The Ministry of Health and the Treasury are Shortening Regulatory Processes for Clinical Trials, and thus Advancing Medicine in Israel
The Ministry of Health and the Treasury are promoting a program to shorten regulatory processes for clinical trials in Israel. The program to shorten the regulation of clinical trials will significantly assist investigators and will advance medical research, thus contributing in the final analysis to patients and to medicine in Israel. The program will also reduce costs for companies, and will contribute to the competitiveness of Israeli companies on the international scene. The program is part of the government’s initiative to encourage growth in the framework of the Arrangements Law.
The program includes a number of main components:
- Shortened timetable for approving clinical trials, so that the process will take no longer than 90 days.
- Enabling the option of submitting applications for clinical trials to hospitals and to the Ministry of Health in parallel (currently, submission can be made only via hospitals).
- Improvement of the Health Ministry’s system for assisting companies in preparation, and in seeing them through the entire process.
- Improvement in transparency, information and communication between companies and sponsors and the Ministry of Health regarding applications that have been submitted.
- Reinforcement of the system of consulting experts, and reinforcement of the regulatory body.
Improving the mechanism for approval of clinical trials in Israel, and bringing it to internationally accepted standards, is expected to increase the number of young Israeli companies performing clinical trials in Israel, improve the ability of these companies to develop, significantly reduce costs and bring about significantly improved competitiveness of life science industries at an international level. This result will maximize the potential value of the developed life sciences industry in Israel, create jobs and increase the income of hospitals. Furthermore, this program is expected to make it easier for multinational companies to set up research and development centers in Israel and to carry out trials, and as mentioned, improve the quality of treatment of patients.
One of the main issues in the development of the life sciences industry is the conduct of clinical trials in order to test various technologies. In Israel, this industry is composed of a unique mix when compared internationally (many young companies, and a high percentage of companies engaged in medical development), which holds potential for much growth. Furthermore, many multinational companies have chosen in the past decade to engage in research and development activity in Israel, thus creating many jobs and contributing income to hospitals to the value of hundreds of millions of shekels per year.
In order to promote this field in Israel, and in order to serve as a magnet for multinational companies, the Ministry of Health and the Treasury set up a think tank which assessed the range of regulatory processes necessary for the approval of clinical trials, assessed the corresponding processes overseas and their characteristics, pinpointed bottlenecks and points at which the process can be advanced, and compiled a plan of operation, the principals of which are being submitted for government approval in the framework of the current Arrangements Law.
The approval and implementation of the program is expected to increase the rate of growth in the number of clinical trials performed in Israel, and to brand Israel as a significant player in the developing international competition in the field of research and development in the life sciences industry. It is also expected that the shortened time for approval of clinical trials, the improved assistance given to companies in preparing and during the process, improved transparency of the process, in parallel with the wooing regulator and the resources allocated to the matter, will increase the chance that Israeli companies will locate their main activities in Israel, thus contribution to the realization of the potential for growth in the field.