Progressive Licensing:  The time has come

Overshadowed by the medical isotopes crisis, the announcement by Prime Minister Stephen Harper on December 17, 2007 regarding Canada’s new Food and Consumer Safety Action Plan slipped by my radar screen largely unnoticed. The title alone is vague and nondescript.

Having spent considerable time and energy over the past two years working with Health Canada’s Health Products and Food Branch updating Canada’s ancient and outdated drug policies, I thought this announcement was related to the recent issues on food importation from China and was happy this was going to be addressed. Imagine my surprise when I realized the new action plan included an initiative called The Progressive Licensing Framework, the very project I have been so involved with.

Canadian drug regulations and legislation have not been updated since the 1960s. It was becoming increasingly clear that the needs of the Canadian public were not being met. The COX 2 inhibitor debacle revealed the sad state of adverse reaction reporting in Canada. It is estimated that only 1% of adverse reactions are reported. It’s well known that many adverse drug reactions (ADR) do not show up until a product receives approval by Health Canada and is on the market. Our saving grace up until about 2003 was that Health Canada was so slow in approving new medications that by the time they made it to market in this country, the major ADRs had already shown themselves in other countries. Health Canada has significantly improved its timelines and we now have a major issue. Historically, patient/consumer involvement in Canadian health policy falls far behind that of other jurisdictions. Pharmaceutical companies could be selective about which clinical trials they would reveal when applying for a license to sell their product in Canada. The new framework will address these issues. Instead of assuming a product is 100% safe when it is approved for use, we all know, or should know, there are risks and benefits associated with the use of any drug, prescription or non-prescription, natural or pharmaceutical. One must always weigh the facts and decide with a physician on any treatment plan.

The Progressive Licensing Framework will begin pre-market, with the company including a risk management plan. Approval for selling a product could come with conditions, and will depend on the product. A bar of soap will not have the same conditions imposed as a new drug for arthritis. Products will be monitored continuously throughout their life cycle; as the body of evidence builds, the knowledge of adverse reactions increases, enabling Health Canada to respond appropriately. Vioxx posed serious risks for certain individuals. There were many people, however, who derived great benefits from the drug, including those with hemophilia. This patient population was at no risk for the reported side effect that caused the product to be pulled from the market. They experience tremendous joint pain and because the old regulations forced a complete withdrawal from the market, hemophiliacs have one less option for treatment. The new system could allow for certain patient populations to continue having access to a product, with the information available for them to make an informed decision regarding their healthcare.

Don’t believe those that say the Progressive Licensing Framework will put the health of Canadians at risk. We have already been exposed to great risks with an out-dated system put into place pre-internet. Not all that long ago information took over a week to go across the country via Canada Post, many Canadians shared their telephone service with other families and three television channels were the norm on a black and white console television set. The Progressive Licensing Framework is health policy for now and the future. We welcome it.