Proposals for stricter environmental requirements for pharmaceutical industry
Thursday, December 17, 2009
Medical Products Agency (MPA) has been commissioned by the Swedish Government to identify opportunities for strengthening the environmental requirements pertaining to the manufacturing of medicinal products with greatest emphasis on EU and international efforts rather than national work. The report suggests, among other, requirement for an environmental certification of the production facilities to be introduced to the legislation on good manufacturing practice (GMP).
In the 21st century, results from the Swedish research indicate that emissions from the manufacture of medicinal products in India to an extent which might seriously affect human and animal health, as well as their environment. Pharmaceuticals are found in both ground- and drinking water.
Current studies show that levels of pharmaceuticals in”purified” waste water are above the level of a normal dose of a drug in a human being. With this background, the discharge of substances from the pharmaceutical production in the third world is of sincere concern.
– One serious problem is the development of antibiotic-resistant bacteria. This risk increases with the production of pharmaceutical products in low cost countries, says Charlotte Unger, Scientific Director Environment at the MPA.
A significant part of the current manufacture and production of raw materials or intermediate products takes place in low cost countries and many large companies are planning to place even more of their production there. National legislation is insufficient and these measures are better met with harmonised EU legislation, since level of requirements also may affect conditions outside the EU.
The MPA therefore proposes, as a first priority, that requirement for an environmental certification of the production facilities, with respect to the production of medicines and active pharmaceutical ingredients to be introduced to the legislation on good manufacturing practice (GMP) in order to include also an environmental perspective in the legislation for improved cleaning technician at production facilities.
In order to better reflect the sustainable development in accordance with the EC Treaty, the MPA proposes that the current EU legislation for the authorisation of medicinal products for humans should be changed so that an environmental risk assessment is also included in the approval.
Today authorities may not include environmental risk assessment in the risk/benefit analysis when assessing whether a drug will be approved for marketing authorisation. This means that today’s legislation does not allow a denial of authorisation of medicinal products for humans due to any risk of negative environmental effects.
– Sustainable development is a relatively new concept in the pharmaceutical sector, perhaps because the drugs have had great importance for public health. However, we now begin to realise the link between public health and environment, says MPA Director General Christina Åkerman.