Final Record of Decisions - October 5, 2017, Meeting with Innovative Medicines Canada (IMC)
Health Canada - Health Products and Food Branch (HPFB)
Bilateral Meeting Program
1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario
October 5, 2017
(1:00 p.m. to 3:40 p.m.)
- Ed Dybka, AstraZeneca Canada Inc.
- Keith McIntosh, Innovative Medicines Canada
- Samar Darwish, Boehringer Ingelheim (Canada) Ltd.
- Neerja Goyal, GlaxoSmithKline Inc.
- Loretta Del Bosco, AbbVie Corporation
- Rocelyn Del Carmen, AstraZeneca Canada Inc.
- Sandra Usik, Eli Lilly Canada Inc.
- Catherine Lau, Janssen Inc.
- Laura King, Novartis Pharmaceuticals Canada Inc.
- Lorella Garofalo, Pfizer Canada Inc.
- Martin Cloutier, Bristol-Myers Squibb Canada
- Dounia Maizi, Servier Canada Inc.
Health Canada Participants
- Celia Lourenco, Therapeutic Products Directorate (TPD), Co-Chair
- Denis Arsenault, Controlled Substances Directorate (CSD), Healthy Enviroments and Consumer Safety Branch (HECSB)
- Marilena Bassi, Bureau of Policy, Science and International Programs (BPSIP), TPD
- Kristen Beausoleil, Office of Legislative and Regulatory Modernization (OLRM), Policy, Planning and International Affairs Directorate (PPIAD)
- Jason Berg, Marketed Health Products Directorate (MHPD)
- Léo Bouthillier, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), TPD
- Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
- Michèle Chadwick, Biologics and Genetic Therapies Directorate (BGTD)
- Mandy Collier, OPPRS, TPD
- Gary Condran, Bureau of Pharmaceutical Sciences (BPS), TPD
- Émile Geoffroy, OPPRS, TPD
- Debra Haltrecht, OLRM, PPIAD
- Abdullah Hassen, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD
- Tanja Kalajdzic, MHPD
- Trish Larwill, Resource Management and Operations Directorate (RMOD)
- Michelle Remillard, BGTD
- Kelly Robinson, Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS), TPD
- Jeanne Siegert, OPPRS, TPD
- Donna Watt, OPPRS, TPD
- Barbara Wong, CSD, HECSB
1. Welcome and opening remarks
Celia Lourenco, Interim Senior Executive Director of the Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB) welcomed everyone to the meeting and indicated that Health Canada values these meetings. For organizational changes within TPD, Marion Law has left for a two year assignment at the World Health Organization; Dr. John Patrick Stewart is now Director General; Léo Bouthillier is Director of the Bureau of Cardiology, Allergy and Neurological Sciences (BCANS); and Mandy Collier is Director of the Office of Planning, Performance and Review Services (OPPRS). Kendal Weber is the new A/Associate Assistant Deputy Minister of the Health Products and Food Branch.
The mandate letter of the new Minister of Health, The Honourable Ginette Petitpas Taylor, is posted on the Prime Minister of Canada website. Themes of the letter include transparency and improving access to necessary prescription medications.
Ed Dybka, IMC Co-chair, emphasized the importance of these bilateral meetings as they set the stage for broader engagements.
2. Review of the agenda
There were no changes to the agenda.
3. Approval of meeting notes of April 4, 2017 / previous action items
The Record of Decisions from the previous bilateral meeting on April 4, 2017 was approved. There were no action items in the previous minutes.
4. Regulatory affairs committee’s strategies and progress update
Keith McIntosh and Neerja Goyal, IMC, presented an update on the progress of phase 3 and next steps of the “Time to Notice of Compliance (NOC)” study that was undertaken by the Association. TPD noted that it would be helpful to look at medians or quintiles when examining review length.
Action: Loretta del Bosco indicated that IMC would work with TPD to set a date and an agenda for a workshop.
5. Regulatory Review of Drugs and Devices (R2D2)
Michèle Chadwick, Lead, Regulatory Review of Drugs and Devices Initiative, Biologics and Genetic Therapies Directorate provided an R2D2 update, including the status of project plans and consultation plans. TPD is interested in consulting IMC on the definition of healthcare system need.
An operational working group has been formed between the Health Products and Food Branch and the Canadian Agency for Drugs and Technologies in Health (CADTH) to better align Health Canada’s reviews with CADTH’s HTA assessments. CADTH relies heavily on contractors to do reviews and would benefit from access to early pipeline data. TPD indicated that it would be seeking IMC input on the idea of sharing pipeline information with CADTH.
IMC indicated that clinical data often comes before economic data. Health Canada noted that this parallel review pathway would be optional and that the company would need to be on board and in agreement. IMC was pleased to hear that alignment is related to timing only and that each review/mandate would be kept separate.
IMC indicated that industry has already worked with CADTH which has a fee based service. The Institut national d’excellence en santé et en services sociaux (INESSS) has a different framework than CADTH. IMC noted that there is a need to determine whose service it is and where the fees are so that fees are not paid more than once.
Health Canada indicated that foreign reviews are currently being used as a supplement and that it is developing a Guidance Document for systematic use of foreign reviews. Although it also captures the foreign review as supplemental data and partial use of a foreign review, focus will be on high use products that are currently being accessed through the Special Access Programme (SAP) that don’t usually come to Canada. It is anticipated that a Notice of Intent will be posted on the Health Canada Website in January 2018. Health Canada would appreciate IMC’s comments on the use of foreign reviews. IMC expressed concern that if fees increase significantly under cost recovery that products will come in under SAP and will not be brought into Canada.
In order to reduce review time, Health Canada is working on sharing reviews with Australia. Health Canada will be starting a pilot with Australia for a joint review for a new chemical entity but is having challenges in identifying a candidate. Health Canada asked IMC members if they were aware of a suitable product for this pilot that they would like to submit to Australia and Canada at the same time. The product would need Canadian and Australian labelling. Loretta del Bosco, IMC, indicated that the company she represents may be interested in this pilot.
Michèle Chadwick mentioned that Health Canada is trying to define healthcare system need and is interested in receiving feedback from IMC. If IMC has any input on the concept of healthcare system need, contact Michèle Chadwick in this regard.
Marilena Bassi, Director, Bureau of Policy, Science and International Programs, TPD, provided a presentation on renewing the Special Access Programme (SAP) in order to adapt it to meet the needs of patients. TPD is interested in receiving input from IMC on why drugs are still on SAP and how they can be moved into market authorization. TPD would also like to have a discussion with IMC on topics such as products that have just completed a Phase I clinical trial and what can be done for terminally ill patients.
TPD will be consulting with stakeholders about various topics related to this SAP project. A consultation plan is being developed for block release regulations, which enable the stockpiling of drugs for emergency purposes. TPD also noted that there will be an opportunity to consult in the near future on compassionate release, common submission intake and the public release of clinical information.
IMC indicated that it appreciates being a part of consultations with other stakeholders but due to confidentiality, also appreciates industry-only consultations.
6. Notices, Guidances, and Policies update
Marilena Bassi, Director Bureau of Policy, Science and International Programs, TPD, provided an outline of a number of guidance documents, notices and policies that are in development or being updated in 2017-18. IMC indicated that it would be requesting a face-to-face meeting on the Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products that was posted on July 27, 2017. TPD indicated that it would welcome a meeting.
TPD noted that a final version of the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) is expected in the near future.
IMC mentioned that it would prefer a 90-day review period for the Revised guidance document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Guidance.
Action: Marilena Bassi, TPD, indicated that she would inform the Office of Submission and Intellectual Properties, TPD, that IMC would prefer a 90-day review period for the Guidance Document.
Update: Action completed.
7. Cost recovery
As a follow-up to the first Cost Recovery consultation with stakeholders held July 26, 2017, Innovative Medicines Canada requested an update on the status of the Cost Recovery initiative with special emphasis on future stakeholder consultations and implementation date. Trish Larwill, Senior Policy Advisor, Strategic Initiatives, Resource Management and Operations Directorate (RMOD) addressed this item. RMOD indicated that the main objective of the Cost Recovery Information Session of July 26, 2017 was to provide stakeholders with a preview of the details of the draft Fee Proposal (consultation document). The Fee Proposal is expected to be published shortly on the Health Canada website, with a consultation window of 75 days.
Loretta del Bosco, IMC, requested information as to whether the costing information behind the fee proposal would be available. RMOD indicated that the proposal focuses on what the revised fees will be. RMOD added that the consultation window is 75 days so that implementation can begin in early 2019. Fees are being increased as they have not changed in six years. In regard to timelines, a number of considerations will come into play. Health Canada is interested in having an agile system that will evolve in a more timely manner and has committed to consulting before fees are adjusted.
Ed Dybka highlighted that while the association is not opposed to a change in fee structure, Health Canada should take into account all of the other changes in the Industry’s environment that layer on additional barriers and costs onto industry. The association added that cost recovery and the additional burdens may challenge the economic viability of products and this may result in less products being brought to Canada.
8. Regulations amending the Food and Drug Regulations and Guidance Documents
IMC indicated that it appreciated the opportunity to provide comments to Health Canada on the Draft Regulations and Guidance documents related to the Protecting Canadians from Unsafe Drugs Act. IMC noted that the key challenge identified by members is the short 48 hour turnaround for notifications of safety events. The association highlighted that it is a challenge for a Canadian affiliate to become aware of information that might happen in another affiliate and turn that around in 48 hours.
Debra Haltrecht, Manager, Policy Development, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate (PPIAD) addressed this item. Health Canada is in the process of analyzing all of the comments received on the proposal. It is anticipated that the proposal will go to Canada Gazette, Part I in spring 2018. Health Canada is interested in hearing more from IMC on the limitation of 48 hours vs 72 hours. 48 hours is only if there is a risk in order to take action as soon as possible. IMC members indicated that even 72 hours is a challenge as it may take months to analyze the root cause. IMC requested that Health Canada consider making it a graduated request where some information would be provided immediately and additional information would be provided within five days. IMC requested that Health Canada take into account that IMC members have global colleagues. Member companies have Canadian content but they are really global and timing is critical. IMC indicated that in other parts of the world, the turnaround for notifications of safety events is approximately 72 hours.
IMC noted that the proposal seems to expect that the Canadian company is receiving information directly from a foreign manufacturer. The reality is that the global operation is providing the information. IMC offered to do more analysis, if necessary, to allow more flexibility in certain situations. The association noted that for global, standardization is the key and that regulators should align as much as possible.
Action: Keith McIntosh, IMC, to provide to Debra Haltrecht, Policy, Planning and International Affairs Directorate (PPIAD), examples of information that would be more problematic than others in regard to the turnaround for notifications of safety events.
Update: Action completed. In the interim PPIAD has determined that there is sufficient rationale for modifying the timelines from the proposed 48 hours to the requested 72 hours.
9. Opioid action plan - Health Products and Food Branch activities update
Léo Bouthillier, Interim Director of the Bureau of Cardiology, Allergy and Neurological Sciences, TPD and Tanja Kaladzic, A/Manager, Post Market Surveillance of Prescription Opioids, Marketed Health Products Directorate presented an update on the activities that the Health Product and Food Branch are undertaking as part of the Federal Action on Opioids. These activities include but are not limited to:
- better informing Canadians about opioid risks by requiring a mandatory warning sticker be applied on containers and an information handout be provided to patients, for all dispensed (prescription) opioids
- reducing easy access to unnecessary opioids by further updating information in Product Monographs (such as contraindications/warning and precautions) for approved opioids, and requiring mandatory risk management plans for all opioids
Health Canada indicated that it has received the comments that IMC provided during the consultation period and is currently analyzing all comments. Publication in Canada Gazette, Part II is expected in June 2018. IMC indicated that Health Canada may not receive the anticipated outcome on a marginalized population. The association noted that Health Canada approaches the innovator first but that generics represent 95% of the market.
10. Public consultation on potential changes to non-prescription availability of low-dose codeine products
Denis Arsenault, Manager, Policy Development, Controlled Substances Directorate (CSD), Healthy Environments and Consumer Safety Branch (HECSB) presented this item. Problematic use of non-prescription codeine products has been a concern for many years in Canada. Manitoba introduced changes that resulted in stricter controls in early 2016, but low-dose codeine products (also known as exempted codeine products) are still available without a prescription in most of Canada. Health Canada is considering regulatory changes that will require all codeine-containing medications to be sold by prescription only. A public consultation is underway, ending on November 8, 2017. Feedback from this process will allow Health Canada to more fully understand potential impacts on stakeholders and help determine whether and/or how to move ahead with this potential change.
A consultation Notice to Interested Parties was published in Canada Gazette, Part I on September 9, 2017. So far, over 100 submissions have been received. Health Canada encouraged any of IMC’s members who may be affected to submit comments for the proposal.
11. New prescription status for hydroquinone-containing products at concentrations greater than 2% for topical use
Abdullah Hassen, Manager, Bureau of Gastroenterology, Infection and Viral Diseases, TPD presented this item. Health Canada has posted a Notice of Intent to Amend and an Information Update on Health Canada’s website on August 29, 2017 confirming to trade and patient and professional associations its intent to exclude hydroquinone from the Natural Health Products Regulations at concentrations greater than 2 % in products for topical use on the skin, once added to the Prescription Drug List. This revision will come into effect 12 months from the date of this Notice, in August 2018. A one-year transition period has been granted to existing products on the Canadian market to allow market access to products for healthcare professionals and patients while the regulatory status of these products is changed. Health Canada intends to regulate these products under Division 1 of the Food and Drug Regulations.
12. TPD performance
Jeanne Siegert, Manager, Planning and Reporting Unit, Office of Planning, Performance and Review Services (OPPRS), TPD provided a presentation on updated performance metrics for TPD including a performance summary for User Fee Average Days for fiscal year 2017-18 (to August 31, 2017), TPD on-time performance, received vs forecasted submissions, performance details and a pipeline data summary.
IMC indicated that in terms of the drop in IMC member pipeline participation, some of the companies who are members of the association have merged, so this may account for some of the perception that participation has decreased. IMC also requested that it would be helpful, when presenting data for decisions made on time, to put it side by side with last fiscal year. This would make it easier to identify any trends.
13. Round table
Mandy Collier, Director, Office of Planning, Performance and Review Services, TPD, updated that a consultation on pre-market transparency has been posted on the Health Canada website. IMC has been invited to participate in a teleconference on the topic on October 16, 2017.
Action: IMC requested Word and PDF versions of the online pre-market transparency consultation questions.
Update: Completed. The requested information was sent to IMC on October 11, 2017.
b) Pre-submission meeting process improvement
Mandy Collier, Director, Office of Planning, Performance and Review Services, TPD, thanked IMC for including its question on pre-submission meetings within their member survey. Health Canada is seeking to further engage stakeholders in Fall 2017 regarding their experiences and needs for pre-submission meetings in order to inform the development of a comprehensive framework. IMC indicated that it would provide consolidated data for Health Canada’s survey. A pre-submission framework is to be developed and a pilot is planned for Spring 2018. The changes will depend on feedback received during the consultation. Health Canada is interested in finding out if industry feels that its needs are being met. TPD plans to standardize the pre-submission meetings.
c) Organizational Review of the Evaluation of Human Therapeutic Products (OREHTP) Project in the Biologics and Genetic Therapies Directorate
IMC indicated that positive feedback has been received from IMC members in regard to the OREHTP Project led by the Biologics and Genetic Therapies Directorate.
14. Closing remarks and adjournment
Celia Lourenco and Ed Dybka, Co-chairs, thanked everyone for the productive meeting. TPD indicated that it is looking forward to the workshop and to receiving IMC input for the consultations.
The meeting was adjourned at 3:40 PM.
15. Next Meeting
The next bilateral meeting is expected to be held in Spring 2018.
Original signed by:
Interim Senior Executive Director
Therapeutic Products Directorate
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