During the pandemic, Grupo Galilea has underwritten most of the clinical trials carried out in Spain for COVID-19 research.
Studies of new treatments or drugs have a testing phase in patients. These tests are known as clinical trials which are carried out to find out the usefulness of the new treatment, whether the effectiveness is greater than other treatments already available, the side effects of the new drug and whether they are greater or lesser than the conventional treatment, whether the benefits outweigh the side effects, in which patients the new treatment is most useful, etc. But what happens if during one of the clinical trials in Spain there are side reactions in the person being tested? Is there any insurance that protects the pharmaceutical company if the patient has an irreversible side effect after undergoing the trial?
First of all, it is important to know that patients who participate in clinical trials in Spain must know beforehand the objectives of the study, its risks and benefits and sign the informed consent in which it is guaranteed that the person has voluntarily expressed his/her intention to participate in the research, after having understood the information given to him/her, aboutthe objectives of the study, the benefits, discomforts, possible risks and alternatives, his/her rights and responsibilities, etc.
In addition, clinical trials must pass through an ethics committee. This committee will verify the scientific and medical interest of the study, the risk/benefit ratio, the conformity with good methodological practices, especially those concerning the sponsor and the principal investigator of the study, and the presence of insurance to compensate the participants in the study in case of damage. However, since 2016, it is no longer mandatory.
The presence of an insurance policy makes it possible to indemnify study participants in the event of damage.
When is insurance not mandatory for clinical trials in Spain?
Insurance in clinical trials that protect the patient is not mandatory on two occasions: when it is a low-intervention clinical trial and when it is non-commercial clinical research.
What does the clinical trials insurance cover?
The existing insurance in clinical trials in Spain consists of a policy that covers damages and losses, as well as the civil liability of the sponsor, researcher, collaborator and center. That is to say, it covers the damages that may be caused to the patient as a consequence of the treatment or drug to be tested and also covers the civil liability of all the professionals involved in the clinical trial. This insurance covers all damages affecting the patient's health after one year from the end of the trial.
Lastly, the indemnity usually guaranteed is around 250,000 euros per person undergoing a clinical trial. However, a maximum insured capital per clinical trial of 2.5 million euros per year may be established.
You may also be interested to know that since the last royal decree came into force, as of May 2016, all clinical trial evaluation procedures are common for all member countries of the European Union.
Si desea recibir más información sobre los seguros para ensayos clínicos acceda aquí: https://www.grupogalilea.com/seguro/ensayos-clinicos/