Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines

The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented Medicines Regulations that were released on Friday, August 9, 2019. The amendments will come into force on July 1, 2020.

Once the amendments come into force, the PMPRB will use a different basket of price comparator countries. Significantly, the new basket excludes the US. The PMPRB will also consider new pharmacoeconomic market size, and gross domestic product (GDP)-based factors in its price tests and require patentees to report prices net of confidential rebates.

Overview of the amendments

The final version of the amendments includes the same key changes and overall objectives as an earlier draft version published on December 2, 2017. Here is a summary of some of the notable features of the final amendments:

New factors for assessing excessive pricing.
- The PMPRB must consider three new factors when assessing excessive prices: (1) the medicine’s pharmacoeconomic value in Canada, (2) the size of the market for the medicine in Canada, and (3) the GDP and GDP per capita in Canada.
- These new factors do not apply to medicines that receive a drug identification number (DIN) before the day that the final amendments are published in Canada Gazette, Part II, which is expected to happen on Wednesday, August 21, 2019. All other features of the amendments apply to all patented medicines upon their coming-into-force.
New powers to collect information regarding the pharmacoeconomic factors.
- The amendments contain specific guidance regarding the triggers and timing for reporting cost-utility analyses and market size information.
- Cost-utility analyses need only be reported if the pro-rated cost of the medicine’s use over a 12-month period is greater than or equal to 50% of the GDP per capita in Canada.
New obligations to report price adjustments.
- The amendments expand the information that must be included when calculating average price per package and net revenue from sales for reporting in Form 2. These calculations will be required to factor in any price “adjustments that are made by the patentee or any party that directly or indirectly purchases the medicine or reimburses for the purchase of the medicine”.
- This new requirement is intended to include confidential third-party rebates paid to insurers under formulary listing agreements.
OTC and generic medicines to benefit from risk-based reporting.
- The amendments list the categories of medicine that benefit from reduced reporting requirements because they are considered to be a low risk for excessive pricing.
- The list now includes most non-prescription/over-the-counter drugs (including those containing controlled substances), veterinary medicines, and generic drugs (defined as those that were approved on the basis of an abbreviated new drug submission). However, non-prescription Schedule D drugs (e.g., non-prescription biologics) are excluded and remain subject to normal reporting requirements.
Revised international price comparators.
- The list of international comparator countries (previously known as the “PMPRB7”) is modified, deleting the United States and Switzerland while adding Australia, Belgium, Japan, the Netherlands, Norway, and Spain. France, Germany, Italy, Sweden, and the United Kingdom remain on the list, which is now being referred to as the “PMPRB11”.
- The final version omits the Republic of Korea, which had been proposed as a twelfth comparator country in the draft version of the amendments.

Update on the Guidelines

During technical briefings held on August 9, 2019, Health Canada and PMPRB officials stated that details regarding implementation of the amendments will be outlined in a revised set of Guidelines.

PMPRB officials indicated that a proposed set of revised Guidelines will be published for stakeholder consultation this fall. The revised Guidelines should be finalised prior to the amendments coming into force on July 1, 2020.

Officials also indicated that until the amendments come into force in 2020, the PMPRB will continue to apply the existing Guidelines.

Competition Bureau issues statement regarding off-label use of vaccines

By Ian Trimble, Kevin Ackhurst, Richard Wagner and David Yi on July 29, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Competition Bureau (Bureau) recently conducted a preliminary investigation into possible competition concerns arising from a proposal to include a clause in a procurement contract that would restrict off-label use of a vaccine. The Bureau concluded that there was no abuse of dominance as the provision was not included in the procurement contract; however, it issued a statement providing guidance on off-label use of vaccinations.

After outlining vaccine approval and reimbursement, and administration of immunization programs in Canada, the statement indicates that, while manufacturers are prohibited from selling or advertising vaccines for off-label use, off-label use can and does occur in the administration and delivery of health care. From the Bureau’s perspective, public health authorities may elect to use a vaccine off-label if it deems it appropriate.

The Bureau has identified the potential for abuse of dominance in certain circumstances, for example where a manufacturer attempts to restrict an off-label use when that use is in conjunction with a competitor’s product. The Bureau focused on conduct that may hinder a public health authority’s jurisdiction and discretion to administer its immunization programs in a way that would exclude competitors.

The Bureau will look to the underlying intent of the conduct in question when engaging in its analysis. The statement suggests that where the conduct is motivated by legitimate health concerns backed by scientific evidence rather than to exclude current or potential competitors, that the conduct may not contravene the Competition Act. The effect on competitors or potential competitors, and the scientific basis should therefore be considered when contemplating anything that could restrict the off-label use.

Health Canada consulting on clinical trial requirements and “new class” of advanced therapeutic products

By Ian Trimble, Christopher A. Guerreiro and Sara Zborovski on July 24, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

As we reported, the Budget Implementation Act, 2019 (BIA) paved the way for changes to the regulation of clinical trials and created a new class of “advanced therapeutic products” (ATPs) regulated by Health Canada. Health Canada is consulting on what it should consider in developing regulations for clinical trials and implementing the approval pathway for ATPs until August 30, 2019.

Background

The BIA received Royal Assent on June 21, 2019. The changes to clinical trial regulation will come into force once new regulations are developed and implemented. While the ATP provisions from the BIA are now in force as part of the Food and Drugs Act, Health Canada is consulting on how to best implement them.

In the context of the consultation, Health Canada has published a discussion paper entitled Agile regulations for advanced therapeutic products and clinical trials (the Discussion Paper). This paper is premised on the idea that some Health Canada regulations for drugs and medical devices have not kept pace with innovation. The paper describes an “ambitious regulatory reform agenda” in order to accommodate highly complex technology while still protecting the health and safety of Canadians.

Clinical Trials

The Discussion Paper indicates that the current “one-size-fits-all” approach to clinical trials may discourage certain types of studies, and may poses challenges to small and medium sized companies. The intention of the new regulatory framework is to:

allow for new types of trials;
decrease cost for low-risk trials and regulate in proportion to risks; and
improve alignment with global partners and increase Canada’s competitiveness in attracting trials.

Health Canada intends to expand its focus in order to control the conduct of all parts of a clinical trial. It will expand the use of evidence gathered through trials. It will also give patients greater access to information on available clinical trials and to the results of these trials.

Health Canada also intends to expand the clinical trials framework to include studies of food for special dietary purposes (e.g., infant formula). Currently, it is not possible to conduct clinical trials with these foods in Canada.

Advanced Therapeutic Products

The Discussion Paper indicates that most products will continue to be regulated via one of the existing pathways, rather than as ATPs. The new ATP pathway is being created for exceptional circumstances where drugs or devices are “so novel, complex, and distinct that current regulations are not equipped to handle them” (e.g., gene editing).

Health Canada envisions a flexible pathway with a “concierge service” that provides a flexible, risk-based way to authorize products while protecting the health and safety of Canadians. Under the new pathway, Health Canada will consult with stakeholders and consider:

The risks and benefits associated with the product, and steps available to adequately manage and control these risks.
The extent to which the product is different from already approved drugs or devices.
The extent to which there are other appropriate controls in place, e.g., through provincial and territorial legislation.

ATPs will be authorized either by (1) licence (with associated terms and conditions) or (2) an order of permission (more suitable for lower-risk products). In both instances, Health Canada would aim to ensure that the ATP meets market licensing and health technology assessment requirements.

Consultation

The paper concludes by providing three questions to guide feedback:

What products would you want to put forward for consideration under the ATP pathway?
Can you suggest any good models of an enhanced client “concierge” service that would help companies wishing to be considered for the ATP pathway?
What recommendations do you have for creating clinical trials regulations that would attract clinical trials in Canada and be an effective model in the Canadian context?

A copy of the document can be requested from, and feedback can be provided to, hc.hpfb.engagement-mobilisation.dgpsa.sc@canada.ca.

Health Canada consulting on draft guidance distinguishing promotional and non-promotional activities for health products

By Meghan Allard, Veronique Barry, Ian Trimble and Sara Zborovski on July 22, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada is consulting on a draft guidance document entitled The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products (Draft Guidance), which is intended to replace the current 1996 policy entitled The Distinction Between Advertising and Other Activities (Current Policy). Copies of the Draft Guidance are available from Health Canada on request; comments can be submitted until September 3, 2019.

Background

As with the Current Policy, the Draft Guidance is intended to outline the factors that contribute to rendering a message or activity non-promotional, in order to determine if it is subject to the advertising provisions of the Food and Drugs Act and Food and Drug Regulations. Health Canada developed the Draft Guidance, in collaboration with advertising pre-clearance agencies, with the intention of making it more up to date, accurate, and relevant given significant evolution in the advertising landscape.

Highlights of changes

The scope of the Draft Guidance is broader than the Current Policy. While the Current Policy applies to drugs for use in humans, the Draft Guidance applies to drugs, medical devices, natural health products, biologics, and vaccines for human use as well as veterinary health products.

Like the Current Policy, the Draft Guidance sets out factors that contribute to a non-promotional determination, followed by some examples of non-promotional messages and activities. These factors have been reorganized into two overarching categories:

Content and context, which includes accuracy, objectiveness, consistency with the terms of market authorization, sponsor/manufacturer influence, layout and design, focus of the message, linkages to other messages, and cautions/disclaimers.
Sponsorship and dissemination, which includes frequency and breadth of delivery, intended audience, type of staff delivering the message, and the willingness of a competitor to fund the same message.

Other notable changes include:

Technology updates. The Draft Guidance now accounts for the dissemination of information through technology such as web sites, social media, digital applications, and email. It outlines certain factors that need to be taken into consideration in this context such as the use of links, the “sharing” options, the duration of the availability of an announcement on a health product manufacturer’s website, and whether a social media web site or platform is unbranded.
New examples. New examples have been added to the Draft Guidance, such as Medical Condition and Treatment Awareness Related Materials. The Draft Guidance also introduces Other Learning Activities and Risk Management Plans and provides guidance as to when these activities will be considered non-promotional. Meanwhile, other examples from the Current Policy have been omitted from the Draft Guidance, such as Help Seeking Announcements, Consumer Brochures, and 1-800 Telephone Numbers.
Definition of “general public”. Various terms have been defined. For example, “general public” has been defined as “ordinary people, especially all the people who are not members of a particular organization or who do not have any special type of medical/scientificknowledge [sic]”. Notably, this definition does not appear to exclude patients prescribed a drug. Health Canada’s stance on the meaning of the “general public” is important, as the Food and Drugs Act and Regulations place limits on advertising to the general public.
Clinical Trial Recruitment. The Draft Guidance indicates that the manufacturer’s name should be included in clinical trial recruitment messages. This reverses the position in the Current Policy, which indicates that a manufacturer’s name should be excluded from these messages.
Patient Information. Under the Current Policy, Patient Information Booklets that accompanied the drug product were considered part of the labelling, and labelling requirements applied. Under the Draft Guidance, Patient Information Materials and Packages is defined more broadly as information in the form of a website, application, leaflet, brochure, or booklet published by the manufacturer concerning a health product. The Draft Guidance does not include a requirement that these materials accompany a drug in order to be considered part of the label (i.e., it implies that they will always be considered part of the label), and labelling requirements will apply. If the materials pertain only to a health product that is being, or has already been, prescribed to a patient (or is contained on a gated website), they will not be considered promotional.
Press releases and conferences. New considerations are introduced for Press Releases and Press Conferences. Any announcement posted on a manufacturer’s website can be posted for a maximum of 30-days. However, the Draft Guidance now clarifies that statements regarding the degree of safety or efficacy and comparison to other treatments may be included when limited to factual and observed information.
Unsolicited requests for information. The Draft Guidance explicitly states that in order for responses to inquiries to be considered non-promotional, they cannot be communicated by sales and/or marketing personnel.

Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis

By Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on July 9, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the invention of the patent, in a case concerning Differin^®. Having provided this guidance, the Court of Appeal set aside the judgment under appeal and remanded the final determination of whether or not the patent in question pertains to Differin^® to the Board.

Background

This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to the use of adapalene to treat dermatological disorders. The patentee, Galderma Canada Inc. (Galderma), markets two adapalene products in Canada:

Differin^®, which contains 0.1% adapalene.
Differin XP^TM, which contains a higher concentration of adapalene — 0.3%.

As we reported, in an application before a hearing Panel of the PMPRB, the Board staff successfully argued that the 237 Patent pertained to Differin^®. Galderma argued that the 237 Patent is not intended or capable of being used to make Differin^® — a 0.1% adapalene formulation — because on its face, the patent is specific to 0.3% adapalene formulations (such as Differin XP^TM). The Board Panel did not accept that argument.

Galderma sought judicial review of the Board’s decision and, as we reported, Galderma was successful before the Federal Court on the basis that the PMPRB had failed to consider the entirety of the 237 Patent when determining whether it pertained to Differin^®.

The PMPRB must consider the whole patent

The first issue before the Court of Appeal was whether the Board acted unreasonably in limiting its review of the 237 Patent to selected portions of the patent.

The Court of Appeal held that the Board must read the patent as a whole — including the claims — in order to identify the invention. However, the Board is not required construe the patent and the claims as a court would. The Board must arrive at a “reasonable” or “sufficient” understanding of the invention, but is entitled to take the patent “at face value” and is not required to arrive at the “correct” interpretation of the patent.

There was only one reasonable interpretation of the invention of the 237 Patent

The second issue before the Court of Appeal required determining the invention of the 237 Patent.

The Court of Appeal held that there was only one reasonable interpretation of the invention in the 237 Patent, and that the Court was entitled to supply that interpretation without returning the matter to the Board. Considering the patent as a whole, the Court of Appeal concluded that the invention of the 237 Patent is a pharmaceutical composition having a concentration of 0.3% adapalene to be used in the treatment of dermatological conditions with an inflammatory or proliferative component, such as common acne.

In the decision under review, the Board could not conclude that the 237 Patent pertains exclusively to 0.3% adapalene. The Court of Appeal held that the Board’s finding arose from an insufficient review of the 237 Patent. As a result, the Board’s finding was “erroneous and unreasonable”.

The Board must now determine if the invention of the 237 Patent pertains to Differin^®

As a final step, the Court of Appeal considered whether the invention of the 237 Patent pertains to Differin.

Is the medicine “adapalene” or “Differin”? The Court of Appeal held that for the purpose of the patent-pertaining analysis, the “medicine” is the thing sold in Canada at the material time, i.e., Differin^® (a 0.1% adapalene formulation) and not adapalene per se.
The “merest slender thread”? The Court of Appeal held that when conducting the patent-pertaining analysis, the Board must be guided by the statutory definition of “pertains to” and cautioned against any strict substitution of “the merest slender thread” test for the words Parliament has chosen. The Court added that the metaphor may be useful to express the idea that the connection may be “tenuous” — provided it remains within the Act.
Does the invention of the 237 Patent pertain to Differin? Having provided the above guidance, the Court of Appeal returned the matter of whether the 237 Patent invention pertains to Differin^® to the Board for redetermination. The Court of Appeal noted that:
- (1) If the Board reached its decision solely on the basis that the patent did not relate exclusively to 0.3% adapalene, it was wrong and its decision should be quashed. The 237 Patent only relates to 0.3% adapalene.
- (2) On the other hand, the Board referred to other factors that could have influenced its decision including evidence of similarities or differences between Differin^® and Differin XP^TM.

In the Court’s view the latter factors invoke policy considerations best decided by the Board. On that basis, the Court returned the matter to the Board to complete its inquiry with a proper understanding of the invention of the 237 Patent.

The case is Canada (Attorney General) v Galderma Canada Inc., 2019 FCA 196.

Patent Act Infringement Actions Cannot be Joined to PM(NOC) Infringement Actions During NOC Prohibition Period

By Kassandra Shortt, Christopher A. Guerreiro and Jordana Sanft on June 25, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting a NOC. The Court stated that an infringement action under the Patent Act could instead be brought in a separate proceeding.

With cooperation between the parties and simultaneous scheduling of the trial of common issues, separate Patent Act and Regulations infringement proceedings could proceed efficiently without formal joinder. The Court’s position is consistent with its recent decision in Bayer Inc. v Teva Canada Limited, 2019 FC 191 (Tabib P.).

Background: Pharmascience seeks to market a new dosage form

Teva markets glatiramer acetate in Canada under the brand name Copaxone in two dosage strengths: 20 mg/mL and 40 mg/mL. Copaxone is used in the treatment of multiple sclerosis. Teva listed Canadian Patent No. 2,702,437 (the 437 Patent) on the Patent Register in respect of 40 mg/mL Copaxone; however, no patents were listed against 20 mg/mL Copaxone.

Pharmascience obtained a Notice of Compliance (NOC) to market its own 20 mg/mL glatiramer acetate product, Glatect 20 mg, in August 2017. Pharmascience was not required to address the 437 Patent because it was not listed against the 20 mg/mL product.

In November 2018, Pharmascience filed a Supplementary New Drug Submission (SNDS) for approval to market Glatect 40 mg and was therefore required to address the 437 Patent, which it did by way of Notice of Allegation (NOA). Teva responded by filing an infringement action pursuant to subsection 6(1) of the Regulations, asserting that:

Pharmascience would infringe the 437 Patent by marketing Glatect 20 mg and Glatect 40 mg in accordance with the SNDS; and
Pharmascience was already infringing the 437 Patent through its past or current activities relating to Glatect 20 mg.

This decision concerns a motion by Pharmascience to strike Teva’s pleadings relating to Glatect 20 mg.

Strict rule against joinder: the Court strikes Teva’s infringement claim in part

The Federal Court struck Teva’s infringement claim relating to Pharmascience’s past or current activities relating to Glatect 20 mg because they were not done “in accordance with the submission or supplement” that precipitated the NOA underlying the proceeding, as required by subsection 6(1) of the Regulations. Rather, they were done pursuant to Pharmascience’s earlier submission for Glatect 20 mg, which did not trigger the Regulations.

Having found that Teva’s claim for past and current infringement could not be grounded in subsection 6(1) of the Regulations, the Court went on to consider whether it could be supported by subsection 55(1) of the Patent Act instead. The Court held that Teva was free to bring such a claim. In particular, the Court confirmed that such a claim would not be barred by section 6.01 of the Regulations because it could not have been brought pursuant to subsection 6(1).

However, the Court found that once properly constituted under subsection 55(1) of the Patent Act, Teva’s claim for past and current infringement could not be joined with the subsection 6(1) action due to the rule against joinder in section 6.02 of the Regulations. The Court held that this provision strictly prohibits the combination of subsection 6(1) actions with any other rights under the Patent Act while the Minister is prohibited from granting a NOC by the statutory stay under subsection 7(1) of the Regulations. The Court found that this mandatory prohibition on joinder left no discretion to the Court, unlike the rule of joinder under the Federal Courts Rules.

Accordingly, Teva’s infringement claim regarding Pharmascience’s past or current activities marketing Glatect 20 mg was struck as failing to disclose a reasonable cause of action.

Pharmascience also argued that the balance of Teva’s claim in respect of Glatect 20 mg should be struck on the basis that the SNDS in issue only pertained to Glatect 40 mg — as such, Pharmascience would not make, construct, use, or sell Glatect 20 mg in accordance with the SNDS even after it issued. The Court rejected this argument on the basis of Teva’s pleading that Pharmascience’s SNDS related to both Glatect 20 mg and Glatect 40 mg. In doing so, the Court refused to consider affidavit evidence filed by Pharmascience to contradict the pleading in the statement of claim, finding that it was required to take the pleading as true for the purpose of determining whether the pleading disclosed a reasonable cause of action.

The Court also dismissed Pharmascience’s assertion that Teva’s claim was frivolous, vexatious, or an abuse of process. In reaching its conclusion on this issue, the Court found that it was permitted to receive evidence, but stated that it had significant doubts as to the propriety of using such a motion as a means of adducing evidence that goes specifically to disproving the truth of an allegation of fact made in a pleading.

Teva Canada Innovation v Pharmascience Inc., 2019 FC 595 (Tabib P.)

Health Canada proposes updates relating to sale of unapproved drugs for emergency treatment

By Ian Trimble and Sara Zborovski on June 4, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Amendments have been proposed to the Food and Drug Regulations that relate to the sale of drugs that have not been approved in Canada for emergency treatment. These amendments update the Special Access Program (SAP) and create a mechanism whereby drugs can be purchased for immediate use or stockpiled for public health or Canadian Armed Forces (CAF) emergencies.

I. Changes to the SAP

The proposed amendments are intended to streamline the application process for practitioners in respect of previously approved drugs and clarify when a manufacturer can have an unapproved drug warehoused in Canada in advance of receiving an SAP request.

Health Canada has also published a new draft guidance document indicating how it intends to implement the SAP following these changes. The draft guidance document would replace the existing guidance document dated December 20, 2013 However, the primary substantive changes made to the content relate to the proposed amendments to the regulations.

Consultations on the proposed amendments and draft guidance document are open until July 19, 2019.

Reduced supporting data requirement

Under the present system, a practitioner requesting a drug under the SAP is required to submit supporting data concerning the use, safety, and efficacy of the drug with each request. The proposed amendments are intended to remove this requirement, provided that the following conditions are met:

The drug has been previously authorized by the SAP for the same medical emergency;
The drug is authorized for sale without terms and conditions (e., without any further restrictions placed on the drug) by the European Medicines Agency or the United States Food and Drug Administration for the same medical emergency for which the drug is requested; and
Any drug identification number or natural product number previously issued for the drug has not been cancelled for safety reasons.

This is intended to reduce the burden on practitioners associated with making SAP requests for frequently used drugs.

Importing & warehousing permitted

The present system prohibits importing and warehousing unapproved drugs in Canada in anticipation of an SAP request. For small individual shipments, Health Canada has nonetheless allowed this practice of “pre-positioning” through an exercise of enforcement discretion. This practice is intended to reduce the length of time it takes to get frequently requested drugs.

The proposed amendments will provide clarity by allowing a manufacturer to apply to Health Canada for approval for a drug establishment license (DEL) holder to import and warehouse a drug that may be requested under the SAP for a particular medical emergency. The DEL holder will be permitted to distribute pre-positioned drug in response to a letter of authorisation under the SAP, and will be required to comply with certain good manufacturing practices (e.g., around storage and recall traceability).

Other amendments relating to the SAP

Other amendments to the Regulations relating to the SAP include:

granting the Minister the power to request a copy of any report that was submitted to a foreign regulatory authority for the purpose of evaluating the safety, efficacy, and quality of the drug;
removing the requirement that SAP drugs be sent to an institution, allowing them to be shipped to a community pharmacy;
explicitly allowing SAP requests to be made when the identity of a patient is not known (e., for future use); and
requiring reporting for veterinary products that contain certain listed antibiotics, similar to those imposed for marketed veterinary products in 2017.

The Regulatory Impact Analysis Statement (RIAS) accompanying the proposed amendments also indicates that Health Canada anticipates having an electronic system for SAP requests in place by the end of 2019.

II. Additional regulations relating to public or CAF emergencies

The government has also proposed a second set of amendments, intended to govern the sale of drugs to public health officials for immediate use or stockpiling in connection with public health or CAF emergencies. This would be achieved by introducing a new Division 11 of the Food and Drug Regulations.

These proposed amendments would also amend the Certificates of Supplementary Protection Regulations under the Patent Act in order to clarify that an authorisation pursuant to Division 11 is not a “prior authorisation for sale” for the purposes of that regime.

The proposed amendments concerning public health/CAF use are published separately from those concerning the SAP, and are the subject of their own draft guidance document. However, the RIAS describing these proposed amendments was included in the RIAS published for the amendments to the SAP. As with those affecting the SAP, these proposed regulations and draft guidance document are open for consultation until July 19, 2019.

CUSMA Implementation Bill Introduced

By Kassandra Shortt, Christopher A. Guerreiro and Kristin Wall on June 4, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On May 29, 2019, the federal government introduced Bill C‑100 to implement the new trilateral trade deal known as the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA), making Canada the first of the three member countries to introduce legislation that would ratify the treaty.

CUSMA provides more protections for biologic and innovative pharmaceuticals under Canadian law. However, the treaty does not require the immediate adoption of these new protections and none of them are directly implemented by Bill C‑100.

As we reported, full implementation of CUSMA will require Canadian law to include:

Extended data protection for biologics (Article 20.49). CUSMA requires ratifying states to provide a minimum of ten years’ data protection from the date of first marketing authorization for new biologics. This increases data protection available to new biologics in Canada from eight to ten years, but does not match the 12 years of protection provided in the U.S.

When will it come into force? Bill C-100 creates the authority to implement this obligation by making regulations under the Food and Drugs Act, paving the way for a specific regulatory proposal at a later date. Canada must fully implement this obligation no later than 5 years after the date of entry into force of CUSMA (Article 20.90).

Patent term restoration (Article 20.44). CUSMA requires Canada to adopt a patent term restoration (PTR) system to recover time lost due to “unreasonable delays” in the issuance of a patent, at the request of the applicant. PTR will exist in addition to any certificate of supplementary protection (CSP) available for pharmaceutical patents under Canadian law.

When will it come into force? Bill C-100 does not include any amendments to the Patent Act. Canada must fully implement this obligation no later than 4.5 years after the date of entry into force of CUSMA (Article 20.90).

Bill C‑100 passed first reading in the House of Commons and will proceed to second reading. It is uncertain whether Bill C‑100 will pass before the current Parliament dissolves, with only three weeks remaining before summer recess and a federal election scheduled for October 21, 2019.

Nonetheless, the federal government has expressed confidence that Bill C‑100 will pass. Foreign Affairs Minister Chrystia Freeland was clear, stating, “I am confident we will be successful moving forward.” Trade Committee Chair Mark Eyking also suggested taking the unusual step of recalling Parliament for an extended summer sitting, if needed, to pass Bill C‑100.

Meanwhile, CUSMA itself will not come into force until the first day of the third month after it has been ratified by all three member countries. Due to a variety of intervening factors including ongoing disputes on tariffs, it remains unclear when this milestone will be reached.

Quebec Court of Appeal confirms CPA does not apply to the sale of prescription drugs

By Dominic Dupoy on May 15, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

In a May 8 decision, the Quebec Court of Appeal confirmed that the Quebec Consumer Protection Act (CPA) does not apply to the sale of prescription drugs. The decision, Brousseau v Laboratoires Abbott limitée, 2019 QCCA 801 provides critical guidance on the liability regime in Quebec for manufacturers of pharmaceutical products facing product liability claims.

A French version of this post follows.

Relevant facts

Abbott Laboratories manufactured a drug commercialized under the name Biaxin®. Abbott was named as a defendant in a class action where the plaintiff alleged the use of the drug causes side effects that had not been disclosed to users. The class action was based on Civil Code of Quebec (CCQ) provisions outlining the manufacturer’s liability regime relating to security defects, but also on section 53 of the CPA, which allows a consumer to commence an action in damages directly against the manufacturer of a good affected with a security defect. It is important to note that the means of defense that can be raised to oppose an action based on section 53 CPA are more limited than under the CCQ since the manufacturer is not allowed to claim that the state of scientific knowledge made it impossible to know of the defect.

The decision of the Court of Appeal

The Court of Appeal decision analyzes a number of important issues that are relevant in the context of a class action based on an alleged breach of the duty to warn imposed on drug manufacturers. As a result of that analysis, the court dismissed the action and held that Abbott had adequately disclosed the risks associated with the use of the product.

As it relates to the CPA claim, the court dismissed the action on the grounds that the CPA provisions were simply not applicable to the sale of prescription drugs. According to the court, a pharmacist who sells prescription drugs does not act as a merchant within the meaning of the CPA, but rather acts as a health professional. As a result, the sale by a pharmacist of prescription drugs does not lead to a contract between a consumer and a merchant and therefore the CPA does not apply.

In support of its conclusion, the court also noted that the CPA’s bar on a manufacturer raising a defense based on the state of science (as is available under the second paragraph of section 1473 CCQ) is difficult to reconcile with the specificities of drug development. The court held the Quebec legislature could not have intended to impose an absolute presumption of knowledge on drug manufacturers of all risks and dangers that could materialize after the drug enters the market.

It is also to be noted the Court of Appeal confirms the applicability of the learned intermediary doctrine in the context of Quebec civil law. Although many decisions from lower courts had applied this theory in the past, this is the first decision from the Court of Appeal confirming the applicability of the learned intermediary doctrine in Quebec. This doctrine is an important defense available to prescription drug manufacturers to establish they have met their duty to warn.

Key takeaway

As a general statement, the provisions of the CPA impose on manufacturers a liability regime that is more stringent than that provided under the general principles of the CCQ. In addition, the CPA also provides for a potential award of punitive damages in certain circumstances. The Court of Appeal decision confirming that the CPA does not apply to the sale of prescription drugs thus represents an important legal development in the field of manufacturers’ liability for pharmaceutical companies.

————————————————–

Le 8 mai 2019, la Cour d’appel du Québec a rendu une décision très importante pour les fabricants de produits pharmaceutiques. Dans l’affaire Brousseau c Laboratoires Abbott limitée, 2019 QCCA 801, la Cour d’appel a en effet confirmé que les dispositions de la Loi sur la protection du consommateur (LPC) ne s’appliquaient pas à la vente de médicaments sur ordonnance.

Les faits pertinents

La défenderesse Laboratoires Abbott limitée fabriquait un médicament connu sous le nom de Biaxin^®. Elle faisait face à une action collective en vertu de laquelle la demanderesse alléguait que ce médicament vendu sur ordonnance entraînait des effets secondaires importants qui n’avaient pas été dévoilés aux utilisateurs. L’action collective était fondée sur les dispositions du Code civil du Québec (CCQ) encadrant le régime de responsabilité du fabricant applicable en matière de sécurité des biens, mais également sur l’article 53 LPC, lequel permet à un consommateur ayant contracté avec un commerçant d’exercer directement contre le fabricant un recours fondé sur un vice caché ou un défaut de sécurité. Il est important de mentionner que les moyens de défense à l’encontre d’un recours intenté en vertu de l’article 53 LPC sont plus limités qu’en vertu du CCQ puisque le fabricant ne peut alors alléguer que l’état des connaissances scientifiques ne lui permettait pas d’être au courant du vice ou du défaut.

L’arrêt de la Cour d’appel

L’arrêt rendu par la Cour d’appel est intéressant à plusieurs égards puisqu’il analyse en détails plusieurs questions importantes dans le contexte d’une action collective alléguant le défaut d’information d’un fabricant de produits pharmaceutiques. À la suite de cette analyse, la Cour a rejeté l’action au motif que la défenderesse s’était adéquatement déchargée de son obligation d’information.

Cette décision s’avère toutefois particulièrement intéressante en ce qui concerne l’analyse du recours fondé sur l’article 53 LPC. La Cour d’appel a en effet rejeté ce recours au motif que la LPC était tout simplement inapplicable à la vente de médicaments sur ordonnance. Selon la Cour d’appel, le pharmacien qui vend un médicament sur ordonnance n’agit pas comme un commerçant au sens de la LPC, mais comme un professionnel de la santé. La vente de médicaments sur ordonnance par un pharmacien ne constitue donc pas un contrat de consommation susceptible d’entraîner la responsabilité du fabricant en application de l’article 53 LPC.

Au soutien de sa conclusion, la Cour note que l’absence, sous la LPC, d’un moyen d’exonération basé sur l’état des connaissances scientifiques au moment de la fabrication du bien (comme celui prévu au deuxième alinéa de l’article 1473 CCQ) apparaît peu conciliable avec les particularités du développement d’un médicament. La Cour en vient à la conclusion que le législateur québécois ne pouvait avoir voulu imposer aux fabricants de produits pharmaceutiques une présomption absolue de connaissance de tous les risques et dangers susceptibles de se matérialiser à la suite de la commercialisation d’un médicament.

Il est également à noter que la Cour d’appel confirme l’applicabilité de la doctrine de l’intermédiaire compétent en droit civil québécois. Bien que certaines décisions des tribunaux inférieurs avaient déjà appliqué cette doctrine au Québec, il s’agit du premier arrêt de la Cour d’appel confirmant l’applicabilité de cette doctrine dans la province. Ainsi, les fabricants de médicaments d’ordonnance disposent d’un important moyen de défense afin d’établir qu’ils se sont acquittés de leur obligation de mise en garde.

L’importance de l’arrêt de la Cour d’appel

Les dispositions de la LPC prévoient, d’une manière générale, un régime de responsabilité beaucoup plus strict que celui prévu par les principes généraux de la responsabilité civile. De plus, la LPC prévoit la possibilité pour le tribunal d’imposer au fabricant des dommages punitifs en certaines circonstances. La décision de la Cour d’appel confirmant que la LPC est inapplicable dans le contexte de la vente de médicaments sur ordonnance constitue donc un développement jurisprudentiel important en matière de responsabilité du fabricant.

Federal Court of Appeal affirms cancellation of reconsideration of ANDS for Apo-omeprazole

By Kassandra Shortt and Judith Robinson on May 2, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal has dismissed an appeal by Apotex Inc. (Apotex) in its unsuccessful application for judicial review of a decision by the Minister of Health (the Minister) to cancel the reconsideration of approval for Apo-omeprazole.

Background

As we reported, the Minister revoked Apotex’s Notice of Compliance (NOC) for Apo-omeprazole and declined to issue the NOC again in 2013 due to inadequate evidence of bioequivalence in its Abbreviated New Drug Submission. Apotex sought reconsideration of the Minister’s decision by an external expert panel on the basis of safety and efficacy. The Minister took the position that the issue for reconsideration was bioequivalence, and cancelled the reconsideration process when the parties could not agree on the question to put to the panel.

The Federal Court dismissed Apotex’s application for judicial review of the Minister’s decision to cancel the reconsideration process. The Court held that Apotex had no legitimate expectation that the Minister’s discretion would be exercised in its favour. The Court further held that the Minister did not fetter her discretion in requiring the reconsideration process to focus on bioequivalence.

Apotex’s Appeal Dismissed

On appeal, Apotex recast its position to argue that the Minister had no authority to cancel the reconsideration process entirely. Apotex asserted that it had a legitimate expectation that the reconsideration process would continue, despite the continued disagreement regarding the question to be put to the panel.

The Court of Appeal rejected this argument, as it was not raised in Apotex’s Notice of Application and was not properly before the Court. In its Notice of Application, Apotex had not sought relief to compel the Minister to continue the reconsideration process — instead, it focused exclusively on requiring the Minister to frame the question for the panel without regard to bioequivalence.

Based on the Federal Court’s reasons, the Court of Appeal was otherwise satisfied that the question as framed by the Minister was reasonable.

Link to decision: Apotex Inc. v Canada (Health), 2019 FCA 97 aff’g 2017 FC 857