Mr. Speaker, I would like to thank the hon. member for North Vancouver for raising this important issue and also to make members of this House aware that the government is interested in finding common ground on this important issue.
The subject the hon. member has raised is quite serious for many people, those diagnosed with these rare diseases, their families and loved ones, and Canadians across Canada who sympathize with their suffering.
Rare disorders affect people of all ages, races and ethnic backgrounds. Some disorders are genetic, for example, Tay-Sachs, Huntingdon's, or Sickle Cell disease. Some disorders are acquired, such as Legionnaires' disease. Other rare disorders can cause general health conditions, such as heart disease and cancer. Most have no known treatment.
A rare, or orphan, disease is one that affects fewer than 1 in 2,000 people. However, there are more than 6,000 rare disorders that, taken together, affect approximately 3 million Canadians. One in ten individuals in Canada has been diagnosed with a rare disorder. Many Canadians are affected, but very few with any one particular disorder. This is a serious issue for this government.
We recognize that Canadians who suffer from rare diseases have health needs that frequently are not met, particularly, in terms of access to needed treatments. Few therapies exist to treat these diseases.
The rapid advance in medical technologies and therapies has given many Canadians new hope, but developing and providing these medical techniques, such as genetic therapies, requires enormous resources. Potential treatments have often been considered too difficult and expensive to develop because of a very small patient population.
It is often difficult to conduct clinical trials and to demonstrate outcomes because the number of people suffering the disease is too small to allow the standard scientific techniques, like random sampling, control groups and so on. Nonetheless, we cannot ignore the suffering of Canadians with rare diseases.
Recently, new drugs for rare disease have become available in Canada, but evidence on whether they work is often weak and the costs of these drugs are beyond the budgets of most Canadians. Thus, important public policy regarding these drugs is essential.
This government has not been idle on this issue. My colleagues can attest to the fact that we have already taken many steps towards improving pharmaceutical management in this country, most notably in relation to drugs used to treat rare diseases.
We are improving the way we regulate drugs as part of the food and consumer safety action plan. This includes a life-cycle approach which goes beyond a simple decision on market access and also monitors drugs once they enter the market.
Along with our provincial and territorial partners, we have been working on improving the common drug review process.
We continue to work with the provinces and territories to improve drug management, including for rare diseases, as part of our collaboration under the national pharmaceutical strategy, a component of the 2004 health care accord.
As mentioned before, the government and the hon. member for North Vancouver have been working behind the scenes to find common ground so that this motion can pass this House. We have focused our discussions on several aspects of the motion and I am happy to outline these areas for my colleagues.
First, and foremost, the government believes the motion ought to take into account the roles played by the provinces and territories with this issue.
Our provincial and territorial counterparts are primarily responsible for deciding the extent of drug coverage for Canadians. Provincial and territorial governments determine who qualifies for public coverage within their jurisdictions, what drugs qualify for reimbursement, and what portion of the costs will be covered.
They also negotiate with drug manufacturers on the prices for the drugs they choose to reimburse, including prices for rare disease drugs. They regulate prescribing and dispensing of these drugs within their jurisdictions. This is an important element of this issue, given the key roles doctors play in determining appropriate prescribing and developing clinical practice guidelines.
As such, the government believes that we must include a reference in this motion to our provincial and territorial colleagues; a fact that the hon. member for North Vancouver has listened to and demonstrated a willingness to accept.
The government also believes that Motion M-426 should note the important role of the common drug review process—a productive collaboration between federal, provincial and territorial governments that assists them in their decisions about drug coverage.
The common drug review process evaluates the therapeutic benefits of drugs as well as their cost-effectiveness in comparison with existing therapies. It also provides recommendations such as if and under what circumstances drugs should be covered under government drug plans.
As the House is aware, the Standing Committee on Health undertook an examination of the common drug review and released a final report this past December. In that report, it recognized the importance of the role played by the common drug review and it made recommendations to improve it. One of those recommendations was the creation of a public advisory board for the common drug review.
The recommendation is quite similar to an element of this motion, which suggests that we consider establishing “a multi-stakeholder advisory body, including treaters and patients, to recommend treatment access for life-threatening or serious rare disorders”.
This government believes that the common drug review should be included in any work on rare disease issues.
In our response to the committee's report, the government indicated its interest in pursuing discussions with participating provinces and territories on opportunities to appropriately involve the public in the common drug review process. Appropriate public involvement can lead to better decisions, as well as confidence in the fairness of the decision making process.
Adapting the common drug review approach to assessing drugs for rare diseases was also highlighted.
One of the more challenging aspects to the motion surrounds a reference to defining a “rare” disorder. While experts have focused their study on defining this issue, to date there is no common definition of a rare disease.
Determining what diseases count as rare and, therefore, who will benefit from any changes that governments might collectively or individually implement, is a vital step and not one to be taken lightly.
If governments adopt special approaches for rare diseases, how then do we deal with the almost rare?
For example, if diseases affecting fewer than 500 Canadians are considered rare and treated differently, what happens to the people suffering from diseases that affect slightly more than 500 Canadians?
The government feels that we need processes that can adapt to the needs of all Canadians and all diseases, and we thank the welcoming nature with which the sponsor of Motion No. 426 has received these comments.
We recognize that these diseases have few options for treatment and that available drug therapies are often extremely costly. However, in the absence of solid analysis of other ways in which we could address these challenges, we are not convinced that this motion's proposed fund is the best way to deal with this difficult issue.
The government recognizes the difficulties faced by Canadians suffering from rare diseases and acknowledges the spirit in which the motion was put forth. However, the hon. member's motion does not take into account the necessity of working with the provinces and territories and the government is also concerned that some elements of this motion are premature.
These are serious issues that need to be addressed but we must do so in way that is prudent and respects the roles of those involved.
I can identify personally in a very small way with those who suffer from rare diseases. When our son was born in Germany 34 years ago, he was initially diagnosed as having PKU disease. Although PKU disease is not that rare, it does involve severe lifelong dietary restrictions to prevent irreversible brain damage. The prospect for our son was scary but in the end the diagnosis, thankfully, proved to be inaccurate.
The motivation and intent of the motion are entirely honourable and worthy of very serious consideration. I know the hon. member for North Vancouver has a strong personal investment in this issue and that he is committed to doing the right thing. I and all members of this House applaud him for that.
We look forward to working with him and other colleagues to arrive at a positive course of action that will ease the load on families dealing with the impact of rare diseases, while still respecting the requirement for collaboration and cooperation with all levels of responsibility and authority in the delivery of effective and affordable health care to all Canadians.