By Gordana Basovic

Unregistered, smuggled medicines problem, mostly common in developing countries, is also obvious in the most developed world states primarily because of unregulated medicines trade via Internet that does not require prescription. However, it is virtually impossible in the EU countries` pharmacies to find an unregistered medication, which has been the case in every other pharmacy in Serbia for years. Besides, it is impossible for doctors to prescribe regularly the medication being still aware it has not been registered in the Medicines and Medical Devices Agency of Serbia. This means the only way it gets onto the market is - smuggling.

Medicine Utrogestan that is used in the cases of extracorporeal insemination and pregnancy observation, although not registered has been one of the most recommended medications for several years now. It is being sold in almost every pharmacy in the country where, upon asking for it, you are regularly questioned who are you buying it for, who has recommended it and at which clinic and then the excuse comes for the absence of receipt since the medication is unregistered. Another possibility is for your doctor to direct you to the certain pharmacy and a person to ask for and in that case - there are no questions asked. And this cycle has been turning around for years. Another question - whether the medicine is the original one or not - belongs to the domain of luck.

We have asked several questions regarding Utrogestan - so frequently prescribed and claimed by doctors the best for the mentioned conditions. Why it was not listed and how it could be possible for a medicine to be prescribed, even at public clinics where extracorporeal insemination is free of charge, and in whose favour goes the whole situation. Our questions remained unanswered.

After several days of waiting, the only one answer that has come from the Health Ministry of Serbia, precisely from Ruzica Nikolic, Deputy Minister for Medicines and Medical Devices, was regarding the inspection authorities` work.

According to her, Ministry of Health inspectors for medicines and medical devices, in accordance with authorities granted by the Medicines and Medical Devices Law and the Public Health Law, regularly check pharmacies for possible unregistered medicines and medical devices.

"Besides regular supervision we organise periodically targeted extra control of unregistered medications and medical devices sale. During one extra control, organised at the end of 2006 with the Ministry of Interior Affairs inspectors, we checked 20 Belgrade pharmacies. Violation charges were brought against those pharmacies that were selling Utrogestan and by the inspector`s decision, the sale of that medicine was forbidden. At the end of 2007, we carried out extra supervision of pharmacies on the whole territory of Serbia. Violation charges were brought against pharmacies selling unregistered Utrogestan and by the inspector`s decision the sale of that medicine was forbidden", claims Ruzica Nikolic adding inspectors for medicines react upon every notification on unregistered medicines sale addressed to the Ministry of Health.

It is up to us to decide whether this official explanation regarding the inspection officials` work reflects actual situation since there is no answer why the medicine is still on the market and prescribed by the public clinics doctors who perform extracorporeal insemination free of charge. One should not be an economics expert to calculate enormous earnings having in mind every fifth Serbian couple has sterility problem. In addition to this, women included in the extracorporeal insemination programme must use Utrogestan for at least 15 days and one pack, the price of which is 850 dinars, can last three to four days. In the case of pregnancy observation, women take this medicine for months.

Aleksandar Tucovic, the Medicines and Medical Devices Agency of Serbia spokesman says that every producer of domestic or imported medicines has the obligation to submit every medicine or series for control in the Agency.

"According to the Serbian legal procedure every medicine entering the country has to be declared and registered with the Agency. Until now, nobody has asked for Utrogestan to be registered. Actual situation in pharmacies is the Ministry of Health inspection domain. According to law, the Agency is not authorised to follow further sale of medicines that are being sold in pharmacies. The Agency has no insight into the medications quality sold in pharmacies. It only controls and registers medicines after which they get certificate. Upon this the Agency is not responsible any more", explains Mr. Tucovic.

The key point in the EU citizens` treatment is guaranteed access to medications at acceptable prices, and assurance medications are safe and efficient. They also should be well informed in order to make decisions based on information regarding their best and high quality treatment.

Aiming to fulfil its goal to authorise and follow up medical products available on the market, the EU has founded the European Medicines Agency. Its purpose is to provide the member states with best advice regarding quality, safety and efficiency of medical products. Although even the EU has not yet managed to win the war with medicine smugglers, it is not possible to buy almost regularly unregistered medicine in pharmacies of Barcelona, Berlin or Krakow.