Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 17 - Evidence - May 17, 2012
OTTAWA, Thursday, May 17, 2012
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 10:28 a.m. to study prescription pharmaceuticals in Canada (topic: clinical trials); and to examine the subject matter of those elements contained in Division 54 of Part 4 of Bill C-38, An Act to implement certain provisions of the budget tabled in the House of Commons on March 29, 2012, and other measures.
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
The Chair: I am Kelvin Ogilvie, chair of the committee and a senator from Nova Scotia. I will ask my colleagues to introduce themselves.
Senator Seidman: I am Judith Seidman from Montreal, Quebec.
Senator Housakos: Leo Housakos from Montreal, Quebec.
Senator Martin: Good morning. I am Yonah Martin from Vancouver, British Columbia.
Senator Campbell: Larry Campbell from British Columbia.
Senator Cordy: I am Jane Cordy, a senator from Nova Scotia.
Senator Hubley: My name is Elizabeth Hubley, and I am a senator from Prince Edward Island.
Senator Callbeck: Catherine Callbeck from Prince Edward Island.
Senator Eggleton: I am Art Eggleton from Toronto, and I am deputy chair of the committee.
Senator Wallace: John Wallace from New Brunswick.
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
We continue our study today on prescription pharmaceuticals. I wish to remind colleagues that we have an agenda that calls for two sessions. This session will end at 11:30 a.m. Is that agreed?
Hon. Senators: Agreed.
The Chair: The second session will end at 12:30 p.m. Is that agreed?
Hon. Senators: Agreed.
The Chair: We will proceed with the ethical aspects of clinical trials. We have two individuals appearing as individuals, even though they have significant affiliations. I will identify them as I call you to present.
By earlier agreement, Matthew Herder, Assistant Professor, Health Law Institute, Faculties of Medicine and Law, Dalhousie University, will present first.
Matthew Herder, Assistant Professor, Health Law Institute, Faculties of Medicine and Law, Dalhousie University, as an individual: Thank you, Mr. Chair, for the privilege of appearing before you today. My remarks focus on the absence of transparency around clinical trials in Canada. The practice right now — pushed forward by the manufacturer and accepted by the regulator — is to keep clinical trial designs and data secret. There are many reasons why this lack of transparency is problematic. Most important, it risks — or in some cases harms — Canadians. For that reason alone, greater openness in the regulatory system should be required.
In the first part of my comments I will offer three additional reasons why we need greater transparency and in the second part I will close with what should be more transparent.
The first part and the first reason is why greater transparency is needed. Keeping clinical trials secret violates a fundamental principle of research ethics. Every health product submitted to Health Canada for approval has been previously tested on humans. Keeping secret the knowledge that those participants help generate, quoting a recent article published by the New York Times, "is a disservice to those who volunteer their bodies for clinical trials." It also violates a fundamental principle of research ethics, namely that there must be an acceptable harm to benefit ratio. In the case of clinical trials involving a drug, biologic or medical device the potential harms to human participants are significant. However, in most of those cases, the only potential benefit is the generation of new knowledge. If we accept that to count as new knowledge, a scientific finding must be reproducible in principle, then the alleged benefit of participating in clinical trials becomes an illusion. When conditions of secrecy are imposed upon the trial, a significant barrier to reproducibility is introduced. Therefore, the harm to benefit ratio must be considered unacceptable in every case.
Clinical trials that are not published or kept confidential thus violate the ethical principle that the research must carry an acceptable harm to benefit ratio.
The second reason is that shifts in scientific knowledge, product development and regulatory standards demand enhanced transparency.
We are in the midst of great change in molecular biology in how companies develop their products and how regulators assess their safety and efficacy. The scientific literature is flooded with exciting but largely unproven scientific findings from the genetic and epigenetic realm. Companies are using this wealth of new but poorly understood information to develop so-called personalized therapies. Moreover, there are increasing demands for greater regulatory flexibility around what evidence of safety and efficacy should suffice for market approval.
Regulators seem increasingly receptive to alternative trial designs, yet two recent studies suggest the evidence behind orphan medicines for cancers and neurological conditions depart in troubling ways from important experimental standards. The authors of one of those two studies summarized the implications of their findings as follows in the Journal of the American Medicine Association:
The Food and Drug Administration's flexibility regarding clinical trial designs for orphan cancer drugs has meant that these drugs can be approved on a more expedited time frame, and this approach may have some advantages, for example, in life-threatening circumstances or where no other therapeutic options exist. But our study found that such flexibility can also lead to a worrisome lowering of trial design standards, excessive willingness to lower those standards for orphan drugs can lead to identifying benefits that are not real or missing risks that are.
In other words, the authors of this study show that the pressure upon regulators to both accelerate approvals and accommodate alternative trial designs can carry significant safety and efficacy trade-offs. The rapid growth of genetic information and the challenges involved in using that information to better understand and treat human disease will test the capacity of regulatory science in profound ways. Therefore, transparency must be a precondition to any regulatory changes that are made in the name of accelerating or better accommodating new submissions for personalized therapies.
The third reason is that secrecy is wasteful and transparency creates opportunities for innovation. Greater transparency in Health Canada's decision making and the evidence that informs it promises two kinds of innovation benefits.
First, making Health Canada's decisions transparent can reduce redundant research and development efforts; companies can learn from each other's missteps.
Second, making data available that is submitted to the regulator gives manufacturers the opportunity to aggregate those findings with their own and predict whether patients will respond well to other treatments under investigation. Some manufacturers may focus on the potential downside of making data openly accessible, suggesting that others will free ride on their efforts.
I have three responses to that concern.
First, the drop-off in production of new treatments in the pharmaceutical industry is well documented. In an effort to address the problem some companies have begun to embrace more open and collaborative models of innovation. Therefore, opening up clinical trial data may be seen as an opportunity by some members of the industry.
Second, other measures are already in place — including patent rights and data exclusivity protection — that reduce the amount of competitive harm that openness of clinical trial data might occasion.
Third and most important, the primary goal of health research is not knowledge production at all costs. Rather, the primary goal is to create robust evidence that can enable policy makers and health care providers to make better decisions about how to allocate limited health resources, how to advance care and so forth. The social importance of creating a robust evidence base to inform health care decision making should therefore trump free riding concerns.
It is time for the debate to shift away from why greater transparency is needed to the specifics of doing so.
Presently Canada — as I have illustrated in the table I provided for you in my written submissions — is worse in essentially every aspect of the pre-market approval process in terms of transparency than other jurisdictions like Europe and the United States. Clinical trial registration is not legally required in Canada. This requirement is instead contained in guidelines that do not capture all research. They lack detail. There is poor oversight and enforcement. Further, only a subset of Health Canada's decisions regarding applications for market approval is publicly disclosed, and no results database has been created to allow for independent data analysis.
Therefore the following the three elements of the premarket regulatory process should be made more transparent.
First, all clinical trials including phase 1 — as well as observational studies — should be subject to mandatory registration. It is not a panacea, but it can mitigate gaming of trial results by manufacturers and can bring important gaps between the published and unpublished evidence to light.
Second, all of Health Canada's decisions regarding applications for market authorization and the reasons behind them should be open to public scrutiny. That is regardless of whether an application succeeds, fails, is abandoned, or is withdrawn. That outcome — and any assessment performed by Health Canada — should be transparent.
The European Medicines Agency currently discloses its refusals and the Food and Drug Administration in the United States is contemplating doing the same. Health Canada should move forward with it its own plans in this regard.
Third, Health Canada should be empowered to release full data reports accompanying applications for market authorization. There are technical solutions to any potential privacy concerns that this action might raise.
Providing comprehensive access to clinical trial data stripped of any personally identifying information will enable manufacturers to learn from each other's missteps, aggregate data and streamline product development.
In conclusion, each of these changes to the premarket approval process is necessary; none is sufficient on their own. Clear authority should be built into the Food and Drug Act and/or regulations in order to allow Health Canada to adopt these critical transparency measures.
The Chair: Thank you. I will now turn to Dr. David Moher.
Dr. David Moher, Senior Scientist, Clinical Epidemiology Program, Ottawa Hospital Research Institute, as an individual: Thank you for inviting me to present to the committee today. It is a privilege.
My comments are focused on transparency in clinical trials. I will cover a lot of territory because transparency is relevant across many issues related to the production of clinical trials. I would like to begin by stepping back for a moment and providing a little context.
Where do clinical trials fit in the life cycle of clinical research? The global health research enterprise is very large; almost $200 billion is spent annually. This results in about 3 million manuscripts submitted to journals, of which about 1.5 million are subsequently published. We do not know what per cent of this enterprise is accounted for by clinical trials. It is likely substantial, since more than 500 trials are published monthly. Recent estimates suggest that 75 trial reports are published daily.
Randomized trials are important and have made substantial contributions to the health of Canadians. They are the gold standard for evaluating the effectiveness of health interventions. When conducted correctly and reported completely, they are powerful, empowering clinicians, systematic reviewers and patients alike.
Dr. Drummond Rennie, Deputy Editor of the Journal of the American Medical Association, has said "the whole of medicine depends on the transparent reporting of clinical trials." Trials are often reported inadequately, diminishing their usefulness. For example, a recent examination of more than 500 reports revealed that more than half of them did not provide details about how they were randomized; for example, flipping a coin or using a computer program. This is an essential element, and possible in every trial. Randomized trials that do not provide this information can report spuriously exaggerated effects of drugs and other interventions.
Even more basic information is often missing from trial reports. Duff and his colleagues examined 262 reports of randomized trials from the most prominent cancer journals. They found that only 11 per cent of articles reported 10 essential items about the cancer interventions they studied, such as the drug name and dose.
Dr. Groves, the Deputy Editor of the British Medical Journal recently stated:
Yet even journals, some of which have been in the business of reporting research for many decades, are still not producing articles that are clear enough to really judge a study's conduct, quality, and importance—let alone to allow other researchers to reproduce it or build on it.
In summary, there is a lack of transparency and understanding regarding what the clinical trials did and found.
One solution is to develop checklists for researchers to follow when reporting their randomized trials. I led an effort to develop one such checklist for reporting randomized trials — CONSORT. It is endorsed by hundreds of medical journals around the world and international editorial groups, such as the World Association of Medical Editors. We have growing evidence that when CONSORT is used, reports of randomized trials are more complete and transparent. While I am proud of CONSORT, there are still many problems with the transparency of how trials are reported. One solution is for journal editors to follow up their endorsement with enforcement.
Why are there inadequately reported clinical trials, particularly when all of this research has passed the peer-review filter? It is a complex issue with many reasons. While medical journal editors can take advantage of short educational courses — perhaps two or three days — and some journals are committed to getting it right, most medical journal editors and peer reviewers are not sufficiently trained to carry out these functions.
One solution is to train editors, peer reviewers and authors in much the same way as we train people to drive cars and pilots to fly airplanes. Such training would benefit all Canadians.
For the most part, the pharmaceutical industry invests substantially to develop new drugs. The effectiveness of these drugs is evaluated in randomized clinical trials, some of which are subsequently published in peer-reviewed journals. Those trial reports are compiled together to provide a global summary of the effectiveness of the drug under investigation.
Systematic reviews provide busy clinicians and consumers with knowledge about the effects of the intervention under investigation, globally. These systematic reviews play an important role in the development of clinical practice guidelines that are used by your physician to help optimally manage your health. Clinical trials are hugely important building blocks for managing the health of all Canadians.
I would like to briefly discuss two major transparency problems affecting randomized trials: publication bias and selective outcome reporting.
In 1959, a Canadian researcher first reported that in the psychology literature, more than 90 per cent of published reports were statistically positive. What was published appeared to depend on the direction of the result; namely, did the study report a positive effect of the treatment? This study was repeated about twenty years later and included medical as well as psychology publications. The results were pretty similar in that there was a preponderance of statistically positive results and a lack of transparency about the existence of all studies.
You might well be thinking: Does it matter that trials are not published? Surely it is better for the cream to come to the top. Professor Simes, an Australian cancer specialist, reported nearly 30 years ago that if a physician based his or her treatment plan on published reports, they would make a different treatment decision compared to having both published and unpublished reports.
Only through full transparency of all randomized trials can we provide Canadians with a complete picture about the effectiveness of health interventions. I believe we need to advocate for legislative authority with teeth. That means enforcing to the full extent of the law. Endorsement without enforcement is a weaker option; it is less effective.
While this form of publication bias is concerned with issues about full studies missing, there is a more difficult problem called selective outcome reporting, and it also speaks to a lack of transparency in clinical trials. Selective outcome reporting occurs when authors select specific outcomes to report in the report of their research. Such selection is associated with those outcomes that appear to reach statistical significance. It is a very prevalent problem.
Clinical trial registers are an important tool to identify all trials, not just those with statistically positive results. The largest of these registers, clinicaltrials.gov, is a service of the U.S. National Institutes of Health and contains information on almost 1,000 trials. It has proven to be an important tool in increasing our knowledge about the existence and content of trials. It is not perfect; for example, only about half of the trials are registered completely, and even for those trials that are appropriately registered, about one-third of articles showed discrepancies between the primary outcomes registered and the outcomes published.
Clinical trials are incomplete despite legislative authority because of a lack of enforcement. No fine possible of up to $10,000 a day has ever been issued for not registering or incompletely registering a clinical trial.
Canadians volunteering to participate in research, particularly those agreeing to be allocated to an intervention by chance — namely, randomization, often with potential for substantial health risks — expect that the information gleaned from their involvement would have one of several possible outcomes. Most immediately, it might improve their health and it might provide accumulating information about the benefits and harms of the intervention under consideration. As such expectations are a minimum, they can only be realized if the data is actually reported. As we enter a new millennium, such minimally reasonable expectations, sadly, are not always reached.
Researchers are largely responsible for ensuring transparency. They are also uniquely positioned to help resolve the problem.
Is industry influential in clinical trials? Very much so. They conduct many of the trials, provide much-needed employment, and significantly contribute to the growth of our economy.
My belief is that the pharmaceutical industry and others in the business of developing and promoting health discovery should not conduct and report trials. They should be required to participate in a publicly controlled program whereby they provide the finances to conduct and report trials. Industry is not an independent bystander. They are conflicted. They are heavily invested in and must provide economic returns for their shareholders. That is their primary obligation, and it is an important one.
To answer questions of health effectiveness, the academic community is a more objective and independent group better positioned to meet the needs of Canadians. We need to promote and foster sound manufacturing practices and translate them to efficiently conduct clinical trials across a broad spectrum of our population, including children, the elderly and the disadvantaged. Harmonization is important, from having central and possibly singular ethics committees to standardizations for conduct practices and operational procedures, including agreed-upon budget line items.
In closing, I believe transparency in clinical trials essential. This can be achieved through better training of editors, peer reviewers and authors. Enforcement will also ensure transparency.
Thank you for the opportunity to present to you today.
The Chair: Thank you very much. Before I open it up to my colleagues, should we still have a list as we approach the end, I will interrupt and ask remaining senators to put their questions on the record. Our witnesses have kindly agreed to follow up afterward should that be the case, so we will ensure all your questions get responded to one way or the other.
Senator Eggleton: Thank you for your presentations. Transparency is a key theme obviously today.
In that regard, we are getting conflicting information. The very first session we had was with Health Canada officials and others, CIHR, and they indicated that basically the information was being provided. Even if it was not a mandatory registration, it was there. It was available. CIHR said they made all the trials they were involved in public, although we have had conflicting information on whether they withdrew some of the guidelines on that or not.
We were also told that many of these clinical trials are multinational and they would be registered either in Europe or the United States. We were getting the information that a lot of that was already out there.
How does that dovetail with what you are talking about today? Is some of it out there but not enough?
Mr. Moher: Well, definitely there is some trial information on clinical trial registers. There is no question about it. We have lots of evidence. It is not all there. What is there is not complete and in some cases is not accurate. We have fairly good evidence about that.
I was certainly involved with Dr. Alan Bernstein who was the then President of CIHR when they brought out the policy of registering the trials that they funded, and they endorsed that idea. Endorsement is not sufficient; it has to be enforced. We need somebody to go and very regularly look and see what is there from the Canadian perspective. It might be that all agencies in Canada could play in the sandbox together and have a single individual or single group who might be responsible for looking at what is there and enforcing it.
Endorsement is wonderful, but if it is not enforced, then I think we will run into significant problems, and the evidence is that we do run into significant problems.
Mr. Herder: I would echo my colleague's comments. We do not have all the information we need.
Senator Eggleton: One thing that came up yesterday on research ethics board, REBs, we heard there are for-profit entities as well as the usual institutional entities we are familiar with. Do you have any comments on that, on whether that is inappropriate or needs further restrictions? What guidelines need to be set for those kinds of entities?
Mr. Herder: I would bring it back to an issue of conflict in terms of being a sustainable business but at the same time providing oversight, and that poses considerable concern from my perspective. There is a definite need for oversight of those kinds of entities, which is not to say that boards rooted and entirely populated by academic members are without problems. Often they may not have enough institutional support, so there are tensions within non-profit organizations as well. There is a need to increase oversight and a move towards a national system of research ethics that is enforced and monitored overall so it would be irrespective whether it is for-profit or not.
Senator Eggleton: Another thing that came up is competitiveness for getting clinical trials in Canada. Some industry people have said we are losing ground and we need to be more competitive in getting these trials here. Is that clouding the picture? Is that making or resulting in a desire to relax the regulations so that we could attract more? Is there an inherent conflict there, do you think?
Mr. Herder: It is important to think about why we are doing clinical trials. A certain amount of infrastructure and having a number of ongoing clinical trials in the country is really important to be able to sustain, but if those clinical trials are investigating me-too products, they are not clinical trials that really add to the evidence base. They are seeding trials designed to make physicians more aware of a product rather than actually advancing health care by testing the standard of care against a new potential treatment.
It is important to keep in mind the overarching goals of why we want clinical trials done, not just the quantity but the quality of the clinical trials. That has to be the overriding goal.
The other thing with respect to this issue of competition, there are a lot of other factors. Lax oversight is very far down the list as to why our clinical trials may be dropping off in this country. Emerging markets, it might be cheaper to do it elsewhere. I believe Dr. Lexchin yesterday talked about how much cheaper it can be to do the trials in some of these emerging economies — market size, industry presence. A lot of trials are done in Germany. There is a huge industry presence in Germany relative to Canada, for example. Other factors that have little to do with complications with the REB or maybe intellectual property protection, something I focus on, which is engaged by transparency, are way down the line in terms of consideration as to why clinical trials are being carried out here.
Dr. Moher: I think that while we may want to encourage innovative trials to be done in Canada, and we may want to be a world leader, we need to always remember that patients participate in these trials in a voluntary manner, and I think we have an obligation to ensure that those trial reports and data is transparently made available and not put on a shelf or hidden. I feel we really need to do some work in that area.
Senator Callbeck: Thank you both for coming this morning. Many countries make it mandatory to register clinical trials. Are there some countries that have a checklist, if you register in that country, that you have to put specific information on there?
Dr. Moher: If you go to clinicaltrials.gov, it is the largest clinical trials register in the world. It has approximately 100,000 records. To register, you need to fill in a bunch of information. One could conceive of it as a checklist.
The evidence indicates that, first, despite it being legislated, not all trials are registered. Even of those trials that are registered, many are registered incompletely. It has not enforced, though.
The analogy I would give is that if we started driving on the wrong side of the road and we got away with it, then maybe lots of people will do it, and maybe that would send quite a strong message and many people will start doing that.
I think a checklist is fine to have, but it must be enforced.
Senator Callbeck: When they are registered, the initial registration, are there progress reports that are put up? Also, if a trial is terminated for some reason, is that put there as well?
Dr. Moher: That information can be put there. Certain trials are required to report their results and, in many cases, the results of the trials are there as well. However, it is not complete and there are serious problems. As I indicated, one of the more disturbing problems, at least to me, is that the primary outcome when they were designing the trial is, let us say A, and then later on it has changed.
Senator Callbeck: There is not really any country that is following up on this and making sure that it requires mandatory registration. Is that right?
Dr. Moher: The United States requires it. It is legislated. They do not seem to be enforcing it because it is incomplete.
Mr. Herder: It is also a legislated requirement in the European Union. Again, there are questions about how well it is being enforced.
Senator Callbeck: Why are they not enforcing it?
Dr. Moher: Manpower is certainly one of the issues. You need people to do it, and there may be other reasons for it as well, in terms of not being enforced.
Senator Callbeck: Professor Herder, you had an article in 2012 in the Canadian Medical Association Journal where you stated that there are institutional barriers within Health Canada that degrade our openness. Could you talk about and expand on those barriers?
Mr. Herder: I would be happy to. That part of the article really springs from how long it has taken for Health Canada to implement meaningful measures of transparency. The idea of one of the initiatives that is supposed to allow for more transparency of Health Canada's decision making is called the Summary Basis of Decision project. It was announced in the 1990s. The first phase did not begin until the early to mid-2000s, so just that time line, which took very long to implement.
By the time they had actually created and started that project, a lot of information which in the 1990s, when the project was conceived, was not in the public domain because the product monograph was not considered part of the public domain at the time, had been then relegated to the public domain by the time they started. When they did an internal review of the Summary Basis of Decision project, they concluded it was basically redundant with the information now in the public domain, because the public monograph is now in the public domain. Just the fact that it took that long is one of the reasons I am suggesting there is an institutional barrier to openness.
Another reason for that claim is under the Access to Information Act, there are provisions to reserve information because it is, in theory, owned by a third party. Health Canada uses those exemptions more than any other exemption under the access to information legislation. That, too, I think, suggests that there is a willingness to defer to the claim from the manufacturer that this information is proprietary. They are in conversation, in dialogue with those people that they regulate, so that hurts openness as well.
Senator Callbeck: In the same journal you mention agreements, regulatory authorities in other jurisdictions, such as the United States, Europe and Australia, with respect to non-disclosure of trade secrets. You say that the trade secrets have not been identified.
Can you discuss how Health Canada's definition of "trade secret" differs from that of, let us say, the United States?
Mr. Herder: I can try. The point I was trying to make, just in case it is not clear, was that there are these boilerplate clauses in memoranda of understanding with other regulators in United States, Europe and Australia, and all of them have a provision which says we will share information but we do not disclose trade secrets or confidential information, but they do not define in those memoranda what that encompasses. It is up to the regulator to define that. Clearly there must be a difference because the FDA in the United States, for example, discloses way more than Health Canada.
When I look at the legal definitions that are offered up for a trade secret or confidential business information, they do not depart very much. I would be happy to provide these four-part tests that have been defined by courts in the two different jurisdictions. In the abstract they do not look very different, but they are being interpreted and applied in different ways. That is why you are getting more or less openness in one jurisdiction or another. The other reason is that there is clearer authority around the apparent regulation of the FDA in the United States to disclose some of this stuff. In the absence of that authority in Canada, I think Health Canada is playing it safe in terms of the information but not playing it safe in terms of helping patients and physicians be aware of very important health information.
Senator Callbeck: Dr. Moher, do you have any comment on that?
Dr. Moher: No.
Senator Seidman: Professor Herder, you say that Canada is less transparent than other jurisdictions in essentially every part of the pre-market approval process. In fact, you give us a table with six categories in which you have "no" beside each category for Canada. In other words, we do not have access to that information, whereas in the United States you have "yes" in four out of the six. Indeed you are indicating we are less transparent in a whole host of areas.
I would like to know what you think is holding up more transparency in Canada, specifically the issues around the registry over which there has been an awful lot of confusion. Let us start with that, if we might.
Mr. Herder: I think it builds upon some of the things I was saying previously around the lack of specific legal authority in the Food and Drugs Act or the regulations. In a previous proposed bill, Bill C-51 in 2008, there was going to be an amendment so there would be power to create regulations to disclose more information. There was an amendment to the act itself being proposed in that bill.
I would argue that because there is not a court decision or a memorandum of understanding or a treaty that prevents Health Canada from being more proactive than it currently is in terms of disclosing, there is room. However, it would be a lot easier, and I am sure people in the legal academy might disagree with me and say you absolutely need a specific power in the regulations or the act to do things like make registration mandatory.
I think it is the absence of those kinds of legislative provisions or regulations that explain a lot of the hesitancy at present. Places where those powers are being used but maybe not followed through with as much as we need, those legislative provisions have been put in place.
Senator Seidman: Are you suggesting that registration in Canada should be mandatory?
Mr. Herder: Absolutely.
Senator Seidman: If that is the case, then you are suggesting that registration in international registries, including clinicaltrials.gov, which we have heard a lot about here, is not enough, that there should be a national registry?
Mr. Herder: I am not sure that it would have to be rooted in Canada. I think things like creating a national database for some of the research results — not just registering and providing information such as contained in the CONSORT statement — could be done on something like clinicaltrials.gov or databases maintained by the World Health Organization. I am not clear whether it must be a Canadian site per se, but I think there is room to do other things at a national level like a results database, which could be helpful as well.
Dr. Moher: I think we could join the global community, but we could do a lot to ensure that what we have there — what is Canadian — is complete. We could perhaps have a national body to ensure that it is there, it is complete, it is mandatory and that it is enforced.
Senator Seidman: Now you are getting to the nitty-gritty, which is who will look after this, who will ensure it, and who will enforce it. Are you saying there should be some national agency?
Dr. Moher: I do not know if it needs to be a national agency, but a group. It could be that across our great country — the people who fund trials — could come together and see if CIHR wants to take on that responsibility. Does another agency already within the country want to take on that responsibility? I do not think we need to create something new. There are excellent groups and bodies within Canada that can do it.
Senator Seidman: Are you clear on the data that should be recorded if we went to a system of national data collection? That is what I believe Professor Herder was suggesting, as opposed to a registry.
Dr. Moher: I think there are probably a few essential ingredients. I will work backwards. The results; it is absolutely essential that we have the results for every single trial. Working backwards, we then need to know what the intervention was, what was used. We need to know details about that. How many people were involved?
Part of the backbone of information from clinicaltrials.gov is based on the CONSORT checklist. I do not think it is hard to do, but I would really want to emphasize the results. That should be our commitment to Canadians. Any single piece of data that they generate because they participate in trials must be available.
Mr. Herder: It would be a mistake to think about the different transparency measures as mutually exclusive. Registration is helpful in terms of seeing changes to a trial along the way or if the outcome measures have been changed. We might want to know that. Results are important to see, but not just positive results; there is a publication bias in favour of those. Access to full trial reports would help people assemble data from multiple trials and maybe carry out additional trials in a more efficient manner. I think it is very important not to see it as one versus another, versus how we can use all these transparency measures to achieve a more robust evidence base.
Senator Cordy: I was going to ask about registration but that is taken care of. I will go back to the transparency of clinical trials. You are certainly not the first witness who has spoken about the lack of transparency. In fact, the Auditor General spoke about it and Mr. Neil Maxwell, the Assistant Auditor General, also spoke about the lack of transparency on drugs that are rejected, withdrawn or approved with conditions. We were not aware of all of that information. Yet, we have Health Canada appearing before us saying everything is coming along, it is fine. However, that is not at all what we are hearing.
I am concerned about the access to information requests where we are not getting the information because it is third party information. What can we do to ensure that changes to transparency through Health Canada and CIHR are in fact improved substantially in a quick period of time, not years and years later? I think more and more Canadians are greatly concerned about drugs they are taking. They would like to know if there conditions, the pros and the cons. No drug is perfect; every drug has side effects. Yet, we are not hearing about the clinical trials and what is going on. What can we do as a committee? What recommendation can we make to Health Canada?
Mr. Herder: Ironically, access to information legislation — or that mechanism — is not the root to transparency, primarily for reasons of time. It just takes too long. Even if Health Canada was meeting the time lines required under the Access to Information Act — which is not always the case — it would still be far too long, particularly if it is challenged by a manufacturer. It would be their right to do that. That whole time and delay, none of the information that physicians and health care patients require would be kept in confidence while that litigation plays out, or just while Health Canada investigates whether it can disclose it.
Reliance on the access to information legislation as a mechanism for transparency just will not work. We need more proactive measures and clear legislative authority to release information that Health Canada has, and not wait for an ad hoc after the fact request. The only reason that is coming up so much is because there is so little that is publicly available. That is improving a little bit, but not nearly enough. People have been trying the Access to Information route because they have no other choice. However, it takes way too long.
Senator Cordy: We also hear of drugs that are under review. No one knows why they are under review and suddenly six months later they are pulled off the market. You think perhaps while they were under review they should have been pulled off the market, but you do not know why. Would legislating the Department of Health work? Is there legislation — not from access to information as you said it would not work — that we should be thinking about as a committee?
Mr. Herder: That kind of real time access is more a question of resources. When there are safety concerns and so on, there are clear grounds for Health Canada to release the information and put people on notice that they might be at risk. Being able to figure out if that risk is real, in my understanding — I am not a scientist — is obviously very complex. Being able to do so and communicate that information might sound simple, but that active communication is very difficult. To put it in a format that reaches a lot of people, is comprehensive and evidence-based takes time and resources. It is not clear to me that there are enough resources available for those kinds of activities.
Dr. Moher: I would like to add that long term, we need to start teaching people who are starting graduate school or research careers about the notion of research integrity; the notion that you should not keep things hidden and the whole idea of publication ethics. If I look at universities here and abroad, there is very little devoted to this. We mint new physicians and new researchers and they are not always trained in these very important issues. We need to integrate this. It is obviously more long term, but we cannot continue to neglect it.
Senator Cordy: The whole privacy thing becomes an issue as well.
The Chair: I want to follow up on a couple of things that have come up and a couple that have not. I think you have given the answer to this in different ways, but I want to be absolutely clear.
With regard to the issue of transparency, are you including information on patients who withdraw during the trial? Are you also including full information on any trials that are truncated? Are those two aspects part of your request for full disclosure and transparency?
Dr. Moher: Absolutely.
Mr. Herder: Absolutely on the truncated trials, but we do need to protect patients' privacy. When they are enrolling in clinical trials, they are usually told that measures will be put in place to protect their privacy. We need to uphold that part of the informed consent process. There are ways to do that. There are still remote risks of being identified. People have shown that, particularly when dealing with genetic information, it is conceivable that someone could figure out whose data that actually is.
However, a lot of the time we allow research to go forward despite those risks, provided the participants are aware of that potential risk up front. Similar kinds of technical measures to protect patient privacy, to strip any materials of identifying information we should strive to do. The two objectives are not incompatible.
The Chair: To go to a couple of issues that have not come up in detail this morning, where would you stand on the issue of standardized ethics board approaches? We know that in every province there are many different ethics boards. I will leave it at that. Where would you be in terms of standardizing an ethics board approval approach with regard to both the issue of protecting patients as well as the issue of efficiency of clinical trials? Dr. Moher?
Dr. Moher: Probably I can speak a little bit to efficiency. I think we really need to push hard and do this. Having spent probably too many years on ethics committees, it is very difficult for researchers. Often they are left with quite a bad taste in their mouth about, "I will never get this trial up and going." Each committee has a different way of looking at it, and it seems to me highly inefficient. Anything that we can do that would standardize, and perhaps for trials that are large, multi-centre trials, going to a single committee, a single pass of approval I would very much favour and think many researchers would favour as well.
Mr. Herder: I would largely agree with those comments. I would just add that national ethics review seems to make a lot of sense, particularly where you have novel science, a novel set of issues where you need certain kinds of expertise that may not be locally available. However, in other kinds of clinical trials there might be room for regional or local boards that can still do a lot of work. That kind of division of labour might be helpful.
The Chair: The next question was sort of incidentally touched in one of your answers, and I will put the question to you this way: Where there are disease indications for which there are existing products on the market and a new entity is proposed to be tested in a clinical trial to enter that particular disease symptom, would you favour trial structures that not only have the traditional trial versus placebo but would include in the trial the application of existing approved medicines for comparison within the total clinical trial?
Dr. Moher: Can I just ask for clarification? What you are asking is if there is a product on the market and there is a new product in development that those be compared?
The Chair: Yes. In addition to comparing the new one against the placebo, the comparison be made against the existing marketed product.
Dr. Moher: I think it may depend. In some cases, I think absolutely. I think comparing a new treatment to an existing treatment would be highly appropriate. Comparing a treatment to a placebo might have a legal importance, but if the standard of care is not a placebo, then I am not quite sure why some of those trials are done because the standard of care is not a placebo.
Mr. Herder: I would agree entirely. It cannot be in addition to doing a placebo with the existing treatment or standard of care. That should not, in my opinion, get through research ethics because you would be offering something lower than standard of care through randomization to compare. We need more comparative effectiveness research, and incentivizing that is key.
Dr. Moher: We need less me-too research. This is not the tenth biologic for rheumatoid arthritis. We need some innovative products.
The Chair: Right. Those would be subject to other issues in terms of decision making. I am coming to the case, how do you determine that compound B, the new one, really is superior to compound A, the one on the market? I think, professor, you touched on the case of the ethical issue where there is a situation with a significant disease indication that is unethical to remove an individual from medication. I see you both agreeing with that concept.
The last question will go to Senator Seidman, and if it is not fully answered, I will have to end the meeting and ask you to follow up.
Senator Seidman: Quickly, Dr. Moher, I think I know the answer but I would like to be clear for the record, I think you said that in your meta-analysis of CTs you discovered a preponderance of statistically positive results. I would like it clear on the record how you think the type of transparency we are talking about, including mandatory registration of trials, would alter or change this.
Dr. Moher: If we are only going to look at positive results and combine them, we will only get a positive answer. If we really want to know the true answer, we have to look at the corpus of information out there. Some of that is positive, some of that is not so positive and some of it is negative, but we really are obliged to pull it all together, not just the positive stuff.
Senator Seidman: Exactly, including knowing dropouts of patients in truncated trials, as the chair has already referred to. All this data collection and final publication of all results would help in increasing the transparency?
Dr. Moher: Absolutely.
Senator Seidman: Thank you.
The Chair: Thank you very much. On behalf of the committee, I want to express our appreciation for the clarity and focus of your answers. If after you leave you think of any best practice examples on the issues that you have discussed with us today that you think might be of additional value to us, please submit that through our clerk.
With that, on behalf of the committee, I thank you for appearing before us today.
Honourable senators, we now welcome the Minister of Citizenship and Immigration and his colleagues to the start of our discussion on Division 54 of Bill C-38.
I welcome you to the Standing Senate Committee on Social Affairs, Science and Technology.
I will immediately turn the meeting over to the minister for his presentation.
Hon. Jason Kenney, P.C., M.P., Minister, Citizenship and Immigration Canada: Thank you very much, honourable senators, for this opportunity.
As you know, this legislation contains certain provisions of the budget we tabled in Parliament on March 29, as well as other important measures.
Our government's number one priority remains the economy. This bill will help address important economic and labour market issues facing Canada. It is especially important during these uncertain economic times.
Today, I will focus my remarks on the measures that will help transform Canada's immigration system. I say "transform" because, with these changes, we will maximize the benefits of immigration to Canada's economic well- being and fuel our long-term prosperity.
Today, I will focus my remarks on the measures that will help transform Canada's immigration system.
We are bringing in historically high, sustained levels of immigrants, among the highest relative levels in the developed world, yet many of them are facing unemployment and underemployment in an economy with growing labour shortages.
We need an immigration system that can help fill the significant labour shortages that we are facing across Canada. We also need one that can help respond to our economic needs in a timely manner. In order to get our system to where it needs to be, we absolutely need an immigration system that is fast, flexible and proactive.
We have made some progress in recent years to help turn the corner and improve the outcomes of immigrants. However, if we want an immigration program that more directly meets our economic needs in a timely and efficient manner, there should be no question that more needs to be done.
We envision a "just in time" immigration system where the entire process for a skilled immigrant to apply to come to this country, be accepted, be admitted and then gainfully employed would take only a few months rather than several years.
The changes we have proposed will not only better serve our national interest. They will also serve the best interest of the immigrants we select for their economic potential.
Allow me to explain how and why, by providing an overview of the measures we have proposed under this legislation.
Right now, there are hundreds of thousands of skilled immigrants who can expect to wait for up to eight years before receiving a decision on their application.
Reforms we introduced in 2008 under the Action Plan for Faster Immigration helped us to reduce the backlog of federal skilled worker applicants by half. The Federal Skilled Worker Program is the main federal immigration program known as the point system. When the current government came to office, we inherited a backlog of over 600,000 people in that application. As a result of the limitations on the number of new applications that we imposed subsequent to amendments to the Immigration Act in 2008, we have been able to cut that backlog by about half.
It is simply not in Canada's interest to deal with a large backlog of applications that are seven or eight years old, nor is it in the interest of immigrants. That is why we will close all applications received before February 27, 2008, for whom an immigration officer has not made a decision based on the program's selection criteria by March 29 of this year.
February 27, 2008, is the date when we renounced the new legislative powers to limit new applications. That has become a very important date in managing inventories in our system. We will subsequently return all fees paid to Citizenship and Immigration Canada and invite applicants who are still interested in coming to Canada to reapply under the terms of our new programs.
In recent months, Prime Minister Harper has spoken about doing more in the economy of the future than just passively accepting immigration applications. Toward that goal, we will be exploring with provinces and employers approaches to develop a pool of skilled workers who are ready to begin employment in Canada at their skill level upon arrival as much as possible with a prearranged job.
The federal government will continue its job of assessing the human capital of skilled immigrants, which is the rationale of the skilled worker program points system, to determine whether they have the ability to succeed in Canada over the long term.
We remain responsible for ensuring that immigrants meet our security and medical requirements before they are admitted.
Essentially, we hope to have the best of both worlds with this new system. What we have in mind is a system that combines our points grid — which assesses applicants on a variety of factors such as education, work experience and language ability — with a greater emphasis on the ever-changing needs of the Canadian labour market.
This legislation recognizes the inevitability that our country's economic needs will change in the future. Under the IRPA, the Immigration and Refugee Protection Act, ministerial instructions provide the minister with the authority to instruct immigration officers on the processing of applications in order to best attain our immigration goals.
Bill C-38 would amend subsection 87.3 of the IRPA in order to allow ministerial instructions to be applied against applications that are already in our system. This would ensure more flexibility in managing our inventory, enable the government to address backlogs and, most importantly, avoid new ones from developing in the future. This proposed policy would also be used to prioritize candidates who meet niche occupational demands — doctors, for example — where there is a regional shortage.
Similarly, we will also propose to amend section 5 of the IRPA, which provides the government with clear authority to apply new regulations, once passed, to previously received applications in the permanent family and economic classes, as well as temporary programs and work and study permits.
These measures are expected to help draw down backlogs in other immigration categories and would ensure that all applicants are assessed against up-to-date criteria. That would ensure that the immigration system is more responsive to changing needs of our economy and society.
In order to help foster our country's economic growth, we also plan to make changes to our business immigration program. Bill C-38 would enable the minister to create a new class of permanent residence as part of the economic class. We want to attract immigrants who want to invest in Canada's future by making a significant investment in private sector innovation and growth. I argue that our current investor immigrant and entrepreneurial programs have massively undersold the value of permanent residency in Canada.
We have been holding consultations on how to redesign those programs, and we have some creative ideas about how to get more bang for our buck in the Canadian economy in redesigned immigrant and entrepreneurial programs.
For example, we plan to introduce a new start-up visa for immigrant entrepreneurs. The start-up visa could help talented newcomers with great ideas come here and contribute to our economy if, for example, they are being supported financially by a credible Canadian investor, angel investor, for example, or venture capitalist. The idea is to link immigrant entrepreneurs with private sector organizations that have experience and expertise working with start- ups and who are very qualified at their due diligence.
This is not only to important to ensure immigrant innovators and entrepreneurs can succeed. It also ensures innovators with great ideas are able to overcome some of the hurdles that might prevent them from translating their ideas into successful job-creating businesses in Canada.
Mr. Chairman, with these changes we are well on our way to achieving our vision. A "just in time" immigration system will ensure that immigration has a more direct impact or our current economy and will help it to continue to grow in the future. These proposed changes are good for newcomers who will experience better economic outcomes and be able to contribute more fully to their potential and to our economy.
I thank the honourable senators in advance for their thoughtful review and consideration of these proposed measures, and I hope we can count on their support. My officials and I are available to answer your questions.
The Chair: In the event we are unable to get through the full list before the time expires, could we get your willingness, if I can get the questions on the record, to follow up with written responses?
Mr. Kenney: Yes, and as quickly as we can.
Senator Eggleton: I have three questions. Let us see how many of them I can get through here. I will start with the Federal Skilled Worker Program.
You said in your remarks that previously when there was a backlog you were able to find a formula to deal with that and cut it in half. You also said in your remarks that we have significant labour shortages and yet we will cut 100,000 applicants, I believe it is. There are 280,000 people involved under this Federal Skilled Worker Program on the basis of the deadline in February of 2008. These people have been in the lineup for a long time, waiting many years, playing by the rules. They have been putting their life on hold and doing it the proper way. Instead of what some people consider to be others jumping the line, these are people who have waited in the line, and now they will be told that their application will no longer be processed.
You say they will be able to reapply, so my question is: How many of them are likely to qualify under the new rules? The rules will change for those people. How many will be able to qualify under the new rules?
In addition, I am concerned about what this will do for Canada's reputation. These people will talk to their friends and relatives and say Canada is unreliable, untrustworthy. You get into the line and then they cut you out.
At a time where we do have this labour shortage and need more people, and it is becoming more competitive internationally to get this kind of talent into our country — other countries will be competing with us this get these people — we need the immigration into our country. Therefore, what will you do in terms of the international reputation that could be damaged by these kinds of measures?
Mr. Kenney: Did you have a third question?
Senator Eggleton: There are other aspects of the bill. I do not know if I will get to them.
Mr. Kenney: Thank you for those thoughtful questions, Senator Eggleton.
First of all, all of these changes are actually designed to better address the labour shortages we are experiencing. Let me be clear about one thing. We are not proposing to reduce the number of immigrants coming to Canada. We are talking about how to ensure that those who come have a better chance of actually filling the jobs that are available in our economy. The well-known problem over the past three decades is we have seen a reduction in incomes and economic results for newcomers and an increase in relative unemployment for newcomers.
By moving beyond the burden of these huge backlogs and seven- or eight-year wait times, we are trying to get to a system where qualified applicants can be connected to employers who cannot find Canadians to do their jobs so they can be brought into the country in a matter of months, allowing us to significantly increase the percentage of economic immigrants who arrive with a pre-arranged job. You cannot do that if you are waiting in the back of a seven-year queue. No employer will wait for seven years, but an employer might work within our new faster system to proactively recruit people from abroad, do their due diligence and ensure that a person has the skill level to work in Canada upon arrival in a particular job.
Our data tells us that immigrants through the Federal Skilled Worker Program who arrive with pre-arranged jobs after their third year in Canada are earning nearly $80,000 of income, twice as much as those who arrive without a pre- arranged job. The only way to get to that better system of more pre-arranged employment, more market-driven recruitment, is a faster system, which means we simply must get beyond the old backlog.
I understand your point. I am regretful about those sitting patiently in the backlog. Their applications will come back to them with their fees, but in terms of the reputational issue, I think we are doing ourselves considerable reputational damage around the world by telling people they can make an application to Canada and we will get back in touch with them in seven or eight years. That was not exactly enhancing our reputation, nor was the experience of many newcomers who came through that system only to find unemployment or underemployment in Canada, being stuck in survival jobs.
One failure of our system is that we have seen a significant number of immigrants go back to their countries of origin because they were not able to realize their potential or work at their skill level in Canada. In many respects the system has been broken. It has been underperforming, and that is why we need some fundamental change here.
The backlog reduction this bill empowers us with will make us able to get to the "just in time" system by 2014 rather than 2017 or 2018. This means three or four years of much better performance for immigrants.
Senator Eggleton: You addressed the backlog before, and you did not go to this extreme extent in dealing with that. Have you looked at other options for dealing with this, other than cutting these people off?
Mr. Kenney: Yes, we addressed the backlog, but with limited success. We managed by controlling the number of new applications coming into the system at about 10,000 a year to reduce the skilled worker backlog from 640,000 people to about 320,000. We cut it in half, but that still is a several-year wait time. We can continue that steady-as-she- goes approach and finally, hopefully, eliminate the old backlog by about 2017 or 2018, but that would delay our ability to put in place a faster, more market-driven system, which I am certain will generate higher incomes and levels of employment for immigrants.
Senator Eggleton: Is it a question of temporary manpower? Many people out there know a lot about the immigration system who can help clear this backlog.
Mr. Kenney: One misunderstanding or perhaps fallacy about this is that the backlog is the result of operational inefficiencies. I would refer your committee to a study done by the House Standing Committee on Citizenship and Immigration earlier this year which examined this question in detail and demonstrated that we have been admitting huge numbers of immigrants. The average number over the past six years is 254,000 new permanent residents running just below 0.8 per cent of our population per year. That is the highest sustained level of immigration in Canadian history in absolute terms and the highest per capita level in the developed world, so it is not that we are not bringing in enough immigrants. We are bringing in record high numbers of immigrants. The problem is that in the past there was a permanent surplus of applications over the number of people that Canada agreed to admit. In some years, we were getting 450,000 applications for 250,000 positions. We were selling more tickets on the plane to Canada than there were actually seats available. We were overselling the immigration plane every single year, which is why we ended up with a million people in the queue. It was not a lack of efficiency in the department. Sure, if the government decided that we wanted to admit 600,000 permanent residents this year, we could hire the public servants and process those applications, but there is not public support for that.
Senator Verner: Thank you for your visit this morning, Minister. I have three very brief questions. As a senator from Quebec, I was wondering if the new provisions would have an impact on the Canada-Quebec Accord relating to immigration.
As you know, in Quebec, there are already initiatives in place to choose foreign skilled workers in light of the provincial needs. Will the agreement be respected? And have you had the opportunity to discuss this with Quebec?
Mr. Kenney: The answer to both questions is yes. The proposed changes in Bill C-38 fully comply with the Canada- Quebec immigration agreement. One of our obligations under the agreement is to hold consultations with Quebec on the changes. However, these changes do not affect Quebec's power to choose their economic immigrants. It affects the choice of immigrants for the nine other provinces and the three territories.
Senator Verner: Thank you. We have seen in Quebec — and I can well imagine that is the same thing in the other provinces — that one of the problems facing skilled workers is obtaining some kind of accreditation from the professional associations. Have you had any discussions with the provinces and the professional bodies? I think that there are people who are well-intentioned and well-qualified who want to come to Canada and who are facing this impediment.
Mr. Kenney: Yes, it is a very serious problem. First, the problem of credentials recognition is one of the main explanations for the level of underemployment among immigrants who are trained professionals in their countries of origin, but cannot obtain recognition of their credentials by the professional associations in Canada. That is the reason why our government set up the foreign credential recognition office, so as to give immigrants advice following their selection, but prior to their arrival in Canada. We give them a hand to help them apply for recognition of their credentials so they can find a job.
Second, the Prime Minister entered into an agreement with the ten provincial premiers so as to have a pan-Canadian approach to accelerate and simplify the recognition of foreign credentials. Through the economic action plan, we are investing $50 million in the process to bring together the professional associations in the ten provinces in order to achieve a system of recognition that is much faster and simpler.
Third, along with the Department of Human Resources and Skills Development, we have launched a pilot program for funding the costs of extra education and the costs of exams for foreign professionals. This allows them to get a financial hand up in order to obtain their recognition. We are doing all kinds of things, but at the end of the day, it is up to the provinces and not the federal government, because it is the provinces that deal with the regulation of professional associations.
Senator Verner: I would now like to address the issue of Canada's reputation internationally in the field of immigration. We have read reports many times according to which other countries have measures to quickly welcome skilled workers, which means that Canada has lost quality foreign skilled workers, who, because they are tired of waiting for seven or eight years, preferred to send their applications into other countries. I would like to hear your perspective on that.
Mr. Kenney: I agree entirely that we have lost the competition with some other countries who are attracting immigrants that have a great deal of potential. For example, New Zealand and Australia, who are two of Canada's fiercest competitors on the immigration front, accept skilled immigrants within a few months. In Canada, it takes several years.
Two years ago, I met with one of the best graduates from one of the best universities in India, in Mumbai. I discussed the possibility of immigrating to Canada with him. He asked me: "How can I do so?" I told him he would have to send in an application to our system for skilled workers and wait six to eight years before getting an answer. He told me: "But Minister, I have friends who went to the same school as me who immigrated to Australia within a few months' time!" That means we have lost the competition for skilled workers because of the slowness of our system. It is one of the reasons why it must be reformed.
Senator Cordy: Thank you, chair. It is a bit unusual to have the Minister of Immigration dealing with the budget bill, but welcome.
Were the specific needs of French-speaking minority communities taken into account in the new measures put forward by the department? Were the Acadian and francophone communities consulted in the spirit of the Official Languages Act before the changes were made to the budget bill in this case? Did consultation take place?
Mr. Kenney: First of all, it is certainly not the first time we have had amendments to the Immigration Act in a budget bill because we see these as being economic measures.
With respect to consultation, these measures do not touch on our plan to recruit 4 per cent of francophone immigrants to locate themselves in provinces outside of Quebec. We are continuing with that plan. We work closely with the Acadian and francophone communities on it. We fund about $20 million a year through our department for that part of "la Feuille de route" for official languages. We have a plan, and frankly, if anything, that will be assisted by the faster system. We will be able to bring in francophone immigrants to help reinforce the French fact of minority communities outside of Quebec more quickly.
Les Linklater, Assistant Deputy Minister, Strategic and Program Policy, Citizenship and Immigration Canada: We have an established consultation forum with the Fédération des communautés francophones et acadienne du Canada. The minister is right; we continue to support attaining the goal of 4.4 per cent.
As we move forward with implementation of these initiatives, certainly there will be a process to engage with communities who have an interest in seeing faster services, as the minister pointed out. We work closely with the FCFA to ensure we are doing all we can to improve the service to potential migrants outside of Quebec who are francophone.
With our new global case management system, we are now able to globally count more systematically the number of francophone immigrants who are coming forward. We are pleased that we are moving close to our interim target for 2013, which I believe is 1.8 per cent. We are on a good path.
Senator Cordy: Those who are in touch with my office were concerned they were not consulted about these changes and they were also concerned about Destination Canada which will be having its budget cut by $600,000. I am only going by what I was told.
My second question is on the Citizenship and Immigration website it says:
Canada needs to select immigrants who are ready, willing and able to fully integrate into Canada's labour market and fill gaps in our economy, particularly where we have existing skills shortages.
Minister, you said in your remarks that we need an immigration system that can help fill the significant shortages across the country. However, we have had over 100,000 people removed from the queue or the lineup. Are you suggesting that, out of all these people, they and their dependents were not willing and able to fully integrate into Canada? That would be the feeling they would get from listening to comments — that they are not willing — and I am sure they would disagree with that.
You said in your comments today that those dropped from the list will receive fees without interest. What would be the cost of returning those fees? I am not just talking about the dollar cost of the fees themselves, which I believe is without interest, but what about the cost related to the person hours? It is not easy to just locate them. My understanding is that some of them will be fairly difficult to track down. Would not those person hours be better utilized looking at people on the list and allowing them to come to Canada?
Mr. Kenney: There will be no reduction in the number of people admitted to Canada.
Senator Cordy: I understand that. It simply will not be the people on the list, or they will have to start over again.
Mr. Kenney: Right. It is not a question of losing processing capacity for permanent resident applicants. It is a question of trying to restart a much faster system.
To correct one thing, it is not 100,000 people. It is 100,000 cases representing, we believe, about 300,000 people. We do not think there should be too much difficulty reaching most of them. In the past, we have mailed all or most of the people in the Federal Skilled Worker Program backlog, asking them if they want to retain their applications. We have managed to successfully contact well over 95 per cent of them.
The administrative operational costs cost of handling the backlog reduction would be in the range of $15 million. We estimate we will be returning about $100 million in fee revenues that were never spent. They were, if you will, essentially held in escrow, pending the processing of their application. That is not a loss to the Consolidated Revenue Fund; it is just a return on their fees.
Senator Cordy: Why no interest? It is over eight years.
Mr. Kenney: This is not an investment. The point of this legislation is that we do not believe people have a financial interest when they make a processing fee to Canada. Our Parliament and government reserve the right to determine how we manage our immigration system. We do not see it as a kind of savings account.
Senator Seth: I have two questions for you, minister. Bill C-38 provides you the ability to establish new, small, economic class immigration programs on a trial basis for a period of five years. What type of pilot project do you see being developed under the provision?
Mr. Kenney: One of the elements of the bill would allow the minister to create pilot programs for economic immigrants. Those programs would exist for up to five years, through which as many as 2,750 visas could be issued each year. These programs would be constructed based on the "power of ministerial instructions" in the Immigration and Refugee Protection Act.
Essentially, we intend to use the power to create discrete but fast-moving programs that can respond to certain categories of potential immigrants who might not otherwise qualify but who can add a lot of value to the economy.
I mentioned in my opening statement the idea of a start-up visa. This is a concept originally proposed in the U.S. Congress. It is a bill that has yet to become law there. It is strongly supported by the venture capital and angel investment industries in Canada. They often identify brilliant young entrepreneurs in India, for example, who have tremendous concepts for new businesses, often in the high-tech industry. Those Canadian investors have done their due diligence and are willing to put what are sometimes millions of dollars behind the business plan of one of these bright young Indian scientists, for example, or information technologists.
Regardless, those investors would like to have that business started in Canada. We have an interest in bringing the potential future Bill Gates or Steve Jobs to Canada, often from developing countries. This would be a program that allows us to do that quickly, in a streamlined fashion. If investors have verified the credibility of a business plan, have done their due diligence and are willing to put their money behind an individual, we should also be willing to take a risk on them by granting them permanent residency so that those businesses that do succeed end up creating value, jobs and innovation here in Canada. That is the kind of concept we are looking at.
We are still doing policy work on it. However, the power to create these programs would be designed to achieve objectives like that.
Senator Seth: I have a second question, which I think you have answered: Will the applicants accepted under the ministerial instructions be granted permanent status?
Mr. Kenney: That is the intention.
Senator Seth: If so, is the status really permanent or can it be taken away if a pilot project is determined to be unsuccessful?
Mr. Kenney: One of the great advantages of this power we are proposing in Bill C-38 would be to innovate. One of the problems of our immigration system in the past is that it became very rigid. When we saw problems developing in a particular program, we would spend years analyzing it, then come back and often make legislative changes. It would take years to respond to problems.
Under this much more nimble power that we propose in Bill C-38, we would be able to suspend or shut down programs if indeed they are subject to abuse or are not meeting our objectives. We would be able to do so quickly.
However, if someone qualifies for a program like that and they do receive permanent residency, we would have no intention to revoke that permanent residency unless they engaged in a misrepresentation — unless it became clear after the fact that they lied about what they intended to do in Canada.
Senator Callbeck: Welcome, minister, and thank you for appearing. I want to ask about the Federal Skilled Worker Program and the backlog. The 300,000 applications that came in before February 27, 2008, will be sent back. Were any estimates made on how much it would have cost to bring in the resources to deal with these applicants?
Mr. Kenney: First, to make a correction, it is 100,000 applications, representing 300,000 individuals.
To answer your question, yes, we know the resources that would be required to bring them in. If we were to bring them all in at once, this would mean moving our immigration plan from about 260,000 permanent residents to about 560,000. That would be unlikely to meet public support.
Alternatively, we could continue with caps on new applications over the next few years and seek to process the 100,000 in the Federal Skilled Worker Program backlog. However, we believe, based on current levels, that it would take us until about 2017 or 2018 to admit all those people and eliminate the backlog. The cost would be static, whatever our operational costs currently are.
Senator Callbeck: It certainly does not seem fair that people have applied and have been on the waiting list for years, and now they will get their applications back. I know they are getting their fee back, but they have been waiting for years.
What about the people who are on that list from March 1, 2008? Will they be judged under the new criteria of this Federal Skilled Worker Program?
Mr. Kenney: Yes. It is our intention to apply the new criteria, which we intend to develop this year, to those who are in the backlog in the inventory. For example, I intend to pre-publish this June a new points grid for the Federal Skilled Worker Program that would then come into effect later in the year, and it would be our intention to assess applicants who remain in the backlog against those new criteria that we think are more pertinent, which better assess the likelihood of people succeeding in the Canadian economy.
In terms of fairness, I would reiterate our view that it has been unfair to have all our skilled worker applicants waiting in the queue for seven or eight years. I do not want to be too partisan about this, but this is not a problem that developed in the last five years. When the current government came to office, we inherited a backlog in the immigration system of 840,000 people waiting for years to come to Canada. We are trying to move beyond that, as other developed countries have, so we can attract people more quickly with a higher ratio of their having jobs already lined up so that they have higher levels of employment and income.
Senator Callbeck: The new criteria for the Federal Skilled Worker Program has not been established yet.
Mr. Kenney: No, although we have been very transparent. We have had widespread consultations. While we have not published it, I can tell you it is our intention to raise the points allocated to younger workers, essentially, to focus more on younger applicants, higher levels of language proficiency for those hoping to come into regulated professions, higher points for people with pre-arranged employment, and higher points for people with Canadian as opposed to foreign work experience. We also intend to create a new skilled trades stream that will facilitate the admission into Canada of people who can work in skilled trades rather than just professions.
Senator Callbeck: Can the 300,000 that are getting their applications back after they have waited for years reapply under the new criteria?
Mr. Kenney: Yes.
Senator Callbeck: Will they be fast-tracked?
Mr. Kenney: No, with a qualifier. If any of them can obtain an offer of employment with a Canadian employer, they can go to the front of the line right now, and they can in the new system as well.
Senator Callbeck: Anyone can go to the front of the line?
Mr. Kenney: Anyone who has a credible offer of employment right now. We limit the number of new applications currently to the Federal Skilled Worker Program to only 10,000 per year as part of our backlog reduction strategy. The exception is that people can get into that fast-track program to be admitted in less than a year if they have pre-arranged employment.
Senator Callbeck: With respect to the temporary economic classes that the minister will have the authority to establish, you said the classes would be temporary up to five years, but my understanding is that those classes can be changed within that five years. Is that right?
Mr. Linklater: Essentially, the minister would have the authority under these proposed amendments to establish pilot projects, as you say, for up to five years. If during the course of those five years we find we have a resounding success, something we would want to make permanent based on data and evaluation findings, we can move to regulate that class permanently as part of the regulations under the act.
Conversely, if we find that a pilot is being tested and is not having the desired outcomes, the minister can cancel it through a new ministerial instruction.
Senator Martin: Thank you so much for being here, minister. I want to share with you that I am the daughter of a highly educated immigrant who came here in the 1970s, who was definitely underemployed. My parents went through the struggle. In terms of fairness, transparency and making sure immigrants are successful when they come to Canada, I really applaud you, minister, in these changes that are being made to ensure that we are focusing on the fairness and the success of these immigrants.
My question also relates to consultation. I am curious, minister. In your consultations with immigrant communities, what sort of input, support or concerns were considered in the changes being proposed?
Mr. Kenney: Our consultations have been very widespread. I read recently an op-ed in The Globe and Mail by Ratna Omidvar that said we have not consulted on these changes. In fact, every single one of our many proposed immigration reforms has been subject to exhaustive consultations, formal and informal.
To give you one example, with respect to our Federal Skilled Worker Program points grid changes, we did consultations with stakeholders, provinces and territories and online consultations with the general public. We are constantly doing polling and focus groups. I have to say that I am living in a non-stop focus group with new Canadians in particular. I have met with tens of thousands of people over the past five years talking about these issues — hundreds, if not thousands, of organizations. I think I have developed a pretty robust sense of the successes and failures of our immigration system and the overwhelming desire of new Canadians to have an immigration system that works for our economy and ensures the faster and more successful integration of newcomers.
To be honest with you, these reforms were the culmination of several years of work I have had in immigrant communities realizing the struggles that people are going through. For too long, our system has been obsessed with process, managing inventories and numbers rather than with the quality of the experience or outcomes. When you look at the outcomes, our system has been a qualified failure. For three decades, we have seen declining incomes amongst newcomers and higher levels of unemployment. This is unacceptable. The status quo is not working to achieve the potential of immigrants, and this is particularly paradoxical in an economy with large and growing labour shortages.
How does it make any sense for us to admit people, many of whom face unemployment or underemployment, in an economy with acute skilled job shortages?
What we will be better able to do under the new system is to link the immigrants who arrive with the jobs that exist, ensuring that they are satisfied, realizing their potential, and who are not facing the survival job trap or chronic underemployment; rather, they are working at their skill level shortly after arrival. That is what this is all designed to do.
Senator Martin: One such person that I have had some extensive conversation with is Nick Noorani, who is the former publisher of Canadian Immigrant. One of the initiatives he talked about, which I am sure you are aware of, is preparing these immigrants before they come to Canada and the kinds of pilot programs that are being undertaken now. He does work in India not just connecting them to employment but also ensuring that other important elements are also considered, whether it is setting up a bank account or cultural education. I know that S.U.C.C.E.S.S. has something similar in Korea where I have heard of immigrants going through training prior to coming to Canada.
I know you alluded to this, but will you be focusing on such programs and expanding them?
Mr. Kenney: The program to which Mr. Noorani is referring is called the Canadian Immigration Integration Project, which is administered by the Association of Canadian Community Colleges in most countries, and in Taipei and Seoul by the settlement service organization S.U.C.C.E.S.S. This provides free two-day seminars on integration, job search, foreign credential recognition, plus a session of individualized counselling for selected economic immigrants before they get to Canada. When they get the letter saying, "Congratulations, you have been approved to come to Canada as a federal skilled worker, as a provincial nominee," typically, there is a period of several months where they wrap up their affairs at home and do their medical and security tests. We are trying to use that period to get them to create a plan for their arrival so they can set up housing, a job and begin the process of credential recognition online and so forth.
The program has been undersubscribed as we have not seen as many people enrolling as we would like, but our evidence so far is those who go through that pre-arrival orientation are getting higher levels of employment upon arrival in Canada.
Senator Wallace: Minister, as you pointed out, one of the strong objectives of the bill is to have a more targeted approach to the economic and labour force needs of our country and tying that in with an effective immigration strategy. The economic and labour force needs vary across the country; regions vary quite dramatically. In particular, being from Atlantic Canada, I would say the needs would be different there than in Alberta.
I am wondering what you might be able to tell us as to how the bill responds to those specialized economic and labour force needs of the regions, in particular the programs of the provinces. Is there going to be a seamless coming together of those provincial and federal objectives?
Mr. Kenney: Yes. One very important reform we have already implemented has been the huge expansion of the Provincial Nominee Program. Since the current government came to office, we have gone from I believe about 4,000 to 40,000 admissions under the Provincial Nominee Program. There has been a huge expansion. This has led to a much better geographic distribution of primary immigrants across the country. It used to be that about 85 per cent were located in Toronto, Montreal and Vancouver. That has gone down substantially over the past five years, and we have seen a doubling of immigration to Atlantic Canada, a tripling to the Prairies and more newcomers going to the interior of B.C. relative to the greater Vancouver region because of B.C.'s PN Program. This has been a great success. We have done an evaluation on it demonstrating that provincial nominees are doing quite well. When the program works best, it is based on pre-arranged employment offered by an employer.
I think that is the most important regional aspect of the reforms we have made. It is not touched on in Bill C-38 per se, but I can tell you that there is a lot of interest in Atlantic Canada amongst people in the IT sector and regional development with respect to the pilot programs we expect to create.
For example, I think we just had consultations this week with some of those folks who were interested in bringing European scientists and IT experts to parts of Atlantic Canada with their business plans to help develop some of these clusters in the IT sector.
Let me be explicit about this: We are very keen on ensuring that our reforms address regional labour shortages, and we believe these changes will help to do that.
Senator Wallace: Thank you very much.
The Chair: Colleagues, I will get your questions on the record. Please minimize your preambles.
Senator Eggleton: In his budget speech, Mr. Flaherty said there would be better coordination between the Temporary Foreign Worker Program and the efforts of Canadians to find available jobs. He has made more pronouncements on that in the last few days. Your department is now saying that employers can fast-track temporary foreign workers and pay them 15 per cent less than Canadians. I have a couple of questions in that regard.
Why would an employer hire a Canadian if they can get the foreign worker for 15 per cent less? If they do end up having both foreign workers and Canadians working side by side doing the same work for 15 per cent difference, is that a fair government policy?
Mr. Kenney: Thank you —
The Chair: I will get the questions on the record first. Then we will come back to that one first if there is time.
Mr. Kenney: Thank you.
Senator Cordy: What consultations and procedures have you put in place to ensure that the foreign credentials of the new chosen skilled workers will be able to work in their profession in Canada? Do you have agreements in place with the provinces to ensure integration and recognition of foreign credentials? Do you have agreements with professional bodies to ensure integration and credential recognition when they come into Canada under the new provisions?
Senator Martin: I wanted to know what all the options are available to the foreign skilled worker applicants who are being eliminated from the backlog. Are they given that information? Do they have access to various options as a result of this elimination?
Senator Seth: The Minister of Human Resources and Skills Development, currently the Honourable Diane Finley, has the power to create regulations in relation to employers of temporary foreign workers. How will these regulations be different from the ones currently in place? Why is Citizenship and Immigration Canada not responsible for handling this process?
The Chair: Thank you very much.
Minister, I assure you, the clerk will follow up with you if you were not able to get the questions down. The clerk will provide them in detail.
Could you please start with Senator Eggleton's question for the time we have available?
Mr. Kenney: Yes. I will actually address his and Senator Seth's questions in the same answer because they are similar.
What Minister Finley announced recently was the implementation of what is called an Accelerated Labour Market Opinion process for employers.
Just to be clear for senators, the Temporary Foreign Worker Program has two steps. First, an employer must obtain a labour market opinion demonstrating to Service Canada, a division of HRSDC, that they have advertised the position, typically for at least three weeks, at the prevailing regional wage rate and that no qualified Canadian has applied. They go to Service Canada and seek to get that certified. Once that is certified, a labour market opinion is issued. The employer then recruits someone from abroad who can fill that position at the prevailing regional wage rate, and then, in principle, Immigration Canada issues the work permit. Those are the two steps.
The problem is that the labour market opinion process, or LMO, had become very cumbersome; it was taking sometimes months. Therefore, Minister Finley has announced a streamlining through a new Accelerated Labour Market Opinion for trusted employers, those who have used the program without compliance problems in the past, to issue LMOs in 10 days or less for high-skilled occupations.
The second change she announced is a modification on the assessment of the prevailing regional wage rate. Until now, that wage rate has been established based on surveys of employers and what they are paying people in particular occupational categories, and the wage rate has been set at the average.
An agricultural business in southern Alberta, for example, might pay between $16 and $20 for someone doing agricultural processing. HRSDC will then set the average at $18, and that is the wage the employer is required to pay to the temporary foreign worker.
Here is the problem, getting to Senator Eggleton's question. The problem was that the average was not the starting wage, so Canadians who were being offered employment in those workplaces were typically coming in at the starting wage, which was, by definition, below the average. You had an awkward situation where many temporary foreign workers were being paid more than Canadians.
To be clear, the new flexibility recognizes that there is a range within every occupational category; not everyone in every occupation is paid a precise amount. There is a starting salary, with raises over time. The 15 per cent flexibility recognizes that fact.
However, let me be clear: The employer will only be able to pay the temporary foreign workers 15 per cent less than the average prevailing wage if there are Canadians being paid 15 per cent less. Therefore, no Canadians will be undercut. What we will be doing is removing the aberration of forcing employers to pay more to foreign workers than to Canadian workers.
On Senator Cordy's question regarding the FCR, the federal government does not have agreements with professional bodies because they are creatures of the provinces, although we are working through the provinces in what is called the Pan-Canadian Framework for the Assessment and Recognition of Foreign Qualifications. It is a very cumbersome name. It is the result of an agreement that the first ministers, including the Prime Minister, arrived at in January of 2009, which is being supported by a $50 million investment through the Economic Action Plan. It involves bringing together all 10 provincial licensing bodies in the 40 some regulated professions to hammer out a streamlined and simplified process for assessing foreign qualifications, the objective of which is to give applicants an answer within a year so they do not have to take years and years of red tape to get a yes or no answer. The objective is not to lower the bar for professional credential recognition for foreign trained professionals, but to have a streamlined process. We are making progress on this, and I would invite senators to study that issue more closely. It is a very complex issue.
The third point, on Senator Martin's question, about what options exist for those people in the skilled worker backlog who will be affected by the backlog reduction, they will be receiving feedback during the course of the next year. We will make them aware that there are options for them to reapply. They can come in through the Provincial Nominee Program. They can come in under the Federal Skilled Worker Program. They can come in under the new Skilled Trade Stream. They could come in under an entrepreneurial stream or through one of the Quebec selection programs.
The bottom line is that our future system has far more options. It is more flexible and faster moving, so if they are qualified for any one of those programs, they will probably be able to get there more quickly than sitting in the back of the FSW queue.
The Chair: Thank you very much, Mr. Minister, and thank you to my colleagues for getting right to the point with your questions. We thank the minister's colleagues for being here with us. We look forward to proceeding with this.
Again, on behalf of my colleagues, I want to thank you particularly, Minister Kenney, and your colleagues for being here with us today.
(The committee adjourned.)