Subject_Environmental risk posed by uncontrolled disposal of household pharmaceuticals

Subject: Environmental risk posed by uncontrolled disposal of household pharmaceuticals

Reliable scientific studies have confirmed the presence of pharmaceutical residues in drinking water, surface water and groundwater. The effects of these substances on the environment have been examined in many research programmes, some of them funded by the European Union. The effects of long-term exposure to pharmaceutical residues in water are a matter of concern not only for humans but also for other living organisms.

A significant quantity of unused household pharmaceuticals ends up in disposal sites, together with conventional waste. In many cases, these are outdated medicines, which penetrate the aquifer in different ways. Subsequently, some of their active substances re-enter the biological cycle through the medium of water. Although some European countries have special collection points, there is no harmonised framework at European level for environmentally sound management of household pharmaceuticals, nor any organised support measures to alert European consumers to the dangers posed by the uncontrolled disposal of such products. Given the trend towards ever-increasing use of medicines in the European Union, the problem is expected to worsen. Directive 2004/27/EC stipulates that ‘Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired’ (Article 127b), but fails to define any framework for the sound management of household pharmaceutical residues.

In the light of the above, will the Commission answer the following:

— Does it have statistics showing the extent of this problem in the Member States?

— Will it support specific measures to raise awareness of the need for environmentally sound management of unused household pharmaceuticals?

— Will it introduce a single institutional framework for the environmentally sound management of household pharmaceuticals?



E-004499/2011 Answer given by Mr Dalli on behalf of the Commission

The consideration of environmental aspects during the authorisation of medicinal products has been introduced in EU legislation in 2004(1). An application for marketing authorisation of a medicinal product must be accompanied by the evaluation of its possible environmental impact. The environmental risk assessment involves the generation of data on the environmental exposure and eco-toxicity of medicinal products and may lead to risk minimisation measures in the marketing authorisation. In the case of veterinary medicinal products, environmental risks may even lead to the refusal or revocation of a marketing authorisation(2).

Pharmaceutical wastes can pose a risk to both human health and the environment if not properly managed. This waste stream should therefore be treated properly, so as to minimise the risks of release into the environment, in line with the provisions of Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste(3). In particular, in accordance with Article 13, Member States shall take the necessary measures to ensure that waste management is carried out without endangering human health, without harming the environment and, among other, without risk to water, air or soil, or to plants or animals.

The Commission does not possess comprehensive quantitative data on systems for collecting unused medicinal products in Member States at the moment. However, the Commission is aware of the analyses on this issue performed by EEA(4) or some Member States authorities(5).

Commission Communication COM(2008)666 on ‘Safe, innovative and accessible medicines: a renewed vision for the pharmaceutical sector’ recognised that the pollution of the environment with pharmaceutical residues is an emerging environmental problem and also an emerging public health concern and that there is a need to focus on measures to reduce the potential harmful impacts of pharmaceuticals on the European environment and public health.

The new pharmacovigilance legislation(6) calls upon the Commission, based, inter alia, on data received from the European Medicines Agency, the European Environment Agency and Member States, to produce a report on the scale of the problem, along with an assessment of whether amendments to Union legislation on medicinal products or other relevant Union legislation are required. The Commission services are currently launching a study to underpin the report.

(1) Directive 2004/27/EC amending Directive 2001/83/EC on human medicine and by Directive 2004/28/EC amending Directive 2001/82/EC on veterinary medicine, OJ L 136, 30.4.2004.

(2) Articles 1(19), 1(20) and 28 of Directive 2001/82/EC, OJ L 311, 28.11.2001.

(3) OJ L 312, 22.11.2008. In particular, Article 10(1) of Directive 2008/98/EC states that ‘Member States shall take the necessary measures to ensure that waste undergoes recovery operations, in accordance with Articles 4 and 13’ and Article 10(2) states that ‘Where necessary to comply with paragraph 1 and to facilitate or improve recovery, waste shall be collected separately if technically, environmentally and economically practicable and shall not be mixed with other waste or other material with different properties’. Article 12 of that directive states that ‘Member States shall ensure that, where recovery in accordance with Article 10(1) is not undertaken, waste undergoes safe disposal operations which meet the provisions of Article 13 on the protection of human health and the environment.’



(6) Recital 3 of Regulation (EU) No 1235/2010 and Recital 6 of Directive 2010/84/EU, OJ L 348, 31.12.2010.