Health Committee on April 16th, 2007

[The Vice-Chair, Bloc, Christiane Gagnon]

Good afternoon. I'm going to be chairing the meeting today, since the chairman cannot be here. We have our work cut out for us. Over the coming weeks we are going to be assessing the effectiveness of the Common Drug Review Program. We will be hearing briefs from the representatives of several organizations.

Today we will be hearing from industry representatives. Later we will be hearing witnesses from Health Canada, and the Canadian Agency for Drugs and Technologies in Health, as well as experts and patients' groups. This is in fact a topic of concern to various groups in the community that are involved directly or indirectly with prescription drugs.

The fact that today we are hearing industry representatives is not a strategic choice. It is simply due to the availability of those people who were willing to share their perspective with us. I hope that as the weeks go by the members of the committee will be able to form an opinion on these matters. I think that having access to drugs, and the best possible drugs, to treat patients are very important factors.

Before giving over the floor to the groups who are with us today, I would like to welcome Mr. Patrick Brown. He is replacing Mr. Dykstra who had to attend a hearing of the Committee on Justice and Human Rights.

I think that this committee is terrific. Today we will be hearing from four groups: Canada's Research-Based Pharmaceutical Companies, the Canadian Generic Pharmaceutical Association, AMGEN Canada Inc., and BIOTECanada. Each group will have 10 minutes to present their point of view on the effectiveness of this monitoring procedure for the acceptance of drugs. Before a province includes a drug on its list, a whole array of evaluations must be done. Your role is to enlighten us on this matter and to give us your advice, and ours is to evaluate the overall process.

I will now yield the floor to Mr. Williams. You are accompanied by Mr. Ferdinand, is that correct? The floor is yours.

[Russell Williams, President, Canada's Research-Based Pharmaceutical Companies (Rx & D)]

Thank you very much, Madam Chair.

Good afternoon, everyone. I am pleased to be here on behalf of Canada's Research-Based Pharmaceutical Companies (Rx&D).

The Standing Committee on Health plays a vital role in ensuring that wherever the federal government invests money to improve the health of Canadians, it is done in an effective, transparent and accountable manner.

We are pleased to assist you in your efforts to evaluate the effectiveness of the Common Drug Review, or CDR as it is commonly known.

We are, however, concerned when less than two business days before the hearings were to begin, the Canadian Agency for Drugs and Technologies in Health, or CADTH, issued a communiqué announcing a significant expansion of CDR. We have to ask ourselves if this usurps the work of the committee and your efforts to establish the true value of CDR.

Today I will make it clear to the members of this committee that the CDR process is, at best, a duplication and, at worst, a barrier for patients' access to medicines. I also believe it is unaccountable and lacks transparency. In short, CDR is fundamentally flawed.

Thirty percent of the funding of CDR and 80% of the funding of its umbrella agency, CADTH, comes from the federal tax dollars of hard-working Canadians. I would be more specific as to what these figures are, but we have found it almost impossible to do so. We have no idea how the federal government money is allocated, and this should be of great concern to us.

Innovative medicines and vaccines improve and save lives. They can prevent disease, reduce hospitalization and make our health care system more effective. However, to truly benefit from biopharmaceutical innovation, Canadians must have access to new medicines and vaccines as soon as they are approved by Health Canada.

One of the first steps of making a medicine available to Canadians is the Health Canada review. I would like to commend Health Canada for their efforts to reduce approval times and eliminate their backlogs, but these important gains are offset by CDR. This is counterproductive to patient health.

About 10 million Canadians are affected by CDR decisions through public drug plans, with the exception of Quebec, which, as you know, has chosen not to be part of CDR. Every time CDR says no to innovative medicine, it removes a treatment option for seniors, low-income families, and others who rely on these public drug plans. It is simply not right that so many Canadians are left behind.

Before a new medicine reaches a patient, it must be approved by Health Canada. Then CDR conducts its review, and each province and territory conducts its own review. This unnecessary duplication of effort means that patients are forced to wait longer for the medicines they need.

What we find incredibly troublesome is how CDR makes a negative listing recommendation after Health Canada has recognized the value of an innovative medicine. Let me repeat, these medicines have already been approved by Health Canada. But equally troublesome is the amount of time it takes provinces to list the drug that has received a positive recommendation from CDR.

Over the last three years, provinces have taken, and in some cases are still taking, hundreds of days to list these positively recommended drugs. Let me give you one of many examples of how CDR doesn't work in the best interests of patients. When Health Canada recognizes the value of an innovative medicine, it moves quickly and efficiently to ensure that the medicine is available to Canadians on a priority basis. This happened with a medicine known as Sutent, which is a new treatment found to be effective in battling against both gastrointestinal and kidney cancer.

Health Canada recognized the importance of this innovation to patients and fast-tracked it through a priority review. Within four months of approval by Health Canada, Quebec agreed to reimburse this new medicine for treatment of gastrointestinal cancer through the exceptional use program. Ontario also provided access to its patients suffering from gastrointestinal cancer.

What has CDR done? While the indication for gastrointestinal cancer was finally given a “list with criteria” recommendation at the end of March 2007—six months after Quebec made a decision to provide access to it—the CDR has yet to make a final recommendation for the kidney cancer indication. It means that patients are still waiting for access to a drug that was approved some eleven months ago by Health Canada.

Given that CDR is an added barrier to access, I would ask the members of this committee whether they think Canada needs three separate review processes for a single innovative medicine—Health Canada, then CDR, then the provinces.

Canadians should be the first to benefit from new medicines. An international comparative study done recently for Rx&D demonstrates this quite clearly. The authors of the study evaluated 50 listing recommendations by CDR with recommendations from other international peer agencies. They found that European countries recommend significantly more new drugs for listing than CDR recommends.

Madam Chair, it's the same molecule. It's the same science, but we have different outcomes. How can we explain this, and is this in the best interests of Canadians?

We believe the CDR places too much emphasis on cost containment and not enough on patient outcomes, but we do not need to look outside the border to find patients who have better access to innovative medicines. As mentioned earlier, Quebec is the only province that does not participate in CDR, and therefore they don't have that extra layer of duplication. They list more drugs, and patients are better off because of it.

In addition, CDR has added to the inequity in the access to medicines for Canadians. Simply put, the many Canadians who have private plans have far more choice and better access than those who are on public drug plans.

We, as a community, understand the challenges governments face to sustain funding for the health care system. We strongly believe that investing in new medicines is an investment in the health of Canadians and a stronger and more effective health care system.

Rx&D member companies also believe that all Canadian patients deserve access to the best therapies when they need them.

Madame la présidente, this committee decided to hold these public hearings, and I quote, “on the process used under the CDR to evaluate drugs and obtain your comments on the effectiveness of the CDR”. However, the agency overseeing CDR has already decided to expand, stating that it has met its objectives. In our view, this is not the case. Furthermore, it is not in the public interest to expand a process that clearly is not working.

CDR has had a regressive impact on patients' access to Health Canada-approved medicines. This is particularly true for medicines approved by Health Canada to treat serious, life-threatening, and severely debilitating illnesses and conditions under the notice of compliance and conditions policy. To date, CDR has made negative recommendations for all but two of those NOCC drugs. Therefore, Rx&D urges the honourable members of this committee to recommend to the federal government that funding for CDR be frozen immediately.

In the meantime, we urge the Government of Canada to conduct an independent comprehensive review of its objectives and the accountability, value for money, and health outcomes as they relate to CDR. We must build a better system that avoids duplication and delay and mixed signals. We believe that by taking this action the standing committee will provide a voice to millions of Canadian patients who are waiting too long for access to medicines because of CDR and because provinces are taking too long to make decisions.

Before concluding, Madam Chair, I would also like to make one quick comment about the recently created joint oncology drug review. I encourage the JODR not to make the same delays as the common drug review.

Canadians expect and demand the best health care in the world. Our health care system is part of our social fabric and our identity. Rx&D believes that we have been, and continue to be, part of the solution in improving the health of all Canadians. A process that limits choice or delays or denies access to the world's most innovative medicines is not the answer.

Thank you very much, Madam Chair. I will be pleased to answer your questions after the other presentations.

[The Vice-Chair, Bloc, Christiane Gagnon]

The second speaker will be Mr. Jim Keon, from the Canadian Generic Pharmaceutical Association.

[Jim Keon, President, Canadian Generic Pharmaceutical Association]

Thank you, Madam Vice-Chair.

I am President of the Canadian Generic Pharmaceutical Association. I'm going to make my presentation in English.

I would like to start by saying that we appreciate the opportunity to make comments before your committee on the common drug review. The Canadian Generic Pharmaceutical Association, or CGPA, is the national trade association representing Canada's generic pharmaceutical industry.

To give a little context to start, according to the Canadian Institute for Health Information, since 1997 Canadians have been spending more on drugs each year than they have on physicians. IMS, the industry source for data, reports that between 1997 and 2006, spending on pharmaceuticals rose from $6.8 billion to $17.8 billion, a 162% increase over the 10 years. It is a trend that will continue to grow as the population ages, as expensive new medicines replace existing ones and as drug treatments form a larger part of patient care. IMS predicts that sales of prescription medicines will grow at 7.5% annually, to reach $23.4 billion by 2010.

The generic industry plays a key role in the health care system. We provide safe, proven, high-quality medicines, and the Canadian generic industry helps maintain the sustainability of government and employer-sponsored drug plans. Generic drugs are used to fill more than 44.5% of all prescriptions in Canada, and yet they represent only 18.1% of the expenditure. As these figures illustrate, generic drugs provide excellent value for money in Canada.

I should start out by saying that generic drugs are not actually evaluated by the common drug review, and you should keep that in mind for my comments. However, we do have some views on the common drug review.

The CDR was established to serve an important function for Canadians. When new drugs are approved by Health Canada, a brand name manufacturer must show that the product for the disease, condition, or ailment for which it is to be prescribed is more effective than a placebo. It must also be proven to be safe, which is obviously a relative term, as all prescription drugs have side effects, some more serious than others. We have seen high-profile withdrawal of such drugs as Vioxx, Rezulin, Baycol, and Propulsid in the past several years.

As has been demonstrated time and again, just because a drug is new does not mean that it is any more effective or any safer than drugs that are already on the market.

The Patented Medicine Prices Review Board, PMPRB, appraises the therapeutic novelty of every patented medicine in Canada to distinguish breakthrough drugs from other medicines, and it publishes these appraisals in its annual reports. Between 1990 and 2003, the PMPRB appraised 1,147 new drugs. Of these drugs, 68, or only 5.9%, met the PMPRB's regulatory criteria of being a breakthrough drug.

What physicians, provincial governments, and patients cannot know simply from the fact that the product has been approved by Health Canada is whether or not the new drug is more effective or safer than drugs that are already on the market. For physicians who need to determine whether and under what circumstances they should be prescribing the drugs, for governments and employers who are trying to determine whether they should be paying for the drug, and for patients who might be prescribed the new drug, these are the most important questions. The common drug review was created to answer those very questions.

There have also been concerns expressed that prescription drug coverage in Canada varies from province to province. A drug might be covered by the government plan in one province but not another. Again, the common drug review is intended to be a tool for helping to address this patchwork of coverage by making recommendations to all provinces on whether or not the therapeutic improvement offered by a new drug justifies its additional cost.

Governments, physicians, and the public must have information regarding the relative safety and efficacy of the product versus other drug or non-drug treatments in order to make decisions about whether to prescribe and pay for these new drugs. Health Canada's current approval process does not provide that information.

I suggest that the spirit of the formation of the common drug review be extended to apply to generic pharmaceutical products. Closer federal-provincial cooperation on the approval and listing of generic pharmaceutical products would benefit patients, taxpayers, and even brand name companies.

When generic drugs are submitted for inclusion on provincial formularies—the list of drugs for which each province will pay—they have already been approved by an exhaustive evaluation process at Health Canada. Yet while Health Canada standards of review are internationally recognized, some provinces continue to operate their own redundant review systems. This needless duplication of the federal approval delays the entry of generic drugs and costs taxpayers millions of dollars every year as provinces continue to pay for higher-priced brand versions for longer than they should.

The approval of generic pharmaceuticals at the provincial level should be a quick and easy process. Once a provincial government has weighed the therapeutic value of a new drug against its cost and decided to pay for it, which they do with a new brand drug, the decision to add a generic—generally 12 or 15 years after the introduction of the brand—to its formulary should be clear. After paying for a brand drug for years while it is under patent protection, the government should start to save money at the earliest opportunity by listing cheaper generic versions as soon as they are approved by Health Canada. Because private sector drug plans often base their benefits on what drugs are covered by government plans, a faster process would also provide Canadian employers and consumers with better access to generic drugs, resulting in even more significant savings. This would also provide the budget headroom so that drug benefit plans could pay for more of the brand name industry's new drugs.

Thank you for your time and attention.

[The Vice-Chair, Bloc, Christiane Gagnon]

We will now be hearing from Mr. Daniel Billen, Vice-President and General Manager of AMGEN Canada Inc.

[Dr. Daniel Billen, Vice-President and General Manager, AMGEN Canada Inc.]

Good morning, Madam Chair, honourable members of the committee. My name is Daniel Billen. I'm vice-president and general manager of Amgen in Canada.

I want to thank the committee for having invited me to this hearing and I am very pleased to have this opportunity to present AMGEN's viewpoint on the effectiveness of the Common Drug Review Program.

Too many of us in this room have family and friends who have suffered from cancer, kidney disease, rheumatoid arthritis, or other grievous illnesses. Many of those people are dependent on the government to provide medicine to deal with their disease.

At Amgen, our mission is to serve patients, especially those patients who suffer from serious disease.

Let me begin by telling you about how biotechnology is unique. It's a technology that uses living organisms to make new medicines instead of using traditional chemicals.

Biotechnology is a relatively new science, and advances in biotechnology provide unprecedented opportunities in medicine.

With this revolutionary approach that uses living organisms to make new medicines, biotechnology creates the potential to deal with critically unmet medical needs to treat cancer, multiple sclerosis, renal failure, and Alzheimer's, to name just a few.

The current biotechnology medicines are among the world's biggest breakthrough products—medicines such as Herceptin, Enbrel, and Neupogen. Today, 20% of all approved medicines are biotechnology medicines, and if we look 5 to 10 years ahead, that number will grow to close to 50%.

Let me now turn to Amgen and the impact on the patients we serve. Amgen is the largest biotechnology company in the world, and it prides itself on having served more than 10 million patients around the world for over 15 years. In Canada, half of our patients suffer from rheumatoid arthritis, and a quarter of our patients suffer from cancer or kidney disease.

If we look at Amgen's experience with CDR, it is the patients who have suffered the most. Over the last 15 years, Amgen has had five major medicines approved by Health Canada. Prior to CDR, all three of these medicines received wide public reimbursement across Canada. However, under CDR, zero out of the two remaining products received public reimbursement. Clearly, CDR did not improve patient access to Amgen's medicines.

Let us look at the facts from a global perspective. In an international study conducted by Rx&D in 2006, we can clearly see that Canada reimburses fewer medicines than other industrialized nations such as France, Switzerland, Sweden, the United Kingdom, and even Australia.

Let us focus on first-in-class medicines, or medicines that are the first of their kind. Of the seven medicines that came to market, the countries I just talked about on average recommended that five of them be publicly reimbursed. In Canada, zero of these medicines received a positive recommendation from CDR. Ladies and gentlemen, the picture on this slide is worth a thousand words.

CDR has been a fundamental failure. It has denied access to vital medicines. It puts Canadians at an overwhelming disadvantage compared to other modern countries. This denial of access is absolutely tragic for patients. It is unacceptable for us as Canadians.

So what should we do? We propose three practical, actionable, and deliverable reforms that could be implemented immediately: first, create a separate assessment process for first-in-class medicines; second, improve public accountability with public interest hearings and by making CDR subject to access to information requests; and third, establish an independent administrative appeal process for CDR recommendations.

Our common goal is to improve the human condition by providing patients access to critically important medicines.

Ladies and gentlemen, every day across this country patients hear the following words: “I'm sorry, there's nothing more we can do.” Well, ladies and gentlemen, there is something we can do. Can we not agree here and now that our shared goal as a society must be—it must be—to put patients first, to make critically important medicines available to Canadians?

Thank you.

I will be happy to answer your questions.

[The Vice-Chair, Bloc, Christiane Gagnon]

We have one last witness, Mr. Peter Brenders, president and CEO of BIOTECanada.

[Peter Brenders, President and Chief Executive Officer, BIOTECanada]

Merci. Madame la présidente, on behalf of Canada's biotechnology industry, I thank you and the Standing Committee on Health for conducting this important study of the process and effectiveness of the common drug review.

Today we would like to present to the standing committee the challenges that Canada's biotechnology community has faced as a result of the CDR process in bringing innovative new therapies to Canadian patients. Our recommendations, designed to bring Canada up to international standards of patient access, include having the CDR recognize the value of innovation, developing a review mechanism that can evaluate breakthrough and first-in-class products, and ensuring this process becomes fully accountable to the Canadian public by holding open meetings of its review committee.

Beginning our remarks this afternoon is Sean Thompson, director of corporate development for YM Biosciences in Mississauga.

[Sean Thompson, Director, Corporate Development, YM Biosciences Inc., BIOTECanada]

Good afternoon.

YM Biosciences is an early stage cancer product development company, which was founded in 1994. We are currently developing new therapeutic products that we have licensed from the Universities of Saskatchewan, Manitoba, and Dalhousie.

Our most advanced product is nimotuzumab, a biologically derived and produced molecule that is being developed for several underserved cancer indications. The lead indication for nimotuzumab is pediatric pontine glioma, which affects fewer than 50 Canadian children each year. In early studies, nimotuzumab has been shown to improve the quality and length of survival for affected patients.

I'm here today because my company is concerned that CDR, given its history to this point, would reject this Canadian-developed product and deny Canadian patients access to this potentially life-prolonging therapy.

A large part of my job is to identify the financial resources that are necessary to bring exciting new health discoveries to market. Often these development efforts are in partnership with leading multinational pharmaceutical companies or through venture capital investments. That job is made more difficult when venture funds and corporate licensing executives observe that the Canadian marketplace provides little or no market access for innovative biologic products as a direct result of CDR recommendations.

If Canada is to realize the full return on our investments in our universities and programs such as the Canadian Foundation for Innovation, Genome Canada, and the Canadian Institutes of Health Research, we must ensure that the fruits of those investments can reach Canadian patients.

To encourage further investment and development of innovative health inventions, Canada, through the CDR review, must recognize the value of innovation. In the United Kingdom, for example, the National Institute for Health and Clinical Excellence, NICE, a common comparator to CDR, explicitly takes into account the innovative nature of technology and wider societal interests. NICE also works with a citizens council in making reimbursement decisions on new medicines.

Incorporating these elements of the NICE system into CDR would begin to demonstrate that the Canadian system can accommodate the needs of vulnerable patient populations and that it values the innovation of breakthrough therapies.

[Peter Brenders]

YM is one example of the Canadian biotechnology industry's goal to develop new therapies for unmet needs of Canadian patients and to provide economic opportunity through the development of Canadian biotechnology. The latest data from Statistics Canada, released in January of this year, show that the 303 health biotechnology companies currently employ nearly 11,000 Canadians in high-skilled jobs and spend nearly $1.5 billion annually on research and development. This figure represents over 12% of the total business expenditures on research and development in Canada.

Our Canadian companies, located in every major city and province, are developing new cancer therapies, new treatments for Alzheimer's disease, osteoporosis, Parkinson's disease, and, perhaps most importantly, for rare diseases for which no other therapies exist. In fact, there are at least 27 Canadian companies that have received U.S. Food and Drug Administration orphan product designation for the products they are developing, the very types of products that the CDR has consistently rejected.

For three years, BIOTECanada has advocated that the CDR become publicly accountable for the decisions of the Canadian Expert Drug Advisory Committee, or CEDAC. Under the current system, the 12 CEDAC members meet behind closed doors to offer their collective opinion on the value of new treatments and on whether Canadians should have access to the new life-saving therapies. The CDR then issues recommendations to participating drug plans based on that opinion.

Thousands of Canadian patients live with the reality of CEDAC decisions, and taxpayers foot the bill for their deliberations. Yet the public has no access to the decision-making process that will determine the value of treatments for them. This situation is particularly troubling because CEDAC has rejected every single treatment for an unmet need, leaving Canadians without access to the most modern therapies available and sending a message to the world not to bother to bring innovations here. Moreover, as countries provide some level of public access to all these treatments for unmet needs that CEDAC has rejected, Canada is out of step in treating patients for these often rare and fatal conditions.

A 2005 evaluation of CDR by EKOS Research, conducted on behalf of the CDR, revealed widespread public dissatisfaction with the fairness and transparency of the review process. Not surprisingly, industry and patient advocacy groups felt strongly that the CDR process was not transparent. Canadians must have confidence that the review process to determine an opinion on value is robust and accountable. Accountability cannot be achieved in a process behind closed doors that ignores the views of the public. BIOTECanada maintains our position that accountability can be realized through open meetings of CEDAC that engage the public.

As we have seen, the CDR process has prevented those in need from getting access to innovative treatments. The challenging patient access environment in Canada presented by the CDR is becoming well known around the world, as I mentioned, and places us very much out of step with the global evaluation bodies. These same data, submitted to the CDR, have been used by reimbursement bodies in other parts of the world to approve public access for these products, and many countries have developed unique programs and mechanisms for the review of treatments for unmet needs.

The common-sense issues and concerns described above regarding the process and effectiveness of CDR's system have been repeatedly communicated to the CDR. Moreover, even the previous chair of CEDAC has publicly stated that the CDR process was not appropriate to deal with treatments for rare diseases. So why does it persist without fundamental change? Sadly, the changes we've seen are actually reflected in the provinces' spending more to set up alternative mechanisms to address issues presented by first-in-class or specialty treatments. The JODR is one example.

Our members recognize the complexity of some of these issues and are willing to work with Health Canada, the provinces, and the CDR towards solutions that can bring innovative therapies to the Canadian patients who need them.

I'd like to conclude by pointing out that BIOTECanada recommends that before this government make further investments in the CDR, the organization become fully accountable to the Canadian public through opening the CEDAC meetings. It must develop effective procedures to evaluate novel treatments for unmet medical needs, and it must explicitly incorporate mechanisms that recognize the value of health care innovation into its mandate. We believe Canadians can be better served by a more accountable process. The Canadian biotech industry is looking to help make this happen.

Merci.

[The Vice-Chair, Bloc, Christiane Gagnon]

We will now move on to our question period, beginning with Ms. Brown.

[Bonnie Brown, Liberal, Oakville, ON]

Thank you, Madam Chair.

Before I start, I'd like to make a point of order. I'm finding this meeting rather surprising, because while I'm aware that the committee decided to do a study on prescription drugs, and I'm aware that the common drug review is a piece of that rather large puzzle, I'm very surprised that, before starting a study, we have not had a document presented to us, as committee members, called “Terms of Reference for the Study on Prescription Drugs”.

In addition to the terms of reference for a study, which is the normal procedure at this committee, we are also, usually, provided with a work plan that tells us what the first meeting will be about, what the second meeting will be about, and so on. None of those things has happened. I don't know why, Madam Chair, but perhaps you could make some inquiries for us.

When one considers that we did a study of prescription drugs a few years ago, one might assume that the health committee could move directly into some of the nitty gritty problems concerning prescription drugs this country faces. However, when you also consider that of the 12 members on this committee, at least six were not present for that rather large study we did, one would realize that we should be following a more formalized structure. We should have Health Canada come and tell us about its responsibilities for prescription drugs. If the CDR is part of our study, as approved in a work plan—a work plan we haven't seen yet—then the people from the CDR should come, and so on.

So it seems to me that we are starting today with a rather thorny issue. Nothing that has been said here so far has surprised me, Madam Chair. Many of us are going to be jumping into this without sufficient background information—the history of the thing, how this came about, and so on—to really understand what's being said. It's obvious that this study has been launched at about stage 7 of a normal study. So I would ask, Madam Chair, that—

[The Vice-Chair, Bloc, Christiane Gagnon]

Thank you.

Mr. Fletcher.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

On a point of order, may I comment?

Actually, I think the member brings up a valid point. Starting at step 7 is not as good as starting at step 1. Perhaps the steering committee could get together and discuss some of the concerns the member has raised so we can do a proper study. I think that's what the member is looking for. So I think that's fair game.

[Bonnie Brown, Liberal, Oakville, ON]

Thank you, Madam Chair.

[The Vice-Chair, Bloc, Christiane Gagnon]

Is that okay?

[Bonnie Brown, Liberal, Oakville, ON]

Yes, I am. Thank you.

I apologize to the witnesses for bringing a point of order, but we've been away for two weeks, and I was very surprised by today's agenda, although I wasn't surprised by anything you said.

Can someone who's here on the panel tell me something? With the exception of Quebec, which never joined the common drug review, how many of our provinces are still carrying on their own reviews?

Mr. Williams.

[Russell Williams]

To your question, and I stand to be corrected, my understanding is that the general answer is most. Part of it is the reason I highlighted. One of my concerns is not just the rejections, but how long it takes after a positive recommendation. It ranges, in some cases, to several hundred days, so one would presume that there is something happening during all that time, and again, it's another review. That's why I talked about the three levels of review for the same drug.

[Bonnie Brown, Liberal, Oakville, ON]

I'm aware of that.

[Russell Williams]

If there are any corrections from the other panellists—

[Bonnie Brown, Liberal, Oakville, ON]

Okay. Now my question has always been about this. It's not whether it's appropriate for the federal government to be ruling on safety and efficacy. I wonder about a federal agency ruling on cost effectiveness when the federal government does not have a drug reimbursement plan for the general public. Do you have any opinions on that?

Mr. Williams, you were a politician. Is it not usual for the person who pays the piper to call the tune?

[Russell Williams]

To your question, most politicians, certainly, if they're paying the piper, as you say, like to make the decision.

Again, we talk about a good idea that sounds good on paper, but ultimately, who makes the best decision? Who runs it and who pays? In many cases, it is the provincial government. It is very difficult. You heard presentations from two companies today about the precision of the medications we're talking about. It is difficult to actually come up with a macro decision at a very high level to say that this is good for everybody. Provinces know their own jurisdictions better than anybody else.

[Bonnie Brown, Liberal, Oakville, ON]

Excuse me, but that's unless that authority is paying. If they're paying, they have the right to say that. But what we have is a jurisdiction that's calling the shots but not paying the piper. It's the lower jurisdictions that pay, which was Mr. Brenders' point.

[Russell Williams]

I'm not sure we can call it even a federal one. One of the issues is it seems to fall in between every level of government and the whole notion of appeal, transparency, accountability, and where the buck stops. I wouldn't quite call it a federal level; actually it's a creation of the FPT process. One of the concerns we've heard is that in fact it isn't accountable to any level.

[Bonnie Brown, Liberal, Oakville, ON]

I have another question here. The joint oncology drug review has now been contracted out to the Ontario government's cancer agency to make these decisions for everybody, I understand. Is that not the common drug review admitting it can't do cancer drugs? My question is, is the same thing true for biologics? Do the people who present those therapies feel that the common drug review is not as capable as they would like? Is the same thing true for drugs for rare diseases?

Dr. Billen would like to comment.