Vaccines
Mușat & Asociații / Romania
Join industry executives in staying informed on the market access and HTA process in Romania.
1. What is the definition of a vaccine in your country?
The Health Law classifies vaccines as immunological medicinal products (any medicinal product consisting of vaccines, toxins, serums or allergenic products).
2. What are the classifications of vaccines in your country?
The in force legislation in Romania does not expressly provide for a definition of vaccines. The Health Law specifies that the notion of vaccines, toxins or serums refer especially to:
- agents used to produce active immunity (g. holeric vaccine, BCG, polio vaccine, variola vaccine);
- agents used to diagnose immune status (g. tuberculin);
- agents used to produce passive immunity (g. smallpox globulin).
3. Describe the pricing process for vaccines in your country (based on their classifications).
The competent authority which approves the prices of prescription-only (Rx) medicines, including vaccines, is the Ministry of Health.
By law, the manufacturer price for Romania should be lower than or (at most) equal to the lowest price of the same medicinal product in 12 (twelve) comparison countries (Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany).
Hence, the price of vaccines should be proposed by the marketing authorisation holder or its representative, by comparison with the prices of such medicinal products in the 12 reference countries.
The price should be approved by the Ministry of Health within 90 days as of receiving the price application dossier and is valid for 1 (one) year.
Further to the approval of the manufacturer price, the maximum wholesale and retail prices are calculated by the Ministry of Health according to a special formula, by considering the maximum applicable wholesale and pharmacy margins set forth by the applicable regulations; the approved prices are published in the national price catalogues.
Every year, the marketing authorisation holders and/or their representatives should submit a price correction dossier with the Ministry of Health for updating the price of each medicine placed on the Romanian market; the updated price will be valid also for 1 (one) year.
4. Describe the reimbursement approval process for vaccines in your country (based on their classifications).
In principle, all medicines could be reimbursed in the Romanian health insurance system pursuant to the same rules applicable to medicinal products in general, if the following conditions are met: (1) they have a valid marketing authorisation; (2) their price for Romania is approved by the Ministry of Health and (3) they are included in the INN Reimbursement List, approved by the Romanian Government based on the health technology assessment (HTA) performed by NAMMD.
If NAMMD issues a favourable HTA decision, the medicines in question should be included in the INN Reimbursement List. Subsequently, NHIH and/or the Ministry of Health will include the medicine in question in the Trade Names Reimbursement List, a list which mentions the trade names and the reimbursement prices for the medicines reimbursed in the national health insurance system and in the national health programs.
5. Other than the clinical studies required, do the data and studies required for the pricing and reimbursement of vaccines differ from that of other drugs?
With regard to pricing, vaccines fall within the category of Rx medicinal products and the appropriate pricing rules shall apply, including the price comparison with the prices approved in the 12 reference countries provided by law. In principle, the same is applicable for the HTA evaluation and for the inclusion in the reimbursement list.
