Green Manufacturing of Medicine - a Swedish Proposition for an Update of the EU-GMP Rules

15 July 2011

Malin Ekstrand, Ida Smed Sörensen, Sara Sparring

Recently, the manufacturing of medicine in low-cost countries such as India and China has come under the microscope because its significant environmental impact. Swedish research into this area has shown the manufacturing of medicine in India and China to cause a high level of emissions which can seriously affect human health and environment, for example because of an increased risk of multi-resistant bacterial strains. This issue has become all the more pressing with the localised growth of the sector, with a significant amount of medicine manufacture taking place in low-cost countries. 

The European Commission addressed the issue of assessing the environmental impact of medicine manufacture in its communication COM 2008 (666). It stated then that  “Pollution of waters and soils with pharmaceutical residues is an emerging environmental problem and also an emerging public health concern […] It is now necessary to focus on measures that could reduce the potentially harmful impact of pharmaceuticals on the environment and public health.”

Upon request of the Swedish Government, the Swedish Medical Products Agency (MPA) has presented a report on how environmental standards for manufacturing of medicine may be tightened. The purpose of the report is to make it possible for the Swedish Government to initiate a revision of the EU rules on good manufacturing practice (GMP). The move seems to suggest that the Swedish Government believes that the EU-GMP rules should include provisions on environmental control, which would require amendments of the Directives 91/412/EEC and 2003/94/EC and the drafting of a new Council Regulation.

If such new provisions were enacted as part of the GMP-rules, its effect would extend to those manufacturers based in low-cost countries. All manufacturers of medicine, including those outside of EU, are required to follow the GMP-rules if their products are manufactured in or imported into the EU.

Currently, there is no regulation or control of medicine manufacture that is directed at controlling environmental standards. The EU-GMP rules for medicine manufacture are aimed at ensuring that medicines are safe and manufactured in a safe manner. European environmental law includes various kinds of industrial emissions, but these are general in scope, and not directed at the emission of individual harmful substances. The MPA would like to make it possible to regulate the emission levels of individual substances in the pharmaceutical industry.

According to the MPA’s proposal, the new regulation should set maximum emission levels for some specified pharmaceutical substances for which there is scientific evidence of their negative impact on the environment and human health. The substances referred to are mainly antibiotics, but also include other pharmaceuticals such as endocrine disruptors and those substances of which large-scale production may entail environmental risks.

At present there is a well functioning inspection system for supervision of medicine manufacturing. By adding new provisions to the GMP-rules, this supervision would be enhanced to include inspections on the environmental impact of manufacturers as well as drug quality.

The Swedish proposal is the first of its kind and if it is put into law it would lead to more environmentally friendly medicine manufacturing, with the potential to improve standards even where this manufacture has been outsourced to low-cost countries.