So, once again the holiday season is coming to an end. We still have a lot of snow here in Sweden, which enables skiing and other winter sports. A lot of fun, but it is about time to get back into the office…
Before I went on vacation, I wrote a blog post where I summarized 2010 and looked into 2011. One of the things I discussed was the on-going process regarding MPA’s report on ”stricter environmental standards”. I wrote
”We have from the industry been very clear that we like to participate in all discussions with MPA and other relevant stakeholders regarding legislative initiatives as propsed by MPA in their report from Dec 2009 (e.g. environmental requirements in GMP). However, we do strongly believe that market driven measures are more efficient and much faster to implement. Hence, an overview of the reimbursement system and the generic reform, is high on our list. I am sure that 2011 will include a lot of discussions on this topic.”
And it is now clear that these discussions will start directly now in 2011. The Swedish MPA has been given a governmental commission to continue working on their proposal to include environmental standards in GMP:
”Pharmaceuticals and the Environment
The MPA is given the task of, following consultation with the National Chemicals Inspectorate and the Environmental Protection Agency, develop a basis for, if deemed appropriate, allow the initiation of a revision of EU legislation on GMP (Good Manufacturing Practice), with the aim of legislation should also include environmental considerations. The task will be based upon MPA’s governmental commission on opportunities for higher environmental standards in the manufacturing of pharmaceuticals and active ingredient (from 2009). The commission should be reported in two steps, as follows:
The MPA should, based on considerations from an EU perspective, e.g. through dialogue with European institutions, present an analysis for how the work on a revision of the GMP legislation should be designed to have the greatest opportunity for success. It is to be reported March 31, 2011, at the latest.
Furthermore, the Authority shall draw up concrete amendment proposals to the GMP legislation. It is to be reported June 30, 2011, at the latest.”
As you see, fairly short timelines. And you may recall from my blog post from Dec 21, 2010, that this will coincide with the development of the Swedish National Pharmaceutical Strategy, where Sustainable Development is one of the focus areas. It will be very important for all stakeholders to collaborate on these tasks, and actually manage to keep the ”broader perspective open” through the process. As I have mentioned several times before (see for instance my blog post from Nov 18, 2010), environmental standards in GMP is in my opinion not the best, nor the fastest way to move forward. I strongly believe in market-driven solutions where green incentives are given to ”green products”. I foresee interesting discussions during spring 2011!