I participated in two good and productive meetings yesterday with several of the stakeholders within the pharmaceutical sector. The first meeting was on un-used medicines and the second one on the environmental classification scheme for pharmaceutical substances on Fass.se.
LIF, the association for the research-beased pharmaceutical industry in Sweden, has been collaborating for several years with relevant stakeholders, e.g. the old Swedish pharmacy monopoly Apoteket AB and Svenskt Vatten (in English: The Swedish Water and Wastewater Association), to secure that the public returns un-used medicines to pharmacies and a secure and proper disposal of those medicines. Some of the conclusions drawn over the years regarding attitudes among the public and “technical data” has been published in ScienceDirect by Matilda Persson and others. And Matilda Persson, working at LIF, was one of the representatives on yeasterday’s meeting on un-used medicines. Additional participants to me and Matilda, as seen in the picture above, were Nina Viberg from SKL (in English: Swedish Association of Local Authorities and Regions), Staffan Castensson from Swedish MPA, Kajsa Wahlberg representing Svenskt Vatten, and Inger Näsman representing the Swedish Pharmacy Association.
We all felt the importance of initiating a campaign, with relevant follow-up, to secure continued high awareness among the public on the necessity of returning un-used medicines to a pharmacy. This is important both from a safety/security point of view and from an environmental point of view. Due to the fact that the Swedish pharmacy market has been de-regulated (i.e. no more pharmacy monopoly) we all felt a need to inform the public that no matter where medicines were bought, any un-used medicines can be returned to any pharmacy. LIF will take the leading role and drive the project with an aim of running a jointly designed campaign and attitude survey in fall 2011 and into 2012. I will definitely come back to this project as time goes by.
Yesterday afternoon was spent with some of the same stakeholders discussing the future of the environmental classification scheme for APIs (Active Pharmaceutical Substances) published on www.fass.se. Partcipants in this meeting was myself, Matilda Persson and Gisela Holm (eco-toxicologist from AstraZeneca) representing LIF, Åke Wennmalm representing Stockholm County Council, Nina Viberg from SKL, Staffan Castensson and Charlotte Unger from Swedish MPA, Inger Näsman representing Swedish Pharmacy Association, and Karl Lilja from IVL Swedish Environmental Research Insitute.
The classification scheme was developed collaboratively with the stakeholders and launched by LIF on Fass.se 2005. The plan was to present environmental risk assessments and existing environmental data for all pharmaceuticals substances available on the Swedish market before end of 2010. We have met the objective, and gone through all the different so called ATC-codes. Although, as you all are aware of I guess, several data gaps exist it is possible now to draw some general conclusions regarding environmental characteristics of APIs, e.g.:
- Most of the substances are considerad to have insignificant environmental impact. Moderate risk or high risk has only been ascribed to 4% and 1% of the APIs respectively. This is very positive information.
- Roughly 80% of the assessed susbtances do not show bioaccumulative potential. Also a very positive outcome.
- The negative results are to be found regarding the stability of the substances. The majority of the assessed molecules are potentially persistent.
But as you probably understand, an environmental risk assessment of the substance itself does not tell the full story. There has for instance been a lot of discussions the last few years regarding releases of APIs from manufacturing facilities in e.g. India. For more information on the topic in detail see my blogpost from August 16, 2010. Also as a direct consequence of the discussions regarding “green incentives” it is about time to start evaluating whether or not additional aspects and pespectives should be added to the environmental classification. For more details on “green pharmaceuticals” and/or “green incentives” you could read my blogpost from e.g. Nov 12, 2010. As you know, I personally and the member companies in LIF, are strongly favouring “market driven solutions” before regulatory actions. This is due to both that we believe in general in the power of financial incentives, but also due to the fact that proposed regulatory initiatives, e.g. introduction of environmental requirements in GMP, will probably take at least 10 to 15 years before they are realized. LIF’s environmental committee and the “LIF Sustainable Development Task Force” has developed the following 4 step process to reach a sustainable use of pharmaceuticals:
It might be somewhat problemativ to read the details in the figure above. But I promise that I will come back to the scheme several times here at the blog during spring since there will be a lot of discussions for instance driven by the National Pharmaceutical Strategy. But in essence the scheme says that “green incentives” and “green criteria” are extremely important in step 4, entitled “Green Choices within Health Care and Society”.
And what is a “green criteria”, based on which a products and/or a company could be branded “green”? Of course one critical aspect is the environmental risk assessment of the substance itself, but additional aspects could be manufacturing releases and emissions, packaging solutions, transport patterns and so on. In the meeting yesterday, Åke Wennmalm talked about his ideas regarding a “crash test” of pharmaceuticals. Read more about his ideas on via this link to Läkemedelsvärlden. Since the criteria must be possible to evaluate objectively by authorities such as Swedish MPA and TLV (in English: The Dental and Pharmaceutical Benefits Agency) in order for them to be able to present “green incentives” to industry we of course need to find ways to present enviromental information in an “science based, clear and concise manner”. One proposal worth to look further into was presented by Staffan Castensson at the meeting: Water footprint. Staffan participates on behalf of MPA in a working group focused on the development of an international standard in the area (i.e. ISO 14046).
We have a long way to go, but the process has been initiated. And I am proud to say that, as for the environmental classification scheme development, LIF has decided to be in a driving seat.