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India should pact with Australia to avail PBS for selecting, listing & pricing processes of exported drugs: Sudarshan Jain
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Shardul Nautiyal, Mumbai
July 27 , 2023
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India should try to formulate an arrangement with Australia to avail Pharmaceutical Benefit Scheme (PBS) towards selecting, listing and pricing processes of exported medicines, according to Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance (IP Alliance).
IP Alliance is a leading industry association representing a large consortium of research-based pharmaceutical companies in India.
PBS is part of the Australian government’s broader National Medicines Policy, under which the government subsidizes the cost of medicine for most medical conditions. It has also been learnt that access to the PBS scheme would provide greater transparency and would assist Indian generic drug manufacturers in ensuring that price reductions are not unjustified.
“Australia’s primary direct benefit scheme in healthcare is the PBS, under which the Australian government directly subsidizes the cost of medicine for most medical conditions. Under its agreements with the United States of America (USA), Australia has given access to American firms in the selecting, listing and pricing processes under the PBS, along with an avenue for alternative review,” Jain further informed.
IP Alliance officials have further recommended that in the long term, India must endeavour to gain access to the alternate resolution provision and the listing, pricing and selection processes of the PBS through its Free Trade Agreement (FTA) mechanism.
According to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), close to 18 Indian companies hold market authorisations for the Australian market and 47 companies export formulations to Australia through arrangements with local ‘sponsors’. Approximately 90% of the prescriptions generated are estimated to be covered by the state-run PBS. The high utilization of the PBS Scheme is another factor due to which generic medicines are not as popular in Australia.
The PBS scheme has been prescribed under the National Health Act 1953. Under Section 101 of the National Health Act, 1953, the Pharmaceutical Benefits Advisory Committee (PBAC) has been established as an independent statutory body. PBAC is responsible for assessing the price proposed by a company for listing its medicines under PBS, and they also have the power to deny the inclusion of medicine on the list if the producer declines to reduce the price.
Given the obvious influence that PBS approval would have on the overall demand for any drug, a producer must ideally ensure that their drug is registered with the program. Under the 2005 FTA signed between Australia and the USA, Australia has provided certain concessions to US companies with respect to the PBS scheme. These concessions allow for greater participation of American firms throughout the selecting, listing and pricing process under the PBS.
“In the India-Australia Comprehensive Economic Partnership Agreement (CEPA), India may adopt a similar approach and gain larger access to PBS,” emphasized regulatory experts.
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