[Ip-health] Pharmalot: Reps Seek 12 Years Data Protection In TPP Talks

Peter Maybarduk pmaybarduk at citizen.org
Fri Jul 29 08:56:38 PDT 2011


By Ed Silverman // July 29th, 2011<http://www.pharmalot.com/2011/07/29/> // 10:16 am

A group of 40 members of the House of Representatives have written President Obama urging the Trans Pacific Partnership talks currently under way should include a requirement that countries offer 12 years of data exclusivity for new biologics. The missive is the latest move by the pharmaceutical industry to create what it calls parity with US law.

"The US-led biopharmaceutical industry would be disadvantaged if the US does not ensure consistency with US law as part of the TPP, because foreign countries do not provide the same type of protection rules," according to the July 27 letter<http://freepdfhosting.com/591c09b619.pdf>, which PhRMA is circulating. The trade group has also distributed this document<http://freepdfhosting.com/b862d1fe3a.pdf> as part of its lobbying campaign.

You may recall that brand-name drugmakers won a 12-year exclusivity period as part of an effort to create a so-called FDA approval pathway for biosimilars. Generic drugmakers, of course, wanted a shorter term. Earlier this year, though, the White House proposed to shrink exclusivity to seven years from 12 years, a move that would roll back a provision in health care reform and which the Obama administration believes would save money (read here<http://www.pharmalot.com/2011/02/obama-shrink-exclusivity-and-end-pay-to-delay/>).

The issue has heated up with the TPP talks. PhRMA is urging the US Trade Rep to go beyond provisions contained in the Korea-US trade deal, known as KORUS, and include 12 years of data exclusivity for biologics. As noted previously<http://www.pharmalot.com/2011/05/phrma-wants-12-years-data-protection-in-tpp-talks/>, drugmakers usually want the USTR to replicate patent provisions found in KORUS into the TPP context, but KORUS did not contain 12 years of data exclusivity for biologics. This provision, though, was not part of US law when KORUS was negotiated.

But patient advocacy groups argue that increased data exclusivity is not necessary, since patent protections are already contained in the TRIPS Agreement that was negotiated under the auspices of the World Trade Organization. This allows drugmakers to recover R&D costs. By extending data exclusivity, they maintain generic competition and access is diminished, causing prices to rise.

"There already is a level global playing field - it's called the World Trade Organization's TRIPS Agreement. But big pharma refuses to accept any limits, and in free trade agreements since, the US Trade Representative has too often shilled for whatever special monopoly protections big pharma desires," Peter Maybarduk, who heads Public Citizen's access to medicines program, tells us.

"President Obama is right to oppose twelve-year government-issued monopoly protections for biologic medicines. Advancing long exclusivity periods in the Trans-Pacific free trade agreement would lock American consumers in to higher medicine prices here at home, and impose the same crooked idea on poor countries - compromising access to medicines."

Meanwhile, another letter is currently circulating on Capitol Hill that would demand a meeting with US Trade Rep Ron Kirk to discuss the industry-sponsored effort to roll back an earlier Congressional agreement to maintain a balance between intellectual property provisions and access to needed meds. This letter, though, has only just begin circulating and it is not yet clear how many reps will sign.

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