Evidence of meeting #58 for Health in the 41st Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drugs.
A recording is available from Parliament.
11 a.m.
Conservative
The Chair Conservative Joy Smith
Good morning, everybody, and welcome to the health committee. It's great to see everybody here this morning. Pursuant to Standing Order 108(2) we're studying technological innovation.
We have very credible witnesses with us today, very distinguished witnesses.
From the Department of Health, we have Barbara Sabourin, director general. Is that Dr. Sabourin?
11 a.m.
Barbara Sabourin
No.
11 a.m.
Conservative
The Chair Conservative Joy Smith
From the Canadian Institutes of Health Research, we have Dr. Alain Beaudet. Welcome, it's nice to see you again.
From the Canadian Agency for Drugs and Technologies in Health, we have Dr. Brian O'Rourke, president and chief executive officer. Welcome.
We shall begin with Barbara Sabourin.
11 a.m.
Barbara Sabourin Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
Thank you Madam Chair. I am pleased to be here today to speak about emerging technologies in health care and the important regulatory role played by Health Canada.
I am the Director General of the Therapeutic Products Directorate within the Health Products and Food Branch (HPFB).
The health products and food branch, HPFB, is the part of Health Canada responsible for the regulation of food and health products such as pharmaceuticals, biologics, and medical devices. A key part of our mandate is to take an integrated approach to managing the health-related risks and benefits of health products and food. We do this by minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food. As a regulator, it is essential that we adapt to the evolving expertise required to effectively assess submissions by continually re-evaluating our approaches. Many new technologies push the boundaries between the impossible and the possible. Technologies once thought impossible are now seen as mainstream therapies to address long-standing medical conditions. I have prepared a short document highlighting a few key initiatives, and I will take this opportunity to speak more generally to how our current priorities support emerging technologies.
To keep pace with evolving scientific innovations, we are taking steps to modernize our regulatory framework by advancing the regulatory road map, implementing ways to support innovation by reducing unnecessary regulatory burden on industry, and strengthening our partnerships and alignments with both domestic and international partners.
Providing timely access to new innovative therapies so that Canadians can maximize their health outcomes is a key departmental objective. One manner in which to achieve this objective is the priority review process, which facilitates fast-tracking and shorter review time of eligible new drugs and devices intended for treatment, prevention, or diagnosis of serious, life-threatening or severely debilitating diseases or conditions. The review time for a typical new active drug substance is 180 days as opposed to 300 days. For a medical device such as a class IV, or highest-risk, device, the priority review time is 45 days as opposed to 90.
For example, Health Canada granted priority review status to the Edwards Sapient heart valve, which will provide certain patients who cannot undergo open heart surgery with the option of valve replacement. This device was licensed on June 22, 2011.
In the field of oncology, Health Canada has granted priority review for drugs that serve disease states with high unmet needs and drugs for personalized medicines. An example is Jakavi, which is intended for the treatment of the effects of a rare blood cancer. It received priority review status because it demonstrated a marked and durable improvement in overall patient quality of life. This drug was approved on June 19, 2012.
In the area of innovative biologics, Canada became the first country in the world to license, in May 2012, a stem cell therapy for the treatment of complications of transplant in children.
Other mechanisms that enhance access to innovative therapies include setting internationally competitive performance targets for review times, facilitating earlier access to drugs by physicians and patients based on promising evidence of clinical effectiveness, adding a 30-day default review period for all clinical trial applications, and expediting the review of alternate sources of drugs that were recently in a shortage situation.
The increasing pace of technological change and the globalization of the health products industry present opportunities for HPFB to seek and promote harmonized standards and technical requirements, regulatory convergence, reduction of duplication, and increased collaboration with international regulatory counterparts. We continue to introduce guidance, when applicable, to assist sponsors in meeting the regulatory requirements relating to evolving technologies.
HPFB is highly respected worldwide and continues to strengthen international ties with other key regulators through our active involvement in all aspects of the International Conference on Harmonisation and through collaborative agreements such as the oncology cluster. In addition, the branch continues to build knowledge capacity by using foreign reviews and pooling expertise with international partners in innovative areas.
In an effort to facilitate innovative therapies, HPFB has also implemented new regulatory frameworks allowing decisions to be made for new drugs that are intended to be used in emergency situations, based on limited human studies that are supported by animal studies.
To conclude, HPFB places considerable emphasis on supporting innovation and emerging technologies to improve the health and safety of Canadians. As well, Canada has strong patent laws that provide eight years of market exclusivity for sponsors of innovative products. This makes our country attractive for clinical researchers and drug developers in the area of emerging technologies.
Thank you for the opportunity to appear before you today and I would be happy to respond to questions.
11:05 a.m.
Conservative
The Chair Conservative Joy Smith
Thank you very much. I appreciate your insightful comments this morning and your presentation that you handed out.
I will now go to the Canadian Institutes of Health Research. Dr. Beaudet, go ahead, please.
11:05 a.m.
Dr. Alain Beaudet President, Canadian Institutes of Health Research
Thank you Madam Chair.
Medicine is evolving incredibly rapidly. The future of medicine is a world where doctors use their smart phone instead of a stethoscope to examine a patient’s heart rate, a world where novel biomarkers will be used as part of early detection systems for physicians to better treat rejection of organ transplants, a world where an electronic nose is able to detect tuberculosis immediately and non-invasively from the patient’s breath in order to replace testing with sputum, a world where a surgeon from Toronto can perform surgery remotely on a patient in Yellowknife.
All these examples have the common attribute of representing new opportunities for improving the quality, the accessibility, and the safety of health care. That is what emerging technologies are all about, innovation. The future of health care in Canada lies in our ability to innovate. This means we must think differently, be bold, and be prepared to engage partners not traditionally associated with the health sector.
In other words, this means daring to support ambitious and groundbreaking projects that involve researchers from various disciplines, including biology, of course, but also physics, chemistry, mathematics, computer science and engineering. This means promoting co-operation and opening up to the international scene.
CIHR has been working more and more with its federal partners, including the Natural Sciences and Engineering Research Council of Canada, the National Research Council of Canada and Genome Canada, with a view to supporting research in this cutting-edge area of technology where various disciplines meet.
One of our initiatives is the advancing technology innovation through discovery program. This program allows researchers to apply new genomics technologies to identify the genetic causes of childhood diseases.
I am pleased to inform this committee that, in terms of emerging technologies, Canadian researchers are leading the way in many fields. In September, the Council of Canadian Academies released its assessment of science and technology performance in Canada and confirmed this. In the field of psychology and cognitive sciences, for example, Canada has both an extremely high output, with twice the volume of publications one would expect based on our population, and the fifth highest impact in the world.
In terms of nanosciences and nanotechnology, the assessment noted that Canada is growing the fastest in the world. The Canadian Institutes of Health Research are directly supporting the development of emerging technologies in a wide range of research areas. These include the development of new tools and applications in fields as varied as robotics, nanotechnology, genomics, regenerative medicine, and medical devices, but they also include innovations in the field of health care delivery, such as e-health and telemedicine, to name only a few.
Since 2006, CIHR has funded over 200 projects related to robotics, nanotechnology and the development of applications and medical devices. Those investments represent more than $200 million.
Maurice Ptito form the University of Montreal is a concrete example. With the support of CIHR, Dr. Ptito developed a sensory substitution device that could potentially help blind people with navigation. This tongue display unit retransmits visual information through a camera; the pixels are translated by the tongue. Results show that not only is the information perceived by the tongue unit through the camera sent to the brain, but also that this information is decoded in the brain with sufficient accuracy to enable the person to develop strategies in order to avoid obstacles and to move adequately.
Another fascinating example of futuristic brain machine interface is the work carried out at the incubator of Ryerson University by two young biomedical engineers who, in addition to developing such products as artificial lungs and assistive walking tools for paraplegics, have developed an artificial muscle-operated arm. This experimental device allows one to control an artificial limb just by thinking about it, a little bit as we normally do when thinking about moving a limb. It offers a greater range of movement than traditional prostheses and does not require the amputee to undergo invasive surgery. It is also easy to use and is relatively inexpensive to make.
Not only have these young researchers-entrepreneurs pushed the limits of the application of cybernetics to health, they have also made it a commercial success by creating a start-up, Bionik Laboratories, which has already attracted interest from major hospitals in the U.S. and Canada. The federal government has an important role to play in assisting companies like this one with the uptake of research activities and with ensuring that their successes are brought to market.
Other areas that hold great promise for new advances in helping those living with incurable diseases are genomics and stem cell research. Already, genome sequencing is changing the way we treat and prevent disease. For instance, thanks to early funding through CIHR's regional partnerships program, Dr. Patrick Parfrey and his colleagues from Memorial University in Newfoundland have made substantial strides in the research that led to the discovery of the gene responsible for young Newfoundland men falling dead suddenly from heart failure. Now, a simple blood test can reveal whether or not a person carries the fateful genetic mutation. Those identified with the gene have defibrillators implanted near the collarbone, with the result that Newfoundland’s sudden death syndrome has virtually disappeared. This example illustrates why CIHR and Genome Canada have launched a major strategic partnership on personalized medicine.
It is often said that the brain is the last frontier. Unravelling the mysteries of the brain so as to offer hope and cures for patients suffering from neurological and mental health disorders is another of CIHR’s major thrusts. Brain research is one of the areas in which we can hope to gain most from emerging technologies, in fields ranging from epigenetics to brain imaging.
Take, for example, the work of Dr. Antoine Adamantidis, who is the Canada research chair in neural circuits and optogenetics at the Douglas Hospital at McGill University. Dr. Adamantidis is studying the brain structures involved in the behaviour and psychological state of sleep and wakefulness. He has pioneered the use of optogenetics, which has opened new perspectives and unprecedented experimental strategies to probe the nerve circuits that control wakefulness. His research will help identify new treatments for illnesses associated with sleep disturbances, including depression, schizophrenia, and cognitive-related disorders.
Madam Chair, I wouldn’t want this committee to feel that the emerging technologies projects supported by CIHR are only about new tools, new gadgets, and new devices. They are also about developing new business models, integrating services in different settings, and scaling up successful initiatives into new models of care and services.
This is reflected in projects like that of Dr. Mikiko Terashima from Dalhousie University, whose research initiative seeks to track the locations of all of Nova Scotia's ambulances by use of global positioning systems. The goal is to find out what happens to overall ambulance services when there is overcrowding in hospital emergency departments. Researchers hope to use findings from the project to improve emergency services across the province.
As you can see, Madam Chair, the Canadian Institutes of Health Research are supporting leading edge research endeavours that are critical to ensuring the best health care and health outcomes for Canadians. In supporting these endeavours, CIHR and its partners from the public and private sectors remain focused on the principles of research excellence, research integrity, and patient safety. These are the gold standards for supporting the best ideas and the brightest minds and maintaining Canada’s competitiveness in our knowledge-based economy.
Thank you.
11:15 a.m.
Conservative
The Chair Conservative Joy Smith
Thank you so much, Dr. Beaudet.
We'll now go to the Canadian Agency for Drugs and Technologies in Health. We will start with Dr. Brian O'Rourke.
11:15 a.m.
Dr. Brian O'Rourke President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health
Thank you, Madam Chair, and thank you for inviting me to appear before the committee.
Let me begin by telling you a bit about the Canadian Agency for Drugs and Technologies in Health, or CADTH. We are an independent, not-for-profit corporation that was established in 1989. We refer to ourselves as a health technology assessment organization, meaning that we provide evidence-based assessments of the clinical and cost effectiveness of pharmaceuticals, of diagnostics, and of medical, dental, and surgical devices and procedures. In essence, we have two broad areas of work: our drug portfolio and our non-drug or technology portfolio, which covers devices, diagnostics, and procedures.
Our operating budget is approximately $22 million annually, with the majority of the funding coming from Health Canada and all of the provinces and territories with the exception of Quebec, which has its own agency. The members or owners of CADTH are the federal, provincial, and territorial deputy ministers of health, who fund the agency. We are governed by a board of directors that reports to the deputy ministers.
Madam Chair, CADTH operates with a dual value proposition. First, we are a producer of evidence, advice, tools, and recommendations that promote the optimal use of drugs and other health technologies. We also operate as a broker of Canadian and international health technology assessment activities.
As a producer, CADTH provides a range of services to support the effective management of pharmaceuticals and other health technologies in Canada. One of our flagship programs is the common drug review, a federal-provincial-territorial process used to review the clinical and cost effectiveness of new drugs and of existing drugs with new indications. The common drug review supports coverage decisions by 18 of the 19 publicly funded drug plans in Canada. Again, Quebec has its own system in place.
As you will recall, Madam Chair, the Standing Committee on Health studied the common drug review and released a report with recommendations in December 2007.
We also do therapeutic class reviews on pharmaceuticals and conduct optimal use projects, products that are the result of expert deliberative processes that provide the evidentiary foundation for jurisdictions to promote the appropriate prescribing and utilization of drugs and other technologies.
Another valuable service offering is quick summaries of the dauntingly large and complex medical literature, our rapid response service. This service is extremely helpful in that it addresses urgent jurisdictional needs for digestible and balanced information that informs policy and practice decisions concerning drug and non-drug technologies.
We also conduct more comprehensive and complex health technology assessments when warranted. Recent examples include assessments of robotic surgery, of magnetic resonance imaging units, of pharmacologic-based therapies for smoking cessation, and medical isotopes, to name a few.
As I mentioned, in addition to being a major producer of health technology assessments, CADTH also operates as a broker, helping to create and nurture an environment for evidence generation and adoption across Canada. As a pan-Canadian body, we are well positioned to work collaboratively with health technology assessment organizations operating at the provincial level, in academia, and within hospitals.
CADTH's mandate, whether as a producer or a broker, is to support the effective management of health technologies throughout their life cycle, from innovation to obsolescence. We do not make the final decisions on what technologies will be funded by health ministries or used by patients and clinicians; however, our work informs technology-related decision-making at both the policy level and the practice level.
As an organization involved in promoting the optimal use of health technologies, we support innovation. We recognize that advances in medical devices, drugs, and procedures help to improve health care delivery and patient outcomes.
We also recognize that new does not necessarily mean better and that some new health technologies offer no or only marginal improvements, but often at a much higher cost.
We see our role and the role of health technology assessment generally as providing the evidence to ensure that health technologies add value to the system, that they contribute to improved patient outcomes and/or health system sustainability, and that they are in fact innovations and not simply cost drivers.
With jurisdictions across the country dealing with significant economic challenges, the need to extract maximum value from every health care dollar has never been greater. Specifically, CADTH provides decision-makers with the information they require to make informed decisions in health care with respect to the additional benefits from new technologies balanced against their additional costs to the health care system.
In this way, decision-makers are able to make wise choices, ensuring that with each choice increasingly scarce health dollars gain more health benefit than they forgo.
Let me provide you with a few examples, Madam Chair.
Approximately 250,000 Canadians suffer from a heart condition referred to as atrial fibrillation, an irregular heartbeat that can lead to serious medical complications such as stroke. Most patients need lifelong therapy with anticoagulants, drugs that prevent the formation of blood clots. A drug by the name of warfarin has been the mainstay of therapy for about 60 years, but new oral anticoagulants are now available that are being touted as breakthrough drugs.
A rigorous review by CADTH showed only a small potential benefit over warfarin, no long-term safety data, and highly uncertain cost-effectiveness if these drugs were used broadly as a replacement for warfarin. Our review confirmed warfarin's continued place as first-line therapy, and our committee of experts recommended that the new oral anticoagulants be funded only when warfarin should not or cannot be used.
CADTH has made significant contributions in identifying the appropriate use of drugs and other technologies used in diabetes care. I want to highlight one example, in particular. Our research on the use of test strips to measure blood glucose levels has huge implications for the health system and for patients. Test strips are a costly and widely used technology. In 2010 Canada's public and private drug plans spent more than $500 million on them. But our research shows that people with diabetes who do not use insulin do not need to routinely self-test.
Acting on these findings has the potential to free up between $450 million and $1.2 billion between 2012 and 2015. Let's be clear. That's $450 million to $1.2 billion that not only produces no health benefit, but worse, in an economy with constrained health care budgets, it also prevents funders from spending this money on innovative technologies that would produce health benefit.
Since 2009 we've been working closely with partners across Canada, including the Canadian Diabetes Association, to disseminate this information, to educate health care professionals and patients, and to support the use of test strips only in circumstances where the patient will actually benefit.
Robotic surgery, computer-assisted surgery, and robot-assisted surgery are terms for technological developments that use robotic systems to aid in surgical procedures. This technology is, however, associated with significant capital, maintenance, and operating costs.
CADTH's work on robotic surgery, completed last year, confirmed that surgical robots do lead to improvements in some short-term outcomes, such as length of hospital stay, blood loss, and transfusion rates.
Our work also showed that there are ways to make the use of this technology even more cost-effective, such as using the robot for several different kinds of surgeries, increasing surgical volumes, and having the right support systems in place. Thus, our work is supportive of this innovative technology in some circumstances.
These examples show that health technology assessment provides clear guidance for public investment in health technologies—helping decision-makers choose between different therapeutic alternatives for the benefit of patients and the health system.
Madam Chair, I'd like to leave you with three messages.
First, now more than ever policy-makers need to be confident that their health technology purchasing choices increase health benefit. Health technology assessment is vital to informing those choices.
Second, health technology assessment helps ensure that patients attain the maximum benefit from new technologies by providing guidance with respect to appropriate use.
Third, health technology assessment is supportive of technological innovation, where innovation provides value to patients, to the health system, and to taxpayers.
CADTH, and health technology assessment in general, supports the adoption of those innovative technologies that produce health benefits. However on the flip side, it also plays a role discouraging the adoption of those innovations that do not produce health benefits.
Thank you, Madam Chair, for allowing me to present to you today, and I welcome any questions you may have.
11:25 a.m.
Conservative
The Chair Conservative Joy Smith
I want to thank all the witnesses for their very insightful commentary this morning. It's very helpful to our study.
We will begin our seven-minute round of questions and answers with Ms. Davies.
11:25 a.m.
NDP
Libby Davies NDP Vancouver East, BC
Thank you very much, Madam Chairperson.
Thank you to our witnesses for being here today. Today is actually the first meeting of a new study we're beginning, so you kicked it off for us. We're beginning to get into this whole issue, which I think is pretty huge, in terms of innovation and technology in the health care system. The questions I have are fairly broad. I'm hoping there are issues we will explore further as we get into our study. All of you made very good presentations. It gives us the sense of what your department and agencies are working on. I have the feeling that great attention is paid to safety issues, monitoring, and evaluation.
What bodies, whether federal or provincial, are overseeing the impact of these new technologies? There must be an impact on human health resources. If there are new technologies coming in, that may require different kinds of expertise in various facilities. Who monitors that? Who responds to that?
The other part of that is accessibility. You have a whole menu of technologies coming in, and various research things are emerging. How do we ensure under the principles of the Canada Health Act there is even application across the country and that cherry-picking is not involved? For example, province X can afford this and, therefore, it gets some new technology and another one doesn't. There is an issue here of health equity. There are many players, and you're just at the federal level. It's not clear to me, with all the players involved, who keeps an eye on the bigger picture in terms of our health care system.
Could you address that question? Is anybody doing that, and if not, where are the gaps and what should we be doing?
11:25 a.m.
Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
Perhaps I could start and my colleagues could join in if they have additional comments.
11:25 a.m.
Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
In terms of the impact of technologies, the Food and Drugs Act and regulations provide us with some ability to oversee especially the safety side and the adverse events that might happen with the use of new technologies, especially drugs and devices. We take that role very seriously.
For many products, we do safety assessments when we see that the number of adverse events or the type of adverse events might be troubling, and then we might ask the manufacturer, for example, to change something on the label to more clearly prescribe or describe the risks and benefits of the products. We do certainly have a role.
That said, the Food and Drugs Act and regs focus on sale. As I'm sure you're aware, our role is somewhat limited and the provinces certainly have jurisdiction in the delivery of health care and monitoring of health outcomes for Canadians.
11:30 a.m.
President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health
Perhaps I could speak to the second question regarding accessibility and the cross-border issues in Canada.
Our common drug review, for example, was a program that was set up by the provinces and territories and the drug programs within the federal government. They created it about 10 years ago because of that issue. They were all dealing with their own processes and all looking at the information in a slightly different way. The common drug review has balanced that information. We do that assessment on behalf of all of the provinces and territories, except Quebec, and produce a recommendation that informs their decision-making. Our statistics show that about 92% of the time when they make a decision, it's consistent with a recommendation we put forward.
11:30 a.m.
NDP
Libby Davies NDP Vancouver East, BC
What about some of the technologies? I heard you on the common drug review, but what about the technology side?
11:30 a.m.
President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health
It's very different on the technology side. Drugs are so much easier because it's very top-down in most provinces. They have a drug plan and people in the ministry who do have controls in place. Devices are very bottom-up. New devices and new technologies are introduced into the system when, say, a manufacturer provides something to a surgeon or to a nurse and it slowly and easily becomes diffuse within the system without having a lot of information or assessment done of that technology. There are many decision points involved with the non-drug technologies.
11:30 a.m.
NDP
Libby Davies NDP Vancouver East, BC
Before Dr. Beaudet answers, I would ask you whether or not you could provide the committee with some notes. We're going to visit a facility in Montreal. I think it's called CAE Healthcare. They are producing some of these new robotic-type devices. It would be really helpful if the agency had any general notes about what we need to watch for. I don't know whether you could produce something for us. We're going on November 6. That's maybe too short a time, but it would be very helpful if we had some background if you're able to produce anything.
11:30 a.m.
President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health
We'll work very closely with the clerk and see what we can produce.
11:30 a.m.
President, Canadian Institutes of Health Research
As you know, we're supporting research. More and more we are mindful of the importance of evaluating the impact of these new technologies.
The best example I can give is the recent initiative on personalized medicine that we've launched with Genome Canada. It's a major initiative, $67.5 million to be matched equally by the provinces. We're talking $135 million on personalized medicine. It is about discovering new ways of producing care, diagnosing disease, and stratifying patients to ensure that treatments are appropriate. Imbedded in the request for application, RFA, and in the initiative itself is a clear intent to ensure that we measure the social impacts, economic impacts, and health impacts of these new technologies, and ensure in particular on the economic side, as my colleague explained earlier, that the expenses that will undoubtedly be linked with personalized medicine and genome sequencing linked to that will be compensated for by improved health, improved care, and actual savings, also, let's say, for all the patients we won't have to be treating because they don't have the right profile to respond, for instance, to a given drug.
11:30 a.m.
Conservative
11:30 a.m.
Conservative
Colin Carrie Conservative Oshawa, ON
Thank you very much, Madam Chair.
I want to thank all the witnesses for being here today. As my colleague said, we're just starting this new study, which I'm incredibly excited about. I want to thank each and every one of you for showing a leadership role in Canada and working in partnership with our provinces and territories. I know sometimes that can be very complicated with the complicated system we have here in Canada. It's wonderful to see you taking a leadership role in that regard.
My first question would be for Dr. O'Rourke. My question is about red tape. We hear about industry and about communication between provinces and territories. I know you've worked closely with Health Canada giving advice to help streamline, if possible, advice to provinces and territories and different decision-makers out there. You've been a part of the efforts to reduce this paperwork burden and all the stuff we hear about with industry. Sometimes we hear industry complain about that burden in Canada and about how it stops them from moving forward. I wonder if you could talk a little about that.
11:35 a.m.
President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health
Madam Chair, there are probably two things I'd like to say about that. One would be related to the common drug review again. When it was established, every province and the federal programs that deliver health care had their own systems in place. Over the 10 years or so that the common drug review has been in place, there have been some independent analyses that have actually shown that we've reduced that duplication and we've actually allowed quicker access to some of these innovative technologies. That's been a great advancement on the drug side.
One of the recommendations that came out of the review done by this committee in 2007 was about priority reviews and about how we could maybe streamline the process for some of these new breakthrough or first-in-class drugs. We did have some very good discussions with our colleagues at Health Canada about how we could perhaps streamline that.
The typical process is that Health Canada does their risk-benefit review, and when they give market authorization, then the manufacturer makes a submission to us. We wouldn't do our work until that market authorization was given.
For these priority review drugs that my colleague mentioned, we now start our process anywhere from two to three months prior to market authorization. There is a type of pre-notice of compliance program. Initially we put some criteria on that. The drug had to demonstrate significant benefits or safety issues, or it had to create the opportunity for some significant cost savings to the provinces. We've just decided that we'd like to remove those criteria and leave it totally open to the manufacturer to make that submission. If they'd like us to start our review in parallel with the review at Health Canada, not exactly when they start but somewhere in the process, that's their choice. That's been very helpful to us and very beneficial to the sponsors as well.