Government Decision on Medicinal Products for Human Use

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UPDATE (October 31) – The Decision has been published under no. 800/2016 in the Official Gazette no. 869/2016.

On Wednesday, October 26, the Romanian Government adopted the Decision on the approval of the Methodology on the calculation system and approval procedure of the maximum prices of medicinal products for human use authorized for marketing in Romania.

The Government Decision brings more stability and predictability with respect to the economic and legal framework applicable to prescription medicinal products.

To ensure patients’ access to treatment and to avoid a new crisis of medicines, the products for which the patent has expired (off-patent) will become cheaper gradually. Thus, starting with April 1, 2017 the price of medicines whose patent has expired will decrease by 10% in the first year, by another 10% in the second year , and by 15% in third year .

For the rest of the prescription medicinal products the price calculation procedure remains unchanged, relying on the lowest price from a list of 12 European countries.

A second provision of the Government Decision concerns the introduction of a different calculation system for the price of essential medicinal products listed by the World Health Organisation, which are 100% reimbursed in Romania. With this new methodology, the Ministry of Health aims to prevent the disappearance from the market of essential medicinal products. Most of these medicinal products are cheap, over 50% of them having a price below 50 lei. These are medicinal products intended for common diseases, such as heart diseases or cancer. Since these medicinal products are 100% reimbursed, no financial burden will lay on the patients.

The adoption of the Decision comes after the Ministry of Health has organized public debates with all stakeholders. Thus, following public consultation, the Ministry decided to include vaccines and plasma and blood products on the list of essential medicinal products. Both product categories are considered by the World Health Organisation as finished products for which the manufacturing process is extremely difficult. There have already been interruptions in the supply of these products and, therefore, the Ministry of Health considered it essential that patients have access to these products, given that they are intended for a very large population (vaccines) or for critical patients in hospitals (plasma and blood products).

The files related to the new prices will be submitted within 30 days from the adoption of the Government Decision, the process of price correction ending on March 1, 2017 and the prices of medicinal products will come into effect on April 1, 2017.

The full (Romanian language) press release is available here.

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