Expert Review Panel on Medical Isotope Production
Call for Expressions of Interest
Proponent’s Guide

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Preface – Expert Review Process

This Proponent’s Guide outlines the Call for Expressions of Interest (EOI) process for the Expert Review Panel (the Panel) on Medical Isotope Production. It explains how the Panel will review, in a consistent, fair, and transparent manner, EOIs submitted in response to the Call.

The Panel’s opinions and advice will only be provided for consideration and will not bind the Government of Canada. Further, the Government of Canada makes no commitment nor will it have any obligation to provide a financial contribution to any project, including any costs incurred or paid in the preparation of the said EOI.

1. Introduction and Objectives

Technetium-99m (Tc-99m) is widely used in medical imaging and accounts for the largest proportion of nuclear medicine diagnostic procedures. Canada’s supply of Tc-99m generators is largely met by two U.S.-based manufacturers that, in turn, source the parent isotope, molybdenum-99 (moly-99), principally from five research reactors, including Atomic Energy of Canada Limited’s (AECL) National Research Universal (NRU) reactor in Chalk River, and four other reactors located in Europe and South Africa. Production of moly-99 at AECL’s Chalk River facility is part of a complex supply chain that originates with the import of highly-enriched uranium (HEU) “targets” that are irradiated in the NRU reactor and processed on site for moly-99 extraction. Moly-99 is then shipped to the facilities of MDS Nordion in Kanata, Ontario, for purification, before being exported to Tc-99m manufacturers in the U.S. and offshore. Steps in this process are overseen by national and foreign nuclear and medical regulatory authorities to ensure health, safety, and security.

Given the relatively short half-life of molybdenum-99 (66 hours) and the shorter half-life of technetium-99m (6 hours), it cannot be stockpiled for later use. The production of molybdenum-99 must be done on a frequent basis to assure continuous availability, which adds to the complexity of ensuring security of supply.

While Canada accounts for less than ten per cent of the global demand for Tc-99m generators, AECL’s NRU typically has represented 30 to 40 per cent of the global supply of moly-99. Correspondingly, domestic production of moly-99 has far exceeded domestic requirements and served an important export market. Tc-99m sourced from moly-99 produced at the NRU has typically represented 85 per cent of the Canadian market and about 50 per cent of the U.S. market. There are currently no sources of moly-99 in the U.S., and hence, the North American market has been very dependent on the NRU.

Over the long term, the supply chain to meet Canada’s needs of Tc-99m could take many forms. Solutions must be integrated in a supply chain that will be situated in a North American and global market and that will assure enhanced security of supply. This may entail a domestic source of moly-99 that may be reactor or non-reactor based, as well as processing capabilities and facilities or arrangements for the manufacture of Tc-99m generators in Canada or abroad.

The nuclear and medical isotope industries are highly sophisticated, technology intensive industries and new sources of medical isotopes, from existing or new facilities, will require expert capabilities, deliberate planning, research and/or development, and significant investment, as well as close oversight on the part of regulatory authorities. The process of bringing new sources of supply on stream is expected to take a number of years. Correspondingly, as an interim solution, the Government of Canada has confirmed the intention to pursue an extension of the operating license of the NRU past the current license expiry date of October 2011.

The Government of Canada has established an Expert Review Panel (the Panel) to report on new options for secure medium to long-term supply of medical isotopes for the Canadian health care system, specifically, Tc-99m and its generators.

The Expert Review Panel solicits and will review confidential expressions of interest, supported by a secretariat staffed by Natural Resources Canada (NRCan) and Health Canada employees. It may also engage resources to assist in its assessment of the submissions. In that event, proponents will be asked for permission to release EOIs to expert reviewers, and appropriate confidentiality agreements will be discussed and negotiated as and when required.

In the pursuit of its work, the Panel may request information from any source, including the nuclear medicine community, to better understand the many considerations that have bearing on the determination of a long-term strategy for Canada given its position in the North American and global markets for medical isotopes.

The output of this process will be a report documenting the Panel’s assessment of the most viable options for securing supplies of technetium-99m to the Canadian health system over the medium and long term, and the actions that may be required by governments and others to facilitate realization of the options.

2. EOI Structure and Content

The Expressions of Interest must include the following:

1. The completed covering forms given in Appendix 1 with the signature of a duly authorized officer for the proponent;
2. Detailed information structured and organized according to the headings given below. Proponents must include information related to each of the headings, in the order given, providing supporting documentation for all assertions; and
3. All other information considered necessary by the proponent for the fair evaluation of its proposal.

2.1 Project Details

The information provided in this section should be concise, but sufficient to provide reviewers with a sound understanding of the proposal. Please take into account the selection criteria outlined in Appendix 4 of the Proponent’s Guide.

2.1.1 Project Description and Technology Identification

This section should provide a general overview of the project and provide information on the ability of the project to contribute to a significant and reliable quantity of technetium-99m to the Canadian health care system at a specified time in the future.

• Explain the reasons for undertaking the proposed project, including why the various parties are involved in its implementation.
• Describe in detail the technological basis for the proposal.
• Identify all technologies that would be required to implement the proposal, including detailed information on the stage of development and the commercial readiness of the technologies. If the proposal can be implemented using commercially available technology, this should be highlighted.
• If additional scientific or technological investigations are required, a plan must be specified and an estimated timeframe provided. This should be included as part of the Project Statement of Work described in Section 2.2.1. Where possible, scientific and technological support for the plan (for instance in the form of peer reviews) should be provided to substantiate the plan.
• Developed plans to bring the technology to a commercial scale should be provided and substantiated with evidence that such scale is possible.
• Describe past work upon which the proposal builds. Provide references to the results of that past work that have been used in developing this EOI. If applicable, also include description of previous regulatory approvals or engagement with regulatory authorities in other jurisdictions or other countries.

2.1.2 Partners and Collaborators

List all partners and collaborators, including the proponent, and explain the nature of their role in, and contribution to, the project. Why are these other stakeholders and collaborators involved, what value do they bring to the project, and how might they be involved in further deployment of the project concept? How will they interact with each other, and what legal understandings are expected?

For all organizations involved, provide evidence that they would have the financial and technical means to deliver their proposed contribution to the project.

2.2 Methodology and Risk Mitigation

This section is the statement of work for the proposal and how project risks might be mitigated.

2.2.1 Statement of Work

Describe in detail the “what and how” of the project proposal: what work would be carried out, and how it would be done. Describe the different phases (if appropriate) and activities. Identify and explain the key stage gating “go / no go” decision points. Explain clearly how the project would be managed and coordinated. Refer to the tables in Section 2.2.3 to avoid duplication.

2.2.2 Milestones and Outputs

Complete Table A1 (see example in Appendix 2) summarizing the principal phases / activities to be undertaken (identified under 2.2.1) on a year-by-year basis, with expected completion dates. Include principal milestones and outputs. The proponent should identify the timeframes required for each stage of project development, including uncertainties that could result in delays. Timeframes should be provided for: research and development, construction of facilities, testing, regulatory approvals from nuclear safety and medical authorities, and production and processing of isotopes for supply to the market.

2.2.3 Financial Structure & Business Case

Provide a business case justifying the pursuit of this proposal. This should include cost estimates for the overall proposal from today through to the first use of technetium-99m by a health care institution. Include as much detail as possible at this time.

The proponent should provide an assessment of the cost of new infrastructure required and/or costs for using existing infrastructure. Operating costs for facilities proposed should be estimated and the access of the proponents to required existing facilities should be described. A list of resources secured by the proponent and its partners should be identified.

A projection of the revenues required for project viability should also be given. Revenues should be specified as originating from the market, and if necessary, public sources.

The proponent should describe how the project will be integrated into the existing supply chain and should describe any existing or proposed partnerships with current supply chain participants.

Identify the financial risks and the mitigation plan. Proponents are advised that NRCan may carry out financial due diligence on the proponent as part of the review process.

2.2.4 Expectations of Government

Discuss any actions that would be required on the part of the Government of Canada or any other government to realize the option.

2.2.5 Risks and Risk Mitigation Strategy

Provide a review of the project risks in terms of technical risk, business risk, and other risks (environmental review, permitting etc). Note that regulatory issues and risks are to be discussed in Section 2.2.6. The project will be evaluated based on how well the risks have been identified and on the risk mitigation strategy. It is understood that all proposals will carry risk. What is needed is for the proponent to demonstrate that they understand the risks at various stages of the project development and that there is a well thought out plan to execute the project in such a manner that risk is mitigated.

2.2.6 Regulatory Issues

The proponent must identify nuclear and medical regulatory issues that could impact the EOI and identify a strategy for obtaining approvals from the Canadian Nuclear Safety Commission and Health Canada, respectively.. Any special requirements, including those associated with the siting of facilities, handling controlled materials, highly-enriched uranium (HEU) or low-enriched uranium (LEU), nuclear waste management, and approval of new medical products, should be highlighted.

2.3 Impact and Expected Outcomes (Benefits to Canadians)

Describe the potential impact of the project if it were implemented. The EOI should include an estimate of its potential contribution to the security of supply of moly-99 and/or Tc-99 to serve the Canadian, North American and/or global markets for Tc-99m. Export capacity may represent a benefit for the domestic health care system if contributing to enhanced, more resilient North American or global supply. The EOI should also identify other medical isotopes that may be supplied, if any, to serve wider health care needs in Canada, North America or globally.

Investment in facilities for the production and potential export of medical isotopes may also represent an opportunity for research and development, application of science, and employment that would have broader benefits for Canada. These benefits would be facility and technology specific and ought to be identified and quantified to the extent possible.

Investment in facilities may also create broader opportunities for Canada's nuclear industry, Canada's medical industry, or Canada's research community. Again, such benefits should to be identified and quantified to the extent possible.

Appendix 1: Expression of Interest Cover Form

CONFIDENTIAL WHEN COMPLETED¹

Section 1 General Information and Proponent’s Attestations

Please note that the proponent’s name, project partners’ names, project title, non-confidential overview, and expected benefits, will be released publicly, unless expressly requested otherwise by the proponent.

1. Project Title
2. Project proponent(s) (legal names of companies)
3. Project partners (legal names of companies, utilities, provinces )
4. Project Start Date: (year/month)	5. Project Completion Date: (year/month)
6. Project Location(s) (i.e. location(s) where isotopes would be produced and processed)
7. Project Summary (max.1 page) (non-confidential)
8. Expected Benefits (non-confidential)

¹ Except the information identified as public in Section 1 of this form.

Attestations By submitting this EOI, the project proponent attests that: It is acting on behalf of all partners and collaborators and has received written permission from them to do so. It agrees with the terms and conditions of the Panel Call for Expressions of Interest process as described in the Proponent’s Guide. Any proprietary or confidential information provided as part of the submission, by any party, is provided with the authorization of that party. Reviewers are bound by the requirements of the Access to Information Act and the Privacy Act regarding the treatment of confidential information. It understands and acknowledges that no liability and no commitment or obligation exists on the part of NRCan to make a financial contribution to the project, and, furthermore, that any costs or expenses incurred or paid by the proponent in the preparation of the Expression of Interest are the sole responsibility of the proponent, and no liability exists on the part of NRCan. It understands and acknowledges that NRCan reserves the right to alter or cancel the currently envisaged process at its sole discretion. The individual signing below attests that he/she has authority to sign on behalf of the proponent.

 

Please sign below to confirm these attestations: ________________ Name of Duly Authorized Officer for Proponent: Title:

______________ Date

Appendix 2: Example of Table for Section 2.2.2

The following is an example of a table summarizing the principal phases / activities and completion dates for the proposal.

Table A1

Activities	Year	Principal Milestones	Completion date	Outputs
Phase 1 – R&D
Phase 2 – Design
Phase 3 – Construction
Phase 4 – Commissioning and Operation

Appendix 3: Submission Process

A submission must include a completed Expression of Interest having the structure and content requested in Section 2 of this Guide. The evaluation criteria are detailed in Appendix 4. Confidentiality considerations are outlined in Appendix 5. Other terms and conditions are given in Appendix 6.

A proponent may provide supporting material for any aspect of the EOI. Proponents are required to submit all of the required documents by 11:59 p.m. EDT, July 31, 2009. It is the proponent’s responsibility to retain proof of time the documentation package was sent to NRCan. This may be required in the event that NRCan does not receive the documentation package by the deadline for reasons that are beyond the control of the sender.

As per Appendix 5, NRCan recognizes that e-mail is not a secure means of communication, and NRCan cannot guarantee the security of confidential information sent via email while it is in transit. Nonetheless, proponents who regularly use email to communicate confidential information within their own organizations may choose to submit their documentation packages by e-mail to:
isotopeERP@nrcan-rncan.gc.ca.

Proponents may also submit their documentation by courier or registered mail to:

  Expert Review Panel on Medical Isotope Supply
  Natural Resources Canada
  580 Booth St., 17th floor
  Ottawa, ON K1A 0E4

Where proponents submit by courier or registered mail, we request that an electronic version on a memory stick or CD-ROM be included in the package, clearly marked with the name of the organization and the title of the EOI.

Submission of an EOI and other required information does not imply that the EOI will be approved or funded by the Government of Canada. Failure to provide all of the requested information may lead to the rejection of the EOI.

The Panel’s opinions and advice will only be provided for consideration and will not bind the Government of Canada in any way whatsoever. Further, the Government of Canada makes no commitment nor will it have any obligation to provide a financial contribution to any project, including any costs incurred or paid in the preparation of the said EOI.

NRCan reserves the right to alter the process and deadlines. Any changes will be communicated via the website. Proponents are asked to check the site regularly for new information.

Appendix 4: Selection Criteria

Proponents are asked to address all of the criteria below in their Expression of Interests, providing supporting documentation for all assertions. Note that the description of the individual criteria below are indicative of the factors considered by reviewers, but are not meant to be all inclusive. Proponents are urged to submit all information they feel would be relevant in addressing the criteria in their EOIs. Project EOIs will be rated and ranked on a comparative basis, against other EOIs being reviewed, based on the following criteria and on an overall assessment of individual Expression of Interests.

Evaluation Criteria

Assessment criteria used by the panel will include:

• Technical Feasibility: The Panel will assess the scientific and technical merits of projects taking into account risks associated with the introduction of new technologies and the likelihood that technologies could be realized on a commercial scale.
• Business Implementation: The Panel will assess the business merits of the EOIs, taking into account the partnerships established by the proponents; funding requirements and secured resources; access to existing or new physical infrastructure required; the ability of the proponents to integrate their proposal within a supply chain; and cost structure and required revenue. The Panel will take into account business risks associated with these elements.
• Timeliness of Proposal: The Panel will assess the schedule for implementing proposed options, including the risks of delays.
• Regulatory Issues: The Panel will assess EOIs with regard to the capacity of proponents and the project to meet nuclear and medical safety standards and provide an assessment of potential issues, including nuclear and medical regulatory issues that could affect implementation. The EOI should provide information about how facilities would be sited, how controlled nuclear materials would be handled, facility safety and security would be ensured, and waste management or transportation issues would be addressed.
• Benefits to Canadians: The Panel will provide an assessment of the benefits of implementation to Canadians. While this assessment will focus on the overall ability of the project to assure supplies of technetium-99m generators to the Canadian health care system, it will also consider concomitant scientific and technological benefits, economic benefits, or any other benefits to Canadians.

Appendix 5: Confidentiality and Security of Information

The Access to Information Act, (the “Act”) governs the protection and disclosure of information, confidential or otherwise, supplied to a federal government institution. This Act is a law of public order which means that the government of Canada, including NRCan, can not contract out of it.

Paragraph 20(1) (b) of the Act states that:

a government institution [such as NRCan] shall refuse to disclose any record requested under the Act that contains financial, commercial, scientific or technical information that is confidential information supplied to a government institution by a third party and is treated consistently in a confidential manner by the third party.

Paragraph 20(1) (b) of the Act sets out two mandatory criteria in order to protect proponent’s confidential information supplied to NRCan from disclosure. First, the proponent’s documents supplied to NRCan must contain financial, commercial, scientific or technical information. Second, the proponent must consistently treat such information in a confidential manner.

In other words, NRCan will protect the proponent’s confidential information in its possession as much as the proponent protects said confidential information in its own establishment: if the proponent chooses to send the EOI or other confidential information to NRCan by e-mail, NRCan will respond by e-mail. Similarly, if the proponent’s correspondence is through regular mail, NRCan’s response will be in like manner. However, in all cases, NRCan will use e-mail correspondence to the proponents for all non-confidential matters.

For more information on this subject, a careful reading of the entire section 20 of the Access to Information Act is recommended.

Note that the Panel may engage non-governmental experts to review the Expression of Interests, or parts thereof. If and when required, proponents will be asked to authorize the release of their Expression of Interests to specific individuals or organizations outside of NRCan for the purposes of expert review. Non-disclosure agreements or other confidentiality agreements may be negotiated if and when required.

Appendix 6: Terms and Conditions

The Government of Canada has established an expert panel (the Panel) to report on new options for secure supply of medical isotopes for the Canadian health care system, specifically, technetium-99m and its generators. The Panel will consult broadly across the public and private sectors to better understand the many considerations that factor into a determination of a long-term strategy.
To ensure that the broadest range of ideas and concepts are considered by the Panel, the Call for Expressions of Interest process has been launched to encourage organizations to submit proposals they may have.

1. General Features

The Call for Expressions of Interest process will accept EOIs until July 31, 2009. All EOIs will be reviewed against the mandatory criteria identified in Appendix 4. Those EOIs that meet the mandatory criteria will be assessed against the evaluation criteria given in Appendix 4. Only the most promising EOIs, as determined by the Panel, will be further scrutinized through due diligence research, external reviews and requests for supplementary information from proponents. The Panel may, at its sole discretion, determine which EOIs will be discussed in the final report.

A proponent may withdraw its EOI without penalty at any stage of the assessment process.

All non-confidential communications in relation to this process should be in writing via e-mail to isotopeERP@nrcan-rncan.gc.ca.

2. Timeframe

Expression of Interests must be submitted by July 31, 2009. The Panel will issue a final report by November 30, 2009.

3. Eligible Proponents

To ensure that the broadest range of ideas and concepts are advanced, the process will be open to public sector and private sector organizations, including: for-profit and non-profit organizations, industry associations and research associations; academic institutions; federal, provincial, territorial and regional and municipal governments and their departments and agencies, and non-Canadian organizations.

4. Requests for Information

The Panel may contact proponents as required to request additional information and clarifications as necessary to perform a thorough assessment of EOIs. Proponents are asked to expect such requests for information and to be prepared to respond to such requests in a timely manner. The Panel may ask proponents to provide written materials, written correspondence, and/or to be available for telephone or in-person meetings. Proponents may be asked to make one or more presentations to the Panel.

5. Sharing of Information

EOIs submitted on July 31, 2009 should be based on information available to the proponent through its own means. Sufficient detail should be included to allow for measurement against assessment criteria so as to inform the panel in identifying the most promising options. As the panel investigates further the short list of options, it may solicit additional information that may, in turn, require that proponents of short-listed projects have access, on a confidential basis, to a virtual data room. The timelines for the submission of additional information and the details of the data room, should it be necessary, will be provided under the instructions of the Panel.

6. Other Terms and Conditions

No commitment or obligation exists on the part of NRCan to make a financial contribution to any Expression of Interest.