New rules for carrying out clinical trials in Spain: in a faster, safer and more transparent way

Following a lengthy process going back over two years, on 24 December 2015, Royal Decree No. 1090/2015, regulating clinical trials involving medicinal products was published in the Spanish Official Journal. Said Royal Decree came into force on 13 January 2016 and replaces Royal Decree No. 223/2004 and Order SCO/256/2007. The new Royal Decree seeks, on the one hand, to adapt Spanish legislation to Regulation (EU) No. 536/2014 on clinical trials involving medicinal products and, on the other, to further regulate those aspects which said Regulation leaves in the hands of the national law. According to its preamble, it seeks to “drive and facilitate clinical research with medicinal products in Spain, the creation of knowledge, transparency, the safety of participants and the usefulness of results”. Below, we refer to a number of the new features of this Royal Decree that seek to secure Spain’s position at the forefront of clinical research.

Simplification of the process

The procedure to obtain the authorisation to start a trial, or to make a substantial change to the conditions under which such authorisation is originally granted, have been simplified considerably, in particular for low-intervention clinical trials. The most noteworthy new feature, in addition to a shortening of timescales, is that an opinion need only be sought from one Ethics Committee (now known as Research Ethics Committee) rather than one per participating centre, as had been the case up until now. This change will lead to obvious time savings in the procedure, in addition to a reduction in costs as only one fee shall be paid as part of the assessment of the trial, regardless of whether several Committees are involved in said process.

Importance of the contract

Another important new aspect involves the contract that the sponsor must sign with each centre participating in the trial. Historically, the negotiation and signature of contracts has been a nightmare for sponsors, often leading to delays in starting trials. The Royal Decree seeks to speed up this process by implementing two measures. First, it calls on the competent health authorities to agree on just one valid contract template for the entire National Health System (SNS), the drafting of which is based on the general principles established by the Interterritorial Council of the SNS. And second, it allows for the contract to be executed at any time, and not solely upon authorisation of the trial, as had been the case up until now. In the event that the contract is signed before the trial is authorised, the regulation sets out that the contract will not become effective until authorisation is obtained.

Figure of the sponsor

The contract is particularly important when the sponsor decides to delegate all or part of its duties to a third party, such as a CRO. Thus, special care must be taken to appropriately document which tasks have been delegated and the scope of liabilities must be defined.