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A CPhI report predicts how two potential mega free-trade deals, one among Pacific-Rim countries and the other between the US and EU, could affect pharmaceutical companies.
CPhI Worldwide released part 3 of its annual report, which includes a Pharma Insights report, "Mega Trade Pacts and Their Impact On the Pharmaceutical Markets," at CPhI Worldwide 2015 (Oct. 13–15, Madrid). Authored by Dilip G. Shah, CEO of Vision Consulting Group and CPhI panel member, this report predicts how two potential US mega free-trade deals, one among Pacific-Rim countries and the other between the US and EU, could affect pharmaceutical companies.
The Trans-Pacific Partnership (TPP) and the Trans-Atlantic Trade and Investment Partnership (TTIP) are on a fast track. An agreement was reached on the TPP on October 4, 2015, according to a press release by the US Trade Representative. The TTIP deal is expected to be concluded in 2016. "Academia, civil society, media and political commentators have all raised concerns about the impact of the TPPA on the public health and the TTIP on the inability of the governments to regulate the big corporations," said Shah in the report.
US negotiators for the TPP sought regulatory harmonization to fast-track drug registration and limitations on generic competition, said Shah in the CPhI report. The Generic Pharmaceutical Association and its Biosimilars Council expressed optimism, however, in an Oct. 5, 2015 press release, that “the TPP brings us closer to achieving [worldwide patient access to affordable medicines] by embracing competition from safe, effective biosimilar therapies. Trade provisions that facilitate both the development of innovative, life-saving medicines and the availability of affordable generic medicines are a win for patients.”
The TTIP, in addition to removing tariff barriers to improve trade flow, also aims to remove non-tariff barriers. Possible provisions include changes in intellectual property regulations, limits on pricing and reimbursement policies, and limits on transparency of clinical trials, among others. "The most likely outcome of this trade deal is promotion of interests of the brand-name industry by delaying generic competition," concluded Shah. He further suggested that generic companies will be negatively affected and the the brand-name industry will suffer backlash for a rise in medicine prices.