The power of attorney granting representatives of foreign authorities access to health information must be approved by the Danish Medicines Agency and submitted at the same time as the application for approval of a clinical trial of a medicinal product. Following the entry into force of the amended Danish Act on the Scientific Conduct of Research Projects in the Health Sciences and Article 89(3) of the Danish Medicines Act on 1 July 2016, the authorisation no longer applies to the sponsor and the monitor, as consent to the trial also includes direct access by the sponsor, the monitor and investigator to the health information of the subjects. Only one legal representative may be appointed for a particular clinical trial. The roles and responsibilities of the legal representative under the Clinical Trials Directive 2001/20/EC are subject to change under the new Regulation (EC) No 536/2014 on clinical trials. These changes are likely to affect the way in which third-country clinical trial sponsors approach the appointment of the legal representative to comply with the sponsor`s obligations under the Regulation. It is not clear whether a distinction is made between the obligations of the proponent and the responsibilities or sanctions associated with non-compliance with those obligations and the obligation of the legal representative to ensure that the proponent complies with those obligations. It is possible that there is a separate liability with probably less consequences for the failure to ensure compliance by the proponent. A special power of attorney to appoint the legal representative must be signed by the sponsor and included in clinical trial applications. To the extent that the immediately following statements in Article 75 confirm that the responsibilities of the sponsor and the principal investigator are not affected by “this Chapter” (which contains the provisions on legal representatives). `Where the sponsor of a clinical trial is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. That legal representative shall be responsible for ensuring compliance with its obligations under this Regulation and shall be the addressee of all communications with the sponsor provided for in this Regulation. Any notice to such legal representative shall be deemed to be notice to the Sponsor.
The final version of the 2014 RTC was published on September 27, 2014. May 2014. The authorisation should therefore be a separate document dealing with access to and purpose of access to health information for participants. Please also take note of the Danish Implementing Regulation on GMP (available in the box on the right: “Bekendtgørelse nr. 264 af 4 April 1997 om god fremstillingspraksis (GMP) og god distributionspraksis (GDP) for lægemidler”), Directive 2001/20/EC, Article 13 and GMP Directive 2003/94/EC. The guidelines are available at ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm. For Directive 2001/20/EC, click on “Volume 1”; For the GMP guideline, click on “Volume 4”. We have in-depth knowledge of legal and national requirements in eu member states and the EEA. Our representative office service saves you costs and resources, as the establishment of a statutory headquarters in the EU/EEA is no longer necessary. The 2014 CTR states that each Member State can determine whether it needs a legal representative or a contact person for third-country promoters (or possibly the option of both).
Article 74(2) of the CTR 2014 provides: Contrary to the requirements of the legal representative, it should be clarified that the CTR 2014 does not appear to oblige the contact person to ensure compliance with the obligations of the non-EU sponsor under the CTR 2014. It therefore seems that under the RIE 2014, the role of the legal representative seems much more cumbersome. It obliges the legal representative to ensure that the non-European promoter fulfils its obligations under the 2014 CTR. For clinical trials conducted in Switzerland, Article 2(c) of the Ordinance on Clinical Trials of Therapeutic Products requires a sponsor not established in Switzerland to appoint a representative based in Switzerland. Promoters who are not located in the EU/EEA must appoint a legal representative based in the EU/EEA. Given the context in which the RR was introduced in 2014, i.e. to promote more trans-European and transnational audits, most Member States should not opt for the more binding role of a legal representative instead of a contact person under the DRR 2014 in the interest of their own attractiveness to promoters. As far as the UK is concerned, neither the MHRA nor the Human Research Authority (HRA) has announced any changes that will be made to the current role of the legal representative.
Given the way in which the UK has implemented the CPC 2001 and the current requirements, one would expect that it would be unlikely that the UK would opt for the legal representative under the 2014 CTR, but instead opt for the contact person (largely the status quo) or possibly give the non-EU sponsor the option to: or to elect a legal representative or contact person. The 2014 RTC is not expected to come into force until May 2016. In the meantime, Member States should clarify whether they will require third-country promoters to have a legal representative or contact person in the EU.