Affordability of Unregistered Medicines to the Patients for Vital Indications


A new video is related to the legal procedures for import, funding, and usage of unregistered medicines in Russia and provides a brief overview of the applicable regulations, court practice and ethical guidelines.

Pharmaceutical products and therapies which do not hold a marketing authorization certificate in the Russian Federation may be prescribed to a patient for the vitally necessary treatment (further – the Vital Indications) and imported into the Russian Federation under an import permit, issued by the responsible Ministry of Healthcare department. The relevant procedure is described in details in the Federal Law “On Circulation of Medicines”, various sublegal acts and is aimed to provide patients with unmet medical needs a legal and ethical route to access therapeutic cures despite their lack of regulatory approval for commercial sales in the Russian Federation.

Unregistered medicines are prescribed to a patient on the basis of Vital Indications confirmed by a board of healthcare professionals (called the medical concilium) from a specialized federal level medical institution (e.g. federal level hospital). Such federal level medical institutions usually have the necessary expertise to make the opinion that no alternative therapy exists for the patient and that an unregistered medicine would be the best standard of care.

The access to unregistered medicines may be funded through: (i) budgetary funds; and / or (ii) charitable foundations. A patient may also fund the relevant medicine from his (her) personal resources.

Pharmaceutical companies and their representing partners may conduct educational and scientific activities targeted to raise disease awareness including treatment methods. All activities must be non-promotional and based on publicly available scientific data, preferably peer-reviewed, and targeted only to a healthcare professional and within his or her practice and expertise.