Massive functional problems with the EU portal CTIS threaten drug research in Europe
29.11.2022 12:07
Regulation (EU) No. 536/2014 for clinical drug trials has been applied since the end of January 2022. From January 31, 2023, all research projects involving human medicinal products must be applied for and approved across Europe in accordance with this regulation via the electronic portal CTIS. Without sufficient functionality of this portal, the entire system of EU regulation risks failing.
The Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK) and the associations of applicants for drug trials from university research1 and the pharmaceutical industry2 agree that, even after 10 months of use, the CTIS portal suffers from serious deficiencies and is largely unusable for everyone involved. These deficiencies have not been eliminated in recent months, but have increased. This means that the submission of applications for clinical trials as well as their processing by the ethics committees is massively impaired and cannot be managed. This will likely lead to a significant weakening of the competitiveness of Europe as a research location and to disadvantages and risks for patients. There is a tangible risk that the dysfunction of the CTIS portal will lead to a possible permanent migration of drug trials to other regions of the world. This would also have negative consequences for early access to new therapies for patients in Germany and the EU. In addition, the careful review of research applications by ethics committees is severely hindered by the dysfunctionality of the portal.
The Working Group of Medical Ethics Committees and the above-mentioned associations therefore consider it urgently necessary that the transition period expiring on January 31, 2023 in accordance with Article 98 paragraph 2 of Regulation 536/2014 be extended until the EU Portals CTIS was actually manufactured and proven. The Federal Government is urged to work with other EU member states to bring about such an extension as soon as possible.
1 German University Medicine (DHM); Network of Coordination Centers for Clinical Studies (KKS Network)
2 Federal Association of Drug Manufacturers (BAH); Federal Association of the Pharmaceutical Industry (BPI); Association of Research-Based Pharmaceutical Companies (vfa); Federal Association of Medical Contracting Institutes (BVMA).