Data protection push likely in Australia-EU FTA

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Australia may have avoided making a detailed commitment on extending the data protection period for biologics in the Trans-Pacific Partnership Agreement but the issue will almost certainly be part of negotiations for a new free trade agreement with the European Union (EU).

Negotiations have commenced for an Australia - European Union Free Trade Agreement.

The Trade Commissioner of the European Union, Cecilia Malmström, is currently in Australia and was asked about data protection for biologics during a media conference with Australia's Trade Minister Steven Ciobo.

Asked to state the EU's position on data protection for biologic medicines, and whether it would demand ten years as part of any agreement, Commissioner Commissioner simply said, "Let's see how those negotiations go."

The EU currently maintains a 10-year data protection period for biologics and small molecule medicines. This compares to five years in Australia.

In response to similar questions during the media conference, Minister Ciobo said, "Absolutely. On the Australian Government's position on biologics, let me make two comments. Ordinarily I would not want to go into positions that we'll take into negotiations because I don't think that serves anyone's purpose. But I'm also realistic to know if I even leave the door slightly ajar, you'll race off Peter and others and write articles about us surrendering our Medicare system. So, let me be very clear; our position is as it always has been."

Australia led opposition to a US proposal for the adoption of a 12-year data protection period for biologics during the negotiation of the Trans-Pacific Partnership Agreement (TPPA).

In the end, the agreement included a somewhat ambiguous outcome, giving 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".

The Australian government argued during the negotiation that its regulatory and reimbursement system effectively provided an additional period of 'market protection'.

US President Donald Trump withdrew the US from the TPPA as one of his first acts in office. The remaining 11 countries decided that the text relating to intellectual property for pharmaceuticals, including data protection for biologics, should be held in abeyance pending a potential future return by the US.

Some of the world's largest biopharmaceutical companies are European. They are likely to push for the extended data protection period. A similar push is likely with the proposed Australia - UK Free Trade Agreement.