Treatment of severe diseases such as cancer requires timely availability of safe and efficient drugs.
However, the journey from the moment the drug appears on the market to its availability to patients in the public health system of Bosnia and Herzegovina is often debt and complicated. The registration process, price determinations and listings often faces bureaucratic and financial obstacles.
About these challenges, as well as the phenomenon of the so-called Uncomparable biological drugs (NCB), in the show, the new day were spoken by representatives of the BiH Medicine Agency, Arijana Omanović-Goković, Pharmaceutical Inspector, and Sabina Bećirović, Expert Advisor for Quality Assurance.
How does the drug come to the patient?
Sabina Bećirović explains that the proceedings begins with the request of the MP of the European Medicine for His Imports in BiH. This is followed by check and evaluation by the Agency, and then the Commissions composed of domestic experts, including doctors, but also pharmacists.
“It is necessary for a European remedy to request a request for the import of this medicine. Then the medication goes to the Commission consisting of experts from BiH. We are accepting professional evaluations and revise the reports of the EU. The legal procedure lasts 210 days,” Bećirović explains.
According to her, certain medications never come to the BiH market because there is no interest of representatives or a wholesale. To import them.
“We do not know whether it is due to the financial interest. We accept each requirement. We are sensitive to rare and severe diseases. After the approval of the price, which is being formed on the basis of the reference regulations,” Bećirović adds.
Why are medications in BiH more expensive?
Arijana Omanović-Goković points out that the Agency determines the maximum price of the drug, while the minimum price is not prescribed.
“There is always negotiating proceedings and manufacturers must not set a price greater than that determined by the Agency. The maximum price is determined according to the precise methodology. Oncological therapies are extremely expensive and patients should not bear their own costs,” Omanović-Goković emphasizes.
For patients whose drug is not currently available, there is a legal mechanism for the waiting list, and the wholesale market then submits the request to the competent entity ministries.
Strict regulations and restrictions
Bećirović adds that the agency is strictly managed by medicinal regulations, not practice.
“We have a new rulebook for adoption. It is not a matter of whether we believe in the EU medications, they undergo an accelerated verification, but it still needs to be controlled,” says Bećirović.
It also points out that the European Union cannot register a drug that is not originating from the EU, and to set a high scale when it comes to standards.
NCB Drug phenomenon
When it comes to uncomparable biological drugs (NCB), Omanović-Goković states that the procedure leads the Sector for Medicine Agency, with the engagement of external experts in case of innovative drugs.
“After the evaluation, the medicine goes to the Agency Commission. I currently have no information that there are NCB medications in BiH,” Omanovic-Goković said.
Bećirović reveals that one such drug is analyzed and approved after satisfying all prescribed standards.
“We did an analysis of one medicine, I think it was the first series, the manufacturer harmonized all the guidelines and the Commission established that the medicine is met by oncological patients, although we do not know exactly his name,” Bećirović said.
He adds that a large number of registered medications are formally exists, but it is not in the market.
Priority: patient security
Omanović-Goković emphasizes that the most important thing is for the patient to receive a drug that is examined and registered.
“Markets from the EU market may not apply to us at all, as the manufacturer, to register a drug in the EU, must intend to put it on the EU market,” Omanović-Goković concludes.
