Negotiators for the Trans-Pacific Partnership reached an in-principle agreement on 6 October 2015, but have not yet released the text for analysis.
While the finalised TPP text has not yet been released, on 9 October 2015 Wikileaks published a document it claims is the finalised version of the chapter of the TPP dealing with intellectual property.
Final chapter on intellectual property leaked: what does it mean?
Intellectual property law covers a broad range of topics. The development of new disease treatments, patients' access to affordable medicines, punishment for online piracy and the ways that we access legal content online can all be affected by intellectual property provisions.
CHOICE sought out some expert advice on exactly what's in the bit of the TPP that we've seen, and how it will impact ordinary Australians.
Experts and advocates have long been concerned that the final text of the TPP would strengthen the monopoly power of pharmaceutical companies while making Australian patients wait longer for affordable treatments to hit the market.
Dr Ruth Lopert, a former negotiator for Australia during the AUSFTA negotiation process, provided CHOICE with her initial thoughts on what key impacts the TPP will have on access to medicine in Australia:
"Overall, much of the TPP intellectual property text is business as usual for Australia, though it will clearly reduce future policy flexibility. There are also some residual and potentially problematic ambiguities.
The TPP clearly promotes evergreening; requiring patents to be made available for new uses and new methods of using existing products. This reflects existing provisions in Australian law, but it reduces future policy flexibility.
In additional to evergreening concerns, the issue of exclusivity for biologics was one of the most contentious provisions in the IP chapter and one of the last to be resolved in the entire negotiations.
The US biopharmaceutical industry was pushing for provisions equivalent to those in the US. The US legislation specifies 12 years of market exclusivity (the period of time which must elapse before the government may approve a follow-on product). By contrast, Australia currently has five years of protection; the Therapeutic Goods Administration in Australia cannot begin evaluating a follow-on biologic until this time has passed. This means that, in effect, six or more years are likely to pass until the follow on product is approved for marketing.
The TPP provision on biologics is highly ambiguous. The Australian government's statement on this part of the TPP is equally ambiguous:
The TPP has a two-track outcome on biologics protection. Parties can choose to provide effective market protection through at least 8 years of data protection. Alternatively, Parties can choose to provide effective market protection through at least 5 years of data protection, along with other measures, including existing measures in the case of Australia, and recognising market circumstances. These measures and circumstances include regulatory settings, patents, and the time it takes for follow-on medicines to become established in the market. Australia will follow the 5 year option, which reflects our current system and requires no changes. This acknowledges that different tracks can deliver comparable outcomes.
It is entirely unclear what is meant by "effective market protection", "other measures" or "recognising market circumstances". While the government has said it won't need to amend the law, should the as-yet unspecified mechanisms and processes provide biologics with protection from competition for up to eight years in all cases, then this will inevitably mean delays in the listing of cheaper biosimilars on the PBS and substantial savings foregone – an effect similar to extending data protection beyond the current five years."
*'Biologics' are a type of pharmaceutical drug that can be used to treat cancer, arthritis and other diseases. Market exclusivity enables a drug company to maintain an effective monopoly on a product even if the patents on the product have expired. While a drug is enjoying market exclusivity, generic or biosimilar versions of the drug cannot be approved for release onto the market. Longer protection periods can lead to longer wait times for cheaper drugs, increasing costs to the Pharmaceutical Benefit System.
Copyright expert Trish Hepworth provided CHOICE with her initial thoughts on what key impacts the TPP will have on consumers and the way they access and use content online:
"The leaked text of the intellectual property chapter of the TPP confirms that the copyright provisions protect the interests of large companies over consumers. The provisions are heavy on enforcement, lack consumer protections, and lock us into antiquated and cumbersome copyright laws incapable of dealing with the future.
The language of the chapter is strikingly unbalanced. Consumer protections are aspirational, but rights-holder protections are mandatory. Essential exceptions that protect education, reporting the news and disability access are protected only to the extent that countries should "endeavour" to "achieve balance". Meanwhile countries "shall ensure" all the criminal and civil penalties specified in the chapter are applied, including "penalties that include sentences of imprisonment" for commercial-scale piracy, where commercial scale includes "at least" any acts carried out for commercial advantage or financial gain.
The few consumer protections provided are likely to be obsolete before the agreement comes into effect. There is, for an example, a protection for consumers to bypass geoblocking technologies on physical media (such as CDs or DVDs), but nothing to address geoblocking for the same content delivered digitally. And there is nothing in the agreement that would oblige rights holders to make content available equally across the TPP countries.
Thankfully, our negotiators did manage to defeat some of the most egregious proposals we saw in earlier leaks. The ban on parallel imports and the explicit extension of copyright protections to temporary digital copies are gone, and countries' enforcement measures should "avoid the creations of barriers to legitimate trade" and "provide safeguards against their abuse".
The biggest danger of the IP chapter may be that its implementation will be subject to Investor State Dispute Settlement (ISDS). These provisions mean that rights holders such as large movie studios or publishers could sue the government arguing our copyright laws were not in compliance with the IP chapter. Laws such as a fair use exception, bypassing geoblocks, or attempts to deal with orphan works are all potentially open to challenges by corporations, whereas consumers are unable to use ISDS to ensure fair and equitable access to content or the ability to use content they have paid for in the manner they wish.
Overall the copyright provisions in the TPP continue the recent tradition of IP chapters that concentrate on enforcement of rights-holder rights and lack balancing protections for consumers. While they are unlikely to require immediate legislative change, they lock the region into an overly rigid and complex system, removing pathways governments may consider to protect consumers and creators in the digital age."
When TPP negotiations began, the 12 Pacific-Rim nations involved signed non-disclosure agreements, promising not to release details of the agreement during negotiations and for a period afterwards.
Usually, when new laws are introduced to Australia, they are subject to open debate in Parliament and are often accompanied by a public consultation process. These safeguards let everyone have their say on new policy, and help make sure mistakes aren't made.
Although the TPP has been finalised and agreed to in-principle, the text has still not been released for public analysis, meaning that experts and advocates need to rely on leaks in order to assess the potential impacts that this agreement will have.
CHOICE has called for the Productivity Commission to conduct and publish a cost-benefit analysis of the TPP, so the Australian public can gain a better idea of what we're trading away. Tweet your thoughts to Trade Minister @AndrewRobbMP using the hashtag #TPP.
Ruth Lopert is an adjunct professor in the Department of Health Policy & Management at George Washington University in Washington DC and Deputy Director, Pharmaceutical Policy and Strategy at Management Sciences for Health. From 2008–11 Dr Lopert was Principal Medical Adviser at the Therapeutic Goods Administration, and previously directed the pharmaceutical policy unit in the Department of Health. She was also a key negotiator of the pharmaceutical provisions of the Australia US Free Trade Agreement.
Trish Hepworth is a lawyer and public policy expert specialising in copyright and trade related aspects of intellectual property.