Regulatory Update – Pharmaceuticals and the Environment

There are several governmental initiatives, all of them with possible regulatory implications, ongoing here in Sweden regarding pharmaceuticals and the environment. I have today given a brief presentation to LIF’s Regulatory Affairs Committee summarizing these initiatives and also briefly discussed the potential impacts from the EU Water Framework Directive. LIF is the association for the research based pharmaceutical industry in Sweden.

There are three ongoing governmental commissions and/or initiatives:

- The work by Swedish MPA regarding the inclusion of environmental criteria in GMP (Good Manufacturing Practice). I presented the commission here at the blog on Jan 5, 2011, and have mentioned it several times since then, e.g. May 20, March 28, Feb 18. As you probably know, LIF’s position on this is that we like to participate in the process, but we do however believe it is a very long and slow process… It will probably take at least 10 to 15 years to make environmental additions to GMP, and quite frankly given the problems existing for instance in India from manufacturing releases of pharmaceutical substances, we do not have the time to wait that long… We believe more could be done faster through other mecahnisms, e.g. economic incentives for green pharamceuticals.

- The Swedish National Pharmaceutical Strategy. One of the objectives in the strategy is ”minimal negative environmental impact from pharmaceuticals”. The strategy document will be published during summer and several actions and initiatives are expected to follow. I expect to see both connections to the GMP-discussions but also to the discussions on green criteria and green incentives. I have written several blog posts lately regarding green criteria and incentives which I believe are crucial for success. See for instance the posts from March 28, April 20, May 11, and May 17.

- Miljömålsberedningen, which could roughly be translated into ”the Review of the Swedish National Environmental Goals”. One of the environmental goals being under review is ”A Non-Toxic Environment”. Our government seem to have a clear view that ”pharmaceuticals” should be more clearly expressed and discussed as part of this ”chemical control goal”. See my blog posts from discussions earlier this month, June 2 and June 7.

I strongly believe it is extremely critical that these different governmental initiatives are well coordinated. One initiative to secure this was the invitation to LIF’s ”round-table-discussion” that went out to all relevant stakeholders in March. See my comments from the meeting held on March 28. Several discussions and meetings will follow, for instance a meeting at the Confederation of Swedish Enterprises tomorrow regarding the review of the goal ”A Non Toxic Environment”, and another meeting with the full round-table group on September 28. Stay tuned…

And we will of course also be affected if the EU Water Framework Directive (WFD, Directive 2000/60/EC) would include any pharmaceutical substances on e.g. the so called Priority Substances list. The WFD establishes a framework for the protection of inland surface waters, transitional waters, coastal waters and groundwater. One means of doing this is by identifying Priority Substances (PSs) for control of emissions, including environmental quality standards (EQSs) in particular water compartments. EQSs are maximum allowable concentrations in the designated compartments and member states are responsible for their achievement and monitoring. The WFD also provides for designation of certain substances as Priority Hazardous Substances (PHSs) – emissions to water of these substances have to be phased out over 20 years.

Discussions are ongoing regarding a handful of pharmaceutical substances:

- ethinyloestradiol (EE2), oestradiol (E2), diclofenac and ibuprofen as potentially to be proposed as PSs

The WFD discussions will definitely continue, and it will be very interesting to see the outcome. Personally I cannot really understand how an EQS 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)… Once again – stay tuned, more to come!


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