CHAPTER 29

 

PUBLICATION AND ADMINISTRATION

 

 

 

Section A

 

Publication and Administration

 

 

 

Article 29.1:  Definitions

 

For the purposes of this Chapter:

 

administrative  ruling  of  general  application  means  an  administrative  ruling  or interpretation1  that applies to all persons and fact situations that fall generally within the ambit of that administrative ruling or interpretation and that establishes a norm of conduct, but does not include:

 

(a)       a determination or ruling made in an administrative or quasi-judicial proceeding that applies to a particular person, good or service of another Party in a specific case; or

 

(b)       a ruling that adjudicates with respect to a particular act or practice.

 

 

 

Article 29.2:  Publication

 

  1. Each Party shall ensure that its laws, regulations, procedures and administrative rulings of general application with respect to any matter covered by this Agreement  are  promptly published or otherwise made available in a manner that enables interested persons and the other Parties to become acquainted with them. To the extent possible, each Party shall make these measures available online.

 

  1. Each Party shall, to the extent possible:

 

(a)       publish in advance any measures referred to in paragraph 1 that it proposes to adopt; and

 

(b)        provide interested persons and the other Parties a reasonable opportunity  to comment on proposed measures referred to in subparagraph (a).

 

 

 

 

 

1   For greater certainty, an interpretation or ruling that is not binding is not an administrative ruling of general application.

 

 

 

  1. Each Party shall ensure that its laws and regulations of general application at the central level of government are published on a freely accessible website that is capable of performing searches for these laws and regulations, respectively, by citation or through a word search, and shall ensure that this website is kept updated. Annex 29-A specifies each Party’s websites.

 

 

 

Article 29.3:  Administrative Proceedings

 

With a view to administering  in a consistent,  impartial and reasonable  manner  all measures of general application with respect to any matter covered by this Agreement, each Party shall ensure in its administrative proceedings2  applying measures referred to in Article

29.2.1 (Publication) to a particular person, good or service of another Party in specific cases that:

 

(a)       whenever  possible,  a person of another Party that is directly  affected  by  a proceeding is provided with reasonable notice, in accordance with  domestic procedures, of when a proceeding is initiated, including a description of the nature of the proceeding, a statement of the legal authority under which the proceeding is initiated and a general description of any issue in question;

 

(b)        a person of another Party that is directly affected by a proceeding is afforded a reasonable  opportunity  to  present  facts  and  arguments  in  support  of  that person’s position prior to any final administrative action, when time, the nature of the proceeding and the public interest permit; and

 

(c)       the procedures are in accordance with its law.

 

 

 

Article 29.4:  Review and Appeal

 

  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. Such 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.

 

  1. 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, where required by its law, the record compiled by the relevant authority.

 

 

 

 

2   For greater certainty, administrative proceedings subject to this Article do not include advisory opinions or decisions that are not legally binding.

 

 

 

  1. 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) shall be implemented by, and shall 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

Devices3

 

Article 29.10:  Definitions

 

For the purposes of this Section:

 

national health care authority means, with respect to a Party listed in Annex 29-B,  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 such reimbursement.

 

 

 

Article 29.11:  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 devices4  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;

 

 

 

 

3 For greater certainty, the Parties confirm that the purpose of this Section is to ensure transparency and procedural fairness of relevant aspects of the Parties’ applicable systems relating to pharmaceutical products and medical devices, without prejudice to the obligations in this Chapter ), and not to modify a Party’s system of health care in any other respects or a Party’s rights to determine health expenditure priorities.

 

4 For the purposes of this Section, each Party shall define the scope of the products subject to its laws and regulations for pharmaceutical products and medical devices in its territory, and make that information publicly available.

 

 

 

(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 29.12:  Procedural Fairness

 

To  the  extent  that  a  Party’s  national  health  care  authorities  operate  or  maintain procedures  for listing new pharmaceutical  products or medical devices for  reimbursement purposes, or setting the amount of such reimbursement, under national health care programs operated by the national health care authorities,5 6 the 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 applicants8  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 national health care authorities;

 

(e)       make available:

 

 

 

 

5 This Section shall not apply to government procurement of pharmaceutical products and medical devices. If a public entity providing health care services engages in government procurement for pharmaceutical products or medical devices, formulary development and management with respect to that activity by the national health care authority shall be considered an aspect of such government procurement.

6     This Section shall not apply to procedures undertaken for the purpose of post-market subsidization of pharmaceutical products or medical devices procured by public health care entities if the pharmaceutical products

or medical devices eligible for consideration are based on the products or devices that are procured by public health care entities.

7  In those cases in which a Party’s national health care authority is unable to complete consideration of a proposal

within a specified period of time, the Party shall disclose the reason for the delay to the applicant and shall provide for another specified period of time for completing consideration of the proposal.

8   For greater certainty, each Party may define the persons or entities that qualify as an “applicant” under its laws,

regulations, and procedures.

 

 

 

(i)        an independent review process; or

 

(ii)       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 authorities 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 29.13:  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 includes a balance of  risks  and  benefits  and  encompasses  all  indications  for  which  the  Party’s  competent regulatory authorities have approved the marketing of the pharmaceutical product.

 

 

 

Article 29.14:  Consultation

 

  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 consultation 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 agree otherwise.11

 

 

 

 

 

9 For greater certainty, the review process described in subparagraph (e)(i) may include a review process as described in subparagraph (e)(ii) other than one by the same expert or group of experts.

10 For greater certainty, subparagraph (e) does not require a Party to provide more than a single review for a request

regarding a specific proposal or to review, in conjunction with the request, other proposals or the assessment related to those other proposals. Further, a Party may elect to provide the review specified in subparagraph (e) either with respect to a draft final recommendation or determination, or with respect to a final recommendation or determination.

11   Nothing in this paragraph shall be construed as requiring a Party to review or change decisions regarding

specific applications.

 

 

 

  1. 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 29.15: 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, 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

 

(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 healthcare authorities in Article 29.10, national health care authorities 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.

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