The new Ordinance #10 of 2009 Amendment Bill



On 6 January 2020, The Ministry of Healthcare (MH) published for a public discussion a new Amendment Bill of Ordinance No 10 of 2009 on the conditions, procedure, mechanism and criteria for payment by the National Health Insurance Fund of medicinal products, medical devices and diet foods for special medical purposes, negotiation of discounts and reimbursement of exceeded amounts through the application of mechanisms which guarantee the predictability and sustainability of NHIF’s budget (“Ordinance No 10”).

According to Ministry’s reasoning accompanying the project, the main purpose of the Bill is to place Ordinance No 10 in compliance with the latest alterations and supplementations of the Health Insurance Act (“HIA”) and the Ordinance on the conditions, rules and order for regulation and registration of medicinal product prices (the “Pricing Ordinance”).

The main changes are, as follows:

Changes to the regime for payment of the medicinal products, for which therapy effect monitoring has been established

  • In accordance with the changes to the HIC, the regime for payment of the medicinal products, for which a contract for therapy effect monitoring has been signed, established in Ordinance No 10, is amended. While before the amendments the Ordinance established that the price of such medicinal products shall be paid only after the therapy result report, according to the new regime the price of such medicinal products will be reimbursed by the National Health insurance Fund (“NHIF”) through the standard procedure, but if ineffectiveness of the therapy has been reported, the received funds shall be returned by Marketing Authorization Hoders (“MAHs”).
  • Everywhere in the Ordinance the phrase “payment after therapy result report” is replaced by “payment, based on the therapy result”. The purpose thereof is to overcome the unclarity, whether it is possible that the respective medicinal product is payed for, even if the therapy proved to be ineffective.
  • The mechanism for therapy effectiveness reporting is established in greater depth:
    • The information about the effect of the therapy with the monitored medicinal product is collected from selected healthcare institutions (the criteria for selection of the healthcare institutions are established in the Pricing Ordinance);
    • The information, collected by the healthcare institutions is processed in a way, suitable for analysis, by the National council for pricing and reimbursement of medicinal products (“NCPRMP”) once every six months;
    • The information, summarized by the NCPRMP, is sent to the NHIF, where it is analyzed by the Commission for medical reports, under Art. 78 (2) of the HIA. The analysis identifies the number of patients, whose therapy with the respective medicinal product in the monitored period proved to be ineffective;
    • Based on the analysis, the NHIF drafts separate notifications to every MAH. Within 10 days from receipt of the respective notification, the MAH must restore to the NHIF the funds received for therapy with medicinal products, which proved ineffective, signing a template protocol, as provided in Ordinance #10. 

Changes to the regulation of contracts for discounts

  • New deadlines in the procedure for negotiation of discounts have been set:
    • For provision of a draft discount contract by the NHIF to the MAHs – within 20 days from the approval of the NHIF resolution, with which the results of the conducted discount negotiations with the MAHs have been summarized (according to the old regulations a commission within the NHIF  had to present the manager of the NHIF with the draft agreement within 10 days from the above mentioned resolution. A deadline for its provision to the MAH’s was not specified);
    • For conclusion of a contract for discounts – until 1 March of the year, to which the former refers (the Ordinance establishes a retroactive effect of the contract – from 1st January of the respective year);
    • In case a discount agreement has not been reached for some or all of the products of a given MAH in the abovementioned term, the respective products will not be reimbursed by the NHIF. The draft project of Ordinance No 10 does not specify whether such delay shall be due to the MAH’s or NHIF’s fault, meaning that even in the case of a delay due to the NHIF, the respective products would not be subject to reimbursement; 
    • It is noted, that in the period from the beginning of the year until the date of conclusion of the discount contract, MAH’s are obliged to provide a discount within the statutory minimum (10%). Although it is not explicitly specified in the Ordinance, taking into account the retroactive effect of the concluded discount agreement, after its conclusion, the discount should be retroactively recalculated and the MAH will be obliged to pay NHIF the difference.
  • New deadlines have been set for the conclusion of discount agreements for medicinal products, belonging to new International Nonproprietary Names (“INN”), which have been included in the Positive Drug List (“PDL”) for the first time in the respective year:
    • Deadlines for conclusion of discount agreements, under Art. 21, para. 1, items 1, 3 and/or 4 of Ordinance No 10:
  • If the latter have been included in the PDL until 30th September of the current year, the negotiation of discounts for these products is carried out together with the negotiation of discounts for all other medicinal products of the MAH;
  • If the products with a new INN are included in the PDL after 30th September of the current year, the negotiation of discounts for these products is carried out separately – from the beginning of the next calendar year. Interim deadlines and deadlines for such negotiations have not been specified, as well as whether this kind of medicinal products are subject to reimbursement, if discount agreements are not concluded until 1st March of the following year.
    • Deadlines for conclusion of discount agreements under Art. 21, para. 2 of Ordinance No 10: within one month as from the submission of a proposal.
  • New deadlines for negotiation of discounts have been set for medicinal products, reimbursed by the NHIF, which as a result of amendments and supplementations of the PDL have become the subject of obligatory centralized negotiation of discounts.
  • Provisions have been added, concerning the discounts for medicinal products which are no longer the sole products in the respective INN group. Within two weeks from the update of the PDL, the MAH shall notify the NHIF, that it intends to terminate the discount agreement regarding this product. Otherwise, it is deemed, that the MAH shall proceed to grant the discount as voluntary. Until that moment, such a clause used to be present in the templates for discount agreements, approved by the NHIF, despite not being provided in the applicable legislation.  

Changes to the Mechanism for guaranteeing predictability and sustainability of NHIF’s budget

  • The Amendment Bill reflects last year’s amendments to the HIA, according to which the specifics of the Mechanism for guaranteeing predictability and sustainability of NHIF’s budget (“The Mechanism”) will no longer be established in the secondary legislation (in Ordinance No 10), but will be annually approved with a decision of the Supervisory Board of the NHIF, to be promulgated in the State Gazette by the manager of the NHIF. It may be disputed whether such act will comply with the applicable requirements under the Statutory Instruments Act and the Administrative Procedure Code.
  • In connection thereto, the Amendment Bill revokes Appendix #10 to Ordinance No 10: “Mechanism for guaranteeing predictability and sustainability of NHIF’s budget”.
  • Ordinance No 10 continues to provide only the procedure for conclusion of contracts for application of the Mechanism and the procedure for return by MAHs of received funds to the NHIF in cases of exceeding of NHIF’s budget:
  • The amendments to the procedure for conclusion of contracts are, as follows:
    • The notifications for commencement of the negotiations for contract conclusion are published on the Internet page of the NHIF within 5 days from the promulgation of the resolution of the Supervisory Board of the NHIF in the State Gazette;
    • The contracts for participation in the Mechanism are to be concluded with the NHIF until 1st March of the year, for which the respective Mechanism is being adopted (this deadline is synchronized with the deadline for conclusion of a contract for discounts. It could be expected that the NHIF will publish a template which covers both contracts’ clauses);
  • The amendments to the procedure for return of reimbursed funds by MAH’s to the NHIF are the following:
    • The content of the NHIF’s reports is laid down in more detail (the aggregate report concerning the various groups of medicinal products, which is published on the webpage of the NHIF every three months, and the individual report with information for the medicinal products of a particular MAH);

The regulation for return of the excess of the reimbursed funds by the MAH is refined. Its logic, however, remains unchanged – the MAH shall restore the full amount of the funds that exceed NHIF’s expenses for medicinal products, laid down in the NHIF Budget Act for the relevant year, after subtraction of NHIF’s unexpected expenses reserve.

For more information, please contact:

Ilya Komarevski, Partner

Philip Kiossev, Senior Associate

This article has an informative purpose and is not representative of detailed legal advice. If you are interested in receiving advice in the context of a certain situation, we can happily assist you. The law firm is not responsible for any harm caused by acts or omissions undertaken due to this text.
©TBK, 2020


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