As a large part of my current workload involves looking at the financial and economic implications of nanotechnology (hence the silence in this column), with drug delivery and medical devices being two of the lowest hanging fruits, there wasn’t too much to learn about the technology that hadn’t already been covered. However, the two areas of real interest, especially to business, were regulation and toxicology.
There has been a lot of discussion about toxicology and nanotechnology recently, with various studies indicating that a variety of fullerenes and nanoparticles have toxicities ranging between those of water and dioxins, which doesn’t really help us. A question raised by some of the world’s top toxicologists at the meeting was whether it is the reactivity of nanoparticles, their size or their surface morphology that is the cause of inflammation. This is further complicated by the large variations in toxicity depending on the surface treatment of particles. This is something I have observed in a number of projects, with slight and poorly understood variations in the properties of materials containing fullerenes of different batches from the same source. The upside is that if we can understand and control this effect it paves the way for the neutralization and safe disposal of materials. From a medical viewpoint, control over toxicity is a beneficial thing - compounds that are highly toxic at one dose can in some cases be highly effective drugs at another. So we have plenty of work still to do.
Regulation always rears its head when nanotechnology meets policymakers. While there is an impression that Europe tends to be somewhat overzealous when it comes to regulation, this is an area where business and regulators are keen to co-operate. From a business standpoint, we simply want to know what the rules are, or will be. Nobody wants to risk investing in the production of materials that may be banned at some stage in the future, or may be subject to the same sort of regulation as pharmaceuticals, which would dramatically affect the viability of a whole sector of industry. One very good question was raised at a recent meeting at the European parliament: “Do we need to regulate nanotechnology at all?”
It’s a tricky question. Regulating nanotechnology is a little like regulating physics or chemistry. You could do, but what would the legislation look like? Would we have hordes of inspectors dashing into university labs to determine whether the wrong kind of science was being done? It is far better to regulate the applications of science than science itself. Are we talking about regulating pharmaceuticals or polymers? It is all chemistry. Similarly, the same TiO2 nanoparticle will fall under a different regulatory framework depending on whether it is applied to the skin (cosmetics), or painted on a wall (chemicals). The regulations will be different again for production, storage and shipping.
What we did learn was that although much of nanotechnology falls under existing regulatory frameworks, there are a number of gaps. Should TiO2 fall under the same regulations as bulk materials, or perhaps some other rules concerning ultrafine powders? On the medical side, there are questions over whether standard tests are capable of picking up nanoparticles and other new materials used in drug delivery as the tests were designed for rather different materials. While at first sight we seem to be generating more questions than answers, the hardest task in solving any problem is always defining and bounding it. Once we know what we don’t know, the job gets easier.
Another area that has long been a cause for concern has been the apparent lack of coordination between the commission bodies that are funding research, regulating and stimulating business, and dealing with public health. One of the other interesting features of this meeting, and one that may prove to be more significant in the future, was the presence of European Commission staff from the Directorates-General of Research, Enterprise and Sanco (Health and Consumer Protection) sitting and working together. Both Research and Sanco have publications concerning nanotechnology and nano safety due out in the coming weeks.
In the same way that nanotechnology has ensnared scientists from what were previously fiercely rival disciplines, a similar effect is occurring with commission directorates. Joined up science and joined up government. Now, about those budget increases called for by the European Parliament…