Through Executive Decree No. 337 issued on January 27, 2022, published in the Official Register (Fourth Supplement) No. 630 of February 1st, 2022, the Law of the National Public Procurement System Regulations (hereinafter the “Regulation”) were amended replacing the Section related to the “ACQUISITION OF PHARMACEUTICALS AND STRATEGIC HEALTH GOODS”. The purpose of this reform is to achieve greater controls, have adequate planning, guarantee the quality of public expenditure, and avoid shortages of health units that are part of the Integral Public Health Network (IPHN).The main aspects of this reform are: 1. In order to select and incorporate the supplier of pharmaceuticals or strategic health goods (hereinafter the “Supplier”) in the electronic catalog of the public procurement portal (hereinafter the “Portal”), the corporate reverse auction procedure will be used. 2. The entities of the IPHN, together with SERCOP, will select the Supplier that will be included in the Portal. The purchase orders will be generated in the Portal for the acquisition of the health goods they require on an independent and periodical manner. 3. Once the selection procedure is completed, SERCOP will award the selected suppliers, with whom it will enter into a framework agreement that gives the supplier the right and obligation to be included in the Portal’s electronic catalog. If the framework agreement is not signed, the selected supplier will be declared as a failed awardee. 4. Once the Supplier is enabled in the Portal, the entities will be able to make direct public purchases by generating the corresponding purchase orders. 5. For the acquisition of pharmaceuticals, it will be necessary that such goods are included in the current National Plan for Basic Medicines, or their acquisition must be authorized according with the provisions issued by the National Health Authority. 6. Procedures for the acquisition of pharmaceuticals and strategic health goods: 6.1. Electronic Catalog: IPHN contracting entities will acquire pharmaceuticals and strategic health goods through this procedure. 6.2. Exceptionally and in accordance with the provisions of the Regulation, acquisitions may be done through the following procedures: 6.2.1. Institutional Reverse Auction, as long as the pharmaceuticals or strategic health goods are not available in the electronic catalog under centralized acquisition models. 6.2.2. Single Supplier of Pharmaceuticals when the manufacturer or supplier is unique in the market and provided that it is not available in the electronic catalog. This will be verified through a market study. 6.2.3. Acquisition through international organizations or agreements as long as their acquisition optimizes public procurement, guaranteeing the quality, safety and efficacy of pharmaceuticals and strategic health goods to be acquired. 6.2.4. Direct import when special medications are required for specialized treatments that are not included in the Portal’s electronic catalog. 6.2.5. For the cases foreseen above, if there are no established procedures for the acquisition, it will proceed in accordance with the legal regulations of the country in which the pharmaceuticals or strategic health goods are contracted, or the commercial practices or business models of international application; or, failing that, respective procedural agreements will be previously subscribed under centralized procurement models. 7. IPHN procuring entities should perform adequate planning processes for the acquisitions. 8. Acquisitions will be subject to quality, safety, efficacy, technical data sheets, random post-registration controls, in the places of manufacture, storage, transportation, distribution and traceability. The traceability system will consist of the individual and unequivocal identification of each unit of pharmaceuticals or strategic health goods to be delivered, which will allow monitoring throughout the entire distribution chain. 9. In order to carry out selection procedures for corporate purchase, an Inter-institutional Committee will be formed composed of the highest authorities or delegates of the SERCOP, Ministry of Public Health, IESS, ISSFA and ISSPN. 10. All entities, public or private, that participate in the execution of the Decree must ensure the protection and confidentiality of patient data. 11. When the Supplier does not comply with the purchase orders for pharmaceuticals and strategic health goods generated in the electronic catalog tool by the IPHN entities, the values derived from the execution of the guarantees will be deposited in the SERCOP account to be distributed among the health subsystems of the IPHN. 12. All medical devices, supplies or goods that currently appear in the catalogs of standardized goods and services, and that could be declared strategic health goods, must maintain this category until the termination of the respective framework agreements. 13. Until the SERCOP signs the framework agreements with the Suppliers for the acquisition of medicines and strategic health goods whose reference budget does not exceed the coefficient of 0.0000002 of the initial State budget (US$7,099.68), the contracting entities of the IPHN may carry out low value procedures if it is not possible to use any of the procedures established in the Law of the National Public Procurement System on a timely manner. 14. Until SERCOP, together with the Interinstitutional Committee, carries out the process of cataloguing medicines and strategic health goods, the IPHN contracting entities may acquire them through the exceptional processes established in the Regulation through centralized or decentralized acquisitions, guaranteeing the supply of these products.
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