Law proposed for environmentally suitable pharmaceutical products
Christina Åkerman, Generaldirektör Läkemedelsverket.
The Swedish Medical Products Agency wants to see an EU-wide law requiring manufacturers to pay due regard to the environment during the production of pharmaceutical products. If the investigating committee has its way, it will also be possible to deny approval for a product if it is environmentally hazardous.
On behalf of the Swedish government, the Medical Products Agency has examined the possibility of tightening the international environmental requirements concerning the manufacture of pharmaceuticals. The background to the investigation is that at present there are large numbers of pharmaceutical by-products in our environment that may have a harmful effect on both animals and human beings.“Sustainable development is a relatively new concept in the pharmaceuticals sector, perhaps because of the immense significance of medicines to health-care. However, we are beginning to have increasing understanding of the link between health and the environment, matched by the realisation that a good environment is a precondition for good health among animals and human beings alike," says Swedish Medical Products Agency director-general Christina Åkerman.The Medical Products Agency therefore wants to introduce a requirement for environmental certification for production plants in legislation governing Good Manufacturing Practice, GMP.
The investigating committee also suggests that the pharmaceutical regulatory authorities in the EU should start undertaking an environmental risk assessment during the approval process for all medicines. According to the proposal, new products will be able to be denied approval if their production involves any risk to the environment.
The Swedish Association of the Pharmaceutical Industry, LIF, welcomes the proposal. However, Bengt Mattsson, chairman of LIF´s environmental affairs committee, wants to see the introduction of financial inducements to stimulate environment-enhancement measures until any new legislation is ready for introduction. “One example might be that medicines meeting certain set environmental criteria are allowed to sell at a somewhat higher price," explains Bengt Mattson.
Source: Biotech Sweden 
