Regulatory and compliance

New Royal Decree regulates clinical trials with medicines for human use

Published on 23rd Dec 2020

On 26 November, the Official State Gazette published Royal Decree 957/2020, of 3 November 2020, regulating observational studies with medicines for human use (the "Royal Decree"). This Royal Decree, effective as of 2 January 2021, will replace the current legislation, that is, Order SAS/3470/2009, and chapter VI on Post-authorization Studies of Royal Decree 577/2013.

The new rule on observational studies stems from the need to bring national legislation into line with new European regulation with an impact on the conduct of such studies and aims mainly to simplify administrative procedures by facilitating independent research.

Before achieving this objective, the new rule unifies the definition of observational studies with medicines for human use and implements an assessment procedure common to all of them.

As a result of the above, the requirement prior to the study to obtain authorisation from the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios ("AEMPS")) is replaced by (i) the favourable decision of a Research Ethics Review Committee ("ERC"), which will be exclusive, binding and recognized in all the national territory; and (ii) an agreement with the healthcare centre where the participants of the study will be treated. The Committee for the Post Authorization Studies Coordination is abolished, as its tasks are considered to overlap with the functions of the ERCs.

Additionally, it is worth noting that, for observational studies with medicines for prospective monitoring, the competent health authorities of the Regional Autonomies may set out further requirements, based on feasibility and relevance criteria.

Another new feature introduced by this Royal Decree concerns Patient Support Programmes. In this respect, any Patient Support Programmes that anticipate registering information on the use of medicines, via scheduled contacts with patients, may only be carried out in Spain within the framework of a protocol whose objectives are those set out in the Royal Decree. That is, the opinion of the ERC, agreement with the healthcare centre and, if appropriate, any requirements that regional governments set out before the studies begin.

Changes are also introduced in relation to both the informed consent of patients taking part in the study and associated economic aspects. To this end, there will be an exemption to requesting the informed consent of the participant if the ERC considers that:

  1. the observational research has significant social value;
  2. that its development is not feasible or viable without such an exemption; and
  3. that it involves minimal risks to the participants.

Regarding the financial aspects, participants are allowed to receive compensation which, under no circumstance, may influence the participant's decision to take part in the study. Besides, the remuneration of healthcare professionals must be limited to a consideration based on the time invested and the expenses incurred.

Finally, in terms of transparency and information, the sponsor of the study, not only will publish the results of the study in scientific journals, but they will also be responsible for publishing said results in the Spanish Clinical Studies Registry (Registro Español de Estudios Clínicos (REec)). Likewise, the obligation to access information about observational studies on medicines through the web page of the AEMPS is established.

As mentioned, the Royal Decree is effective as of 2 January 2021. However, any observational studies that have been subject to a classification decision by the AEMPS prior to the entry into force of the Royal Decree will be subject to the regulations in force at the time the classification decision is obtained.

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* This article is current as of the date of its publication and does not necessarily reflect the present state of the law or relevant regulation.

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