I was chatting earlier this week, in the most general way possible, with someone in Ottawa about nanotechnology and regulations. The individual noted that nanotechnology initiatives in various countries and regions are attaining traction and I think the evidence is in the increased (and heated) discussion/debate about defining nanomaterials. The latest twist in the discussion comes from Alok Jha, a science writer for The Guardian. In his Sept. 6, 2011 article, Nanotechnoglogy world: Nanomedicine offers new cures, he tackles the topic from the nanomedicine perspective.
The EU ObservatoryNano organisation, which supports European policy makers through scientific and economic analysis of nanoscience and nanotechnology developments, produced a report on the ethics of nanotechnology written by Ineke Malsch, director of Malsch TechnoValuation. She says the problem with regulating medical nanotechnology can be how to define a product’s area of application. “The distinction between a medical device and a pharmaceutical is quite fuzzy. …”
How do you regulate a drug-releasing implant, for example? Is Cuschieri’s nano-carrier a pharmaceutical or a medical device? One of [the] key issues, says Malsch, is that there is the lack of common agreement or definition, at the international level, of what a nanoparticle is and what constitutes nanomedicines. “There is continuing discussion about these definitions which will hopefully be resolved before the end of the year.”
Current regulations are more than enough for current technologies, says Malsch, but she adds that this will need to be kept under review. But over-regulating now would also be a mistake. Pre-empting (and trying to pre-regulate) technology that does not yet exist is not a good idea, she says.
This view was backed up by Professor Andrew Maynard, the director of the Risk Science Centre, who says: “With policy-makers looking for clear definitions on which to build ‘nano-regulations’, there is a growing danger of science being pushed aside.”
This (the fuzzy distinction between a pharamaceutical and a medical device) certainly adds a new twist to the debate for me.
Also, I should note that this article’s banner says: Nanotechnology world, in association with Nano Channels.Tim Harper (Cientifica and TNTlog) noticed in an earlier Guardian article on nanotechnology (from his July 7, 2011 posting),
My delight at seeing a sensible piece about “nanotechnology in everyday life” by Colin Stuart (@skyponderer) published in the Guardian Newspaper turned to puzzlement when I noticed that the article was “Paid for by NanoChannels.”
There seems to be some distinction between “paid for” and “in association with,” but I can’t confirm that at this time. Now back to the topic.
In my August 31, 2011 posting, I noted the latest salvo from Hermann Stamm, of the European Commission Joint Research Centre, Institute for Health and Consumer Protection where he reiterated that a hard and fast definition based on size is the best choice. In his Sept. 6, 2011 posting, Andrew where he expands on a concern (i. e. policymakers will formulate a definition not based on scientific data but based on political pressures and/or public relations worries) that I’ve given short shrift. From his Sept. 6, 2011 posting,
And despite policy makers repeatedly stating that any form of nanomaterial regulation should be science-based, I have the sense that they are scrambling to use science to justify a predetermined conclusion – that engineered nanomaterials should be regulated on the basis of a hard and fast definition – rather than using science to guide their actions.Instead, I would suggest that we need to put aside preconceptions of what is important and what is not here, and start by asking how new generations of sophisticated (or advanced) materials interact with biological systems; where these interactions have the potential to cause harm in ways not captured within current regulatory frameworks; and how these frameworks can be adapted or altered to ensure that an increasing number of unusual substances are developed and used as safely as possible – no matter what label or “brand” is applied to them.
He was a little more explicit about what he thinks are the reasons behind this preference for a “hard and fast definition” in his April 15, 2011 posting,
Sadly, it now looks like we are heading toward a situation where the definitions of nanomaterials underpinning regulations will themselves be based on policy, not science.
This scares the life out of me, because it ends up taking evidence off the table when it comes to oversight, and replacing it with assumptions and speculation on what people think is relevant, rather than what actually is – not good for safety, and certainly not good for business.
All this got me to thinking about the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials and the public consultation which ended August 31, 2010. According to the website, we will be learning the results of the consultation,
Reporting to Canadians
Health Canada will make the results of this consultation available on this Web site. Health Canada will take further steps to illustrate how the policy statement will be applied in specific contexts. These steps could include guidance documents for specific products or substances, targeted workshops and postings of answers to frequently asked questions. The Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials will be updated as comments are received, as the body of scientific evidence increases, and as international norms progress.
If you have any questions, contact email@example.com.
Strangely, there’s no mention of the 29 submissions that were made (my May 27, 2011 posting) or a listing of who made the submissions as was done for Canada’s ‘innovation consultation’ or, more formally, the Review of Federal Support to Research and Development (which started in Oct. 2010 and ended in Feb. 2011 and received some 250 submissions).
Tags: Alok Jha, Andrew Maynard, EU ObservatoryNano, Harmann Stamm, Health Canada, Industry Canada, Ineke Malsch, Interim policy statement on Health Canada's Working Definition for Nanomaterials, Nanochannels, Nanotechnoglogy world: Nanomedicine offers new cures, Review of Federal Support to Research and Development, time