Dan Whalen is a JD candidate at Osgoode Hall Law School.
The Canada Gazette published amendments to the Patented Medicines (Notice of Compliance) Regulations, which include much-anticipated provisions for Extraordinary Use New Drugs (EUNDS). This addition is aimed at empowering Canada to prevent and respond to the threat of disease outbreaks and align its approach with that of international equivalents.
Health Canada defines EUNDS as drugs “that would be used to treat, mitigate or prevent a life threatening or serious health condition in humans which result from exposure to a chemical, biological, radiological or nuclear substance in an emergency situation.” Such contemplated situations include an outbreak of pandemic influenza, an attack with chemical or biological weapons, a chemical spill or a natural disaster. “An EUND… is intended to treat a condition that does not lend itself, ethically or logistically, to study through a traditional clinical trial in humans prior to approval,” wrote Associate Director, Elwyn Griffiths, in 2007. Accordingly, such drugs may be classified as an EUND and thereby become exempt from the usual drug approval channels.
Traditionally, these drugs have been approved through Canada’s Special Access Programme (SAP). However, in a 2005 report, the Office of the Auditor General declared that the SAP was an inappropriate means of authorizing the sale of EUNDS because it was increasingly being employed as a way of obtaining broad access to drugs that were merely in the later phases of clinical trials or in the new drug submission process. As a result, the SAP permitted the sale of drugs without comprehensive pre- or post-market monitoring. Such a consequence defeated the programme’s original purpose of providing access to unauthorized drugs for medical emergencies on a case-by-case basis.
In an effort to put right the shortcomings of the SAP, a new category of drug submission for EUNDS was created by amendment to Canada’s Food and Drugs Regulations. Under this framework, drug manufacturers must still provide efficacy and safety data to qualify for initial market authorization, but such pre-market information is limited to in vitro and animal studies supportive of use in humans. Manufacturers must additionally commit to post-market surveillance and data acquisition and annual reporting, none of which was required under the SAP. There are also new regulatory safeguards, such as limiting the sale of EUNDS to the different levels of Canadian governments for distribution rather than direct sale to consumers.
As the Regulatory Impact Analysis Statement indicates, the cost to industry stakeholders under the new regulations will not be significant considering their current responsibilities under the existing drug development and authorization regime. However, the difference to Canadian patients requiring EUNDS will be significant because of the added protections regarding these drugs and government’s facilitated access to them.