The new import procedure for unregistered medicines

Pepeliaev Group advises that a new procedure has come into force for obtaining a permission to import unregistered medicines into the Russian Federation.

The Federal Law “On the circulation of medicines” establishes that individuals may import unregistered medicines for personal use. No permission of the Russian Ministry of Health (the “Ministry of Health”) is required for the import of such medicines. Legal entities (medical institutions and wholesale organisations) may import unregistered medicines to organise medical treatment for a specific patient to maintain his/her vital functions. They can do so only with the permission of the Ministry of Health.

These rules have not changed. The procedure has been changed for obtaining permission to import unregistered medicines.

Resolution No. 771 of the Russian Government dated 29 September 2010 established the procedure for obtaining such permission. Resolution No. 853 of the Russian Government dated 1 June 2021 has been regulating this issue since September. This resolution has substantially changed the list of documents required for a permission of the Ministry of Health to be obtained.

According to clause 11(d) of the previous Rules, in order to obtain permission to import an unregistered medicine for it to be applied with a view to organising medical treatment for a specific patient to maintain his/her vital functions, three documents were required:

1. an opinion of the council of physicians of a federal institution...where medical treatment is organised for a specific patient;

2. an application of the authorised executive authority of a constituent entity of the Russian Federation that the unregistered medicine needs to be imported with a view to organising medical treatment for a specific patient to maintain his/her vital functions;

3. a copy of an opinion of the physicians' council of the Russian constituent entity’s institution where medical treatment is organised for such patient, prescribing the unregistered medicine with a view to organising medical treatment to maintain the patient's vital functions. 

Therefore, before 1 September 2021, in addition to a decision of the Federal Council, there was a requirement that, for unregistered medicines to be imported into Russia, a council should be held of the physicians of the medical institution of the Russian constituent entity where the patient was treated.

Since 1 September 2021 this rule has changed. According to clause 6(f) of the Rules, for the purpose of obtaining a “permission document” in this case, the following documents should be submitted:

• ”a copy of the opinion of the medical committee or of the physicians' council of the federal institution...where medical treatment is organised for the patient...that the unregistered medicine has been prescribed to the patient with a view to organising medical treatment for the patient to maintain his/her vital functions…

• or an application of the authorised executive authority of a constituent entity of the Russian Federation that the unregistered medicine needs to be imported with a view to organising medical treatment for a specific patient to maintain his/her vital functions with an enclosed copy of the opinion of the medical committee or of the physicians' council of the Russian constituent entity’s institution where medical treatment is being organised for the patient...that the unregistered medicine has been prescribed to the patient with a view to organising medical treatment for the patient to maintain his/her vital functions...”.

Therefore, since 1 September 2021 if there is a decision of the Federal Council:

• there is no longer any need for the physicians' council of the medical institution of the Russian constituent entity to prescribe the medicine;

• neither there is a need for a consent (application) of the regional authorities to/for the purchase of the medicine.

Therefore, since 1 September 2021 the federal legislature has deprived the regional healthcare authorities of the opportunity to prevent the purchasing at the expense of regional budgets of the medicines prescribed to patients by medical institutions controlled by the federal authorities (the Ministry of Health).   The regional authorities must comply with the prescription issued at the federal level instead of acting at their own discretion.

On the other hand, now regional medical institutions can proceed without federal councils when prescribing unregistered medicines to patients. A decision of the physicians' council or of a medical committee of a regional medical institution is sufficient.

Finally, the form of the physicians' meeting (whether it is a committee or a council) no longer matters. This will make things substantially easier for regional medical institutions that have determined that prescribing an unregistered medicine can help a patient’s vital functions to be maintained.

Indeed, the previous procedure provided for three conditions:

1. a federal council should be held;  

2. a report should be prepared following the physicians' council of the regional medical institution;

3. the regional healthcare authority should prepare an application in order to obtain a permission.

After the permission had been obtained a decision of the medical committee was to be prepared for the purposes of compliance with article 83(2)(7), article 83.1(2)(3) and article 93(1)(28) of the Federal Law “On the contractual system in the area of the procurement of goods, work and services to secure public and municipal needs”.

At present, it is sufficient for a regional medical institution only to convene a medical committee in order to determine that prescribing an unregistered medicine can help a patient’s vital functions to be maintained. A report of this committee can be used both when obtaining permission to import it and when organising procurement.  

What to think about and what to do

Healthcare institutions and authorities responsible for the supply of medicines to patients of the relevant region should adapt the processes tailored to the previous procedure in accordance with the new Procedure.

Charitable foundations and patient organisations assisting patients with exercising the right to be supplied with medicines free of charge should take account of the specified changes when providing assistance to patients.

Pharmaceutical companies that, in accordance with the terms and conditions of procurement, are obliged to obtain permissions to import unregistered medicines should also take into account the changes that have taken place when preparing applications to the Ministry of Health.

Patients whose medical condition and vital functions depend on medicines that are not registered in Russia and that have no registered equivalents should adapt the medicine supply strategy taking into account the changes that have taken place.

All of the parties involved should consider applying the above procedure to the current relationships, for example, in cases when the supply of a medicine is denied owing to the non-compliance with the rules which do not need to be complied with given the new procedure.

Help from your adviser

Pepeliaev Group’s specialists promptly monitor the changes in the legislation on the supply of medicines and healthcare. They are ready to provide any assistance, including with respect to preparing applications to the Ministry of Health, the Russian Federal Service for Surveillance in Healthcare, regional healthcare authorities, or medical institutions, and with respect to adapting processes to the statutory requirements.

Pepeliaev Group’s attorneys provide legal assistance to patients free of charge with respect to disputes relating to the supply of medicines.