Sharing Responses to Public Consultations

Sharing Responses to Public Consultations

PDCI voluntarily hosts this webpage as an information sharing platform for recent public consultations concerning pharmaceutical policy issues. PDCI invites ALL stakeholders who have participated in any of the below-listed public consultations to publicly share their written comments with other stakeholders via this PDCI webpage. Our objective for this record of responses on Government consultations is to support transparency in policy-making. We wish to ensure public dialogue and information-sharing is as comprehensive as possible and includes all voices that will inform forthcoming policy decisions on consultation topics.

If you or your organization responded to any of the below-listed public consultations and would like to share your response with the public, please contact PDCI’s Managing Director, Kaitlyn Proulx at Kaitlyn.Proulx@pdci.ca or (613) 742-8225 ext. 33. Please attach PDF version(s) of your English and/or French submissions and indicate your permission for PDCI to share your submission on on this webpage. If your submission contains confidential or proprietary information but you are still wish to share your comments, you may send a PDF copy with confidential information redacted, or you can be added to the list of “Other Stakeholders who Shared Confidential Comments”.

PMPRB Amended Final Guidelines Consultations – Summer 2021

PDCI Launches Sharing Page for Submissions to the PMPRB Notice and Comment – On proposed changes to the definition of Gap medicines, the references to the comparator countries, and the international price tests for Grandfathered medicines and their line extensions

On June 29, 2021, the implementation of the PMPRB Regulations and guidelines were delayed for the third time, to January 1, 2022. On July 15th, 2021, the Board issued a Notice and Comment on proposed changes to the Guidelines, including a change to the International Price Referencing test for Grandfathered medicines. Although not explicitly stated in the Notice and Comment, the Board’s intention is to revert to a one reporting period deadline for compliance with new Maximum List Prices (MLPs) for Grandfathered and Gap medicines. PDCI continues to support transparent consultations on public policy. We invite all organizations and individuals to share with PDCI their Notice and Comment submissions. PDCI staff will post all submissions we receive onto our website sharing page for public information.

Please e-mail Jennifer Mathews, Manager Pricing Data, at Jennifer.Mathews@pdci.ca with a PDF version of your response including consent for PDCI to publish the response on its website.

Note: PMPRB may publish all submissions it receives as part of this consultation, however timing for this is not yet clear. Once PMPRB publishes the comprehensive set of submissions, PDCI’s sharing page will direct visitors to the PMPRB website.

Thank you to all stakeholders who shared their responses.

Health Canada National Strategy for High-Cost Drugs for Rare Disease – Spring 2021

On January 27, 2021, the Government announced a consultation titled the National Strategy for High-Cost Drugs for Rare Diseases Online Engagement. Health Canada has invited Canadians to read their discussion paper and provide feedback around key considerations and questions for developing a national strategy for high-cost drugs for rare diseases. In its 2020 Fall Economic Statement, the Government of Canada reaffirmed Budget 2019’s commitment to funding $1 billion over two years starting 2022-23 with up to $500 million per year thereafter towards Canada’s rare drug strategy. The consultation closes March 26, 2021.

PDCI strives to support timely transparency around public policy consultations and invites organizations and individuals to share their submissions here so ideas may be shared publicly. Please e-mail Julia Shen, Associate, Policy and Health Economic Research, at Julia.Shen@pdci.ca with a PDF version of your response including consent for PDCI to publish the response on its website.

Thank you to all stakeholders who shared their responses.

Government of Canada ISED Biomanufacturing Consultations – Spring 2021

Innovation, Science and Economic Development Canada (ISED), in partnership with Health Canada, and the Public Health Agency of Canada (PHAC), requested input and feedback from stakeholders to inform its goal of rebuilding a robust domestic biomanufacturing sector, including the expansion of domestic manufacturing capacity and related enhancements to the life sciences ecosystem. The mandate proposed from ISED includes: Ensuring Canada retains and develops its biological intellectual property from research discoveries through commercialization. The consultation closed March 12, 2021.

PDCI strives to support timely transparency around public policy consultations and invites organizations and individuals to share their submissions here so ideas may be shared publicly. Please e-mail Julia Shen, Associate, Policy and Health Economic Research, at Julia.Shen@pdci.ca with a PDF version of your response including consent for PDCI to publish the response on its website.

Thank you to all stakeholders who shared their responses.

PMPRB Amended Final Guidelines Consultations – Winter 2021

On December 29, 2020, the coming into force date for the amended PMPRB regulations and guidelines were further delayed to July 1, 2021. The PMPRB has invited stakeholders to comment on two critical amendments to the regulations with responses due by February 15th. Specifically, the PMPRB proposes to change the definition of Gap medicines and the timeline for compliance with the Maximum List Price (MLP) ceiling for Grandfathered and Gap medicines. PDCI strives to support timely transparency around public policy consultations and invites organizations and individuals to share their submissions here so ideas may be shared publicly.

Please e-mail Jennifer Mathews, Manager Pricing Data, at Jennifer.Mathews@pdci.ca with a PDF version of your response including consent for PDCI to publish the response on its website.

Thank you to all stakeholders who shared their responses.

PMPRB Draft Guidelines Consultations - Summer 2020

UPDATE – August 20, 2020: PMPRB has now published all submissions received as part of its Draft Guidelines Consultation. Submissions can be found on the PMPRB website under the Feedback tab.

In June 2020, PMPRB published new draft Guidelines and launched a public consultation as a next step towards implementing the recently amended Patented Medicines Regulations on January 1, 2021 (recently delayed from July 1, 2021). As part of PDCI’s continuing efforts to support transparency around public policy consultations, PDCI invites organizations and individuals to share their submissions here so ideas may be shared publicly. PDCI has began collecting responses. Please e-mail Kaitlyn Proulx, Managing Director, at Kaitlyn.Proulx@pdci.ca with a PDF version of your response and consent for PDCI to publish.

Thank you to all stakeholders who shared their responses.

PMPRB Draft Guidelines Consultations – Winter 2020

UPDATE – March 19, 2020: PMPRB has now published all submissions received as part of its Draft Guidelines Consultation. Submissions can be found on the PMPRB website under the Submissions tab at the bottom of the page.

On November 21, 2019, the PMPRB published its draft Guidelines and launched a public consultation as a step towards implementing the recently amended Patented Medicines Regulations. Since then, the PMPRB engaged with stakeholders to obtain feedback on its proposed pricing Guidelines. The consultation period closed on February 14, 2020.

As part of PDCI’s continuing efforts to support transparency around public policy consultations, and prior to PMPRB sharing all consultation responses received, PDCI invited organizations to share their submission here so ideas could be shared publicly among stakeholders. Below are stakeholder responses to this consultation which had been voluntarily shared by their authors for posting on this landing page prior to PMPRB publishing the comprehensive set of consultation submissions. PDCI thanks all stakeholders who contributed their submission to PDCI’s sharing page.

Below are stakeholder responses to this consultation which have been voluntarily shared by their authors for posting on this landing page:

Expensive Drugs for Rare Diseases – Provincial Working Group Consultation – Winter 2019

In keeping with our ongoing efforts to support transparency and share input submissions for public policy consultations, PDCI is hosting responses to a recent CADTH survey that was conducted on behalf of the Provincial/Territorial Expensive Drugs for Rare Disease Working Group (EDRD WG). The EDRD WG developed sought public feedback and ideas on its “proposal for a supplemental process for complex/specialized drugs that builds upon the existing national and jurisdictional drug review processes.” (source: EDRD WG Consultation Paper)

Consultations on a Supplemental Process for complex/specialty drugs occurred throughout the fall of 2018. Potential implementation of a revised process for health technology assessment, negotiations and possible mechanisms for reimbursement could be launched by P/Ts as early as Spring 2019, according to their consultation document.

If your organization submitted and retained copies of responses to the recent P/T SurveyMonkey®, you are invited to share the response for public information through our PDCI sharing site. PDCI will add your response here.

Below are stakeholder responses to this survey which have been voluntarily shared by their authors for posting on this landing page.

Please email your submission to drdresponses@pdci.ca if you would like your voice added to this page.

National Pharmacare Consultations – Summer 2018

National Pharmacare Consultations – Summer 2018

Announced in the 2018 federal budget and chaired by former Ontario Health Minister Eric Hoskins, the Advisory Council on the Implementation of National Pharmacare is currently engaging in a national dialogue on how the federal government could implement affordable national pharmacare for Canadians. As part of this dialogue, the Council is seeking written responses to its discussion paper Towards Implementation of National Pharmacare, including questions around who should be covered, what drugs should be covered and who should pay for the coverage. Written consultation comments are due by September 28, 2018.

Input received from this and the Council’s other ongoing consultation activities will inform the Council’s report to the federal ministers of health and finance in Spring 2019.

Below are stakeholder responses to this consultation which have been voluntarily shared by their authors for posting on this landing page. Please email your submission to Kaitlyn.Proulx@pdci.ca if you would like your voice added to this page.

Canada Gazette Part I Consultation Responses – February 2018

Canada Gazette Part I Consultation Responses – February 2018

The process to amend the Patented Medicines Regulations is well underway in Canada. These amendments are anticipated to significantly change the way patented medicine prices are regulated in Canada. As part of the process, Health Canada has held two consultations seeking stakeholder feedback on its proposed amendments.

In December 2017, the Governor-in-Council published Health Canada’s proposed changes to the Patented Medicines Regulations in Canada Gazette Part 1. Stakeholder comments were invited on the Regulatory Impact Analysis Statement (RIAS) and proposed regulatory text, with the consultation period ending February 14, 2018.  Below are stakeholder responses to that consultation which have been voluntarily shared for posting on this landing page.

Please email your submission to Kaitlyn.Proulx@pdci.ca if you would like your voice added to this page.

  • Best Medicines Coalition
    • Alliance for Access to Psychiatric Medications
    • Arthritis Consumer Experts
    • Asthma Canada
    • Better Pharmacare Coalition
    • Brain Tumour Foundation of Canada
    • Canadian Arthritis Patient Alliance
    • Canadian Breast Cancer Network
    • Canadian Council of the Blind
    • Canadian Epilepsy Alliance
    • Canadian Hemophilia Society
    • Canadian PKU & Allied Disorders
    • Canadian Psoriasis Network
    • Canadian Skin Patient Alliance
    • Canadian Society of Intestinal Research
    • Canadian Spondylitis Association
    • Canadian Treatment Action Council
    • Crohn’s and Colitis Canada
    • Foundation Fighting Blindness
    • Gastrointestinal Society
    • Health Coalition of Alberta
    • Kidney Cancer Canada
    • Lymphoma Canada
    • Ovarian Cancer Canada
    • Parkinson Canada
  • Draft prepared and coordinated by Myeloma Canada and Save Your Skin Foundation and endorsed by 28 Patient Organizations:
    • Canadian Arthritis Patient Alliance (CAPA)
    • Canadian Cancer Survivor Network (CCSN)
    • Canadian MPN Network
    • Canadian Obesity Network
    • Canadian Psoriasis Network
    • Canadian Skin Patient Alliance (CSPA)
    • Canadian Spondylitis Association (CSA)
    • Canadian Treatment Action Council (CTAC)
    • Carcinoid-NeuroEndocrine Tumour Society of Canada (CNETS)
    • Cardiac Health Foundation of Canada
    • Centre Associatif Polyvalent d’Aide Hépatite C (CAPAHC)
    • Collective Oncology Network for Exchange, Cancer Care Innovation, Treatment Access and Education (CONECTed)
    • Colorectal Cancer Canada
    • Life-Saving Therapies Network
    • Lung Cancer Canada
    • Lymphoma Canada
    • Melanoma Network of Canada
    • Myeloma Canada
    • Pancreatic Cancer Canada
    • Save Your Skin Foundation (SYSF)
    • Schizophrenia Society of Ontari(SSO)
    • Sickle Cell Awareness Group of Ontari(SCAGO)
    • Team Finn Foundation
    • The Canadian CML Network
    • The Chronic Myelogenous Leukemia (CML) Society of Canada
    • The Lung Association – Ontario

Other Stakeholders that Shared Confidential Comments with Health Canada

  • Servier Canada inc.

Proposed Amendments to The Patented Medicines Regulations – June 2017

Proposed Amendments to The Patented Medicines Regulations Consultation Responses – June 2017

The process to amend the Patented Medicines Regulations is well underway in Canada. These amendments are anticipated to significantly change the way patented medicine prices are regulated in Canada. As part of the process, Health Canada has held two consultations seeking stakeholder feedback on its proposed amendments.

In May 2017, the Federal Minister of Health launched a consultation on proposed amendments to the Patented Medicines Regulations that would have significant effects on how patented drug prices are regulated in Canada. The consultation period closed June 28, 2017. Below are stakeholder responses to that consultation which have been voluntarily shared for posting on this landing page.

  • Draft prepared and coordinated by Myeloma Canada and Save Your Skin Foundation and endorsed by 18 Patient Organizations:

    • Canadian Cancer Survivor Network (CCSN)
    • Canadian Psoriasis Network
    • Canadian Spondylitis Association
    • Carcinoid-NeuroEndocrine Tumor Society (CNETs)
    • Collective Oncology Network for Exchange, Innovation in Cancer Care, Treatment Access and Education (CONECTed)
    • Hep C BC
    • Lifesaving Therapies Network
    • Lung Cancer Canada
    • Lymphoma Canada
    • Melanoma Network of Canada
    • Myeloma Canada
    • Ontario Caregiver Coalition
    • Rethink Breast Cancer
    • Save Your Skin Foundation
    • Schizophrenia Society of Ontario (SSO)
    • Sickle Cell Awareness Group of Ontario (SCAGO)
    • Sickle Cell Disease Association of Canada (SCDAC)
    • The Lung Association Ontario

Please be advised:

  • The views and opinions expressed in the consultation submissions on this page are solely those of the author and DO NOT represent those of PDCI Market Access.
  • This page is intended to be a repository of submissions for the purpose of transparency and information sharing. It is not intended to promote or lobby on behalf of any specific stakeholder, individual, group or interest.
  • PDCI has accepted no funds whatsoever to support this initiative.
  • PDCI is welcoming submissions from ALL individuals, stakeholders, groups, etc. who made submissions as part of these public consultations, however this repository is not comprehensive. PDCI makes efforts to reach all stakeholder communities who may have submitted to make them aware of this repository and to provide information on how to be included, if desired. PDCI will continue to post new submissions as they are received.
  • PDCI is unable to verify the identity of stakeholders who made submissions, nor the content of those submissions. In hosting this website, PDCI therefore assumes that those who have provided PDCI their submissions for inclusion in this repository have done so in good faith and have provided PDCI with the submission identical to that which they provided to Health Canada for purposes of the consultation.
  • To the best of PDCI’s knowledge, all submissions have been prepared independently and/or authors of submissions have appropriately disclosed any conflicts of interest within their submissions.
  • PDCI cannot be held responsible for the content of any submissions including but not limited to any inaccurate information.