Resolution No. 27/2022 of the National Ministry of Health: approval of the list of active ingredients and establishment of reference prices.
Healthcare & Life Sciences Department Report | Resolution No. 27/2022 of the National Ministry of Health: approval of the list of active ingredients and establishment of reference prices.
Dear Sir or Madam,
On January 7, 2022, the National Ministry of Health issued Resolution No. 27/2022 published on January 10, 2022, in the Official Gazette (the “Resolution”), by means of which, as the most relevant point, a list of active ingredients was approved for which reference prices shall be established according to certain calculations determined by the Resolution.
In line with Resolution No. 2949/2021 of the Ministry of Health – which approved the “Plan for the Development of Pharmaceutical Services in Primary Health Care” and Law No. 25,649 – which promotes the use of drugs by their generic name and establishes that all prescriptions and/or medical or dental prescriptions must be made expressing the generic name of the drug -, the Resolution aims at “guaranteeing” the free choice of the drug by the users and the access to all available pharmaceutical products.
Please find below an executive summary of the Resolution:
• Health Insurance Agents registered in the National Registry of Social Works (RNOS) and entities registered in the National Registry of Prepaid Medicine Entities (RNEMP) must cover all commercial presentations included in the National Drug Vademecum (VNM by its acronym in Spanish) published by the National Administration of Medicines, Food and Medical Technology (“ANMAT”), of the drugs listed in the following appendix (the “Covered Drugs”), without any limitation by brand and/or commercial presentation.
• A list of the active ingredients for which reference prices must be established (the “Active Ingredients”) was approved. The list of these Active Ingredients can be found in Annex I of the Resolution.
• The reference price (the “Reference Price”) will be estimated through an average of the retail selling prices (“RRP”) weighted by the quantities demanded of each product; the weights corresponding to the RRP will be estimated through the shares of the last available semester. The RRP for the estimation will be obtained from the VNM and the latest available published price will be used.
• The fixed amount to be covered for drugs containing the Active Ingredients is set at 70% of the Reference Price:
(i) those drugs containing the Active Ingredients whose RRP, as consigned in the VNM, is lower than the Reference Price, will be covered as follows: (a) 70% of the Reference Price by the financing agent (e.g. social security or prepaid medicine entity) and (a) 30% of the RRP by the affiliate.
(ii) in the event that the RRP is equal to or lower than the Reference Price, 70% of the Reference Price shall be covered by the financing agent (e.g. social security or prepaid medicine entity), and the difference shall be paid by the affiliate until the RRP is covered.
• The Reference Prices will be updated on a monthly basis according to the percentage increase of the simple average of the wage index and the consumer price index prepared by INDEC, in each case the latest available.
• The Reference Price will be published monthly on the Ministry of Health website, as well as the modifications that may have occurred in terms of additions and deletions of commercial presentations and the price variations that were considered for the update of the Reference Prices.
• All the active principles destined to treatments of prevalent chronic pathologies included in the Covered Drugs, may be prescribed in sufficient quantity to cover up to a maximum of THREE (3) months of treatment, according to the prescribing professional’s indication.
• The progressive incorporation of pharmacies shall be encouraged in order to guarantee the availability of medicines to each beneficiary in establishments close to their respective places of residence.
• A single prescription model shall be established, of mandatory use for the prescription of medicines, in paper, electronic and digital format, which shall contain the following minimum contents: i) Univocal identification of the patient, ii) Univocal identification of the medicine prescribed by generic name, iii) Date of preparation, and iv) Effective date of the prescription, which may be the same or later than the date of preparation.
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