On October 11 2021, the Senate, as the first chamber of the Parliament, adopted Law No. 353 on the management of pharmaceutical waste from the population.
The explanatory memorandum states the reasons behind the initiative of this law project, namely the protection of the environment from pollution caused by medicine waste and the subsequent need for prompt regulation of the medicine waste found in the possession of the population regime as a result of expiry, packaging damage, withdrawal from the market by the manufacturer etc., as their improper decomposition seriously affects wildlife and human health.
In the context of this legislative project, “waste from the general public” means “by-products, fractions of products, substances, materials of medicinal nature, as well as primary packaging which cannot be separated from the pharmaceutical substance, which the holder, being a natural person, wishes to return to the collection point for disposal”.
According to the law, the duty bearers for the management of pharmaceutical waste from the population are the medicine manufacturers, importers and, where applicable, the extended producer responsibility implementation organisations (“OIREP”). The OIREPs will be able to operate after receiving approval from a Commission. The composition and functioning of the forementioned Commission will be regulated by the Ministry of Environment, Water and Forests.
Their obligations include:
– the obligation to register with the Environmental Fund Administration (AFM);
– the obligation to report monthly, on the basis of supporting documents, to the Political Directorate for Medicine, a quantitative record of both the pharmaceutical substances collected and disposed of, along with the quantity of the packaging;
– the obligation to bear the costs of managing medicine waste from the population.
The main obligations for outlets that market pharmaceutical products to final consumers (community pharmacies, drugstores, etc.) are:
– to conclude waste management contracts with authorised economic operators;
– to ensure that the general public can dispose the waste in dedicated containers free of charge and without being asked for any personal data;
– to keep a monthly record of the quantity of waste collected and handed over for disposal and to report the data to the control authority, i.e. the Environmental Fund Administration;
– to inform the public about the availability of take-back and disposal of pharmaceutical substances.
Unlike OIREPs, the outlets selling pharmaceutical products to final consumers are not considered collectors within the meaning of Law 211/2011 on the waste regime and have no additional licensing obligation.
Expected performance targets as a result of future implementation are listed:
– by 2021 – 10% of the weight of the pharmaceutical substance placed on the market in the previous year;
– for 2022 – 20% of the weight of the pharmaceutical substance placed on the market in the previous year;
– from 2023 onwards – a percentage calculated by the Ministry of the Environment, Water and Forests, at the latest by 15 September 2022, but not less than 20% of the weight of the pharmaceutical substance placed on the market in the previous year.
Regarding penalties, the bearers of the obligation of managing pharmaceutical waste from the population will have to pay an annual contribution of 30 RON/kg for waste that has not been properly collected and disposed of. If the manufacturer delegates the obligation to an OIREP and the OIREP eventually enters insolvency proceedings, this obligation is re-imposed on the manufacturer.
According to the law, failure of the manufacturers/importers/OIREPs to fulfil their obligation to register with the Environmental Fund Administration is an offence and is punishable by law. Also, certain contraventions (e.g. failure to keep records) are punishable by a fine of up to 1% of the total turnover in the financial year preceding the sanction.
We will be back with further information when the law is published in the Official Monitor – bnt Gilescu, Văleanu & Partenerii team