Opportunity to foster the development of clinical trials in Ukraine
On May 27, 2020, the European Business Association appealed to the Minister of Health of Ukraine regarding necessary amendments to the basic regulation of clinical trials in Ukraine. Those are amendments to the Order of the Ministry of Health of Ukraine No.690 of September 29, 2009, which is the main document regulating the Procedure for clinical trials of medicines. The EBA member companies, that sponsor clinical trials, have been working on amendments to this crucial legal act for more than a year with the State Expert Center. The public discussion of these amendments is available on the website of the Ministry of Health of Ukraine and currently comes to an end.
For a long time, this basic by-law on clinical trials has remained unchanged, although it needed significant amendments. Most of the provisions to the current document do not meet the modern requirements of the industry and do not ensure the competitiveness of Ukraine as a country for clinical trials. The provisions of the document were often perceived by international sponsors as a barrier to the implementation of projects in Ukraine. Thus, important projects did not come to Ukraine as sponsors chose other countries to conduct their activities.
As a result, Ukraine has lost investments in health care, and patients have lost the opportunity to receive innovative treatment free of charge. It is well known that clinical trials are especially important for patients in cases where traditional treatment no longer works, while other approaches do not yet exist or are not available in the country. Participation in a respective clinical trial is the only chance left for the patient to prevent the illness aggravation, disability, or death is to participate. Furthermore, clinical trials are essential for medical science and physicians’ training.
Since the Ministry of Health has already initiated amendments to the Order, there is currently a chance to improve the regulatory conditions to increase Ukraine’s attractiveness in terms of sponsorship for clinical trials. The increased investments will benefit the medical field, provide many seriously ill patients with innovative treatment, ensure the development of other areas of medicine that have either not been enough studied or not studied at all.
Thus, the European Business Association has appealed to several provisions that need to be improved in the updated version of the Order, as they will influence the final decisions of sponsors. Thus, the EBA Clinical Trials Subcommittee considers it necessary to reduce the time of clinical trials, to introduce electronic submission of documents and electronic document flow between the Ministry of Health and SEC at all stages, to establish clear deadlines for documents at each stage of examination and approval by the Ministry of Health.
At the same time, EBA experts provided other important clarifications and proposals to the draft Order to foster innovation and be able to compete with other countries for a bid to conduct clinical trials. With those proposals considered, there is an opportunity to develop the field of clinical trials in Ukraine at a faster pace.
Therefore, the European Business Association expects the proposals to be included in the latest version of the Order of the Ministry of Health which would enter into force. This would significantly improve Ukraine’s position as a strategic partner for clinical trials.