Health committee  The problem is that we're conflating what the PMPRB does currently with what's proposed. Currently we compare our prices to PMPRB7, which is a fairly premium-priced set of countries. What we're proposing is to compare ourselves to this basket of 12 countries where, on average, prices are more aligned or in tune with the OECD median.

Health committee  The answer is that it depends on the drug and how effective it is and how much value it brings for the cost you're paying for it, right? Now unfortunately, all we can do in setting price ceilings with respect to these types of drugs that are first to market, first in class, have no competitors, is to look at the prices the company that has the patent for that drug is charging in other countries.

Health committee  Well again, that's not within the purview of the PMPRB. It's a Health Canada question, but it is actually moving in that direction to some degree, especially for the SAP drugs that they're trying to get onto the market and formalize their presence in Canada. They are contemplating working with the EMA, to a lesser extent the FDA, and I'm not sure about Australia, and accepting at face value the market authorization that's been granted in that country as a basis to grant it in Canada.

Health committee  What's wrong with South Korea?

Health committee  As I mentioned before, PMPRB is supportive of the changes to the regulations, but they don't originate with us. We don't have policy authority over them. I think you'd be better served by directing that question to Health Canada. There are criteria they've identified in the RIAS that they considered in selecting those 12 countries.

Health committee  It's hard to improve on that answer, but some of the reforms we're looking at do, in fact, borrow from best practices abroad. Canadians try to incorporate these reforms into our regime and adapt them to the Canadian system. At the end of the day, everybody is struggling with this issue; everybody's grappling with it.

Health committee  Well, I think you might have missed a line of questioning on that very issue. I don't think there's anything we can do under our patent regime that will serve as a policy instrument to attract R and D to Canada. The literature would suggest that other policy instruments are much stronger determinants of where pharmaceutical R and D investment is located, and they typically are things like head office location—companies usually focus their R and D efforts in proximity to their head offices—scientific clusters, access to good patient data, genomic data.

Health committee  It really does depend on the drug. We do have service standards. Typically three months, but it will also turn on whether the patentee is inclined to comply voluntarily or whether we end up in a hearing. If it's a hearing, then there are no service standards that apply to hearings.

Health committee  Before I came to the PMPRB, I worked at the Competition Bureau and dealt with many different industries and sectors of the economy. Everybody wants price certainty. No one gets it. What you want is the most predictability and visibility in the regime, but there is no country that I'm aware of where a company can go back to its headquarters, and say this is the price we're going to get before it goes through the various processes, the HTA process, the negotiation process.

Health committee  I think that's the ideal. If we had to pick our top three, that's where we would land. I think it would be helpful if we had a more enhanced ability to compel information from companies, and if we had something in the nature of administrative monetary penalties in the cases of non-compliance.

Health committee  Yes, it certainly is.

Health committee  I would say not at all. It's not unique to Canada the fact that both prices and R and D are not disclosed publicly.

Health committee  There is a mechanism in our act that would enable a hearing panel of the board to compel that type of information from the company if it felt it was germane, and if it required that information to make a ruling on whether the price of the drug was, in fact, excessive. But there have been all manner of drug transparency bills proposed before various state legislatures in the U.S., whereby they are trying to compel companies to open up the books and actually reveal how much they are spending on these drugs and whether there is some proportionate relationship between R and D and prices.

Health committee  I couldn't give you numbers off the top of my head.

Health committee  How much time do I have?