Evergreening delays access: GBMA

lots of pills with an antibiotic capsule on top

Evergreening strategies delay market entry for generic medicines to the detriment of the Australian community and there is a lack of evidence to support extending market exclusivity for pharmaceuticals, according to the Productivity Commission’s draft report into Australia’s intellectual property arrangements.

The report’s release has been welcomed by the Generic and Biosimilar Medicines Association.

“The Productivity Commission’s draft report provides further evidence of an imbalance in Australia’s pharmaceutical patent system,” says GBMA CEO, Belinda Wood.

“Building on recommendations of the 2013 Pharmaceutical Patents Review, this draft report emphasises the need to get the balance right to deliver the best outcome for the Australian community,” she says.

“GBMA is highly supportive of genuine innovation. Intellectual property protection should be focussed at the cutting edge of innovation and not merely used as a commercial strategy to deny market entry of competitors.”

The report refutes claims that further intellectual property protection is required to incentivise innovation, says GBMA. It states there is no evidence to suggest the existing extension of term policy has attracted R&D to Australia.

“The report concludes that extensions of patent terms do not incentivise innovation, while excessive protection costs the Australian government, taxpayers and consumers a quarter of a billion dollars each year,” Wood says.

GBMA says it welcomes the recommendation that there should be no extension of the period of data protection, including that applicable to biological medicines.

“GBMA has consistently argued that a longer period of data exclusivity for biological medicines is unnecessary,” says Wood.

“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.”

The report recognises that evergreening strategies employed by originator pharmaceutical companies delay the supply of generic medicines in Australia.

These delays cost money, as delaying generic medicine entry onto the market means that through the PBS, the government and taxpayers unnecessarily overpay for medicines, says GBMA.

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