The world’s largest pharmaceutical manufacturers are even considering withdrawal options from Bosnia and Herzegovina (BiH) due to a new practice of the Agency for Medicines and Medical Devices of BiH.
For almost ten years, the Agency for Medicines and Medical Devices of BiH has applied the “administrative headquarters” practice in the procedure of registration of medicines from foreign manufacturers. This practice was reflected in the fact that domestic companies registered in BiH, which have concluded representation agreements with foreign pharmaceutical companies, have the responsibility, ie the status of the holder of a license for placing foreign medicines on the market.
Foreign pharmaceutical companies mostly operate within larger business groups that have several dozen to several hundred affiliated companies. In such huge systems, the management of marketing authorizations and regulatory activities are implemented by specialized companies called administrative headquarters.
They are called like this because they are specialized for the administrative function, and within the mentioned legal entities there is no factory production of the finished medicine. This is why most companies that are administrative headquarters are not registered for the production of finished medicine.
Ten years ago, the Agency for Medicines and Medical Devices of BiH introduced the practice of administrative headquarters. Thus, in 2011, at the proposal of this Agency, the Ordinance on the procedure and manner of granting a marketing authorization was adopted. This Ordinance, as well as the forms prepared by the Agency itself, undoubtedly determined the category of the administrative headquarter of the manufacturer as separate and different from the manufacturer of the finished medicine. Where does the problem arise?
Now, after a ten-year well-established practice that has functioned without a single known incident, the Agency for Medicines and Medical Devices has begun requiring the administrative headquarters of foreign pharmaceutical manufacturers to submit manufacturing licenses.
Foreign administrative headquarters are located all around the world. They usually do not have factory facilities and manufacturing permits, so they cannot meet the agency’s request.
This has led to a critical situation, and according to the information journalist got, at least some foreign companies are considering withdrawing from BiH. Representatives of foreign companies were not in the mood to discuss this topic. One of the employees who are in charge of relations with the Agency said this:
“Unofficially, there are two reasons for that. The first one is that making public statements is a specially regulated procedure that requires seeking and obtaining internal approvals, which takes time. The second and more serious reason is mistrust of the agency or, to be more clear, the fear of agency reaction. There is an impression that, like other over-bureaucratized administrative organizations in BiH, the agency has become its own purpose and has lost touch with the real world, ” he said.
He points out that, according to the Law on Medicines and Medical Devices of BiH, the main purpose of the agency is the protection and promotion of health by providing quality, safe, and effective medicines. This also includes establishing the availability of such medicinal products in the territory of BiH.
“However, the Agency has a neglectful manner of behavior towards us and I would say towards anyone who does not blindly accept their attitude. More or less, Agency officials openly criticize pharmaceutical companies as profitable organizations. Besides the fact that profit is a normal business purpose, and such criticism of the agency is incomprehensible, it is well known that medicine development costs are included in its price structure. In the context of the development of the Covid vaccine, as the general public knows, medicine development involves the comparative work of several ‘candidates’ for a given medicine. Out of all these processes, only one candidate will be developed into a final product, while others will be stopped at different stages. Meanwhile, all these processes incur costs, ” he stated, Klix.ba writes.