The Government of Serbia adopted in the beginning of August amendments to the Rulebook on clinical trials of human medicines (“Rulebook on Clinical Trials“), which entered into force on 12 August 2023. There are two significant changes which negatively affect clinical trials in Serbia.
The first amendment relates to the site of a clinical trial, which is now limited to public healthcare institutions. Therefore, clinical trials can no longer be conducted in privately-owned healthcare institutions.
The second amendment excludes phase I clinical trials (phase I, Ia, and Ib) from the Rulebook on Clinical Trials, which means phase I clinical trials can no longer be pursued in Serbia.
New limitations to clinical trials, introduced by the amendments to the Rulebook on Clinical Trials, do not follow from the top legislation on clinical trials, the Medicines and Medical Devices Act (“Medicines Act“). On the contrary, the Medicines Act provided that clinical trials must be conducted in accordance with the Guidelines for Good Clinical Practice, and those Guidelines provide in article 1.30 that a clinical trial may be conducted in a “public or private healthcare institution or multiple healthcare institutions…”.
The amendments are surprising in light of the fact that the Serbian Government has been promoting improvement to the conditions for clinical trials in Serbia in order to attract sponsors. Removal of the possibility to conduct of phase I clinical trials may negatively impact the interest of the sponsors. It is worth noting that such strict limitation is not found within the European Union. Although health and safety concerns are legitimate, other, less restrictive, measures could have been considered, such as stricter conditions for conduct of phase I trials, additional safety measures and reporting obligations.
The reason for exclusion of private healthcare institutions from the possibility to function as sites for clinical trials is unclear, considering that the Healthcare Act provides that healthcare institutions may be established equally as publicly and privately owned on all levels, including general and specialised hospitals. The private healthcare sector has been flourishing in Serbia in the last years. This limitation could decrease access to clinical trials.
It remains to be seen whether the Government will respond to the appeals from the industry to reconsider the changes and consider alternative measures to address the concerns which motivated these amendments.
Pending clinical trials can be completed in line with the provisions which were in force when the clinical trial started.
Photo by Louis Reed on Unsplash
