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Table 3 Comparison of transparency provisions in AUSFTA, KORUS, and TPP

From: Understanding the trends in international agreements on pricing and reimbursement for newly marketed medicines and their implications for access to medicines: a computational text analysis

 

AUSFTA

KORUS

TPP

Timely decision

(a) ensure that consideration of all formal proposals for listing are completed within a specified time;

(a) ensure that consideration of all formal requests for the pricing or approval of pharmaceutical products or medical devices for reimbursement is completed within a reasonable, specified period;

(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;

Disclosure rules

(b) disclose procedural rules, methodologies, principles, and guidelines;

(b) disclose to applicants within a reasonable, specified period all procedural rules, methodologies, principles, criteria, and guidelines;

(b) disclose procedural rules, methodologies, principles and guidelines;

Opportunities to provide comments

(c) afford applicants timely opportunities to provide comments at relevant points;

(c) afford applicants timely and meaningful opportunities to provide comments at relevant points;

(c) afford applicants and, if appropriate, the public, timely opportunities to provide comments at relevant points;

Provision of information

to applicants

(d) provide applicants with detailed written information regarding the basis for recommendations or determinations;

(d) within a reasonable, specified period, provide applicants with meaningful, detailed written information regarding the basis for recommendations or determinations;

(d) provide applicants with written information sufficient to comprehend the basis for recommendations or determinations;

to public

(e) provide written information to the public regarding its recommendations or determinations;

Not Applicable

(f) provide written information to the public regarding recommendations or determinations

Review process

(f) make available an independent review process that may be invoked at the request of an applicant directly affected by a recommendation or determination.

(e) make available an independent review process that may be invoked at the request of an applicant directly affected by a recommendation or determination;

(e) make available:

(i) an independent review process; or

(ii) an internal review process; and

Others

Side letters PBS

3 (c) expedited procedures for processing of applications not requiring an economic evaluation

4. provide opportunities to apply for an adjustment to the price of a pharmaceuticals.

(f) make all reimbursement decision-making bodies open to all stakeholders; and

(g) make publicly available the membership list of all committees.

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