Drug bearing nano-shells that can be utilized for targeted drug delivery have been shown to enhance the therapeutic index by increasing the dug concentration in diseased tissue and reducing the toxicity in normal tissue.  The controllability of the drug bearing shell size provides predictability measure for the amount of drug payload per shell which improves the administration of the therapeutic dose.  The FDA approved different formulations for clinical use in metastatic and recurrent breast cancer, among other diseases.  At the moment, some of these formulations are the subject of international clinical trials.  Informed consent is legally mandated in administering drug bearing nano-shells.  The risks of the new formulations, as with all new technologies, are not well known and are continue to be a subject of intensive research, thus exacerbating the existing informed consent legal issues, thus exacerbating the existing informed consent legal issues.  This short essay focuses on proposing a framework to mitigate liabilities administering a new formulation on nano-enabled drug carriers particularly when uncertainties of the benefits and damages are not fully known.

This chapter examines Article 43 of the United Nations Convention on the Rights of Persons with Disabilities (CRPD). The formal act by which a state consents to be bound by a treaty is expressed through ratification. The various legal terms used to denote such consent (ie acceptance, approval, or accession) produce the same functional and legal effect in the international sphere. Their differences lie chiefly in the states’ internal/constitutional sphere. Article 43 CRPD departs from equivalent provisions in other treaties under the UN aegis, as well as other multilateral treaties, at least in phrasing. Other multilateral treaties specifically distinguish between the two classical types of consent: a) that which is open to signatory states, namely ratification, acceptance and approval and; b) that which is open to non-signatories, namely accession. Article 43 does not make this distinction explicit. Its wording seems to suggest that acceptance and approval are excluded from its ambit, but given that both of these produce exactly the same legal effects as ratification, the distinction is practically meaningless.