Health Committee on Nov. 6th, 2013

[Robert Ianiro]

Madam Chair, I will turn the question over to Dr. Stewart, who I think is best placed to speak to the drug approval process in this particular case of generic OxyContin. If there is an opportunity after he responds to provide some data that we're aware of in the way of uptake of the generic OxyContin versions as well as the new version of OxyContin, I'd be happy to add that, but I want to ensure he has time to answer that part of the question. Thank you.

[The Chair, Conservative, Joy Smith]

Excuse me.

Yes, Dr. Fry?

[Hedy Fry, Liberal, Vancouver Centre, BC]

Madam Chair, before that answer occurs, I would prefer to get very crisp and concise answers, because I have another question I want to ask in my period of time, if possible. Thank you.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Fry.

Dr. Stewart, would you, through the chair, reply.

[Dr. John Patrick Stewart]

Madam Chair, my response would be this. In Canada, under the Food and Drugs Act and its regulations, a drug will be issued a market authorization if, after a risk-based decision-making process, Health Canada determines that the drug demonstrates safety, efficacy, and quality under its recommended conditions of use for the intended patient population. That is the group under which we consider the information is presented.

OxyContin had a DIN, so the innovative product had a DIN on the market. The generic company, under the Food and Drugs Act and regulations, can apply as a sub-entry product if it provides both scientific evidence under pharmaceutical equivalency and bioequivalency to have a market authorization as a generic product. For OxyContin, which had already been on the market, six generic companies were able to provide that information. Our Food and Drugs Act and its regulations allow only to consider the scientific evidence around risk, safety, efficacy, and quality in the intended population.

Now, I'll speak to the comment about the U.S. approach. The U.S. food and drug regulations are somewhat different from Canada's. They do have the ability to consider implications of the product, implications that are outside of the intended use, if it has a public health issue. They have some flexibility in the way they can evaluate the evidence, and evidence that might be related to abuse deterrents outside of the intended population. Under our framework in Canada we have to focus on the intended use. Under that regulatory framework, the generic manufacturers were able to meet the bar to receive a market authorization.

[Hedy Fry, Liberal, Vancouver Centre, BC]

May I interject?

[The Chair, Conservative, Joy Smith]

Dr. Fry.

[Hedy Fry, Liberal, Vancouver Centre, BC]

If that's the case, why is the minister considering that she might actually do what she was asked to do by all of the provinces? I think risk is a factor, you said, in allowing for a drug to be produced, and the risks were clear. All of the public health officers, all of the provinces, showed the risk of OxyContin, a generic drug, being given as a prescription but hitting the street. I happen to know. I was part of the SNUD committee that looked at this issue. People would get a package from their doctor and they would go out and sell it on the street.

We know the risks. I'm saying if you wanted to have risk as one of your criteria, the risks were clear. You were asked by provinces, and you say you want to work with the provinces and territories, and you were asked by public health officers. We have an evidence base as to why one should get rid of OxyContin and not allow it to continue, remove the DIN, replace the DIN, based on risk of addiction and risk of street use.

I don't understand why this wasn't done then and why the minister is musing that she just might do it now. You haven't changed your regulations.

[The Chair, Conservative, Joy Smith]

I remind you to direct your answers through the chair.

Who would like to answer that?

[Dr. John Patrick Stewart]

I can respond to that, Madam Chair.

Our framework is as it is. We do look at risk. We look at risks to intended patients, the ones that the drug is supposed to be used by, and we ensure that it's labelled properly. We have a parallel set of regulatory frameworks that looks at the issue around diversion and abuse. I'll turn in a minute to my colleague to speak a little bit about some of the additional measures that were put in place at the time that OxyContin was approved to hopefully reduce the potential of this product being abused, a deterrent.

Our understanding is that OxyContin as a drug is a very valuable analgesic that's used widely to manage chronic pain. There is a large burden of chronic pain illness nationally, and we've heard from many stakeholders that OxyContin plays an important role in managing those patients' symptoms. So there's a clear efficacy, a clear need, a clear patient population where it makes sense to have this product available. I'm all in support as a federal government of making sure that we can minimize the likelihood that this may be abused, and deter it.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Stewart.

We now go to Mr. Wilks.

Go ahead, Mr. Wilks.

[David Wilks, Conservative, Kootenay—Columbia, BC]

Thank you, Madam Chair, and thank you to the witnesses for being here today.

My questions will be directed to Ms. Bruce and Ms. Gillis with regard to first nations and Inuit programs.

Within my riding of Kootenay—Columbia, I have what is referred to as the Three Voices of Healing Society, which is one of the 55 centres that are funded partially by the national native alcohol and drug abuse program which you mentioned in your speech. It probably receives a portion of that $92 million that is given annually.

I'm wondering if you could talk about what the first nation and/or Inuit people seeking treatment through the NNADAP, the national native alcohol and drug abuse program, are doing as a result of their use of prescription drugs.

Also, Madam Chair, has there been an increased demand for treatment services through that program as a result of the misuse of prescription drugs in recent years?

[The Chair, Conservative, Joy Smith]

Ms. Gillis, would you like to answer that question?

[Debra Gillis, Acting Director General, Interprofessional Advisory and Program Support, First Nations and Inuit Health Branch, Health Canada, Department of Health]

Yes, I'd be pleased to answer that question, Madam Chair.

We have recently conducted a study within our NNADAP, the national native alcohol and drug abuse program, treatment centres to really look at the extent of prescription drug and polydrug use of people seeking treatment through these centres. We have found that about 30% of all people entering the treatment centres use opioids in addition to alcohol. Some could be using other types of illicit drugs as well. So it's about 30% of those.

Through the increased knowledge around prescription drugs and the increased evidence that there are actually possibilities of working with and treating prescription drug abuse as part of an overall treatment program, we are seeing an increase in the demand for prescription drug abuse treatment in the NNADAP treatment centres. We've had a very high success rate actually, Madam Chair.

In the research that we have done, we've found that 72% of the clients who entered those treatment programs with an opioid use problem left without an opioid use issue. They terminated the use. Of that small number of clients who didn't, almost 90% reduced the use.

[The Chair, Conservative, Joy Smith]

Excuse me, I've just been informed that the bells are ringing. I'm going to have to adjourn this meeting right now. We will not be reconvening today, because I understand the votes are going to continue, but I want to thank the witnesses so much for coming today. I'm sure we'll have a chance to have you back again.

The committee meeting is adjourned.