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Trilateral Cooperation Charter
Between
The Health Products and Food Branch,
Health Canada
Canada,
The Food and Drug Administration,
Department of Health and Human Services
The United States of America,
and
The Federal Commission for the Protection from
Sanitary Risks,
Secretaria de Salud
Mexico
MEMBERSHIP (Participants to the Trilateral Cooperation)
CRITERIA FOR IDENTIFYING ISSUES FOR DISCUSSION
Agenda Development and Dissemination
SUMMARY OF OPERATING PROCEDURES
Meeting Process
Decision Making
Responsibilities of Members
Sub-committees
Amendments
APPENDIX A: GOVERNANCE STRUCTURE
APPENDIX B: TERMS OF REFERENCE OF THE WORKING GROUPS
APPENDIX C: KEY PRIORITIES FOR 2004
To increase communication, collaboration, and the exchange of information among the three countries in the areas of drugs, biologics, medical devices, food safety and nutrition to protect and promote human health.
To protect and promote public health through a trilateral forum that shares information and works collaboratively on issues of mutual interest.
United States: | Food and Drug Administration (USFDA)* and the Federal Trade Commission (FTC). |
Canada1 : | Health Products and Food Branch (HPFB)*, Canadian Food Inspection Agency (CFIA), and the Commissioner of Competition (Competition Bureau). |
Mexico: | Federal Commission for the Protection from Sanitary Risks (COFEPRIS),* Federal Office of the Judge Advocate General of Consumers (PROFECO). |
*Signatories
This Charter recognizes that others may be invited to participate (based on the issues before the Trilateral Cooperation). It also recognizes that non-signatory organizations have mandates in the areas of drugs, medical devices, food safety, and nutrition (to protect and promote human health) as well as in the areas of general marketplace competition and consumer benefit.
In pursuit of this mission, members intend to actively engage in achieving the following strategic objectives:
To achieve these objectives, the Parties to the Trilateral Cooperation should be guided by the following principles:
The Trilateral Heads of Delegation Team is the decision-making body of the Trilateral Cooperation. It comprises the leaders of HPFB (Assistant Deputy Minister), the FDA (Commissioner of Food and Drugs), and COFEPRIS (Federal Commissioner). The role of the Trilateral Heads of Delegation is to provide overall leadership for and direction to the Trilateral Cooperation.
Reporting to the Heads of Delegation, the Steering Committee sets the agenda for each meeting in line with the principles and strategic objectives, focusing on priorities that benefit all countries.
The Steering Committee consists of an equal number of members from each country, with the selection being the responsibility of the individual countries. The Committee provides leadership to the Working Groups and recommends high-level policy issues to the Heads of Delegation. As well, it identifies and discusses new and emerging issues confronting the three countries. The Steering Committee is led by country Co-chairs who serve as liaisons to the Working Groups.
Specifically, the Steering Committee
The Trilateral Cooperation undertakes its work through Working Groups. Three Co-chairs representing each country head each Working Group. The Co-chairs are responsible for identifying issues for discussion and for seeking the Steering Committee's support. Current Working Groups include the following:
Management and support services are provided by each of the countries to the Trilateral Cooperation. Country Coordinators coordinate input and develop agendas for the Trilateral meetings. They are also responsible for selecting a facilitator, creating a record of decisions at each Committee meeting, establishing schedules for Steering Committee conference calls and meetings, and developing and tracking action items from each meeting.
The Trilateral Cooperation serves the mutual interests of all three countries and provides a forum for participants to discuss effective means for achieving its mission. Joint problem-solving techniques and consensual decision-making processes are used in reaching resolution of issues in a way that advances public health and gives consideration to the economic impact of health fraud. To avoid duplication and overlap, the Trilateral Cooperation should not deal with issues that are being discussed in other fora unless requested to do so as a means of solving a specific problem affecting the three countries or unless directed to do so by the Heads of Delegation. The Committee recognizes that the work under the Trilateral Cooperation is not a substitute for bilateral cooperation, nor does it impose obligations on its counterparts. Countries should use existing and new fora to discuss bilateral issues.
To prioritize its discussions, the Steering Committee uses the following criteria in selecting issues for discussion. Each issue must
The Steering Committee and the Working Groups should meet in the spring and fall of each year, with any additional meetings (teleconferences or videoconferences) called by the Steering Committee as required. Meetings should be hosted by each country on a rotating basis (Canada-Mexico-US). The host country is responsible for all scheduling, logistics, and management of the meetings.
The spring meeting will be devoted to reviewing progress, resolving any impediments to progress, and evaluating accomplishments.
The fall meeting, which includes a meeting of the Heads of Delegation, will be devoted to a year-end review, the assessment of outcomes, the identification of new issues, and the setting of priorities for the following year.
A tracking system (Action Plan) is to be developed by each Working Group to track major projects including action items, performance measurements, progress and accomplishments. The system should be updated regularly with summaries provided to the Steering Committee and the other Working Groups ahead of the spring and fall meetings. The Steering Committee expects to use these meetings to determine whether to renew its procedures and/or to make changes in any aspect of the partnership.
Agenda Development and Dissemination
Meeting agendas (subject to the Steering Committee's final approval) are developed by the host country in collaboration with the other two countries. All potential agenda items should be submitted to the country Coordinators who will forward them to the host country. The host country develops a mutually agreeable agenda for the spring and fall meetings. The final agenda should be distributed to all participants at least 10 working days prior to the meeting. For issues that require the Steering Committee to make a decision, all related information must be distributed to participants no later than 10 calendar days prior to the meeting.
Meeting Process
Decision Making
Responsibilities of Members
Sub-committees
Amendments
Signed on this twenty-seventh day of February 2004, in the English, French and Spanish languages, each version being equally valid.
For The Health Products and Food Branch
HEALTH CANADA
CANADA:
________________________________
Diane C. Gorman
Assistant Deputy Minister
Head of Delegation (Canada)
For The Food and Drug Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
THE UNITED STATES OF AMERICA:
________________________________
Mark B. McClellan, M.D., Ph.D.
Commissioner of Food and Drugs
Head of Delegation (United States of America)
For The Federal Commission for the Protection from Sanitary Risks
SECRETARIA DE SALUD
MEXICO:
________________________________
Ernesto EnrĂquez Rubio
Federal Commissioner
Head of Delegation (Mexico)
Purpose
To consolidate and maintain a formal framework for trilateral cooperation in combating health fraud, so as to protect and promulgate the health and economic well being of citizens of all three nations and to identify appropriate lines of communication to ensure a continual exchange of information on compliance and enforcement activities among the three countries.
Health Fraud Definition
For the purposes of this Working Group, health fraud may include the following:
The false, deceptive, or misleading promotion, advertisement, distribution, sale, possession for sale, or offering for sale of products or provision of services, intended for human use, that are represented as being safe and/or effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), to rehabilitate patients or to provide a beneficial effect on health.
Objectives
To the extent compatible with their laws, enforcement policies, and other important interests, each member country shall
Membership
The Working Group shall consist of the following:
The Working Group shall be chaired by one representative from each country. These three Co-chairs shall be individuals with responsibility for implementing or recommending policy changes within their organizations.
Structure
The Co-chairs shall chair Working Group meetings and conference calls on a rotational basis.
Ad hoc committees shall be created or disbanded according to Working Group needs.
Ad hoc committee members are to be drawn from the Working Group membership, although non-members may be asked to contribute on the basis of specific expertise.
Each ad hoc committee shall develop Terms of Reference and structures as required. As a general rule, ad hoc committees shall report directly to the full Work Group membership unless urgency dictates a more immediate response. In such cases, the Working Group Chair shall determine the appropriate reporting process.
Secretariat Services
Secretariat services shall be provided through the offices of the Head of Delegation of the member country hosting the event. These services comprise the following:
Decisional Process
Decisions shall be based upon consensus rather than majority vote.
Meetings Schedule
The Much Working Group shall meet twice a year. The first meeting shall be held immediately prior to the Trilateral Heads of Delegation meeting, in order to provide a report at the latter on achievements and progress over the previous year and seek their guidance and direction on specific issues as required. The second meeting shall be held six months after the Trilateral Heads of Delegation meeting and will have to follow up on the commitments previously established.
Language
The meetings shall take place in the three official languages
pertaining to the ensemble of the Working Group Membership: English,
French,
and Spanish. The host country shall be responsible for ensuring
simultaneous translation
as may be necessary.
With respect to press releases, communiqués, and other
such materials, each member country shall be responsible for
ensuring appropriate
translation
for dissemination within their own national boundaries obtaining
necessary approvals within mutually agreeable time frames.
These terms of reference have been adopted simultaneously in
versions prepared in the three official languages and are intended
to have
the same meaning
in each version.
October 2003
Purpose
The purpose of CUMCIG is to increase the exchange of compliance and enforcement information and to increase cooperation between the United States, Canada, and Mexico in the areas of drugs, biologics, medical devices, food safety, and nutrition.
Objectives
To the extent compatible with their respective statutory and regulatory authorities, policies, and other important priorities, each member country shall
Membership
The CUMCIG Working Group shall consist of the following:
The Working Group shall be chaired by one official government representative of the regulatory agencies from each country. The three Co-chairs shall be individuals with relevant expertise.
Structure
The Co-chairs shall chair the CUMCIG meetings and conference calls on a rotational basis. Issues requiring follow-up will be delegated by the Chair to Working Groups that are created on ad hoc basis.
The CUMCIG Co-chair reports to the Trilateral Steering Committee.
Individual participants brief their respective
organizations on the discussions and action
items resulting from
the CUMCIG meeting.
Secretariat Services
Secretariat services shall be provided through the offices of the Head of Delegation of the member country hosting the event. These services comprise the following:
Decisional Process
Decisions shall be based upon consensus rather than majority vote.
Meetings Schedule
The CUMCIG Working Group shall
meet twice a year. The first meeting
shall
be held immediately
prior
to the
Trilateral
Heads of Delegation
meeting
in order to provide a report at
the latter on achievements and
progress
over
the previous year and to seek guidance
and direction on specific issues
as required.
The
second meeting
shall be held six
months after the Trilateral
Heads of Delegation meeting and
will have to follow up on the commitments
previously
established.
Operating Principles
The CUMCIG Working Group’s activity will be based on the following principles:
An appropriate agenda will be developed jointly. However, the host country will be responsible for developing, distributing, and maintaining the Action Items. The agenda will be made available a minimum of five working days in advance of each meeting.
The Working Group will not duplicate work being carried out by other Working Groups or committees.
The agency raising an issue shall lead the discussion.
The Working Group should focus on the exchange of information on compliance and enforcement activities. This exchange may be of a general nature, health protection policy issues, safety and quality issues or specific issues (e.g., canned mushrooms).
Language
The meetings shall take place in the three official languages pertaining to the ensemble of the Working Group membership: English, Spanish, and French. The host country shall be responsible for ensuring simultaneous translation as may be necessary.
With respect to press releases, communiqués, and other such materials, each member country shall be responsible for ensuring appropriate translation for dissemination within their own national boundaries-obtaining necessary approvals and/or clearances within mutually agreeable time frames.
The Terms of Reference have been adopted simultaneously in versions prepared in the three official languages and are intended to have the same meaning in each version.
October 2003
Purpose
The purpose of the Laboratory Cooperation Working Group (LCG) is to identify and share analytical methods with the long-term goal of building a trustworthy analytical network. The LCG is also to work closely with and provide support to CUMCIG and MUCH, in their investigations of fraudulent products, counterfeit or unsafe drugs, and shortages of legitimate drugs.
Objectives
To the extent compatible
with their respective
statutory and
regulatory
authorities, policies
and priorities,
each member
country shall
· identify and establish lines of communication to ensure a continual
exchange of information on
laboratory and regulatory science issues among the three
countries;
Membership
The LCG shall consist of one lead representative of each of the Heads of Delegation and representatives from other bodies as deemed appropriate by all member countries.
Structure
From the membership, a representative of one of the three Heads of Delegation shall chair the LCG on a rotational basis such that the period shall end with the conclusion of the meeting in the Chairperson’s country.
The last item of business of each meeting shall be to elect the next Chairperson who will be the member in whose country the next LCG meeting is to be held.
Issues requiring follow-up may be delegated by the Chair to ad hoc groups.
The Chairperson of the LCG reports to the Trilateral Heads of Delegation.
Secretariat Services
Secretariat services shall be provided through the offices of the Head of Delegation of the member country hosting the event. These services comprise:
Decision Process
Decisions shall be based upon consensus of lead representatives rather than majority vote.
Meetings Schedule
The Working Group shall conduct its business on a continual basis and shall meet as required, either face-to-face or by telephone and then face-to-face immediately prior to the Trilateral Heads of Delegation meeting to report on its achievements and progress over the previous year and to seek guidance and direction on specific issues, as required.
Operating Principles
The Working Group’s activity will be based on the following principles:
Language
The meetings shall be conducted in the three official languages pertaining to the ensemble of the Working Group Membership: English, French, and Spanish. The host country shall be responsible for ensuring simultaneous translation as may be necessary.
With respect to press releases, communiqués, and other such materials, each member country shall be responsible for ensuring appropriate translation for dissemination within their own national boundaries obtaining necessary approvals within mutually agreeable time frames.
These terms of reference have been adopted simultaneously in versions prepared in the three official languages and are intended to have the same meaning in each version.
November 2003
Purpose
To share existing and future information, to establish a communication strategy between the Training Working Group and the other Working Groups and to assist the Trilateral leadership in identifying training needs of common interest for the three countries of staff who will be engaged in activities related to initiatives of the Trilateral Cooperation.
Objective
1. To develop or assist in the development and delivery of training intended to further the purpose of the Trilateral Cooperation, in line with its strategic objectives, which are to
2. To organize a pre-trilateral seminar prior to each annual meeting. The pre-trilateral seminar will be managed by the host country.
Membership
One person from each country will serve on the Working Group.
Structure
A chairperson will be elected for a term of two years.
Secretariat Services
The Chairperson will provide secretariat services to include the following:
Decisional Process
Decisions shall be based upon consensus rather than majority vote.
Meetings Schedule
The Working Group will meet, if possible, two times per year in person at the two trilateral meetings, and via e-mail and conference call as often as necessary to meet the objective of the Working Group.
Operating Procedures
Language
The meetings shall take place in the
three official languages pertaining to the ensemble
of the Working Group Membership:
English, French, and Spanish.
The host country shall be responsible for ensuring simultaneous
translation as may be necessary.
With respect to press
releases, communiqués,
and other such materials, each member country
shall be responsible for ensuring appropriate
translation for dissemination within their
own national
boundaries obtaining
necessary approvals within mutually agreeable
time frames.
These
terms of
reference have
been adopted
simultaneously in
versions prepared
in the
three official
languages, and
are intended
to have
the same
meaning in
each version.
January
2004
Steering Committee
Complete Charter and Information Sharing Agreement for signature by Heads of Delegation
MUCH
CUMCIG
Emergency Response and Preparedness:
Laboratory Cooperation
Training Working Group
Heads of Delegation
" A" LIST (High-Priority Areas):
"B" LIST:
1Health Canada and the CFIA share unique and complementary roles and responsibilities. Health Canada is responsible for food safety and nutrition policies, standards and regulations, including related labeling issues, while the CFIA is responsible for food inspection and compliance activities, as well as the development of regulations and policies related to other food labeling and compositional standards.