Competition Bureau statement regarding off-label use of vaccines
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In its 2018-2019 annual plan, the Competition Bureau made a priority of ensuring competition and innovation in the health and biosciences sector. As such, the Bureau is committed to providing guidance to the pharmaceutical industry on practices that may be of concern under the Competition Act (the Act).
The Bureau recently conducted a preliminary investigation into possible competition concerns related to the supply of a vaccine for a provincial public immunization program. Specifically, the alleged conduct involved a manufacturer's proposed inclusion of a clause in a procurement contract that would have restricted off-label useFootnote 1 of its vaccine by public health authorities. As a result of this proposed restriction, provinces would have been potentially prohibited from implementing public immunization programs that contemplate off-label use (such as fewer doses or mixed schedules using competing manufacturers' products), resulting in higher costs to the province.
The Bureau ultimately concluded that there was no contravention of the abuse of dominance provisions of the Act at this time given that the alleged conduct did not materialize. However, if the Bureau became aware of a similar practice in the future, it would not hesitate to pursue further enforcement or advocacy. This statement identifies and provides guidance on some of the competition issues relevant to off-label use of vaccines and pharmaceutical drugs. In particular, while the Bureau recognizes that health and safety issues may create legitimate concerns for manufacturers, these issues should not be used as a pretense to exclude competitors. The Bureau encourages manufacturers to avoid strict prohibitions of off-label use where such conduct would restrict a public health authority’s jurisdiction and discretion to administer its immunization programs, particularly where these prohibitions would foreclose the use of competing manufacturers’ products.
A. Vaccines in Canada
Vaccination in Canada is a shared responsibility between the federal, provincial and territorial governmentsFootnote 2. The federal government has various roles including regulatory approval, vaccine safety monitoring, bulk purchasing and national leadership and coordination in knowledge development and transfer, among other things. Administration and delivery of health care, including the planning and delivery of immunization programming, is a provincial and territorial responsibility. Provinces and territories are therefore responsible for developing immunization policies and schedules in their jurisdiction based on their specific needs.
Vaccines are regulated by Health Canada under the Food and Drugs Act (F&DA) and Food and Drug Regulations, as are pharmaceutical drugs. Health Canada reviews clinical and manufacturing information of vaccine submissions (including the Product Monograph) and authorizes the use and sale of the product in Canada. While Health Canada monitors vaccine safety and effectiveness throughout the life cycle of the product, it does not review off-label use of vaccines and pharmaceutical drugs. Following product approval, additional post-marketing data may support a specific off-label use of a vaccine. However, only the manufacturer may apply to Health Canada to update its Product Monograph to include new usesFootnote 3.
The Public Health Agency of Canada (PHAC) offers guidance on immunization practices, but does not play a regulatory role. As part of its mandate, PHAC publishes the Canadian Immunization Guide, which represents an important resource on immunization for healthcare professionals. The scope of PHAC’s analysis differs from that of a regulator; PHAC’s analysis goes beyond data on safety and efficacy and looks at a broad spectrum of considerations from a public health perspective. PHAC also relies on recommendations from the National Advisory Committee on Immunization (NACI), a national advisory committee of experts that makes recommendations on current or newly approved vaccines. NACI’s recommendations on immunization practices may include off-label use of a particular vaccineFootnote 4.
Provinces and territories may also have their own committee of experts to provide advice on immunization policies. These public immunization policies implement recommendations from expert committees (e.g. from NACI and/or a province or territory’s own respective committee) in order to meet a jurisdiction’s specific needs, while being mindful of health and safety considerations, resource availability, constraints and identified priorities. A province or territory’s immunization schedule may include off-label uses of a vaccine.
B. Off-label use
A vaccine (or drug) may be useful for indications, population groups and dosages beyond those set out in the Product Monograph and authorized for use by Health Canada. Under Canada’s regulatory framework, manufacturers must submit the necessary safety and efficacy data to Health Canada to support the specified uses of a vaccine, and only the manufacturer can apply to modify the Product Monograph to include additional uses.
A manufacturer may decide to not update a Product Monograph to include an off-label use even where evidence supporting such use becomes available following initial approval. For example, a manufacturer may not have the incentive to update a Product Monograph where costly clinical trials would be required in order to secure Health Canada approval for a new use or where including a new use would facilitate the use of a competing product.
The F&DAprohibits manufacturers from selling or advertisingFootnote 5 a product in a manner that is false, misleading or deceptive, which may include the promotion of off-label use. The Bureau does not understand the provision to prohibit a manufacturer from entering into a supply contract for a publically administered program, which may include an off-label use of a vaccine. Off-label use can and does occur in the administration and delivery of health care. Public health authorities may decide to administer an off-label use of a product in an immunization program after having considered several criteria, including the burden of disease and the cost effectiveness of a given product.
II- Competition Issues
The Bureau has found that the particular interplay between the regulatory requirement for vaccine and drug approval and the administration of an off-label use may give rise to competition concerns in certain circumstances. For example, where off-label use involves the use of a manufacturer’s product in conjunction with a competitor’s product, manufacturers should be mindful of restricting off-label use by public health authorities. Where such conduct, which may lack a valid scientific basis, prevents a potential competitor from entering the market or excludes an existing competitor, it may contravene the abuse of dominance or other provisions of the Act.
Under the Act, an abuse of dominance occurs when a dominant firm or group of firms in a market, engage in a practice of anti-competitive acts, with the result that competition has been or is likely to be lessened or prevented substantially. A key component of the Bureau’s assessment will involve an analysis of the underlying intent of the conduct, for example, whether the overriding purpose of the conduct is motivated by legitimate health concerns or to exclude current or potential competitors.
Competition can be an important factor in the administration of vaccination programs as provinces may seek to lower their costs by leveraging competing products. In instances where public programs provide for off-label use of a product, the Bureau will be particularly vigilant where alleged conduct by pharmaceutical manufacturers may hinder a public health authority’s jurisdiction and discretion to administer its immunization programs for the purposes of excluding competitors. Such conduct may include imposing restrictions on off-label use that would prevent the use of a competitor’s product as a partial substitute.
The Bureau remains very mindful of the importance of competition in the pharmaceutical industry given the significant existing barriers to entry stemming from patent protection, stringent regulations and costs to develop vaccines and pharmaceutical drugs. While the conduct being investigated in connection with the supply of a vaccine to a provincial public immunization program did not materialize, the Bureau is of the view that the type of conduct described in this statement has the potential to raise serious concerns under the abuse of dominance provisions of the Act in certain circumstances.
Should a situation arise providing compelling evidence of harm resulting from a manufacturer imposing restrictions on off-label use or any other conduct that excludes competitors, the Bureau will not hesitate to take appropriate action.
This publication is not a legal document. The Bureau’s findings, as reflected in this Position Statement, are not findings of fact or law that have been tested before a tribunal or court. Further, the contents of this Position Statement do not indicate findings of unlawful conduct by any party.
However, in an effort to further enhance its communication and transparency with stakeholders, the Bureau may publicly communicate the results of certain investigations, inquiries and merger reviews by way of a Position Statement. In the case of a merger review, Position Statements briefly describe the Bureau's analysis of a particular proposed transaction and summarize its main findings. The Bureau also publishes Position Statements summarizing the results of certain investigations, inquiries and reviews conducted under the Competition Act. Readers should exercise caution in interpreting the Bureau’s assessment. Enforcement decisions are made on a case‑by‑case basis and the conclusions discussed in the Position Statement are specific to the present matter and are not binding on the Commissioner of Competition.
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