Market Study Notice: Digital Health Care

Notice of Study

  1. The Competition Bureau (Bureau) has commenced a market study of Canada's health care sector to better understand existing or potential impediments to innovation and choice, and possible opportunities for change, in digital health care (the Study).
  2. The Study supports the Bureau's Strategic Vision for 2020-2024, to encourage competition and innovation in areas that matter to Canadians, so that businesses and consumers can thrive in an increasingly digital marketplace.

Role of the Competition Bureau

  1. The Bureau is as an independent law enforcement agency that ensures Canadian businesses and consumers prosper in a competitive and innovative marketplace.
  2. Headed by the Commissioner of Competition, the Bureau is responsible for the administration and enforcement of the Competition Act (Act), the Consumer Packaging and Labelling Act (except as it relates to food), the Textile Labelling Act and the Precious Metals Marking Act.
  3. As part of its mandate, the Bureau participates in a wide range of activities to promote and advocate the benefits of a competitive marketplace. Among the tools the Bureau uses to advocate for competition are market studies.Footnote 1
  4. Market studies allow the Bureau to assess a sector from a competition perspective to identify relevant laws, regulations, policies (collectively, rules) or other factors that may impede competition. Through market studies, the Bureau makes evidencebased recommendations on ways to enhance competition in a particular sector.

Purpose of the Study

  1. The Study will enable the Bureau to better understand the competitive dynamics of the health care sector in order to make recommendations to decision-makersFootnote 2 on how to support digital health care in Canada through procompetitive rules.
  2. The COVID-19 pandemic has accelerated the use of digital health care,Footnote 3 increased the need for technologies and tools to support the delivery of care through digital means,Footnote 4 and highlighted the importance of a regulatory landscape that is nimble and responsive to a rapidly evolving sector.Footnote 5
  3. Competitive markets can lead to innovation in product and service delivery, increased choice, higher quality and lower costs.  At the same time, the Bureau recognizes that rules may be necessary to address important policy objectives in the health care sector, including patient safety. As the health care landscape evolves, steps should be taken to ensure that these rules take competition considerations into account wherever possible.
  4. By undertaking a market study in the health care sector, the Bureau has an opportunity to work with industry stakeholders, including federal, provincial and territorial decision-makers who administer and deliver Canada's health care services,Footnote 6 to address existing or potential impediments to innovation and choice, and highlight possible opportunities for change in an area that is of the utmost importance to Canadians.

Scope of the Study

  1. On July 30, 2020, the Bureau launched a public consultation, inviting industry stakeholders to share their views on factors that may be impeding access to digital health care, or limiting innovation and choice in Canada's health care sector. As summarized in our Digital Health Care Consultation: What We Heard from Industry Stakeholders report, stakeholders identified issues related to six common themesFootnote 7 that can impact the availability and adoption of digital health care in Canada.
  2. In December 2020, the Bureau also conducted a voluntary online survey to hear from Canadians about their experience accessing and using digital health services. As summarized in our Digital Health Services Survey: What We Heard from Canadians report, respondents told us about the digital health services that they use and who provides those services, what they value when using digital health services, the key barriers preventing their use of digital health services, as well as factors that would help them increase their use of digital health services.
  3. Based on the information received through the public consultation and digital health services survey, the Bureau has identified three broad topics and related research questions for further examination as part of the Study:
    1. Data and information: The Bureau will examine ways to increase access, use and sharing of digital health data and information, including by considering how shared data standards, data and information exchange, data portability and interoperability can improve the competitive landscape and accelerate the development and adoption of digital health care.Footnote 8

      On the topic of data and information, the Study will aim to answer the following:
      1. Are there barriers (regulatory or non-regulatory) that are preventing the access, use and sharing of digital health data and information? How have these barriers impacted the competitive landscape for digital health care?
      2. What changes can be made to reduce barriers to the access, use and sharing of digital health data and information? How can this encourage more competition and innovation in digital health care?
    2. Products and services: The Bureau will examine issues related to the development, approval, procurement and commercialization of digital products and services intended for use by health care providers and patients. In addition to exploring issues that may be preventing the introduction and adoption of digital products and services in the market, the Bureau will also examine barriers that are restricting or limiting innovation, and consider how pro-competitive rules can reduce those barriers.

      On the topic of products and services, the Study will aim to answer the following:
      1. Are there barriers (regulatory or non-regulatory) that are restricting the range and scope of digital health products and services available for use by health care providers and patients? How have these barriers impacted the competitive landscape for digital health care?
      2. How do rules regarding the development and approval of digital products and services impact their availability and use? What steps can be taken to facilitate the development and approval of digital products and services?
      3. How do procurement and commercialization processes impact the ability for businesses to innovate and compete in the market for digital health care products and services? How can more innovation and competition be encouraged?
    3. Health care providers: The Bureau will examine the ability of health care providers to deliver digital care to patients. The Bureau will explore issues related to billing codes, compensation, licencing, and scope of practice, and consider opportunities to increase access to care.

      On the topic of health care providers, the Study will aim to answer the following:
      1. Are there barriers (regulatory or non-regulatory) that are restricting the ability of health care providers to deliver digital health care to patients? How have these barriers impacted the competitive landscape for digital health care?
      2. How do billing codes and compensation mechanisms for health care providers impact the delivery of digital health care? What steps can be taken to facilitate digital health care delivery?
      3. How do rules regarding medical licencing impact the ability of health care providers to deliver digital health care? What steps can be taken to further enable the delivery of digital health care?
      4. How do rules regarding the scope of practice for health care providers impact their ability to deliver digital health care to patients? For whom and how can the scope of practice be modified to further enable the delivery of digital health care?
  4. While there are many important issues relating to digital health care beyond those mentioned in paragraph 13, in conducting the Study, the Bureau does not intend to evaluate:
    1. issues pertaining to the privacy of digital health data and information;
    2. issues pertaining to digital infrastructure, including broadband and cellular access; or
    3. issues pertaining to the appropriateness or efficacy of specific digital health care products and services.
  5. As the Study progresses, the topics within the scope of the Study may change (including adding, substituting, or removing topics). In the event that the scope is changed significantly, the Bureau will update this notice and advise stakeholders of the changes through the market study portal.

Outcomes of the Study

  1. The Bureau expects to publish the results of the Study in a public report, which may include recommendations to health care sector decision-makers.
  2. In addition, the Study will enable the Bureau to, among other things:
    1. Make more informed regulatory interventions regarding key considerations that health care sector decision-makers and other relevant authorities ought to take into account to further support innovation and choice in the health care sector; and
    2. Increase its knowledge and understanding of the competitive dynamics of the health care sector more generally, to inform the Bureau's future work.

Timeline

  1. The Bureau intends to conduct the Study according to the following timeline:
    1. Spring – Summer 2021: Stakeholder engagement and research
    2. Summer 2021 – Winter 2022: Information analysis and continued stakeholder engagement
    3. Spring 2022: Pre-publication consultations and publication of a final report
  2. The Bureau will modify this schedule at its discretion if necessary. Should there be any material change to this schedule, the Bureau will update this notice and advise stakeholders of the changes through the market study portal.

Information Gathering

  1. Over the course of the Study, the Bureau will gather and analyze information from various sources. The Bureau will consult experts, health care sector decision-makers and other key stakeholders, as well as review the academic literature and the experience of other jurisdictions.

Getting Involved

  1. Those with an interest in the Canadian health care sector are invited to provide written or oral submissions on the Study, or on the research questions and issues relevant to areas within the Study scope, as detailed in paragraph 13.
  2. For those who wish to make a written submission, please include as much relevant detail as possible, for example, by including reference to specific rules, or by using specific data or anecdotes. Please provide written submissions by mail or email to the officers identified below. All submissions will be made public and posted on the Bureau’s website in the language provided unless it is specifically requested that they be kept confidential. If you would like the Bureau to contact you for an oral interview, please provide your contact information.
  3. The Bureau would appreciate receiving submissions and/or indications of willingness to participate in an oral interview by July 2, 2021, in order to provide adequate time to review and conduct follow-up interviews as necessary.
  4. The main contacts for the Study are:

    Stephanie Gillespie
    Senior Competition Law Officer
    Competition Promotion Branch

    Email: cbmarketstudies-etudesdemarchebc@ised-isde.gc.ca

    Competition Bureau
    Place du Portage Phase I
    50 rue Victoria Gatineau, QC
    K1A 0C9

    Kristen McLean
    Competition Law Officer
    Competition Promotion Branch

    Email: cbmarketstudies-etudesdemarchebc@ised-isde.gc.ca

    Competition Bureau
    Place du Portage Phase I
    50 rue Victoria Gatineau, QC
    K1A 0C9

Confidentiality

  1. The Bureau conducts its advocacy and enforcement activities under the authority of the Act. Section 29 of the Act protects information obtained by or provided to the Bureau, including the identities of the persons who provided the information, and any information that could reveal their identities. However, when information has been made public or where persons providing information authorize its communication to other parties, subsection 29(2) permits the disclosure of such information. Additionally, subsection 29(1) provides exceptions for the communication of information to a Canadian law enforcement agency or for the purposes of the administration or enforcement of the Act.
  2. The Bureau encourages stakeholders to consult its Information Bulletin on the Communication of Confidential Information under the Competition Act or direct specific questions to the contacts identified above.
  3. Any reports or other products published in relation to the Study may contain analysis that is based on confidential or commercially sensitive information. We encourage stakeholders to identify any confidential or commercially sensitive information in their submissions or discussions with Bureau officials. The Bureau will anonymize the information to the best of its ability.
  4. The Bureau will conduct its analysis in confidence. To help ensure that no confidential or commercially sensitive information is publicly disclosed, the Bureau will endeavour to provide affected stakeholders, as appropriate, with an advance copy of any report forty-eight (48) hours prior to its intended publication for the sole purpose of allowing them to identify whether any confidential or commercially sensitive information has been included.

Annex A: Previous Bureau advocacy in the health care sector

  • Submission by the Commissioner of Competition to the Government of Ontario – Digital Health Interoperability (July 2020)
    In this July 2020 submission to the Government of Ontario, the Bureau highlighted its support for the establishment of interoperability specifications, which can spur competition, enable new and innovative business models, and help deliver better and more affordable health care products and services to Ontarians. The Bureau noted that in order to maximize the benefits of competition in the health care sector, standards, including interoperability specifications, should not create barriers that can reduce choice and innovation.
  • Bringing Competition into Focus (July 2018)
    In July 2018, the Bureau released a Competition Advocate examining certain regulations in the eyewear industry, including their potential effect on online eyewear retailers, as well as on the ability for consumers to purchase prescription eyewear online. In order to minimize the potential for negative or unintended effects arising from regulation in the industry, the Bureau recommended that decision-makers take steps to ensure that regulations are evidence-based, and strictly necessary to address legitimate policy concerns, including patient health and safety.
  • Competition and the Common Cold (March 2017)
    In March 2017, the Bureau released a Competition Advocate examining the regulations governing the ability of nurse practitioners to operate independently. The Bureau called on health regulators to consider whether certain policies that restrict the ability of nurse practitioners to operate an independent practice are in fact necessary to protect patient safety, promote longterm health or achieve other important policy goals. If not, the Bureau encouraged regulators to pursue less restrictive policy options that can achieve important policy objectives while minimizing harm to competition and innovation.
  • Advertising Restrictions (October 2016)
    In October 2016, the Bureau released a Technical Guidance Document regarding various advertising restrictions in the health care sector. The Bureau analyzed a crosssection of health care regulations across Canada, and discovered that most regulators tend to restrict advertising in some form. The report called on governments and self-regulatory bodies to begin collecting and compiling information on marketplace outcomes in Canada's health care markets in order to facilitate greater emphasis on empirical evidence in decision-making.
  • Generic Drug Sector Study (October 2007)
  • Benefiting from Generic Drug Competition in Canada: The Way Forward (November 2008)
    In October 2007, the Bureau released findings from its market study on the generic drug sector. The study was conducted in order to better understand the price differential between prescription generics in Canada and other countries, and to identify areas where changes in the market framework may secure greater benefits through competition. The Bureau found that while strong competition exists in the supply of many generic drugs, the benefits of this competition are not reaching the Canadian public in the form of lower prices. This was determined to be primarily due to the design of public and private drug plans, which allowed competitive rebates to be provided to pharmacies by manufacturers, but provided little incentive for pharmacies to pass these savings on to plan sponsors.

    In a November 2008 follow-up to this study, the Bureau developed recommendations examining possible options for obtaining the benefits from competition, including recommendations for both private and public drug plan providers.
  • Self-Regulated Professions – Balancing Competition and Regulation (December 2007)
  • Self Regulated Professions – Post Study Assessment (September 2011)
    In December 2007, the Bureau released findings from its market study on selfregulated professions. The study examined the way regulation affects competition in relation to five self-regulated professions (accountants, lawyers, optometrists, pharmacists and real estate agents), with the objective of identifying measures that may be unnecessarily restricting the benefits of competition for Canadians. In conclusion, 53 recommendations were communicated to the appropriate selfregulating professional bodies across the country. These professions were challenged to reexamine the restrictions identified, and to remove those that were not clearly required to protect the public interest.

    In 2011, the Bureau conducted a post-study assessment in order to review and assess progress made in implementing the recommendations made in its study. The assessment found that certain self-regulating professional bodies had made significant progress in reviewing the regulations identified in the study, and in some cases, had amended regulations or rules to eliminate unnecessary restrictions on competition. However, the Bureau found that more work was required to obtain the full benefits of competition.