The key issues for the medicines EPR scheme are to: 

• Collect and recover unused medicines safely in order to preserve the environment. Medicines contain active substances (or active ingredients) that can pose an environmental hazard if they are released into the environment or wastewater;
• Prevent and avoid health risks relating to the misuse of medicines (compliance with treatment, management of expiry dates, risks of poisoning, etc.). 

The producers concerned, within the meaning of article L. 541-10 of the Environmental Code, are the marketing authorisation holders (‘exploitants’) of medicines as referred to in point 3 of article R. 5124-2 of the Public Health Code.

A 'marketing authorisation holder' (‘exploitant’) is: “a company or organisation engaged in the marketing (‘exploitation’) of medicines other than the experimental medicines, generators, kits and precursors referred to in point 3 of article L. 4211-1.

Marketing comprises wholesale distribution or supply free of charge, advertising, information activities, pharmacovigilance, batch tracking and, where applicable, batch recall, as well as any corresponding storage operations.

Marketing is undertaken either by the holder of the market authorisation referred to in article L. 5121-8, of the early access authorisation referred to in article L. 5121-12 or of one of the registrations referred to in articles L. 5121-13 and L. 5121-14-1,or, on behalf of the said holder, by another company or organisation, or by both, each in this case undertaking one or more categories of operations constituting the marketing of the medicine or product.”   

The specifications set a target of 70% of unused medicines collected as of 2024.
 

How is the collection rate calculated? 

The collection rate is calculated as the net tonnages of unused medicines collected relative to the estimated annual amount of unused medicines generated.

To calculate the net tonnage collected, the starting point is the gross tonnage of waste from medicines returned to pharmacies by individuals, from which the following are deducted: 

• The mass of the empty Cyclamed collection boxes,
• The mass of the empty primary and secondary packaging, which is outside the scope of unused medicines EPR (because it falls under household packaging EPR),
• The mass of the waste which does not constitute unused medicines (personal hygiene products, veterinary products, etc.). 

Estimating the share of waste other than unused medicines in the collection 

To estimate the share of waste medicines not included in the EPR scheme, the producer responsibility organisation must conduct an annual study to characterise the collection. This characterisation is carried out as follows: 

• Five wholesale distributor sites in different regions are selected,
• Samples of collection boxes are taken from the skips at these wholesale distributors’ premises,
• Sorting and weighing operations are then carried out on about twenty waste categories/sub-categories (packaging by material, waste medicines by type (tablets, syrups, creams, etc.), and other waste types by category (veterinary, personal hygiene products, infectious risk healthcare waste, etc.). 

French regulations 

• Latest accreditation of the Cyclamed producer responsibility organisation: Order of 22 December 2021
• Specifications: Order of 29 October 2021
• Second accreditation of the Cyclamed producer responsibility organisation: Order of 17 December 2015
• First accreditation of the Cyclamed producer responsibility organisation: Order of 25 January 2010
• Organisation of collection and recovery: Article R. 4211-23 to 28 of the Public Health Code (section 7: unused medicines for human use)
• Framework for enforcement of obligations: Decree no. 2009-718 of 17 June 2009
• Legislation establishing the scheme: Article L541-10-1 of the Environmental Code
   

European Union regulation 

• Establishment of a collection system: Directive 2004/27/EC of 31 March 2004 
  Article 127b states that “Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired”. 

The producer responsibility organisation (PRO) for the medicines scheme is CYCLAMED, a non-profit organisation governed by the French law of 1901, all of whose revenues are used for the purposes set out in the accreditation specifications.

The unused medicines EPR scheme is backed by all the actors along the chain:  

• the marketing authorisation holders (producers) of medicines, which contribute financially,  
• the dispensing pharmacies, which collect unused medicines returned by individuals free of charge,  
• the wholesale distributors, which retrieve the boxes of unused medicines during their daily deliveries to the pharmacies,
• the waste-to-energy plants, which incinerate the unused medicines. 

Prevention

In terms of information and awareness-raising, the PRO is required to produce communication resources to inform the public of: 

• the importance of returning medicines that are unused or have expired in order to prevent risks of domestic accidents and risks for the environment and public health;
• the sorting instructions provided for in article  
• L. 541-9-3 of the Environmental Code, and the products that fall outside the scope of the EPR scheme;
• the free take-back of unused medicines by dispensing pharmacies as provided for in article L. 4211-2 of the Public Health Code.
   

Each year the PRO allocates at least 10% of the total amount of the financial contributions it receives to carrying out these information and awareness-raising activities.

The specifications for accreditation also stipulate that the PRO must undertake a study of the possibilities for reusing the containers in which unused medicines are collected.

According to article  

L. 541-10-12 of the AGEC Law, all producers are required to draw up and implement a prevention and ecodesign plan. The PRO Cyclamed is consulting its members and is due to publish a public summary of the prevention and ecodesign actions undertaken by the actors in the medicines EPR scheme
 

Collection

The collection of unused medicines is initiated by individuals first of all, by sorting them correctly (identifying the medicines and separating the cardboard packaging and paper leaflet, which must be disposed of in the yellow waste bin.

Pharmacies collect unused medicines from individuals free of charge.

Wholesale distributors, whose main role is to deliver medicines to pharmacies, also distribute the containers for collecting unused medicines to them free of charge and pick them up once they are full during their daily delivery rounds, ultimately storing them in secure dedicated skips located on their premises.
 

Treatment

Once the unused medicine skips stored on the wholesale distributors’ premises are full, they are taken by specialist transport operators to the nearest waste-to-energy plant for incineration.