For more than a year, the rulebook on clinical studies has been waiting for the approval of the Ministry of Civil Affairs of Bosnia and Herzegovina (MCPBiH).
The Association of Innovative Drug Manufacturers in BiH does not hide their disappointment, stating that the new rulebook is fully compliant with European rules and that they are not clear about what is expected.
The Ministry carried out additional checks related to the compliance of the rulebook with European standards and the valid BiH. legislation, which did not result in significant remarks, so the Association emphasizes that it is time to sign the document and send it to the procedure.
The agency is ready
– The Agency for Medicines and Medical Devices of Bosnia and Herzegovina is fully prepared. There is already a public registry of clinical trials that anyone can see. After the approval of the regulations, the e-portal for clinical trials is ready – says Ana Petrović, director of the Association.
Clinical studies represent an important development opportunity for our country because they bring multiple benefits to the health system, patients and the professional community.
According to Petrović, they are the basis of the development of new drugs and therapies, and Bosnia and Herzegovina still underutilizes their potential.
– We did not recognize the potential and importance of clinical studies for all patients, especially those with rare diseases and diseases that occur in the pediatric age. They are a chance for patients with rare diseases to receive new therapy or to wait for the drug to be registered in Bosnia and Herzegovina, and then to be added to the list, which is another problem because we don’t even have a list of drugs for rare diseases – notes Petrović.
According to the data of the Agency for Medicines and Medical Devices of BiH, in the period from 2023 to 2025, only 65 clinical studies were conducted in BiH, of which 57 were clinical research, while eight were non-interventional studies.
– What we can notice is that the number of clinical studies is decreasing by year, because in 2023 we had 27, and then in 2024 and 19 a year later. This is a problem, because instead of their number increasing, the number is falling in our country, regardless of the fact that we have poor availability of drugs, especially new ones, but also generic ones. Clinical studies can be real clinical research in the sense that the effectiveness of a new drug is questioned, and there are also the so-called non-interventional studies that are conducted after the drug has already been used. In our country, the latter are not carried out in significant numbers, regardless of the fact that they are medicines that are used in the European Union, and are not yet available in Bosnia and Herzegovina – emphasizes Petrović.
We are not part of the big studios
The reason for this, as our interlocutor says, is that in BiH there is still caution towards clinical studies, even though they are part of the progress of modern medicine, treatment of diseases and general care for the population.
– All the medicines we take, whether through a pharmacy or online, should undergo clinical trials or at least post-marketing trials. For the pharmaceutical industry, especially the innovative one, it is important to prove not only the effectiveness, but also the safety of the drug through previous clinical studies. This is exactly what is being done, while new information is obtained through non-interventional studies in terms of how comfortable the patient feels, whether he is comfortable taking the medicine once or twice a day, whether he prefers to have a tablet or a solution… All this contributes to further modifying the therapy into a form that is simpler for the patient – explains Petrović.
He emphasizes that in BiH the procedure itself is long-lasting, because when the Agency approves the study, it goes on to clinical centers, hospitals, where it is additionally approved and confirmed by the ethics committee of that health institution.
On that path, as Petrović says, the clinical study is additionally delayed.
– The complicating factor is that we use, handle and deal with data quite poorly because we do not have patient registers, specific treatment protocols, because every clinical center here has them. All this causes complications that prevent us from being part of large studies – says Petrović.
It should be noted that, due to the low availability of particularly innovative drugs, many patients in Bosnia and Herzegovina have improved their health and extended their lives thanks to clinical studies.
– In this way, patients managed to be treated with the latest therapies. It is also an opportunity for our doctors to be a part of education and serious global teams of doctors in a simple way, without the state or clinical center paying anything. This strengthens the capacities of the health sector. In fact, our biggest problem is that the clinical study is not seen as part of an investment that brings better medicines to patients and the improvement of the health sector, but rather shys away from it – concludes Petrović, reports Factor.
