Nanomedicine is regarded as one of the most promising fields of nanotechnological development. It includes applications in nanopharmaceuticals, surgery, diagnostics, implant technology, bionics, bio-active surfaces, tissue engineering, textiles and actuators. Several nanomedical products are already on the market and there are many more applications to come. For example, approximately 18 nanomedicinal products have gained market authorization from the American Food and Drugs Authority, while around 11 nanodrugs have been approved by the European Medicines Agency.
At present, many of the relevant stakeholders – including the regulatory agencies, pharmaceutical companies and bodies such as the International Standards Organisation – are addressing various kinds of regulatory questions. Some have questioned the appropriateness of existing regulations to provide for the safety, quality and efficacy of nanodrugs, because of new product properties, new modes of action and unknown toxicity.
More specifically, pharmaceutical companies and pharmacists have drawn attention to the difficulties of complying with the regulatory obligation to assess the environmental impact of (nano-) medicines. This was incorporated into European regulations in 2004. In the case of combined products (e.g. a drug that is delivered by a nano-device), it is not clear which regulatory regime applies. Do these hybrid products fall under the strict regime of pharmaceutical regulation or does the ‘lighter’ regime of medical devices apply? If European regulators ‘go’ for medical devices regulation, they have to be aware of the lack of in-house expertise at certain authorization bodies (‘notified bodies’), and aware of badly functioning post-marketing controls.
Despite these doubts and questions, regulatory bodies feel that the current regulatory frameworks are robust enough to adapt to the technological challenges. They do not call for new specific regulations on nanomedical products. In their view, the risk-benefit balance principle that guides medical technology assessment can be successfully applied to nanomedical products. It is not clear, however, how nanomedical risks can be measured and how thresholds for exposure can be found.
Furthermore, it is not clear how the benefits of these products for larger patient groups can be measured. Since one of the promises of nanomedicine is to tailor medical products to the needs of individual patients (personalized medicine), it is likely that only a tiny group of the population will benefit from nanomedicine. At the international workshop on nanomedicines convened by the European Medicines Agency last week, a take-home message was to reflect on the consequences of nanomedical development for public health systems.
The regulatory problems of nanomedicine and how to responsibly cope with them will be discussed at a conference at the University of Twente on 9-10 September.