The ins and outs of regulatory reforms in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for USD 99.
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 methodology for computing the prices of medicinal products;
- the clawback tax, a statutory contribution due by the pharmaceutical companies whose medicines are traded in Romania and borne from the National Sole Social Health Insurance Fund and the Ministry of Health’s budget;
- the health technology assessment for medicinal products;
- the catalogue of medical devices reimbursed in Romania;
- the implementation of the Falsified Medicines Directive;
- the reorganization of NAMMD.
2. When are they likely to come into force?
The legislative changes mentioned above could enter into force in the current year.