Post Tagged with: "health"

Migraine Meds by Tanya (CC BY-NC-ND 2.0) https://flic.kr/p/eaDjxg

The Trouble With the TPP, Day 33: Setting the Rules for a Future Pharmacare Program

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:

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February 18, 2016 3 comments News
Stethescope by Dan Wiedbrauk (CC BY-ND 2.0) https://flic.kr/p/mTmYTX

The Trouble with the TPP, Day 9: Limits on Medical Devices and Pharma Data Collection

The link between health care and the TPP’s intellectual property chapter is easy to spot, but there are other chapters with implications for the issue. The Trouble with the TPP series today considers Chapter 8, which covers Technical Barriers to Trade (TBT). The chapter contains some surprising restrictions on the ability for national regulators to require the disclosure of certain information as part of the regulatory review process for pharmaceutical products and medical devices (prior posts 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).

The Canadian government summary of the TBT chapter does not disclose that there are data collection restrictions. In fact, the only reference to the issue states that the chapter “improves regulatory transparency in the areas of cosmetics, medical devices, and pharmaceutical products.” Yet the chapter does far more than address regulatory transparency. For example, Annex 8-C 7bis requires each party to makes its determination on whether to grant marketing authorization for a specific pharmaceutical product on the basis on factors such as clinical data, manufacturing quality, and labelling information. However, it also states that:

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January 14, 2016 4 comments News