FOI on Directive 2004/27/EC (relating to medicinal products for human use)

Directive 2004/27/EC (relating to medicinal products for human use) introduces an obligation for Member States to implement appropriate collection schemes for unused pharmaceutical products. It is designed to reduce the volumes of medicines flushed into water supply.

However, the Directive does not appear provide any guidelines on implementation of schemes

eg “specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place”

The Irish programme is/was called the “Dispose of Unused Medicines Properly” (DUMP) Programme and is designed to prevent disposal of unused medicines into drains and waterways

FOI submitted to HSE on Monday 18 October 2021 to request any information of the existence, scope, scale and funding for the HSE programme for ‘take back’ of medicines at Irish pharmacies

HSE confirm that they do not operate a Programme for the “take back” of medicines at Irish Pharmacies

Follow on FOI to EU

Based on HSE response, FOI submitted to EU to ask has Ireland implemented Directive 2004/27/EC, is there a reporting requirement, has Ireland reported, and please supply any reports made under the Directive

Submitted 22/11/21

https://www.asktheeu.org/en

Unused Pharmaceuticals Where Do They End Up

Hundreds of different active pharmaceutical compounds are being discovered in waterways around the world. Concern is increasing about the harm these might be doing to human health and the environment.

Whilst pharmaceutical residues can enter the environment during the production, consumption and disposal, incorrect disposal of
household pharmaceutical waste is considered the second major pathway into the environment.

Proper collection and disposal of household pharmaceutical waste can contribute to reducing the impact of pharmaceuticals in the environment. Effective collection schemes would divert unused medicines from mixed waste streams that are not designed to deal specifically with pharmaceutical products.

Directive 2004/27/EC (relating to medicinal products for human use) introduces an obligation for Member States to implement appropriate collection schemes for unused pharmaceutical products. However, it does not provide any guidelines on implementation of schemes and a number of studies have pointed to significant differences between Member States.

In Ireland, where up until now pharmacies are responsible for all the expenses of the collection scheme (the legislation is currently under revision), there are reports of pharmacies accepting unused medicines all year but then waiting for the national annual campaign sponsored by the Health and Safety Executive to get rid of the collected medicines, thus avoiding any costs related to the disposal.

An ideal collection scheme, as proposed by Health Care Without Harm Europe, would be:


• Easy to use and accessible
• Funded by the Pharmaceutical Industry Groups
• Free of charge for the public
• Well-communicated so that people are motivated to participate
• Able to sort and recycle packaging
• Safe for public heath, by ensuring collected residues cannot be tampered with
• Responsible for the chemical deactivation of pharmaceutical waste