WikiLeaks reveals White House view on trade and drug prices
For months, consumer advocates have railed that the Obama administration was taking a secretive approach toward the Trans-Pacific Partnership trade talks and likely jeopardizing access to essential medicines throughout the Asia and the Pacific region. They warned that a restrictive deal would increase the power of the pharmaceutical industry and, eventually, bind Americans to the same terms.
Now, those concerns appear to have been validated after WikiLeaks released a trove of negotiating documents dated as recently as three months ago that indicate the White House was pushing Asian countries to reach such a deal by the end of this year. However, the documents also reveal there is division among the countries over such key issues as patent protection for drugmakers (here are the leaked documents).
“The document confirms fears that the negotiating parties are prepared to expand the reach of intellectual property rights, and shrink consumer rights and safeguards,” says Jamie Love of Knowledge Ecology International, an advocacy group that focuses on intellectual property issues and access to medicines, in a statement.
“… The text reveals that the most anti-consumer and anti-freedom country in the negotiations is the US, taking the most extreme and hard line positions on most issues… The US proposals would create new global legal norms that would allow foreign governments and private investors to bring legal actions and win huge damages, if TPP member countries do not embrace anti-consumer practices" (here is the statement and a KEI analysis of the documents).
“The Obama administration proposals are the worst – the most damaging for health – we have seen in a US trade agreement to date,” says Peter Maybarduk of Public Citizen, in a statement. The “shameful bullying on behalf of the giant drug companies would lead to preventable suffering and death in Asia-Pacific countries. And soon the administration is expected to propose additional TPP terms that would lock Americans into high prices for cancer drugs for years to come.”
The WikiLeaks disclosure has also angered members of Congress, some of whom wrote letters to the White House to express their annoyance that talks are not transparent. Specifically, both Democrats and Republicans vowed to prevent the Obama administration from using the so-called Fast Track approach to trade negotiations (letters are here and here). The reactions suggest the White House may find it more difficult to conclude the TPP talks by the end of the year, as hoped. A meeting is scheduled next week in Salt Lake City.
Among the US initiatives that are drawing fire is a proposal for evergreening, which refers to patent extensions based on minor changes in a drug. The practice is often employed when a patent is set to expire and the modification is used to claim a newer version of a drug has been hatched, which can allow a drugmaker to seek extended patent protection and keep the cash register ringing. This was an issue in the controversial Indian court case over the patent for the Gleevec cancer drug sold by Novartis.
The US is also proposing to require countries to make patent term extensions available when regulatory review exceeds a certain amount of time. And the measure would introduce patent extensions not only for new medicines, but also for methods of making or using pharmaceuticals, according to an analysis of the trade documents by Public Citizen.
Another proposal calls for extended data exclusivity, which refers to exclusive access to clinical trial data. The US wants at least five years of exclusivity for safety and efficacy data submitted for marketing approval and at least three years of added exclusivity for submitting new clinical information on new uses or indications of existing drugs, even if the data has already been disclosed or is in the public domain. And drugs considered similar are also prevented from using the data, according to the analysis.
The documents do not indicate what position the US will take on exclusivity for biologics, although the pharmaceutical industry has pushed for 12 years (back story). The Affordable Care Act offers four years of data exclusivity and eight years of market exclusivity, although the White House has publicly stated its intention to lower this to seven years. However, any TPP provision may lock the US into the same terms.
The possibility that the US will eventually agree to longer exclusivity periods alarms many consumers groups. Last week, the AARP , Consumers Union and Families USA, along with a dozen other organizations, wrote a letter to the White House over concerns that lengthened exclusivity will, ultimately, cause federal and state healthcare care programs to pay higher prices for extended periods and consequently hurt the pocketbook of the average American or, worse, limit their care (here is the letter).
The US also proposes linking marketing approval to patent status and shifts the burden for early patent enforcement to regulatory authorities, which Public Citizen maintains is more aggressive than in other free trade agreements. The provision would require countries to provide a mechanism to identify patents covering an approved drug or approved method of use. The proposal includes a notification system for patent holders, an automatic stay of marketing approval and measures to block medicines that allegedly infringe patents, according to the analysis.
We asked PhRMA, the pharmaceutical industry trade group, for comment and will update you accordingly. [UPDATE: ” We can’t speak to the authenticity of the text , but we will continue to press for the strongest standards of protection for biopharmaceutical innovation on behalf of patients and our innovators. Nothing that we understand is being negotiated is beyond US law.”]
Source: Pharmalot
