Early access by patients to the necessary treatment and to the most recent medicines is provided by the Amendment to the Act on Medicinal Products, which allowed the first issue of new authorisations for the therapeutic and diagnostic use of unregistered human medicinal products.
The aim of the Department of Health in drafting the amendment to Law No 362/2011 The Z.z. effective from 1 August 2023 was in particular to enable patients to have timely access to medicines that can not only save their lives but especially improve their quality.
The amendment introduced the possibility for granting authorisation for therapeutic or diagnostic use of investigational medicinal products for human use which are the subject of an application for registration for a patient who has not been subject to a clinical trial. The amendment of the law will also allow the Ministry of Health to authorise therapeutic or diagnostic use of the medicinal product within the framework of a treatment programme based on the consent of the State Institute for the Control of Medicinal Products, which is the competent authority in the field of clinical trials on medicinal products for human use.
The Ministry of Health received the first applications to authorise the therapeutic and diagnostic use of a non-registered human medicinal product containing the active substance talkvetamab for patients in the therapeutic indication for the treatment of adult patients with relapsed and refractory multiple myeloma,
Multiple myeloma is a rare malignant disease of haematopoietic formation characterised by overproduction and poor function of plasma blood cells forming in the bone marrow. Excess plasma cells accumulate to form tumors or tumours at different sites of the body, especially in the bone marrow.
The active substance talkvetamab is a bispecific immunoglobulin antibody directed against specific receptors on myeloma cells and specific receptors on T-lymphocyte cells. Its mechanism of action supports increased cytotoxicity mediated by T cells by recruitment T cells, resulting in their activation and subsequent degradation of cells producing specific myeloma receptors.
We consider allowing this medicinal product to be administered from the patient's point of view to be crucial, as all available therapeutic interventions in Slovakia have been exhausted. At the same time, administration of the medicinal product to these patients, depending on their current state of health, may potentially have a positive impact on both their clinical perspective and their quality of life.

The medicinal product containing the active substance talkvetamab is currently the subject of an application which has been positively assessed by the Committee for Medicinal Products for Human Use and is expected to deliver a decision by the European Commission in the near future. The costs of this advanced therapy will be reimbursed to patients from the fund of the future marketing authorisation holder.
Thanks to the amendment of Act No. 362/2011 Coll. on medicinal products and medical devices, Slovakia can approach other Member States of the European Union by a small step in terms of access to new innovative medicines for the treatment of cancer, rare and other serious diseases, where ensuring the timely availability of innovative medicines for patients is the therapeutic standard.