European regulatory landscape for nonprofit studies
Nonprofit clinical research is represented by those studies without a lucrative aim, which collected data are not used for commercial and industrial development purposes. In Europe, nonprofit clinical trials represent the 40% of conducted trials. Conversely, profit studies are conceived for an economic purpose by the pharmaceutical industry, which owns the property of the study data and results, generally used for industrial development and business purposes. The nonprofit trials are promoted by public or private research organizations, hospitals, autonomous investigators and not by the pharmaceutical industry, and are aimed to the improvement of clinical practice. Results and data obtained from this type of investigations will not be used for profit, but conclusions derived from data will be used for the implementation of practice, diagnostics and therapeutic strategies.
In a nonprofit study, the promoter and the investigators do not own the investigational drug or device patent and will not have any business relations with the company that produces the drug or device. A statement that excludes any conflict of interest in the conduction of the trial must be provided by all the investigators, before the initiation of the trial. The promoter (generally the institution where the trial is held) retains the ownership of collected data, is responsible for carrying out the experimentation and scientific divulgation of results, through reports, academic publications and congresses.
In recent years, several changes to the regulatory path were provided by the Authority. Firstly, with the European Directive 2001/20/EC, and then with the current European regulation on the clinical trial of medicines for human use of the EU Regulation n.536/2014, 16th of April 2014. In the latter, nonprofit studies have gained a number of advantages, either for interventional or observational design. The observational studies on pathologies, the observational studies on drugs already on the market and the clinical trials at a low level of intervention are subject to a reduced or no fee for the evaluation of the protocols by the Ethics Committee and are not subject to the local drug Authority (e.g. MHRA in the United Kingdom, AIFA in Italy) submission fee. Moreover, the promoter does not pay the insurance costs and compensations for possible damages to the subjects included in the trial. These compensations are generally covered by the insurance of the research institute.
For interventional studies, with drugs or devices at a new indication (not in accordance with marketing authorization) or not previously approved, the promoter will have to pay the insurance, but not the submission fee, if the nonprofit promoter retains the ownership of data. A further economic advantage of the nonprofit studies concerns the cost of the investigational medical product. The drugs or devices used in a nonprofit trial, which are expected to be paid by the National Health Service, continue to be paid as expected and the patient or the promoter are not charged of any cost.
In some of the European Countries (i.e. Italy, ex Legislative Decree no. 52/2019), it has been defined that the data and results collected in nonprofit studies can be transferred to other industrial entities for registration and regulatory purposes. In these cases, the promoter is expected to reimburse all the expenses and pay previously unpaid fees for the initial qualification of the study as a nonprofit study.