In Russia the “named patient supply” is used; accordingly the new law “On drug circulation” (articles 47-49) the state-run hospital may adopt a decision about use of the particular drug (not registered in Russia) for a single-patient; then they need to receive the authorization with the Federal Service on Control in Healthcare (Roszdravnadzor) – and after that the drug may be imported officially.
Only state-run hospitals/clinics subordinated to the federal government (so-called “federal healthcare entities”) may adopt decisions for the named patient supply; moreover – not each of the federal hospitals, but only those that are counted to be “specialized” in treatment of a specific group of diseases (i.e. the general-practice federal clinics can’t do this).
Decision for the named patient supply has to be adopted with the consultation board (concilium) of the specialized federal healthcare entity; the decision has to indicate the volume of the drug to be imported.
After that the hospital transfers application to Roszdravnadzor; application documents contain: application form; written agreement of the patient (or his representatives) with the use of the drugs non-registered in Russia; copy of the consultation board’s decision; copy of the quality certificate for the drug (it may be the certificate issued with the drug producer).
Roszdravnadzor has to issue the permission for the named patient supply in 5 working days (it may also decline the application – if any of the required documents has not been provided).
After the federal clinic has a permission with Roszdravnadzor it may buy the drug from the foreign producer (or patient may buy the drug abroad and import it to Russia).
Since 2010 there is no import duty tax for the drugs imported at the named patient supply – however still need to pay 10% VAT at import. The charity funds and the federal clinics ask the government to cancel VAT at all for the named patient supply, but the Finance Ministry protects the tax – and it’s almost zero probability it will be cancelled. The rate for VAT used at the named patient supply is another issue; the case is that the Russian laws apply 10% (reduced) rate only to the “drugs registered in Russia” while drugs imported at the named patient supply are not formally “registered”; thus in many cases the tax office required 18% (regular) VAT rate to be used at named patient supply, not 10% as for the registered drugs; however sometimes they could pay 10%; this issue may be regulated by direct inclusion of the named patient supply in 10% rate.
Few sources of financing are permitted for the named patient supply:
- The specialized federal healthcare entity may buy the drug with own funds (i.e. funds granted with the federal government); it’s a rare thing – because the managers in the state hospitals are usually afraid of the claims in “corruption” when using governmental funds – and thus they prefer to spend money only for “well-known” solutions; however it’s possible – and usually the state controlling agencies are more or less loyal when find this or that federal clinic has spent state money for let’s say cancer drugs
- Patient may finance the drug with own money; in such case the importation of drug is also done with the patient’s relatives or friends
- Charity funds; in such case the importation of drug is usually done with the employees of the charity organizations
The current rules for the named patient supply are valid since Sept 1, 2010; prior to this date the permission process for the named patient supply was much longer (from 30 days) and harder – so only few federal clinics agreed to initiate the processes. However despite the easier procedure since Sept 1, 2010 there were some challenges – for instance they cancelled import duty tax for the named patient supply only since Nov 2010; the process of interaction between the Healthcare Ministry and Federal Custom Service (at named patient supply) was adopted with the government only at Feb 2011; so until Feb 2011 the rules are almost not worked – even in Dec 2010 there were incidents at import of drugs with the charity funds. So in a word – the “named patient supply” schema (in its current – easy – edition) works in Russia only last month, and the doctors still have no any strong experience in its implementation.
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