On 17 March the Russian Duma approved the bill on the “Circulation of Drugs” at its second reading. However, the amendment put forward by deputy Nina Astanina (CPRF) about the use of so-called orphan drugs was not passed.  She became interested in these drugs relating to cancer patients after reading a report about a boy in Tomsk suffering from cancer who did not receive treatment in time to save his life. In commenting on the passing of this bill, Ekaterina Chistyakova, director of programmes of the charitable foundation “Grant Life”, stated that in Russia there were no studies or registers classifying diseases as “orphan diseases.” A complex series of measures including research was needed in the legislation to take account of people suffering from rare diseases. Every day patients and their relatives had turned to “Grant Life” with requests to obtain the latest rare drug.  Despite the amendment on orphan drugs not being passed in the bill, the efforts being made were not in vain and representatives of the Ministry of Health and Social Development had started showing an interest in the amendment. It was to be hoped that the ministry and deputies in the Duma would soon include the concept of “orphan” (rare) diseases, allowing people with rare diseases to have access to effective medical treatment, stressed Chistyakova.

(Information Provided by “Grant Life”).  Drugs needed for the treatment of rare diseases – the so-called orphan drugs – have not been made legal in Russia. They are expensive to produce and licence and it is not profitable for pharmaceutical companies in Russia to produce or import such unregistered drugs. In Russia about 5 million people suffer from rare diseases and most of the orphan drugs needed are for treatment of various forms of cancer.  At present patients are most frequently turning to charitable organisations to try to obtain these drugs. In order to obtain officially one of these unregistered drugs in Russia, an application has to be obtained from doctors at one of the federal clinics, which is then passed to the health ministry authority for approval to import it.  Even if approval has been obtained the patient frequently does not know where to purchase the required drug.  In most cases these drugs are regarded as for use in hospitals only and not by private individuals. The volunteers of the charities who have experience in obtaining orphan drugs deal with “tame” pharmacies that are willing to sell hospital drugs on Russian prescriptions.  When importing drugs that are already expensive the volunteers or the patients themselves pay 20% VAT and 10% import duty.