We thank you for the invitation to participate in your study on post-market surveillance of pharmaceutical products. As you mentioned, I'm accompanied by Neil Maxwell, assistant auditor general. I believe that some of our past findings on regulatory and post-market surveillance activities at Health Canada would be useful to the committee in its study.
In my presentation, I will highlight some of our findings on the drug products program discussed in our 2006 chapter entitled “Allocating Funds to Regulatory Programs--Health Canada”. I am also pleased to talk about two other audits, where we examined programs similar to pharmaceutical products. We reported these findings in our 2004 chapter on regulation of medical devices and our 2000 chapter on the regulatory regime of biologics.
I will start with our 2006 Chapter—Allocating Funds to Regulatory Programs. In this audit, we examined issues related to the allocation of financial resources in three regulatory programs.
These programs regulate the safety and use of consumer products, medical devices and, what is of more interest today, pharmaceutical products. It is important to note that the audit was on the allocation of financial resources and how this affected that Department's ability to carry out its regulatory responsibilities.
We did not examine other aspects of pharmaceutical products, such as post-market activities. We concluded that Health Canada did not know if it was fully meeting its regulatory responsibilities for the Drug Products program.
First, Health Canada needed to determine the activities that must be carried out in order to meet the Department's regulatory responsibilities. Program managers for Drug Products indicated that they considered the level of post-market compliance and enforcement activities to be insufficient. This could have consequences for the health and safety of Canadians, such as exposure to unsafe, ineffective or dangerous products.
Second, we found that Health Canada needed to determine performance targets for the activities.
Third, Health Canada needed to determine the level of financial resources required to carry out the activities necessary to meet is regulatory responsibilities. We found that the demands on regulatory programs were increasing while the funding remained constant, making it difficult for program managers to fully meet the Department's regulatory responsibilities. Although the funding remained constant, the core funding for the Drug Products program had decreased 32% over three years, if all sources are considered.
Furthermore, most of the additional funding that Health Canada received had been allocated to pre-market activities, and funds that were meant for the Drugs Product program were reallocated to other programs. For more details about funding, please refer to the table we distributed.
In its responses to our recommendations, Health Canada stated that it planned, among other things, to improve the operational planning process; review the funding, including core funding allocated to regulatory programs; work on a cost recovery strategy and regime, including the establishment of a full costing model; introduce a budget management framework with guidelines on resource allocation and monitoring of Treasury Board decisions; and improve performance measurement.
Health Canada also promised to conduct comprehensive reviews that would serve to establish program baselines by defining the required level of activities that the program must carry out, identify the targeted performance for these activities, and identify the resources needed to carry out these activities.
Health Canada promised to make these changes by March 31, 2008, or earlier. The department's next progress report is scheduled for the end of April, and your committee might wish to examine what progress has been made, especially concerning the baseline study for pharmaceuticals.
The two other audits were about programs similar to pharmaceuticals. We found similarities in the findings related to post-market activities. We would ask you to note that these audits are dated, and we have not conducted recent audits to see if our concerns have been resolved.
Post-market activities were a concern in our 2004 audit on the regulation of medical devices. We found that health Canada did not carry out any inspection activity at the post-market phase and did not know the extent to which the regulations were being respected.
The Department had made it mandatory for the manufacturers to report serious adverse events, but had done little work to increase the number and quality of reports received from health care professionals. The rate of reporting on adverse events was significantly less for Canada compared with the US and the UK. In addition, there were weaknesses in the analysis and interpretation of adverse events, and there was no proactive system to identify patterns that could signal a serious safety concern.
We also noted that Health Canada had never developed a communications plan or strategy for medical devices to ensure that Canadians were fully aware of risks.
In addition to recommending that Health Canada address these weaknesses in post-market activities, we also recommended, due to the weaknesses also found in pre-market activities, that Health Canada make a choice: either provide adequate human and financial resources to deliver the program as designed, or redesign the Medical Devices program and the Regulations to manage risks in a way that requires fewer resources.
Finally, in our 2000 audit on the regulatory regime for biologics, we found that Health Canada had difficulty managing the workload of pre-market and post-market activities. Officials told us they had trouble staffing positions. We recommended that sufficient databases be implemented to adequately process, analyze, and disseminate information on adverse reactions and events for biologics.
As you can see from these three chapters, we have had concerns about resource allocation and post-market surveillance for several years now. It seems that the emphasis has been on pre-market activities, to the detriment of post-market activities.
As you know, I cannot comment on the policy approach, but I am encouraged to see that some of the issues raised in our reports, such as problems with post-market surveillance and under-reporting of adverse events, are included in the government's Blueprint for Renewal: Transforming Canada's Approach to Regulating Health Products and Food.
I would like to take this opportunity to update the committee on other work we are conducting. We have a chapter on infectious disease surveillance in our report to be tabled on May 6. We would be pleased to meet with you again after tabling to discuss that.
We are also beginning an audit on electronic health records, and we plan to provide this report to Parliament in fall 2009. Several provincial auditors general will concurrently carry out audits on the same subject matter, leading to a comprehensive look at the implementation of electronic health records in Canada.
Lastly, we will soon begin developing a plan identifying the audits we will conduct over the next five years. We would be pleased to discuss our plan with you at a future date.
I hope our comments today will help your study on post-market surveillance of pharmaceutical products. I look forward to reading your report and the government's subsequent answer to it.
Mr. Chair, that concludes our opening statement. We would be pleased to answer any questions the committee members may have.
Thank you very much, Mr. Chair.
I am very pleased to speak to the committee about the privacy implications of the post-market surveillance of pharmaceutical products. With me today is Patricia Kosseim, General Counsel and an expert in health law.
You have received a fairly comprehensive document prepared by our Office which starts out by saying that while Canadians regard the health care they receive as a top priority, they also consider ongoing privacy protection to be very important.
This morning, I will begin by briefly discussing some issues that are addressed at greater length in my submission, a copy of which has been circulated to members. These include the potential re-identifiability of data, the privacy implications of electronic health records, data breach notification requirements and finally, the concept of “work product” information.
The Privacy Act applies to federal government institutions, agencies and Crown corporations. As such, it applies to government health surveillance programs such as Health Canada's Canadian Adverse Drug Reaction Information System or CADRIS, and other government initiatives, such as the Federal Health Care Partnership's plans to develop electronic health records.
I'll start with the issue of re-identification of data as a privacy issue in post-surveillance of medications.
From a privacy point of view, one of the key issues we grapple with is the concept of re-identifiability, particularly in the era of increased digitization of health data and surveillance programs, proliferation of publicly available information through the Internet, and sophisticated technological capacity to link up information across different databases. Personal information is critically defined in both the public and private sector law as “information about an identifiable individual”. Exactly what is identifiable or potentially identifiable is a relevant issue for your present study.
Re-identification was at the heart of a recent decision in January of this year by the Federal Court in the matter of Gordon and Health Canada and the Privacy Commissioner of Canada. We were interveners. I bring to the attention of this committee four points.
First, in a situation involving personal information about an individual, the right to privacy is paramount over the right of access to information. That was the first major conclusion of this recent finding, which is not being appealed.
Second, the Federal Court adopted the legal test that was proposed by my office, and I quote: “Information will be about an identifiable individual where there is a serious possibility that an individual could be identified through the use of that information, alone or in combination with other available information.”
Third, the court concluded that disclosure of some information, in particular factual circumstances, where it is combined with personal information, is to be scrutinized for its effect on personal information.
Finally, the Federal Court emphasized the importance of ministerial discretion in deciding whether or not to exceptionally release this personal information in the public interest.
On privacy considerations in electronic health records, major initiatives under way to develop electronic health records promise great things for Canada's health care system: improved quality, efficiency, productivity of health care services, enhanced patient safety, more evidence-based decision-making, facilitated knowledge transfer, and greater accessibility to services and treatment.
So as health information structures proliferate across the country, the traditional lines between health care, surveillance, quality assurance, and research will become increasingly blurred. This is not necessarily a bad thing; however, the notion of purpose, which is such a critical concept in data protection laws, and the ones individuals actively turn their minds to when they provide informed consent in any meaningful way--we all ask what you want this information for, and what's going to be done with it--is increasingly being challenged by this approach.
As the concept of purpose becomes stretched, other purposes can begin to creep in. Beyond health-related purposes are other more worrisome purposes to which personal health information may eventually be put, particularly as external pressures for such information continue to rise. Marketing, employment, insurance considerations, law enforcement, and national security are just some purposes that loom on the horizon. These are clearly not part of the deal that Canadians think they are getting themselves into when they think of the development of electronic health records.
Another critical concept that is increasingly being challenged in the context of EHRs and electronic clinical trials is the central concept of accountability, particularly as more and more entities join up through interoperable systems, as public-private partnerships develop to leverage resources and achieve commercialization objects, and as data flows across provincial and national borders in a global economy. So I guess that's where I join up with my colleague the Auditor General.
In order to help work through some of these challenges, our office is participating in the recently created Canada Health Infoway privacy forum that brings together representatives of the health ministries and privacy oversight offices across Canada. We're very pleased to be part of this critical discussion that is starting to address issues of informed consent, secondary purposes, and accountability as they relate to the implementation of interoperable pan-Canadian electronic health record systems.
The third issue is data breach notification requirements as they relate to privacy.
With the growing digitalization of health data also comes increased scope and impact of potential breaches. A number of recent cases which I highlight in my submission have brought this problem to light. Not a day goes by in Canada without a report of someone finding identifiable personal health records in a trash cash behind a clinic, hospital or doctor's office.
Industry Canada is currently looking at how to incorporate into the Personal Information Protection and Electronic Documents Act, or PIPEDA, mandatory breach notification requirements. This is a welcome development which we hope will serve as an incentive for organizations to put proper security safeguards in place and to be open and transparent when something goes wrong.
In the meantime, our Office has issued guidelines to support organizations through critical actions steps, including assessing the risk and extent of potential harm, and deciding when, how, who and whether to notify individuals. When dealing with highly sensitive personal health information, special considerations should be taken into account, such as psychological risk of harm.
I would now like to turn to the section of my submission on work product, an issue that was discussed at length when other parliamentary studies were conducted on personal information protection. I am available to answer all of your questions about how concerns over protecting information apply to this area.
, Mr. Chair and members of Parliament. With me today is Mike Sheridan, our chief operating officer. On behalf of Canada Health Infoway, I want to thank you for the opportunity to contribute to your study on post-market drug surveillance.
Since we don't have too many opportunities to appear before you, I'd really like to take the liberty of telling you about some of the important work we're engaged in, work that I believe will transform the delivery of health care in Canada.
Created in 2001 by Canada's first ministers, Infoway's mandate is to accelerate the development and adoption of electronic health records--or EHRs, as we call them--across the country. Infoway is an independent not-for-profit corporation whose members are Canada's 14 deputy ministers of health. We are funded by the federal government and operate as a strategic investor with all 13 provinces and territories, jointly investing in core systems across the country. I will explain in a moment what these core systems are.
First I will say that the collaboration has been unique and a remarkable success story. By working together, provinces and territories are sharing best-practice designs and systems, which have dramatically reduced the cost, the time, and the risk.
Having read some of the testimonies before the committee, I note that previous presenters suggested our emerging EHR infrastructure could be part of the solution of effective post-market surveillance of drugs. Infoway certainly agrees that the potential exists, but as I will outline, there are some challenges.
The good news is that while our solutions have not been specifically designed for surveillance, they are already contributing to reduce adverse drug events.
I have a simple example, if you will allow me to share it with you. In Ottawa one evening a senior enters an emergency ward, confused and disoriented. Physicians need to stabilize his condition with drugs, but first they need to know which other medications the senior may be taking. Fortunately, today every emergency room in Ontario now has access to the drug profile viewer, which enables authorized physicians to view the medication profile of every recipient on the Ontario drug benefit plan, thus preventing dangerous interactions and adverse drug events before prescribing or dispensing.
I would like to explain some of the core systems that Infoway and its partners are introducing, but first, as a precursor to everything else I say, we recognized from the start that the success would depend on privacy and security being fundamental to all the plans we develop, to all the technology we design, and to all the systems implemented by the provinces and territories.
Our chief privacy strategist works closely with her counterparts at the federal level and with the territories and provinces. We have a team of senior engineers dedicated to designing privacy and security best practice into our core architectures, which are the basis of specifications that jurisdictions will use with their vendors.
Each project must carry out a privacy impact assessment that examines the solutions against the privacy requirements of that applicable province or territory.
To support the data needs of public health officials, researchers, and policy-makers, the systems are being designed to accommodate the identification. This would allow data to be accessed and studied anonymously, providing a wealth of health indicators.
So where are we today? Each province and territory has established a detailed three- to five-year road map to build the foundation of the electronic systems they need. Almost 260 projects are under way, representing an investment by Infoway of approximately $1.5 billion, or 95% of our total funding.
Jurisdictions' contributions, I should add, for development, deployment, adoption, and ongoing maintenance often represent multiples of this amount.
The bedrock of electronic health records are five complementary clinical information programs, or the core programs, which we jointly invest in. Each program on its own is delivering important benefits to Canadians and our health care system. Together, they capture a patient's comprehensive medical history. This is where we ultimately need to be, where all clinicians have all the right information at the right time to deliver safe, efficient care.
The first program is our registries programs, basically a sophisticated electronic directory that unambiguously identifies patients, health care providers, and in some jurisdictions health institutions.
Our next program is the diagnostic imaging program, focused on digital storage, retrieval, and sharing of a patient's X-rays, ultrasounds, MRIs, and CT scans. Going digital eliminates the cost and the inconvenience of handling film. It allows radiologists in urban centres to service remote or under-serviced locations. It has increased diagnostic speed and integrity, while improving the productivity of our radiologists--and they are pretty scarce.
Our next program is the lab information system, which allows clinicians to electronically capture and view lab results and reports from hospitals and community and public health laboratories. This reduces the time for diagnosis and eliminates duplicate tests.
The drug information system represents Infoway's fourth clinical program. Drug systems allow prescriptions to be sent, viewed, dispensed, and confirmed electronically. When they are fully implemented, they will automatically flag to the prescribing physician and dispensing pharmacist the potential dangerous drug-to-drug interactions and allergic reactions associated with a particular drug.
When Infoway began its drug investment program, very few provinces and territories had plans for a system that would provide all these capabilities. Over the last year, however, the strategies of collaboration, development, and shared cost have spurred most jurisdictions to undertake drug information systems that will cover all drugs for all people, which is a very important development.
Our last, and in many ways most important, program is the interoperable EHR, or the glue that hangs some of these other programs together. It consolidates an individual's health information from a variety of sources, including the ones I've outlined, into a single secure and integrated health record. Depending upon funding considerations and jurisdictional readiness by 2010, we're very hopeful that the interoperable EHR will be available for 50% of Canadians.
Let me close with specific issues on post-market surveillance. As you well know, the complexity of drug monitoring is exacerbated by the explosion of new products and by the aging population living with multiple chronic diseases and taking several different drugs. Drug trials typically target a limited population over relatively short durations. Often they lack real-world exposure. Analyzing de-identified data sources from EHRs that contain prescription information, examination findings, lab reports, diagnostic test results, and other patient outcome information at the population level would allow benefits and risks to be more rapidly and effectively assessed. Subject to privacy considerations, technically de-identified data could be loaded into an aggregated database in a format that allows analysis using various reporting tools.
In the future, it may be possible early in the drug life cycle, or at any point, to track efficacy and patient safety across a wide population.
Now comes the bad news, because having said this, I must caution the committee that, first, our current plans and funding do not include the tools or the required analysis systems to do post-market surveillance studies. Second and more immediate, although completion of our current goal in 2010 represents a significant milestone, it represents less than half of the EHR solution.
To finish what we've started takes commitment, and unfortunately it takes money. Two recent studies estimate that a total of EHRs for all Canadians in all settings would be about $350 a Canadian, or about $10 billion spread over 10 years. The promising news is that these same studies confirmed that once fully implemented, electronic health records will deliver savings estimated at between $6 billion and $7 billion each year, money that can more productively be reinvested in other priorities, whether they be health care, education, innovation, or infrastructure.
In conclusion, Canada is implementing a powerful health information platform whose driving force has been better health care for individual Canadians. Once in place, it may present opportunities for building secondary applications such as post-market surveillance for drugs.
Mr. Chair, that concludes my opening remarks. I would be delighted to answer your questions.
Thank you all very much.
My concern has always been that the technology is there to actually help us do this right away. If we look to the veterans administration in the United States, from the worst care in the country to the best care in the country, most of that was transformed because of their insistence on an electronic health record in a hurry.
I have huge concerns that even though the technology is prepared and able to encrypt the data, the examples that keep being used around privacy are ones where the data was not encrypted, and that privacy bogeyman keeps getting in the way of our getting on with what we need to do.
If we remind ourselves of Judith Maxwell's very important work during the Romanow commission on what patients and Canadians think about privacy, where they are more than willing to let their family doctor let the consultant know what's going on, we have been hindered sometimes by various health professions not wanting their prescribing practices tracked, as opposed to the patients, who actually do want to know whether their information being shared without the identifiers on it could make a safer system. I think most Canadians would want to be part of that.
If we go forward—and we heard in this committee last week that it's the written prescription that means the diagnosis can't be put on it, because it's a scrappy piece of paper that can fly anywhere and have the diagnosis and the prescription on it—I would want to know, first from the Privacy Commissioner but also from Infoway, can we and could we, if we had the resources, go immediately to electronic prescribing that included the diagnosis, which would actually help us with off-label prescribing and would help us with everything from recalling a drug to all the things that we are worried about in this real-world safety, of what we're talking about in post-market surveillance?
: Veuillez m'excuser
. I'm going to answer in English, but my colleague over here might want to add something.
First, these numbers haven't been pulled out of the air. The numbers have basically been derived from two major studies, one by Booz Allen, one by McKinsey & Company. Also, we have similar sorts of numbers when studies have been taken in the U.S., certainly when projects like this have been rolled out in the NHS system in England, and certainly in the Scandinavian countries, etc., and in Australia when they've done the numbers.
The simple fact is this. For years we haven't invested in these systems, because it's very difficult at times to sell these infrastructure systems to the public. It's much easier to sell another doctor, another nurse, another MRI machine, another piece of equipment. If you're really going to transform the system, then you have to have some evidence-based medicine in which to work, and this is the way it brings you evidence-based medicine, by having these technologies.
Look at the financial industry. It would not be able to perform today without the kind of computerization it put in. Let me tell you, that in itself took 20 years and a lot of money. When they transformed that industry, they were spending anywhere up to 12% of all their revenues. Today they're spending probably about 6%, because the systems, the ATMs, are there.
In Canada we're spending anywhere between 1.5% and 2% on information technology, and that's right across the country. We can't make these kinds of changes unless we get it up to about 4%, but it's a very tough sell to be able to do that.
In terms of the benefits, I don't think treasury's going to take out that $6 billion and $7 billion. I can tell you that with the tsunami of our aging population and chronic disease, they really are going to be in a position where we can expand the capacity, improve the access, if we put these systems in place.
The last time we actually looked at that question was in 2004, when we looked at the regulation of medical devices. We looked at the whole licensing activity there and at the pre-market evaluation process. We found that Health Canada was following their process rigorously. The issue there seemed more to be delays, but they did have a process.
That doesn't mean that because you have a good process to license a product problems won't surface after it's on the market. That's because of the limited trials and a number of reasons. So when we looked at medical devices, we found that the pre-market was fine. For post-market, though, there were a lot of issues--very few inspections of manufacturers, the whole question of reporting of adverse reactions, and the list goes on and on.
The more recent audit we did was on the department's ability to assure Parliament and Canadians that they were carrying out their regulatory activities appropriately. We expected, for a regulatory program, that the department would know what activities it should carry out, at what level--for example, the number of inspections it should do--what resources would be required, and what funding would be needed. We found, quite honestly, none of that. They would have inspections, but they would not be able to tell us how they had arrived at the number, what an appropriate number of inspections they should be doing was, or what resources would be required.
So there was the whole question of how the department itself knew that what it was doing was appropriate and sufficient.
On the whole question of funding, it started, actually, in our audit on medical devices. Some of the regulatory programs effectively have no base funding, and funds are being reallocated. Even funding that's been given for special initiatives--it could be for pre- or post-market activities--is being reallocated to other programs within the department.
So unless there's a clear baseline, a clear analysis of what activities should be carried out--what the baseline is, what the results of all that are, and what resources are required for the regulatory programs--it's difficult, I think, for Parliament to have assurance that these regulatory programs are being managed well.
Thank you, Mr. Chair, and thank you, witnesses.
I would also like to welcome Rob Clarke, the new member from Saskatchewan. I think Rob would be pleased to see that this committee is well behaved and is doing important work.
I won't comment on who's here and who's not here at present, but just on the Auditor General's report. Health Canada did respond to that report by tabling an action plan in February 2007. The action plan included commitments, I understand, by the department to put in place measures to improve resource allocation and operational planning, processes, performance measurement, and costing programs.
I believe the department also committed to conducting comprehensive reviews of its regulatory programs, and there are progress reports being provided every six months to the public accounts committee dealing with your report. I understand that report will be tabled here at health committee as well.
Madame Fraser, I wonder if you could comment on the impact of these follow-ups. I believe Health Canada accepted all of your recommendations.
I am just going to get all my questions out off the top.
In regard to Infoway, it seems that Infoway is going to be key in any post-market surveillance program. I wonder if you could explain to us the challenges of dealing with 14 different jurisdictions, private sector physicians, and all the other stakeholders, and what your approach is in dealing with those challenges? What is your vision regarding the health records of the surveillance tool?
If there's time, I'd ask the privacy people to comment on the previous two witnesses' comments.
Certainly the challenge of dealing with federal, provincial, and territorial realities is a real one, and we commend the leadership of Infoway for the great work they do in that area.
From a regulatory perspective, juggling those different regulatory frameworks is also quite challenging. Not only are there 14 jurisdictions and laws, but within each jurisdiction there are different laws, some dealing with the private sector, some with health information, and some with general personal information.
One example of where leadership can come to bear on these sorts of challenges is how, over time, the regulatory frameworks have either adapted or evolved or have been amended to enable the reality of electronic health records to work with the Canadian public to an acceptable and agreeable solution for implied consent within a circle of care, so that when individuals go to see their physicians, they understand that the information in the electronic health care arena can be shared with other health professionals engaged in their circle of care or their treatment without necessarily having to go back to get their informed consent every time. That concept has grown to be acceptable and workable.
However, there are other concepts that remain very distinct in each jurisdiction, that have yet to be resolved and harmonized. For instance, the rules for using personal health information to support research or surveillance or other secondary purposes outside that circle of care are not harmonized around a certain agreeable standard.
There is still work to be done. We're pleased to work with Canada Health Infoway and the privacy forum to begin to address those challenges. As well, Infoway senior officials have come to our FPT privacy commissioners meetings in recent years to give us regular updates.
I'm not sure I'm intimately involved with the project, but certainly it is a pilot project. It was intended to show some innovation and adoption techniques.
The innovation was to change the way reporting was being done, in this case in a neonatal unit, with the assumption that once deployed and in place, this certainly could be used in other care settings, in other institutions, in other types of wards and care facilities.
The notion was that prior to the implementation of this particular system, the majority of the reporting was done on paper, and as Mr. Alvarez has always indicated, our health system on paper doesn't always look that good. So the system that was put in place was very standardized, computer-usable, a web-based application. That all sounds very complicated, but the reality is that it was click and point, enter the information, and then that went to another base.
Who was involved? Part of the process of getting electronic health records to work is adoption of these things by the actual users in the care community. The three hospitals that were involved in this particular project had a great approach. They created a team, and ostensibly, in the neonatal units, everybody became a part of the team--the doctors, the nurses, and the staff. In fact, when we had a presentation at our last board, they had created these little buttons that said “I am part of the team”. And of course everybody was trying to do that.
In terms of the actual adoption, the process was a team effort within the hospitals per se. The result, in terms of the reporting, was a web-based reporting tool that was much easier to use and much more accessible than the paper products that had been in place before.
The final piece was that this was aggregated into a centralized database, where the information could be used by “the team” in terms of giving better care and better follow-up.