Legal & Regulatory > Romania > Regulatory Reforms

1. Are there proposals for reform or significant change to the healthcare system?

The Romanian authorities announced their intention to implement certain changes in the pharmaceutical legislation, including in relation to:

• the new advertising norms for medical devices, which will bring significant changes in connection with the marketing and advertising activities which can be performed in Romania for such products;
• the advertising norms for medicinal products, aiming to align the applicable rules with the latest developments in the technological field;
• the amendment of the current pricing methodology for medicinal products, aiming to improve the pricing methodology for the benefit of both the marketing authorisation holders and the patients;
• the amendment of the legislation on the health technology assessment for medicinal products, based on in depth studies prepared by international financial institutions;
• the conclusion of “early reimbursement access protocols” as mechanisms which allow the marketing authorisation holders or their representatives to temporarily co-fund the patients’ treatment with certain medicines;
• the elaboration of Romania’s critical medicines List;
• the amendment of the legislation regulating the conclusion of cost-volume and cost-volume-result agreements with the NHIH;
• the Ministry of Health’s and the Ministry of Economy’s intention to set up a working group with representatives of main pharmaceutical industry organizations aimed at developing partnerships with the private sector of the pharmaceutical industry and facilitating the access to medicines, including critical medicines;
• national transposition of Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC;
• implementation of projects under the national programme for investments in the infrastructure of hospital institutions.

At European level, the European Commission adopted a proposal for a new Directive and a new Regulation for the revision and replacement of the existing general pharmaceutical legislation, as part of the Pharmaceutical Strategy for Europe.

2. When are they likely to come into force?

The legislative changes mentioned above could enter into force or be further developed in the upcoming period.