According to medicine importing companies the sale of unregistered medicines in the Armenian market is stipulated by the high fees of medicine registration. Since the producing organizations are the one to pay for the registration and expertise of medicines they also decide where to export their products.
In this regard the Armenian market is not attractive for producers. Therefore they prefer to sell their products to Georgia out of all the countries of the region because the registration fees are not very high there. If in Armenia the registration of one brand of medicine costs about $2000 in Georgia it costs $400. That’s the reason why there are unregistered medicines in the Armenian market. However, according to the deputy-director of the “Experimental Center of Medicines and Medical Technologies” LTD Albert Sahakyan Armenia is one of the fewest countries in the world that has minimum fees for medicine registration (according to the decision of RA Government the registration of reproduced medicines costs 900.000 AMD, registration of each medicine form is 450.000 AMD and each medicine portion is 250.000 AMD). “Two years ago in Georgia they reduced the cost of medicine registration from $1500 to $400. Now they regret that and if I am not mistaken they increased it again,” says Sahakyan. He mentioned the expertise of the World Health Organization in this field and said that as a rule in those counties where the registration of medicines is not expensive it means that there is no expertise. “We do not increase the cost of registration or expertise on purpose. That is a very complicated and expensive process. Expensive technologies are applied during the expertise. This process is enduring around the worldd. We took the minimum. Maybe in Georgia the registration is lower by $50-60 compared to Armenia. But I can surely say that we carefully survey the medicines,” pledges Sahakyan.
The unregistered medicines sold in our market are mostly called “orphan medicines” in the world. These are the medicines that are necessary, however do not have demand and neither the importers nor the consumers are interested in them. According to Sahakyan the RA Ministry of Healthcare has prepared the list of “orphan medicines” necessary for our republic. 10 different brands of “orphan” medicines have been surveyed and registered on behalf of the state.
The medicine importers are mentioning another fact as well. In contrast to Georgia, where the medicines are registered for a period of 10 years, in Armenia the registration lasts 5 years, which may appall the medicine producers. “Medicine is not the kind of product to just produce and keep producing. Its application and effects must be permanently supervised. In case some effect comes out the producer mentions all those changes in the documentation of the medicine. The bodies, which expertise those medicines, must take those changes into account. All the international documents regarding the medicines must be checked to make sure that inefficient and low-quality medicines are not sold in Armenia,” thinks Sahakyan.
Very often doctors also prescribe unregistered medicines. The doctor doesn’t have a right to prescribe an unregistered medicine for the patient. “We have done surveys among doctors and found out that not all of them apply the registration book of the Ministry while making prescriptions. They must have these register-books because all the new changes and additions are mentioned in the book,” says Sahakyan, whose surveys showed that our doctors most do a favor for the medicines advertised on Russian TV channels without taking into account whether the medicine is registered or not. “Perhaps our registered medicines are much better than what’s advertised on TV. They think what’s advertised is good,” says Sahakyan.
There are about 3538 medicine brands registered in our country. However ointments are not among these medicines (facial scrubs, creams, etc). However the new law draft presented to the NA for discussion includes a provision about the ointments.
“Vaga Farm” against the Ministry of Healthcare of RA
Certain companies dealing with the import of medicine complain about the work done by the “Experimental Center of Medicines and Medical Technologies”. When the brand is imported, it should have the positive expertise of the mentioned company, after which the Ministry of Healthcare gives them an importation license. In particular, “Vaga Farm”, which has the permission of the mentioned companies imported “Biseptol” medicine last year. This year, however, the Ministry doesn’t give “Vaga Farm” a license based on the negative result of the “Experimental Center of Medicines and Medical Technologies”. According to the founding director of “Vaga Farm” Vahe Varsanyan the reason is that certain changes took place on the medicine packets – some letters are added on the pack. “Last year we were allowed to import the same brand with the same design and with the same contents. However this year they don’t let us, claiming that the inscription on the packet doesn’t conform to the “registered sample”. There is nothing about that in the law. The law defines the registered product, not the sample. This is extra bureaucracy”, said the director and informed that they had brought a court suit against the Ministry of Healthcare of RA. On March 9 the suit of “Vaga Farm” against the Ministry will be discussed at the Economic Court. “Although the “Experimental Center of Medicines and Medical Technologies” has given us a negative expertise result the Ministry could oppose that opinion because last year they were the ones, who registered our brand”, said Vahe Varsanyan by blaming the “Experimental Center of Medicines and Medical Technologies” for giving them an incorrect conclusion. “They could give us a negative conclusion due to a few minor things. Meanwhile they didn’t conduct a thorough laboratory expertise of the medicine and the Ministry goes along with whatever they say”, ensured the director.