Initiative for Global Access to Medicines
Global Health Advocacy 4ZZ3
Ten years ago this week, the Canadian Access to Medicines Regime was created. Its purpose was to improve global access to medicines by allowing Canadian generic pharmaceutical companies to reproduce patented medicines at a lower cost, which could then be distributed to countries where these medicines are inaccessible.
In doing this, Canada was a global leader and tried to set an international precedent to use inexpensive generic drug manufacturing to improve access to lifesaving drugs worldwide.
Unfortunately, Canada’s leadership was short-lived. In its ten-year existence, CAMR has only been used once, highlighting its failure. CAMR procedures were found to be too cumbersome, and the only generic pharmaceutical company to ever use CAMR vowed never to try it again.
Last year, Canada had a chance to plug the holes in the original legislation. Although petty politics got in the way of the Canadian government’s chance to where to get azithromycin fix CAMR, there is still hope for improving global access to medicines. There is another option for Canada to use its strong pharmaceutical sector for the global good.
The Orphan Drug Regulatory Framework, a set of incentives meant to encourage research and development for rare and neglected diseases, is being brought to Parliament in Winter 2014. Rare diseases are those that affect less than five in 10,000 Canadians, while neglected diseases are those that disproportionately affect low- and middle-income countries, but receive little research funding. The ODRF legislation is a key opportunity for Canada to address the global disease burden.
Right now, Canadian pharmaceutical companies are not motivated to perform research on drugs for the diseases that most affect the developing world. The ODRF does not do enough to help stimulate such interest, particularly in the case for ultra-rare and neglected diseases. An additional incentive is needed so that researching these drugs is profitable for Canadian companies.
Canada should look to the United States’ in its innovative creation of Priority Review Vouchers. To provide further incentives to the ODRF, priority review vouchers can be awarded to pharmaceutical companies that develop rare and neglected disease therapies. In the regular review process, it takes Health Canada an average of 18 months to review and approve a new drug. Most of this time is spent waiting in line to begin the testing process. But under the priority review, certain drugs, such as those that target life-threatening diseases, are reviewed in just 3 months.
Priority review ensures that drugs complete the same approval processes and pass the same safety and quality testing, but without waiting in line. Priority review vouchers — which would allow companies to redeem these priority reviews for any drug — could be worth up to $300 million dollars in profits for pharmaceutical companies, since they allow for earlier market introduction of drugs.
This is a low-cost solution for the Canadian government that will increase profits for pharmaceutical companies, thus making it a financially sustainable enterprise.
Priority review vouchers will have a significant impact not only for Canadians living with rare and ultra-rare diseases, but can also have implications on global access to medicines. By incentivizing research and development on treatments for neglected diseases in addition to rare disorders, Canadian pharmaceutical companies will also be targeting the issue of availability of essential drugs to people in the developing world.
Canada has come a long way, but it still has a ways to go to fulfill its global commitments. Although the ODRF is an important step forward, but Canada needs to include priority review vouchers if it is to improve global drug access.
Canada was once a leader in access to medicines, and Canada can re-establish this role on the world stage once again.
Contributors: Asha Behdinan, Justina Ellery, Anna Foster, Esaba Kashem, Jennifer Romano, Sarah Silverberg.