Clinical trial results to be publicly available
On September 4, the Verkhovna Rada of Ukraine approved the law on public disclosure of all clinical trial results. The Ministry of Health of Ukraine can now disclose the results of all preclinical studies and clinical trials of medicines. This means that every Ukrainian can now check whether a particular medicine, either purchased in a pharmacy or prescribed by a doctor, is really safe and effective.
In the next 6 months, the Ministry of Health of Ukraine will develop and approve the Procedure for public disclosure of the clinical trial results to make this data available to all Ukrainians. Henceforth, the results of the clinical trials of specific medicines available in the Ukrainian market are to be disclosed to the public.
The Law provides for public sharing of summary data from clinical trials, including the information about therapeutic effects and adverse events. At the meantime, the Ministry of Health of Ukraine will guarantee the protection of personal data of clinical trial participants. Similarly, any information that is considered “commercially confidential” will not be disclosed or made publically available.
Sharing and reporting the results of clinical trials will allow:
- doctors to make informed decisions about which treatments are best and to be confident that they prescribe safe and effective medicines: doctors will not only rely on commercial information about medicines provided directly by manufacturers, but will also have access to non-commercial information sources;
- experts, who form the lists of essential medicines to be procured for taxpayers' money, to be sure that the medicines that have been selected have proven efficacy and safety;
- the public to analyze in detail the decision on registration or procurement of particular medicines and healthcare products.
Patients and doctors around the world agree that researchers have an ethical imperative to make results from all clinical trials publicly available. Patients and the public now have the right to a full access to the results of all trials of treatments in current use. This is a common worldwide practice.
In addition, this is one of the important steps towards bringing the Ukrainian legislation in line with the EU laws and regulations.
The Ministry of Health of Ukraine supports this initiative, as this law will significantly contribute to preventing unfair competition and circulation of medicines with unproven efficacy and safety.