HCWH Europe reveals limitations in the current regulation of nanomedicine

Brussels 14/01/2014 – In a study released this week by Health Care Without Harm Europe, evidence suggests that the European regulatory framework is insufficient to protect human health and the environment from the use of nanotechnology in healthcare.

Although nanomedicine could potentially bring benefits to patients and the healthcare sector, HCWH Europe warns that nanomaterials are essentially new, largely untested chemicals and little is known about their persistence, bioaccumulation and toxicity to the human body and the environment. HCWH Europe’s Executive Director, Anja Leetz states “without a clear knowledge of the risks involved for human health and the environment, products should not be allowed onto the market unmonitored”.

A main focus of HCWH Europe’s report is on the applications and products that are already in commercial use or which are currently being tested in clinical studies as these are likely to have a significant impact on industry and society in the near future. Concerns about the new risks posed to human health and the environment are also presented. These are mostly due to the different properties of nanomaterials, the many gaps in knowledge, and the lack of methodologies and tools for the assessment and management of risks. Most importantly however, is the inadequacy of the European regulatory framework.

HCWH Europe therefore proposes a number of specific recommendations to address limitations in the current EU regulatory framework on nanomaterials and nanomedicine. These include the application of the precautionary principle, an improvement in the current nanomaterial definition that does not restrict the size threshold and encompasses all nanomedicine products, the classification of nanomaterials as new substances within EU legislation and the placement of the burden of proof and safety in the hands of nanotechnology producers and distributors. As many nanomedicine products will be a crossover or borderline product with mechanical and chemical functions, it is also of utter importance that the new Medical Devices Regulation, which is currently under revision, acknowledges the risks of both intentional and non-intentional release of nanomaterials into the bodies of patients and healthcare professionals.

HCWH Europe claims that in addition to establishing a strong regulatory framework, which will give confidence in the use of nanomedicine, there are other vital steps that need to be taken. These steps involve prioritising research to address safety concerns regarding the risks of nanomedicine products, considering the entire lifecycle of products when evaluating the benefits of nanomedicine and involving patients, workers and communities in the decision making process.

As more and more nanomedicines enter the market without any awareness of the risks inherent in their manufacture, use and disposal, more transparency and data to manage risks
 and the urgent adaptation of legislation are required in order to protect human health and the environment. HCWH Europe hopes that this report will encourage and emphasise to European policy makers that nanomedicine will only reach its full potential if it is responsibly regulated.

Please click here to view the report. For enquiries regarding the report, please contact HCWH Europe via maria.jose@hcwh.org or the author of the report Rye Senjen at ryesenjen@yahoo.com.