Democracy Gone Astray

Democracy, being a human construct, needs to be thought of as directionality rather than an object. As such, to understand it requires not so much a description of existing structures and/or other related phenomena but a declaration of intentionality.
This blog aims at creating labeled lists of published infringements of such intentionality, of points in time where democracy strays from its intended directionality. In addition to outright infringements, this blog also collects important contemporary information and/or discussions that impact our socio-political landscape.

All the posts here were published in the electronic media – main-stream as well as fringe, and maintain links to the original texts.

[NOTE: Due to changes I haven't caught on time in the blogging software, all of the 'Original Article' links were nullified between September 11, 2012 and December 11, 2012. My apologies.]

Tuesday, January 26, 2016

The troubling link between health care and intellectual property in the TPP

Problems? Oh, the Trans-Pacific Partnership has a few! Read about them all in the new seriesThe Trouble with the TPP.
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 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.

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:
"no Party shall require sale or related financial data concerning the marketing of the product as part of such a determination. Further, each Party shall endeavour not to require pricing data as part of the determination"
Annex 8-E for the approval of marketing of medical devices is similar:
"no Party shall require sale, pricing, or related financial data concerning the marketing of the product as part of such a determination"
As KEI notes in its presentation to the U.S. International Trade Commission:
"It is certainly desirable to require drug and device makers to provide information about product prices, revenues, and a variety of related financial data, including the outlays on R&D and marketing of products. These are the very topics that the State of California and other state governments are seeking to obtain from drug companies, but it is much easier to mandate such disclosures at the federal level
Much of the pricing and sales data for drugs is now controlled by IMS, the company that holds a near global monopoly on the most detailed information on sales revenue and pricing of drugs. Other "related financial data concerning the marketing of the product" might include data on R&D outlays, a topic shredded in unhelpful secrecy and subject to too much controversy, when the facts exist and could be shared. From the text, it is not that clear how far the ban on requiring financial data extends, and to which activities of a regulatory agency or another government body would be constrained by these provisions."
It is not clear why the Canadian government has agreement to these limitations nor why the summary documents do not reference them. This information could assist regulators in making better decisions on medical devices and pharmaceutical products, yet the TPP will inexplicably block them from doing so.
Original Article
Source: rabble.ca/
Author: MICHAEL GEIST

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