Earlier Trouble with the TPP posts focused on the health care implications of the agreement, focusing on patent term extensions, biologics protection, and limits on medical devices and pharma data collection. There is another health-related aspect of the TPP worthy of examination, but it is easy to miss. Chapter 26 of the TPP addresses transparency and anti-corruption, which is not the place you would expect to find provisions with a direct impact on health care. Yet Annex 26-A contains a full section on “transparency and procedural fairness for pharmaceutical products and medical devices.” What does this section do? The key aspect is to establish mandatory requirements for a national pharmacare program:
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 programmes operated by the national health care authorities, 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;
(b) disclose procedural rules, methodologies, principles, and guidelines used to assess such proposals;
(c) afford applicants, and where 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 healthcare authorities;
(e) make available: (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 such a review process includes, at a minimum, a substantive reconsideration of the application and that may be invoked at the request of an applicant directly affected by such recommendation or determination by a Party’s national healthcare authorities not to list a pharmaceutical or medical device for reimbursement; and
(f) provide written information to the public regarding such recommendations or determinations, while protecting information considered to be confidential under the Party’s law.
At the moment, these rules do not apply to Canada because we do not have a national pharmacare program. In fact, the chapter specifically acknowledges that “for greater certainty, Canada does not currently operate a national healthcare programme within the scope of this Annex.” While that may be true today, it might not be true tomorrow. In recent years, provincial cabinet ministers, researchers, health care groups, and hundreds of health care experts have all called for the creation of a national pharmacare program. Moreover, at a recent meeting of federal and provincial health care ministers, the need to address the high cost of drugs was a top priority.
A national pharmacare program may not become an immediate reality, but given the enormous cost pressures, the frustration with the pharmaceutical industry, and the support within the health care community, it seems like a real possibility in the future. Should Canada decide to establish a national program, the policy choices will not be limited to domestic considerations. Instead, the TPP will be waiting to mandate many program requirements, including appeals and reconsideration of decisions for the benefit of pharmaceutical companies.
(prior posts in the series include Day 1: US Blocks Balancing Provisions, Day 2: Locking in Digital Locks, Day 3: Copyright Term Extension, Day 4: Copyright Notice and Takedown Rules, Day 5: Rights Holders “Shall” vs. Users “May”, Day 6: Price of Entry, Day 7: Patent Term Extensions, Day 8: Locking in Biologics Protection, Day 9: Limits on Medical Devices and Pharma Data Collection, Day 10: Criminalization of Trade Secret Law, Day 11: Weak Privacy Standards, Day 12: Restrictions on Data Localization Requirements, Day 13: Ban on Data Transfer Restrictions, Day 14: No U.S. Assurances for Canada on Privacy, Day 15: Weak Anti-Spam Law Standards, Day 16: Intervening in Internet Governance, Day 17: Weak E-commerce Rules, Day 18: Failure to Protect Canadian Cultural Policy, Day 19: No Canadian Side Agreement to Advance Tech Sector, Day 20: Unenforceable Net Neutrality Rules, Day 21: U.S. Requires Canadian Anti-Counterfeiting Report Card, Day 22: Expanding Border Measures Without Court Oversight, Day 23: On Signing Day, What Comes Next?, Day 24: Missing Balance on IP Border Measures, Day 25: The Treaties With the Treaty, Day 26: Why It Limits Canadian Cultural Policies, Day 27: Source Code Disclosure Confusion, Day 28: Privacy Risks from Source Code Rules, Day 29: Cultural Policy Innovation Uncertainty, Day 30: Losing Our Way on Geographical Indications, Day 31: Canadian Trademark Law Overhaul, Day 32: Illusory Safeguards Against Encryption Backdoors)