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New draft law initiatives to tackle medical waste in Romania

On 11 October 2021, the Senate of Romania adopted the following initiatives to tackle medical waste in Romania.

(i) Draft Law on the management of medical waste from the population and the amendment of other legislation (“Draft law on medical waste”) and; 

(ii) Draft Law amending and supplementing Law no. 95/2006 on health care reform (“Draft law for return to pharmacy”), which regulates the obligation to mention warnings for the return of expired medicines.

These draft laws are now pending before the Chamber of Deputies as the decision-making chamber.

1. Draft law on medical waste

This draft law aims to implement a national waste management system for collection and disposal of medical waste from the population, with a view to fulfill Romania's annual objectives regarding the collection and disposal of waste.

Separate from the general waste system under Law 249/2005 on managing packaging and packaging waste (which covers medicine packaging and medicine packaging waste), this new management system would be dedicated to the waste of medicines owned by the population and would ensure proper collection and management in order to eliminate them (such as the medicine, fractions of medicines, active substances, materials or materials of a medicinal nature, as well as primary packaging which cannot be separated from the pharmaceutical substance).

A set of rules and specific obligations are provided by this draft law to various entities; such as manufacturers, retailers, special designated entities appointed to take over responsibility (licensed OIREP), waste holders/population.

Annual targets are set for waste collection and disposal on the market, including pre-established quotas for medicine manufacturers.

New competences and increased powers are set for the Ministry of Health and the Ministry of Environment, respectively the environmental authorities.

The draft law proposes a sanctioning regime for breaches of its provisions: criminal liability and significant administrative fines (up to fines linked to turnover). The sanctioning regime does not establish a clear and predictable set of rules based on which the authorities will assess, evaluate and decide on the application of the fines.

Secondary legislation shall be adopted for the implementation of the above.

2. Draft law for return to pharmacy

This draft law aims to amend Healthcare Law 95/2006 and to ensure that consumers are informed of the need to return expired medicines to pharmacies in order to eliminate them properly.

The summary of product characteristics, any advertising material, primary / secondary packaging for medicines shall include special warnings for the disposal of the packaging and its expired content to be returned to pharmacies (“MEDICAMENTELE EXPIRATE TREBUIE RETURNATE IN FARMACII”). Certain visibility, text size and font requirements shall be observed when such warnings are displayed.

As well, the details on the nature and content of the packaging will be detailed in the summary of product characteristics as per packaging material identification system provided by Annex 3 of Law 249/2005 on managing packaging and packaging waste.

This draft law also includes the obligation of National Audiovisual Council (CNA) to implement rules for advertising and other public interest notices broadcast in line with this draft law.

Tags

regulation, medical waste, romania

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