How US Health Reform Is Hitting Canada - Pharmaceutical Executive


How US Health Reform Is Hitting Canada

Pharmaceutical Executive

PE: What priorities have you and your board CEO colleagues set for Rx&D in the coming year?

RW: Our focus will be on four areas. First, and most important, we intend to advance the agenda for better access: to ensure all Canadians can obtain the latest treatments and cures, particularly when these are made available in other markets. To be effective in the healthcare challenge, we can't cede ground by depriving the provider and patient of the best clinical options in drug therapy. Hence Rx&D will continue to upgrade research in documenting where Canada falls short on the access barometer. We will also be active in the early stage discussions with the federal government and the provinces on a new entente agreement on funding for healthcare; the last one was negotiated in 2004 and it is due for revision by no later than 2014. This represents an opportunity for us to demonstrate value as a driver of efficiency, system savings, and productivity.

The second priority is IP. Here, we intend to advocate for improvements during the bilateral negotiations now under way with the EU on a Comprehensive Economic Trade Agreement, as a way to: 1) upgrade our level of data protection to the higher European standard (eight years in Canada versus more than 11 in Europe); 2) obtain an effective right of appeal to patent court decisions. (Today, if a company loses a case, there is no automatic option to continue); and 3) legislate patent term restoration. (Canada is the sole major industrialized country without it.)

Third, we will push forward with a proactive plan to improve the coherence and efficiency of the regulatory process, with particular emphasis on collaborative approaches to accelerating new drug approvals from Health Canada. One element is looking at ways to boost coordination with the FDA so that duplicative reviews and processes are addressed and mitigated. Approval times here in Canada are much longer than in the US and Europe; that's a drag on our global attractiveness as a site for early launch.

The last priority is broader: Enhancing our reputation and building trust. To do this, we will be looking for new ways to create true partnerships across the stakeholder community. The industry's Code of Ethical Practice is a solid starting point and we will continue this year to work on ensuring it is fully up-to-date with changes in technology and business practice. We are extremely proud of our leadership role in the field of corporate ethical behavior.

PE: What's the logical next step in a policy agenda that will position Big Pharma for long-term success?

RW: All the initiatives I have reviewed matter in preserving our basic "license to operate." One neglected area is how we cooperate internally as associations, across borders. This industry is global; our member companies are active in virtually every country. Yet as industry associations we often fail to seize the opportunities that stem from convergence. The list is endless—regulatory standards, IP, supply chain security, trade liberalization, health technology assessments, among others. We have very strong and constructive ongoing relations with PhRMA and we are developing cooperation that involves all three of the countries of North America, including Mexico. We should work jointly with our three governments to showcase the entire region as the preferred global destination for life sciences investment.


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