PA Focus on Pharmaceutical Market June 2024

PA Focus Pharmaceutical Report

This article provides an overview of the latest updates, including new provisions in the Framework Contract for medical assistance, price updates in the Public Catalog, new regulations regarding medicines and food supplements, and upcoming modifications to the legal status of narcotic and psychotropic substances. These developments reflect ongoing efforts to optimize healthcare delivery and ensure better access to essential medicines and treatments for the Romanian population.

Clawback classification for Q1 2024: In early June, an order was published approving the Q1 2024 clawback classification for medicines. This classification outlines the quarterly contributions owed by medicine authorization holders: 25% of the value for type I medicines based on centralized consumption, and 15% for type II medicines.

New therapeutic protocols were introduced or updated for several conditions, including chronic kidney disease, hepatitis delta virus infection, chronic myeloid leukemia, pemphigus vulgaris, breast cancer, non-infectious uveitis, multiple sclerosis, juvenile idiopathic arthritis, and Still’s disease. These protocols guide the prescription and monitoring of treatments provided by physicians under contract with health insurance houses.

New prescription forms for medicines were introduced or updated last month to verify compliance with therapeutic protocols under the social health insurance system and national health programs. New forms were introduced for conditions like relapsed or refractory follicular lymphoma, atypical hemolytic uremic syndrome, paroxysmal nocturnal hemoglobinuria, and chronic hepatitis delta virus infection. Updated forms were provided for psoriatic arthritis, rheumatoid arthritis, immune thrombocytopenia, cystic fibrosis, and spinal muscular atrophy. Additionally, new forms related to therapeutic protocols approved in June were published in early July.

Fees for clinical trials have been established by the Academy of Medical Sciences for opinions issued by the National Bioethics Commission of Medicines and Medical Devices. The fee is EUR 500 for issuing opinions on amendments or notifications for already authorized and ongoing clinical trials, and EUR 1850 for opinions on conducted clinical investigations involving medical devices.

Price updates in CANAMED: Starting July 1, the prices of several medicines were revised, and new prices were introduced through an update of the National Catalog (CANAMED) for medicines authorized for sale in Romania. These changes are mandatory for marketing authorization holders, wholesale distributors, and providers of medical services and medicines in Romania who have contracts with the Ministry of Health, health insurance houses, or county public health departments.

Regulation on marketing authorizations for medicines: Delegated Regulation (EU) 2024/1701, issued by the Commission on March 11, 2024, aims to streamline procedures for more efficient life-cycle management of medicines. It focuses on improving efficiency, reducing the administrative burden on the pharmaceutical industry, and making better use of regulatory authorities’ resources by simplifying the processing of variations. This regulation, published in the Official Journal of the European Union, is an intermediate step towards broader reforms in EU pharmaceutical legislation and will take effect on January 1, 2025.

What to expect in July?

Updated norms for approval and calculation of medicine prices: At the beginning of July, the norms for calculating and approving maximum prices for human-use medicines were updated. These updates include developing a list of critical medicines within 60 days, simplifying the process of correcting medicine prices for 2024, and specifying conditions under which a request to increase maximum medicine prices can be made. Additionally, prices of innovative medicines with an approved manufacturer price over RON 50 that lack a generic/biosimilar/innovative reference price will be corrected, while prices approved in the Public Catalog will not be subject to correction in 2024.

New provisions in the Framework Contract: Starting July 1, new provisions will be introduced in the Framework Contract regulating medical assistance, medicines, and medical devices within the social health insurance system. Following recent decisions and orders, changes include service packages for both insured and uninsured individuals aimed at detecting serious conditions like cancers, chronic hepatitis B and C, and HIV/AIDS in pregnant women. As part of the National Cancer Plan, 120 service packages are dedicated to diagnosing oncological conditions, including psycho-oncological services.

Price updates in the Public Catalog: In July, the maximum prices of several medicines for human use in Romania may be updated. These medicines, which are available exclusively through community pharmacies, local distribution offices, closed-circuit pharmacies, and pharmacies not in contractual relationships with health insurance houses or county public health directorates, could see price changes if a draft order issued by the Ministry of Health last month is published in the Official Gazette.

Regulations regarding medicines and food supplements: The President of Romania has promulgated a law approved by the Chamber of Deputies in June, which includes provisions from GEO no. 88/2023. This law covers hybrid medicines, registration obligations for marketing authorization holders in the National Medicines Verification System, exemptions from quarterly contributions for special needs medicines, redefinition of the legal representative of marketing authorization holders, establishment of the Electronic Health Information Management System, and regulations for food supplements. The law, published in the Official Gazette, also mandates the development of rules for food supplement advertising by the Ministry of Health.

Regulations regarding narcotic and psychotropic substances: The legal status of narcotic and psychotropic substances and preparations may be altered if a Government Emergency Ordinance currently under consultation since May is adopted in July. The ordinance addresses administrative procedures, deadlines, sanctions, and fees, including eliminating distinctions in prescribing medicines containing psychotropic or narcotic substances, bringing medicines containing tramadol, zopiclone, and cinolazepam under national control, and updating fees for authorizations related to the production, manufacturing, storage, trade, intermediation, possession, and distribution of these substances, as well as their destruction.