The Canadian province of British Columbia is removing an internationally-renowned independent watchdog from its drug approval process, in a move which critics say will increase costs and endanger patient safety.
As part of its revamp of the process for reviewing which products should be provided by BC’s PharmaCare drug plan, the Health Ministry will terminate the C$1 million it pays each year to fund the Therapeutics Initiative (TI), which was established in 1994 to “provide physicians and pharmacists with up-to-date, evidence-based, practical information on rational drug therapy” and is part of the University of British Columbia medicine school.
Supporters of the TI say it saves taxpayers about C$50 million a year for its C$1 million funding, and has been instrumental in keeping BC’s per capita spending on prescription drugs to the lowest level in Canada, at around 27% less than the national average. It has also saved lives, they add; its reluctance to approve Merck & Co’s nonsteroidal anti-inflammatory drug (NSAID) Vioxx (rofecoxib) – which the firm withdraw from the market on September 30, 2004 – and the restrictions placed on its use following recommendations from the Initiative are estimated to have saved around 500 lives in the province.
“We strongly believe in the need for independent assessments of evidence on drug therapy to balance the drug industry-sponsored information sources,” says the Initiative’s website.
The TI’s abolition was called for earlier this year by the provincial government’s Pharmaceutical Task Force which, while praising its therapeutic evaluation work, said it should be removed from formulary decision-making because it is “narrow, insular and resistant to meaningful stakeholder engagement.”
The Task Force, which was set up in 2008 by Health Minister George Abbott to “provide advice to government on how best to maximize value for patients and value for money as well as examine ways to continuously improve the pharmaceutical approval process,” has attracted criticism because five of its nine members have links with the industry.
Moreover, in another controversial decision, BC's new approval system will give drugmakers four separate opportunities to make their case for a product to be included in the PharmaCare formulary.
Previously they have had no part in such decisions, but they will now have ”an opportunity to comment” both before and after the government-appointed Drug Benefit Council makes its final recommendations, on which they will receive “embargoed” notification, and also before and after the Health Ministry’s final decision, and will be able to respond to proposals which are unfavourable to them. Officials have said the increased opportunities for industry feedback are aimed at avoiding having unanswered questions at the end of the process, while industry spokesmen say the changes will speed up patient access to innovative new drugs and increase transparency in the process.
However, Michael McBane, of the advocacy group Canada Health Coalition, says that no other provincial drug plan in Canada offers the industry as much involvement in such decisions, and that BC will move from having the best drug review process in the country to the worst.
The changes represent a conflict of interest, he says, not least because, from this month and uniquely in Canada, the new process also permits patients, caregivers and patient advocacy groups to contribute information and personal input to the review process for certain drugs. Patient groups frequently receive financial support from drugmakers.
- Meantime, in what the Times Colonist newspaper describes as “an act of spite” by the government, TI staff will not be offered posts on the Drug Benefit Council. “The experts who ran Canada’s most successful drug review programme have been told they are not wanted,” the newspaper says, but adds: “they won’t be short of employment. There have already been expressions of interest from officials in Ontario and in Britain.”