New ordinance amending the Romanian law on healthcare reform

On 31 August 2021, Ordinance no. 18/2021 (Ordinance) for amending Law no. 95/2006 on healthcare reform was published in the Official Journal of Romania. The Ordinance enters into force in 3 days after its publication in the Official Journal, except for certain particular provisions for which the Ordinance establishes a later date for entry into force.

The main amendments introduced by the Ordinance are summarized below.

1. Transfer of products between healthcare units

Products purchased from funds allocated for national healthcare programs can be transferred between healthcare units in the following situations:

a) The healthcare unit that purchased the products no longer needs them

b) The healthcare unit that purchased the products anticipates that it will not be able to use them before they expire

c) In order to ensure access/ continuity for the diagnosis and /or treatment of the patients

2. Public hospitals may become associated into consortiums

Public hospitals may form consortiums to carry out certain activities in common, such as: investments in infrastructure, acquisitions of medicines, medical devices, sanitary materials or other products.

The conditions for the organization and functioning of the consortiums are to be established through Government decision. The Ordinance provides that the Government decision is to be issued within 60 days.

3. Funding of hospitals based on performance indicators

Public hospitals can receive additional funding from the state budget based on performance indicators and quality of the services offered to patients. This will be implemented as a pilot project for a limited period of 1 year.

The conditions and criteria for granting such additional funds are to be established through Government decision.

4. Transit/ hub for medicines that are not authorized in Romania

Wholesale distribution activities are permitted for medicines that are authorized locally in a Member State, except for sale to pharmacies or other units that can release medicines to the public.

5. Enforcement of the public service obligation

The Ordinance introduces explicit provisions that (i) ANMDMR undertakes the legal measures to ensure that MAH/ local representative of the MAH and the wholesale distributors comply with their public service obligation; (ii) ANMDMR may undertake legal measures to prevent or reduce the medicine deficit.

6. Advertising to medicines for human use

If ANMDMR’s approval is required for an advertising material, disseminating such material without obtaining ANMDMR’s approval can be sanctioned with an administrative fine between RON10,000 and 30,000.

7. Remote sale of medical devices

The Ordinance clarifies that the remote sale of medical devices (including through IT means) requires authorization from ANMDMR.