Copyright only extends to creative works, not facts, meaning that clinical trial data (and other data sources) are in the public domain as soon as they're published — unless governments create special "sui generis" rights to scientific research data.
One of the key issues holding up the negotiations over the secretive Trans Pacific Partnership is "data exclusivity" in which the US Trade Rep is demanding that its powerful biologics industry (which produces medicines from living organisms) gets 12 years' worth of exclusive rights to use and publish clinical research data (for comparison, the first sui generis rights to data endured for six months).
This despite the fact that the Obama administration — for whom the US Trade Rep works — has been trying to shorten the monopoly over biologics trial data to seven years.
As Glyn Moody writes at Techdirt: "what clinical trials produce is safety data about a drug, which is simply a certain kind of scientific fact concerning a particular complex compound, as unchanging as all its other features. It is not something that depends on the ingenuity of the person measuring it, because it represents intrinsic information about a substance. Granting data exclusivity is thus nothing less than giving a monopoly on knowledge itself, since it forbids any other company from being able to use that newly-established scientific fact."
Eight years of data exclusivity won't be an appealing option for any of the other TPP countries, with the exception of Japan and Canada, which already allow for eight years. New Zealand's trade minister recently faced outrage at home over admissions that the cost of medicines may be expected to increase after the agreement. The country's opposition, also Labor, has declared it won't support a deal that raises the costs of medicines.
The US stance itself is contradictory as the Obama administration has been trying to reduce the exclusivity period for biologics to seven years, to speed up the availability of cheaper alternatives and save an estimated US$16 billion in the next decade.
It seems clear to everyone except US negotiators – and biopharmaceutical industry lobbyists – that the demand for extending data exclusivity for biologics needs to be dropped if the TPP is to be finalised.
How the battle over biologics helped stall the Trans Pacific Partnership
[Deborah Gleeson & Ruth Lopert/The Conversation]
(via Techdirt)
(Image: data.path Ryoji.Ikeda – 4,
r2hox, CC-BY-SA)
