MPA Proposal: No GMP Certificate in Case of Violation of environmental Constraints

On July 4, 2011 the Swedish Medical Products Agency (MPA) published a report about an initiative for "green medicine production" on its website. The principles and the reasons for this initiative are laid down in a document entitled "Platform to enable the initiation of a revision of EU legislation on Good Manufacturing Practice, GMP, in order for legislation also to comprehend environmental considerations". The title itself reveals what it is about: namely a revision of the GMP Guidelines and more precisely their extension through the introduction of binding rules for the environment-friendly production of drugs and APIs.

This proposal from Sweden is not really surprising. Already in December 2009, the Agency has put forward proposals to the Swedish Government regarding consideration of environmental aspects in the manufacture of medicinal products. In accordance with this proposition, facilities should perform an environmental risk assessment and underlie a certification scheme. Moreover, the marketing authorisation should be denied for medicinal products whose production could damage the environment. This year again, the Swedish government asked the MPA to elaborate a platform dedicated to the revision of the EU GMP Guidelines. The result can be found in a report with the following core demands:

An EU regulation should be established to define emission limit values for the production of certain substances. This requirement should be included in the basic requirements of the GMP rules. Even the definition of GMP should comprise the environmental protection aspects.

Each substance to be monitored should be included in this regulation with top priority for the substances which already have scientifically been proven to have damaging effects, like for example: antibiotics, hormone-disrupting substances which are produced and consumed in large volumes and have a slow biological degradability.

The new regulation should establish a procedure for how to identify further substances which are harmful to the environment and how to determine concentration limits.

The authors of the reports recommend to use the Cosmetics legislation in the EU as a model for structuring the new directive to be established.

The Swedish initative is a response to the trend to outsource the production of API mainly to China and India and the fact that in these countries environmental concerns are inexistent or rudimentary. The report cites a study performed in 2007 in an Indian purification plant which treats waste water from approximately 90 pharmaceutical manufacturers. Residues of ciprofloxacin have been found in the purified water in a concentration level a million times higher than what is found in purified water from Swedish purification plants. This and further results described in the study as well as the fact that in the named countries the quantity of illegal disposal is unknown must be taken into consideration in the context of massive outsourcing of production by European pharmaceutical companies. This situation is in great contrast to the European concept of environmental protection and represents the driving force of the Swedish initiative.

It will be interesting to follow the evolution of this initiative. We cannot expect the Swedish demands to be implemented quickly and completely because once environmental constraints for Indian and Chinese suppliers would be introduced, numerous supply chains would break down.

For durther details please also see the must-read report of the MPA and

the Website of the Swedish Authority.

Author
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)