Spain passes new regulations on clinical trials to increase transparency and simplify procedures

On 4 December 2015, the Spanish Council of Ministers passed a Royal Decree regulating clinical drug trials, drug-research ethics committees (RECs) and the Spanish Clinical Studies Registry in order to put in place criteria to increase transparency and simplify procedures for clinical trials.

The regulations, which went into effect on 12 January, establish that clinical trials may be approved with an evaluation and report from just one accredited ethics committee and the Spanish Agency of Medicines and Medical Devices (AEMPS), where previously they needed authorization from the ethics committees at all the participating hospitals.

In addition to this simplification, there is another change that mainly favors industry-driven studies. The promoter can negotiate approval to conduct a trial with healthcare centers while simultaneously sending documents to the ethics committee and the AEMPS (to evaluate and authorize), which will shorten timelines. However, Asebio has said a single model contract valid at all healthcare centers should be created because hospital bureaucracy tends to draw the process out.

The regulations also affect the make-up of research ethics committees, which from now on must have at least one patient or person representing the best interests of the people taking part in the trial, protecting their rights and wellbeing.

Additionally, the royal decree aims to promote public, non-commercial research by creating a “promoter of non-commercial clinical trials” to incentivize research in areas the pharmaceutical industry ignores, at universities (where there are powerful teams in areas that aren’t priorities for the market) and within the National Health System.

The project’s aim to make the process more transparent can be seen in the regulation of the Spanish Clinical Studies Registry (REec), which is already available online and allows anyone to see which clinical trials have gained authorization in Spain and which centers are participating. All drug trials must appear on this registry, which is also open to any other sort of clinical trial.

Pioneering regulations in Europe

By passing this royal decree, Spain is adapting to the new EU regulations on clinical trials, which will be in force as of May 2016. In fact, Spain was the first to apply the European regulations, which may attract the global pharmaceutical industry.

The European regulations also seek to simplify bureaucracy, in addition to ensuring maximum patient safety and solid, reliable data. This is why one of its initiatives is to create a public database of all information on clinical trials conducted in Europe, except when justified for reasons of confidentiality.

The new regulations on clinical trials were passed by the European Parliament in 2014 but won’t really be put into practice until the European clinical trials portal and database are operational (which is expected for August 2017). The Spanish Clinical Studies Registry has generated some controversy and has been seen as unnecessary if data must be stored on a European level in the long run because it will only duplicate information.

Another registry established by the new Spanish decree will cover rare diseases, in order to create a census of patients with more than 7,000 pathologies currently considered rare diseases. This registry will record the prevalence and incidence rate, becoming a research and analysis tool for studying these diseases, which affect an estimated three million people in Spain.

The Spanish Ministry of Health has highlighted that Spain is competitive in terms of clinical trials, participating in approximately 18% of all studies conducted in the European Union. The AEMPS authorized 820 trials last year and 10% to 15% of these were phase I.