The European Commission hopes to create a favorable environment to conduct clinical trials in the EU with the implementation of the Clinical Trial Regulation (CTR), which will be going live at 31 January 2022. In the weeks before we will publish articles to help you prepare. In this article we provide an overview of the key considerations with regards to legal representation under CTR.
Legal representative requirements under CTR
According to Article 74 of the CTR, if a sponsor of a Clinical Trial is not based in the EU, then they are required to appoint a representative within the EU to act as a Legal Representative. If the sponsor is based in the EU, then a legal representative is not required under CTR, because the organization based in the EU will act as legal representative. The legal representative ensures compliance with the Sponsor’s obligations under EU CTR and notifies the sponsor immediately in the case of becoming aware of incompliance with EU CTR.
The Legal Representative is accountable for the sponsor’s compliance with obligations under EU CTR and is the addressee for all communications with the sponsor provided for in the Regulation. However, Member States can choose not to require a legal representative for clinical trials that are conducted on their territory or on their territory and that of a third country as long as they establish at least a contact person in respect of that clinical trial for all communications with the sponsor. If the clinical trial is conducted in more than one Member State for example in multi-territory trials, then all of the Member States concerned can choose to only apply a contact person established in the Union.
However, from our research it is becoming evident that the majority, if not all, Member States will require a Legal Representative instead of a simply a Contact Person for organizations not established in the EU.
Key considerations for organizations
With many organizations currently assigning a sponsor outside the European Union, the CTR presents a challenge. Below we present several options for organizations to comply with the requirements for a legal representative.
Possible approaches to meet the requirements for legal representative:
- Continue with the current set-up
Depending on the internal organizational structure, this option is only applicable for organizations that either have their clinical trial activities in-house or their sponsor and legal representative are firmly based within the European Union.
- Outsource the legal representative
Another option would be to outsource the legal representative, either by contracting the sponsor as well as another external party. This option may however be undesirable, as outsourcing the position of legal representation effectively means outsourcing the organizations compliance with the CTR. This option therefore creates full reliability on this party for the organizations representation, responsibility and liability within the EU.
- Establish an EU-based location or using an EU-based affiliate
An organization may also opt for establishing an EU-based location or using and EU-based affiliate. This can be seen as a preferred option in case the sponsor is based outside the EU. The legal representative can then be based in the EU-based location or affiliate.
- Establish a single central resourced organization
Another option is for organizations to establish a single central resourced organization under which all clinical trials within the EU are managed and executed. The single central resourced organization would include the role of both the sponsor and legal representative. This would be beneficial, as a legal representative would not be required as the sponsor is based in the EU.
Relevance for organizations
As the requirement of legal representative is an essential part of the CTR, it is important for organizations to be aware of their current organizational setup and how they use external organizations (e.g. Contract Research Organizations (CRO)) in order to decide what approach is best suited. The choice of approach and organizational setup can also be influenced by access and user management within the Clinical Trial Information System (CTIS) as introduced by CTR.
by Sebastian Payne
A Director at Deloitte, leading a team of Life Science specialists and focusing in Life Science Risk Advisory with over 20 years of experience in LSHC consultancy. Assisting organizations with insight and strategy delivery, in the face of significant Life Science regulatory and technological change.