Rare case

The government has allowed the import of unregistered drugs into Russia

Russians with rare hereditary diseases, who previously did not have access to vital medications for them, will now be able to be treated and live in peace. The problem of treating a number of serious diseases in our country should be solved by a government decree signed recently by Prime Minister Vladimir Putin regulating the procedure for importing the latest medicines. This document complements the recently adopted law “On the Circulation of Medicines” and removes a number of claims against it put forward by public associations of patients. Now even unregistered drugs can cross the border if authorized by the Ministry of Health and Social Development. Officials will issue the appropriate permit on an individual basis for those patients who cannot be treated with medications available on the domestic market.

Until recently, the issue of drug provision for a small but very severe group of patients was not resolved, although it was discussed, among other things, in the presidential office. There are no definitions of “rare diseases” and “orphan drugs” in Russian legislation; customs and other preferential regulations were not provided for them. There are more than 40 rare pathologies listed in the registries of Western countries; people suffering from them often receive medications prepared individually for them by large pharmaceutical companies. In Russia, at best, they can diagnose half of them, and only seven nosologies are included in the state program for expensive drug provision. Patients with rare diagnoses were simply abandoned by official healthcare; their salvation depended solely on relatives who, by hook or by crook, tried to obtain strictly prescription drugs abroad and brought them at their own peril and risk. The fact that this completely gray segment of the pharmaceutical market is now legalized by a new government decree is a real breakthrough, and doctors, patients, and business analysts are unanimous in their assessments.

In fact, the problem of providing medicines to people with rare diseases in recent years was not so much financial as legislative, and therefore it could only be solved at the level of the government and the president, says David Melik-Huseinov, director of the analytical company Cegedim. According to his calculations, the total need of Russians for orphan drugs is estimated at approximately $2 billion a year; the state currently allocates $1.3 billion for expensive and innovative drugs; the country’s budget will certainly be able to cover the resulting gap. “The new order opens up great prospects for both patients and the market,” Mr. Melik-Guseinov told Vremya Novostei. “Worldwide, the orphan drug market is the fastest growing segment, as the largest pharmaceutical companies promote personalized medicine approaches and are actively working on creating drugs for non-mass demand.”

It is noteworthy that officials promise to issue import permits as soon as possible and not to create any obstacles for patients with rare diseases. “The importation of unregistered drugs for medical reasons, and these are often orphan drugs, is noticeably simplified - the maximum period for reviewing an import application is limited to five working days. An import permit is issued in the form of an electronic document certified by an electronic digital signature. That is, a patient from the region will not need to come to Moscow to submit an application,” noted Tatyana Golikova, head of the Ministry of Health and Social Development, that the new order is focused on the ordinary patient.

In addition to orphan drugs, the new government decree allows the import into Russia without registration of batches of those drugs that are intended for clinical trials or to undergo the registration procedure.

Galina PAPERNAYA