The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines

The Trans-Pacific Partnership

“…Many developing nations have intentionally loose patent regulations so that they can produce or purchase generic alternatives to brand name drugs that are beyond the financial reach of many of their citizens. 18 MSF purchases over 80% of their antiretroviral drugs (drugs used in the treatment of human immunodeficiency virus/acquired immunodeficiency syndrome) from India, a country famous for skirting US patent law. India has a history of ignoring the validity of US patents and producing their own generics long before patent expiry.…”

Protecting Pharmaceutical Patents and Test Data: How the Trans-Pacific Partnership Agreement Could Affect Access to Medicines in the US and Abroad

“…Such products include insulin, erythropoietin, filgrastim, growth factors, and monoclonal antibodies such as trastuzumab or infliximab. Although the US currently protects test data for biologics for 12 years [25], a majority of TPP member countries have no pre-existing regulations protecting trial data specifically for biologic drugs [26]. Thus the TPP creates a new norm in many countries with regards to test data protection for biologics and may contribute to maintaining high biologic drug prices in the future [26].…”

Patents, Data Exclusivity, and the Development of New Drugs

“…The negotiations of the Trans-Pacific Partnership (TPP) -a trade agreement among initially twelve Pacific Rim states accounting for about 40% of the global economy -took more than five years and were closely followed by the public. TPP put the discussion on the design of intellectual property rights that protect new drugs against imitation and generic competition back on center stage (Luo and Kesselheim, 2015). In particular, the period of data exclusivity for novel pharmaceutical products and biological medicines was one of the most controversial issues.…”