Leith van Onselen wrote in Macrobusiness -
Wikileaks leaked the final draft of the Intellectual Property chapter of the Trans-Pacific Partnership (TPP) over the weekend, which has been panned by various experts.
Most notable of these is La Trobe Universtity lecturer in Public Health, Dr Deborah Gleeson, who has analysed the chapter and concluded that it represents nothing less than a disaster for global health.
Here are the specific quotes from Dr Gleeson’s critique -
Many harmful provisions still remain in the final chapter, bearing out the concerns of public health advocates. These include:
Patents for new uses and new methods of using existing products (Article QQ.E.1.2, p. 17);
A low inventiveness threshold potentially preventing countries from tightening the criteria for granting patents (Footnote 33, p. 17);
Patent term extensions to compensate for delays in granting patents (Article QQ.E.12, p. 20) and delays in marketing approval (Article QQ.E.14, p. 22);
Data protection for small molecule drugs at least 5 years for new pharmaceutical products plus 3 years for new indications, formulations or methods of administration (Article QQ.E.16, p. 23-24);
Patent linkage provisions likely to result in delays in marketing approval for generic drugs (Article QQ.E.17); and
Market exclusivity for biologics, provided through one of two options: at least 8 years of data protection, or at least 5 years of data protection and other measures to deliver a comparable outcome in the market (Article QQ.E.20, p. 25-26).
This is the first time a provision for market exclusivity for biologic products has ever appeared in a trade agreement and this is a new obligation for many TPP countries.
The outcome of this suite of obligations will be delayed competition from follow-on generics and biosimilars which means delayed access to affordable medicines, placing them out of reach altogether for many people in developing countries. Even countries like Australia, the TPP obligations will lock in current intellectual property standards, making it difficult or impossible to reform our system to improve access to affordable medicines in future
If the TPP countries ratify the deal, Big Pharma will have succeeded in cementing intellectual property standards that will stymie access to medicines for up to 800 million people in the short term, and more if additional countries sign up in future. Furthermore, the TPPs intellectual property chapter sets a new norm that is likely to become the template for future trade agreements: its implications are global as well as regional.
The governments of TPP countries have been complicit in a global health disaster of unimaginable proportions a deal that will prevent untold numbers of people from obtaining medicines that those in many developed countries take for granted
The Australian Governments brief about the TPP outcomes for biologics says:
In the TPP, Australia has negotiated protections that are consistent with Australian law and practice. Australia is not required to change any part of its current law, including data protection for biologics, or our patent regime. There will be no adverse impact on the Pharmaceutical Benefits Scheme and no price increase for medicines. But the final text of the TPPs IP chapter contains some problematic language and troubling ambiguities.
Article QQ.E.20.1 (p. 25-26) outlines two options that countries can implement to protect new biologics:
1) At least 8 years protection of clinical trial data (QQ.E.20.1(a)); or
2) At least 5 years protection of clinical trial data along with other measures to provide effective market protection and deliver a comparable outcome in the market.
Whatever the understanding reached between parties in the negotiating room, according to the agreed legal text, it appears that the TPP parties are obliged to ensure the same market exclusivity outcomes regardless of which option they choose.
The legal language provides room for the United States to continue to pressure the other TPP countries to ensure that they keep biosimilars (more affordable follow-on products) off the market for eight years, in order to provide equivalent effective market protection and a comparable outcome to eight years of data protection
The provisions relating to biologics are problematic and ambiguous. They appear to commit countries to providing either eight years of clinical trial data protection, or five years of clinical trial data protection along with other measures to deliver comparable outcomes. While the Australian Government has said that the regime for biologics in Australia will not change, the language leaves room for continued pressure by the United States to ensure that TPP countries prevent biosimilars from entering the market for eight years. The definition of biologics is very broad and likely to limit countries flexibility in determining the scope of the obligation. A review by the TPP Commission of both the length and scope of protection after ten years provides a further mechanism for US pressure to expand and extend monopolies on expensive biologics.
Germany saw “The Biggest Protest In Years” over these trade deals last weekend with quarter million persons attending -
Reuters reported -