Ian MacKay
Health Canada
Special Access Program

Ian MacKay is a native of Nova Scotia and trained as a biologist earning both an B.Sc. and an M.Sc. before joining the Royal Commission on New Reproductive Technologies in 1990 as a researcher.

Following work at the Commission, he joined Health Canada as a junior officer at Emergency Drug Release Programme within the Drugs Directorate in 1992. The EDRP (now called the Special Access Programme) is a component of the federal drug regulatory framework that coordinates compassionate access to non-marketed drugs for patients suffering from serious or life-threatening conditions who have failed other therapies.

The programme in any given year manages upwards of 35,000 requests for approximately 80,000-100,000 patients. The programme operates around the clock and calendar and manages access to over 500 different pharmaceutical, biologic, and radiopharmaceutical products for treatment, diagnosis and prophylactic purposes. The programme also manages the availability of drugs following drug withdrawals and discontinuations and during acute shortages of important products. The programme also works closely with emergency preparedness and response communities on contingency planning and ensuring the availability of adequate supplies of important, yet non-marketed, countermeasures.

After working in a number of capacities in the programme he was appointed manager of the programme in 2000. Since that time Ian has overseen major changes to the programme including implementation of a risk management framework, updates to publically available information, information technology and is currently coordinating a comprehensive review of the policy framework supporting the programme in the context of anticipated changes to federal legislation concerning therapeutic products.

Ian is also in the midst of a related project examining the ethical dimensions of the work of the SAP the outcome of which will inform ongoing policy deliberations.