TPP on registration of drugs, bans requirements to disclose or consider certain financial or pricing data
KEI | 5 November 2015
TPP on registration of drugs, bans requirements to disclose or consider certain financial or pricing data
This is from one of the 26 chapters that was never leaked before.
CHAPTER 8 TECHNICAL BARRIERS TO TRADE, ANNEX 8-C: PHARMACEUTICALS, Annex 8-E: Medical Devices (Page 25)
ANNEX 8-C: PHARMACEUTICALS
7bis. Each Party shall make its determination on whether to grant marketing authorisation for a specific pharmaceutical product on the basis of:
(a) information, including, where appropriate, pre-clinical and clinical data, on safety and efficacy;
(b) information on manufacturing quality of the product;
(c) labelling information related to safety, efficacy and use of the product; and
(d) other matters that may directly affect the health or safety of the user of the product.To this end, 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: Medical Devices
8. Each Party shall make its determination on whether to grant marketing authorisation for a specific medical device on the basis of:
(a) information, including, where appropriate, clinical data, on safety and efficacy;
(b) information on performance, design and manufacturing quality of the product;
(c) labelling information related to safety, efficacy, and use of the product; and
(d) other matters that may directly affect the health or safety of the user of the product.To this end, no Party shall require sale, pricing, or related financial data concerning the marketing of the product as part of such a determination
While there an argument in favor of focusing drug registration decisions on medical considerations only, there is also a paucity of information on drug prices, revenues and other relative information on the economics of the pharmaceutical market. Linking marketing approval to providing reports on these issues should not be prohibited by the TPP. Much of this information is now controlled by IMS, the company that holds a near global monopoly on 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, or reports on marketing outlays post marketing approval. 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.
Note there some minor differences in the wording for the two industries.
For drugs: To this end, 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.
For medical devices: To this end, no Party shall require sale, pricing, or related financial data concerning the marketing of the product as part of such a determination
