1. Each Party shall establish or maintain judicial, quasi-judicial, or administrative tribunals or procedures for the purpose of the prompt review and, if warranted, correction of a final administrative action with respect to any matter covered by this Agreement. These tribunals shall be impartial and independent of the office or authority entrusted with administrative enforcement and shall not have any substantial interest in the outcome of the matter.

2. Each Party shall ensure that, with respect to the tribunals or procedures referred to in paragraph 1, the parties to a proceeding are provided with the right to:

(a) a reasonable opportunity to support or defend their respective positions; and

(b) a decision based on the evidence and submissions of record or, if required by its law, the record compiled by the relevant authority.

3. Each Party shall ensure, subject to appeal or further review as provided for in its law,

that the decision referred to in paragraph 2(b) be implemented by, and govern the practice of, the office or authority with respect to the administrative action at issue.

Section B. Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices  (3)

Article 29.5. Definitions

For the purposes of this Section:

national health care authority means, with respect to a Party listed in Annex 29-B (Party- Specific Definitions), the relevant entity or entities specified therein, and with respect to any other Party, an entity that is part of or has been established by a Party's central level of government to operate a national health care program; and

national health care program means a health care program in which a national health care authority makes the determinations or recommendations regarding the listing of pharmaceutical products or medical devices for reimbursement, or regarding the setting of the amount of that reimbursement.

Article 29.6. Principles

The Parties are committed to facilitating high-quality health care and continued improvements in public health for their nationals, including patients and the public. In pursuing these objectives, the Parties acknowledge the importance of the following principles:

(a) the importance of protecting and promoting public health and the important role played by pharmaceutical products and medical devices (4) in delivering high-quality health care;

(b) the importance of research and development, including innovation associated with research and development, related to pharmaceutical products and medical devices;

(c) the need to promote timely and affordable access to pharmaceutical products and medical devices, through transparent, impartial, expeditious, and accountable procedures, without prejudice to a Party's right to apply appropriate standards of quality, safety, and efficacy; and

(d) the need to recognize the value of pharmaceutical products and medical devices through the operation of competitive markets or by adopting or maintaining procedures that appropriately value the objectively demonstrated therapeutic significance of a pharmaceutical product or medical device.

Article 29.7. Procedural Fairness

To the extent that a Party's national health care authority operates or maintains procedures for listing new pharmaceutical products or medical devices for reimbursement purposes, or setting the amount of that reimbursement, under a national health care program operated by the national health care authority, (5) (6) that Party shall:

(a) ensure that consideration of all formal and duly formulated proposals for such listing of pharmaceutical products or medical devices for reimbursement is completed within a specified period of time; (7)

(b) disclose procedural rules, methodologies, principles, and guidelines used to assess such proposals;

(c) afford applicants (8) and, if appropriate, the public, timely opportunities to provide comments at relevant points in the decision-making process;

(d) provide applicants with written information sufficient to comprehend the basis for recommendations or determinations regarding the listing of new pharmaceutical products or medical devices for reimbursement by its national health care authority;

(e) make available:

(i) an independent review process, or

(i) an internal review process, such as by the same expert or group of experts that made the recommendation or determination, provided that the review process includes, at a minimum, a substantive reconsideration of the application,(9) and

that may be invoked at the request of an applicant directly affected by a recommendation or determination by a Party's national health care authority not to list a pharmaceutical product or a medical device for reimbursement; (10) and

(f) provide written information to the public regarding recommendations or determinations, while protecting information considered to be confidential under the Party's law.

Article 29.8. Dissemination of Information to Health Professionals and Consumers

As is permitted to be disseminated under the Party's laws, regulations, and procedures, each Party shall permit a pharmaceutical product manufacturer to disseminate to health professionals and consumers through the manufacturer's website registered in the territory of the Party, and on other websites registered in the territory of the Party linked to that site, truthful and not misleading information regarding its pharmaceutical products that are approved for marketing in the Party's territory. A Party may require that the information include a balance of risks and benefits and encompass all indications for which the Party's competent regulatory authorities have approved the marketing of the pharmaceutical product.

Article 29.9. Consultations

1. To facilitate dialogue and mutual understanding of issues relating to this Section, each Party shall give sympathetic consideration to and shall afford adequate opportunity for consultations regarding a written request by another Party to consult on any matter related to this Section. The consultations shall take place within three months of the delivery of the request, except in exceptional circumstances or unless the consulting Parties decide otherwise. (11)

2. Consultations shall involve officials responsible for the oversight of the national health care authority or officials from each Party responsible for national health care programs and other appropriate government officials.

Article 29.10. Non-Application of Dispute Settlement

No Party shall have recourse to dispute settlement under Chapter 31 (Dispute Settlement) for any matter arising under this Section.

ANNEX 29-A. PUBLICATION OF LAWS AND REGULATIONS OF GENERAL APPLICATION

For the purpose of Article 29.2.3 (Publication), laws and regulations of general application of each Party are published in the following websites:

(a) For Canada:

http://laws.justice.gc.ca/eng/

See also: http://www.gazette.gc.ca/accueil-home-eng.html;

(b) For Mexico: www.diputados.gob.mx/LeyesBiblio/index.htm

See also:

www.dof.gob.mx; and

(c) For the United States:

https://www.govinfo.gov/help/whats-available

See also:

http://uscode.house.gov/ (laws)

https://www.ecfr.gov/cgi-bin/text-idx ?tpl=%2Findex.tpl (regulations)

ANNEX 29-B. PARTY-SPECIFIC DEFINITIONS

Further to the definition of national health care authority in Article 29.5 (Definitions), national health care authority means:

(a) For Canada, the Federal Drug Benefits Committee. For greater certainty, Canada does not currently operate a national health care program within the scope of this Annex.

(b) For the United States, the Centers for Medicare & Medicaid Services (CMS), with respect to CMS's role in making Medicare national coverage determinations.

Chapter 30. ADMINISTRATIVE AND INSTITUTIONAL PROVISIONS

Article 30.1. Establishment of the Free Trade Commission

The Parties hereby establish a Free Trade Commission (Commission), composed of government representatives of each Party at the level of Ministers or their designees.

Article 30.2. Functions of the Commission

1. The Commission shall:

(a) consider matters relating to the implementation or operation of this Agreement;

(b) consider proposals to amend or modify this Agreement;

(c) supervise the work of committees, working groups, and other subsidiary bodies established under this Agreement;

(d) consider ways to further enhance trade and investment between the Parties;

(e) adopt and update the Rules of Procedure and Code of Conduct applicable to dispute settlement proceedings; and

(f) review the roster established under Article 31.8 (Roster and Qualifications of Panelists) every three years and, when appropriate, constitute a new roster.

2. The Commission may:

(a) establish, refer matters to, or consider matters raised by, an ad hoc or standing committee, working group, or other subsidiary body;

(b) merge or dissolve a committee, working group, or other subsidiary body established under this Agreement in order to improve the functioning of this Agreement;

(c) consider and adopt, subject to completion of applicable legal procedures by each Party, a modification to this Agreement of:

(i) the Schedules to Annex 2-B (Tariff Commitments), by accelerating tariff elimination or improving market access conditions,

(ii) the adjustments to the Tariff Preferential Levels established in Chapter 6 (Textile and Apparel Goods),

(iii) the rules of origin established in Annex 4-B (Product-Specific Rules of Origin),

(iv) the minimum data requirements for the certification of origin,

(v) any provision as may be required to conform with any change to the Harmonized System, or

(vi) the lists of entities, covered goods and services, and thresholds contained in the Schedules to Chapter 13 (Government Procurement);

(d) develop arrangements for implementing this Agreement;

(e) seek to resolve differences or disputes that may arise regarding the interpretation or application of this Agreement;

(f) issue interpretations of the provisions of this Agreement; (1)

(g) seek the advice of non-governmental persons or groups;

(h) modify any Uniform Regulations agreed jointly by the Parties under Article 5.16 (Uniform Regulations), subject to completion of applicable legal procedures by each Party; and

(i) take any other action as the Parties may decide.

3. For the purposes of an action with respect to a provision that applies only as between two Parties, including the interpretation, amendment, or modification of that provision, the Commission shall be composed of, and decisions taken by, the Commission representatives of those Parties.

Article 30.3. Decision-Making

The Commission and subsidiary bodies established under this Agreement shall take decisions by consensus, except as otherwise provided in this Agreement, as otherwise decided by the Parties, or as provided for in Article 30.2.3 (Functions of the Commission). Unless otherwise provided in this Agreement, the Commission or a subsidiary body shall be deemed to have taken a decision by consensus if all Parties are present at a meeting when a decision is taken and no Party present at the meeting when a decision is taken objects to the proposed decision.

Article 30.4. Rules of Procedure of the Commission and Subsidiary Bodies

1. The Commission shall meet within one year of the date of entry into force of this Agreement and thereafter as the Parties may decide, including as necessary to fulfil its functions under Article 30.2 (Functions of the Commission). Meetings of the Commission shall be chaired successively by each Party.

2. The Party chairing a meeting of the Commission shall provide any necessary administrative support for the meeting.

3. Unless otherwise provided in this Agreement, the Commission and a subsidiary body established under this Agreement shall carry out its work through whatever means are appropriate, which may include electronic mail or videoconferencing.

4. The Commission and a subsidiary body established under this Agreement may establish tules of procedures for the conduct of its work.

Article 30.5. Agreement Coordinator and Contact Points

1. Each Party shall designate an Agreement Coordinator to facilitate communications between the Parties on any matter covered by this Agreement, as well as other contact points as required by this Agreement.

2. Unless otherwise provided in this Agreement, each Party shall notify the other Parties in writing of its Agreement Coordinator and any other contact point provided for in this Agreement no later than 60 days after the date of entry into force of this Agreement.

3. Each Party shall promptly notify the other Parties, in writing, of any changes to its Agreement Coordinator or any other contact point.

4. On the request of another Party, the Agreement Coordinator shall identify the office or official responsible for a matter and assist, as necessary, in facilitating communication with the requesting Party.

Article 30.6. The Secretariat

1. The Commission shall establish and oversee a Secretariat comprising national Sections.

2. Each Party shall:

(a) establish and maintain a permanent office of its Section and be responsible for its operation and costs;

(b) designate an individual to serve as Secretary for its Section, who shall be responsible for its administration and management; and

(c) notify the other Parties of the contact information for its Section's office.

3. The Secretariat shall:

(a) provide assistance to the Commission; provide administrative assistance to:

(i) panels and committees established under Section D of Chapter 10 (Review and Dispute Settlement in Antidumping and Countervailing Duty Matters), and

(ii) panels established under Chapter 31 (Dispute Settlement), including under Annex 31-A (Facility-Specific Rapid Response Labor Mechanism);

(c) be responsible for the payment of remuneration to and expenses of panels and committees established under Section D of Chapter 10 (Review and Dispute Settlement in Antidumping and Countervailing Duty Matters) and panelists, assistants, and experts involved in dispute settlement proceedings under Chapter 31 (Dispute Settlement), including under Annex 31-A (Facility-Specific Rapid Response Labor Mechanism); and

(d) as the Commission may direct:

(i) support the work of other committees and groups established under this Agreement, and

(ii) otherwise facilitate the operation of this Agreement.

Chapter 31. DISPUTE SETTLEMENT

Section A. Dispute Settlement

Article 31.1. Cooperation

The Parties shall at all times endeavor to agree on the interpretation and application of this Agreement, and shall make every attempt through cooperation and consultations to arrive at a mutually satisfactory resolution of a matter that might affect its operation or application.

Article 31.2. Scope

Unless otherwise provided for in this Agreement, the dispute settlement provisions of this Chapter apply:

(a) with respect to the avoidance or settlement of disputes between the Parties regarding the interpretation or application of this Agreement;

(b) when a Party considers that an actual or proposed measure of another Party is or would be inconsistent with an obligation of this Agreement or that another Party has otherwise failed to carry out an obligation of this Agreement; or

(c) when a Party considers that a benefit it could reasonably have expected to accrue to it under Chapter 2 (National Treatment and Market Access for Goods), Chapter 3 (Agriculture), Chapter 4 (Rules of Origin), Chapter 5 (Origin Procedures), Chapter 6 (Textile and Apparel Goods), Chapter 7 (Customs Administration and Trade Facilitation), Chapter 9 (Sanitary and Phytosanitary Measures), Chapter 11 (Technical Barriers to Trade), Chapter 13 (Government Procurement), Chapter 15 (Cross-Border Trade in Services), or Chapter 20 (Intellectual Property Rights), is being nullified or impaired as a result of the application of a measure of another Party that is not inconsistent with this Agreement.

Article 31.3. Choice of Forum

1. If a dispute regarding a matter arises under this Agreement and under another international trade agreement to which the disputing Parties are party, including the WTO Agreement, the complaining Party may select the forum in which to settle the dispute.

2. Once a complaining Party has requested the establishment of, or referred a matter to, a panel under this Chapter or a panel or tribunal under an agreement referred to in paragraph 1, the forum selected shall be used to the exclusion of other fora.

Article 31.4. Consultations

1. A Party may request consultations with another Party with respect to a matter described in Article 31.2 (Scope).

2. The Party making the request for consultations shall do so in writing, and shall set out the reasons for the request, including identification of the specific measure or other matter at issue and an indication of the legal basis for the complaint.

3. The requesting Party shall deliver the request concurrently to the other Parties through their respective Sections of the Secretariat, including a copy to its Section.

4. A third Party that considers it has a substantial interest in the matter may participate in the consultations by notifying the other Parties in writing through their respective Sections of the Secretariat, including a copy to its Section, no later than seven days after the date of delivery of the request for consultations. The Party shall include in its notice an explanation of its substantial interest in the matter.

5. Unless the consulting Parties decide otherwise, they shall enter into consultations no later than:

(a) 15 days after the date of delivery of the request for a matter concerning perishable goods; (1) or

(b) 30 days after the date of delivery of the request for all other matters.

6. The consulting Parties shall make every attempt to arrive at a mutually satisfactory resolution of a matter through consultations under this Article or other consultative provisions of this Agreement. To this end:

(a) each consulting Party shall provide sufficient information to enable a full examination of how the actual or proposed measure or other matter at issue might affect the operation or application of this Agreement;

(b) a Party that participates in the consultations shall treat the information exchanged in the course of consultations that is designated as confidential on the same basis as the Party providing the information; and

(c) the consulting Parties shall seek to avoid a resolution that adversely affects the interests of another Party under this Agreement.

7. Consultations may be held in person or by a technological means available to the consulting Parties. If the consultations are held in person, they shall be held in the capital of the Party to which the request for consultations was made, unless the consulting Parties decide otherwise.

8. In consultations under this Article, a consulting Party may request that another consulting Party make available personnel of its government agencies or other regulatory bodies who have expertise in the matter at issue.

9. Consultations shall be confidential and without prejudice to the rights of a Party in another proceeding.

Article 31.5. Good Offices, Conciliation, and Mediation

1. Parties may decide at any time to voluntarily undertake an alternative method of dispute resolution, such as good offices, conciliation, or mediation.

2. Proceedings that involve good offices, conciliation, or mediation shall be confidential and without prejudice to the rights of the Parties in another proceeding.

3. Parties participating in proceedings under this Article may suspend or terminate those proceedings.

4. If the disputing Parties decide, good offices, conciliation, or mediation may continue while a dispute proceeds for resolution before a panel established under Article 31.6 (Establishment of a Panel).

Article 31.6. Establishment of a Panel