A most interesting movement that’s gathering steam within pharmaceutical development is that of Green Pharma.
The concept began in Germany and Sweden, home to many environmentally and socially aware initiatives. Simply put, Green Pharma is the practice of considering the broader implications and consequences of the entire process of drug development and striving to ensure that when a drug gets to market it can be considered benign by design.
Similar to environmentally friendly carbon emission schemes, benign by design takes into consideration environmental factors in evaluating the social responsibility of corporate entities. Parameters such as generated waste, resources used during the process and effect on the environment are key. Patient health and economic costs to the broader community are no longer the sole criteria when evaluating drug development.
Consider the mainstream analgesic (painkiller) ibuprofen. Initially its manufacture involved a six step process that created 45 million pounds of by-product for every 30 million pounds of drug granulated. Most of this waste was in the form of solvents and separation agents and was simply discarded. During the 90’s the ibuprofen manufacture process was completely overhauled and became a three step process where 80-99% of the materials used ended up as part of the final product, with the remainder mostly able to be recycled and reused in future or other processes. Not only did ibuprofen develop a more cost effective process, it’s a much less wasteful process as well.
Consideration of environmental consequences and social impact, alongside financial return, can be referred to as managing the ‘triple bottom line’. Essential to implementing these changes in pharmaceuticals is an adopted awareness and diligence at each step of development. No points are to be deserved for this approach; in the near future the pharmaceutical sector will be asked for accountability on all fronts.
In some Scandinavian countries, prescribing physicians are now able to access a database that includes the environmental ‘rating’ of the drugs they are considering. Environmental impact does not form part of the drug approval process, but all new applications are receiving a rating during this stage, while existing drugs are also under review with the database due for completion by the end of 2010. This is direction we are taking and at Clinuvel we aim to implement these changes ahead of time and make them an integral part of our drug development.
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