The length of a study varies depending on the disease. I think there are obviously international standards with respect to the length of a study. To demonstrate the efficacy of a product you don't necessarily have to test the product for a year. However, certainly for safety, studies are required to be longer.
There is a sense now that standards have been lower in recent years, but I do not agree, personally, with that view. As a matter of fact, if you look at the number of studies in the average new drug submission in the last 10 years, it has doubled. The number of studies that are required for a new drug submission has doubled. The number of patients has doubled.
I do not believe we are lowering the standards. I do not believe the time to review a drug is necessarily correlated with the outcome of that review. In other words, you could have an excellent review done in six months and a terrible review done in three years. So we have to be very careful about associating this concept of time with the quality of the data, the quality of the review.
The other thing I would add is that in Canada we see drugs actually available on the market significantly later than in some other jurisdictions, so there is time as well to observe the experience on the market.
I believe we have a system here in Canada, in some cases, where the international standard actually might not be followed. Health Canada was an observer of the International Conference on Harmonization. They endorse the standards that they feel are adequate, but the don't necessarily endorse others.
I hope this will address your question.