6 October 2015.
The Generic and Biosimilar Medicines Association (GBMA) welcomes the news that Australia has not agreed to extend the data exclusivity period for medicines in the finalisation of the Trans Pacific Partnership Agreement (TPP).
Initial reports indicate that the Australian Government has recognised that the current system of data protection adequately balances innovation for new medicines with market access for affordable medicines and that it has deflected international pressure to move from that position. The fact is, the longer the term of data exclusivity granted by a country, the longer that country will be without generic versions of patent-expired medicines and the longer patients will have to wait for affordable access to the latest therapies.
“It is so important that Australian patients have ongoing access to affordable medicines through the Pharmaceutical Benefits Scheme (PBS). Pressure from the US to extend Australia’s current 5-year data exclusivity period in the TPP would only delay market access for generic and biosimilar medicines, unnecessarily delay the realisation of savings to the PBS, and delay patient access to affordable medicines,” said GBMA CEO Belinda Wood
“We are encouraged by the strong stance taken by the Australian Government in the TPP negotiations. Trade Minister Robb has put the needs of Australian patients ahead of the interests of US-based brand name medicine companies,”
“The finalisation of the TPP without an extension to data exclusivity means Australian patients will continue to have timely access to affordable generic and biosimilar medicines. However, when it comes to trade agreements, the devil is in the detail and we await the public disclosure and scrutiny of the agreed final text,” she said.