Poland – Medicinal products for the blood and blood-forming organs – BISPECIFIC ANTIBODY mimicking activated factor VIII, together with successive deliveries to Hemophilia and Related Bleeding Disorders Treatment Centers and patients’ homes; procedure reference: ZZP.ZP.411.100.2026

Opportunity description

The subject matter of the contract includes the delivery to Direct Recipients (Hemophilia and Related Bleeding Disorders Treatment Centers) of a bispecific antibody mimicking activated factor VIII together with administration sets—hereinafter the “medicinal product”—in order to ensure continuity of treatment for patients with type A hemophilia complicated by an inhibitor, as part of the implementation of the health policy program of the minister responsible for health entitled “National Program for the Treatment of Patients with Hemophilia and Related Bleeding Disorders for 2024-2028”, hereinafter referred to as the “MZ program”, as well as the delivery of administration sets, the organization of deliveries to patients’ homes, understood as the patient’s place of residence or permanent stay, for the specified number of patients indicated by the National Blood Centre (hereinafter NCK), the collection and disposal of disposable equipment and medical waste, ensuring strict records of the medicinal product delivered, with monitoring of medicine consumption through the implementation of an electronic diary, the development and preparation of informational materials on the safe use of medicinal products for all patients, and the training of all patients in the safe use of the medicinal product no later than the date of the first delivery, as well as the delivery of medical waste containers for all patients that meet the requirements of the applicable regulations, under the terms set out in the SWZ. 1. The subject matter of the contract includes the delivery to Direct Recipients (Hemophilia and Related Bleeding Disorders Treatment Centers) of a bispecific antibody mimicking activated factor VIII together with administration sets—hereinafter the “medicinal product”—in order to ensure continuity of treatment for patients with type A hemophilia complicated by an inhibitor, as part of the implementation of the health policy program of the minister responsible for health entitled “National Program for the Treatment of Patients with Hemophilia and Related Bleeding Disorders for 2024-2028”, hereinafter referred to as the “MZ program”, as well as the delivery of administration sets, the organization of deliveries to patients’ homes, understood as the patient’s place of residence or permanent stay, for the specified number of patients indicated by the National Blood Centre (hereinafter NCK), the collection and disposal of disposable equipment and medical waste, ensuring strict records of the medicinal product delivered, with monitoring of medicine consumption through the implementation of an electronic diary, the development and preparation of informational materials on the safe use of medicinal products for all patients, and the training of all patients in the safe use of the medicinal product no later than the date of the first delivery, as well as the delivery of medical waste containers for all patients that meet the requirements of the applicable regulations, under the terms set out in the SWZ. 2. The health policy program of the minister responsible for health entitled “National Program for the Treatment of Patients with Hemophilia and Related Bleeding Disorders for 2024-2028” includes deliveries in 2026-2027 of the aforementioned medicinal product to Direct Recipients indicated by NCK—Hemophilia and Related Bleeding Disorders Treatment Centers (hereinafter “OLH”) and/or other entities indicated by the National Blood Centre or another authorized entity—and to patients’ homes, understood as the patient’s place of residence or permanent stay. 3. Pursuant to Article 256 of the Pzp Act, the Contracting Authority may cancel the contract award procedure before the deadline for submission of tenders, as applicable, if circumstances arise that render the further conduct of the procedure unjustified. 4. Pursuant to Article 257 of the Pzp Act, the Contracting Authority may cancel the contract award procedure if the public funds that the Contracting Authority intended to allocate to finance all or part of the contract have not been granted to it. 5. The Contracting Authority reserves the right to cancel the procedure or, by 31 December 2027, to withdraw from the contract with ex nunc effect, without compensation payable to the Contractor by the Contracting Authority or the Minister of Health, if at least one of the following conditions occurs: 5.1. The National Blood Centre does not receive financing for the implementation of the health policy program of the Minister of Health entitled “National Program for the Treatment of Patients with Hemophilia and Related Bleeding Disorders for 2024-2028” in the anticipated year of contract performance, either in full or in a portion sufficient to perform the contract. 5.2. The Minister of Health decides not to modify the program, to modify the program, to withdraw from implementation or suspend implementation of the “National Program for the Treatment of Patients with Hemophilia and Related Bleeding Disorders for 2024-2028”, or amends the content of the program in a manner resulting in the removal of the medicinal product that is the subject matter of the contract/agreement. 5.3. The purchase of medicinal products covered by this public contract award procedure, carried out under the “National Program for the Treatment of Patients with Hemophilia and Related Bleeding Disorders by the National Blood Centre for 2024-2028” through the Public Procurement Department at the Ministry of Health, is to be financed from funds for which final confirmation of their allocation will become possible after the financial plan of the National Health Fund has been adopted and approved. In view of the above, the National Blood Centre—as the Contracting Authority/Purchaser—identified in the contract notice concerning this open procedure and/or in the remaining documentation relating to the contract in question, has provided for the possibility of cancelling this public contract award procedure and withdrawing from the contract. The Contracting Authority stipulates that compensation may not be obtained from the National Blood Centre or the Ministry of Health in the event of cancellation of the procedure or withdrawal from the contract, subject to Chapter II point 11 of the SWZ. 6. The subject matter of the contract includes the delivery of the medicinal product specified above, provided that the total volume of the basic purchase for 2026-2027 in the minimum (guaranteed) quantity is 462 000 mg for 85 patients, including the Contracting Authority’s planned purchase in 2026: 154 000 mg, and in 2027: 308 000 mg. 7. The allocation list of Direct Recipients to whom the subject matter of the contract will be delivered will be provided to the Contractor no later than 7 (seven) working days before the scheduled delivery date to the Direct Recipients and, in exceptional cases, no later than 3 (three) days before the scheduled delivery date. 8. The Contracting Authority requires the delivery, for all patients, of medical waste containers that meet the requirements of the applicable regulations. 9. The contract must be performed in accordance with the requirements set out in the SWZ and the Draft Contractual Provisions. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.