US secures major data protection victory

Latest News

The US has achieved a major trade-related breakthrough on intellectual property for pharmaceuticals and in doing so sent a very clear signal to countries like Australia.

The US has negotiated major changes to the 24-year old North American Free Trade Agreement including securing 10 years of data protection for biologic drugs from Mexico.

The outcome is considered a major breakthrough for the research-based sector and the Trump administration's trade agenda.

The administration has sought to reopen a number of existing trade agreements it believes disadvantage the US.

NAFTA, which includes the US, Canada and Mexico, was the first and has been followed by the bilateral trade agreement with Korea.

“I have directed US Trade Representative Bob Lighthizer to make fixing this injustice a top priority with every trading partner. And we have great power over the trading partners. You're seeing that already," said Mr Trump last year.

"America will not be cheated any longer, and especially will not be cheated by foreign countries. The American people deserve a health care system that takes care of them, not one that taxes and takes advantage of our patients and our consumers and our citizens."

The US-Korea bilateral free trade agreement includes many of the provisions on pharmaceuticals included in the US-Australia free trade agreement.

The US is likely to now push Canada and other countries to adopt longer data protection periods for data protection. Canada currently maintains an 8-year data protection period for pharmaceuticals.

Australia, which maintains a 5-year data protection period for all pharmaceuticals, was at the forefront of blocking US efforts to secure agreement on longer data protection periods during the negotiation of the Trans-Pacific Partnership Agreement (TPPA).

The final text of the agreement included a somewhat ambiguous outcome. It gave countries the option of providing a legislated 8-year data protection period for biologics or a 'market protection' period that delivers a "comparable outcome" of 8 years comprised of a legislated 5-year period plus "other measures".

Mr Trump withdrew the US from the TPPA as one of his first acts in office. As a result, the remaining TPPA countries put the pharmaceutical provisions on hold, including on data protection.

The administration's success in securing 10-years from Mexico suggests it could pursue countries like Australia through existing bilateral agreements or if it returns to the TPPA.