ARCHIVED - Consultation Findings


Proposed New Regulatory Framework For Cells, Tissues And Organs For Transplantation

Phase ii workshops
March 2005

Policy and Promotion Division
Centre for Policy and Regulatory Affairs
Biologics and Genetic Therapies Directorate

September 2005

Table of Contents

5.1 Adverse Reaction Reporting for Phase I
5.2 Proposed Options for Adverse Reaction Reporting in Phase II
5.3 Summary of Phase II Adverse Reaction Discussion
5.4 Error/Accident Reporting for Phase I
5.5 Proposed Options for Phase II Error/Accident Reporting
5.6 Summary of Phase II Error/Accident Discussion

6.1 Compliance Monitoring and Enforcement for Phase I
6.2 Compliance Monitoring and Enforcement for Phase II
6.3 Summary of Phase II Compliance Monitoring and Enforcement Discussion


1.0 Overview

Health Canada is currently developing a comprehensive framework for the regulation of human cells, tissues and organs for transplantation, under the authority of the Food and Drugs Act. This framework will be implemented in two phases. Phase I of the regulations will incorporate basic safety requirements into law, contain minimum requirements for adverse reaction and error/accident reporting and establish a registration program for compliance monitoring and enforcement. Phase II of the framework will build on these safety-based requirements and most likely incorporate additional oversight for adverse reaction and error/accident reporting and compliance monitoring and enforcement (c&e).

An integral piece in regulatory development, as outlined in the Government of Canada Regulatory Policy, is consultation with stakeholders. To this end, Health Canada sponsored a national series of two-day consultative workshops in March 2005 related to the proposed new regulatory framework for human cells, tissues and organs (CTO) for transplantation. Participants of the sessions in Toronto (41), Edmonton (37), Halifax (18) and Montréal (29) were professionals in healthcare and industry, not-for profit organizations, members of patient groups and representatives from the Canadian Standards Association (total 125)1. Representatives from the United States Centers for Disease Control were also in attendance at the Edmonton workshop. These workshops offered participants the opportunity to learn about, discuss and provide input on aspects of the proposed new regulations. The information obtained from the workshops will be taken into consideration as Health Canada moves forward with the development of the new regulatory framework.

1. Please refer to Appendix A for a list of attendees at each location.

2.0 Workshop Objectives

The objectives of the workshops were to:

  • share information with stakeholders regarding the proposed CTO regulatory framework (Phase I);
  • obtain stakeholder views and input on the proposed adverse reaction and error/accident reporting options (Phase II);
  • obtain stakeholder views and input on compliance monitoring and enforcement options (Phase II).

3.0 Workshop Approach

Prior to each workshop, background materials and workbooks were sent to the participants for their perusal. The two-day workshops were divided into sections, corresponding to the above objectives. Day 1 provided information on the role of Health Canada in the regulatory process and an overview of the proposed requirements for Phase I of the CTO regulatory framework. Day 1 also included an options presentation on the proposed adverse reaction and error/accident reporting requirements for Phase II. Compliance monitoring and enforcement requirements for Phase I and options for Phase II of the regulatory framework were presented and discussed on Day 2.

After the presentations, participants were divided into groups of no more than fifteen, with colleagues separated, to consider key aspects of the proposed regulations. Participants were also encouraged to provide additional options that were not presented, if inclined. Workbooks contained questions for guiding the groups through the discussion process. Facilitated brainstorming sessions were utilized for documenting the discussions.2

2. Three submissions have been made to Health Canada after the workshops took place by those unable to attend the workshops. The comments submitted have been taken into consideration throughout.

4.0 Glossary

accident
an unexpected or unplanned event, not attributable to a deviation from standard operating procedures or applicable laws or regulations, that could adversely affect:

  1. the safety, efficacy, or quality of cells, tissues or organs; or
  2. recipients or facility personnel.

adverse reaction
an undesirable and unintended response to the transplantation of cell, tissue, or organ, including the transmission of a disease, that is considered to be definitely, probably, or possibly related to transplantation.

cell bank
an organization or agency that is responsible for processing and storing cells that are not for direct transplantation from the donor to the recipient.

error
an unexpected, unplanned deviation from SOPs or applicable laws and regulations, usually attributable to a human or system problem, that could adversely affect:

  1. the safety, efficacy, or quality of cells, tissues, or organs; or
  2. the safety of recipients or facility personnel.

establishment
means a person, a partnership or an unincorporated association that, under its own name or under a trade-mark, design, trade name or other name or mark owned or controlled by it, carries out any of the following activities in respect of cells, tissues or organs:

  1. importation;
  2. processing;
  3. distribution;
  4. transplantation;
  5. adverse reaction or error and accident reporting; and
  6. record-keeping and tracking.

organ donation organization
an organization or agency with the responsibility for processing organs from deceased donors.

processing
processing, in respect of cells, tissues and organs, means any of the following activities:

  1. donor screening;
  2. donor testing;
  3. retrieval;
  4. laboratory testing;
  5. preservation;
  6. quarantine;
  7. banking;
  8. packaging and labeling; and
  9. release.

Phase I
This is the first phase of the development of the new CTO regulatory framework that focusses on the safety of cells, tissues and organs for transplantation. This phase includes referencing the National Standards developed by the CSA in regulations, Health Canada registration/declaration for compliance monitoring and enforcement, mandatory reporting requirements for adverse reactions and error accidents between establishments and mandatory reporting to Health Canada for infectious agent/ disease transmission.

Phase II
This is the second phase of the development of the new CTO regulatory framework in which Phase I requirements may be amended to include comprehensive strategies as needed for compliance monitoring and enforcement and adverse reaction and error accident reporting.

serious adverse reaction
an adverse reaction that

  1. requires in-patient hospitalization or prolongation of existing hospitalization directly attributable to the transplantation;
  2. results in persistent or significant disability or incapacity;
  3. necessitates medical or surgical intervention to preclude permanent damage or impairment of a body function;
  4. is life threatening; or
  5. results in death

source establishment

  1. in the case of organs from a deceased donor, the organ donation organization
  2. in the case of organs and cells from a live donor, the transplant establishment
  3. in the case of tissues and cells stored for further distribution, the tissue or cell bank.

The source establishment is responsible for the oversight of:

  1. processing whether those activities are carried out by the source establishment itself or carried out on its behalf;
  2. distribution directly to a transplant establishment or to an establishment for further distribution; and
  3. deeming suitable for transplantation, in the case of cells, tissues and organs from live donors, and in the case of organs from a deceased donor offering for transplant.

transplant establishment
the establishment where a CTO is implanted into a human recipient.

5.0 Day 1 Adverse Reaction and Error/Accident Reporting

5.1 Adverse Reaction Reporting for Phase I

Adverse reaction reporting is an essential component of a regulatory framework for therapeutic products to help identify risks to the supply chain and to help ensure appropriate action is taken to minimize future risk. The authority granted to Health Canada under the Food and Drugs Act for surveillance is linked directly to the safety of products regulated under the Act and the supply chains of those products. Adverse reaction monitoring for the purpose of regulation under the Food and Drug Regulations is significantly different from epidemiological comprehensive surveillance by the Public Health Agency of Canada (PHAC) intended to track, monitor and assess the outbreak of infectious diseases and adverse outcomes.3

Phase I of the Regulations will clearly delineate the roles and responsibilities of all establishments to report and assist in the investigation of adverse reactions. The onus will be placed on the source establishments to investigate adverse reactions and to report the transmission of infectious disease/agent, or the possibility for infectious disease/agent transmission, to Health Canada due to the source establishments strategic location in the supply chain.

In Phase I of the proposed CTO Regulations, there are requirements for reporting and investigating both adverse reactions and errors/accidents. The proposed requirements for reporting adverse reactions in Phase I were presented at the workshop as follows:

  • All adverse reactions are reported to the source establishment.
  • The source establishment is responsible for investigating these reports.
  • Source establishments will report all instances of infectious disease transmission to Health Canada.

3. See Appendix C for list of reportable diseases to PHAC.

5.2 Proposed Options for Adverse Reaction Reporting in Phase II

Having been presented the above background information, the participants broke out into groups to discuss the following options for Phase II adverse reaction reporting.4

Phase II Options for Adverse Reaction Reporting

Option 1: Source establishment reports to Health Canada all serious adverse reactions caused by the transmission of an infectious disease.

Option 1 would maintain the status quo established by the implementation of the proposed Phase I regulations.

Option 2: Source establishment reports to Health Canada all serious adverse reactions caused by the transmission of infectious or non-infectious disease.

This option requires additional reporting of serious adverse reactions caused by a non-infectious disease, eg., cancer.

Option 3: Source establishment reports to Health Canada all adverse reactions caused by the transmission of an infectious or non-infectious disease.

This option requires the reporting of both serious and non-serious reactions caused by the transmission of infectious and non-infectious disease.

4. All Phase II options for adverse reaction and error/accident reporting refer to additional obligations on the source establishment. It is anticipated that no new requirements will be placed on other establishments.

5.3 Summary of Phase II Adverse Reaction Discussion

The groups engaged in warm-up discussions after listening to the options presentation. After the warm-up, participants ranked the options for adverse reaction reporting in order of preference. Ten out of twelve groups chose Option 2: Report All Serious Adverse Reactions caused by the Transmission of an Infectious or Non-infectious Disease. One group in Toronto ranked Option 3: Report All Adverse Reactions caused by Transmission of Infectious or Non-infectious Disease as number one. Another group in Edmonton offered an original response as their most preferable choice: report only adverse reactions that result in a recall of CTO.

These results appear to show that participants would prefer additional regulatory intervention in Phase II for adverse reaction reporting, but only to a certain extent. While none of the groups ranked Option 1 (status quo) as the most desirable, secondary rankings showed that Option 1 is preferred to Option 3, which would require the most reporting.

Discussion of the options provided insight into the benefits and detriments to incorporating an adverse reaction reporting mechanism into a regulatory regime. Many participants viewed reporting of adverse reactions to Health Canada as a potential opportunity to identify safety issues associated with a particular centre. Although participants assumed that centres perform their own adverse reaction and safety tracking, a need was identified for follow-up and trending mechanisms. While it was suggested that Health Canada is best positioned to do trending, stakeholders questioned whether it is the right organisation to do so. It was noted that there are existing systems such as the Canadian Institute for Health Information's Canadian Organ Replacement Register, which makes use of long term data collection. It was suggested that if Health Canada reported back the collected information to the community, this could be used as a valuable learning tool.

Where there is support amongst stakeholders for reporting, there are also reservations. Participants questioned what type and how much information Health Canada needs, why it is needed and what Health Canada would do with the information. This is a particularly recurrent theme throughout the four workshops. It was suggested at one workshop that reporting requirements for transplant programs may have to be revisited in Phase II, the reason being that transplant programs may never see a patient again; public health authorities are more likely to hear about any adverse reactions with transplant patients than are the transplant programs themselves.

The issue of over reporting was another concern that was raised in all four of the workshops. Many participants cautioned that reporting too much information could lead to resentment on behalf of the professional community and has the potential to conceal or dilute the more important incidents.

Participants also suggested that the appropriate involvement and support of the provinces and physicians is key to maintaining an appropriate reporting system. Concerns were raised about the requirement for appropriate funds to be allocated towards resources for enabling programs to report; additionally, other concerns were raised about how disagreements between physicians and the establishments would be resolved.

5.4 Error/Accident Reporting for Phase I

In Phase I of the proposed CTO Regulations, there are also requirements for reporting and investigating errors/accidents.

The proposed requirements for error/accident reporting in Phase I were presented at the workshop as follows:

The source establishment:

  • will be responsible for investigating error/accident reports;
  • will be required to report to Health Canada any error/accident that could lead to the transmission of an infectious disease/agent.

5.5 Proposed Options for Phase II Error/Accident Reporting

Option 1: Source establishment reports to Health Canada all errors/accidents that could lead to the transmission of an infectious disease/agent.

This option would maintain the status quo established by Phase I of the proposed regulations. An example of a reportable incident would be the performing transmissible disease testing using expired reagents.

Option 2: Source establishment reports to Health Canada all errors/accidents that could cause any serious adverse reaction.

Option 2 covers reporting of errors/accidents that could lead to infectious disease transmission, and it also requires reporting those errors/accidents that could lead to other (non-infectious) serious adverse reactions, for example, HLA miss-type.

Option 3: Source establishment reports to Health Canada all errors/accidents that could cause any adverse reaction.

This option requires reporting of errors/accidents that could lead to both serious and non-serious adverse reactions.

Option 4: Source establishment reports to Health Canada all error/accidents.

This option requires the reporting of all errors/accidents, whether they have the potential to lead to adverse reactions or not, for example, storage temperature not maintained with no subsequent release of the affected cell or tissue.

5.6 Summary of Phase II Error/Accident Discussion

The groups engaged in warm-up discussions after listening to the options presentation. After the warm-up, participants ranked the options for error/accident reporting in order of preference. Ten of the twelve groups ranked Option 2: Report All Errors/Accidents that could cause Any Serious Adverse Reaction as the most preferable option for error/accident reporting. Of the two groups that differed, one group in Halifax suggested that Option 2 would be the best choice, but added the caveat that only post-distribution errors/accidents that could cause any serious adverse reaction should be reported. Another group in Edmonton suggested that only errors/accidents that lead to recall of a CTO should be reported to Health Canada.

Participants identified drawbacks to reporting errors/accidents. Most of these concerned ramp-up issues for initial implementation of the reporting requirements. Issues such as a current lack of infrastructure to support the reporting and current organizational environments may not support the recording of errors were raised. A clear time frame for implementation was also cited as being critical for successfully meeting the requirements.

Participants expressed an interest in discussing implementation concerns such as resources, phase in and cost-benefit analysis. As with answers to previous questions, participants voiced a desire to handle as much as possible internally. There was some question whether Health Canada needs to know about processing errors/accidents and what the effect of inspections might have in identifying possible errors/accidents.

6.0 Day 2 Compliance Monitoring and Enforcement

6.1 Compliance Monitoring and Enforcement for Phase I

The second day of the workshops focussed on issues of compliance monitoring and enforcement. A series of presentations were made by Health Canada representatives that spoke to:

  • compliance monitoring and enforcement in general, including the factors Health Canada takes into consideration when deciding on a c&e strategy, the importance of an effective c&e strategy to any regulatory framework and they types of strategies that are currently employed for other types of products;
  • the compliance and enforcement measures proposed for Phase I; and
  • the proposed options for compliance monitoring and enforcement for Phase II.

An effective compliance monitoring and enforcement scheme for CTOs will provide Health Canada with a mechanism for staying abreast of the CTO facilities already in existence and for monitoring the activities in which the facilities engage. Additionally, an effective compliance monitoring and enforcement scheme provides a tool for compliance verification.

To meet the above objectives, a registration scheme is being proposed for Phase I of CTO regulations. It is anticipated that any establishment that processes or distributes CTO and any establishment, except a transplant establishment, that distributes or imports a CTO for further distribution would be required to register with Health Canada.

The application for registration would contain a description of the type of CTO imported, processed or distributed and a description of the activities the establishment carries out or for which it is responsible. The application for registration would also include a signed attestation by the medical or scientific director that states that the establishment is in compliance with the regulations. The Minister may request additional information to support the application, if required.

6.2 Compliance Monitoring and Enforcement for Phase II

Having been presented the above information and given an opportunity to ask questions about the proposed Phase I scheme, participants were presented with the following options for Phase II.

Option 1: Registration

This is the Phase I status quo option and would impose no new regulatory requirements on the community.

Option 2: Establishment Licensing Based on Application

This option is similar to Option 1 in that the application would be made to the Minister and would include similar information as in the registration scheme. Option 2, however, would require more than an attestation of compliance. Other information which could be required upon application including copies of standard operating procedures for critical control points, donor suitability assessment forms and questionnaires and self-audit documentation.

Option 3: Establishment Licensing Based on Health Canada Inspection

As in Option 2, an establishment license would be required for operation, however, in this case, an inspector may need to enter an establishment to observe processes first hand, prior to the issuance of the license. Other information that might be required for this option include a sampling of records and a review of descriptions of processes or procedures.

Option 4: Establishment Licensing Based on Third-Party Accreditation

This option contains two possible scenarios. The first could accept an accreditation as being equivalent to meeting the requirements of the Food and Drugs Act and the proposed CTO Regulations. Achieving accreditation would then a pre-requisite to obtaining and establishment license. The second scenario involve the authorization by Health Canada of a third party to assess compliance with the Food and Drugs Act and the proposed CTO Regulations. The third-party information would be submitted to Health Canada (reports from external inspectors, proof of an external accreditation, for example). Health Canada would then make the ultimate decision regarding compliance, and hence, the issuance of the establishment license.

Under all of the presented options for Phase II, Health Canada retains the right to inspect, perform compliance verification and to investigate establishments when required.

6.3 Summary of Phase II Compliance Monitoring and Enforcement Discussion

Having been presented with the options for Phase II, participants asked several points of clarification. The first was related to the role the existing registration scheme would play in the development of Phase II and once Phase II is implemented. The industry information gathered from registrations in Phase I (ex. activities being performed, levels of attested compliance) will be considered when deciding on the most appropriate option for Phase II. As well, Phase II will include transition options, applicable to those establishments who have already registered under Phase I.

Stakeholders were also concerned about the number of options that could apply to any given establishment in Phase II. (i.e., would an establishment have to obtain a registration and an establishment license?) Thought has been given to a mixed compliance monitoring and enforcement strategy, whereby the level of oversight an establishment is subject to is dependent upon the risk level of the activities it performs. However, even under such a approach, an establishment will only be subject to one requirement. (I.e. registration or establishment licensing.)

Participants were then asked to address the appropriateness/effectiveness of each of the four options as they pertain to different activities and to different types of CTO. Unlike the ranking exercises completed in Day 1 for adverse reaction and error/accident reporting, the results for the compliance monitoring and enforcement were difficult to interpret. The differences within groups were as varied as those between groups, and as such, breaking the rankings out into what each group recommended is difficult. For this section, the individual rankings from all groups and workshops have been compiled and are represented in the following tables:

4a, 6a, 8a, 10a
Please rank the compliance monitoring and enforcement options according to appropriateness/effectiveness

4.a. TISSUES

Source
  Registration
Establishment licensing (EL) EL based on HC inspection EL based on 3rd party Inspection
Most desirable) 1 10 38 21
2nd choice 1 18 25 21
3rd choice 11 25 2 17
Least desirable 42 5 0 7
RANK 4 3 1 2
Importer/Distributor
  Registration Option 1 Establishment licensing (EL) Option 2 EL based on HC inspection Option 3 EL based on 3rd party Inspection Option 4
Most desirable 2 15 33 15
2nd choice 5 18 10 16
3rd choice 9 28 15 10
Least desirable 37 0 1 15
RANK 4 2 1 3

6.a. ORGANS

Source
  Registration Option 1 Establishment licensing (EL) Option 2 EL based on HC inspection Option 3 EL based on 3rd party Inspection Option 4
Most desirable) 0 11 37 17
2nd choice 0 13 25 18
3rd choice 7 25 1 13
Least desirable 42 0 0 7
RANK 4 3 1 2
Importer/Distributor
  Registration Option 1 Establishment licensing (EL) Option 2 EL based on HC inspection Option 3 EL based on 3rd party Inspection Option 4
Most desirable 0 2 2 9
2nd choice 0 2 9 0
3rd choice 1 6 1 3
Least desirable 9 0 0 1
RANK 4 3 2 1

8.a. OCULAR TISSUE

Source
  Registration Option 1 Establishment licensing (EL) Option 2 EL based on HC inspection Option 3 EL based on 3rd party Inspection Option 4
Most desirable) 0 6 21 15
2nd choice 0 9 20 13
3rd choice 3 24 1 9
Least desirable 36 0 1 3
RANK 4 3 1 2
Importer/Distributor
  Registration Option 1 Establishment licensing (EL) Option 2 EL based on HC inspection Option 3 EL based on 3rd party Inspection Option 4
Most desirable 3 15 18 15
2nd choice 4 10 13 14
3rd choice 8 23 4 5
Least desirable 25 0 5 10
RANK 4 3 1 2

10.a. LYMPHOHEMATOPOIETIC CELLS

Source
  Registration Option 1 Establishment licensing (EL) Option 2 EL based on HC inspection Option 3 EL based on 3rd party Inspection Option 4
Most desirable) 0 4 19 22
2nd choice 0 8 21 16
3rd choice 5 28 2 5
Least desirable 32 2 2 4
RANK 4 3 2 1
Importer/Distributor
Registration Option 1 Establishment licensing (EL) Option 2 EL based on HC inspection Option 3 EL based on 3rd party Inspection Option 4
Most desirable 3 11 26 15
2nd choice 0 9 19 15
3rd choice 8 26 3 6
Least desirable 33 4 0 5
RANK 4 3 1 2

It is germane to the following discussion to note that in many cases the statistical difference between rankings of Options 3 and 4 are negligible. This compilation of ranking is simply an ordinal account of preferences.

As compiled, the above tables indicate that the majority of participants ranked Option 3: Establishment Licensing Based on Health Canada Inspection as the number one choice for both source establishments and distributors and importers, as well as for the majority of CTO products. These results are somewhat incongruent with previous discussions with the participants, in which many agreed that a compliance monitoring and enforcement scheme should not be a "blanket policy" whereby all activities are regulated in the same fashion. Yet, most participants ranked the highest level of regulatory intervention as the number one choice for activities and types of CTO that inherently contain different levels of risk.

Regardless of the highest ranking of Option 3, the participants did engage in thoughtful discussion around the idea of risk. Some participants suggested that extensive research be undertaken by Health Canada in order to determine the level of risk associated with certain activities, with a panel of experts being suggested as one mechanism for doing this. Others suggested that if a "mixed" approach is taken, some activities could be better suited to a paper review, such as donor testing/screening, retrieval, packaging and labelling.

The second-most preferred option was Option 4: Establishment Licensing Based on Third-Party Accreditation. The third-party accreditation was ranked as the preferred choice overall for importers and distributors of organs and for lymphohematopoeitic source establishments. It was not clear in the discussion why this was the case. However, it may have some connection to the frequently-raised concern that Health Canada may not have the in-house expertise for conducting the inspections themselves. Third-party accreditation would most likely be performed by those with experience in the field, thereby lending this option more credibility, particularly in such specific cases as organ and lymphohematopoeitic transplantation.

Other outstanding compliance monitoring and enforcement issues that were raised in several workshops include concern that any such program should be designed and delivered in a way that is positive, not punitive or adversarial.

Resources were also raised as an issue. Particular concerns were raised regarding the fear that financial burdens incurred by meeting the regulatory requirements would most adversely impact smaller banks in smaller communities, thereby potentially creating supply problems. Additional resources dedicated to coming into compliance could also be seen as a barrier to entry for new establishments trying to entering the community. Almost every group asked where money will come from for achieving compliance with the proposed regulatory requirements, even though earlier that day, many participants stated that significant resources had already been applied in order to come into compliance with the Directive and Guidance Document issued in January 2003.

7.0 Lessons Learned

The sessions on adverse reaction and error/accident reporting and compliance monitoring and enforcement raised unexpected results, with respect to the degree of regulatory intervention desired by the participants. At the outset, it was believed that less, rather than more, regulatory oversight would be preferable to stakeholders; yet, the highest ranked options suggest otherwise. This is not totally surprising, given that stakeholders have worked collaboratively with Health Canada for nearly a decade on this project; however, it may also be indicative of a community that is not experienced in complying with federal regulations and how that can affect daily operations.

A related finding pertains to the type of involvement in the CTO community that Health Canada may need to have as a regulator. At some point during all of the workshops, it was determined that Health Canada may need to play a more educative or promotional role than it does with other communities that are more familiar with federal regulatory oversight; a role that is perhaps more remedial than issuing guidance on how to come into compliance with regulations. It appears that many participants do not understand entirely the role of Health Canada, its authority, its mandate and motivations. Over the last decade, tens of presentations have been made to the community on these very subjects, and it seems that this type of activity may need to continue, at least in the short- to medium-term.

While community experience of regulation may be relatively new to some, knowledge of the science and best practices in the community is very well established. In fact, the professionals in attendance at the workshops made some suggestions that were immediately incorporated into the proposed Phase I regulations and others that were adopted into the policy agenda for Phase II.

  • The proposed Phase I regulations now prescribe adverse reaction reporting for "unexpected" adverse reactions. This inclusion came directly from discussions with participants during the workshop.
  • The title of the proposed Phase I regulations has been changed to include the word "human" to describe CTO.
  • Policy work has begun for the possible inclusion of the regulation in Phase II of cells and tissues for autologous use.

8.0 Next Steps

This report will be presented for information at a federal/provincial/territorial consultation in October 2005. At that time, the regulatory partners will discuss potential collaborations for implementation of any of the options and will raise potential stumbling blocks for the same.

As was raised in the March 2005 consultations, a cost-benefit analysis is currently being conducted to assess potential impact on the implementation of Phase II options for adverse event reporting and compliance monitoring and enforcement mechanisms. Upon completion, this report will be made available to those who request receipt.

Lastly, work has progressed on Phase I of the CTO regulations. It is anticipated that Phase I of the regulations will be published in Canada Gazette I for a 75-day consultation period in late November 2005. Please read these draft regulations and provide the comments that you feel are necessary. After the close of the 75-day comment period, the comments will be acknowledged and taken into consideration during the development of the final regulations. It is expected that Phase I of the CTO regulations will be published in Canada Gazette II, and hence become law, in Spring/Summer 2006.

Appendix A

List of Attendees

TORONTO
March 2 and 3, 2005

Name
Institution

Agbanyo, Francisca
Health Canada

Beaudry - Clouatre, Madeleine
Mount Sinai Hospital

Bissonette, Janice
Ottawa Hospital

Cartlidge, Paul
McMaster Medical Centre

Chadwick, Michèle
Health Canada

Coloma, Fides
Trillium Gift of Life Network

Coovadia, Ahmed
Sunnybrook & Women's College Health Sciences Centre

Cornwall, Sheila
Quinte Health Centre

Dossetor, John
Medicine & Bioethics

Doyle, John
Hospital for Sick Children

Dubois, Odette
Health Canada

Eriksen, Marilyn
Health Canada

Fallenbuchl, Adam
Health Canada

Gaskin, Deborah
London Health Sciences Centre

Gillham-Eisen, Liz Anne
Health Canada

Greig, Paul D.
Toronto General Hospital, University Health Network (UHN)

Guenther, Ellen
St. Joseph's Health Care System

Guest, Cameron
Trillium Gift of Life Network

Hamilton, Tracy
St. Joseph's Health Care System

Harrison, Deborah
Hamilton Health Sciences Centre

Hartman, Jane
London Health Sciences Centre

Haun, Sherry
Canadian Blood Services

Henke, Marjorie
St. Michaels' Hospital

Holatko, Jerry
Health Canada

Hollett, Linsey
Health Canada

Holmgren, Eleonor
Ottawa Hospital

Howson - Jan, Kang
London Health Sciences Centre

Hutton, Ingrid
Kingston General Hospital

Irwin, Stu
Cells for Life Ltd

Kraegel, Jeffrey
Canadian Standards Association

Laguan, Francisco
Health Canada

Lau, Wendy
CBS Toronto Centre and The Hospital for Sick Children

Layno, Norma
Kingston General Hospital

Lazaro, Bienvenido
Hospital for Sick Children

Légaré, Carole
Health Canada

Leroux, Norm
Mentor Medical Systems Canada, Inc.

Leung, Peter C. S.
Cryologics Canada

Lewis, Kirsten
Toronto General Hospital University Health Network (UHN)

Lulat, Ayub
Stem Sciences Inc.

Mahms Richard, Mohamed
London Health Sciences Centre

McDougall, Elizabeth
Hospital for Sick Children

McFarlane, Don
Royal College of Dental Surgeons of Ontario

McLennan, Pamela
Canadian Blood Services

Merkley, Sharon
Health Canada

Mullin, Sharon
Health Canada

Neil, Robert
Health Canada

Salomon de Friedberg, Zofia
Canadian Blood Services

Sheppard, Tina
Health Canada

Sherz, Bernadette
Cord Blood Bank of Canada

Soliven - Llaguno, John
Hemastem Therapeutics

Wankiewicz, Ellen
Eye Bank of Canada - Ontario

Weernink, Corinne
Canadian Association of Transplantation

Yang, Hongyou
Progenics Cord Blood Cryobank

Yates, Joan
Insception Biosciences Inc.

Zsigmond, Ann
Anson General Hospital

EDMONTON
March 10 and 11, 2005

Name
Institution

Agbanyo, Francisca
Health Canada

Akabutu, John J.
Alberta Cord Blood Bank

Ao, Ziliang
Ike Barber Human Islet Transplant Laboratory
Vancouver General Hospital

Bahlis, Nizar J.
Tom Baker Cancer Centre, University of Calgary

Bariluk, Lorrie
Royal University Hospital

Baron, Leonard B.
Patient Representative

Beirnes, Laurena
Cross Cancer Institute

Berry, Brian
Vancouver Island Health Authority

Brand, Tracy
Saskatchewan Transplant Program

Campbell, Trish
University of Alberta

Chadwick, Michèle
Health Canada

Chalmers, Sheryl
Canadian Blood Services

Clarke-Richardson, Penny
British Columbia Transplant Society

Crudder, Sally
Centre for Disease Control and Prevention (U.S.)

Davis, Jeffrey H.
British Columbia Children's Hospital / Oncology

Dubord, Paul J.
Canadian Standards Association

Ekins, Marilyn B. C.
Lion's Eye Bank of Manitoba and North West ON.

Ens, Patricia
Vancouver Island Health Authority - South

Fallenbuchl, Adam
Health Canada

Gillham-Eisen, Liz Anne
Health Canada

Gorembalem, Rodolfo
Lion's Eye Bank of Alberta

Ha, Brian
Eye Bank of British Columbia

Hoffman, Carolyn
Canadian Patient Safety Institute

Hogge, Donna
Leukemia / BMT Program of British Columbia

Hollett, Linsey
Health Canada

Lakey, Jonathan
University of Alberta Hospital - SMRI

Letcher, Brenda
Canadian Blood Services

Martin, Anne Marie
HOPE Program of Southern Alberta

McDonald, Mandy
HOPE Program Edmonton

McGann, Locksley
Canadian Blood Services

Mori, Brian
Health Canada

Mullin, Sharon
Health Canada

Norrie, Anita J.
Health Sciences Centre
Manitoba Organ Donation Program

Paulson, Deanna
University of Alberta

Pearson, Glen
Cardiology

Ritchie, Bruce
University of Alberta

Roger, Christina
University of Alberta

Shenchuk, Muriel
Calgary Health Region

Sheppard, Tina
Health Canada

Snow, Christopher
Tissue Bank Manitoba

Socha, Linda
Saskatchewan Transplant Program

Soucie, Michel J.
Centre for Disease Control and Prevention (U.S.)

Stacey, Ernest
Lifebank Cryogenics Corporation

Topolnisky, Tannis
Health Canada

Voralia, Michael
Saskatoon Cancer Agency

Wozny, Bruce
Health Canada

Young, Kimberly
Canadian Council of Donation and Transplantation

Young, Larry
Health Canada

HALIFAX
March 22 and 23, 2005

Name
Institution

Agbanyo, Francisca
Health Canada

Allain, Aline
New Brunswick Department of Health and Wellness

Chadwick, Michèle
Health Canada

Connell, Katherine
QE II Health Sciences Centre

Corning, Corinne
Nova Scotia Department of Health

Crawshaw, Ed
Dr. Donald MacLellan Tissue Bank

Dayman-Rutkus, Kim
Health Canada

Gatien, Mary
New Brunswick Eye Bank

Gillham-Eisen, Liz Anne
Health Canada

Hollett, Linsey
Health Canada

Hurlbut, Victoria
Nova Scotia Provincial Blood Coordinating Program

Laforest, Teressa
Health Canada

MacMullen, Joyce
Health Authority, Halifax

Margueratt, Sean
QE II Health Sciences Centre

Mohr, Jim
Capital Health - Regional Tissue Bank

Morrel, Marie
Canadian Association of Transplantation

Murphy, Tami
Capital District Health Association

Nikki, Kelly
Capital District Health Association

Ouellette, Nicole
Dr. Donald MacLellan Tissue Bank

Palmer, Jane
QE II Health Sciences Centre, Atlantic Canada

Parrill, Pauline
Organ Procurement and Exchange (O.P.E.N)
Newfoundland & Labrador

Redmond, Brenda
Health Canada

Secord, Ann
New Brunswick Department of Health and Wellness

Sheppard, Tina
Health Canada

Small, Stephanie
Health Canada

Walker, Thomas
Canadian Blood Services

White, Sandra
Organ Procurement and Exchange (O.P.E.N)
Newfoundland & Labrador

Wozny, Bruce
Health Canada

MONTREAL
March 30 and 31, 2005

Name
Institutions

Arias, Ariel
Health Canada

Arpin, Caroline
Health Canada

Aucoin, Guy
Health Canada

Barama, Azeai
HND - CHUM

Baran, Dana
Québec Transplant

Bergeron, André
Health Canada

Bernier, Julie
Health Canada

Bérubé, Alain
Health Canada

Burns, Angela
Montréal Children's Hospital

Cardinal, Eloise
Hôpital Notre - Dame du CHUM

Caron, Danielle
Banque d'Yeux Nationale Inc.

Chadwick, Michèle
Health Canada

Chartrand, Louise
Héma Québec

Clermont, Francine
La Cité de la Santé Laval

Décary, Francine
Héma Québec

Forcione, Raffaele
Québec Transplant

Galal, Ahmed
McGill University

Ganz, Katherine
Canadian Blood Services

Gervais, Julie
Health Canada

Gillham-Eisen, Liz Anne
Health Canada

Goldman, Mindy
Canadian Blood Services

Goulet, Lisa
McGill University

Grondin, Francine
Hôpital Maisonneuve

Herbet, Marie Josée
Hôpital Notre - Dame du CHUM

Huebsch, Lothar
Ottawa Hospital

Iyer, Narayanan
Health Canada

Jacques, Francine
Health Canada

Laliberté, Eric
L' Hôpital de Montréal pour Enfants

Lallier, Michel
Hôpital Ste-Justine

Lambert, Jean
Health Canada

Légaré, Carole
Health Canada

Lord, Francine
Hôpital Laval

McDiarmid, Sheryl
Ottawa Hospital

Mullin, Sharon
Health Canada

Nguyen, Mai
Agence de la Santé Publique du Canada

Pierre, René
McGill University

Robitaille, Annie
Ministère de la Santé et des Services sociaux

Roy, Jean
Hôpital Maisonneuve

Sheppard, Tina
Health Canada

St-Jean, Marie - France
Hôpital Maisonneuve

Tardif, Marie - Josée
Québec Transplant

Tehervenkov, Jean
McGill University

Wagner, Eric
Hôpital Sainte - Justine

Wolff, Jean - Luc
CHU de Sherbrooke

Appendix B

1a List of adverse reactions suggested by stakeholders for reporting to Health Canada, even if only suspected to be related to the CTO.

Patient death
HIV

Hepatitis
Cancer/Malignancy

Transmissible diseases
Genetic diseases

Seroconversions
Anaphylaxis

Life threatening events
Severe hypotension

Infectious diseases
Fever

Neurological reaction
Symptoms of transmissible diseases (SARS, West Nile, MRSA)

Cryopreservation
Positive biopsy reports

Bacterial infections
Fungal infections

Unexpected reactions
Emerging new diseases

Rabies
Allergies

Primary graft failure
Contaminated tissue

1b List of adverse reactions suggested by stakeholders for reporting to Health Canada, but only when confirmed to be related to the CTO. (Includes list from 1a)

Error in HLA typing
Eye graft rejection, confirmed by a physician

CMV
Communicable diseases

Allograft failure
Environmental

Cytotoxic agents
Bone deterioration

Hepatitis C
Everything transmissible

All deaths and events
 

1c List of adverse reactions suggested by stakeholders for reporting to Health Canada at a later date.

Development of malignancy post-transplant (related to donor)
Multiple patients exhibiting same symptoms that have tissue from same donor (unusual and unanticipated)

DMSO
Unexpected poor outcomes, such as slow to function organs

CMV, EBV
Processing errors

Graft loss, death
Unexpected reactions that occur months after transplant

Real time reporting
Expected adverse reactions

Identified trends
Trends and causality

Serology related to organs
Positive bacterial culture

Reactions seen in single recipients
Certain types of primary graft failure

Hepatitis
Number of adverse reactions over a given period of time

2a List of errors/accidents suggested by stakeholders for reporting to Health Canada immediately.

Screening
Pre-donation testing

New donor information
Contamination with infectious agents in a lab or storage facility

Bad batch - reagent testing
Testing errors that impact recipient selection or outcome

Incorrect use of products
Incorrect labelling

2b List of errors/accidents suggested by stakeholders for reporting to Health Canada at a later date.

Technical/processing
Surgical procedures/techniques in procurement

Haemodilutions
Positive culture results

Inconsistency in testing
Errors in protocol that impact a single patient

Mislabelling
Efficacy, sterility, immediate potency that leaves source establishment

Organ testing errors
ABO incompatibility in organs

Defective organ supplies

Appendix C

Diseases Under National Surveillance

It is mandatory to report the following diseases by all provinces and territories of Canada to the Public Health Agency of Canada.

Acquired Immunodeficiency Syndrome (AIDS)
Acute Flaccid Paralysis (AFP)
Anthrax
Botulism
Brucellosis
Campylobacteriosis
Chickenpox
Chlamydia Infection
Cholera
Congenital Rubella Syndrome (CRS)
Creutzfeld-Jakob Disease (CJD)
Cryptosporidiosis
Cyclosporiasis
Diphtheria
Giardiasis
Gonorrhea
Group B Streptococcal Disease of the Newborn
Hantavirus Pulmonary Syndrome (HPS)
Hepatitis A
Hepatitis B
Hepatitis C
Human Immunodeficiency Virus (HIV)
Influenza, laboratory-confirmed
Invasive Haemophilus influenzae type b (Hib) Disease
Invasive Group A Streptococcal Disease
Invasive Meningococcal Disease
Invasive Pneumococcal Disease
Legionellosis
Leprosy (Hansen's Disease)
Malaria
Measles
Mumps
Pertussis
Plague
Poliomyelitis
Rabies
Rubella
Salmonellosis
Shigellosis
SmallpoxSyphilis, Congenital
Syphilis, Infectious (Primary, Secondary and Early Latent)
Syphilis, Other (Late Latent, Neurosyphilis, Tertiary other than Neurosyphilis)
Tetanus
Tuberculosis
Tularemia
Typhoid
Verotoxigenic Escherichia coli Infection
Viral Hemorrhagic Fevers
West Nile Virus Infection (WNV Asymptomatic Infection, WNV Neurological Syndrome, WNV Fever)
Yellow Fever

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