12-Month Lobbying Summary - In-house Organization

Canadian Generic Pharmaceutical Association (CGPA)/L'Association canadienne du médicament générique (ACMG) / JAMES KEON, PRESIDENT

Registration Summary

Active - Last Updated: 2024-04-01

Who is lobbying?

Canadian Generic Pharmaceutical Association (CGPA)/L'Association canadienne du médicament générique (ACMG) (Address, activities & membership)

JAMES KEON, PRESIDENT

Received government funding or funding expected in current financial year

What is being lobbied?

Subject Matter Details

Details Regarding the Identified Subject Matter
Subject matters	Details	Categories
Health, Industry	Discussions with ISED towards a national strategy for the biomanufacturing and the life sciences sector.	Policies or Program
Health, Industry, International Trade	Discussions with officials regarding the COVID-19 pandemic.	Policies or Program
Health	Health Canada regarding the development of a national pharmacare strategy.	Policies or Program
Health, Industry	Health Canada with respect to its Regulatory Systems Review for Therapeutic Products.	Policies or Program, Regulation
Health, Industry	Health Canada with respect to the process for the approval and renewal of foreign sites for Drug Establishment License (DEL) holders. Related guidance documents include the Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080), the Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) and the Guidance on Good Manufacturing Practices for Active Pharmaceutical Ingredients (GUI-0104).	Policies or Program
Health, Industry	Health Canada with respect to user fees for therapeutic product regulatory programs.	Legislative Proposal, Bill or Resolution, Policies or Program, Regulation
Industry	Innovation, Science and Economic Development Canada (ISED) Innovation Agenda regarding the need for a balanced intellectual property regime and the important role competition plays in encouraging innovation.	Policies or Program
Health, Industry, International Trade	Participate in Government of Canada consultations with respect to the Regulatory Cooperation Council.	Policies or Program, Regulation
Health, Industry	Participation in Competition Bureau consultations with respect to pharmaceuticals.	Policies or Program
Health	Proposals related to Health Canada's Identical Medicinal Ingredient Policy.	Policies or Program
Health	Proposals to enhance transparency of the Health Canada Reconsiderations Policy for drug submissions.	Policies or Program
Health, Industry	Provide input into policy discussions with respect to the potential implementation of a national pharmacare program.	Legislative Proposal, Bill or Resolution
Health, Industry, International Trade	Provide input into the Government of Canada's implementation of the Canada-United States-Mexico Agreement (CUSMA).	Legislative Proposal, Bill or Resolution
Industry, International Trade	Provide input into the Government of Canada's negotiations regarding trade negotiations with respect to pharmaceuticals, counterfeit medicines, and intellectual property. This includes trade discussions between Canada and the United Kingdom.	Legislative Proposal, Bill or Resolution
Industry	Provide input into the Patented Medicine Prices Review Board (PMPRB) consultations regarding its Policies, Guidelines and Procedures.	Policies or Program
Health, Industry	Provide input into the modernization of the Food and Drugs Act and related Regulations, Guidelines and Policies as they pertain to pharmaceuticals.	Legislative Proposal, Bill or Resolution, Policies or Program, Regulation
Health, Industry	Providing input with respect to the approval pathway for biosimilar medicines by Health Canada.	Policies or Program
Health, Industry	Seeking harmonization of regulatory regimes and administrative processes nationally and internationally.	Policies or Program
Health, International Trade	To encourage the Government of Canada to continue to participate in truly international discussions with respect to effective measures to combat substandard and falsified medicines in Canada and around the world.	Policies or Program

Subject matter details in previous versions

Details Regarding the Identified Subject Matter
Subject matters	Details	Categories
Subject matters were not required to be associated with subject matter details when this content was submitted	Discussions with ISED towards a national strategy for the biomanufacturing and the life sciences sector.	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	Discussions with officials regarding the COVID-19 pandemic.	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	Health Canada regarding the development of a national pharmacare strategy.	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	Health Canada with respect to its Regulatory Systems Review for Therapeutic Products.	Policies or Program, Regulation
Subject matters were not required to be associated with subject matter details when this content was submitted	Health Canada with respect to the process for the approval and renewal of foreign sites for Drug Establishment License (DEL) holders. Related guidance documents include the Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080), the Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) and the Guidance on Good Manufacturing Practices for Active Pharmaceutical Ingredients (GUI-0104).	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	Health Canada with respect to user fees for therapeutic product regulatory programs.	Legislative Proposal, Bill or Resolution, Policies or Program, Regulation
Subject matters were not required to be associated with subject matter details when this content was submitted	Innovation, Science and Economic Development Canada (ISED) Innovation Agenda regarding the need for a balanced intellectual property regime and the important role competition plays in encouraging innovation.	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	Participate in Government of Canada consultations with respect to the Regulatory Cooperation Council.	Policies or Program, Regulation
Subject matters were not required to be associated with subject matter details when this content was submitted	Participation in Competition Bureau consultations with respect to pharmaceuticals.	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	Proposals related to Health Canada's Identical Medicinal Ingredient Policy.	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	Proposals to enhance transparency of the Health Canada Reconsiderations Policy for drug submissions.	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	Provide input into policy discussions with respect to the potential implementation of a national pharmacare program.	Legislative Proposal, Bill or Resolution
Subject matters were not required to be associated with subject matter details when this content was submitted	Provide input into the Government of Canada's implementation of the Canada-United States-Mexico Agreement (CUSMA).	Legislative Proposal, Bill or Resolution
Subject matters were not required to be associated with subject matter details when this content was submitted	Provide input into the Government of Canada's negotiations regarding trade negotiations with respect to pharmaceuticals, counterfeit medicines, and intellectual property. This includes trade discussions between Canada and the United Kingdom.	Legislative Proposal, Bill or Resolution
Subject matters were not required to be associated with subject matter details when this content was submitted	Provide input into the Patented Medicine Prices Review Board (PMPRB) consultations regarding its Policies, Guidelines and Procedures.	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	Provide input into the modernization of the Food and Drugs Act and related Regulations, Guidelines and Policies as they pertain to pharmaceuticals.	Legislative Proposal, Bill or Resolution, Policies or Program, Regulation
Subject matters were not required to be associated with subject matter details when this content was submitted	Providing input with respect to the approval pathway for biosimilar medicines by Health Canada.	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	Seeking harmonization of regulatory regimes and administrative processes nationally and internationally.	Policies or Program
Subject matters were not required to be associated with subject matter details when this content was submitted	To encourage the Government of Canada to continue to participate in truly international discussions with respect to effective measures to combat substandard and falsified medicines in Canada and around the world.	Policies or Program

Subject matters in previous versions

Consumer Issues
Economic Development
Government Procurement
Health
Industry
Intellectual Property
Internal Trade
International Relations
International Trade
Science and Technology
Small Business
Taxation and Finance
Transportation

Who is being lobbied?

Government Institutions

Canadian Heritage (PCH)
Canadian International Trade Tribunal (CITT)
Competition Bureau Canada (COBU)
Employment and Social Development Canada (ESDC)
Environment and Climate Change Canada (ECCC)
Finance Canada (FIN)
Global Affairs Canada (GAC)
Health Canada (HC)
House of Commons
Innovation, Science and Economic Development Canada (ISED)
National Defence (DND)
Patented Medicine Prices Review Board (PMPRB)
Prime Minister's Office (PMO)
Privy Council Office (PCO)
Public Health Agency of Canada (PHAC)
Public Safety Canada (PS)
Public Services and Procurement Canada (PSPC)
Senate of Canada
Transport Canada (TC)
Treasury Board Of Canada Secretariat (TBS)
Veterans Affairs Canada (VAC)

Communication techniques

Communication techniques that have been used or are expected to be used in the course of the undertaking:

Grass-roots communication
Written communication
Oral communication
Arrange one or more meetings

Who are the lobbyists?

Jeff Connell, Vice President, Corporate Affairs | No public offices held
Jody Cox, Vice President, Federal and International Affairs | Public offices held
James Keon, President | Public offices held
Kristin Willemsen, Vice President, Scientific and Regulatory Affairs | No public offices held

Registration number: 776966-548
View all registrations versions

Monthly Communication Reports

What oral and arranged communications have taken place?

What oral and arranged communications have taken place?
Date	DPOH, Position Title \| Government Institution	Subject Matters
2024-06-20	Simon Kennedy, Deputy Minister Innovation, Science and Economic Development Canada (ISED)	Industry
2024-06-19	Ritu Banerjee, Assistant Deputy Minister \| Life Sciences and Biomanufacturing Readiness Branch, Innovation, Science and Economic Development Canada (ISED)	Industry
2024-06-17	Guillaume Couillard, Executive Director Patented Medicine Prices Review Board (PMPRB)	Industry
2024-05-15	Yasir Naqvi, Parliamentary Secretary \| Office of the Health Minister, Health Canada (HC) Desiree Sam, Parliamentary Secretary Assistant \| Office of the Health Minister, Health Canada (HC)	Health, Industry
2024-05-07	Eshan Naik, Director of Policy \| Minister's office, Health Canada (HC)	Health, Industry
2024-05-01	Jade Mallette, Director of Parliamentary Affairs \| Office of the Health Minister, Health Canada (HC)	Health, Industry
2024-05-01	Michelle Boudreau, Associate Assistant Deputy Minister \| Strategic Policy Branch, Health Canada (HC)	Health, Industry
2024-05-01	Guillaume Couillard, Executive Director Patented Medicine Prices Review Board (PMPRB)	Industry
2024-02-27	Jean-Sebastien Bock, Deputy Chief of Staff and Director of Policy \| Office of the Minister of Health, Health Canada (HC)	Health, Industry
2023-12-12	Jean-Sebastien Bock, Deputy Chief of Staff and Director of Policy \| Office of the Minister of Health, Health Canada (HC) Ophelia John, Senior Policy Advisor \| Office of the Health Minister, Health Canada (HC)	Health, Industry
2023-11-08	Stefania Trombetti, Assistant Deputy Minister \| Drug Shortages Task Force, Health Canada (HC)	Health, Industry
2023-09-25	Stefania Trombetti, Assistant Deputy Minister \| Drug Shortages Task Force, Health Canada (HC)	Health, Industry
2023-09-08	Michelle Boudreau, Associate Assistant Deputy Minister \| Strategic Policy Branch, Health Canada (HC)	Health, Industry
2023-08-28	Jean-Sébastien Bock, Deputy Chief of Staff \| Minister's Office, Health Canada (HC) Mark Holland, Minister of Health \| Office of the Health Minister, Health Canada (HC) Eshan Naik, Director of Policy \| Office of the Health Minister, House of Commons	Health, Industry

View all monthly communication reports

Canadian Generic Pharmaceutical Association (CGPA) / L'Association canadienne du médicament générique (ACMG) - Address, activities & membership

Address:

501 - 4100 Yonge Street
Toronto, ON M2P 2B5
Canada

Telephone number: 416-223-2333

Fax number: 416-223-2425

Contact information in previous versions
- 409 - 4120 Yonge Street
  Toronto, ON M2P 2B8
  Canada
  
  Telephone number: 416-223-2333
  
  Fax number: 416-223-2425
- 409 - 4120 Yonge Street
  Toronto, ON M2P 2B8
  Canada
  
  Telephone number: 416-223-2333
  
  Fax number: 416-223-2425
- 409 - 4120 YONGE STREET
  TORONTO, ON M2P 2B8
  Canada
  
  Telephone number: 416-223-2333
  
  Fax number: 416-223-2425
- 409 - 4120 YONGE STREET
  TORONTO, ON M2P 2B8
  Canada
  
  Telephone number: 416-223-2333
  
  Fax number: 416-223-2425
- 409 - 4120 YONGE STREET
  NORTH YORK, ON M2P 2B8
  Canada
  
  Telephone number: 416-223-2333
  
  Fax number: 416-223-2425

Description of the organization's activities:
The Canadian Generic Pharmaceutical Association's mission is to promote an environment which supports and enhances the provision of affordable generic and biosimilar medicines to Canadians and patients around the world through research, development and manufacturing of pharmaceuticals and fine chemicals in Canada. Through its Biosimilars Canada division, it provides leadership in educating Canadian stakeholders about biosimilar medicines, and advocating for policies that support their approval, reimbursement and market acceptance.

Descriptions of the organization's activity in previous versions:
- The Canadian Generic Pharmaceutical Association's mission is to promote an environment which supports and enhances the provision of affordable generic and biosimilar medicines to Canadians and patients around the world through research, development and manufacturing of pharmaceuticals and fine chemicals in Canada.
- The Canadian Generic Pharmaceutical Association's mission is to promote and environment which supports and enhances the provision of affordable generic and biosimilar medicines to Canadians and patients around the world through research, development and manufacturing of pharmaceuticals and fine chemicals in Canada.
- The Canadian Generic Pharmaceutical Association's mission is to promote and environment which supports and enhances the provision of affordable generic chemicals and medications to Canadians and patients around the world through research, development and manufacturing of pharmaceuticals and fine chemicals in Canada.
- THE CANADIAN GENERIC PHARMACEUTICAL ASSOCIATION'S MISSION IS TO PROMOTE AN ENVIRONMENT WHICH SUPPORTS AND ENHANCES THE PROVISION OF AFFORDABLE GENERIC CHEMICALS AND MEDICATIONS TO CANADIANS AND PATIENTS AROUND THE WORLD THROUGH RESEARCH, DEVELOPMENT AND MANUFACTURING OF PHARMACEUTICALS AND FINE CHEMICALS IN CANADA
- THE CANADIAN GENERIC PHARMACEUTICAL MANUFACTURERS ASSOCIATION'S MISSION IS TO PROMOTE AN ENVIRONMENT WHICH SUPPORTS AND ENHANCES THE PROVISION OF AFFORDABLE GENERIC CHEMICALS AND MEDICATIONS TO CANADIANS AND PATIENTS AROUND THE WORLD THROUGH RESEARCH, DEVELOPMENT AND MANUFACTURING OF PHARMACEUTICALS AND FINE CHEMICALS IN CANADA
- THE CANADIAN GENERIC PHARMACEUTICAL MANUFACTURERS ASSOCIATION'S MISSION IS TO PROMOTE AN ENVIRONMENT WHICH SUPPORTS AND ENHANCES THE PROVISION OF AFFORDABLE GENERIC CHEMICALS AND MEDICATIONS TO CANADIANS AND PATIENTS AROUND THE WORLD THROUGH RESEARCH, DEVELOPMENT AND MANUFACTURING OF PHARMACEUTICALS AND FINE CHEMICALS IN CANADA.
- THE CANADIAN DRUG MANUFACTURERS ASSOCIATION'S MISSION IS TO PROMOTE AN ENVIRONMENT WHICH SUPPORTS AND ENHANCES THE PROVISION OF AFFORDABLE GENERIC AND INNOVATIVE MEDICATIONS TO CANADIANS AND PATIENTS AROUND THE WORLD THROUGH RESEARCH, DEVELOPMENT AND MANUFACTURING OF PHARMACEUTICALS AND FINE CHEMICALS IN CANADA.
- THE CANADIAN DRUG MANUFACTURERS ASSOCIATION'S MISSION IS TO PROMOTE AN ENVIRONMENT WHICH SUPPORTS AND ENHANCES THE PROVISION OF AFFORDABLE GENERIC MEDICATIONS TO CANADIANS AND PATIENTS AROUND THE WORLD THROUGH RESEARCH, DEVELOPMENT AND MANUFACTURING OF PHARMACEUTICALS AND FINE CHEMICALS IN CANADA.

Organization's membership or classes of membership:
The Canadian Generic Pharmaceutical Association represents manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. Through its Biosimilars Canada division, it provides leadership in educating Canadian stakeholders about biosimilar medicines, and advocating for policies that support their approval, reimbursement and market acceptance.

Organization's memberships or classes of memberships in previous versions:
- The Canadian Generic Pharmaceutical Association represents manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. Through its Biosimilars Canada division, it provides leadership in educating Canadian stakeholders about biosimilar medicines, and advocating for policies that support their approval, reimbursement and market acceptance.
- The Canadian Generic Pharmaceutical Association represents manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. Through its Biosimilars Canada Board, it provides leadership in educating Canadian stakeholders about biosimilar medicines, and advocating for policies that support the approval, reimbursement and market acceptance of biosimilars.
- The Canadian Generic Pharmaceutical Association represents manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry.
- THE CGPA IS COMPOSED OF 19 MEMBER COMPANIES IN THE GENERIC PHARMACEUTICAL INDUSTRY, BOTH FINE-CHEMICAL COMPANIES AND FINAL DOSAGE COMPANIES.
- THE CGPA IS COMPOSED OF 18 MEMBER COMPANIES IN THE GENERIC PHARMACEUTICAL INDUSTRY, BOTH FINE-CHEMICAL COMPANIES AND FINAL DOSAGE COMPANIES.
- THE CDMA IS COMPOSED OF 18 MEMBER COMPANIES IN THE GENERIC PHARMACEUTICAL INDUSTRY, BOTH FINE-CHEMICAL COMPANIES AND FINAL DOSAGE COMPANIES.
- THE CDMA IS COMPOSED OF 21 MEMBER COMPANIES IN THE GENERIC AND BIOPHARMACEUTICAL INDUSTRY, FINE-CHEMICAL COMPANIES AND FINAL DOSAGE COMPANIES.

List of Public Offices Held
Position	Period Held	Last Date Designated Public Office Held
Special Assistant, Communications House of Commons, Progressive Conservative's Leader Office	March 2000 to January 2001	Not a designated office

List of Public Offices Held
Position	Period Held	Last Date Designated Public Office Held
Acting Director General Industry Canada, Consumer Affairs	1994 to 1994	Not a designated office
Regional Director Consumer and Corporate Affairs, B.C. and Yukon	1991 to 1993	Not a designated office
Director Consumer and Corporate Affairs, Intellectual Property	1988 to 1991	Not a designated office
Senior Analyst Consumer and Corporate Affairs, Consumer Affairs	1987 to 1988	Not a designated office
Policy Analyst Consumer and Corporate Affairs, Intellectual Property	1978 to 1986	Not a designated office
Research Analyst Statistics Canada, Industry Statistics	1977 to 1978	Not a designated office

Date Modified:: 2024-04-04

Search and menus

Language selection