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The authorized executive bodies are discussing a number of important industry initiatives related to determining the interchangeability of drugs, unifying instructions for use, pricing (including calculating the initial (maximum) price of the contract), etc. The adoption of certain decisions can significantly affect the current vector of development of law enforcement. practice.
It remains unclear which regulatory corridor will be fixed to describe the needs of the customer, and how, as a result, these initiatives will affect patient access to treatment. In this regard, we will consider various approaches to describing and justifying the needs of a medical institution using examples of recent proceedings (which could potentially help the expert community in forming their own positions for participation in public discussions).
Relationship with instruction and contract
Previously, in law enforcement practice, an approach has already been formed in relation to the procurement of medicines in primary packaging, compatible with a certain type of medical equipment. Nevertheless, the detailed rationale of the customer, which is found in the decisions of the antimonopoly authority adopted in September 2019, is of interest.
So the Decision of the Yaroslavl OFAS dated September 12, 2019 in the case No. 076/06 / 64-488 / 2019 considers the following situation. In a complaint about the customer’s actions during the auction for the supply of medicines with the Sevofluran INN, the applicant pointed to the unlawfully established requirement for the primary packaging of the drug in terms of its equipping with a special Quik-Fil closure system. In his opinion, the inclusion of this requirement in the procurement documentation led to a limitation in the number of bidders, since a medicine with the INN Sevofluran with this type of vial is produced by a single manufacturer. At the same time, a number of drugs from other manufacturers have a similar therapeutic effect, but due to the lack of primary packaging equipped with a Quik-Fil closure system, they cannot be delivered. The complainant explained
The customer argued that the purchased anesthetic drug is compatible with those transferred to the medical institution under contracts for the free use of medical vaporizers. At the same time, in order to ensure their technical safety, the medical institution undertook not to use any other anesthetics other than those specified in the instructions for this equipment. Otherwise, the equipment supplier has the right to terminate the contract and withdraw it, which can lead to extremely serious consequences for the institution. In this regard, the antimonopoly authority recognized as lawful the inclusion in the auction documentation of the requirements for the primary packaging of a medicinal product in terms of equipping with a special Quik-Fil type capping system.
Vital and Essential Drugs as a Justification of Need
Earlier in practice, decisions have already been made regarding the inclusion of the characteristics of drugs in the auction documentation in accordance with the List of Essential and Essential Medicines. In September 2019, in law enforcement practice, one can see an indirect confirmation of the corresponding approach.
So, the decision of the Voronezh OFAS dated September 11, 2019 in the case No. 036/06 / 33-640 / 2019 describes the following situation. The complaint was filed with the antimonopoly authority because the customer in the documentation for the purchase of drugs with INT Ertapenem indicated a non-alternative requirement for the dosage form - “lyophilisate for the preparation of an injection solution”, which, according to the applicant, limited the number of participants in the purchase, in particular, having the ability to deliver a drug with the specified INN in the dosage form "lyophilisate for the preparation of a solution for intravenous and intramuscular administration."
UFAS found that drugs with INT “Ertapenem” in the dosage form “lyophilisate for solution for injection” are included in the List of Vital and Essential Drugs for 2019, and their dosage form “lyophilisate for solution for intravenous and intramuscular administration” is not on the list. In this regard, it was concluded that when describing the procurement object by the customer, the requirements of the legislation on the contract system were not violated.
Different interchangeability for outpatient and inpatient care
Earlier in practice, there were separate interpretations regarding the possibility of using a different approach to describing the characteristics of drugs purchased for a hospital and for outpatient treatment of patients. In September 2019, you can see similar decisions by the antimonopoly authority.
So, the Decision of the Tatarstan OFAS dated September 25, 2019 in the case No. 016/06 / 33-1539 / 2019 describes the following approach. The customer announced an auction for the supply of drugs with INN Epoetin Beta to provide citizens eligible for state social assistance. One of the market participants appealed to the antimonopoly authority with a complaint that in the description of the procurement object a number of violations of the legislation on the contract system were committed.
The customer explained that the technical task was formed on the basis of the specific needs of state healthcare institutions, taking into account the fact that the purchased drug was intended to provide certain categories of citizens entitled to social support measures, and was intended for use by the patient independently at home.
The antimonopoly authority did not reveal violations of the law in the actions of the customer. In addition, the decision states that the FAS Letter dated April 9, 2014 No. AK / 13610/14 “On the consideration of the appeal on the interchangeability of drugs” provides for a special procedure for describing drugs used by patients outside medical organizations, i.e. not during inpatient care, but on an outpatient basis.
Differences in the instructions for use as a justification for the need
Since the legislation does not establish requirements for the form and content of the justification for needs, the customer in some cases manages to prove the legitimacy of the requirements for the procurement object through a description of the applicable treatment regimens and links to his own medical practice. The validity of this approach is confirmed, among other things, by individual decisions of the antimonopoly body, adopted in September 2019.
So, the Decision of the Novosibirsk OFAS dated September 13, 2019 in the case No. 054/06 / 69-1774 / 2019 contains the following approach. When purchasing medicines with the INN “Human Immunoglobulin Normal”, one of the bidders found that it did not meet the requirements of the auction documentation due to the fact that there was no indicator “symptomatic hypogammaglobulinemia secondary to main disease or treatment ”, the requirements for which were established in the description of the procurement object.
In the complaint to the antimonopoly authority that followed, the applicant noted that the indication in the description of the procurement object of “symptomatic hypogammaglobulinemia secondary to the underlying disease or treatment” was not an indicator to which the drug should have met, but was justification for establishing requirements for a specific dosage . Representatives of the customer explained that the establishment of the requirement for the presence of appropriate indications for use in the section was primarily due to the fact that the customer, as a medical institution, has extensive experience in the use of drugs with this INN and the clear conclusion is made that the number of deaths is significantly lower in cases when a drug was used to treat patients that has, among the indications, “symptomatic hypogammaglobulinemia,
The antimonopoly authority came to the conclusion that the indication in the description of the procurement object for the presence of indicated indications for use was precisely the indicator to which the drugs offered by the procurement participants should have met.
Preferences: when practice creates new mechanisms
In a special way, practice continues to evolve with respect to the confirmation of the right of a procurement participant to apply preferences for local drugs. Similar solutions have already been encountered in practice before. Nevertheless, it is important to note that in the indicated decisions the current regulation is interpreted broadly.
So, the Decision of the Novosibirsk OFAS dated September 20, 2019 in the case No. 054/06 / 14-1818 / 2019 contains the following approach. In a complaint about the customer’s actions during the auction for the supply of medicines with the INN “Meropenem”, the applicant indicated that the preferences for the full-cycle drugs were illegally applied. In particular, according to the State Register of Medicinal Products, the pharmaceutical substances of a medicinal product offered for delivery by the winner of the auction are produced by two manufacturers, one of which is located in China, the other in Russia. Moreover, the complainant pointed to the lack of unambiguous and reliable information on the production of drugs exclusively from pharmaceutical substances of Russian origin.
The antimonopoly authority found that the winner’s application submitted an information letter from a Russian manufacturer stating that in 2019 the corresponding drug proposed for delivery is made from a substance of its own production. In this regard, UFAS concluded that the customer lawfully applied preferences.
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Summarizing the indicated approaches, we can conclude that in practice the interpretation has been established that the current regulation does not establish requirements for the form and content of the rationale for customer needs, which is included in the procurement documentation. As a rule, a medical institution manages to prove the reasonableness and validity of the requirements for the purchased drug through links to the particularities of treatment for specific groups of patients, the provisions of the instructions for the use of drugs, as well as to established medical practice. How the corresponding interpretation will change in the future is not yet predictable. Nevertheless, it is advisable to continue to monitor the development of the law enforcement approach in dynamics. |
