Alert level: red OPQ: Q-25 Session: 451 Suggested file name: gain_of_function Tabled on: Agencies: PHAC|FIN Estimated questions: 7 Estimated responses: 0 Original filename: Q-25 gain of function.pdf External links / references: https://search.open.canada.ca/en/gc/?sort=score https://rechercher.ouvert.canada.ca/fr/gc/?sort=score%20desc&page=1&search_text=&gc-search- Extracted PDF text preview: ORDER/ADDRESS OF THE HOUSE OF COMMONS ORDRE/ADRESSE DE LA CHAMBRE DES COMMUNES Q-25 Mr. Carrie (Oshawa) Nov 23, 2021 / Le 23 nov. 2021 RETURN BY THE LEADER OF THE GOVERNMENT IN THE HOUSE OF COMMONS DÉPÔT DU LEADER DU GOUVERNEMENT À LA CHAMBRE DES COMMUNES Mr. Lamoureux PRINT NAME OF SIGNATORY INSCRIRE LE NOM DU SIGNATAIRE SIGNATURE MINISTER OR PARLIAMENTARY SECRETARY MINISTRE OU SECRÉTAIRE PARLEMENTAIRE January 31, 2022 / Le 31 janvier 2022 (TABLED FORTHWITH /DÉPOSÉ AUSSITÔT) INQUIRY OF MINISTRY DEMANDE DE RENSEIGNEMENT AU GOUVERNEMENT PREPARE IN ENGLISH AND FRENCH MARKING "ORIGINAL TEXT" OR "TRANSLATION" PRÉPARER EN ANGLAIS ET EN FRANÇAIS EN INDIQUANT "TEXTE ORIGINAL" OU "TRADUCTION" QUESTION NO./NO DE LA QUESTION Q-25 BY / DE Mr. Carrie (Oshawa) DATE November 23, 2021 Reply by the Minister of Health Réponse de la ministre de la Santé Signed by Mr. van Koeverden PRINT NAME OF SIGNATORY INSCRIRE LE NOM DU SIGNATAIRE SIGNATURE MINISTER OR PARLIAMENTARY SECRETARY MINISTRE OU SECRÉTAIRE PARLEMENTAIRE QUESTION With regard to gain-of-function virology research: (a) what is the government's position on (i) funding such research, (ii) such research taking place in Canada; (b) has the government conducted any such studies since January 1, 2016, and, if so, what are the details of each study, including (i) who conducted the research, (ii) the location of the laboratory where research was conducted, (iii) the purpose or goal of the study, (iv) the findings; and (c) what are the details of any such studies or research funded by the government since January 1, 2016, including the (i) amount of funding, (ii) recipient, (iii) date of the funding, (iv) description of the project, (v) project start and end dates? REPLY / RÉPONSE ORIGINAL TEXT TRANSLATION TEXTE ORIGINAL TRADUCTION Public Health Agency of Canada (a) Gain-of-function virology research can have various beneficial applications in the fields of public health, therapeutics, environmental health and agriculture. The Public Health Agency of Canada (PHAC) recognizes these benefits but also the potential implications of gain-of-function virology research. PHAC administers and enforces the Human Pathogens and Toxins Act and its associated Regulations (HPTA/R). All research with human pathogens and toxins conducted in Canada, including gain-of- function virology research, falls under these regulations. It is with this legislation that the government is able to balance safety imperatives with socially responsible scientific innovation. As the regulator, PHAC does not have a role in any funding decisions, as this would be a conflict of interest. Under the HPTA/R, gain-of-function research is regulated to ensure that the benefits outweigh the risks and that any remaining risks are mitigated. There are many requirements in place to address and mitigate the biosafety and biosecurity risks related to pathogens and toxins, including those that have gain-of-function potential. For example, all individuals or organizations wishing to possess, produce, store, permit access to, transfer, import or export, release, or dispose of human pathogens and toxins, must be issued a Human Pathogen and Toxin licence. All facilities performing research on human pathogens must also submit a plan for administrative oversight. The plan must demonstrate how facilities identify, assess and manage risks of research activities, including the qualities of a pathogen or toxin that allow it to be either used for legitimate scientific applications, or intentionally misused as a biological weapon to cause harm. The plan serves as an accountability system to mitigate the potential biosafety and biosecurity risks, and addresses risks that stem from gain-of-function research. A facility is not issued a Human Pathogen and Toxin licence until this plan is reviewed by the PHAC. PHAC works closely with all licensed facilities conducting research under the HPTA/R, to review oversight plans in detail and work with the facilities to strengthen their internal accountability systems. (b) See Annex A. (c) See Annex A. X - 2 - Canadian Institutes of Health Research (a) (i) The Canadian Institutes of Health Research (CIHR) funds research performed outside of the Government of Canada, in accordance with its legislated objective as outlined in the Canadian Institutes of Health Research Act. Recipients of CIHR funding are required to comply with all legislated and other requirements for research they perform, as set out in the Agreement on the Administration of Agency Grants and Awards by Research Institutions. (ii) Where research based in Canada meets CIHR funding requirements, it may be eligible for CIHR funding. (b) N/A (c) CIHR does not systematically track gain-of-function virology research that it may fund. A manual search of funding databases would be required and as such, could not be completed within the allotted time. However, projects funded by CIHR are publicly available on the Open Canada website at: https://search.open.canada.ca/en/gc/?sort=score desc&page=1&search_text=&gc-search- orgs=Canadian%20Institutes%20of%20Health%20Research NAME OF ORGANIZATION: The Public Health Agency of Canada Annex A (i) who conducted the research (ii) the location of the laboratory where research was conducted (iii) the purpose or goal of the study (iv) the findings Q-25 – Part (b) Q-252 — November 25, 2021 — Mr. Carrie (Oshawa) — With regard to gain-of-function virology research: (a) what is the government's position on (i) funding such research, (ii) such research taking place in Canada; (b) has the government conducted any such studies since January 1, 2016, and, if so, what are the details of each study, including (i) who conducted the research, (ii) the location of the laboratory where research was conducted, (iii) the purpose or goal of the study, (iv) the findings; and (c) what are the details of any such studies or research funded by the government since January 1, 2016, including the (i) amount of funding, (ii) recipient, (iii) date of the funding, (iv) description of the project, (v) project start and end dates? (b) has the government conducted any such studies since January 1, 2016, and, if so, what are the details of each study, including Gain of function is a generic term that encompasses a wide spectrum of research, particularly in the field of microbiology. The phrase is often misused to exclusively represent studies conducted in the past decade that involved increasing transmissibility and/or pathogenicity of respiratory viruses with pandemic potential, primarily influenza viruses, SARS-like coronaviruses and MERS coronavirus. Such studies are often now referred to as “gain of function studies of concern” by scientific experts. The National Microbiology Laboratory Branch (NMLB) does not conduct these types of experiments. Through the Human Pathogens and Toxins Act and its regulations, requirements are in place to address and mitigate the biosafety and biosecurity risks related to pathogens and toxins, including those that have a gain-of-function. Given the broad definitions of gain of function studies in the enquiry, PHAC provides clarification on types of studies that by some definitions may be considered gain of function and examples of work that NML conducts within these categories. Category 1: Research activities with the intent of creating a pathogen with increased virulence, pathogenicity, or communicability in humans PHAC does not conduct this line of experiments within the NMLB 1 of 4 NAME OF ORGANIZATION: The Public Health Agency of Canada Annex A (i) who conducted the research (ii) the location of the laboratory where research was conducted (iii) the purpose or goal