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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

 

 

 

Table of ContentsTrilateral Cooperation Charter

 

PURPOSE

MISSION

MEMBERSHIP (Participants to the Trilateral Cooperation)

STRATEGIC OBJECTIVES

PRINCIPLES

GOVERNANCE STRUCTURE

Heads of Delegation

Steering Committee

Working Groups

Country Coordinators (Secretariat)

 

SCOPE OF WORK

CRITERIA FOR IDENTIFYING ISSUES FOR DISCUSSION

MEETINGS

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

 

 

PURPOSE

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.

MISSION

To protect and promote public health through a trilateral forum that shares

information and works collaboratively on issues of mutual interest.

MEMBERSHIP (Participants to the Trilateral Cooperation)

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.

 

STRATEGIC OBJECTIVES

In pursuit of this mission, members intend to actively engage in achieving the

following strategic objectives:

 

Identifying and solving problems;

Sharing information and best practices, and establishing harmonized positions

on issues of mutual interest;

Identifying emerging issues of common interest;

Promoting capacity building;

Developing confidence/capacity and trust among members of the trilateral;

Increasing public confidence;

Developing partnerships; and

Developing mechanisms for cooperation and working collaboratively to

implement solutions for issues of mutual interest.

PRINCIPLES

To achieve these objectives, the Parties to the Trilateral Cooperation should be

guided by the following principles:

 

A focus on health and safety issues;

Equal participation for all stakeholders;

Serving the interests of all three countries;

The use of joint problem-solving techniques and consensual decision-making

processes; and

The advancement of public health.

GOVERNANCE STRUCTUREA. Heads of Delegation

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.

B. Steering Committee

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

 

draws upon the expertise of its members and others to provide advice and

recommendations on high-level issues to the Heads of Delegation;

garners support and promotes the Trilateral Cooperation by communicating

objectives and accomplishments to senior management in its respective

organizations;

establishes ad hoc sub-committees and/or task forces to undertake specific

work;

invites experts to submit information to the Committee, when and as required;

is the forum for joint proactive Trilateral Cooperation planning; and

refers unresolved issues to the Heads of Delegation, as required.

C. Working Groups

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:

 

Canada-US-Mexico Compliance Information Group (CUMCIG): Its purpose is to

increase the exchange of emergency preparedness and response, compliance and

enforcement information between the three countries. The Group coordinates

related enforcement activities with counterpart agencies in appropriate cases.

Lead Country: United States of America.

Mexico-US-Canada Health Fraud Group (MUCH): Its purpose is to maintain a

formal framework for cooperation in combating health fraud and to identify

appropriate lines of communication to ensure a continual exchange of information

on compliance and enforcement activities among the three countries. Lead

Country: Mexico.

Laboratory Cooperation Working Group: Its purpose is to establish and

maintain cooperation in the area of regulatory laboratory operations. Through

continual discussions, this group is expected to share information with a view

to building confidence in our respective analytical results. Lead Country:

Canada.

Canada-US-Mexico Training Working Group: Its purpose is to share existing

training information, establish a communication strategy between the Training

Working Group and the other Working Groups, and to assist in identifying

training needs of staff who will be engaged in Trilateral work. Lead Country:

United States of America.

D. Country Coordinators (Secretariat)

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.

SCOPE OF WORK

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.

CRITERIA FOR IDENTIFYING ISSUES FOR DISCUSSION

To prioritize its discussions, the Steering Committee uses the following

criteria in selecting issues for discussion. Each issue must

 

be a public health concern;

be of common concern to all three countries;

be solvable with realizable outcomes and within a reasonable time frame; and

not detract from discussions or processes in other fora.

MEETINGS

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.

SUMMARY OF OPERATING PROCEDURES

Meeting Process

 

Country Coordinators are responsible for coordinating input for the

development of agendas, and for selecting facilitators and scribes for the

meetings.

New business agenda items may be proposed by any member of the Steering

Committee or Working Groups and should be submitted for consideration to the

Coordinators for inclusion on the agenda 14 days before the meeting.

Meetings are to be held as required, but at least twice each year (spring and

fall).

The Steering Committee may allot time for presentations by non-members

regarding agenda items.

Meeting records should clearly indicate any members responsible for leading

any action arising along with report back dates.

 

Decision Making

 

All decisions are to be made by consensus. Consensus is defined as an

understanding by all members of the group, arrived at through discussion and

compromise. Although it may not be each member's preferred result, it is a

result that all members can " live with " and support.

 

Responsibilities of Members

 

Each member has a responsibility to participate actively in discussions and

decision-making.

Each member of the Steering Committee and the Working Groups share

responsibility for the effectiveness of the group's collaborative

problem-solving and decision-making processes.

All members of the Steering Committee, regardless of whether they are present

at meetings, are expected to support the Committee's decisions and assist in

their implementation.

 

Sub-committees

 

The Steering Committee may establish sub-committees as necessary to undertake

specific work.

 

Amendments

 

The Steering Committee, through mutual written consent and approval by the

Heads of Delegation, may alter, amend, or revoke the Trilateral Cooperation

Charter or any of its operating procedures at any time and may adopt additional

procedures as it deems necessary.

 

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 Enríquez Rubio

Federal Commissioner

Head of Delegation (Mexico)

 

 

 

 

APPENDIX A: GOVERNANCE STRUCTURE

 

 

 

APPENDIX B: TERMS OF REFERENCE OF THE WORKING GROUPSMUCH - TERMS OF REFERENCE

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

 

develop and implement comprehensive collaborative approaches and mechanisms

to deal with health fraud;

share information describing current trends in health fraud and strategies

for addressing emerging problems;

cooperate in the detection of cross-border health fraud;

inform counterpart agencies as soon as practicable of significant

investigations and proceedings involving health fraud occurring or originating

in the jurisdiction of each member country;

consider counterpart agency requests to investigate domestic activities

having harmful cross-border effects;

consider coordinating related enforcement activities with counterpart

agencies in appropriate cases;

coordinate import surveillance activities and share information that would

maximize surveillance efforts;

develop and disseminate joint consumer and business education messages about

health fraud;

seek to promote cooperation among federal, state, provincial and local law

enforcement agencies of all three member countries, and as appropriate, seek to

include such agencies in cooperative efforts to combat health fraud; and

develop further strategies to achieve coordinated compliance and enforcement;

joint consumer and business education; trilateral communication and information

exchanges; and the building of partnerships to combat health fraud.

 

Membership

 

The Working Group shall consist of the following:

 

Representatives of the regulatory agencies relevant to the control of health

fraud from the three signatory countries;

Representatives of the regulatory and law enforcement agencies with authority

or jurisdiction over health fraud issues; and

Representatives from other government agencies as agreed to by the Co-chairs.

 

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:

 

Agenda: Members shall be canvassed in advance of regularly scheduled meetings

and an agenda made available a minimum of five working days in advance of each

meeting.

Logistics: The Secretariat shall assume responsibility for meeting rooms and

other immediate requirements pertaining to the meeting itself. Members shall be

responsible for their own travel and accommodation arrangements.

Meeting Summary: A record of the meetings shall be kept and held to the

appropriate level of detail required to summarize effectively the proceedings

and to reflect decisions taken. Each member country is responsible for

translating record of decision into the language of choice and for maintaining

its own committee files.

Disclosure: Members of the Working Group to the principles of

accountability and disclosure. However, in view of the confidential information

discussed and exchanged at the Working Group meetings that relate to ongoing

investigations by law enforcement and regulatory agencies, the meeting summaries

shall be kept confidential.

 

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

 

CUMCIG — TERMS OF REFERENCE

 

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

 

develop cooperation mechanisms for the solution and follow-up of the proposed

issues in this Working Group;

identify appropriate lines of communication to ensure a continual exchange of

information on compliance and enforcement activities among the three countries;

identify issues of common concern and develop approaches for dealing with

them in a coordinated manner; and

explore and develop areas where joint positions could be of mutual benefit.

 

Membership

 

The CUMCIG Working Group shall consist of the following:

 

Representatives of the regulatory agencies relevant to compliance and

enforcement activities from the three signatory countries; and

Representatives from other bodies, as deemed appropriate by each member

country.

 

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:

 

Agenda: Members shall be canvassed in advance of regularly scheduled meetings

and an agenda made available a minimum of five working days in advance of each

meeting.

Logistics: The Secretariat shall assume responsibility for meeting rooms and

other immediate requirements pertaining to the meeting itself. Members shall be

responsible for their own travel and accommodation arrangements.

Meeting Summary: A record of the meetings shall be kept and held to the

appropriate level of detail required to summarize effectively the proceedings

and to reflect decisions taken. Each member country is responsible for

translating record of decision into the language of choice and for maintaining

its own Working Group files.

Disclosure: Members of the Working Group to the principles of

accountability and disclosure. However, in view of the confidential information

discussed and exchanged at the Working Group meetings that relate to ongoing

investigations by law enforcement and regulatory agencies, the meeting summaries

shall be kept confidential.

 

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).

 

The Working Group should limit the number of issues discussed at a meeting

and should establish priorities jointly.

The Working Group should identify each issue to be resolved, with defined

objectives, an outline of the working arrangements, and a time frame for

resolution of a given issue.

Any structure (e.g., sub-committee, task force, etc.) established to handle a

particular issue should be flexible and responsive.

 

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

LABORATORY COOPERATION WORKING GROUP — TERMS OF REFERENCE

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;

 

identify issues of common concern, and develop and implement approaches for

dealing with them in a coordinated manner;

explore and develop areas where joint or complementary positions and

operations could be of mutual benefit; and

support the work of the other Working Groups by providing laboratory support.

 

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:

 

Agenda: Members shall be canvassed in advance of regularly scheduled meeting

and an agenda made available a minimum of five working days in advance of each

meeting.

Logistics: The Secretariat shall assume responsibility for meeting rooms and

other immediate requirements pertaining to the meeting itself. Members shall be

responsible for their own travel and accommodation arrangements.

Meeting Summary: A record of the meetings shall be kept and held to the

appropriate level of detail required to summarize effectively the proceedings

and to reflect decision into the language of choice and for maintaining its own

committee files.

Disclosure: Members to the principle of disclosure. However, in

view of the confidential information discussed and exchanged at the task force

meetings that relate to ongoing investigations by law enforcement and regulatory

agencies, the meeting summaries shall be kept confidential.

 

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:

 

When a lead representative wishes to propose that a representative of another

body attend one meeting or become a member of the LCG, such a proposal shall be

made well in advance of the meeting.

The agenda will be developed jointly by member countries.

When used by the LCG, the word “accreditation” means accreditation to the ISO

17025 standard.

The Chairperson will be responsible for ensuring that the action items are

recorded, the lead person and time frame identified, and the action items

distributed.

The agency raising an issue shall lead the discussion.

The group should establish priorities jointly.

For significant issues, the committee should identify each issue to be

resolved, with defined objectives, an outline of the working arrangements, and a

time frame for resolution of a given issue.

Any structure (e.g., sub-committee, task force, etc.) established to handle a

particular issue should be flexible and responsive.

Individual participants will brief their respective organizations on the

discussions and action items resulting from any meeting.

 

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

 

TRAINING WORKING GROUP — TERMS OF REFERENCE

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

 

identify and solve problems;

share information;

identify emerging issues;

share best practices;

promote capacity building;

develop partnership; and

establish harmonized positions on issues.

 

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:

 

Meeting Summaries: The chairperson will issue meeting notes via e-mail.

Information Sharing: All members will be responsible for sharing current and

future information with fellow Working Group members on an as-needed basis.

Reports and Recommendations: Reports and recommendations to the Trilateral

and Working Group leadership will be developed by the chairperson, with input of

members on an as-needed and as-requested basis.

Logistics: The secretariat shall assume responsibility for meeting rooms and

other immediate requirements to a meeting and shall advise other members of

appropriate details in advanced of the meeting; he/she will seek the support of

the other members of the Working Group as appropriate in obtaining needed

facilities, equipment and materials.

Agenda: Members will be canvassed in advance of any meeting (teleconference

or face-to-face) and the chairperson shall share an agenda in advance of any

meeting.

 

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

 

The Training Working Group will be responsible for developing a communication

strategy to communicate training needs issues between the Trilateral Working

Groups and the Steering Committee.

The Training Working Group will be responsible for developing and sharing

with the Steering Committee and each Trilateral Working Group, the training

needs request template and process. Evaluation criteria will be developed to

assess training needs requests.

The Steering Committee will be responsible for assessing, prioritizing, and

vetting the submitted training requests. The training should be of common

interest to the three countries in order for the Trilateral Cooperation to carry

out its purpose and objective.

Where there are numerous training needs identified, the Steering Committee

will take into consideration the priority/ranking and develop a list of topics

and share that plan with the Training Working Group. This plan will include

budgetary considerations.

A Training Working Group representative will be assigned to a specific

Working Group and will participate in conference calls/meetings of that

particular group in order to support the Working Group with their training needs

identification, if deemed necessary. The representation will be as follows:

a) MUCH (representative from Mexico)

b) CUMCIG (representative from the United States)

c) Lab Cooperation (representative from Canada)

If within a Trilateral Working Group, a training need is identified, the lead

Co-chair of the Trilateral Working Group will complete and submit the Trilateral

Training Request to the Steering Committee. The Leader of the Trilateral

Workgroup will also advise its Training Working Group representative.

The Leadership/Trilateral Working Group will identify an individual or

individuals who should be contacted to serve as the technical expert or experts

on the training subject.

Once receiving specific training from the Steering Committee, a

representative or representatives of the Training Working Group will

contact/meet with the technical expert or experts to develop a course plan. This

course plan will be shared and discussed with the other Training Working Group

members to ensure that it meets the needs of the three countries. This plan will

include the following:

a) Topic.

b) Rationale (why needed).

c) What is to be accomplished as a result of the course/event (learning

objectives).

d) Who

i. Course advisory group (CAG) to plan, develop, and eventually deliver

the training;

ii. Intended audience; and

iii. Others needed to deliver training (e.g., studio staff; on-site

facilitators).

e) When (development and delivery time lines)

f) How (media to be used to deliver training (e.g., satellite, class room),

agenda, learning materials, speakers; publicity and other elements, with the

goal of ensuring and maximizing access to the learning).

g) Where (e.g., site and types of uplink, sites of downlinks, class room

locations).

Once a plan is developed the Training Working Group will gain concurrence

from the Trilateral and Working Group leadership.

The Training Working Group will assist other members of CAG in developing and

delivering a specific training event.

The Training Working Group will develop instruments to evaluate all sessions

and courses. Evaluation results and other feedback will be given to CAG members,

and to Trilateral and Working Group leadership.

 

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

 

 

APPENDIX C: KEY PRIORITIES

FOR 2004

 

Steering Committee

 

Complete Charter and Information Sharing Agreement for signature by Heads of

Delegation

 

MUCH

 

Enforcement Action on Fraudulent weight loss products

Explore a web-based site to gather information from fraud cases on one site

Develop criteria for selecting health fraud cases

 

CUMCIG

 

Emergency Response and Preparedness:

 

Activities based on preventing and managing risk for public health protection

Emergency preparedness and response activities are aligned with countries’

priorities of public health protection

Share response plans among the three countries

Conduct another more detailed exercise (Canada will host)

Update emergency contacts electronically (FDA to coordinate)

Share organizational structures, including laboratories

Extend exercise to broader membership

Consider contingency plans for alternative communication mechanisms

Explore the potential for sharing classified information

 

Laboratory Cooperation

 

Enter data in eLEXNET and create respective reports

“Play with the system” to become acquainted

Further explore an exercise with the salmonella test

Revisit priorities and purpose of this group: develop concrete priorities and

an action plan for consideration by Heads of Delegation within six months

 

Training Working Group

 

Organize and deliver a pre-trilateral seminar for 2004

Develop a process for vetting training requests

Establish as an activity of the training Working Group, a mechanism to

exchange a list of the courses that each country offers, related to the topics

of Trilateral Cooperation by December 2003

 

Heads of Delegation

 

" A " LIST (High-Priority Areas):

 

GMPs

Health claims

Cross border safety issues (e.g., internet fraud, counterfeits, and unsafe

medical products/practices, including wholesale drugs)

Harmonization of new laboratory methods and validation of new agents

 

" B " LIST:

 

Harmonized inspection systems

Import/export risk management

Direct-to-Consumer Advertising

Emerging science issues

 

 

 

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.

 

 

 

 

 

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" When the power of love becomes stronger than the love of power, we will have

peace. "

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