Irish attorney Gillian Rea on the new European clinical trial regulation. TrialSite News principals have considerable experience with European clinical trials operations and appreciate Ms. Rea’s crisp and concise opinion. Overall the new rules will be a boon for global sponsors however there are enhanced data protection, privacy and informed consent management matters to understand. Ms. Rea would be a fabulous resource, in our opinion, to consult.

According to the Irish Legal News, EU regulation 536/2014 is to replace the ‘Directive’ “and remedy its short comings.” Implementation has been delayed due to factors such as delays in finishing new technology “required to enact particular provisions of the regulation.

TrialSite News summarizes Ms. Rea’s position on the new law:

  1. National implementation vs. Direct effect
    1. This regulation is a binding act, immediately applicable and enforceable throughout the EU once it comes into law (subject to transition period)
  2. Single submission to all member states
    1. Submission of a multi-jurisdictional clinical trial application will now only require one single regulatory authority and ethics committee submission. The submission will be made to all member states in which the clinical trial is to be conducted via a new EU portal. The sponsor will propose one of the concerned member states to act as a the reporting state member. This will hugely cut down on the time and administrative input required by sponsors and clinical research organisations in the submission process.
  3. New category—Low interventional clinical trial
    1. The regulation includes a new category of trial which is subject to lower clinical scrutiny, where the investigated medicinal product is already market authorized or, if not used according to market authorization, is used in a way that is supported by published scientific evidence.
  4. Informed consent
    1. A number of new provisions on informed consent are introduced including:
      1. The components of a valid informed consent and specifically points out that the patient must be given sufficient time to consider, ask questions and must also be given a copy of the signed form of consent
      2. It separates the consent requirements into various groups, for example minors, pregnant and breastfeeding women, incapacitated people and persons deprived of their liberty.

EU portal and EU database (innovation and delay)

The portal will be the go-to place for submissions for all clinical trials carried out in the EU.  A single electronic entry point with all information being stored in a public database, significantly cutting down on costs, time and administrative overhead.  EMA will control the portal.

The EU database will disclose all relevant information on ongoing and completed trials and will be publicly  accessible – dramatically increasing transparency in the clinical trial space. Information will only be protected from this disclosure if it relates to: (i) the processing of personal data, (ii) commercially confidential company information or (iii) confidential communications between member states.

A completely new departure, the EU portal and the EU database have the potential to revolutionise the management of clinical trials. However the significant technical complexities in perfecting the functionality of the portal and database have consistently pushed back the enactment of the new Regulation. The timeframe for entry into force is now early or mid-2020. The portal and database will need to be tested and audited by the EMA management board to ensure the system meets all requirements before the Commission can publish the notice in the Official Journal of the EU to commence the entry into law of the Regulation. Considered opinion is that the date could be pushed back yet again before we see this Regulation come into force.

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Source: Irish Legal

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