Canada: Quebec Unveils Exceptions To The Prohibition On Loyalty Programs

Last Updated: July 23 2018
Article by Mathieu Gagné, Jean-Raphaël Champagne, Dara Jospé and Jean H. Gagnon

Last Wednesday, July 4, 2018, the proposed regulation entitled "Exceptions à l'interdiction de payer ou de rembourser le prix d'un médicament ou d'une fourniture dont le paiement est couvert par le régime général d'assurance medicaments (exceptions to the prohibition to pay or reimburse the price of a drug or a supply, the payment of which is covered by the basic prescription drug insurance plan" [our translation]), was published in the Gazette officielle du Québec ("Draft Regulation").

More than 18 months after the enactment of Bill 92, the government finally revealed the exceptions that will allow the implementation of certain financial support programs. But, does the series of exceptions unveiled on July 4 contain genuine exclusions or is it instead a reversal of the general prohibition in the law?

Since the adoption of Bill 92, the Act respecting prescription drug insurance (CQLR, c. A-29.01) sets out a new prohibition for manufacturers, wholesalers and intermediaries to pay or reimburse all or part of the price of medication or supply covered by the plan, to both public and private sector beneficiaries.1

As part of the debates leading up to the passage of Bill 92, it was agreed to postpone enforcing this ban until the Minister of Health and Social Services ("Minister") defined a regulatory framework that allowed certain exceptions, including notably for humanitarian reasons. At the time, the goal was to limit the disruption that would have resulted from a sudden ban on all patient support programs with a financial component.

After spending more than a year and a half examining the issue of patient support programs, the Minister's experts have finally come up with the Draft Regulation, which contains three short provisions. Despite their succinctness, these provisions will undoubtedly affect the fate of support programs and are all the more surprising given what was announced in Bill 92.

Section 1

Section 1 of the Draft Regulation specifies that manufacturers, wholesalers and intermediaries may pay or reimburse the price of listed medications when: (i) the lowest price method does not apply; or (ii) no generic or biosimilar version is reimbursed.

It should be noted that the Minister has, in a sense, reversed the general prohibition in the act and finally chosen to avoid circumscribing the types of payments or reimbursements exempted based on the humanitarian nature of the programs. Rather than setting out specific and detailed exceptions, the Draft Regulation simply suggests that financial support programs are not prohibited unless the lowest price method applies or a generic or biosimilar is covered by the plan.

Even when a generic version is reimbursed, an interpretation of section 1 may suggest that financial assistance may be available if the physician indicates "do not substitute" in accordance with the relevant rules2 in force. Note, however, that the language of the current proposed draft generates significant confusion about whether all drugs for which the lowest price method does not apply (including prescribed products with a "no substitution" indication) are exempt from the ban or whether only drugs on the « Liste des médicaments pour lesquels la méthode du prix le plus bas ne s'applique pas3 » (List of drugs for which the lowest price method does not apply) are exempt.

Moreover, there is no doubt that loyalty-type programs aimed at maintaining the use of an innovative drug following the listing of a competitor's generic drugs will be banned in Quebec once the Draft Regulation comes into force. This ban is timely for pharmacists and secures their professional benefits as the members of the Association québécoise des pharmaciens propriétaires  (Quebec Association of Pharmacy Owners, or AQPP) have recently ratified their agreement with the Minister.

All in all, this is good news for patients who, in most cases, will continue to benefit from support programs with a financial component, at least until the listing of a generic or biosimilar drug.

In any case the exception in section 1 refers to the notion of "inscription" or "listing" but ignores any reimbursement conditions for exceptional medications. To this end, the use of the term "inscription" or listing is not inconsequential, since it seems broad enough to prohibit all compassionate or copayment programs once a generic is available, unless the physician mentions that a product cannot be substituted. Thus, a patient receiving an innovative product for an indication recognized for reimbursement by the basic plan in Quebec could be prohibited from receiving any assistance from the innovative company as soon as the generic is listed, even if the generic product in question is listed under different, more limiting reimbursement terms.4

Section 2

Section 2 includes a grandfather clause that would allow patients who have received a payment or reimbursement before the prohibition comes into force to continue receiving this financial assistance.

Needless to say, manufacturers, wholesalers and intermediaries whose programs are affected by the general prohibition must remain cautious. Indeed, the proposed grandfather clause does not allow the continuation of all programs; it only allows payment or reimbursement to persons who received the financial assistance in the past. The enrollment of new patients in existing programs would therefore not be permitted.

In fact, funding providers should identify who received payments before the prohibition comes into effect, taking great care, however, to respect the applicable rules on the protection of privacy.

Section 3

Section 3 deals with the coming into force of the regulations, which in turn will trigger the coming into force of the general prohibition under section 80.1 (2) of the Act respecting prescription drug insurance. It is fixed on the fifteenth day following the date of publication of the regulation adopted in the Gazette officielle du Québec.

Given the potential wide-reaching impact of the proposed changes, drug companies may be highly motivated to participate in the government's consultation on these proposed regulations. 

Comments may be provided in writing within 45 days following publication of the Draft Regulations.

Footnotes

1 Act respecting prescription drug insurance, (CQLR c A-29.01), s. 80.2(1) [Not in force]

2      See : RAMQ Infolettre 265, Nouvelles règles concernant le recours à la mention « ne pas substituer » (New rules on the use of the words "do not substitute"), February 19, 2015, online.

3      Schedule V of the list of medications published under section 60 of the Act respecting prescription drug insurance (CQLR c A-29.01).

4       It is worth noting, however, that the general prohibition of the law should not apply to drugs prescribed for an indication that does not meet the reimbursement conditions of the basic plan, even if a generic or biosimilar version is available, or reimbursed by the plan.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions