Swedish initiative for green medicine production
Monday, July 04, 2011
The Swedish Medical Products Agency (MPA) has published a report on how environmental standards in pharmaceutical production can be sharpened within the EU. The proposal is unique and forces all manufacturers to follow the GMP rules on pharmaceuticals sold on the EU markets. In recent years, manufacturing of pharmaceuticals in low cost countries like India and China has drawn attention because of the environmental impact.
Today a considerable share of pharmaceutical manufacturing and production of raw materials and semi-products takes place in low-cost countries, and many large companies plan to locate even more of their production there. In the first decade of the 21st century, Swedish research findings have revealed emissions from the manufacturing of pharmaceuticals in India on a scale that can seriously impact the health of humans and animals, as well as the environment.
- We use pharmaceuticals to remedy humans and animals, it is paradoxical that the production greatly contributes to threatening our health, says Charlotte Unger, Environmental Director at the MPA.
The MPA has recently submitted a report to the Swedish government on how EU environmental standards in pharmaceutical production can be sharpened. The report will be discussed at the Informal Meeting of Ministers for Health on July 6th in Warsaw, Poland.
Anyone granted permission to manufacture pharmaceuticals must comply with a number of requirements under current legislation. One of these is to conform to the principles and guidelines of Good Manufacturing Practice, GMP, for pharmaceuticals, thereby using as raw materials only active compounds that were produced in accordance with detailed guidelines for good manufacturing practice of raw materials.
Good manufacturing practice is a component of the quality assurance that is intended to make sure that the products are always produced and monitored in such a manner that they satisfy quality requirements that are appropriate for their intended use. A production licence will be revoked if, for example, GMP is not observed.
- By inserting the regulations for environmental control among production regulations within the framework of GMP, legislation will also have an impact on third countries, says Charlotte Unger. A further advantage of placing environmental requirements within GMP is that there is a well-developed and well-functioning inspection system for monitoring manufacturing and GMP.
Among directives regarding pharmaceuticals the obligation is added for manufacturers of pharmaceuticals to comply with the requirements in a separate legal document, a new EU regulation in which emission levels for certain compounds are stated. The new obligation among pharmaceutical directives should be inserted in the requirement to comply with GMP in production.
What should receive top priority for a first step in the above-mentioned EU regulation are those pharmaceutical compounds for which there is scientific evidence that the external environment, and thereby public health, is negatively impacted. First and foremost this concerns antibiotics, certain pharmaceuticals with hormone-disrupting compounds, and substances that can constitute a risk to the environment in that they are used and produced in large volumes.