Health Committee on Sept. 27th, 2018

[Marilyn Gladu, Conservative, Sarnia—Lambton, ON]

Very good. Thank you.

My other question is for the PMPRB process.

I think the drug approval process we have today has gotten us to the median price of the OECD, which is why it was put in place, and we are doing lots of clinical trials.

Now, there are proposed changes. I sat with a bunch of stakeholders at the Macdonald-Laurier club. They were people from academia, people involved in clinical trials and people from pharma. Unanimously they were concerned that the changes to the process are going to make the process longer, that it will be almost three years before there will be any price certainty, and that this will cause people to not want to do clinical trials here, and actually have the unintended consequence of Canadians not having access to medications.

I heard that the process changes are now under re-evaluation. I just want a status update on that.

[Catherine Parker]

Karen Reynolds will answer that question.

[Karen Reynolds]

The changes you're referring to are proposed amendments to the patented medicines regulations, which would modernize the way the Patented Medicine Prices Review Board looks at setting non-excessive prices for patented medicine. They were published in the Canada Gazette last December. The consultation period on that closed in February. The department continues to evaluate the results of that consultation and continues dialogue with all the stakeholders before proceeding to Canada Gazette, Part II.

We don't have a definitive date for publication of the final regulations. We're certainly well aware of the comments and concerns of the stakeholder community. We can assure you that both the department and our colleagues at the board continue to work with those stakeholder groups, because we collectively understand the importance as a regulator of certainty, predictability and transparency in the application of those regulations to their ultimate success for Canadians overall and ensuring that Canadians continue to have access not only to the types of drugs that we're talking about today, but all patented medicines.

Thank you.

[The Chair, Liberal, Bill Casey]

Thanks very much.

Mr. Davies.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you, Mr. Chair.

Thank you to the witnesses for being here.

I want to read some excerpts from an article that was written in the National Post just last October, about 11 months ago. It's an article titled, “Health Canada gives 'kiss of death' to planned policy for rare-disease drugs”. It says:

Health Canada has quietly deleted from its website all references to a planned framework for rare-disease drugs that dates back to 2012 and was intended to improve the availability of such drugs in Canada. Canada is one of the only developed countries without a regulatory framework for rare-disease drugs, also known as orphan drugs.... Until Oct. 6, a Health Canada webpage claimed the department was “developing an orphan drug regulatory framework that seeks to encourage the development of orphan drugs and increase the availability of these products on the Canadian market.” It also promised consultations that were “expected to take place before the end of 2017.” The webpage has since been removed.

What happened?

[Catherine Parker]

You are correct that in 2012 the Minister of Health announced that Canada was going to proceed with the development of an orphan drug framework for Canada. We advanced a significant amount of work under that project. Most notable was the enactment of Bill C-17, Vanessa's law, which gave the regulator under the Food and Drugs Act many more powers that would be useful, especially in the rare disease space.

At that time we also considered going forward with a specific set of regulations. We decided on a change of course in this respect. We had conversations and dialogue with our international regulatory partners on some of the challenges they face because they had specific legislation for orphan drugs. We ultimately decided not to proceed with specific regulations, but through a regulatory review of drugs and devices initiative, we incorporated new processes and new pathways that could be very valuable for the approval of orphan drugs and also for some other products.

[Don Davies, NDP, Vancouver Kingsway, BC]

Did the consultations that were promised back in 2012 ever take place?

[Catherine Parker]

The consultations that were promised and that were on our website were consultations on upcoming regulations. We were no longer going to proceed with regulations, so we removed that reference to an upcoming consultation. We now have a full landing page on Canada.ca on our regulatory approach for orphan drugs.

[Don Davies, NDP, Vancouver Kingsway, BC]

One of the answers to that article on Health Canada was “many elements initially proposed as part of an orphan drug regulatory framework are now being considered more broadly for all drugs as part of this initiative”. That's a direct quote from Health Canada.

[Catherine Parker]

Yes.

[Don Davies, NDP, Vancouver Kingsway, BC]

I have two questions.

One, have you taken a focus that was originally on rare disease and orphan drugs and now subsumed that in a larger review of all drugs, as the quote suggests?

Two, when do you expect that review to be complete?

[Catherine Parker]

Yes, I will add caution by saying that we are seeing that many more of the applications that come to Health Canada are for orphan indications.

Relating to the question on genetic testing, as Dr. Stewart said, we're seeing a lot of medications coming through where as a result of genetic work, they are able to identify a subset of a disease. The disease itself may not be orphaned, but the subset is orphaned. We're seeing much more of that, so when we talk about what we're doing for all drugs, we are seeing a large proportion of orphan drugs.

One of the concerns we had going forward with specific regulations was that you have to tie them to a specific definition. Most definitions are based on incidents. For example—

[Don Davies, NDP, Vancouver Kingsway, BC]

Excuse me, but you're straying very far away from my questions and I have limited time.

[Catherine Parker]

Okay.

[Don Davies, NDP, Vancouver Kingsway, BC]

When is the review expected to be complete was my question.

[Catherine Parker]

We have already launched a number of achievable items in the regulatory review of drugs and devices. We are planning to have the entire initiative completed by the end of 2021.

However, we have already launched a number of things. We now offer aligned reviews between the regulator and the HTA to all drug manufacturers. We are providing early advice in drug development to sponsors in parallel with the HTAs. We are developing specific regulations that will allow us, for certain products, which has a great applicability to orphan drugs, to recognize a foreign regulator's decision to approve.

Those are—

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you. I appreciate that.

You mentioned that the EU has legislation. In the article, it says that Canada is a country that doesn't have any regulatory regime.

I take it that's correct.

[Catherine Parker]

We don't have any specific regulations.

[Don Davies, NDP, Vancouver Kingsway, BC]

Okay.

You said that the EU has legislation. What would be the key parts of the regulatory system or legislation that other jurisdictions like the EU have? Are they making a difference? Are they helpful?

[Catherine Parker]

In countries that have legislation, they have a number of things to encourage development. Some provide tax incentives for development. Some provide extended market exclusivity periods. There are also provisions for medications to be eligible for accelerated review, which we already have in Canada.

Those countries that have legislation have a number of components in that legislation. Our priority in Canada is to get the drugs here at the same time as they come to the U.S. or Europe. We are more focused on getting them into Canada and getting them through the regulatory process in the quickest and most efficient way, and working to also get access to them.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you.

[The Chair, Liberal, Bill Casey]

We're going to Mr. Ayoub.

Mr. Ayoub I suspect will be asking his questions in French.

[Ramez Ayoub, Liberal, Thérèse-De Blainville, QC]

Thank you, Mr. Chair.

I would like to thank the witnesses for being with us.

There is another extremely interesting and in many cases very urgent subject, since we are talking about rare diseases and access to drugs for a small part of the population.

I would like to know what Health Canada's mission is in relation to the approval and approach for rare diseases.

What is your mission with regard to this approach?

[Catherine Parker]

Thank you for your question.

Our mission as Health Canada is to provide availability of safe, effective and high-quality medications. That is applicable both to the rare disease community as well as the disease community at large.

[Ramez Ayoub, Liberal, Thérèse-De Blainville, QC]

I imagine that by setting up this mission, you had developed a plan to make it a success. How satisfied are you at the national level? Indeed, there are large gaps in Canada in access to drugs.

How does Canada compare on the international scene with our neighbour country, which we often criticize?

According to the Canadian Organization for Rare Disorders, 60% of drugs from the United States are accepted in Canada and when they are, it is after six years.

When you say that you want to have the drugs along with the other countries, whether it's Europe or the United States, that doesn't seem to be the case.

What is our rank and where are we going with all this? What is your action plan for the coming months?