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The Health of Canadians – The Federal Role
Final Report
Volume Six: Recommendations for Reform
PART V:
EXPANDING CAPACITY AND BUILDING INFRASTRUCTURE
In Volume Five, the Committee presented its findings and general recommendations with respect to the role of the federal government in health care infrastructure.[1] These recommendations were based on the third of the roles the Committee spelled out in Volume Four for the federal government in health and health care, a role intended to “support health care infrastructure and health infostructure.”[2]
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The collection of patient information under a system of EHR and the related use of such information for the purpose of 1) clinical practice, 2) system management, 3) performance and outcome evaluation, and 4) health research, raise a number of important and complex issues with respect to the protection of personal health information; these are reviewed in Section 10.4
In Volume Five, the Committee noted that, despite the importance of health care technology in delivering timely and high-quality health services, the availability of many new technologies continues to be disproportionately low in Canada in comparison with other OECD countries. More specifically, Canada ranks 21st of 28 OECD countries in the availability of CT scanners, 19th of 22 in availability of lithotriptors, and 19th of 27 in availability of MRIs. Its only acceptable ranking is in the availability of radiation equipment, where it ranks 6th out of 17.
Data also show that this technology gap is widening. For example, the availability of MRIs in Canada worsened between 1986 and 1995 relative to other OECD countries, including Australia, France, the Netherlands and the United States.[3]
In addition, we noted in Volume Five that the aging of health care technology is also of concern. For example, information provided to the Committee indicated that between 30% and 63% of imaging technology currently used in Canada is outdated. Not only can the outdated nature of health care technology negatively affect the health of a patient, but it also raises concerns about the legal liability of health care providers.[4]
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In September 2000, the federal government responded to the deficit in health care technology by establishing the Medical Equipment Fund (MEF). The MEF allocated $1 billion (transferred on a per capita basis over a two-year period) to the provinces and territories for the purchase of health care technology. The Committee has welcomed this injection of new federal funds. However, we raised a number of concerns in Volume Five about the MEF:
· First, some provinces have not applied for their share of this fund, possibly because the federal government requires matching grants that some of the poorer provinces have difficulty financing.
· Second, additional resources are required to operate the new equipment. Even if provinces can afford their share of the capital investment, they may have difficulty funding the additional ongoing operating costs.
· Third, the investment did not address the problem of old equipment that needs to be upgraded.
· Fourth, even with this new funding, Canada still does not rank at a level comparable to other OECD countries.
· And finally, there are apparently no mechanisms to ensure accountability on the part of the provinces/territories as to exactly where money targeted to purchasing new equipment is actually spent.
In July 2002, the Canadian Medical Association gave the Committee a report on the Medical Equipment Fund that addressed many of these concerns.[5] This background paper made the following observations:
· Because of the lack of a transparent accountability mechanism, it is very difficult to determine whether the MEF reached its intended destination.
· Of the $1 billion allocated through the MEF, approximately 60% was used for new (incremental) spending on health care technology, while 40% was used to pay for already planned expenditures.
· The MEF resulted in a modest to significant improvement in the availability of health care technology in Canada compared to other OECD countries. For example, the gap in health care technology has been reduced significantly in terms of radiation equipment and MRIs since the introduction of the MEF, while a substantial gap remains with respect to CT scans, PET scans and lithotriptors.
· An estimated investment of $1.15 billion is still needed to bring Canada up to the 1997 level of the 7-OECD country average. Of this amount, $650 million is required for the purchase of new medical equipment and $500 million is required for additional operating costs. The latter amount is critical to ensure that the purchasing funds can in fact be used by all provinces/territories; otherwise, the investments may not be made due to the lack of fiscal capacity of some provinces/territories.
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Other calculations by the Association of Canadian Academic Healthcare Organizations suggest that between $1.7 and $2.5 billion (or some $420 million per year over five years) is required by Academic Health Sciences Centres (AHSCs) for the purchase and operation of advanced medical equipment.
The findings in the papers by both the Canadian Medical Association and the Association of Canadian Academic Healthcare Organizations reinforce the observations and conclusions made by the Committee in Volume Five. Accordingly, we believe that additional funding is required for the purchase of health care technology. We also believe that the federal government should support the provinces and territories to purchase new medical equipment.
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The Committee also noted in Volume Five that there is a need to perform more health care technology assessment (HTA) when considering the introduction of a new technology or the replacement of existing medical equipment.[7] HTA provides information on safety, clinical effectiveness and economic efficiency and also considers the social, legal and ethical implications of the use of health care technology. The Committee stressed that all levels of government invest less than $8 million in total in Canada on HTA, whereas the United Kingdom provides some $100 million to its national HTA body, the National Institute for Clinical Evidence. Accordingly, we recommended in Volume Five that the federal government provide additional funding to HTA agencies for the purpose of assessing new and existing health care technology.
Finally, the Committee believes that a significant portion of the funding for the purchase of health care technology should be provided to AHSCs that currently house a large proportion of advanced medical equipment. AHSCs are also well suited, given their physical and clinical infrastructure, to undertake state-of-the-art HTA activities. It is the view of the Committee that federal funding for health care technology should not be provided to privately owned and operated clinics since they do not perform teaching, assessment and research activities.
The Committee acknowledges the important role of AHSCs in introducing and assessing new health care technology. We also recognize that community hospitals require additional investment in new medical equipment as well. It is our view that the federal government must play a leading role in sustaining long-term investment in needed health care technology.
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More precisely, under this model, teaching hospitals, community hospitals and regional health authorities would be required to accompany a request with a sound rationale for additional resources. Each application would be evaluated on its own merits by an independent expert group that would report to the Minister of Health. Moreover, in order to ensure accountability, successful applicants would have to report on their disposition of the funds received. Therefore, the Committee recommends that:
The federal government provide funding to hospitals for the express purpose of purchasing and assessing health care technology. The federal government should devote a total of $2.5 billion over a five-year period (or $500 million annually) to this initiative. Of this funding, $400 million should be allocated annually to Academic Health Sciences Centres, while $100 million should be provided annually to community hospitals. The community hospital funding should be cost-shared on a fifty-fifty basis with the provinces, while the Academic Health Sciences Centre funding should be 100% federal.
The institutions benefiting from this program be required to report on their use of such funding.
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An important characteristic of an EHR system is that it can make patient data available to health care providers and institutions anywhere on a need-to-know basis by connecting interoperable databases that have adopted the required data and technical standards. Not only can an EHR system greatly improve quality and timeliness in health care delivery; it can also enhance health care system management, efficiency and accountability. Moreover, the data collected from an EHR system can provide very useful information for the purpose of health research.
The benefits of an EHR system are numerous:
National, interoperable EHR solutions that bring comprehensive and portable information to health providers and their patients will empower Canadians and help to significantly improve the quality, safety, accessibility, timeliness and efficiency of services.
Furthermore, EHR solutions will enable the creation, analysis and dissemination of the best possible evidence from across Canada and around the world as a basis for more informed decisions by patients, citizens and caregivers; by health professionals and providers; and by health managers and policymakers. They will also help maximize the return on ICT investments through alignment, and drive the development of common standards and interoperability.[9]
All levels of government in Canada have recognized the importance of developing and deploying EHR systems. On September 11, 2000, the First Ministers agreed to work together to develop an interlinked EHR system over the next three years and to work collaboratively to develop common data standards to ensure compatibility and interoperability of provincial health information networks together with stringent protection of personal health information.
In support of the agreement reached by the First Ministers, the federal government committed $500 million in 2000-01 to a private not-for-profit corporation known as Canada Health Infoway Inc. (or Infoway). Infoway is not a federal agency or a Crown corporation, nor is it controlled by the federal government. The members of Infoway are the Deputy Ministers of Health of the provincial, territorial and federal governments Infoway is governed by a Board of Directors who are representatives of regions of Canada.[10] The Board also involves some independent directors.
In July 2002, Infoway forwarded a copy of its business plan to the Committee. As part of its business plan, Infoway intends to invest in projects that enhance patient care, build on the existing base of information management, ensure leverage of financial investments and align federal, provincial and territorial priorities in a sustained fashion in order to achieve a pan-Canadian EHR system.
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Overall, the Committee is very enthusiastic about the work undertaken by Infoway in deploying a national system of EHR. We believe that both Canadians and their publicly funded health care system will benefit greatly if the system of electronic health records is national in scope. Indeed, a national EHR system is critical. It is our view that, to achieve this, the federal government must provide leadership and the necessary resources. Therefore, the Committee reiterates its recommendation from Volume Five that:
The federal government provide additional financial support to Canada Health Infoway Inc. so that Infoway develop, in collaboration with the provinces and territories, a national system of electronic health records.
Furthermore, the Committee recommends that:
The issue of privacy, confidentiality and protection of personal health information in the context of an EHR system is perhaps the most sensitive one raised during the Committee’s hearings on this question. We address this question in detail in Section 10.4 below. However, it is worth noting here that an EHR system has the potential to actually improve the present situation with respect to the privacy of patients’ health information. Currently, the privacy of individual health records is not secure. Moreover, patients do not have effective access to their own records and, in fact, don’t even know where those records are. The Committee is of the view that, in the absence of a common EHR, both privacy and health care are substantially at risk from the wide dispersal of fragments of a patient’s record here and there in doctor’s offices, hospitals, public health units, home care providers’ files, nursing homes, etc.Additional federal funding to Infoway amount to $2 billion over a five-year period, or an annual allocation of $400 million.
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In Volume Five,[11] the Committee stated that long-term investment in information and communication technology, including an HER system, will allow the collection of more timely and better information on access to care, quality delivery, system performance and patients’ outcomes. We also indicated that while governments must finance the HER system, they should not be responsible for assessing health data and evaluating quality and outcomes. We agreed with witnesses that, currently, collection and evaluation of health-related information is done by the same people who are responsible for paying for, and for providing, health services – that is, governments.
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Moreover, the Committee believes that the work of the National Health Care Commissioner in evaluating health care system performance and outcomes should build on those national organizations that are currently devoted to the task of performing independent health care system evaluation.
One organization that the Committee believes strongly should collaborate in a national system of independent evaluation is the Canadian Institute for Health Information (CIHI). In our view, CIHI has a credible history in collecting standardized data and developing indicators for the health care system. Its work has been developed through a cooperative process involving various jurisdictions and multiple stakeholders.
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Since its inception, CIHI has been providing the Canadian public, health care managers and policy makers with excellent information. However, its budget, which is currently set at $95 million over four years (2001-2005), falls short of the investment necessary to provide the information required to plan, manage and report on the impact on the health care system changes recommended by the Committee. Thus, we believe strongly that CIHI’s budget must be augmented considerably.
Another national organization, the Canadian Council on Health Services Accreditation (CCHSA), has built a solid foundation on the basis of a voluntary accreditation process for health care institutions. The Committee learned that its strength derives from its primary focus on continuous quality improvement, a strength that should be preserved.
The Committee believes that, as part of a national system of evaluation, the mandate of CCHSA should be expanded to require regular accreditation, at regular intervals, for all sectors of health care (RHAs, public and private hospitals, primary health care settings, etc.). Accreditation should be based on well recognized national standards. If standards are not met and remediation is inadequate, then accreditation should not be given. The accreditation process would be supportive of a transparent accountability process.
Therefore, the Committee recommends that:
The federal government provide additional annual funding of $50 million to the Canadian Institute for Health Information. In addition, an annual investment of $10 million should be provided to the Canadian Council on Health Services Accreditation. This new federal investment will help establish a national system of evaluation of health care system performance and outcomes, and hence facilitate the work of the National Health Care Commissioner.
Electronic health records will likely affect the application of fair information principles in a number of ways. As compatible EHR systems are developed and implemented across the country, the traditional, bilateral relationship between patient and provider will be transformed into a more complex web of interactions between the patient and the health care system.
By their very nature, paper records are limited to discrete pieces of personal information that could feasibly be gathered in paper form, contained in a specific physical location, often collected by a single provider and accessible to that same provider in the context of one individual encounter at a time. This contrasts with EHRs, which can assemble a more complete, comprehensive and longitudinal record of a person’s health information originating from multiple sources, captured in electronic form that is readily available and potentially accessible to multiple authorized users, in real-time, irrespective of location.
This transformation will inevitably affect how patients can meaningfully and practically exercise their right to protection of personal health information. Likewise, this transformation will affect how responsibility and accountability are coordinated and shared among the multiple users of that information.
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Moreover, the pan-Canadian health info-structure promises to empower patients with better health information as well. This will allow patients to make more informed choices about their own health, the health of others and the health care system. A health infostructure will allow health care managers to evaluate service providers better and will enhance accountability of the system. It will also provide researchers with the evidentiary bases needed to continue to improve health care and better understand the determinants of health.[12]
Currently, there are three main privacy issues that must be addressed for EHRs to become a reality in Canada in the next five to seven years. These are:
1. The need for a more harmonized approach to privacy across all jurisdictions to allow for more consistent conditions for sharing personal health information among users and more consistent protection of personal health information for patients.
2. The need to develop robust and effective privacy safeguards, policies and procedures that can be implemented in a pragmatic, practical and cost-effective manner.
3. The need to build public confidence that personal health information will be protected in an electronic world.[13]
Currently, there is significant variation in privacy laws and data access policies across the country that poses a challenge for EHR systems that are dependent on inter-sectoral and inter-jurisdictional flows of personal health information. Differences in rules on how the scope of purpose is defined, the form of consent required, the conditions for substitute decision-making, the criteria for non-consensual access to personal health information, periods for retention of data and requirements for destruction, to name but a few, must be seriously addressed in order to enable the development of EHR systems.
In addition, existing oversight bodies in different sectors and jurisdictions have varying delegated legislative authority over some parts of an EHR system, but not others. Without some overarching coordination, this piecemeal approach will render very difficult, in practice, any system of review and oversight, process for approval, procedure for investigation and application of sanctions.
The Committee encourages ongoing federal/provincial/territorial efforts to develop a harmonized approach to protecting personal health information. In particular, the Committee recommends that:
The federal government work to achieve greater consistency and/or coordination across federal/provincial/territorial jurisdictions on the following key issues:
§ Need-to-know rules restricting access to authorized users based on their purposes;
§ Consent rules governing the form and criteria of consent in order to be valid;
§ Conditions authorizing non-consensual access to personal health information in limited circumstances and for specific purposes;
§ Rules governing the retention and destruction of personal health information;
§ Mechanisms for ensuring proper oversight of cross-jurisdictional electronic health record systems.
Another major challenge facing EHR development is the need to find ways of implementing compatible EHR systems in a manner that both protects people’s right to privacy of personal health information and is feasible and workable in practice. While there may be ways of introducing the most stringent physical, technological and organizational safeguards possible, these may simply not work in practice or be cost-effective. Moreover, safeguards change significantly over time as technology and customary practice evolves, requiring constant updating and upgrading. Organizations must distinguish passing trends from well-tested and proven state-of-the-art measures and make realistic investment choices accordingly.
In an EHR environment, many players will be involved in the collection of personal health information for inclusion in the common record. There will be many authorized users that can potentially gain rightful access to the EHR, adding information and collectively participating in the development of the record. As control will be shared among various players and users, so too shall accountability be shared. A real challenge lies in coordinating and apportioning responsibilities so that patients’ rights do not fall between the cracks. Despite the seemingly amorphous environment of an EHR system, patients must be able to direct their questions and concerns to an identifiable, responsible entity and exercise, in a meaningful way, their rights to access, correction and redress in the event of non-compliance.
Therefore, the Committee recommends that:
Canada Health Infoway Inc. and other key investors structure their investment criteria in such a way as to create incentives for developers of EHR systems to ensure practical and pragmatic privacy solutions for implementing the following:
§ State-of-the-art security safeguards for protecting personal health information and auditing transactions;
§ Shared accountability among various custodians accessing and using EHRs;
§ Coordination among custodians to give meaningful effect to patients’ rights to access their EHR, rectify any inaccuracy and challenge non-compliance.
In order to enable the development and implementation of EHRs, public trust and confidence are indispensable. There is currently little research on understanding the determinants of Canadians’ attitudes about the use of their personal health information for different purposes. Such research is vital if EHRs are to be developed and implemented in a manner that takes into account these determinants and respects people’s underlying concerns in specific contexts.
While the advantages of EHRs may be obvious to those who are in the business of developing them, these advantages must also be made obvious to individual Canadians. The promise of an eventual pan-Canadian health info-structure belongs to everyone. An informed and meaningful dialogue should occur, engaging all key stakeholders, including patient groups and consumer representatives. Providers will be better equipped to improve the quality of the care they deliver and integrate their services; policy-makers and managers will be better informed and able to ensure access to health care and accountability for actions throughout the system; researchers will be able to evaluate the effectiveness of health care products and services and better understand the determinants of Canadians’ health; members of the public will be better empowered to make informed choices about their own health, their health care and about health-related policy. An open, transparent, and iterative public communication strategy would go a long way to bring home the many benefits of EHRs and the truly inclusive vision of an eventual pan-Canadian health info-structure. Therefore, the Committee recommends that:
Key stakeholders, including the federal, provincial and territorial Ministries of Health, Canada Health Infoway Inc., the Canadian Institute for Health Information and Canadian Institutes of Health Research, undertake the following:
§ Rigorous research into the determinants affecting Canadian attitudes regarding acceptable and unacceptable uses of their personal health information;
§ Informed and meaningful dialogue with key stakeholders, including patient groups and consumer representatives;
§ An open, transparent and iterative public communication strategy about the benefits of EHRs.
Over the course of its hearings the Committee has heard overwhelming evidence of a persistent human resource shortage in all sectors of the health care system, affecting specialist physicians as well as family practitioners, registered nurses as well as licensed practical nurses, laboratory technologists as well as pharmacists. Addressing the supply of professionals in all health care disciplines and finding ways to increase their individual and collective productivity are two of the most pressing, yet complex, problems facing health care policy makers.
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Hardly a month goes by without the release of a new study or report that further documents the breadth and the gravity of the situation. A number of these that have appeared since the release of the Committee’s last report tell a familiar story.
According to a new report issued by the Canadian Institute for Health Information (CIHI) in June 2002, physician supply in Canada peaked in 1993 and has suffered a 5% decline since then, bringing the ratio of physicians to population down to the level it was 15 years ago.[14] This report provided one more graphic illustration of the extent of the human resource shortage and its consequences, including fewer family doctors, fewer younger physicians and heavier workloads for doctors.
Two recent provincial documents on physician supply also lend further support to the view expressed by the Committee in its previous reports that the human resource question is one area where it is increasingly legitimate to speak in terms of a crisis confronting the system. The Quebec College of Physicians examined the numbers of doctors actually in practice, rather than relying on raw registration numbers, and found that the province would need more than 1,400 additional physicians to provide necessary services to the population.[15]
For its part, the Ontario Medical Association estimated that there was a further net loss of 110 physicians from that province between 1999-2000, bringing the total shortfall to an estimated 1,585 physicians. The report indicates that there are now over 100 underserviced communities in the province.[16]
At the same time, the Committee is concerned that all of the studies referred to above focus on the number of practising physicians, and do not address the problem of productivity. Clearly, improving physician productivity would reduce the numbers of additional physicians required in Canada.
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In other fields, the availability of, for example, information technology has increased the productivity of other professionals over the past 20 years. Surely better diagnostic equipment, more effective drugs, improved out-of-hospital treatments, combined with the improved health status of Canadians over the past 20 years should have made physicians more productive. But whether this has actually happened is not known. This is why the proposed research is needed.
The Committee believes that similar observations to those about physician productivity could also be made about other health care professionals. The Committee therefore recommends that:
Studies be done to determine how the productivity of health care professionals can be improved. These studies should be either undertaken or commissioned by the National Coordinating Committee on Health Human Resources that the Committee recommends be created.
Three recently issued reports provide additional data on the extent of the shortage of nurses. CIHI reported in June 2002 that although there was a slight increase (1.2%) in the number of nurses employed in Canada between 1997 and 2001, it was not sufficient to keep pace with population growth. There are thus fewer nurses per capita in the country today than five years ago. The report also indicated that the nursing workforce is aging rapidly, with the average age of RNs employed in nursing going from 42.4 years in 1997 to 43.7 years in 2001.[18]
A study conducted for the Canadian Nurses Association that examined trends since 1966 noted “throughout the entire 35 years covered by the data series, the nursing workforce has seen the age composition shift to older age groups.”[19] The CNA report also made projections with regard to nursing supply and demand for the next 10 to 15 years, concluding that “there will be a shortage of 78,000 RNs in 2011 and 113,000 RNs by 2016.”[20]
The Final Report of the Canadian Nursing
Advisory Committee, chaired by Mr. Michael Decter, was released in August
2002. It identified three barriers
to a quality workplace for Canadian nurses,[21]
namely:
· the need for an increased number of nurses;
· the need to improve the education and maximize the scope of practice of nurses;
· the need to improve working conditions of nurses.
Amongst its 51 recommendations designed to help eliminate these barriers, the Advisory Committee advocated that the number of new, first-year seats in schools of nursing for Registered Nurses be increased by 25% (roughly 1,100 new seats) in September 2004 and that this number be adjusted upward by a further 20% in each of the subsequent four years.
Still, not enough is known about the
productivity of nurses and what could be done to improve it. For example, in
its report, the Canadian Nursing Advisory Committee endorses the need for
“provincial and federal resources […] to be directed toward the
development of accurate and manageable strategies to measure and report on
workload.”[22]
The Committee believes that the same type of productivity research that is
proposed with respect to physicians is also needed in order to understand
better how nurses spend their time at work, and what institutional barriers
stand in the way of improved productivity. This is why the recommendation made
above includes all health care professionals.
Although allied health professionals receive less public attention, the Committee has repeatedly drawn attention to the fact that the human resource shortage is not limited to doctors and nurses. For example, the Committee noted in previous Volumes that over 20 disciplines reported experiencing important shortages, ranging from physical and occupational therapists to radiography and medical laboratory technologists to public health inspectors.
Moreover, witnesses indicated that despite these shortages, enrolments in training programs are being cut. One example was medical laboratory technology in Alberta, where places in training schools had been cut from 40 to 20 students. Witnesses also referred to other disturbing figures, considering the ever-increasing demand for technical and professional employees attributable both to new technologies and to a growing population. For example, there has been a 42% decrease in the number of graduates from medical laboratory technology programs across the country since 1987, while diagnostic imaging produced 15% fewer graduates over the same period. The Canadian Society for Medical Laboratory Science has predicted a nation-wide shortage of general medical laboratory technologists within the next 5 to 15 years.
A further illustration was provided by the Canadian Pharmacists Association. It noted that a shortage of pharmacists is a problem in many countries including Canada, the United Kingdom and the United States. The under-supply of pharmacists translates into increased vacancies, longer delays in filling vacancies, increases in overtime hours, and market-based wage increases that exceed the cost of living. Another recent study suggests that well over 2,000 additional pharmacists could readily find work in Canada.
The decline in the number of graduates has also been compounded by what has been called “credential creep.” This refers to the gradual increase in the educational levels required to gain employment in a particular field, said to be driven by increasing complexity of the work involved. Among the consequences of “credential creep” are that it takes longer to train new graduates, thereby exacerbating the existing shortages of all health care professionals.
Credential creep also has other consequences. On the one hand, it can lead to the transfer of some programs from community colleges to universities; on the other, it can lead to graduates seeking higher levels of compensation they believe are justified by the additional training they have undergone.
The Committee is concerned that these developments occur without sufficient independent study to verify that the changes in the level of qualification and remuneration are warranted. The Committee believes that a review of the length of time required to train various health care professionals is needed, as well as an examination of what is the most appropriate educational institution to provide the needed training.
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In the Committee’s view, moving forward in this regard entails recognizing that such a strategy cannot be a “federal” one but must rather involve all stakeholders, bearing in mind that the training and education of health care professionals is a provincial responsibility. For Canada to attain the objective of self-sufficiency in health human resources, long-term cooperation and coordination among all stakeholders in the health care field are essential.
In the Committee’s opinion, problems relating to interprovincial competition for graduates in health-related fields further highlight the necessity to develop a national health human resources strategy. Competition among different jurisdictions for scarce human resources, whether interprovincial or international, can lead to severe regional disparities in the ability to provide health care services.
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The federal government work with other concerned parties to create a permanent National Coordinating Committee for Health Human Resources, to be composed of representatives of key stakeholder groups and of the different levels of government. Its mandate would include:
§ disseminating up-to-date data on human resource needs;
§ coordinating initiatives to ensure that adequate numbers of graduates are being trained to meet the goal of self-sufficiency in health human resources;
§ sharing and promoting best practices with regard to strategies for retaining skilled health care professionals and coordinating efforts to repatriate Canadian health care professionals who have emigrated to other countries;
§ recommending strategies for increasing the supply of health care professionals from under-represented groups, such as Canada’s Aboriginal peoples, and in under-serviced regions, particularly the rural and remote areas of the country;
§ examining the possibilities for greater coordination of licensing and immigration requirements between the various levels of government.
As noted earlier, the Committee also believes that the National Coordinating Committee on Health Human Resources should assume responsibility for studying how the productivity of health care professionals can be improved. It is also clear to the Committee that no single group of professionals, nor any single level of government, should predominate in the deliberations of the proposed National Coordinating Committee.
The Committee also recommends that the federal government undertake a number of specific initiatives designed to increase the supply of health care professionals, namely that:
The federal government:
§ Work with provincial governments to ensure that all medical schools and schools of nursing receive the funding increments required to permit necessary enrolment expansion;
§ Put in place mechanisms by which direct federal funding could be provided to support expanded enrolment in medical and nursing education, and ensure the stability of funding for the training and education of allied health professionals;
§ Review federal student loan programs available to health care professionals and make modifications to ensure that the impact of inevitable increases in tuition fees does not lead to denial of opportunity to students in lower socio-economic circumstances;
§ Work with provincial governments to ensure that the relative wage levels paid to different categories of health professionals reflect the real level of education and training required of them.
In previous volumes, the Committee had noted that there was a serious shortage of health care providers from Aboriginal backgrounds. In order to help to address this problem the Committee also recommended in Volume Five that:
The federal government work with the provinces and medical and nursing faculties to finance places for students from Aboriginal backgrounds over and above those available to the general population.
Moreover, since all the measures described in the above recommendations take time to implement, various shorter-term measures are required to deal with the health human resources crisis. One such avenue involves the tax system. Short-term tax incentives were used in the late 1960s and early 1970s to attract university professors to Canada at a time when the country faced a severe shortage of qualified university faculty members. The Committee believes a similar approach should be considered at this time with respect to health care professionals. It therefore further recommends that:
In order to facilitate the return to Canada of Canadian health care professionals who are working abroad, the federal government should work with the provinces and professional associations to inform expatriate Canadian health professionals of emerging job opportunities in Canada, and explore the possibility of adopting short-term tax incentives for those prepared to return to Canada.
The following sections of this chapter contain additional observations related to the health human resources shortage in Canada, as well as a number of further recommendations to help alleviate it.
The recent CIHI report referred to above has made a new contribution to the discussion of physician supply in Canada by assigning weights to the various factors that have contributed to the decline in the ratio of physicians to population:
· about 25% of the decline can be attributed to longer postgraduate training for doctors, both because family doctors now require two years of postgraduate training instead of one before entering independent practice, and because a higher proportion of doctors are choosing to become specialists, which requires much longer training periods;
· 22% of the drop was attributable to fewer foreign doctors entering Canada;
· 17% was caused by increased physician retirement;
· to date, only 11% of the decline can be attributed to decreased enrolment in medical schools, but the full effect of the cuts of the 1990s will only be felt in coming years.
The author of the report, Dr. Ben Chan, notes that several key mistakes were made in policy design during the 1990s. In the first place, unintended consequences were not taken into account. For example, it was not fully appreciated that increasing the length of training (e.g., two rather than one year of postgraduate training for family physicians) permanently reduces the supply of physicians. Second, policies were not reviewed frequently enough, so the effects of a number of policies combined in unexpected ways to generate a larger shortage than was anticipated. Finally, measures that gave the system flexibility were eliminated; for example, students were forced to lock into career choices at very early stages in their undergraduate education without the benefit of practical experience or the possibility of changing their minds at a later date.[23]
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In Volume Five, the Committee recommended that the federal government provide ongoing financial assistance to the provinces to increase enrolments in Canadian medical schools. According to the ACMC, the cost per place in a Canadian medical school is currently estimated at $260,000 over a four-year period. An additional 640 students would therefore cost approximately $160 million per year once the new levels of enrolment were attained.[25] The Committee believes that this would be money well spent, and therefore recommends that:
The federal government contribute $160 million per year, starting immediately, so that Canadian medical colleges can enrol 2,500 first-year students by 2005.
Moreover, it is important to bear in mind Dr. Chan’s conclusion that it is necessary to review regularly the levels of enrolment to ensure that they remain in accord with evolving circumstances. Dr. Fuks estimated that in order to offset current physician shortages (rather than merely maintaining the current physician to population ratio) it would be necessary to increase enrolments further to 3,000 first-year students by 2009. It is important to note, however, that such forecasts do not take into account the impact of potential improvements in productivity. The Committee believes it necessary to keep a careful watch on the situation, and recommends that:
The proposed National Coordinating Committee for Health Human Resources be charged with monitoring the levels of enrolment in Canadian medical schools and make recommendations to the federal government on whether these are appropriate.
Clearly, however, it will take time to raise the levels of enrolment, and it will be even longer before these increases translate into greater numbers of doctors in the field. In the short term, then, measures should also be taken to relieve some of the pressure. The Committee has already reiterated its recommendation from Volume Five that the federal government explore the possibility of adopting short-term tax incentives in order to repatriate health care professionals working abroad.
There are also a number of highly skilled and well-trained Canadians who are completing their basic medical education outside Canada, notably in Australia, Ireland and the UK. Dr. Fuks told the Committee that many of these students, who are receiving their training in high-quality medical faculties, are eager to return to Canada. The Committee believes that there should, therefore, be a robust policy of recruitment for such expatriate Canadians to return to Canada for post-graduate training and practice in this country.
In order to accommodate these returning students, as well as the international medical graduates discussed below, it will also be necessary to increase the number of post-graduate residency positions. Based on figures provided by the Association of Canadian Medical Colleges,[26] the Committee therefore recommends that:
The federal government should contribute financially to increasing the number of post-graduate residency positions in medicine to a ratio of 120 per 100 graduates of Canadian medical schools.
As the Committee noted in Volume Five, this will also allow Canadian physicians who are already in practice greater opportunity to re-enter postgraduate training and pursue additional qualifications.
Another measure specific to dealing with the shortage of physicians is the development of a national plan to make better use of international medical graduates (IMGs) already here. In the past, Canada has been able to rely on recruitment from abroad to fill some of the gaps. For example, over 50% of doctors practising in Saskatchewan are international medical graduates who have been trained elsewhere and recruited to Saskatchewan later in their careers. However, other countries now face many of the same shortages that confront our system. There does not seem to make much sense for all developed countries to poach endlessly each other’s highly trained health care professionals.
Most experts estimate that there are currently at least 2,000 international medical graduates in Canada who are not licensed to work as physicians.[27] There is no common program for issuing credentials to IMGs, and each province has a limited program for admitting IMGs to residency programs. For example, Ontario reserves 40 spots for IMG training, but despite 1,000 applications last year only 25 were admitted.
There are some signs of progress, however. In April 2001, Manitoba launched the first permanent program in Canada to assist IMGs to obtain medical licences. It relies on a three-stage Clinicians Assessment and Professional Enhancement (CAPE) process, an evaluation tool developed by the University of Manitoba’s faculty of medicine, to assess the medical knowledge and clinical skill of foreign-trained doctors. The CAPE program has proved so successful that the College of Physicians and Surgeons of Nova Scotia refers IMG applicants who do not have licensed North American training or clinical practice experience to the Manitoba program for assessment.[28]
Members of the Association of Canadian Medical Colleges recently concluded that there is a pressing need for a national strategy, incorporating national standards, to assist in integrating IMGs into the Canadian medical workforce. They proposed that there be a common evaluation program that would allow IMGs to be classified in one of four categories: their education and training is equivalent and they should be licensed practise in Canada; they need some extra training; their medical education is equivalent but they need to do postgraduate training here; or neither their education nor training is adequate and they have to begin again at a medical school in Canada.
The Committee therefore recommends that:
The federal government work with the provinces to establish national standards for the evaluation of international medical graduates, and provide ongoing funding to implement an accelerated program for the licensing of qualified IMGs and their full integration into the Canadian health care delivery system.
As noted earlier in this chapter, a study conducted for the Canadian Nurses Association indicated that the country would be short 78,000 RNs in 2011 and that this shortfall could reach 113,000 by 2016. The study reached these conclusions despite using what it calls relatively optimistic assumptions with regard to the number of nursing graduates that can be anticipated in the coming five years. The report estimates that “the output from Canada’s nursing schools is expected to grow from 4,599 graduates in the year 2000 to more than 9,000 per annum by the year 2007.”[29] (See Table 11.1, below).
Table 11.1
Number of Nursing Graduates, 1999-2008*
|
Year |
1999 |
2000 |
2001 |
2002 |
2003 |
2004 |
2005 |
2006 |
2007 |
2008 |
|
Canada |
5,221 |
4,599 |
5,499 |
6,782 |
7,578 |
7,678 |
7,834 |
8,829 |
9,182 |
9,382 |
Source: Projections by Eva Ryten for
the Canadian Nurses Association, June, 2002.
* 1999-2001, actual data; 2002-208, projections
But even with almost doubling the number of graduates, and an expected influx of 1,200 nurses trained abroad every year from 2002 onwards, the study categorically affirmed that it will not be possible to meet the anticipated demand for nursing services. Nor is there a sufficiently large pool of trained nurses who are not currently employed in nursing who could be enticed back into the profession in order to help deal with the shortfall. In fact, the report points out that:
It is particularly relevant to note that in both 2000 and 2001, there were fewer than 3,000 RNs who were not working as nurses but looking for jobs in nursing. This is a tiny number compared with the total stock of RNs in the country.[30]
Nonetheless, the Committee believes that everything possible should be done to entice those qualified nurses who have left the profession to return to active nursing. This is all the more important since, even if it were deemed advisable to substitute licensed practical nurses (LPNs) for RNs, the report notes that there are not enough qualified LPNs to make up the shortfall either.
For licensed practical nurses to meet a significant portion of nursing service requirements that cannot be met by RNs due to the nursing shortage, the LPN complement would have to be growing at an extremely rapid rate. But, in fact, the number of LPNs has been stagnant or decreasing for nearly 20 years. In 1983, there were 83,539 LPNs in Canada. By 1999, this number was down to 66,100.[31]
At the same time, Ms. Kelly Kay of the Canadian Practical Nurses Association told the Committee that:
In most jurisdictions, licensed practical nurses are in short supply. However, there are still situations such as in the province of Ontario where 1,400 registered practical nurses reported on their last registration data form that they were seeking employment in nursing.[32]
Although in 1997 it appeared that the trend was towards a decline in the number of applications to nursing schools, this no longer seems to be true. Ms. Ginette Lemire-Rodger, outgoing president of the CAN, explained to the Committee that:
Clearly, then, everything points to the need to increase the number of nursing graduates in fairly dramatic fashion. The committee noted in Volume Five that Human Resources Development Canada (HRDC) has undertaken a major sector study in order to make recommendations with regard to the supply of nurses. However, as Michael Decter remarked to the Committee:In Canada, this year alone, thousands of well-qualified students have been turned away. The universities reject them because there are only 70 places for every 800 applications across the country. There is no lack of young people and not-so-young people wanting to take up nursing, but the governments are not funding the seats in the universities.[33]
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I know the Government of Canada through HRDC is funding two large studies. To paraphrase David Sackett, you do not need a double blind, random clinical trial to apply common sense. Common sense would say we need more nurses in this country and we need them urgently.[34]
In calculating how many new places should be allotted, the CNA report cautions that in the long run it is important to avoid
periods of either very sharp increases or decreases in output over short spaces of time. Doing this repeatedly over long periods of time leads to a roller coaster of surpluses and shortages in supply. Ideally, levels of output would increase gradually each year in line with increased needs.[35]
Had there not been a serious underfunding of nursing positions during the nineties, the CNA estimates that the number of graduates needed would still have been of the order of 10,000 per annum. The CNA report explained that this is because “even if the crisis of the 90s had never occurred, Canada would be facing nursing shortages in both 2011 and 2016, albeit of a smaller magnitude, because of the impending retirement of the larger graduating cohorts who are being replaced by smaller ones.”[36] Taking the consequences of the erroneous decisions of the nineties into account, the CNA felt it prudent to recommend that nursing programs be expanded in order to attain an annual output of 12,000 graduates.
The Committee endorses this estimate. Table 11.1 gives the projections contained in the report for current and projected provincial output of graduates until 2008. The Committee recommends that:
The federal government phase in funding over the next five years so that by 2008 there are 12,000 graduates from nursing programs across the country, and that the federal government continue to provide full additional funding to the provinces for all nursing school places over and above 10,000, for as long as is necessary to eliminate the shortage of nurses in the country.
Using the figures given in Table 11.1 that indicate the anticipated levels of nursing graduates, this means that by 2008 it will be necessary to graduate an additional 2,618 nurses. The numbers could be increased as follows to build towards this figure:
Table 11.2
|
|
2004 |
2005 |
2006 |
2007 |
2008 |
|
Current
anticipated number of graduates |
7,678 |
7,834 |
8,829 |
9,182 |
9,382 |
|
Projected
number of graduates given additional federal funding |
8,000 |
9,000 |
10,000 |
11,000 |
12,000 |
The Committee was told by the CNA that each additional nursing position in Ontario cost $7,700 per year. Based on a four-year program, this translates into approximately $30,000 to train each new nurse. Extending this estimate to all nursing places across the country, it would cost approximately $80 million per year to bring the number of nursing graduates to the 12,000 level recommended by the CNA.[37] To be sure that sufficient funds are available, and in light of the seriousness of the nursing shortage, the Committee believes that it would be prudent to set aside a further $10 million in the hope that more nurses could graduate even sooner. The Committee therefore recommends that:
The
federal government commit $90 million per year from the additional revenue the
Committee recommends that it raise in order to enable Canadian nursing schools
to graduate 12,000 nurses by 2008.
The Committee was not able to obtain sufficient data to work out a detailed proposal with regard to the precise numbers of new graduates that would be needed to respond to the shortages of allied health professionals discussed earlier in this chapter. Nonetheless, the Committee believes that it is essential for the federal government to commit funds to addressing these pressing needs. The Committee therefore recommends that:
The federal government commit $40 million per year from the new revenues that the Committee has recommended it raise in order to assist the provinces in raising the number of allied health professionals who graduate each year.
The exact allocation of these funds be determined by the proposed National Coordinating Committee for Health Human Resources.
The cost of training new health care professionals does not end the moment they graduate from university or college. There are additional costs that are borne in large part by academic health sciences centres, not only for physicians but for the full range of health care professionals. The Association of Canadian Academic Healthcare Organizations (ACAHO) has estimated the additional costs associated with increases in health care training positions for all the health care professions to be in the range of $300 – $550 million over the course of their training cycle (or between $60 and $110 million per year). These costs include funding for instructors, space, overhead and supplies. The Committee therefore recommends that:
The federal government devote $75 million per year of the new money the Committee recommends be raised to assisting Academic Health Sciences Centres to pay the costs associated with expanding the number of training slots for the full range of health care professionals.
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The importance of dealing with this problem on an urgent basis was clearly stated by Dr. Duncan Sinclair, the Chair of the Ontario Health Service Restructuring Commission, in his testimony to the Committee:
Having a doctor do work that a nurse practitioner or nurse could do is like calling an electrician to change a light bulb or a licensed mechanic out of the garage to fill your tank and check the oil and tire pressure – would they do a good job? They would do an excellent job! But would it be a good use of their time, training and expertise? It would not! It would constitute an expensive and inefficient use of scarce resources, both of money and the expertise of very talented people.[38]
The Committee believes that such expensive and inefficient use of scarce human resources needs to cease now. As noted in Chapter Four on Primary Health Care Reform, the synthesis report of the Health Transition Fund’s primary care projects concluded with regard to nurse practitioners that:
A federal/provincial/territorial initiative should develop national standards for terminology and scope of practice. It should include legislative requirements that support an expanded role for nurses and nurse practitioners.[39]
The Committee therefore recommends that:
An independent review of scope of practice rules and other regulations affecting what individual health professionals can and cannot do be undertaken for the purpose of developing proposals that would enable the skills and competencies of diverse health care professionals to be utilized to the fullest and enable health care services to be delivered by the most appropriately qualified professionals.
The Committee acknowledges that there needs to be an increase in the number of people employed in each of the health care professions, and our recommendations are designed to address this problem.
But the Committee is also very concerned about the overall costs that this increase in human resource supply will entail for the system as a whole. The Committee is keenly aware, for example, that physicians are the major cost-drivers in the system.[40] Since increasing the supply of physicians does not decrease the average cost that each physician imposes on the system, as the number of practising physicians increases the only way in which the system could remain fiscally sustainable is for significant productivity improvements also to occur.
The Committee therefore feels that it is necessary for the increase in the numbers of educational positions to be accompanied by detailed studies of how to improve the productivity of each of the health care professions. If these studies are not done, and if productivity is not substantially improved, the Committee is concerned that this could lead to an unsustainable escalation of overall health care costs.|
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Health research is about creating and applying new knowledge with respect to health and health care. Health research encompasses a full spectrum of activities that range from biomedical research, to clinical research, to health services research, and to population health research:
· Biomedical research pertains to biological organisms, organs, and organ systems. For example, this type of research would use animal or human tissues or cell culture to understand how the body controls the production of blood cells in the bone marrow, how those controls break down in leukemia, and how normal controls might be reinstated by treatment with drugs.
· Clinical research relates to studies involving human participants, healthy or ill. An example would include clinical trials on humans to test the toxicity and effectiveness of a possible new treatment for leukemia that has shown promising results in basic biomedical research, and then to compare the new drug with other drugs in terms of their net benefit to patients.
· Health services research embraces health care delivery, administration, organization and financing. An example might be research into the mechanisms for handling patients with leukemia, from the means for diagnosis, through their treatment in hospital, on an out-patient basis, or at home, to their long-term follow-up through hospital or community care.
· Population health research focuses on the broad factors that influence health status (socio-economic conditions, gender, culture, literacy, etc.). An example might be a study using large databases of personal health information gained from a number of sources to learn whether the incidence of leukemia is associated with environmental or other factors.
Health research is the source of new knowledge about human health, how to maintain optimal health, how to prevent, diagnose and treat disease, and how to manage our health care system. Health research leads to the development of new or improved drug therapy, treatment, medical equipment and devices, and new ways of organizing and delivering health care. Health research also contributes to a better understanding of the complex interplay of the social, economic, environmental, biological and genetic determinants that affect our health and our susceptibility to disease.
The Committee was told that health research fosters the creation of knowledge-based employment, which in turn contributes to reversing the brain drain observed in the country. Overall, witnesses stressed that health research improves the personal and economic health of Canadians and enhances our international competitiveness:
Health research provides enormous economic, social and health care rewards to society. The jobs that are created by these investments are high-quality, well-paying, knowledge-based positions that generate worldwide recognition for Canadians. These investments also support the rejuvenation of academic institutions across the country. They help train new health professionals in the latest technologies and techniques and they provide important support for the health care delivery system in Canada. Most importantly, the results of these activities lead directly to better ways to treat patients, which ensures a healthier and more productive population.[42]
The Committee also heard that health research could serve as a catalyst to regional economic development and that the health services innovations generated through health research activities could greatly contribute to enhancing the quality and sustainability of Canada’s health care system. As health research activity spreads out from the academic health sciences centres and government and into more community-based settings, we can anticipate that standards of care will improve, as health care providers engaged in health research will be better connected with the most recent information. Overall, health research provides tremendous opportunities for both economic and health care progress.
The Committee believes that Canada must actively engage in health research to capture its share of benefits. The Committee also strongly believes that the federal government has a critical role to play as a facilitator, catalyst, performer, consensus builder and coordinator in the overall effort to nurture excellence in health research. This chapter addresses a series of issues, including funding, partnerships and ethics, which we believe deserve close attention if Canada is to achieve the highest standard of excellence in health research.[43]|
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As Table 12.1 shows, health research in Canada is characterized by a complex network that involves a wide range of disciplines and a multiplicity of performers carrying out their research activities in a variety of locations. In Canada, health research is performed by universities, teaching hospitals, business enterprises, government, and non-profit organizations. This research is financed from a variety of public, private, Canadian and foreign sources.
TABLE 12.1
THE CANADIAN HEALTH RESEARCH NETWORK
|
DISCIPLINES |
LOCATIONS |
SOURCES
OF FUNDING |
|
§
Clinical
Disciplines §
Social
Sciences and Humanities §
Epidemiology §
Life
Sciences §
Cellular
and Molecular Biology §
Chemistry §
Engineering §
Computing
and Mathematical Sciences §
Health
Services |
§
Academia
(Universities, Teaching Hospitals, Research Institutes) §
Industry §
Government §
Physicians’
Practices §
Community
Organizations §
Community
Hospitals §
Others |
§
Governments
(Federal, Provincial, Departments, Funding Agencies) §
Non-Government
Organizations and National Voluntary Organizations §
International
Sources §
Industry §
Universities §
Others |
The different stakeholders in health research collaborate with each other in various ways: government-university, university-industry, government-industry. In fact, the Committee was told that science is a continuum and the multiple components of health research cannot exist independently of the others. Each component has an important, albeit changing, research role to play in ensuring maximum health benefits for Canadians.
The federal government has always played an important role in health research as a funder, performer and user of research. The federal government financially supports health research carried out in universities, teaching hospitals and research institutes (extramural research); it performs health research in its own laboratories (intramural or in-house research); and it utilizes the outcomes of health research carried out elsewhere. Moreover, the federal government has an important role to play in setting national priorities for health research.
The Committee believes that, in a country as vast as Canada, the federal government has a catalytic leadership role in working with the provincial and territorial governments to ensure that our health care system is driven by research and innovation. To be successful, the federal government needs to have a close collaboration with the provinces and territories to sustain a culture that supports the creation and use of knowledge generated by health research.
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In addition, the Committee agrees with a 1999 report of the Council of Science and Technology Advisors that health research performed, funded and used by the federal government must be of the highest quality. It must be demonstrated to meet or exceed international standards of excellence in science, technology and ethics.[44]
The Committee was informed that, as the cost, complexity and pace of advancement in health research accelerate, individual organizations no longer have the resources or expertise to work in a vacuum:
Traditionally, investigators have worked in isolation, pursuing their own research agendas and living grant-to-grant. This scattered, ad hoc approach simply won’t work in today’s world when the complexity of science requires the pooling of resources.[45]
At the third annual Amyot Lecture organized by Health Canada, Dr. Kevin Keough, Chief Scientist at Health Canada, stated that it is necessary to adopt an inclusive (or horizontal) approach to health research and to find new ways to partner – that is, to bring together multidisciplinary teams of scientists from across the whole health research system to combine their intellectual, financial and physical resources in conducting the research required to better understand the complex and highly interconnected world in which we live. [46]
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The Committee strongly believes that the federal government should assume leadership in Canadian health research and, therefore, we recommend that:
Health research and its translation into the health care system be routinely on the agendas of meetings of federal and provincial/territorial Ministers and Deputy Ministers of Health, and that the Canadian Institute of Health Research be represented and be involved in setting the agendas for health research at those meetings. This would greatly help to sustain a culture that supports the creation and use of knowledge generated by health research throughout Canada.
The federal government set, on a regular basis, national goals and priorities for health research in collaboration with all stakeholders.
The federal government foster multi-stakeholder collaborations when performing, funding and using health research. This should contribute to capitalizing on the best available resources while minimizing overlap and duplication.
Dr. Keough stressed that, as a starting point, the federal government should encourage the interchange of health research scientists between government, academia and the private sector. A freer flow of scientists would enhance the quality of Canadian health research, improve science and research advice to government, maximize the contribution of Canadian scientists to the whole health research community, and contribute to the renewal of the science base in all sectors. The Committee shares similar views and, therefore, recommends that:
The federal government take a leadership role, through the Canadian Institutes of Health Research and Health Canada, in developing a strategy to encourage the interchange of research scientists between government, academia and the private sector, including national voluntary organizations.
The Committee wishes to acknowledge the important role played by national voluntary organizations in health research. These organizations act as a key bridge at the national level between health research and its application through knowledge transfer of information to researchers, health care providers and the general public. It is the view of the Committee that, given the knowledge and experience these national voluntary organizations bring, as well as the significant proportion of the health research enterprise which they support, they must be included in the multistakeholders collaboration in health research.
Witnesses told the Committee that health research in Canada and throughout the world is currently undergoing a scientific revolution. They explained that this revolution in health research is fuelled by the ongoing advances in genomics, engineering and cell biology. Research in these scientific disciplines will have a profound effect on the detection, diagnosis and treatment of various genetically linked diseases. Elucidation of the physiological processes associated with various conditions will require years of efforts to identify the relevant genes and to determine how they interact.
We are in the midst of a profound global revolution being driven by our rapidly emerging understanding of the molecular basis of life, of human biology and of disease. Like prior revolutions in science, this revolution is being driven by the collision of diverse disciplines and approaches: genetics, molecular biology, the broader bio-sciences, [information technology] and computational methodologies, small molecules and surface chemistry, bioethics, epidemiology, health economics, and the social sciences and humanities. The pace of this health research revolution is still accelerating, driven by significant global investments by governments, industry and philanthropy.[47]
As the human genome project approaches completion, the next challenge is to understand the function of the 30,000-40,000 genes that humans appear to possess. These genes encode the entire protein set or proteome estimated at 2 million. Thus, the next frontier in biology appears to be proteomics, the cataloging and functional description of all proteins in living organisms, which is far more complex and promising than genomics.
Similarly, advances in biomedical engineering and miniaturization on the molecular scale will push development of more sophisticated devices for diagnosis and therapy – targeted delivery of drugs, biological testing, molecular imaging, and tissue and organ repair. Canada has a real opportunity to become a world leader in this field of “nanotechnology” or “nanomedicine.”
The study and use of stem cells is another good example of the potential impact that health research can have on health and health care. Stem cells have the unique property, whatever their origin, of becoming specialized cells. Currently, both the research community and related stakeholders are very enthusiastic about the potential of stem cells, both from embryonic and adult sources. It is anticipated that research on these cells will lead to treatments for serious diseases such as Parkinson’s, Alzheimer’s, diabetes and spinal cord injuries. It is also widely believed that these cells can ultimately be manipulated to grow into virtually any tissue or organ thus providing much needed organs for transplant.
Recent research has been successful in programming human embryonic stem cells into producing insulin. Normally, this function is performed by specialized pancreatic islet cells. Should this treatment prove to be able to provide a cure for diabetes, which is presently being treated by regular injection of insulin, it will not only improve the quality of life for the individual, but will also ease the economic burden of disease. In a different study, stem cells isolated from the skin of animals were coaxed into becoming neural, muscular and fat cells.
Other areas where the scientific revolution has a definite impact are chemistry and computer science where advances in molecular modelling combined with synthetic chemistry change the way novel drugs are discovered. Bioinformatics and robotics are also areas that will benefit health research.
The scientific revolution in health research is not limited to basic and biomedical research; it is also creating tremendous opportunities for research into health services and population health. More than ever before, research is undertaken in Canada and abroad to find new ways of delivering quality care and to understand the implications of the interaction of the determinants that affect the health of a population.
At the third Amyot Lecture, Dr. Keough stressed that advances in health research, and the need for governments and individuals to accommodate them, will continue to accelerate. This means that governments must be able to both perform and rely on good science, which is based on sound research harnessed for the public good. The government’s effectiveness in integrating progresses from emerging areas such as biotechnology and nanotechnology depends on this principle.
The Committee agrees with Dr. Keough that it is imperative for Canada to take up the challenges wrought by the scientific revolution. We are convinced that countries with a strong health research network are more capable of translating advances and innovations into cost-effective health services, modern and internationally competitive policy and regulatory frameworks, new or adaptive products, and new health promotion activities. An energetic health research environment contributes to improved health, higher quality of life, and an efficient health care system. This in turn engenders public confidence, a vibrant business environment and a strong economy.
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Along with Dr. Keough, the Committee believes that good science is good economics and that the government has a crucial role in maximizing the gains for Canada and its citizens. Clearly, the costs of doing good science are high; but the costs of not doing it are even higher. These scientific developments are rapidly expanding and there is fierce competition in the field. Along with numerous witnesses, the Committee is convinced that Canada cannot afford to fall behind. The potential pay-off is a fast and economically beneficial transfer of knowledge and its conversion into tangible benefits for the Canadian population.
It is the opinion of the Committee that such a formidable challenge can be met only through a concerted effort by government, industry, academia, non-governmental organizations and international organizations. Each of these partners has its own specific role. However, coordination and support should be provided by the federal government, through its agencies and departments, especially CIHR and Health Canada. Therefore, the Committee recommends that:
The federal government, through both Health Canada and the Canadian Institutes of Health Research, coordinate and provide resources to ensure that Canada contributes to and benefits from the scientific revolution to maximize the economic, health and social gains for Canadians.
The Committee strongly believes that Canada can be a world leader in health research, building on our strengths in human genetics, stem cell biology, population health, bioethics, proteomics, and health economics. We have a tremendous opportunity to apply the knowledge generated from genomics and proteomics research to the study of human populations and human research. For example, the CIHR through its institutes of Genetics and Health Services and Policy Research are partnering with the Federal/Provincial/Territorial Coordinating Committee on Genetics and Health to identify and prioritize emerging issues that can be addressed through research.
The field of genomics and proteomics in Canada could benefit from a more integrated investment approach. For example, with a long-standing record of excellence in protein science research and training, Canada is well positioned to make a significant contribution in proteomics. The Canadian Proteomics Initiative – a partnership between CIHR’s Institute of Genetics and the Protein Engineering Network of Centres of Excellence (PENCE) – is working to build on the federal government’s investments to date in infrastructure to build a large-scale national program that will ensure that Canada’s remains internationally competitive. Therefore, the Committee recommends that:
The Canadian Institutes of Health Research and Genome Canada fund research that positions Canada as a world leader in the new area of genomics and human genetics so that the health care system can take appropriate advantage of this new technology to improve the health of Canadians.
The Canadian Institutes of Health Research play a leadership role in establishing best practices for addressing the complex ethical issues raised by the use of this new technology in health research and health care.
As indicated in Volume Two, the federal
government has had a long tradition in financing health research.[48]
The most recent estimates by Statistics Canada indicate that the
majority (some 79%) of federally funded health research is “extramural” as
it takes place in universities and hospitals (68%), private non-profit
organizations (6%), and business enterprises (4%).[49]
The principal federal funding body for health research is the Canadian Institutes of Health Research (CIHR). In fact, CIHR is the only federal entity whose budget is entirely devoted to health research. Its creation in 2000 involved a major evolution of the mandate of the Medical Research Council of Canada (MRC) and incorporation of the National Health Research and Development Program (NHRDP), formerly Health Canada’s main financing instrument for extramural health research. Despite the creation of CIHR, Health Canada is still involved in the financing of some extramural health research in a wide range of fields (children’s health, women’s health, Aboriginal health, etc.).
There are also a number of federal research-oriented bodies whose funding focuses entirely on health-related research. These include namely the Canadian Health Services Research Foundation (CHSRF) and the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Many feel that for a country of the size of Canada, there are too many federal funding organizations.
In addition, there are several secondary sources of extramural federal health research funding. More precisely, the federal government is responsible for a number of research councils, agencies and programs that devote (to various extents) a portion of their budget for health-related research. These include the Natural Sciences and Engineering Research Council (NSERC), the Social Sciences and Humanities Research Council (SSHRC), the Canada Foundation for Innovation (CFI), the Canada Research Chairs (CRCs), and the Networks of Centres of Excellence.[50] The federal government has also funded Genome Canada, a not-for-profit corporation dedicated to developing and implementing a national strategy in genomic research.
The remainder of the federally funded health research (some 21%) is “intramural” or “in-house” research, that is research conducted in federal government facilities. Federal facilities in which health-related research is performed include Health Canada, Statistics Canada, the National Research Council, Human Resources Development Canada, Agriculture Canada, Environment Canada (in partnership with Health Canada) and the Canadian Food Inspection Agency.
The federal government has, on many occasions, demonstrated its commitment to health research. The Committee applauds the high priority for research given in the 2001 Speech from the Throne and particularly its announcement to increase funding for health research:
Our government’s overriding goal is nothing less than branding Canada as the most innovative country in the world – as the place to be for knowledge creation; where our best and brightest can make their discoveries; where the global research stars of today and tomorrow are born; becoming the magnet for new investments and new ventures.
(…) The Government of Canada will (…) provide a further major increase in funding to the Canadian Institutes of Health Research, to enhance their research into disease prevention and treatment, the determinants of health, and the effectiveness of the health care system.[51]
The Committee also recognizes the creation of CIHR as a major achievement in health research. We laud the increased funding for CIHR announced in the December 2001 Budget Speech, despite the severe financial pressures the federal government faces. In addition, the creation of, and funding for, the Canada Foundation for Innovation in 1997, followed by the Millennium Scholarships, the Canada Research Chairs, and Genome Canada, are clear indications that health research and innovation are integral to public health-related policy in Canada.
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Throughout its study, the Committee was told that while the increase in federal funding represents significant support for health research, Canada still does not compare favourably with other industrialized countries in this regard. In fact, the role of national government in financing health research, expressed in purchasing power parity (PPP) per capita, is much higher in the United States, the United Kingdom, France and Australia than in Canada. For example, as stated in Volume Two, the American government provided in 1998 four times more funding per capita to health research than did the Canadian government.[52]
Witnesses unanimously recommended that the federal government’s share of total spending on extramural health research be increased to 1% of total health care spending in Canada, from its current level of approximately 0.5%. This could involve increasing CIHR’s current budget to $1 billion from the current level of $560 million. Additional resources should also be devoted to federally performed health research (discussed in the following section). Overall, increased investment in extramural and in-house health research would bring the level of the federal contribution to health research more in line with that of national governments in other OECD countries. More importantly, this would help maintain a vibrant, innovative and leading edge health research industry.
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Another concern brought to the attention of the Committee related to the long-term nature of research in contrast to existing budgetary program planning. High quality research is very competitive internationally and requires long-term commitments. Young researchers, on whom Canada’s future in research depends, commit their careers on the basis of their perceptions of the long-term environment for research. Canada will not attract or keep excellent people without providing an excellent environment for research. Research pays little attention to national borders. The world recognizes excellence, and competes vigorously for it.
The Committee strongly supports the view that health research money is money to support the best and the brightest minds. At least two-thirds of funds for health research go to salaries and training stipends for highly qualified and motivated researchers, research assistants, technicians, research trainees, etc. Ultimately, Canada’s challenge in health research is a challenge to attract and retain outstanding people.
The role of the federal government is central to this competition for excellent researchers. In particular, CIHR is the long-term source of research funds for the health research activities stimulated by the Research Chairs, the Canadian Foundation for Innovation, and Genome Canada, all of which are adding greatly to Canada’s capacity for excellence in research. CIHR is also an essential partner for research stimulated by the many health research charities.
Overall, the Committee believes that the federal government must establish and maintain long-term stability in the Canadian health research environment. Providing an adequate and predictable level of funding is a necessary prerequisite. We agree with witnesses that the federal government must increase its investment in health research so that federal extramural funding accounts for 1% of total health care spending.
In our view, such additional federal funding should be directed to research projects that can have a significant impact on health status or that contribute substantially to improvements in health care quality and delivery. Research in such fields as population health, public health, health services delivery, clinical practice guidelines, early child development, and women’s and Aboriginal health should be given the highest priority.
The Committee also believes that the establishment of CIHR has resulted in the creation of a broad platform upon which to launch bold new initiatives in health research. Moreover, we believe that CIHR and its 13 Institutes must insist on the translation of knowledge generated by research; this will ensure that the results of health research are translated into action including changes in clinical practice, health care policy, and individual behaviours.
Health research is a long-term investment; many research projects span a researcher’s whole career, and grants are usually awarded for three- to five-year terms, which are simply not consistent with the one-year-at-a-time budget allocation to CIHR. Overall, the Committee recommends that
The federal government:
§ Increase, within a reasonable timeframe, its financial contribution to extramural health research to achieve the level of 1% of total Canadian health care spending. This requires an additional investment of $440 million by the federal government;
§ Recognize that health research is a long term proposition, and therefore set and adhere to clear long-term plans for funding health research, particularly through the Canadian Institutes of Health Research. More precisely, the federal government should commit to a five-year planning horizon for the CIHR budget;
§ Provide predictable and appropriate investment for in-house health research.
A report by the Council of Science and Technology Advisors identified a clear need for the federal government to perform in-house research. This report stressed that the federal government must have an adequate research capacity to deliver the following key roles:
· Support for decision making, policy development and regulations.
· Development and management of standards.
· Support for public health, safety, environment and/or defence needs.
· Enabling economic and social development.[53]
In other words, the ability of the federal government to set policy and enforce regulations requires it to have an appropriate in-house research capacity. In addition, the government needs to have access to the highest possible quality scientific and technological information in a time frame that meets its needs. Failure to use the best available data and analysis could expose the government to liabilities for damages caused by those decisions.
The major key player in federal intramural health research is Health Canada, for which this function is critical to the fulfillment of its mandate. The department is mandated to help the people of Canada maintain and improve their health and to ensure their safety. Thus, in addition to access to top-quality scientific and technological information, Health Canada must obtain advice to set policy and enforce regulations. The required in-house research capacity includes expertise in:
· the state and spread of disease;
· ensuring the safety of food, water and health products, including pharmaceuticals;
· air quality issues; and,
· fulfilling health promotion obligations.
To undertake these responsibilities, Health Canada’s researchers must possess independent knowledge and skills over a wide range of scientific disciplines, ranging from the behavioural sciences to cellular and molecular biology. In addition, Health Canada must have an adequate in-house capacity to assimilate, interpret and extrapolate the knowledge obtained from other health research partners. Finally, the department must be able to draw widely on expertise and facilities that are not available in-house.
Overall, the Committee learned that Health Canada has a unique role. In order to meet its mandate, the department must be able to provide the best possible independent science advice related to its legislated responsibilities, to undertake a wide range of scientific activities related to its role as regulator and policy advisor, and to provide evidence-based health services and programs. This unique obligation requires Health Canada to have the necessary science and research capacity to fulfill these three functions.
The Committee feels it is important to acknowledge that Health Canada has taken an important step in ensuring, through the appointment in 2001 of a Chief Scientist, that it possess the ability to meet its mandate. The Chief Scientist and his office play a pivotal role in bringing leadership and coherence to Health Canada’s scientific responsibilities and activities by championing the principles of alignment, linkages and excellence espoused by the Council of Science and Technology Advisors.
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Health Canada:
§ Be provided with the financial and human resources in health research that are required to fulfill its mandate and obligations;
§ Engage actively in the establishment of linkages and partnerships with other health research stakeholders.
As indicated on numerous occasions in this report, the Canadian health care delivery system is facing a very serious situation, marked by rising costs, a high degree of dissatisfaction and high expectations. While many recommendations for change to the publicly funded health care system have been made over the years, most of them have not been based on scientific evidence, but rather have been grounded on anecdotal evidence or political posturing. For these reasons, research on all aspects of Canada’s publicly funded health care system is, at the present time, very critical for health care policy makers and managers.
Areas in need of more research are varied and include:
· health promotion policies
· disease and injury prevention strategies (at both the individual and population levels)
· determinants of health
· approaches to primary care management
· new modes of remuneration for health care providers and institutions
· decision-making by health care providers and users
· organizational care delivery models
· health care policy management
· health care resources allocation
· impact of selected areas of privatized health care
· pharmaco-economics
· assessment and utilization of health care technology and equipment.
Clinical research and the involvement of health care providers themselves in health research are key elements in ensuring that fundamental research is translated into better health and health care. Clinical trials and large-cohort population health research studies are under-supported in Canada, in part due to the large, long-term financial commitment that is required before such studies can be launched. Urgent investment in training and subsequent career support is needed for clinician investigators in Canada. Harassed by ever increasing demands for clinical service, they find it increasingly difficult to remain competitive in competitions for grants and awards.
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Moreover, many studies have shown that there is a major gap between new knowledge and its application in every day medicine. For example, only 46% of elderly patients were given pneumococcal vaccine, though it is the group most at risk for suffering from such infections. Aspirin, although recommended for all adult diabetic patients, was prescribed in only 20% of cases, and counselling on HIV transmission was given to less than 3% of adolescents during physician’s office visits.[54] In addition, wide variations in practice patterns and outcomes persist across regions as well as across provinces. The Committee believes that the federal government, given its unique role in health research, should commit a significant investment to promoting, in partnership with the provinces and territories, the adoption of research findings in clinical practice. This must be done while continuing to support new research on priority health issues and the development of new tools, so that in the future this knowledge and the new tools can be translated into and implemented to produce improved health and enhanced health care.
Overall, the Committee acknowledges that more health research should be undertaken in order to enhance quality in health services and in health care delivery. Therefore, we recommend that:
The federal government, through the Canadian Institutes of Health Research, Health Canada and the Canadian Health Services Research Foundation, devote additional funding to health services research and clinical research and that it collaborate with the provinces and territories to ensure that the outcomes of such research are broadly diffused to health care providers, managers and policy-makers.
There are many groups in Canadian society that have, for numerous reasons, less immediate access to health services appropriate to their specific needs. Examples include individuals with mental health problems, individuals with addiction problems, people with physical disabilities, some ethnic minorities, women in difficult circumstances, people living in rural and remote communities, the homeless and the poor. The Committee acknowledges that there is an urgent need in Canada to support cross-disciplinary health research that will provide new evidence on the diverse factors that influence health status, and on approaches to improving access to needed health care for vulnerable groups. CIHR has recently set up a strategic plan through three of its Institutes to study this crucial problem, but more resources are needed. Therefore, the Committee recommends that:
The federal government, through the Canadian Institutes of Health Research and Health Canada, provide additional funding to health research aimed at the health of particularly vulnerable segments of Canadian society.
In Volume Four of its health care study, the Committee stated that the health of Aboriginal Canadians is a national disgrace. There is a disproportionately, and completely unacceptable, large gap in health indicators between Aboriginal and non-Aboriginal Canadians. Aboriginal peoples experience much higher incidence of many health problems, including: significantly higher rates of cancer, diabetes and arthritis; heart disease among men; suicide among young men; HIV/AIDS; and morbidity and mortality related to injuries. Infant mortality rates are twice to three times the national average, with high rates of fetal alcohol syndrome and fetal alcohol effects (FAS/FAE), and poor nutrition. Approximately 12% of Aboriginal children have asthma, in comparison with 5% of all Canadian children. This last trend is attributable, at least in part, to environmental health issues, such as the presence of moulds in houses.[55]
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· compile and analyze available population-based information to identify trends, emerging issues, and differences across geographic regions or communities;
· review programs and services to identify the most effective practices in First Nations and Inuit communities and to assess timely progress in addressing key health issues; and
· maintain and augment the capacity to analyze research both nationally and internationally, and integrate best practice into policy and program development, implementation and evaluation.
Therefore, the Committee recommends as a matter of urgency that:
The federal government provide additional funding to CIHR in order to increase participation of Canadian health researchers, including Aboriginal peoples themselves, in research that will improve the health of Aboriginal Canadians.
Health Canada be provided with additional resources to expand its research capacity and to strengthen its research translation capacity in the field of Aboriginal health.
Research into the field of health in developing countries is also of concern. The Committee learned that very little research activity is directed towards health problems that affect developing countries. In fact, data suggest that less than 10% of health research is devoted to diseases or conditions that account for 90% of the global disease burden.
The primary causes of morbidity and mortality in developing countries can be grouped under four general areas: malnutrition, poor sexual and reproductive health, communicable diseases, and non-communicable diseases including injuries. A recent report by the World Health Organization shows that long-term economic growth is impossible where large numbers of people are malnourished, sick or dying.
It is the view of the Committee that, given its expertise and excellence in health research, Canada should assume a leadership role in this area. The federal government has taken a step in the right direction. In a first-ever collaborative effort, four Canadian government organizations have joined their forces to formalize a shared commitment to address the problems of global health through research. The Canadian International Development Agency (CIDA), CIHR, the International Development Research Centre (IDRC) and Health Canada have formed the Global Health Research Initiative. Not only will this joint undertaking allow the four partners to operate their programs and research more effectively, it will also contribute to a great humanitarian cause – the health protection of citizens of all countries, including Canadians. This is the beginning; much more needs to be done. Therefore, the Committee recommends that:
The federal government provide increased resources to the Global Health Research Initiative.
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Commercialization of health research can happen at many different stages of research and each stage faces different challenges. For example, one of the main challenges facing commercialization of academic health research (occurring in universities and hospitals) is that their early stage of development makes the investment of capital by private sector very risky, thus speculative. By contrast, once a product is marketable, such as the late stage clinical trials (mainly performed by large research-based pharmaceutical firms), the main challenges relate to intellectual property and the patent regime, as well as to approval and monitoring of drugs. Commercialization of health research outcomes brings numerous benefits including:
· improved health, resulting in a more productive workforce;
· enhanced health services quality;
· increased efficiency in health care system delivery;
· expanded research funding leveraged from commercialization and research partnerships;
· enhanced job creation with newly formed companies;
· and greater economic activity from the manufacturing, marketing and sales of new health care products and services.
In its brief to the Committee, the Council for Health Research in Canada indicated that spin-off biotechnology companies formed by CIHR-funded scientists are an important by-product of public investment in health research:
For instance, 23 companies have been formed at the University of British Columbia employing 732 people. At McGill, 18 companies have been formed employing 392 people. At the University of Ottawa, 10 companies have been formed employing 459 people. Such companies cannot flourish without public investments to fund a steady discovery pipeline.[56]
Visudyne is one example of Canadian health research that has produced some powerful advances in health care. The drug, which is approved for use in over 30 countries, is the only approved treatment for age-related macular degeneration, the leading cause of age-related blindness. This treatment was developed at the University of British Columbia (UBC) and was funded, in part, by the federal government. UBC assisted in the start-up of QLT Inc. to commercialize this product that has head offices in Vancouver, employs over 350 people and has a market capitalization of $1.5US billion.
Another example is 3TC, the only inhibitor of HIV reverse transcriptase with few or no side effects and a common component of treatment for HIV/AIDS, which also arose out of federally funded research performed in Montreal. BioChem Pharma Inc., prior to its acquisition by Shire Pharmaceuticals plc. (based in the United Kingdom), had head offices in Montreal, employed 278 people, and had a market capitalization of $3.7US billion.
These examples illustrate the potential of health research to treat disease, create employment and generate economic benefits for Canada. While many academic technologies are licensed to foreign companies, it is reasonable to expect that value should be created and retained in Canada wherever possible and appropriate when the federal government has made investments in health research.
As stated in Section 12.2, “good science is good economics.” However, during his testimony, Dr. Henry Friesen, Team Leader of the Western Canadian Task Force on Health Research and Economic Development, told the Committee that the conditions are not presently in place to enable publicly funded health research to maximize the returns to Canadian taxpayers.[57] In the opinion of this Task Force, the capacity for research commercialization is sub-optimal and clearly unacceptable.[58]
Similar findings were presented in a 1999
report published by the Advisory Council on Science and Technology (ACST) and
prepared by its Expert Panel on the Commercialization of University Research.[59]
The Expert Panel made the
case that research results from federal funding of university research, where
there is commercialization potential, should be managed as an asset that can
return benefits to the Canadian economy and Canadian taxpayers.
The Expert Panel also showed that the United States has a much better
track record in commercialization of university-based research than Canada,
despite a growing private sector involvement in funding research at Canadian
universities.
Most major research institutions (universities and research hospitals) in Canada have in-house technology commercialization offices that are funded by university sources and, in cases of successful offices, by revenue derived from operation. Currently, the expenses associated with commercialization activities are not covered by direct federal research funding. The Committee learned that the vast majority of these technology commercialization offices have costs that exceed their revenue. They are operated as a cost centre and not as a profit centre for the institution. However, while their function is not critical to the research enterprise (creation of new knowledge), an argument could be made to include costs of operating these offices in the calculation of indirect research costs since technology commercialization is a research-related activity.
The question of funding indirect costs in Canadian research by the federal granting agencies has been one of contention in recent years. It has been recognized as one element to explain the lower level of competitiveness of Canadian researchers. Indirect costs are those expenses associated with administration, maintenance, commercialization and the salary of the principal investigator that is attributable to the research project. The ACST in its 1999 report[60] and subsequent publications has made the recommendation that the federal government increase its investment by supporting the indirect costs of sponsored research. Similarly, the brief of the Council for Health Research in Canada stressed:
The Committee acknowledges that, in its December 2001 Budget, the federal government provided a one-time investment of $200 million through the granting councils to help alleviate the financial pressures that are associated with the rising indirect costs of research activities, including commercialization. We both hope that universities and research hospitals will use some of these funds to improve their commercialization abilities, and that the federal government will make this investment permanently recurrent.[The] indirect costs of research must be funded in order to provide a cutting-edge research environment that will fully realize the benefits of the government’s Innovation Agenda.
(…) The Council believes it should be a priority for the government to develop a specific, long-term plan to address this issue as soon as possible.[61]
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The Committee agrees with witnesses and recent reports that there is a need to find ways to maximize the returns to Canadians from the commercialization of federally funded health research. We believe that the federal government should establish the necessary conditions to enable researchers and those technology commercialization offices providing support and services to researchers to perform to their full potential in commercializing the results of federally funded health research.
Further, the Committee believes that CIHR, Canada’s premier vehicle for funding health research with a legislated mandate to translate knowledge into improved health, is uniquely positioned to assess the recommendations made by the Western Canadian Task Force, the ACST’s Expert Panel and other studies on technology commercialization as they apply to health research. We believe that CIHR should use these reports as the basis for developing and delivering on an innovation strategy that considers programs, policies and people. In our view, such a strategy would see CIHR support and strengthen the capacity of academic technology commercialization offices to maximize the transfer of technologies to market, thereby creating of Canadian companies and jobs and enhancing Canada’s innovation capacity. In addition, we believe that this innovation strategy must be developed within a framework that includes governing principles of public good and benefit to Canada so that any strategy to maximize the social and economic impact does not threaten academic freedom or influence the direction of research or the delivery of health care. Therefore, the Committee recommends that:
The federal government require an explicit commitment from all recipients of federally funded health research that they will obtain the greatest possible benefit to Canada, whenever the results of their federally funded research are used for commercial gain.
The Canadian Institutes of Health Research, while not ignoring the social value of health research that does not result in commercial gain, seek to facilitate appropriate economic returns within Canada from the investments it makes in Canadian health research, whenever the results of investments in Canadian health research are used for commercial gain. In doing so, CIHR should develop an innovation strategy aimed at accelerating and facilitating the commercialization of health research outcomes.
The federal government invest additional resources to enhance the output of Canadian health researchers and strengthen the commercialization capacity of performers of federally funded health research through CIHR’s innovation strategy. This new funding would be additional to the current health research investment. In particular, the funding of the indirect costs of research by the Canadian granting agencies should be made permanent. Health research performers should be made accountable for the use of these commercialization funds.
One aspect of the commercialization of health research outcomes that generated controversy recently is the issuance of patents for higher life forms. This subject goes deeply into ethical, intellectual property, and economical issues. Although these questions are highly relevant to Canadian health research and the work of this Committee, they are debated elsewhere. Indeed, the Canadian Biotechnology Advisory Committee (CBAC) has been mandated by the federal government to provide advice on this crucial issue. The CBAC published an interim report on the subject at the end of 2001 where it recommended that human beings at all stages of development, are not patentable.[62] Further, the report recommended that a systematic research program be undertaken to assess the impact of biotechnology patents on various aspects of health services. It is clearly an issue that deserves serious consideration, but is beyond the scope of this report.
The preceding sections have demonstrated Canada’s growing excellence in, and high priority for, health research. However, history has shown that the pursuit of new knowledge in health research can lead, for example, to abuse of the people who are involved as the subjects of research, to invasions of privacy, and to abuse of animals. In various ways, numerous reports have emphasized that new knowledge must not be gained at the expense of abuse of humans and other life forms, and that excellence in health research requires excellence in ethics.
But what is ethics? Laura Shanner, Professor at the University of Alberta, told the Committee that “ethics” is a “systematic, reasoned attempt to understand and make the best possible decisions about matters of fundamental human importance.”[63] When we refer to ethical issues informed by biological knowledge in medicine, we refer to “bioethics.” Dr. Nuala Kenny, Professor of Pediatrics at Dalhousie University (Nova Scotia), defined bioethics as follows:
Bioethics is a particular understanding of ethics that brings the discipline of philosophy to assist in making value-laden decisions. It is about the right and the good. It is a practical discipline. Bioethics is ethics in the realm of the biosphere, human biology. It is actually broader than human health, but most people use it in that context.
It asks how, in a pluralistic society, do you lay out the values, the issues and the interests at stake when making a decision about the right and the good, generally about an individual patient situation. Then, how do you assist the relevant parties in establishing some kind of priority, so that if there are competing goods or competing harms, you make your choices in a responsible way.[64]
In many fields, difficult decisions often involve consideration of numerous factors, each implicating different – and often conflicting – values, principles, viewpoints, beliefs, expectations, fears, hopes, etc. When facing such difficult decisions, people may reach different conclusions not only because they consider different factors, but also because they weigh them against each other in different ways. The practical effect of the discipline of ethics is to help those who face complex decisions to identify the inherent values and principles, to weigh them against each other, and to come to the best possible decision. Though based on strong theoretical foundations, ethics in health care and health research deals with real life situations.
Because research seeks constantly to expand the forefront of knowledge, it poses the most challenging questions of ethics. The purpose of this section is to survey some of the major areas of research ethics in terms of the policies and mechanisms now present and/or needed in Canada, to ensure that health research is carried out in a manner that meets the ethical standards of Canadians.
Health research must involve humans as research subjects. While research with other life forms can provide much essential knowledge, in the end only research directly on human beings can tell us, for example, whether a potential new approach to prevention, diagnosis or treatment of disease is safe enough to use in humans, whether it actually helps patients, what its side effects are, and whether it is better than a treatment that is already available.
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The Research Ethics Board “is a societal mechanism to ensure the protection of research participants.”[65] REBs are multidisciplinary local institution-based boards, independent of the investigator and research sponsor, established to review the ethical standards of research projects within their institutions. They have the power to approve, reject, request modifications to, or terminate any proposed or ongoing research involving human subjects. In effect, the REB attests, for each research protocol, that the proposed research, if it is carried out in the manner agreed to by the REB, meets or exceeds standards of ethics that Canadians expect.
The dominant national policy for the ethics of research involving humans, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), was published by CIHR, the SSHRC and NSERC in 1998. The TCPS followed earlier policies (MRC, 1978, 1987, and SSHRC, 1976). The Panel and Secretariat on Research Ethics, launched in November 2001 by the three federal research funding agencies, are responsible for coordinating the evolution and interpretation of the TCPS. The objective is to keep the TCPS up-to-date in response to the rapidly evolving advances in knowledge, research and technology.
The Tri-Council Policy Statement has been adopted by academic institutions (where the majority of health research involving humans is carried out) and by some governmental departments and agencies, including the Department of National Defence (DND) and the National Research Council (NRC).
Health Canada is establishing its own Research Ethics Board, which will also use the TCPS, to assess the ethical acceptability of in-house research, research that is contracted to non-Health Canada researchers which requires ethical review and research applications to CIHR or other funding agencies. Health Canada has also adopted the International Conference on Harmonization (ICH) guidelines applying to clinical trials involving the participation of human subjects.[66]
Since the 1970s, in accord with national policies governing ethics in research involving humans, some 300 local REBs in Canada have been established in a variety of settings including universities, government laboratories, community organizations and teaching and community hospitals. In many teaching hospitals, at least 50% of the research protocols reviewed by REBs are clinical trials that are sponsored by industry for purposes of testing new pharmaceutical interventions in human health so as to meet the regulatory licensing requirements of Health Canada and the USA Food and Drug Administration. In addition, some company-based and private for-profit REBs have developed over the last few years to allow REB review of privately sponsored research outside academic institutions, and hence without access to local REBs. In Alberta, all physicians who are not covered by an institutional REB are required to use the REB of the Alberta College of Physicians and Surgeons. Newfoundland is moving towards establishing a single REB for all health research in the province.
In 1989, the National Council on Ethics in Human Research (NCEHR) was created by the MRC with the support of Health Canada and the Royal College of Physicians and Surgeons of Canada. NCEHR works to foster high ethical standards for the conduct of research involving humans across the country by offering advice on the implementation of the TCPS, primarily through educational activities and site visits to local REBs. NCEHR is now funded by CIHR, SSHRC, NSERC, Health Canada and the Royal College of Physicians and Surgeons.
The Tri-Council Policy Statement, in effect Canada’s national statement of policy for ethical conduct in health research involving humans, appears to be consistent with world standards. For the most part, REBs in Canada seem to operate to a high standard, building on more than two decades of experience and the dedication of many people across the country. However, the Committee learned that serious gaps have been identified in a number of reports released in recent years by NCEHR and CIHR, as well as by the Law Commission of Canada.[68] A summary of the main issues or gaps identified in these reports is presented below:
· Although the Tri-Council Policy Statement sets very high standards, there is currently no oversight mechanism to ensure compliance with these standards. On the one hand, there is no process of certification, accreditation or regular inspection of the research ethics review procedures performed by REBs. On the other hand, and though more REBs are starting to address this issue, few monitor the conduct of research once a research protocol has been approved. In other words, REBs often have limited knowledge of what happens after they have approved a research protocol.
· Some concerns were raised about real or perceived conflicts of interest by researchers or institutions. Though international consensus suggests that REBs would be established within research institutions, and that the work of REBs requires close collaboration with other institutional responsibilities, REBs must be able to operate free from institutional or researcher pressures.
· Similarly, a lack of public oversight of private REBs that act independently or through Contract Research Organizations hired by drug companies raises concerns about their independence and conflicts of interest.
· There is a basic need for more resources for REBs. As the work becomes increasingly complicated with globalization, technology and commercialization, REBs are struggling to find committee chairs or even members.
· There are currently no standard training requirements for Canadian REB members and researchers in research ethics. However, in the absence of similar Canadian standards, Canadian researchers must meet American educational standards for American funded health research involving human subjects.
· The current ethics review processes are “producer-driven” rather than “consumer-driven.” In other words, there is a lack of representative participation in governance on the part of research subjects.
· There is an urgent need for empirical research on the effects of health research on human subjects as well as on the effectiveness of the ethics governance procedures.
To sum up, the governance, transparency and accountability of the ethics review processes in Canada need to be improved:
(…) we were surprised to see how substantial the gaps were between the ideals expressed in policy and the ground arrangements for accountability, effectiveness and the other criteria for good governance.[69]
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The Committee agrees with many reports that the central concern for Canada is the public accountability of the overall processes for assuring the ethics of research involving humans. We recognize the excellent work that has been done across Canada by dedicated people in many environments who have strived to ensure that health research involving human subjects meets the highest standards of ethics, and we are confident that the standards achieved in Canada are as good as any in the world. Indeed, the report released by the Law Commission of Canada stated:
We are also very much impressed with the calibre of scholarly, ethics and legal expertise represented on many REBs. And, at a general level, Canadians scholars are prominent internationally in research regarding legal and ethical aspects of human subjects research.[70]
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However, the Committee believes that the present varied structures and approaches to health research ethics are inconsistent with the public accountability that an area of this importance requires. Accordingly, we urge the various leading stakeholders of health research involving human subjects to work together to develop a governance system for health research involving human subjects that can meet the following objectives: the promotion of socially beneficial research; the protection of research participants; and the maintenance of trust between the research community and society as a whole.[71] This initiative should involve Health Canada, CIHR, other federal funding agencies, the Panel and Secretariat on Research Ethics, industrial research sponsors, research institutes, health professional licensing bodies and associations, NCEHR, the newly created Canadian Association of Research Ethics Boards, etc. Therefore, the Committee recommends:
Health Canada initiate, in collaboration with stakeholders, the development of a joint governance system for health research involving human subjects for all research that the federal government performs, that it funds, and that it uses in its regulatory activities.
Health Canada, in the development of this ethics governance system, regard the following components as essential to progress:
§ Work initially on all (health) research that the federal government performs, funds, or uses in its regulatory activities, to develop an effective and efficient system of governance that will become accepted as the standard of care across Canada;
§ Give prime importance in the governance system to effective education and training mechanisms for all who are involved in research and research ethics, with certification appropriate to their different responsibilities;
§ Develop standards, based on the Tri-Council Policy Statement, the International Conference on Harmonization guidelines applying to clinical trials involving human subjects, and other relevant Canadian and foreign standards, against which research ethics functions or Research Ethics Boards can be accredited or certified as meeting the levels of function that are consistent with the expectations of Canadians and with those in other countries;
§ Ensure that the Tri-Council Policy Statement is updated and is maintained at the forefront of international policies for the ethics or research involving humans;
§ Remove inconsistencies between the various policies under which research involving humans is now governed, and make Canadian standards consistent with those of other countries that affect Canadian research;
§ Establish an accreditation or certification process for research ethics functions that is at arm’s length from government, but clearly accountable to government;
§ Develop the governance system through open, transparent and meaningful consultation with stakeholders.
Because animals are biologically very similar to humans, animals are used in research to develop new biological knowledge that has a high chance of applicability to the human condition. However, because animals are not identical to humans, new knowledge that arises from research with animals must be tested in humans before it is applied to human health.
Ethical concerns about the use of animals by humanity, particularly their use in research, have been recognized since the 19th century, especially in England. In Canada, these concerns caused MRC and NRC to undertake studies leading in 1968 to the creation of the Canadian Council on Animal Care (CCAC). Currently, CCAC receives 87% of its $1.2 million budget from CIHR and NSERC to cover CCAC services to the research institutions that they fund. CCAC obtains the rest of its revenues from fees for service charged to governmental and private institutions.
CCAC awards the Certificate of Good Animal Practiceâ to institutions that it determines are in compliance with its standards. Compliance is determined through site visits by assessment panels. CIHR and NSERC make participation in the CCAC program mandatory for all those who wish to receive their research funding and inform institutions that they will withdraw funds from institutions that CCAC states are not in compliance with its standards. The CCAC reports that institutions generally comply with its recommendations.[72]
In its brief to the Committee, the Coalition for Biomedical Health Research stated that CCAC standards are recognized both nationally and internationally:
(…) research that complies with CCAC guidelines and policies constitutes ethically sound and responsible activity.
(…) CCAC’s nationally and internationally accepted standards (…) provide the needed balance between the protection of animals and the benefits that are gained by the use of animals in science.[73]
The formal structure of the CCAC, along with its monitoring program, is regarded by many, in Canada and abroad, as an optimal model enabling it to work effectively at arm’s length from and with government.[74] In addition, recent report suggested that such a model could be considered in the field of research involving human subjects. For example:
The Committee acknowledges that CCAC performs a world class service to Canadians in a cost-effective manner. Though there is no doubt that some Canadians will disagree, mainly those who reject any use of animals in research, the Committee believes that the CCAC offers clear evidence that a very sensitive area that requires minute by minute attention and care can be effectively managed by an approach based on:An interesting model in Canada and one, which I think we need to look at seriously with regard to an accreditation process for human research, is the Canadian Council on Animal Care. (…) it now has remarkable credibility with international recognition. (…) It remains a very interesting and almost uniquely Canadian model. It has federal fiscal support and yet, functioning on its own, setting standards and having a very respected accreditation process for animal research.[75]
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· Belief, until proven wrong, that institutions and individuals are seeking to work in a manner that reflects the values of Canadians;
· A firm foundation in increasing awareness and training of individuals on issues and standards;
· An assessment approach that is based on internationally recognized standards and that leads to certification of facilities and processes, that involves experts and lay persons, and that operates in a collegial manner until the point when there is evidence of wrongdoing and failure to take the necessary corrective measures.
While not advocating simply copying CCAC’s mechanisms into the challenge of governance of research involving humans, the Committee believes that much can be learned from CCAC’s experience. The Committee, however, identifies a gap in the interactions between the CCAC and the federal government. Though numerous departments and agencies place themselves under CCAC’s assessment program for research involving animals that is carried out in their own facilities, and CIHR and NSERC require compliance with CCAC’s standards as a condition of receiving research funds, we believe that this is not enough. Therefore, we recommend that:
All federal departments and agencies require compliance with the standards of the Canadian Council on Animal Care for:
§ All research that is carried out in federal facilities, and
§ All research that is funded by federal departments or agencies but performed outside federal facilities, and
§ All research that is carried out without federal funding or facilities, but that is submitted to or used by the federal government for purposes of exercising its legislated functions.
All personal information is precious to individuals, but information about personal health is probably the most sensitive to most people. Health information goes to a person’s most intimate identity, not only because it directly affects the individual him or herself, but also because it can affect family members and others, as well as other aspects of the person’s life, such as his/her employment or insurability.
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The right to privacy and confidentiality of personal health information is a very important value for Canadians. Now more than ever, Canadians need reassurance that their privacy and confidentiality will be respected in this era of rapidly advancing technology. However, the quality of their health and health care is also a value that Canadians cherish very dearly. Health care providers, health care managers and health researchers need access to personal health information to improve the health of Canadians, strengthen health services and sustain a high quality health care system. The present challenge for Canadians is to set acceptable limits around the right to privacy, on the one hand, and the need for access to information (by health care providers, managers and researchers) on the other, in order to achieve an appropriate balance between them.
The Personal Information Protection and Electronic Documents Act or PIPEDA, promulgated in June 2000, has stimulated intensive debate and study of this question in the past two years. The health sector had not recognized the potential effects of this legislation on health research and health care management until the legislative review of the Bill was well advanced through the House of Commons. Representatives from various parts of the health sector therefore intervened strongly in hearings before this Senate Committee in late 1999. Their testimony clearly demonstrated that the health sector was not part of the broad consensus supporting the bill, and also that there was no consensus within the health sector itself as to an appropriate solution to the issues about privacy of health information which are raised by the bill. As a result, the Committee concluded that there was a significant degree of uncertainty surrounding the application of PIPEDA to personal health information that required clarification. In response to the Committee’s recommendation[76], therefore, the federal government decided to delay the application of PIPEDA to personal health information until January 1, 2002. This delay would allow one extra year from the time of proclamation to motivate government and relevant stakeholders in the health sector to resolve these uncertainties and formulate a solution that is appropriate for the protection of personal health information.
The Committee is pleased that several groups in the health sector have seriously addressed many of the concerns raised by PIPEDA, and in particular, the need to protect personal health information, while at the same time allow restricted use of such information for essential purposes such as health research and health care management (which includes the provision, management, evaluation and quality assurance of health services).
Over the past two years, CIHR has undertaken a wide-range analysis of the privacy issues and initiated a broad consultation process with various stakeholders, culminating in recommendations for the interpretation and application of PIPEDA to health research.[77]
CIHR’s recommendations set out precise legal wording in the form of proposed regulations under PIPEDA that, without changing the Act, would facilitate its interpretation and application in the area of health research. These recommendations were presented to the Committee as the most realistic, short-term solution, recognizing that PIPEDA would not likely be amended before January 1, 2002. CIHR emphasizes that its proposed regulations, though significantly limited by the current wording of PIPEDA, could nevertheless provide the necessary guidance to help clarify certain ambiguous terms in a manner that will achieve the objectives of the Act without impeding vitally important research. CIHR is also of the view that regulations, as legally binding instruments, are necessary to enable researchers, and Canadians in general, to understand what the law expects of them and how to govern their conduct accordingly. Furthermore, such regulations could provide the necessary basis on which provinces and territories could develop substantially similar legislation before January 1, 2004, as provided for by PIPEDA.[78]
Finally, CIHR recognizes the need for further work with various stakeholders and the provinces to establish an overall, more coherent, comprehensive and harmonized legal or policy framework for the health sector. Ultimately, whatever law or policy governs this area needs to be interpreted and applied in a flexible and feasible manner, and users need to develop more detailed guidelines for promoting best information practices in their daily work.
The Committee has considered the
regulations proposed by CIHR and we commend CIHR for its efforts in this
regard. We fully support the
intent of the proposed regulations. As
stated in its Fourteenth Report dated December 14, 2001[79],
the Committee believes that these regulations should be given serious
consideration and, therefore, we recommend that:
Regulations such as those proposed by the Canadian Institutes of Health Research receive their fullest and fairest consideration in discussions about providing greater clarity and certainty of the law with the view to ensure that its objectives will be met without preventing important research to continue to better the health of Canadians and improve their health services.
A second and parallel initiative was undertaken by a Privacy Working Group composed of representatives from the Canadian Dental Association, the Canadian Healthcare Association, the Canadian Medical Association, the Canadian Nurses Association, the Canadian Pharmacists Association, and the Consumers Association of Canada. The Privacy Working Group addressed the need to access personal health information for the purposes of health care management. In a report submitted to Health Canada, the Privacy Working Group enunciated the following principles.[80]
· Confidentiality of information in health care delivery is of great importance to Canadians. Fear of disclosure to others of personal health information is likely to harm the trust that is essential in the relationship between patients and providers, and hence limits the willingness to seek care, or to impart information that is important to patient care.
· While an individual’s right to privacy of personal health information is of great importance, it is not absolute. This right is subject to reasonable limits, prescribed by law, to appropriately balance the individual’s right to privacy and societal needs, as can be reasonably justified in a free and democratic society.
· Individuals have the right to: privacy of their personal health information; decide whether and under what conditions they want such information collected, used or disclosed; know about and have access to their health records and ensure their accuracy; and have recourse when they suspect a breach of their privacy.
· In parallel, health care providers and organizations have obligations to: treat personal health information as confidential; safeguard privacy and confidentiality using appropriate security methods; use identifiable information only with the individual’s consent except when the law requires disclosure or there is compelling evidence for societal good under strict conditions; restrict the collection, use and disclosure of personal health information to de-identified information, unless the need for identifiable information is demonstrated; and, implement policies, procedures and practices to achieve privacy protection.
When the Committee met in December 2001 to examine progress made with respect to the application of PIPEDA to health care, we were informed that, while the members of the Privacy Working Group agreed on many issues, they had not yet achieved a definitive and unified position. The Privacy Working Group was of the view that progress towards achieving consensus would require the active involvement and leadership of the federal government. The federal government, however, has taken the position that the concerns of the Privacy Working Group should be resolved between the members of the group and the Privacy Commissioner.
The Committee believes that further guidance and direction is needed in respect of the provision, management, evaluation and quality assurance of health services. For this purpose, constructive and collective efforts by all affected parties must be made to address the relevant issues, and government must lead by example. As stated in its 14th Report, the Committee recommends that:
Like other Canadians, the members of the Committee place a very high priority on the protection of personal health information. Though protection of personal health information is understandably of very high importance, we must recognize what else is at risk if access is summarily rejected because of perceived threats to the privacy and confidentiality. Rather than give absolute status to the right to privacy, the Committee believes that Canadians must engage in a careful and thoughtful consideration of the reasons why personal information is needed for health research and health care management purposes, the social benefits that accrue to Canadians individually and collectively as a result, and the conditions that must be met before access is allowed. Because of its long-standing responsibility in funding health care and financing health research, the federal government should play a major role in promoting greater public awareness and facilitating greater debate in regard to these issues.Discussions continue among stakeholders, the Privacy Commissioner, and those federal and provincial government departments involved with the provision, management, evaluation and quality assurance of health services.
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CIHR’s Draft Case Studies Involving Secondary Use of Personal Information in Health Research (December 2001) constitutes an excellent model for encouraging discussion and broader understanding through very concrete examples of real health research projects involving secondary use of personal information. Parallel efforts by others to develop similar case studies illustrating why and how personal information is used for health care management purposes would also be extremely valuable. In light of the above, the Committee recommends that:
The federal government, through the Canadian Institutes of Health Research and Health Canada, together with other relevant stakeholders, design and implement a program of public awareness to foster in Canadians a broad understanding of:
§ the nature of, and reasons for, the extensive databases containing personal health information that must be maintained to operate a publicly financed health care system, and
§ the critical need to make secondary use of such databases for health research and health care management purposes.
This being said, the Committee believes that if Canadians are to allow restricted access to personal health information for essential functions, such as health research and health care management, it is imperative that their personal health information be adequately protected. We wish to emphasize the importance of ensuring, all the while, that Canadians remain confident that the privacy of their personal health information is being respected. We see here, once again, a major federal role to promote a fulsome discussion of the relevant ethical issues and examination of the control and review mechanisms necessary for ensuring that the secondary use of personal information for health care management and health research purposes is conducted in an open, transparent and accountable manner. Therefore, the Committee recommends that:
The federal government, through the Canadian Institutes of Health Research and Health Canada, together with other relevant stakeholders, be responsible for promoting:
§ thoughtful discussion and consideration of the ethical issues, particularly informed consent issues, involved in the secondary use of personal health information for health care management and health research purposes;
§ thorough examination of the control and review mechanisms needed for ensuring that databases containing personal health information are effectively created, maintained and safeguarded and that their use for health care management and health research purposes is conducted in an open, transparent and accountable manner.
The discussion above has addressed issues of privacy of personal health information arising from databases from the existing health care system. The Committee recognizes that new technologies allowing analysis of genes is also introducing new considerations into the management of personal health information. The exploding abilities to link DNA sequences to disease offer the potential both to greatly increase the health care of the individual but also to intrude into the privacy of both the individual and his or her relatives. In addition, these technologies allow the prediction of diseases that have not yet become evident. However, a majority of these predictions represent increased probability of the incidence of the disease, the test being often statistical in nature (e.g., the likelihood is twice that of the general population) rather than absolute (as for Huntington’s disease, for example).
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The Committee is pleased that interdepartmental discussions are underway within the federal government on this wide range of issues, and encourages their pursuit to provide guidance and advice on means of addressing these complex issues in the best interests of Canadians.
Advances in human health often involve participation of researchers in academia, in government and in industry. The boundaries between these are becoming increasingly blurred, and much mutual trust and collaboration is required between them. For example:
· The large majority of published health research in Canada is done by researchers in academic institutions, who obtain funding from government, philanthropic and industrial sources.
· Academic researchers are increasingly entrepreneurial, and are the source of many start-up companies that are providing fast economic growth in the biological revolution.
· Industries obtain many of their ideas for new commercial entities, including new interventions in health, from academic research, and are starting to establish research centres in academia in exchange for right of first refusal on intellectual property.
· Government regulates health interventions, as well as contributing to knowledge through its in-house research. Regulations depend on research carried out by industry, often in academic institutions, which is assessed by governmental scientists, who may call on academic scientists for advice and other assistance.
The potential for conflicts of interest are obvious, as are the concerns that, for example, industrial interests in protecting intellectual property and commercial interests might adversely affect the performance or publication of research carried out in public institutions or with public funds. Media attention has rightly focused on instances when these fears appear to have been realised.
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However, the Committee understands that the growing role of industry in Canada’s health research spectrum, particularly in clinical trials, is a cause for concern. This was highlighted in a recent editorial by the International Committee on Medical Journal Editors, which laid out the ground rules for avoiding conflict of interest in publications.[81] In particular, there is a need to find an appropriate balance between clinical research performed in the academic sector, the ability to compare different treatments for the same disease, the focus of research on diseases in which profits are most likely, (e.g., diseases of wealthy as opposed to poor nations), the publication of negative results (e.g., the need for a registry of all clinical trials), and related areas.
The Committee welcomes the work of CIHR in expanding the collaborative health research programs between academic and industrial research through the University-Industry Program and the CIHR/Rx&D[82] Program. We understand that CIHR partnerships with industry need to be encouraged. However, there is a need to consider whether explicit guidelines should be developed; these guidelines could assist in determining the impact of ethically problematic areas in CIHR’s relations with industry. We have learned that CIHR has set up a working group to study this issue. Therefore, the Committee recommends that:
The Canadian Institutes of Health Research, in partnership with industry and other stakeholders, continue to explore the ethical aspects of the interface between the sectors with a view to ensuring that the collaborations and partnerships function in the best interests of all Canadians.
[1] Volume Five, pp. 69-89.
[2] Volume Four, p. 9.
[3] Volume Five, pp. 69-70.
[4] Volume Five, p. 70.
[5] Canadian Medical Association, Whither the Medical Equipment Fund?, Background paper and technical notes, July 2002.
[6] Association of Canadian Academic Healthcare Organizations, Background Information in Support of a National Teaching Centre Health Infrastructure Fund, Draft Submission to the Committee, 6 August 2002.
[7] Volume Five, pp. 72-75.
[8] Volume Five, pp. 78-80.
[9] Linda Lizotte-MacPherson, President and CEO of Infoway, Letter to the Committee, 24 July 2002, p. 7.
[10] To date, Quebec has elected not to participate as a member and as such has not availed itself of its right to appoint a representative to Infoway’s Board of Directors.
[11] Volume Five, pp. 80-83.
[12] Canada Health Infoway, Paths to Better Health, Final Report of the Advisory Council on Health Infostructure. December 1999
[13] See Advisory Council on Health Infostructure, Canada Health Infoway, Paths to Better Health, Final Report, December 1999; Federal/Provincial/Territorial Advisory Committee on Health Infostructure, Tactical Plan for a Pan-Canadian Health Infostructure, 2001 Update; discussions of Regional Fora held by Canada Health Infoway Inc. summarized at http://www.canadahealthinfoway.ca/sub.php?lang=en&secLoc=frm).
[14] Dr. Benjamin TB Chan, From Perceived Surplus to Perceived Shortage: What Happened to Canada’s Physician Workforce in the 1990s?, Canadian Institute for Health Information, June 2002.
[15] Medical Post, June 4, 2002.
[16] Ontario Medical Association “Position paper on physician workforce policy and planning”, April 2002.
[17] See Chapter 8 of this volume for the Committee’s proposal for a post-hospital home care program
[18] Canadian Institute for Health Information, Supply and Distribution of Registered Nurses in Canada, 2001 Report, June 2002.
[19] Canadian Nurses Association, Planning for the Future: Nursing Human Resource Projections, June 2002, p. 20.
[20] Ibid., p. 1.
[21] Our Health, Our Future: Creating Quality Workplaces for Canadian Nurses, Advisory Committee on Health Human Resources, 2002, p. 3.
[22] p. 36
[23] Dr. Ben Chan, “How Canada can better manage its MD supply,” Medical Post, June 25, 2002.
[24] Dr. Abraham Fuks, Brief to the Committee, July 23, 2002.
[25] The cost per student, per year is one quarter of the total of $260,000, that is $65,000. However, once there are the desired number of new students enrolled in each year of the four-year medical degree program, this $65,000 per student per year must be multiplied by four, so that the total cost of the new places is $260,000 per year.
[26] Dr. Fuks, op. cit.
[27] Medical Post, June 11, 2002.
[28] Pamela Clarke, “The Foreign Question,” Medical Post, May 28, 2002.
[29] CNA, op. cit., p. 1.
[30] Ibid., p. 13.
[31] Ibid., p. 74.
[32] 61:25
[33] 61:16
[34] 52:8
[35] CNA, op. cit., p. 76.
[36] Ibid., p. 73.
[37] This calculation was done on the same basis as for the medical students (i.e. 2,618. x $30,000)
[38] See Volume Four of the Committee’s study, Issues and Options, p. 110-11.
[39] Ann L. Mable and John Marriott, Health Transition Fund Synthesis Series – Primary Health Care, June 2002, p. 29.
[40] There is also evidence to suggest that Canadian physicians are well remunerated compared to physicians in other countries. OECD data indicates that the ratio of average physician income to average employee compensation in Canada was 3.2. Only ratios in the United States (5.5) and Germany (3.4) were higher than Canada’s, while the ratio was much lower in a number of other countries such as Australia (2.1), France (1.9) and the UK (1.4). See, Reinhardt, Uwe E., Peter S. Hussey and Gerard F. Anderson, “Cross-National Comparisons of Health Systems Using OECD Data, 1999” in Health Affairs, May-June, 202, p. 175.
[41] This chapter is an updated version of Chapter Five included in Volume Five, pp. 91-125.
[42] Dr. Barry D. McLennan, Chair of the Coalition for Biomedical and Health Research (CBHR), The Improving Climate for Health Research in Canada, Brief to the Committee, 9 May 2001, p. 2.
[43] The Committee wishes to
say that sections 12.1 and 12.2 of this chapter were inspired by a speech
given by
Dr. Kevin Keough, Chief Scientist at Health Canada, at the third annual
Amyot Lecture organized by Health Canada.
We found his lecture very useful in highlighting some of the
challenges and opportunities facing health research.
[44] Council of Science and Technology Advisors, Building Excellence in Science and Technology (BEST): The Federal Roles in Performing Science and Technology, December 1999, p. 5.
[45] The Western Canadian Task Force on Health Research and Economic Development, Seizing the Future – Health as an Engine of Economic Growth for Western Canada, Summary of the Report, August 2001, p. 2.
[46] Dr. Kevin Keough, Amyot Lecture, October 2001.
[47] Dr. Alan Bernstein, president of the CIHR, Health Research Revolution – Innovation Will Shape This Century.
[48] Volume Two, pp. 93-104.
[49] Statistics Canada, Estimates of Total Expenditures on Research and Development in the Health Field in Canada, 1988 to 2000, Catalogue No. 88F0006XIE01006, April 2001.
[50] The NCEs are supported and overseen by the three Canadian granting agencies (CIHR, NSERC and SSHRC). It is worth noting that eight networks, of the currently funded 22 NCEs, conduct health research in the fields of: arthritis, bacterial diseases, vaccines and immunotherapeutics for cancer and viral diseases, stroke, health evidence application, genetic diseases, stem cells and protein engineering. Some of the other NCEs may have impact on health and health care (e.g. Institute for Robotics and Intelligent Systems or Canadian Water Network).
[51] Government of Canada, Speech from the Throne, First Session of the 37th Parliament, 30 January 2001.
[52] Volume Two, p. 97.
[53] Council of Science and Technology Advisors (CSTA), Building Excellence in Science and Technology (BEST): The Federal Role in Performing Science and Technology, 16 December 1999, p. 12. The CSTA consists of a group of external experts providing the federal government with on science and technology issues.
[54]
JAMA, vol. 286, p. 1834
(2001).
[55] Volume Four, pp. 129-135.
[56] Council for Health Research in Canada, Health Research: The Engine of Innovation, Brief to the Committee, 30 December 2001, p. 2.
[57] See Committee Proceedings, Issue No. 30.
[58] Western Canadian Task Force on Health Research and Development, Shaping the Future of Health Research and Economic Development in Western Canada, August 2001, pp. 19-20.
[59] Expert Panel on the Commercialization of University Research, Public Investments in University Research: Reaping the Benefits, Advisory Council on Science and Technology, 4 May 1999.
[60] Ibid.
[61] Council for Health Research in Canada, Brief to the Committee, p. 5.
[62] Canadian Biotechnology Advisory Committee, Biotechnology and intellectual property: patenting of higher life forms and related issues, Interim report to the Government of Canada Biotechnology Ministerial Coordinating Committee, Ottawa, November 2001.
[63] Laura Shanner, Ethical Theories in Bioethics and Health Law, University of Alberta, Brief to the Committee, 2000, p. 1.
[64] Dr. Nuala Kenny (42:59-60).
[65] National Council on Ethics in Human Research, Protecting Human Research Subjects: Case-Based Learning for Canadian Research Ethics Boards and Researchers, Ottawa, 2000, p. 7.
[66] Despite the care taken by the three federal granting agencies and Health Canada in the international harmonization of guidelines applying to clinical trials involving human subjects, the Committee would like to be in no doubt that any Canadian participating in clinical trials from outside Canada be protected by ethical standards that are at least as stringent as those applying here.
[67] The following section does not deal with the ethical boundaries surrounding research into human reproductive health as federal legislation is expected to be tabled soon in the House of Commons. The Committee recognizes that this area is at the cutting edge of applied research and evolves rapidly. In our view, all research involving human reproductive material, human organisms derived from such material, other human cell lines, or part of any of them (including human genes) should be subject to full ethical review by REBs and application of the TCPS and other applicable legislation.
[68] More specifically, see the following four reports: 1) NCEHR (formerly National Council on Bioethics in Human Research or NCBHR), “Protecting and Promoting the Human Research Subject: A Review of the Function of Research Ethics Boards in Canadian Faculties of Medicine”, NCBHR Communiqué, Volume 6 (1), 1995, pp 3-28; 2) Draft report of the Task Force established by the NCEHR to study models of accreditation for human research protection programs in Canada, September 28, 2001; 3) McDonald, Michael (Principal Investigator), The Governance of Health Research Involving Human Subjects, research sponsored by the Law Commission of Canada, Ottawa, May 2000; 4) Draft Report of the Task Force on Continuing Review, CIHR, 2001.
[69] Professor Michael MacDonald, Law Commission of Canada.
[70] Ibid., p. 300.
[71] These objectives correspond to those that were identified in the McDonald report cited in the previous footnote.
[72] Louis-Nicolas Fortin and Thérèse Leroux, “Reflections on Monitoring Ethics Review of Research with Human Subjects in Canada”, NCEHR Communiqué, Summer 1997.
[73] Coalition for Biomedical and Health Research, Brief to the Committee, p. 8.
[74] Sub-Committee on Ethics, The Ethics Mandate of the Canadian Institutes of Health Research: Implementing a Transformative Vision, Working Paper prepared for the Interim Governing Council of the CIHR, 10 November 1999, pp. 18-19.
[75] Dr. Henry Dinsdale, Speech to the National Workshop of the NCEHR, March 2001, p. 5.
[76] Second report of the Standing Senate Committee on Social Affairs, Science and Technology, 36th Parliament, 2nd Session, 6 December 1999.
[77] CIHR, Recommendations for the Interpretation and Application of the Personal Information Protection and Electronic Documents Act in the Health Research Context, 30 November 2001. CIHR’s proposed regulations are available on the CIHR Website at http://www.cihr.ca/about_cihr/ethics/recommendations_e.pdf.
[78] Indeed, the Act gives provinces and territories until January 1, 2004, to develop substantially similar legislation.
[79] Standing Senate Committee on Social Affairs, Science and Technology, Fourteenth Report, 37th Parliament, 1st Session, 14 December 2001.
[80] Privacy Working Group, Privacy Protection and Health Information: Understanding the Implementation Issues, report submitted to Health Canada, December 2000.
[81] See Canadian Medical Association Journal, 18 September 2001, Vol. 165, pp. 786-788.
[82] Partnership between CIHR and Canada’s Research-Based Pharmaceutical Companies.
