The Trans-Pacific Partnership and pharmaceutical innovation.

Trade agreements are an overlooked area of research and policy analysis that affect market access, pricing and reimbursement decisions by pharmaceutical manufacturers, and research and development decisions in the long term. The Trans-Pacific Partnership (TPP) is the most recent multi-national agreement under considerations that may have profound implications in developed and developing countries in the Pacific Rim. As in the case of other trade arrangements, the TPP negotiations are not transparent, but a major leak of the most recent draft has been published in WikiLeaks. The leaked document has raised a number of concerns about intellectual property rights (IPR) and regulatory data protection (RDP) that have implications for public health and economic policy throughout the region. In particular, IPR and RDP go beyond the minimum standards set under the World Trade Organization (WTO) and may affect drug access negatively by delaying generic drug and biosimilar product availability and by raising prices by removing national regulations dealing with drug pricing and reimbursement. Of particular concern is the establishment of a litigation process where multi-national companies can sue individual countries before a panel of private attorneys who are appointed by the World Bank or United Nations. This paper addresses these concerns along with a commentary on the likelihood of occurring and the need for future research.