Please read the following information carefully

IMPORTANT NOTICES:

October 26, 2020:

This consultation process will end on October 29, 2020. Given the fast-evolving situation concerning public health crisis, the Government of Canada has decided to conclude the consultation process (this LOI process) and initiate a tendering process for the vaccine supply chain.

If your organization is interested in participating in the tendering process, or would like to obtain more information regarding the envisioned procurement strategy, or participate in a bidders’ conference we invite you to consult the notice of the tender available at the following link https://buyandsell.gc.ca/procurement-data/tender-notice/PW-20-00931397.

You must register for the bidders' conference in order to participate. See more details on the tender notice available at the above-mentioned link. Any questions regarding the tendering process must also be directed to the contracting authority identified under this tender notice.

In the spirit of transparency, the Government of Canada has received more than 50 applications for registration to the LOI and has compiled feedback from more than 40 responses to the questionnaire #1.

Also, to maintain the dialogue among industry members regarding the LOI and future tendering process, the Government of Canada has decided to publish the list of participants who have registered for the consultation process. The list of participants is included under the "Attachment" section below.

We would like to express our sincere appreciation to all participants for their contributions to the consultation process.

October 1st, 2020: Please note that the closing date for this letter of interest (currently scheduled for October 30, 2020) does not represent the desired date for a participant to register. Participants were asked to register by September 30, 2020, as indicated below. Industry members who would like to register may do so at any time, however, we would like to see participants register as soon as possible.

September 24, 2020: Publication of the LOI. Please note that industry members are requested to register to this consultation process before COB September 30, 2020. Information on how to register is identified below.

CONTEXT

This Letter of Interest (LOI) is not an invitation to bid and does not constitute a commitment, implied or otherwise, that the Government of Canada intends to solicit bids for this purpose.

The Government of Canada is issuing this LOI for the purpose of inviting information from industry members regarding the logistics capabilities currently available for the requirement identified below.

Participants, once registered, will be invited to provide general comments and/or recommendations that could help Canada improve its pharmaceutical supply chain, more specifically for vaccines.

Industry members are asked to kindly refrain from using this consultation process as a forum for marketing purposes.

KEY CONSIDERATIONS

In order to participate in upcoming consultation activities, industry members must register by following the instructions identified below. To facilitate the consultation process, Canada may contact registered participants only.

Questions arising from the consultation activities may be recorded in a question and answer document and circulated to all registered participants on a sporadic basis and may be published on this notice at the end of the process, as appropriate.

Canada could subdivide the consultation process in parts and conduct sub-consultations with a specific group of registered participants only. Canada reserves the right to pursue the consultation process with registered participants who provides relevant information via the questionnaires.

The conduct of this consultation process does not commit Canada to issue a subsequent Request for Proposals (RFP) and does not impose any legal or any other obligation on Canada to enter into an agreement or to accept suggestions submitted by registered participants. Canada reserves the right to accept or reject some or all of the comments received.

It should be noted that Canada may, at a later date, require Registered Participants, to sign a Non-Disclosure and Conflict of Interest Agreement. Refusal to comply with this request could prevent a registered participant from receiving the documents or information required to fully participate in the activities of this consultation process.

In addition, the Government of Canada will not be responsible for reimbursing costs incurred by registered participants to provide a response or to participate in any of the identified activities.

Canada's representatives will evaluate the information provided by registered participants throughout the consultation process. It should be noted that external consultants and/or experts in pharmaceutical logistics may be used to analyze the information provided by registered participants.

Participation in this consultation process is neither a condition nor a prerequisite for participation in any subsequent competitive RFP, if any is issued.

It is the responsibility of registered participants to identify confidential or protected information originating from their organization. This information will not be disclosed to the public.

Any significant changes to the activities of this consultation process will be listed on this notice.

REQUIREMENT DESCRIPTION AND RELEVANT INFORMATION

The Public Health Agency of Canada (PHAC) is leading the national health response to the COVID-19 emergency response. The Centre for Immunization and Respiratory Infectious Diseases (CIRID) at the PHAC is the program lead for this novel respiratory pathogen. This involves developing technical public health guidance documents including for the planning and implementation of vaccine strategies to meet the response needs related to COVID-19. 

The scope of this consultation is to obtain information on the end to end vaccine supply chain to support the transport and distribution of COVID-19 vaccines in Canada, notably international and domestic transport of cold chain including ultra-cold chain requirements exceeding current requirements. PHAC does not have a mandate to directly distribute vaccines and collect information on the administration of vaccines in provinces and territories in Canada; this is the responsibility of provinces and territories, and Indigenous Services Canada. However, PHAC has an interest in ensuring that vaccines secured by the Federal government in response to COVID-19 are managed and monitored to achieve the highest level of transparency in the equitable distribution and access, including post-marketing assessment of effectiveness and safety.

PHAC is expected to coordinate and facilitate the process to plan for the distribution, monitoring and evaluation of vaccines in collaboration with Health Canada, Federal/Provincial/Territorial and external partners, including the World Health Organization. To accomplish this, the Government of Canada intends to discuss with registered participants with significant knowledge and experience in vaccines or other biological/pharmaceutical/diagnostic product supply chains requiring cold chain logistics and supply chain solutions (cold chain equipment, vaccines inventory management including track and trace) in compliance with Health Canada and/or WHO guidance on international shipment of vaccines.

In anticipation of technical specifications of COVID-19 vaccines for the transport and distribution in Canada exceeding the current supply chain capacity (i.e. Ultra-cold chain transport of vaccines), Canada may require dedicated 3^rd party logistics supplier(s) to import, warehouse and distribute COVID-19 vaccines across Canada in accordance with the principles of Good Manufacturing Practices and Good Distribution Practises, including, but not limited to, requirements for temperature monitoring, record keeping and recall procedures. Where possible and feasible, existing vaccine supply chains in collaboration with provinces and territories will be used/leveraged to facilitate distribution of goods.

The vaccine to be warehoused and distributed maybe at various storage conditions; including refrigerated conditions (2^oC to 8^oC), frozen conditions (-20^oC ± 5^oC) or ultra-frozen conditions (-80^oC ± 10^oC).

Distribution may include remote regions of Canada, inclusive of air and/or land transport options. Distribution may also require ancillary clinic supplies (e.g. needles, gauze) to accompany vaccine distribution.

HOW TO BECOME A "REGISTERED PARTICIPANT”

Prior to submitting their application to participate and become a "registered participant,” industry members must ensure that they are able to provide relevant information regarding the requirement addressed in this consultation process. More specifically, Canada is looking for feedback and comments from industry members with:

• Significant knowledge and/or experience in supply chain solutions/logistics to support the domestic and/or international transport, warehousing and distribution of vaccines. Experience in other biological, other pharmaceuticals with cold chain/ultra-cold chain requirements and/or diagnostics is acceptable.
• Experience in international and/or domestic vaccines supply chain solutions/logistics that includes compliance with Health Canada regulatory requirements and/or international guidelines for the shipment of vaccines.

Industry members must complete the document "Rules of Engagement and Participation Agreement,” included as an attachment to this notice, and return it to the Contracting Authority before September 30, 2020. Registrations received after this date will still be considered. However, please note that Canada may not accept additional input for the activities undertaken between September 24, 2020 and the participant’s registration date.

Subsequent communications will be by e-mail, therefore it is the responsibility of the participant to provide a valid e-mail address and to monitor its activity on a regular basis.

Once registered for the consultation process, participants will be able to participate in the various activities identified below, as appropriate.

PLANNED ACTIVITIES

Canada plans to conduct the following activities with registered participants, but are not limited to:

• Questionnaires will be sent to registered participants, asking them to provide relevant information on specific topics related to pharmaceuticals or vaccine warehousing, transportation and distribution.
• Request for information (RFI) could be released during the consultation process.
• Canada may consult individually with registered participants for additional information or clarification. These consultations will take place virtually or by teleconference.
• Canada may conduct a virtual industry day if required. This day could also target only a segment of the registered participants.
• A summary of the feedback and outcomes report of this consultation process may be published under this notice before its closure.

Canada reserves the right to add or remove activity(ies) from this consultation process. Registered participants will be notified accordingly.

Canada reserves the right to advance or extend the closing date of this LOI.

The closing date on this notice does not represent the dates on which responses to subsequent inquiries must be provided. A date will be specifically identified under each inquiry, where applicable.

COMMUNICATION AND INQUIRIES

All inquiries or questions regarding this consultation process should be directed to the following Contracting Authority:

Ian Potvin

Public Services and Procurement Canada

Acquisitions Branch

Gatineau (Québec)

Phone: 873-353-4758

Email: Ian.Potvin@tpsgc-pwgsc.gc.ca

QUESTIONS AND ANSWERS RELATED TO THE CONSULTATION PROCESS (non-technical):

(information will be added at a later date, if applicable)