Protect IP To Encourage Switching In Australia, Urges ASMI
Executive Summary
The Australian Self Medication Industry (ASMI) is calling for IP protection for successful prescription-to-OTC reclassification applications to encourage switching in Australia.
The Australian Self Medication Industry (ASMI) has called for greater measures to protect intellectual property (IP) investment within the country’s prescription-to-OTC reclassification application process.
Forming part of its ‘2019-20 Pre-Budget Submission,’ the ASMI recommended to the Australian Treasury that the country’s medicines regulation should “provide appropriate data protection IP measures for switch applications.” (See also ASMI PreBudget Submission 2019)
The fact that the Australian medicines agency, the TGA, did not offer such protection acted as a “major disincentive” for companies to pursue switch applications, the association insisted.
Elaborating on this recommendation to HBW Insight, Jarrod Lomas, the ASMI’s public affairs manager, said that firms sponsoring prescription-to-OTC reclassifications in Australia “may invest millions in the additional research required as part of their switch applications.”
However, because this research was then made publicly available following a successful application, Lomas explained, the way was then paved for competitors to introduce products based on the same ingredients without also having to invest in costly clinical trials.
“What we’re asking government to do,” he continued, “is examine the options available, whether that’s through data protection and exclusivity for the clinical research, or a period of market exclusivity for down-scheduled products, or a mixture of both.”
Look To The US
In its pre-budget submission, the ASMI recommended that the Australian government look to the US as an example of where data exclusivity had been used to encourage prescription-to-OTC switching.
The Hatch-Waxman Act – passed in 1984, with the official title of the ‘Drug Price Competition and Patent Term Restoration Act’ – grants a three-year market exclusivity period to firms that have needed to perform a clinical trial to support a prescription-to-OTC reclassification.
While there are limitations to this approach – for example, exclusivity is only granted to the first switch of a particular ingredient, and as clinical trials are not a requirement of switch applications, the US Federal Food and Drug Administration (FDA) has no obligation to grant exclusivity where such a trial has been undertaken – the Act has provided a significant incentive for firms looking to switch in the country.
The ASMI said it was committed to working together with the Australian government to improve the switch climate in the country, foster innovation and increase consumer access to medicines, “where appropriate and safe to do so.”
“There are many moving parts to this and we’re not claiming to have all the answers,” the association’s spokesperson admitted. “But what we do know for sure is that the current system discourages switch applications.”
Progress Has Been Made
Lomas pointed out that the ASMI had been “long advocating” for a progressive switch environment in Australia and had recently seen some success as a result.
In last year’s pre-budget submission, the ASMI urged the Australian government to adopt a “progressive switch agenda” to help increase significantly the number of medicines available OTC in the country. (Also see "ASMI wants switch plan" - HBW Insight, 12 Jan, 2018.)
Specifically, the ASMI called for the creation of a “mechanism to proactively identify medicines” which could be switched from prescription-only to OTC status.
The ASMI suggested at the time that low-dose statins for high cholesterol, triptans to treat migraines, oral contraceptives and erectile-dysfunction treatments were all ripe for switching in Australia.
As a result of this intervention, Lomas noted that the government had since established a multi-stakeholder working group with the purpose of identifying future switch candidates, drawn from research as well as international comparisons.
The working group had met three times since being set up, he explained, and the outcomes of the most recent meeting would be “published soon.”
In conclusion, Lomas reflected that Australia still had “a way to go” and “a few issues to work through”, but was catching up with its neighbors and comparable markets when it came to creating a progressive switch environment in the country.