Some parts of the TPP that deal with drug, medical device prices, reimbrusements

The whole TPP text.

CHAPTER 8, TECHNICAL BARRIERS TO TRADE.

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

CHAPTER 9, INVESTMENT

CHAPTER 18, INTELLECTUAL PROPERTY

ANNEX 26-A. TRANSPARENCY AND PROCEDURAL FAIRNESS FOR PHARMACEUTICAL PRODUCTS AND MEDICAL DEVICES