The regulatory committee of LIF, the Association of the Ressearch Based Pharmaceutical Industry in Sweden, had invited all member companies to a session on "regulatory updates" today. I participated with a brief presentation on ongoing regulatory initiatives, on an EU level as well nationally in Sweden, in the area of Pharmaceuticals and the Environment.
Since I will start working part-time for LIF on Thursday, December 1 (see my blog post from Oct 19 for more details) I took the opportunity already today to share my "LIF coordinates":
If you have followed my blog over the recent months, the examples of ongoing regulatory initiatives mentioned by me today will not come as a surprise (see for instance my blog post from June 14 for a summary).
On the EU level I mentioned among others things the WFD, the water framework directive. Ethinyloestradiol (EE2), oestradiol (E2), diclofenac and ibuprofen were initiatlly proposed as Priority Substances (PS) under WFD. Ibuprofen is taken away from the discussions as far as I understand, whereas there are still discussions ongoing for the other three (although it seems likely that the sex hormones should rather be discussed together with other "potential endocrine disruptors" under another EU initiative). The WFD discussions will continue, and it will be very interesting to see the outcome. Personally I cannot really understand how an EQS (environmental quality standard) set for a pharmaceutical substance will relate to a market authorization granted through the pharmaceutical regulations. If the EQS is surpassed in a water body, would that imply that no more such substance could be released into the water body. And if so, wouldn’t that in reality mean “no more usage” (due to the simple fact that the publicly owned waste water treatment plants still cannot remove all excreted pharmaceutical substances from patient use).
National initiatives of course included
- Swedish MPA's proposal of including environmnetal requiremenst in GMP (see for instance my blog post from July 19 for comments on the proposal)
- The National Pharmaceutical Strategy, and especially the two first action items identified within the scope of intervention area number 7 “Reduce effects on the environment by pharmaceuticals, locally and globally”:
7.1. Investigate if the environmental aspects should be considered when decisions on subsidy for a pharmaceutical are decided (Lead: Ministry of Health and Social Affairs): Review of possibilities to – within the context of the national reimbursement system - increasingly take environmental considerations. 7.2. Encourage voluntary control of emissions from pharmaceutical factories (Lead: LIF): Introduction of a voluntary environmental labeling of pharmaceutical products.
I will be the project manager for action item 7.2 and will hopefully be able to connect 7.2 strongly with action item 7.1 which is to be managed by Sofia Wallström in her review. I think it is very important, and it feels reasonable, that society presents some form of economic incentives if industry is supposed to "volontary implement a system and an assessment model"...
- The All Party Committee on Environmental Objectives, and especially their work on the goal "A Non-Toxic Environment" where they have been commissioned to more clearly than before include pharmaceuticals in the scope. See my blog posts from Nov 14, Sept 16, and Sept 02 for more details.
I also briefly mentioned the MistraPharma-project which clearly interacts with all these regulatory initiatives. Read more about MistraPharma on the project website and/or in my blog posts from e.g. Nov 10, Sept 22, and Jan 18.