The new rules* for describing medicines in tender documentation for the procurement of drugs by the state and municipal authorities took effect on 1 January 2018. They are aimed at improving the market for public procurement of medicines through the adoption of unified rules for describing the types of drugs needed by the state agencies. The new rules will ensure fair competition in public procurement and improve protection of the interests of patients.

The main requirements for describing drugs in procurement documentation, which were introduced in January 2018, are outlined below. 

The possibility of supplying a drug in an alternative or equivalent dosage

The procurement documentation must indicate the dosage of a drug and the possibility of supplying an equivalent number of the drug in smaller multiple dosages (for example, instead of supplying one tablet with a dosage of 300 mg, it should be possible to supply two tablets of the same drug with a dosage of 150 mg). Multiple equivalent dosages must also be indicated if they give the same therapeutic effect (for example, bottles of 2.5 g, 3 g or 3.5 g).

This change will eliminate certain restrictions on competition. This usually occurs when the author of a tender order indicates only one possible dosage of a drug. Such practices prevent drug suppliers and manufacturers, who do not have the required dosage, but can supply an equivalent amount of the drug in a lower dosage or other dosages that give an identical therapeutic effect, from taking part in such tenders.

In this case, however, the possibility of supplying alternative dosages of a drug should not lead to the division (“breaking down”) of the solid form of a drug. In other words, if a drug’s required therapeutic dose is 150 mg, it is prohibited to purchase this drug at a dosage of 300 mg with the intention of dividing it into two parts for patients. 

The possibility of supplying single-component drugs instead of multicomponent ones

In case of purchases of multicomponent or combined medicines (i.e. drugs that are a combination of two or more active substances), the procurement documentation must provide for the possibility of supplying the equivalent quantity of one-component drugs.

This rule has the same logic as the rule on the multiple dosage requirements. Competition in tenders should not be artificially restricted. Similarly, the patients’ right to receive the necessary therapy as swiftly as possible cannot be compromised by the requirement to supply only a multicomponent drug if the same therapeutic effect can also be achieved by the use of an appropriate combination of single-component drugs.

Stating the remaining shelf life of a drug as a specific period of time rather than as a percentage

From 1 January 2018, the expiration date of a drug must be indicated in absolute units of time (for example, “not earlier than 1 January 2020” or “at least 12 months from the date of signing the contract”), and not in percentages (for example, “not less than 75% of the expiry date set by the manufacturer”).

This change is aimed at determining as precisely as possible the expiration date of drugs by reference to a specific date. Such approach is intended to ensure the protection of patients’ interests and is supported by the regulatory authorities. 

A ban on an unjustified indication of a specific form of a drug

As a general rule, it is forbidden to specify a specific form of a drug (such as “ampoule”, “bottle”, “blister”, etc.) in the tender documentation since this is also considered as a restriction on competition.

However, an exception can be made to this rule, if there is a justified medical reason for the need to indicate a specific form of a drug (for example, a “pre-filled syringe” for administering a drug to a patient).

A prohibition on indicating therapeutically insignificant characteristics of a drug

In order to prevent restrictions on competition in procurement documentation, it is forbidden to indicate therapeutically insignificant characteristics of a drug (for example, the composition of its auxiliary substances, the storage regime of the drug, etc.), except when a proper description of such drugs is objectively impossible without specifying such characteristics.

Comment

It is assumed that the new rules will reduce the number of violations and abuses committed by the authors of tender documentation for procurement of medicines by state agencies. Further, these rules should enable companies that take part in public procurement tenders to more confidently interpret the provisions of the tender terms and, if necessary, challenge any unfair conditions that limit competition. These developments should ultimately lead to an increase in the transparency of the drug procurement market in Russia.

* In Russian