Draft Law “On amending and supplementing the Law no. 105/2014 ‘On medicinal products and pharmaceutical service”

On 04.11.2022, the Ministry of Health and Social Protection submitted to the Parliament the draft law “On amending and supplementing the Law no. 105/2014 ‘On medicinal products and pharmaceutical service’, as amended (“Draft Law”).

The provisions of this Draft Law are partially harmonized with the Directive 2001/83/EC of the European Parliament and of the Council of 06 November 2001 on the Community code relating to medicinal products for human use.

The Draft Law provides for the increase of services in the pharmaceutical market aiming to provide a better environment for assuring patient safety as well as guaranteeing the supply of safe and efficient medicines.

Among others, the Draft Law introduces a new concept with regard to “Managed Entry Agreements” (MEAs). MEAs are a set of instruments to facilitate access to new medicines. They are defined as agreements between the ministry responsible for health and the pharmaceutical companies for originator drugs, within the period for which the molecule (INN) is protected by an international patent, in order to increase access to specific therapeutic treatments and guaranteeing cost/efficiency.

Types and procedures of special agreements (MEA) will be approved by Decision of the Council of Ministers.

The proposed provisions on this Draft Law affect citizens, businesses in the pharmaceutical field, National Agency for Medicinal Products and Medicinal Devices, Compulsory Health Care Insurance Fund and State Budget. 

Impact on citizens

New pharmacies shall be opened in geographical areas where there are not enough pharmacies. The lack of necessary drugs will be filled, and the quality of pharmaceutical service is expected to be increased. Cure opportunities with innovative/rare drugs for patients with special diseases will be covered 100% by the state budget.

Impact on businesses operating in the pharmaceutical industry

The provisions of the Draft Law encourage pharmaceutical businesses to be licensed as Local Trade Authorization Holders, reducing their operating costs so that the pharmacovigilance system can be maintained by them. The process of preparing magistral and officinal formula will be under persistent control according to the certification criteria determined by the National Agency for Medicinal Products and Medicinal Devices. The authorization for the marketing of semi-finished products aims to stimulate the interest of pharmaceutical businesses to enter the market by offering one or several of the drug production processes. Through the proposed amendments, the number of new pharmaceutical businesses is expected to be increased by 5%.

This law enters into force 15 days after the publication in the Official Gazette. The rules for the holder of the local trade authorization enter into force 24 months after the publication.