ANTITRUST COMPLIANCE POLICY AND GUIDELINES

FIFARMA is a not-for-profit organization intended to serve as a forum for health education within Latin America (LATAM).

FIFARMA is not organized to and may not play any role in the competitive decisions of its members or their employees, nor in any way restrict competition among members or potential members.

It is the policy of FIFARMA, and it is the responsibility of every member, speaker, panelist, discussion group leader and participant in the meeting, to strictly comply in all respects with Mexican Antitrust laws and regulations (Ley Federal de Competencia Económica).

I. MEETINGS.

Meetings, including board meetings, committee meetings, videoconferences, and conference calls will be conducted in accordance with the following rules.

a) Each meeting must be preceded by a notice transmitted to all participants through e-mail or other appropriate communication and must be held by a FIFARMA employee or professional staff.

b) An agenda will be prepared and distributed in advance of each meeting. Issues included in the Agenda with potential antitrust implications will be reviewed and discussed by the Chairman and legal counsel, if deemed appropriate. Additions to the agenda having potential antitrust implications should be postponed, or discussions of such matters held with legal counsel.

c) Topics unrelated to the items on the agenda should be avoided.

d) Accurate, detailed meeting minutes of every meeting will be prepared and reviewed, under the following circumstances:

  • d.1) Board and Executive Committee Meetings
  • d.2) Meetings that are determined by staff, in consultation with Counsel, to involve potentially sensitive competitive issues or other matters where the failure to take minutes may create an appearance of impropriety.

All Members or participants who attend meetings should be provided a reasonable opportunity to present their views. The Chair is responsible for ensuring that meetings are conducted in accordance with antitrust regulations.

e) Meeting minutes will be approved at the next meeting.

f) In the event that any member or participant has a concern about potential antitrust implications of discussion during a meeting, he or she shall interrupt discussion and state that concern immediately. If discussions is not terminated ant the concern resolved, the concerned participant should state that he or she is leaving the meeting for that reason, and leave.

g) In the event of concern regarding potential antitrust implications of a discussion, discussion must be discontinued until approval of the legal counsel.

II. DISCUSSION TOPICS

Presentations and conversations involving the following matters, should always be avoided, even in private settings and social gatherings and informal conversations, and may not be tolerated in connection with any FIFARMA’s meeting or activity.

a) Prices and price levels; cost of operations, supplies, labor or services

b) Terms of sale including discounts, credit arrangements, profit margins and mark ups;

c) Regulate production; limitations on the nature of business carried on or products or services.

d) Allocate markets, customers and/or territories;

e) Negotiation of conditions in public bids;

f) Encourage boycotts against one or more companies, entity or institution;

g) Foster unfair trade practices

h) Assist monopolization

i) Predicted research and development by a company, entity or institution

In case of a legitimate need to discuss any sensitive topic, the Chair should consider in advance the purpose of the discussion and the information that may be raised. In these cases, FIFARMA Counsel should be consulted before the meeting and should be present to explain the Guidelines and limitations for such discussions.

III. RULE OF REASON

Some topics and activities are evaluated under a rule of reason – there is a balancing between the pro-competitive and anti-competitive aspects of the activities; in any case the pro-competitive effects must outweigh the anti-competitive ones. These areas also should be consulted with Chair and Counsel before the meeting and at least Counsel should be present to explain the Guidelines and limitations for such discussions.

IV. INTERNATIONAL MEETINGS

Regardless the place of the meeting and the location of the participants in conference calls and video conference, all Members and participants must comply with these Policy and guidelines in FIFARMA meetings.

Developing policy recommendation to regulators and governmental authorities may involve competitively sensitive topics. FIFARMA staff should consult with FIFARMA counsel to determine if antitrust counsel should participate in the meetings.

V. STANDARD- SETTING

Product standards discussions must be restricted to technical, chemistry, engineering, safety, and regulatory factors.

Adoption or modification of a standard must never be taken for the purpose of excluding products of competitors from the market or acquiring a dominant position in the market.

To the extent possible, a standard-setting group should attempt to achieve consensus.

Before the beginning of a standard-setting process, or within 72 hours FIFARMA staff member(s) should inform participants of the disclosure requirements regarding possible conflict of interests. In the event that such disclosure might reveal trade secrets or competitively sensitive information, the disclosure requirements should be discussed with the assigned staff member or the General Counsel’s office in order to reach a reasonable resolution.

VI. SURVEYS AND DATA COLLECTION

It is advisable for FIFARMA to make its survey results and other industry research available to both members and nonmembers. Most surveys are permissible and do not require any special procedures. However, if the data to be collected include, or potentially include, competitively sensitive information, Counsel should also be consulted.

FIFARMA meetings with other organizations and associations and with buyer organizations and governmental entities to pursue its goals may represent the same concerns discussed above and also may present the challenge that representatives of other organizations may not be represented by legal counsel or may not have adopted comparable antitrust guidelines. FIFARMA Members and, or staff should ensure that the meeting conforms to the standards mentioned in this Policy and Guidelines.

VII. PANELS AND WORKING SESSIONS

Panels and working sessions may be structured before audiences that include non-members unfamiliar with these Guidelines. To ensure only appropriate discussion during such panel and working sessions meet this Policy and Guidelines, the session moderator and all panelists must be made aware of these Antitrust Guidelines and sign FIFARMA acknowledge notification form that indicates the participant’s intention to adhere to these provisions, on the schedule enclosed.

ANTITRUST STATEMENT MEETINGS AND CONFERENCE ACKNOWLEDGE NOTIFICATION

On behalf of Federación Latinoamericana de la Industria Farmacéutica, A.C. hereinafter refer to as FIFARMA, welcome to the meeting or conference and thank you for your participation in it.

FIFARMA is a not-for-profit organization intended to serve as a forum for health education within Latin America (LATAM).

FIFARMA is not organized to and may not play any role in the competitive decisions of its members or their employees, nor in any way restrict competition among members or potential members.

It is the policy of FIFARMA , and it is the responsibility of every member, speaker, panelist, discussion group leader and participant in the meeting, to comply in all respects with antitrust laws and regulations.

Presentations and conversations involving the following matters, should always be avoided, even in private settings, and may not be tolerated in connection with any FIFARMA’s meeting or activity.

a) Prices and price levels; cost of operations, supplies, labor or services

b) Terms of sale including discounts, credit arrangements, profit margins and mark ups;

c) Regulate production; limitations on the nature of business carried on or products or services.

d) Allocate markets, customers and/or territories;

e) Negotiation of conditions in public bids;

f) Encourage boycotts against one or more companies, entity or institution;

g) Foster unfair trade practices

h) Assist monopolization

i) Predicted research and development by a company, entity or institution


Taking into consideration that FIFARMA is a Mexican association we will mainly follow Mexican Antitrust Law and Regulations but we ask that you familiarize yourself with the antitrust law and regulations in your country.

Please read the Antitrust Compliance Policy document attached and return a signed copy of the same to FIFARMA at the end of the sessions.

Questions concerning antitrust or other laws or regulations connected to FIFARMA activities please do not hesitate to contact our General Counsel, María Teresa Cantú Reus, at (52) 5554881940. Mobile (52) 1 5554062645. E mail tcantu@crplaw.com.mx

We thank you again for your help in ensuring that we have a successful, antitrust compliant meeting.

I have read and understand the foregoing information, and in my role as member, meeting speaker, facilitator, moderator, panelist, or participant I will abide by the above policy and will not facilitate a discussion that could violate antitrust laws.

_____________________ _________________________________

Name Company/Association

______________________________

Association/Company Position

_______________________ _________________________________

Signature Date Session Place/ Date