Final Record of Decisions - June 22 2017, Meeting with Canadian Generic Pharmaceutical Association (CGPA)

Health Canada - Health Products and Food Branch (HPFB)
Bilateral Meeting Program

1600 Scott Street, Holland Cross, Tower B, 5th Floor, Boardroom 2048, Ottawa, Ontario

June 22, 2017
(1:00 p.m. to 3:45 p.m.)

CGPA Participants

  • Len Arsenault, Sandoz (Co-Chair)
  • Duane Terrill, Apotex
  • Sandra D'Agostino-Ferlisi, Apotex
  • Ana Bascom, Fresenius-Kabi
  • Sudheer Paladugu, Marcan
  • Joanne Manley, Mylan
  • Kent Major, Pharmascience
  • Sonia Gallo, Sandoz Canada
  • Mathi Mathivanan, Teva
  • Alpa Jani, Teva
  • Anne Wilkie, CGPA

Health Canada Participants

  • Kelly Robinson, Bureau of Metabolism, Oncology and Reproductive Sciences, Therapeutic Products Directorate (TPD), Co-Chair
  • Marilena Bassi, Bureau of Policy, Science and International Programs, TPD
  • Kristen Beausoleil, Office of Legislative and Regulatory Modernization (OLRM), Policy, Planning and International Affairs Directorate (PPIAD)
  • Marc Berthiaume, Marketed Health Products Directorate
  • Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
  • Michèle Chadwick, Biologics and Genetic Therapies Directorate
  • Gary Condran, Bureau of Pharmaceutical Sciences (BPS), TPD
  • Émile Geoffroy, Regulatory Project Management Division (RPMD), TPD
  • Heather Gilmer, Natural and Non-prescription Health Products Directorate (NNHPD)
  • Debra Haltrecht, OLRM, PPIAD
  • Celia Lourenco, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD
  • Kelly McClellan, Director General's Office (DGO), TPD
  • Jeanne Siegert, OPPRS, TPD
  • Craig Simon, BPS, TPD
  • Donna Watt, OPPRS, TPD
  • Veronica Yip, BGIVD, TPD

Observers

  • Heather Cherry, RPMD, TPD
  • Amanda Jackson, BGIVD, TPD
  • Ted Kim, RPMD, TPD
  • Aisha Rahmaan, BGIVD, TPD

1. Welcome and introductions

Kelly Robinson, Director, Bureau of Metabolism, Oncology and Reproductive Sciences, Therapeutic Products Directorate (TPD), welcomed everyone to the meeting.  There have been a number of organizational changes within TPD:  Marion Law, former Director General, has left for a two year assignment at the World Health Organization; Dr. John Patrick Stewart will take on the role of Director General on July 17, 2017; Bruce Randall has rejoined TPD as Director of the Bureau of Pharmaceutical Sciences; and Kathy Soltys is the Director of the new Bureau of Medical Sciences.  Kendal Weber is A/Associate Deputy Minister of the Health Products and Food Branch.  Tina Green has moved to the Regulatory Operations and Regions Branch (RORB) as A/Assistant Deputy Minister, and Étienne Ouimette has left RORB to become the new A/Director General of the Resource Management and Operations Directorate in the Health Products and Food Branch.

Len Arsenault, CGPA Co-chair, indicated that these bilateral meetings are a good opportunity to exchange information.  He also noted that CGPA appreciated having the meeting that was held that morning with the Bureau of Pharmaceutical Sciences, TPD.

2. Review of agenda

There were no changes to the agenda.

3. Approval of meeting notes / action items of the November 24, 2016 meeting

The Record of Decisions from the November 24, 2016 meeting was approved.

Action Item 4 from the previous minutes:  Impact of Plain Language Labelling (PLL) - Len Arsenault, CGPA, to provide Veronica Yip, Bureau of Gastroenterology, Infection and Viral Diseases, TPD with the expiry date information provided by the hospital group.  Update:  Len Arsenault has indicated that there have been confidentiality issues related to sharing the expiry date information and will follow up.

All other action items were completed.

4. Improving access and use of necessary therapeutic products

Michèle Chadwick, Biologics and Genetic Therapies Directorate, provided an overview of the work underway on the regulatory review of drugs and devices initiative where the goal is to improve access to necessary therapeutic products that meet a health care system need.  This initiative is a clear government priority as part of the commitment to work with provinces and territories in the development of a new Health Accord that was outlined in the Health Minister's Mandate Letter.

Specifically, there is a focus on key priority areas where change would yield the biggest results. One of those areas is improved access to necessary prescription medications.  Budget 2017 also earmarked support for this initiative.

Key areas of focus for the Health Products and Food Branch include:

  • Health care system collaboration and international engagement;
  • Timely and appropriate access to therapeutic products;
  • Real-world evidence throughout the product lifecycle; and
  • Modernized cost recovery and business systems.

Projects under each of these areas of focus include:

Health care system collaboration and international engagement

  • Aligning regulatory and health technology assessments
  • Providing early advice by Health Canada and health technology assessors
  • Enhanced use of foreign reviews to encourage submission filing for products that would not otherwise be available for sale in Canada
  • Sharing workload with international regulatory counterparts with regulatory colleagues

Timely access to therapeutic products

  • Expanding priority review pathways for drugs that meet health care system needs
  • Enhancing reviews of generic drugs, medical devices and biosimilars
  • Improving reviews of digital health technologies
  • Modernization of the Special Access Programme (SAP)

Enhanced use of real-world evidence

  • Using more real-world safety and effectiveness data for drugs and devices across a product's life cycle

Modern and flexible operations

  • A robust and agile cost recovery regime
  • Modernized business systems-a common submission intake system
  • Sharing of data that is not considered confidential business information

Health Canada is interested in receiving feedback from CGPA regarding all of these projects.  CGPA indicated that these would be good topics for future bilateral meetings.

5. Policies and guidance update

CGPA requested an update on TPD policy and regulatory initiatives and their potential impact on the generics industry.

a) Identical Medicinal Ingredient (IMI) Policy

This item was covered in the Bureau of Pharmaceutical Sciences (BPS), TPD/CGPA meeting held earlier in the day.  Craig Simon, Associate Director, BPS, TPD provided highlights of the discussion.  TPD is taking the lead on policy development aimed at revising the current identical medicinal ingredient policy and regulatory requirements, in consultation with other areas of the Health Products and Food Branch.  A Notice of Intent (NOI) will be published in summer 2017 and will serve as a consultation document.   Stakeholders will have until October 13, 2017 to provide comments to inform future policy and regulatory work.  Health Canada encouraged CGPA to provide input into this document.   The path forward will depend on the analysis of the comments received.

b)  Importation of products for urgent health needs

Marilena Bassi, Director, Bureau of Policy, Science and International Programs, TPD and Debra Haltrecht, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate addressed this item.  Health Canada will publish a regulatory package in Canada Gazette, Part II, amending the Food and Drug Regulations to allow the importation of drugs not approved in Canada.  These drugs will be used for urgent public health need, like the current opioid crisis in Canada, for example.

In Canada, there are mechanisms that allow access of unapproved drugs for sale, such as the Special Access Programme (SAP) or through filing a Clinical Trial Application, however these methods are for an individual basis and were never intended for a population health treatment context. The amendment to the Food and Drugs Regulations will allow drugs that are currently approved in the United States, European Union, or Switzerland but not Canada, to be accessed by physicians for immediate use.

Health Canada has been made aware of certain drugs the Provinces and Territories wish to be included on this list. Health Canada is in the process of publishing a list that will include details about the drugs that will be made available for import, post amendment.
Update: the List of Drugs for an Urgent Health Need.

Similar to the drugs approved in Canada, Health Canada will be able to recall drugs or take other necessary actions should there be any safety concerns, and will maintain oversight of controlled drugs imported through this pathway to help prevent their diversion to illicit uses.

A Guidance Document in the form of "Questions and Answers: Access to Drugs in Exceptional Circumstances" is being developed to accompany the proposed regulations. 
Update:  The Guidance Document has been posted on the Health Canada.

c)  Opioids, stickers, labelling, RMPs, etc.

Marilena Bassi, Director, Bureau of Policy, Science and International Programs, TPD, Marc Berthiaume, Director, Marketed Pharmaceutical and Medical Devices Bureau, Marketed Health Products Directorate and Kristen Beausoleil, Office of Legislative and Regulatory Modernization addressed this item.  The Health Products and Food Branch is undertaking a number of activities as part of the Federal Action on Opioids.  These activities include but are not limited to:  developing a regulatory proposal that would better inform Canadians about opioid risks by requiring a warning sticker and patient information handout to be provided with prescription opioids at time of sale; reducing easy access to unnecessary opioids by requiring mandatory risk management plans for all opioids and considering further modifications to the labelling of approved opioids (including contraindications).  Scientific Advisory Panels were held in November 2016 and March 2017 to advise on these activities.  A Guidance Document will be posted in June 2017.

6. Deloitte report follow up

CGPA had requested TPD feedback on the "Deloitte Report" entitled "Ensuring a Consistent Supply of Safe, Effective and High Quality Generic Medicines for Canadians" published by Deloitte in October 2016.  At the Bureau of Pharmaceutical Sciences, TPD/CGPA meeting held earlier in the day, TPD provided responses to specific headings from the report.  Craig Simon, Associate Director, Bureau of Pharmaceutical Sciences (BPS), TPD and Kelly McClellan, Senior Advisor, Director General's Office, TPD provided highlights of the discussion.  In March 2017, TPD published the notice "Tablet Scoring of Subsequent-entry Pharmaceutical Products" that sets out the criteria that the BPS will use to consider allowing score line configurations in subsequent entry pharmaceuticals that differ from the reference product.  For non-Canadian Reference Products, a revised version of the policy will soon be published.  TPD will be seeking input with respect to desired changes or further expansion of scope.

7. Modernizing the regulation of self-care products in Canada

Heather Gilmer, Bureau of Consumer Health Product Modernization, Natural and Non-prescription Health Products Directorate, presented this item.  Health Canada is looking to modernize its approach to regulating self-care products.  These products are available for purchase without a prescription and include cosmetics, natural health products and non-prescription drugs.  A modernized approach is being proposed that would make it easier for Canadians to make informed choices about the right products for them.

Health Canada is proposing that:

  • self-care products would be regulated according to risk to consumers;
  • self-care products making similar claims would require similar evidence; and
  • the Department would have appropriate powers to address safety concerns and non-compliance.

To ensure that the proposed approach is informed by a broad range of perspectives, Health Canada has been consulting extensively.   Informed by the feedback received through the consultation that was held in fall 2016, Health Canada has refined elements of the proposal.   Health Canada has been undertaking a series of in-person and online consultation sessions in various cities across Canada throughout spring-summer 2017 to seek feedback on the refined proposal.

Stay tuned to the self-care website for updates as they become available.

8. TPD review performance

Jeanne Siegert, Office of Planning, Performance and Review Services, TPD thanked CGPA members for providing data for the pipeline template and provided an update on TPD Review Performance.  Detailed performance data will no longer be formally provided at the bilateral meetings.  Quarterly reports are available on request.
Action:  Jeanne Siegert, Office of Planning, Performance and Review Services, TPD to provide CGPA with the next quarterly report when it becomes available.
Update:  Action completed June 26, 2017.

9. Plain language labelling (PLL):  implementation and review challenges

Celia Lourenco, Director, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD and Veronica Yip, Manager, Labelling Division, BGIVD, TPD addressed this item.  As part of TPD's ongoing efforts to establish consistency in review approach and decisions related to PLL, a new TPD Labelling Division was created in August 2016.  The new Labelling Division was created to ensure consistency among labelling reviewers in implementing the new PLL requirements and recommendations, and encourage sharing of best practices within the pre-market area in TPD, as well as with other HPFB directorates responsible for implementing PLL for prescription drugs (and soon to include non-prescription drugs).  Tools (e.g., check lists) have been developed for the labelling reviewers, and the Division meets frequently for reviewers to stay apprised of the review decisions that are being applied per the PLL initiative and foster consistency.

During review, labelling reviewers work collaboratively with sponsors on a case-by-case basis to find a solution that best addresses the labelling challenges applicable for that given drug product.  Sponsors are presented with various options to consider when revising their bilingual labels to ensure that the labels are legible, readable, and balance how all the regulatory information and key elements/designs recommended by the Good Label and Packages Practices Guide are applied.  TPD is willing to be flexible in order to find labelling solutions.

For any questions related to Plain Language Labelling, please contact Veronica Yip (Veronica.Yip@canada.ca) of the Bureau of Gastroenterology, Infection and Viral Diseases, TPD.

10. Common Product Monograph

The discussion of a common product monograph was initiated at the November 24, 2016 bilateral meeting.  CGPA indicated that it is very interested in exploring the idea further.  The association noted that there has been no further process with its discussions with Innovative Medicines Canada on the topic.  CGPA added that the Canadian Pharmacists Association (CPhA) is interested in being involved.

Craig Simon, Associate Director, Bureau of Pharmaceutical Sciences, TPD and Veronica Yip, Bureau of Gastroenterology, Infection and Viral Diseases, TPD addressed this item.  TPD suggested that CGPA contact Vikesh Srivastava (vikesh.srivastava@canada.ca) of the Resource Management and Operations Directorate as his area is involved in a number of projects.

A discussion followed about Product Monographs having product-specific attributes.  CGPA noted that a consensus approach is not going to be readily achievable.  Health Canada indicated that it is an opportunity for CGPA to think about how that might be presented.

11. International regulatory collaboration & convergence

Celia Lourenco, Director, Bureau of Gastroenterology, Infection and Viral Diseases, TPD and Gary Condran, Senior Scientific Advisor, Bureau of Pharmaceutical Sciences, TPD provided a presentation on this item.  Updates were provided from the recent International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and International Generic Drug Regulators Programme (IGDRP) meeting that was held in May (in Montreal) and in June (in Ottawa) respectively.  Considerations of future directions in the areas of international regulatory cooperation and convergence we also discussed.

Celia Lourenco provided general comments on the Department's Return on Investment (ROI) analysis of participation in international activities and specifically ICH.  The complete report will be presented at the fall DIA Canada meeting.
Action:  Celia Lourenco, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD) to circulate an additional presentation deck after the meeting.
Update:  Action completed June 26, 2017.

12. Roundtable

There were no roundtable items.

13. Closing remarks and adjournment

Kelly Robinson and Len Arsenault thanked everyone for participating in the meeting.   Kelly Robinson indicated that it is very interesting to hear CGPA's perspective on the topics.

Meeting adjourned at 3:45 p.m.

14. Next meeting - November 30, 2017

Original signed by:

Celia Lourenco
Interim Executive Director
Therapeutic Products Directorate

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