Europe as a vanguard in science, but there were also significant economic costs to be paid by all participants within the EU clinical research community.

 

What is the goal of the new clinical trial regulation?

The new Clinical Trial Regulation EU No. 536/2014 (CTR) has the following goals:

  • Simplifying the submission process: Initially, the sponsor had to go through a thorough application process in each member state where only the local language could be used, and every state had their own special requirements regarding further customised documents. Every change in the trial process requested from one country automatically affected the trial process in another member state. The new regulation prescribes only one approval for all countries. The sponsor can submit their application through the European Medicines Agency.
  • Harmonization of clinical trial studies within the EU: Germany and a few other EU member states are counted among the most popular places to conducting clinical trials worldwide. The hope is that through the harmonization process, the EU will become the number one destination for clinical trial studies.
  • Publishing the Clinical Study Reports: Historically, it has long been agreed among the EU member states that the summarized results of clinical studies have to be published. However, for laymen it was rather difficult to understand these results in detail and to consequently draw a sensible conclusion. The new regulation obligates the sponsors to publish a clinical study report accompanying the results.

All these changes should help making the EU a more attractive place for clinical trial research and thus encourage sponsors to conduct more investigations of medicines, while at the same time keep a high standard of patient safety.

 

What does this mean for clinical trials conducted within Switzerland?

As of a request by the Federal Office of Public Health (FOPH), Prof. Dr. Christoph Zenger, lecturer of Public Health Law, at the University of Bern, analysed the impacts on Switzerland and drew the following conclusions in a public study:

  • No selective takeover of EU legislation: The EU willl probably not allow Switzerland to only adapt certain rules. If Switzerland wants to be part of this new procedure, it will be expected to take over all the rules within the CTR.
  • No EU-friendly interpretation possible: It is very difficult to modify the interpretation of the Swiss law in order to adapt it to the new EU legislation. In the end, a new legislation would have to be introduced by the parliament to the voters of Switzerland. However, Art. 118 BV makes it difficult for Switzerland to introduce the new EU legislation anyway.

In his final remarks, Prof Dr. Christoph Zenger, concludes that the main scope of the Swiss and the new EU legislation is quite different. While the EU legislation is more about efficiency and harmonisation, the Swiss legislation is more about protecting the clinical trial candidates.

The Swiss Medical Lawyers Association raises important questions in their Newsletter such as:

  • Would Switzerland have the same status as a place for approval regarding the submission of a new clinical trial study as the other EU member states?
  • Would Switzerland be forced to change their regulation simply because of the need to participate in the EU research programmes?

 

Conclusion

To conclude, all these improvements mentioned in the text above will, if implemented smoothly, have a very positive effect on the clinical trial regulatory environment in the EU. On the contrary, Switzerland needs to make a decision if it wants to introduce this new legislation somehow into Swiss law or if it wants to create their own law, which must be more or less identical to the CTR. Lastly, on the political level, there is always the possibility for negotiations. Unfortunately, as history has shown, there has never been a pragmatic approach to bilaterial bargaining between the EU and Switzerland.

 

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References:
 
Dr Dehlinger-Kremer, M. (n.d.). The New EU Clinical Trials Regulation: The Good, the Bad, the Ugly. Retrieved May 28, 2018, from https://www.synteract.com/Renderers/ShowMedia.ashx?id=MediaArchive:e144a997-7beb-4f1c-b8e0-89a3d093c47d&download=false
Dr. Zenger, C. (2014, September). Bericht über den Vergleich zwischen dem eidgenössischen Humanforschungsgesetz einschliesslich des Verordnungsrechts sowie der neuen EU-Verordnung vom 16.04.2014 über klinische Prüfungen mit Humanarzneimitteln an Menschen und zur Aufhebung der Richtlinie 2001/20/EG. Retrieved May 27, 2018, from https://www.bag.admin.ch/bag/en/home/themen/mensch-gesundheit/biomedizin-forschung/forschung-am-menschen/klinische-pruefungen-humanarzneimitteln-eu.html
Verband Forschender Arzneimittelhersteller, & Fischer, B. (2014, April 15). Die neue EU-Verordnung zu klinischen Studien: Was sagt der vfa? Retrieved May 27, 2018, from https://www.vfa.de/de/arzneimittel-forschung/so-funktioniert-pharmaforschung/eu-verordnung-zu-klinischen-studien.html
 
Swiss Medical Lawyers Association. (n.d.). EU-Verordnung für klinische Medikamententests am Menschen verabschiedet [Press release]. Retrieved May 27, 2018, from http://www.medizinalrecht.org/?p=105
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