Consultation Summary: Health Products Stakeholder Engagement Session June 27, 2018

Theme and Objectives

On June 27, 2018, Health Canada's Health Products and Food Branch (HPFB) welcomed health product stakeholders to an annual stakeholder engagement session. The objective of the annual event is to provide stakeholders with the opportunity to provide input on current priorities and initiatives. Approximately 100 stakeholders attended the event in person, including industry representatives, academics, patient and consumer groups, health practitioners, non-governmental organizations and other government partners. The session was also webcast to approximately 150 people online.

The title of this year's event was "Regulation and Health Innovation". Throughout the day, participants discussed ways in which the current domestic and international approach to regulating health products could evolve to better support innovation. They also shared their views on how to best regulate health products of the future, particularly around increasingly personalized and innovative products, including, for example, advanced cellular therapies or applications of artificial intelligence.

The event was also an opportunity to engage participants on the Government of Canada's recently announced regulatory reform agenda. This review of existing regulations presents Health Canada with an opportunity to further modernize our regulatory system, particularly in the area of new or disruptive health technologies such as 3D printing. Our overall vision is to enhance our regulatory frameworks so that they are more agile, transparent and responsive to the needs of the Canadian health care system.

Opening Remarks

Pierre Sabourin, the Assistant Deputy Minister of HPFB, opened the session by emphasizing the need for collaboration in the design of flexible, efficient, and adaptable regulatory processes that accommodate innovation. He outlined three areas of focus for the coming year: adaptable and agile product approval processes, prioritizing important and emerging health needs to guide future investments based on their impact on Canadians, and better incorporating patient voices into our regulatory work.

Mr. Sabourin also highlighted key accomplishments from the past year and encouraged participants to read HPFB's 2017 Drug and Medical Devices Highlights Report, which provides a detailed overview of the drugs and medical devices Health Canada approved in 2017.

Keynote Address

As one of the Department's key international partners, Health Canada was very pleased to welcome Mr. Guido Rasi, Executive Director of the European Medicines Agency (EMA), to deliver the keynote address. In his remarks, titled "Regulating Innovation from an International Perspective", Mr. Rasi outlined the EMA's vision with respect to advanced technology and underscored the longstanding partnership between Canada and the European Union.

Some of the key themes from Mr. Rasi's remarks included:

Innovation in an increasingly complex health product system

• Research and technological innovation is advancing at an exponential pace and rapidly integrating with other technologies and systems. These new developments require regulators to consider how their systems allow for rapid adoption of promising treatments and products.
• Regulators play a unique role in enabling technologies by fostering a health ecosystem that accommodates innovation. This means having flexible processes, flexible use of expertise, and competencies and skills that are always up to date.

The European Medicines Agency's model to support innovation

• The EMA's plan includes four components that follow a lifecycle approach to support the introduction of innovative health technologies:
  • Employing a constant cycle of horizon scanning, triaging signals, identifying gaps, and estimating impact of incoming signals;
  • Integrating stakeholder input to develop evidence generation plans that clearly outline all the evidence required as part of a product's lifecycle;
  • Ensuring that proper infrastructure is in place to collect post-licensing pharmacovigilance data through new and evolving mediums (apps, patient registries); and
  • Using evidence following market authorization for ongoing regulatory decision making.
• Stakeholder collaboration is at the core of the EMA's regulatory model, and includes diverse actors that interact with the entire product life cycle, from investors, right through to patients.
• The EMA, through the International Coalition of Medicines Regulatory Agencies (ICMRA) works internationally to engage partner regulators on addressing new trends, discuss best practices in horizon scanning, and find new, practical approaches to licensing.

Mr. Rasi concluded by explaining that the future role of regulators lies in enabling scientific and technological advances to serve health care needs. Going forward, regulators will need to take an active role to foster patient-centered health care, while continuing to safeguard health.

Associate Deputy Minister Remarks

Mr. Rasi was followed by Christine Donoghue, the Associate Deputy Minister of Health Canada, who discussed the implications of globalization and rapid innovation for Health Canada's regulatory work. Ms. Donoghue highlighted the federal government's multifaceted approach to fostering health innovation in Canada. She also identified some of the recent investments the government has made to support health innovation including: $4 billion for research funding, $53 million over five years for the Canadian Institute for Health Information, $51 million over three years to the Canadian Foundation for Healthcare Improvement, and the creation of the Canada Research Coordinating Committee. She highlighted Health Canada's commitment to a more efficient and flexible regulatory regime to advance the quality and pace of reviews without compromising the safety of Canadians.

Panel Discussion: The Evolving Role of the Regulator

Cathy Parker, Director General of the Biologics and Genetic Therapies Directorate of Health Canada, moderated a panel discussion on the evolving role of the regulator.

Three panelists provided different perspectives on the topic:

• Guido Rasi, Executive Director, European Medicines Agency
• Catherine Beaudry, Professor and Canada Research Chair, École Polytechnique de Montréal
• Anne Snowdon, Academic Chair, World Health Innovation Network

The panelists shared their thoughts on how regulators can best anticipate and help address future health needs, and then responded to questions posed by the moderator and the audience. Some of the key themes from the discussion included:

Anticipating and adapting to change

• Putting in place a system of scanning and early detection will help regulators anticipate and prepare for scientific and technological advances that may affect their regulatory environment. For example, the EMA has built a network of academic experts that allow them to better understand local contexts through regular dialogue.
• Using a modular governance system, regulators can employ a matrix approach to their approval process to benefit from a higher level of flexibility when making decisions. At the EMA, having separate approval streams for regulatory compliance and scientific evidence provides added flexibility when addressing incoming pressures.
• Adopting innovative collaboration models to bring together a variety of stakeholders (i.e. regulator, industry, patients, academia) can assist regulators in developing agile frameworks that facilitate getting potentially beneficial innovations to practitioners and patients.
• When engaging stakeholders and partners, the value proposition for each stakeholder group needs to be considered. If value is not being achieved for all, then innovation will not be scaled to the system-level and adopted.

Opportunities for collaboration at the intersection of innovation, commercialization and government regulation

• Canada's share of world research in the health sector in ranked high, yet there is a large gap between our academic expertise and our industrial research and development, particularly in the pharmaceutical environment.
• To remain competitive in enabling advanced technologies, consideration should be given to investing and building on Canada's strengths (i.e. regenerative medicine, bioinformatics) before expanding to newer developments.
• Collaboration is critical to developing a more agile framework which could be used to bring technology to the domestic market.

Prioritizing patient safety and experience

• When innovative products enter the health care system, it is important to devote attention to measuring the use, impact, and benefit of these products for patients in consultation with a multidisciplinary set of stakeholders.
• The health care system would benefit from additional support in understanding the utility of treatments from both the patient and clinician perspective. Rather than focusing solely on transformative technology, an emphasis should be placed on tracking outcomes at a patient level to understand how treatments are working.
• Real world evidence has great potential to help transform decision making across the health context and achieve value for patients. It is critical to invest in information systems to track data around product use and benefits, and make the data available to clinicians.

Armchair Discussion: Regulation for Innovation

David K. Lee, Chief Regulatory Officer of the Health Products and Food Branch of Health Canada, moderated a discussion around opportunities and challenges for the modernization of the Canadian health products regulatory framework.

Three panelists contributed to the discussion:

• Jean-Guy Forgeron, Assistant Secretary, Treasury Board of Canada Secretariat
• Keith Flanagan, Transition Lead for Policy, Office of New Drugs, U.S. Food and Drug Administration (FDA)
• Pierre Sabourin, Assistant Deputy Minister, Health Products and Food Branch, Health Canada

The context of the discussion was the Government of Canada's recent announcement of sectoral regulatory reviews to support innovation. Some of the key themes from the discussion included:

Sectoral regulatory reviews

• In 2017, the Advisory Council on Economic Growth recommended that the Government of Canada continue to find ways to promote a regulatory system that is able to evolve to fit an economy where innovation and change are the norm.
• The Government of Canada, in Budget 2018, allocated funding for targeted regulatory reviews in three initial sectors: agri-food and aquaculture, health and biosciences, and transportation and infrastructure.
• The reviews would pursue a regulatory reform agenda to make the Canadian regulatory system more agile, transparent and responsive, so that businesses across the country can explore and act on new opportunities, resulting in benefits for all Canadians.
• The Government of Canada is also seeking views on areas that could be impacted by new or disruptive technologies and that are not yet regulated, as these areas offer potential for Canada to develop new, agile regulatory frameworks.

Regulation to support health innovation

• Health Canada is dedicated to supporting innovation while ensuring safety, efficacy, and quality of health products for Canadians
• This initiative will help Health Canada advance meaningful change on regulatory modernization in three key areas:
  • Removing outdated and overly prescriptive provisions;
  • Establishing integrated and responsive regulatory frameworks for health products; and
  • Creating more agile regulations to treat advanced technologies.
• To support this work, Health Canada has been working to develop a culture of regulatory foresight. Initial work in this area has been to identify new trends and disruptive technologies which are radically transforming the way we understand health care.
• Health Canada recognizes that existing regulations are not well suited to regulating advanced technologies and will need to adapt to the realities of these new therapies.
• This process will help Health Canada examine the implications for Canada's regulatory system, regulatory tools, and future investments in resources and infrastructure.
• At a time when science and technology are rapidly transforming health products and production methods, Health Canada is looking for constructive dialogue on ensuring that our system can support innovation while protecting the health of Canadians.

Lessons from the experience of the United States Food and Drug Administration (FDA)

• The FDA reinforced the need for transparent, inclusive consultation processes that benefit from novel, out of box thinking to address complex regulatory challenges.
• The FDA is experimenting with innovative models of integrating patient experience data across the full product lifecycle, with the intention of eventually applying patient experience factors to regulatory decision making.
• The FDA emphasizes the importance of scientific leadership by regulators on behalf of patients. FDA staff engage proactively with academics and advocates to foster drug development for unmet medical needs.

Breakout Session: Preparing for the Future

Building on the modernization principles outlined during the Armchair Discussion, the breakout sessions were used to seek stakeholder feedback on Health Canada's plan to remove out-dated regulatory provisions, develop an agile regulatory framework, and enable advanced technology. Breakout session feedback will build on previous consultations and discussions with stakeholders and help inform Health Canada's approach to regulatory modernization.

The following discussion questions were posed to stakeholders during the breakout session. Stakeholders were also given 30 days following the event to provide additional feedback.

Questions:

1. Pre-Evidence-based Regulating/Ad hoc Regulation:

   We have heard from various stakeholders that outdated regulatory requirements in the Food and Drug Regulations are posing challenges. If this applies to you, can you identify what requirements in the regulations are of greatest concern and examples of the impact these outdated provisions has had for you or your constituents?

2. Evidence-based Regulating:
   1. As we work to consolidate and streamline regulatory requirements for health products in Canada, can you identify some examples of key inefficiencies within the current framework or with respect to international alignment that could be addressed through this process?
   2. In your opinion, to what degree is product classification an impediment to innovation? If Health Canada were to advance a more agile classification system to simplify and clarify what requirements apply to a specific product, how might this impact your business practices?
3. Regulating Advanced Technologies:
   1. To what extent would you say that advanced technologies are challenging the current health product regulatory frameworks in Canada? Can you share examples of challenges that you, your constituents or others are seeing in this area?
   2. What considerations do you think would be important in advancing a new or innovative approach to regulating advanced technologies?
4. Moving Forward:

   With respect to supporting and reducing barriers to innovative products, what would be the most significant outcome that you would like to see as part of the regulatory review and modernization process?"

   Through the group discussions and written submissions that followed, some high-level themes emerged. The following is a summary of these themes. Please note that all comments received through the consultation process will be taken into consideration.

Classification

We heard consistently from stakeholders that having a more agile and simplified classification system would save time, resources and remove barriers to innovation. It was noted that not all companies have the in-house expertise to efficiently navigate the technical aspects of the product classification process. It was raised that potential errors in product classification can lead to lengthy discussions with regulatory and costly delays. A more clear and flexible classification system would save industry time and resources when applying for licenses and submitting compliance information for product innovations, and would allow the regulator to better focus resources. It was also noted that device classification also differs between markets. A more harmonized product classification system across regulatory bodies and international partners would make it easier and more efficient for Canadian companies to register products both in Canada and in export markets.

International alignment

Many stakeholders urged greater alignment of regulatory processes and requirements with other jurisdictions, this would allow for quicker approval processes and faster regulatory and policy response here in Canada. In particular, it was suggested that recognition of evaluations and approvals conducted in other countries according to accepted international standards could speed up approval processes and avoid duplication of efforts. Similarly, it was suggested that differences between jurisdictional requirements be minimized to the greatest extent practicable. We heard that international alignment on the collection, analysis and dissemination of data would increase access to real world evidence and enhance the ability to bring proven and innovative products to Canada. It was also recommended Health Canada make better use of formalized alignments with international regulatory agencies to share expertise and reduce barriers to innovation.

Review process improvements

Stakeholders provided a range of views on potential improvements to the health product review process, particularly around ways to improve the submission process and accelerate review timelines. Suggested improvements included: instituting a submission tracking system to improve the ability to monitor review timelines; ensuring service standards and fees are competitive with global markets; and providing greater opportunity for discussion between sponsors and Health Canada during the pre-submission phase and review process to ensure that high-potential therapies are granted market access as quickly and efficiently as possible.

Risk and outcome-based assessments

Many stakeholders voiced that high and lower-risk drugs and medical devices should not be subject to the same requirements and that there should be greater regulatory flexibility and lower regulatory burden for lower-risk products and activities. A common suggestion was that Health Canada move towards risk and outcomes-based approaches to use regulator resources more efficiently while lowering the compliance burden for lower-risk products and activities. Moving to a risk-based system would prioritize regulatory activities where the risk to health or of non-compliance is the highest.

Labelling

Many stakeholders said modernization of certain labelling requirements would be beneficial. Examples of specific challenges mentioned with current labelling requirements include: Plain Language labelling which can be a challenge for small package products, products without a physical label, and uniquely Canadian labelling standards which can make it costly and complex to produce Canadian-only packaging. Some solutions proposed include using international labelling standards where possible and allowing for other means of product information dissemination (such as web-based information dissemination).

Clinical trials

Clinical trials were mentioned often and in a number of contexts. Precision and personalized medicines have been presenting a challenge to Canada's health technology assessments and they are only increasing in presence and demand from Canadian patients. New clinical trial design options (i.e. basket trials, Real World Evidence trials) should be considered moving forward to allow for greater and faster access to innovative health products. Some stakeholders indicated that clinical trials for niche populations are difficult to generate and assess and their cost is one of the drivers of high drug expenses. We heard that greater emphasis should be put on facilitating clinical trials and providing patient access to lifesaving therapies early in the clinical trial process. With the rapid increase in innovative medical devices, especially from entrepreneurial enterprises, we also heard that developing a separate framework for clinical trials would help small to medium sized enterprises navigate their innovative solutions through a complex regulatory environment.

Advanced technology and software

As health products increasingly incorporate digital and technological advancements, many stakeholders recommended that Health Canada increase collaboration with innovators, industry and academia to continue monitoring the development of advanced technologies, including imminent advances such as those in regenerative medicine and cell therapy. Several stakeholders asked Health Canada to clarify the process of filing submissions for 'significant changes' to medical devices by requesting clearer definitions and guidance, especially as it relates to software technologies. Stakeholders also said international alignment on the definition of 'significant changes' would be beneficial. It would avoid companies having to manage different versions of each device to remain compliant with each jurisdiction's regulations.

Stakeholder engagement

Lastly we heard from stakeholders on how they would like to be engaged as part of the regulatory review initiative. We heard that stakeholders wish to be engaged early and often throughout the initiative, with sufficient time to provide thoughtful responses. We also heard that stakeholders would like to have a clear understanding of how their input will contribute to any proposed changes.

Closing remarks and next steps

Health Canada officials emphasized that this engagement session was the starting point for the work ahead with our stakeholders and partners on regulatory modernization. We look forward to continued collaboration with our key stakeholders to design a flexible, efficient and adaptable regulatory system that facilitates health innovation in Canada.