HEALTH LAW & POLICY WORKSHOP
presents
Dr. David Henry
President & CEO
Institute of Clinical Evaluative Sciences (ICES), Sunnybrook Hospital
The Australia/USA Free Trade Agreement - impact on access to medicines
Thursday, February 14, 2008
12:30 - 2:00
Solarium (Room FA2) - Falconer Hall
84 Queen's Park
Because access to therapeutic medicines is often determined by drug prices, governments have become increasingly involved in price negotiations. This has led to the use of a range of instruments such as reference pricing, pharamaco-economics-based pricing and risk sharing agreements. The U.S. government and pharmaceutical industry have argued that some of these represent anti-competitive behaviors and are barriers to free trade in pharmaceutical products. This position was adopted by the U.S. government during negotiation of the Australia-United States Free Trade Agreement (AUSFTA), which was implemented in 2005. The counter arguments were that there were no trade barriers: Australia imposed no tariffs or quotas and government subsidies were directed at consumers not local producers. Nevertheless, the final text of the AUSFTA included several provisions that appear to have been designed to impair the ability of the Pharmaceutical Benefits Advisory Committee (PBAC) to negotiate lower drug prices. These are described in the paper provided (available at http://www.globalizationandhealth.com/ content/1/1/15). We have been conducting a 3-year study of the impacts of the AUSFTA on subsidization policies and affordability of medicines to consumers in Australia. The main strategy of industry to date has been to weaken the previously rigorous process of reference pricing by persuading the government to change legislation to create two formularies. The first includes ‘innovative’ products, which no longer have to be priced against cheaper generic products, which are placed in a second formulary. The AUSFTA contains other provisions, such as an overarching ‘Working Party’ to review policy implementation, external reviews of PBAC decisions and the possibility of a Dispute Resolution being enacted by the USA if they feel that Australia has not honored its commitments to recognize and reward industry innovation and research and development. The implications of these will be discussed at the seminar.
David Henry was a member of the Australian PBAC from 1992 to 2001, chaired the economics sub-committee of PBAC from 1993 to 2001 and was involved in drafting the first set of guidelines for use of pharmaco-economic analysis in Australia.
A light lunch will be served.
Jointly sponsored by the Faculty of Law and the Department of Health Policy, Management and Evaluation, University of Toronto.
For more workshop information, please go to our web site at http://www.law.utoronto.ca/healthlaw/index.htm or contact Nadia Gulezko at n.gulezko@utoronto.ca
