The Ministry of Health published the Regulation on Units Concerning Neuromuscular Diseases (“Regulation“) in the Official Gazette No. 31501 on 4 June 2021. The Regulation sets forth new rules to open units concerning neuromuscular diseases, such as amyotrophic lateral sclerosis (also known as ALS) or spinal muscular atrophy (also known as SMA), in health institutions and the minimum requirements. The Regulation is available here.
Health institutions that intend to operate a unit concerning neuromuscular diseases must meet certain physical measures in accordance with the Regulation. Additionally, these units must employ at least seven employees, including a child or adult neurology specialist, a physical medicine and rehabilitation specialist, a nurse, a psychologist, a social services specialist, a physiotherapist and a secretary.
Establishing a neuromuscular unit at a health institution requires the permission of the Ministry of Health. If the applicant is compliant with the relevant legislation, the applicant will receive a preapproval certificate. Afterward, the applicant must apply for permission to operate from the Ministry of Health. The Ministry of Health will conduct a detailed assessment by rendering visits to the applicant health institution. If the applicant meets all the requirements set by the legislation, the Ministry of Health will grant a certificate indicating its permission to operate. The health institutions that received operating licenses prior to the Regulation’s publication must comply with the Regulation as of 31 December 2021.
The Regulation sets forth the requirements to open and operate a neuromuscular unit in a health institution. Health institutions that intend to open a neuromuscular unit and heath institutions that received an operating license for neuromuscular units must carefully review the Regulation and take the necessary measures to comply.