Brussels 18.04.13: EFPIA, AESGP & EGA, as the collective voice of the European pharmaceutical industry, welcome the compromise announced yesterday by the Irish presidency on the Priority Substances proposal in the Water Framework Directive. The compromise reached between the European Parliament and the Council includes three pharmaceutical substances, diclofenac, ethinylestradiol and estradiol, in the Watch List for a monitoring exercise.

These pharmaceutical substances have been used by millions of patients globally for more than 30 years for pain relief, contraception and post-menopausal disorders (more than 50 years in the case of contraception) and should continue to meet the needs of European patients for access to safe and effective treatment.

Pharmaceuticals are found in the environment mainly through patient excretion of substances: trace amounts of medicines pass through the human body without being metabolized completely and make their way to surface waters through the municipal wastewater treatment system. There is currently no evidence of human harm and very limited and inconclusive evidence of environmental impact associated with pharmaceuticals in the environment (PIE).

However, the pharmaceutical industry acknowledges and supports greater efforts in understanding the long term environmental impact of man-made substances, including medicines, and in minimising their release into the environment. Concerns over the presence of pharmaceuticals in the environment should be addressed on the basis of sound science and mindful of patient needs.

It is in this spirit that the industry is looking at ways to ensure that the system of environmental risk assessment for medicines continues to be appropriate and to further enhance the scientific knowledge base on the question of pharmaceuticals in the environment. 

The AESGP, EFPIA & EGA welcome the opportunity to participate in all debates to ensure that due and proportional account of the wider public health needs and considerations of European patients are fully addressed as part of the evolving European regulatory and legislative framework for pharmaceuticals in the environment.

The Association of the European Self-Medication Industry (AESGP) is the official representation of manufacturers of non-prescription medicines, food supplements and self-care medical devices in Europe. AESGP was founded in 1964 to contribute to the improvement of responsible self-medication at the European level and to ensure that the value of responsible self-care is recognised in pharmaceutical, food and health matters.

Contact: Christelle Anquez-Traxler – Regulatory and Scientific Affairs Manager
Email: c.anquez@aesgp.eu  – Tel: +32 (0) 27355130 
Website: www.aesgp.eu  

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 35 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2,000 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.

Contact: Gabriella Almberg - Director Government Affairs
Email: gabriella.almberg@efpia.eu  - Tel: +32 (0) 26262573 
Website: www.efpia.org

The European Generic medicines Association (EGA) is the official representative body of the European generic and biosimilar pharmaceutical industry, which is at the forefront of providing high-quality affordable medicines to millions of Europeans and stimulating competitiveness and innovation in the pharmaceutical sector.

Contact: Julie Chauvet - Manager Government Affairs & Communications
Email: jchauvet@egagenerics.com  – Tel:  +32 (0) 25339812
Website: www.egagenerics.com