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French Language Requirements: Quebec Publishes Long-Awaited Draft Regulation on Documents Used in Research

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Life Sciences Bulletin

The National Assembly adopted Bill 96, An Act respecting French, the official and common language of Québec on May 24, 2022, ushering in new provisions of the Charter of the French language (“Charter”). Following this, on March 1, 2023, the Minister of the French Language, Jean-François Roberge (the “Minister”), announced the draft of Regulation respecting the derogations to the duty of exemplarity of the civil administration and the documents drawn up or used in research (“draft Regulation”) in the Gazette Officielle du Québec. The draft Regulation was accompanied by the Draft Regulations respecting the language of the civil administration. The Regulations are empowered by virtue of the Charter.

Stakeholders in the pharmaceutical industry and the university sector have long awaited the release of the draft Regulation, notably due to the anticipated impact on clinical research conducted in the province of Québec. Since the adoption of Bill 96, the research sector has been in  flux, awaiting guidance on how to best adapt practices and processes to ensure compliance with the new, onerous obligations of the Charter.

The following bulletin surveys the draft Regulation’s new language requirements as they apply to the administration of clinical trial research. The Regulation is set to come into force on June 1, 2023. The Minister is accepting written submissions for comments on the draft for 45 days following the Gazette’s publication.

As a general principle, the civil administration (including public research organizations such as hospitals and CIUSSS) are subject to the exemplary use of the French language. This rule generates tension in the research sector, where using another language – namely English – is not merely a theoretical question. Indeed, Québec study sites often take part in national or global multicentric research studies, under a single protocol. In this context, the uniformity of documentation is paramount to ensure consistency and scientific integrity. Safety communications are not necessarily drafted or received in French. Thus, the requirement to translate communications between a Québec establishment and the sponsor’s out-of-province pharmacovigilance department, research ethics boards or other research sites could cause time lags and inconsistencies in translations that unjustifiably jeopardize patient safety.

The draft Regulation aims at addressing some of those issues.

Importantly, the draft Regulation carves out a few exceptions applicable allowing for documents drawn up and used in research to be written only in a language other than French. The following research documents are covered by the proposed exception:

  1. economic and financial documents;
  2. information sent by a participant in research or by a person contributing to the research to provide information;
  3. the material used for a survey, in particular a questionnaire or an interview form;
  4. the documents necessary for a clinical trial, in particular the research protocol, the investigator’s brochure, the procedure schedule, the imaging acquisition guide and the pharmacy manual;
  5. the scientific study and its assessment;
  6. the documents attached to an application for authorization or for financial assistance;
  7. a document for which the exclusive use of the official language compromises the carrying out of the mission of the agency of the civil administration where the agency has taken all reasonable means to have the document drawn up only in French.

Further, the draft Regulation indicates that where the exclusive use of French could compromise the carrying out and the mission of an agency of the civil administration, they may, for a period of two years, use another language in addition to the official one. This will be the case where the agency has exhausted all reasonable measures to comply with the French language requirement.

Importantly, the exceptions put forth by the draft Regulation for documents drawn up and used in research do not derogate from the application of s. 21 of the Charter to contracts in that same context. Contracts entered into by the civil administration, including related sub-contracts, shall still be drawn up in the official language of French. Another language may only be used in the case where civil administrations enter into a contract with a party outside Québec. The drafting and the use of contracts in research in another language, in addition to French, is nonetheless implicitly permitted—although, this is not a resource-conscience compromise.

As mentioned above, the Minister is accepting comments on the Draft Regulation for 45 days. The Minister is likely to receive push-back on the application of s. 21 of the Charter in light of the draft Regulation, due to the challenges and risks associated with a French negotiation of research contracts. However, this would require amendment to the Charter, and not the draft Regulation, which is not the subject of the 45 day commentary period.

It will be interesting to see if and how the Minister responds to concerns of English-dominated clinical trial research in light of the draft Regulation. The life sciences team at Fasken remains available to help guide industry through the amendments, which will come into force on June 1, 2023.

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