The Spanish Ministry of Health has published a draft Royal Decree on Clinical Trials, which the Spanish government is expected to adopt by the end of this year.  Once adopted, the new Royal Decree will replace Royal Decree 223/2004 on Clinical Trials and will regulate all clinical trials with medicines and medical devices in Spain.

Among other changes, the draft Royal Decree would introduce the following:

  • Spanish Clinical Trials Register: the draft Royal Decree would establish a Spanish Clinical Trials Register publicly accessible on the website of the Spanish Medicines Agency.  Study sponsors would be required to publish all information and results of clinical trials and observational studies in this register.  The draft Royal Decree also provides for the voluntary publication in the register of information on all other clinical studies provided that at least one of the participating health institutions is in Spain. 
  • Authorization Process: the draft Royal Decree would also introduce new authorization procedures to initiate clinical trials.  Study sponsors would be required to simultaneously submit their applications by electronic means to the Spanish Medicines Agency and competent Ethics Committees.  Moreover, sponsors would no longer be required to notify the Agency of the favorable opinion of the Ethics Committee.  The draft Royal Decree would also introduce new requirements for Ethics Committees.
  • Economic Agreement: the draft Royal Decree explicitly requires the conclusion of an economic agreement between sponsors and health institutions before the initiation of a study.  Health institutions would be required to decide whether to sign the agreement within sixty days from the sponsor’s submission of a valid proposal. Importantly, the draft Royal Decree requires Spanish health authorities to adopt a common template agreement that would be applicable in all Spanish public health institutions.  This template would harmonize the current diversity of template agreements of the different Autonomous Communities, but could also further limit the discretion of health institutions to accept any changes from sponsors.
  •  Liability: the draft Royal Decree would also introduce some changes to the current liability rules for clinical trials.  Among other things, sponsor would no longer be required to purchase insurance for so-called “low risk” clinical trials.