International
There has been a lot of talk about the Trans Pacific Partnership, for which negotiations successfully concluded in 2015. There were disagreements between Australia and the US regarding the period during which certain patent-related information would be protected (ie would be unusable by competitors). The following commentary about this appeared online:
One of the biggest sticking points in the negotiations had to do with data protection for biologic drugs.
Biologics are treatments made from biological sources, including vaccines, anti-toxins, proteins, and monoclonal antibodies for everything from Ebola to cancer. As the Brookings Institution, biologics are much more structurally complex than regular “small-molecule drugs” and are therefore more difficult and expensive to make, costing on average 22 times more than nonbiologic drugs.
Because of the high prices of these drugs, companies are very interested in developing “biosimilars” — cheaper copies of the original drugs, similar to generic versions of pharmaceuticals. The reason these biosimilars are so cheap is that manufacturers can usually just rely on data from clinical trials submitted by the maker of the original biologic. But, of course, the maker of the original drug doesn’t want everyone using its data and making cheap knockoffs.
So in the United States, there are really protective rules around this: Any maker of a biologic gets 12 years of data exclusivity. The FDA (US Food and Drug Administration) can’t approve a similar drug that relies on the original data during this time. (Theoretically, other companies could conduct their own trials to create a biosimilar, but because this is so expensive, it defeats the point.) By contrast, in other countries, there are looser rules — or no rules — around such data exclusivity. Japan offers eight years, for instance. Brunei offers zero.
As part of the TPP, the United States (and the pharmaceutical lobby) had been pushing to get every country to agree on 12 years of data protection for biologics. The final agreement falls somewhere in between, with a period of data exclusivity from at least five to eight years, according to the New York Times.
This means the agreement will prevent more affordable biosimilars from entering the market for a longer period of time in places that previously had no bar to entry. And the burden of this provision will be felt by the world’s poorest countries, according to Judit Rius Sanjuan, the legal policy adviser for Doctors Without Borders.
“Peru, Vietnam, Malaysia, and Mexico — they had zero monopoly protection on data for biologics,” she said. Now they’ll have to wait at least five years before allowing cheaper biosimilars onto the market. “It’s a loss for people in developing countries. They’ll face higher prices for longer periods of time, and there are many products we need that are biologics.”
Reading this commentary, a corporate client of yours (which is planning to manufacture pharmaceuticals) wants to know Australia’s position on data protection in relation to biologic drugs and also wants to understand the above commentary better. You need to find out the following:
- What kind of data is protected by this period of, inter alia, 12 years? 15 words max. 2 marks
- Why is it protected? 20 words max. 3 marks
- What is the current period of protection for the data in Australia? 1 mark
- Under what section of what Act is the data protected for that period? 2 marks
- Copy in the full text of the relevant section here. 2 marks
- When the Report of the Pharmaceutical Patents Review was handed down in Australia in 2013, did the review panel considering pharmaceutical patents recommend that the period of data protection be increased in line with the longer protection period in the US? Yes or no. 1 mark
- Why was that? Give the two reasons that were given in the Report. 2 marks
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