“An attempt of bringing a batch of potent medicines into Ukraine through the Borispol checkpoint was prevented,” “Medicines for cancer patients, smuggled from Russia, was confiscated by Ukraine’s the Security Service,” “Patients complain about the lack of necessary medicines in drugstores” - such headlines do not cause any surprise in Ukraine, are returned us to that reality.
And if the issue with those medicines that are allowed for import and use on the territory of Ukraine, even if they are not available in some pharmacies, is sometimes solved with a few calls to the government, then the receipt procedure is allowed importing unregistered drugs is somewhat more complicated.
The lack of drugs in Ukraine is a fairly common phenomenon. Ukraine has registered 25-30% fewer drugs (those that are officially imported and approved for use) than the EU countries have. The patients that need exactly those medicines that are still not registered in Ukraine might wait until the state officially registers the needed types of drugs or to bring the necessary drugs from abroad.
Legislative regulation of the import procedure
The issue of importation of medicines is regulated by the Law of Ukraine "On Medicines," as well as the Cabinet of Ministers Decree No. 458 of 05.23.2012 "On the volumes and procedure for the importation of medicines and special baby food."
According to the legislation, medicines registered in Ukraine might be imported into Ukraine if there are a series quality certificate and a license to import medicines in the way established by law.
Unregistered medicines can be imported into Ukraine for:
clinical research, development, and testing;
registration of medicines in Ukraine (samples of drugs in dosage forms);
needs of the anti-terrorist operation in Donbas;
in cases of natural disaster, catastrophe, an epidemic disease in the presence of relevant supporting documents;
treatment of rare (orphan) diseases by the decision of the central executive authority, which ensures the formation of public health policy.
Import options for unregistered drugs
Import of hand luggage;
Import by the individual message of the Ministry of Healthcare;
Import according to a separate decision of the Ministry of Healthcare.
The first and simplest option is to import drugs on your own - in hand luggage (when imported as hand luggage by a patient or his guardians, drugs are not taxed).
Since it is impossible to import unregistered drugs legally for use by patients in large quantities (the perpetrator might be imprisoned for 3 to 7 years), remains a different option - import according to the individual message of the Ministry of Healthcare.
The amount of drugs imported in such a way is also limited by the amount indicated in the prescription. But if you add this amount to the number of imported drugs with your hand luggage, you get a more significant figure for the patient.
Adding the factor of travel costs, the waiting time for the preparation of documents and the permission of the Ministry of Healthcare, the vast majority of patients are simply forced to buy unregistered drugs on the black market.
The third method was determined by the Law of Ukraine "On Medicines" and the Ministry of Healthcare Order No. 237 of 04/26/2011. It allows to import unregistered medicines according to a separate decision of the Ministry of Health, developed exclusively for the treatment of rare (orphan) diseases that are authorized in the established manner to use in the territory of the United States of America or of the Member States of the European Union, irrespective of whether they are registered as medicines by the competent authorities of the US or the EU.
To obtain a decision, the applicant must submit to the Ministry of Healthcare a sufficiently expanded package of documents:
appeal to the Ministry of Health of Ukraine, central or local executive authorities, where information on medicines is provided (name, manufacturer, release form, dosage, the total number of packages, release series number, shelf life);
copies of documents confirming the registration of the medicinal product in the country, from which the drugs come to Ukraine;
copies of a quality certificate issued by the manufacturer for each series indicating the expiration date (at least 6 months at the time of receipt of the medicine);
instructions on the use of the drug with translation into Ukrainian.
Ways to solve the problem
Considering that doctors prescribe unregistered medicines to their patients due to the lack of a Ukrainian analog, and often pharmacies do not dispense such medicines, requiring confirmation of the prescription by a local doctor, there are many challenges, and they require serious decisions.
The state should take care of improving the conditions for patients who import such drugs on their own. The import of such drugs without registration should be facilitated, a register of people should be created. It is important to constantly negotiate with manufacturers because the citizens of the country should not be left alone with their problem.