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 GBP 75.
1. Are there proposals for reform or significant change to the healthcare system?
The Romanian authorities announced their intention to implement certain
reform or significant change to changes in the pharmaceutical legislation, including in relation to: healthcare system?
- improving the legal framework for telemedicine, to allow healthcare professionals and healthcare providers to provide reimbursed and non-reimbursed medical services at a distance;
- the regulation of new types of managed entry agreements to allow the early access to medicines, so that innovative products will be included faster in the national health insurance system;
- new guidelines on the public procurement of medicines and of medical devices;
- improving the methodology for computing the prices of medicinal products;
- the on-line prescription of medicines;
- the catalogue of medical devices reimbursed in Romania;
2. When are they likely to come into force?
The legislative changes mentioned above could enter into force and be further developed in the upcoming period.