Author: Peter Maybarduk

New TPP Maneuvering on Biologics, But 5+3 Still = 8

Ministerial talks for the Trans-Pacific Partnership (TPP) collapsed in Maui last month when trade ministers sparred over issues including monopolies for biotech drugs, which include many cancer treatments. Talks resumed this weekend in Atlanta, where negotiators are reportedly exploring a tweaked approach to the impasse over biologics. But the approach, which may consider introducing a period of post-marketing surveillance in a system analogous to Japanese law, is an illusion, not an improvement. It is a repackaging of the same harmful idea already rejected by many countries. In other words, 5 + 3 still makes 8 years exclusivity. Analysis:...

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Ecuador Takes One Step Forward for Health, and One Step Back

Issues New Compulsory Licenses; Signs Harmful Trade Agreement with the EU [Luz Marina Umbasia and Peter Maybarduk, Link to PDF]  In July, Ecuador issued four compulsory licenses for medicines targeting cancer and arthritis treatment and immunological reception to kidney transplant.[1] These licenses authorize cost-cutting generic competition with patented medicines, in exchange for royalty payments to the patent holders. Compulsory licensing is a crucial tool to expand access to medicines that are prohibitively expensive or whose costs place enormous burdens on budgets for health systems.[2] Ecuador has again demonstrated international leadership by exercising its health rights. The same month, however, Ecuador also signed a trade agreement with the European Union that may undermine access to medicines.[3] Intellectual property was among several sensitive topics in the negotiations. The text is not yet public, but Ecuador ultimately bowed to EU pressure to adopt exclusivity measures which protect pharmaceutical monopolies and keep prices high. Notably, Ecuador’s public pharmaceutical firm ENFARMA withdrew several additional compulsory license requests during the latter stages of Ecuador’s negotiations with the EU. The timing of the withdrawals raises a serious question as to whether this decision was influenced by the negotiations. Ecuador’s pro-health policies continue to suffer inappropriate challenges from commercial interests with influence in the government. Ecuador established ENFARMA in 2009 with the goal of improving the well-being of Ecuadorian society through the manufacture and distribution of safe...

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Resist the Special 301 Watch List

The Office of the US Trade Representative’s 2014 Special 301 Report is expected out shortly.  The 301 Report places countries on a watch list for practices the US Government believes reflect “inadequate” intellectual property protection, even when these policies protect important public interests including health. Public Citizen submitted comments in February to inform this year’s 301 Report. We address the TRIPS compliance and public interest value of specific rules and practices in India, Canada, Chile, Colombia, Indonesia, Peru, Philippines and Turkey. We also criticize 301 – the process should be discontinued entirely – and articulate several principles which could be applied to make meaningful the US Government’s relevant public health commitments, by not listing countries for public interest practices that comply with international rules. Pharmaceutical industry hysterics and complaints this year have concentrated, in ample part, on India and Canada. We take some of the complaints against India to task in this analysis for the US International Trade Commission. We address Canada’s promise doctrine in this analysis. USTR posted video of all testimony from the February 24 Special 301 hearing. Ours is here (all testimonies can be found in the sidebar):...

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Washington Makes Anti-India Push

Last Thursday the Energy and Commerce committee of the U.S. House of Representatives held a hearing entitled, “A Tangle of Trade Barriers: How India’s Industrial Policy is Hurting US Companies.” The hearing is part of a recent big business push which aims to support specific industry complaints against India by lumping them together, in order to claim that India is generally flouting international rules. The strategy could benefit Big Pharma by diverting attention away from access to medicines concerns. We distributed a two-pager which references WTO rules and responds in brief form to some of the specific patent and pharmaceutical-related complaints that seem to be circulating on Capitol Hill, a few of which were raised in a pre-hearing memo circulated by the Republican majority. The Public Citizen two-pager, “India’s Patent System Plays by WTO Rules and Supports Global Health,” is available here:  tinyurl.com/nm3pc6l. Thank you to Adriana Benedict and the PC staff for your work on this. The testimony of hearing witnesses, which included representatives from Pfizer and the U.S. Chamber of Commerce as well as Rohit Malpani of MSF, are available here. Zach Carter wrote this article for Huffington Post.  ...

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US Government Special 301 “Watchlist” and Developing Country Use of Compulsory Licenses for Healthcare

Special 301 is an annual report by the Office of the US Trade Representative (USTR) which places countries on a “watch list” if USTR would like to see greater changes in their intellectual property rules or enforcement practice. This year’s report came out May 1st. We pay attention because USTR relies heavily on comments from big business, and USTR’s opaque standards and criticism of other countries could stymie the development of public interest policies in areas including health. For example, countries have sovereign rights to issue “compulsory licenses” on pharmaceutical patents. Compulsory licensing authorizes price-lowering generic competition with patented drugs in exchange for royalty payments to the patent holder. It’s a key strategy for improving access to affordable medicines, especially in developing countries. But the US has often criticized compulsory licensing, and sometimes sought to stop it (see eg: http://www.citizen.org/leaked-cables-show-US-tried-failed-to-organize-against-ecuador-compulsory-licensing).   This year’s Special 301 Report, and past 301 Reports, have included language to the effect, “the United States respects a trading partner’s right to protect public health and, in particular, to promote access to medicines for all,” and “the United States respects its trading partners’ rights to grant compulsory licenses in a manner consistent with the provisions of the TRIPS Agreement [the World Trade Organization agreement on intellectual property rules].” (See pages 22 and 23 of this year’s 301 report, available at: http://www.ustr.gov/sites/default/files/05012013%202013%20Special%20301%20Report.pdf.) Nevertheless, in recent years, USTR...

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Indonesia Licenses Patents for Seven HIV & Hepatitis B Medicines

Precedent-Setting Government Order has Extraordinary Lifesaving Potential On September 3, the government of Indonesia took a quiet but exceptionally important step to expand access to medicines and help save and improve lives of people living with HIV/AIDS and hepatitis B. President Dr. H. Susilo Bambang Yudhoyono signed a decree authorizing government use of patents for seven HIV/AIDS and hepatitis medicines. If implemented to the full, the measure would introduce widespread generic competition and generate major cost savings in the world’s fourth most populous country. The decree licenses patents for a slate of HIV medicines, and represents one of the most robust uses of pharmaceutical patent licensing power by a country since the World Trade Organization 1995 Agreement on Trade-Related Aspects of Intellectual Property (WTO’s TRIPS). Indonesia’s action sets a powerful example for other countries and a critical precedent for global public health. The Presidential decree is part of an effort to greatly expand access to newer and more appropriate antiviral and antiretroviral treatments in Indonesia. The licensed medicines include efavirenz, abacavir, didanosin, lopinavir + ritonavir, tenofovir, tenofovir + emtricitabine, and tenofovir + emtricitabine + efavirenz.   More information, including a copy of the decree (in Indonesian and a rough unofficial English translation), analysis, a table of the licensed medicines, and more on Indonesia’s response to HIV and hepatitis B, is available here:...

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Public Citizen Press Release: Obama Trade Pact Could Impede ‘AIDS-Free Generation’

Rollbacks of Modest Bush-Era Improvements on Access to Medicines Would Empower Big Pharma, Expand Monopolies WASHINGTON, D.C. – To achieve the “AIDS-free generation” for which President Barack Obama and Secretary of State Hillary Clinton, among others, have called, we must break the monopoly power of drug companies and change the U.S. approach to trade pacts, Public Citizen said today. The Obama administration is negotiating a multilateral “Trans-Pacific Partnership” (TPP) free trade agreement with countries in Asia and the Americas, intended to expand to the entire Asia-Pacific region. Leaked documents reveal that U.S. demands for the TPP would radically expand pharmaceutical monopoly power, keeping treatment costs high and threatening to impede the common goal of an “AIDS-free generation.” “An AIDS-free generation is an audacious and wonderful goal,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines program, who is participating in the “We Can End AIDS” mobilization and march on Tuesday during the International AIDS conference here. “But ending AIDS will depend in part on massively scaling up access to treatment. A major obstacle is the monopoly power of the giant pharmaceutical companies, which leads to vastly higher costs than could be achieved through expanded generic competition. Today, U.S. trade policy threatens to undermine U.S. AIDS policy. It is very important that the Obama administration rethink its position on trade and access to medicines.” Since 2000, generic competition has...

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“Heavy-handed” TPP tactics from US Trade Rep

[Reposted from the citizenvox blog.] The Trans-Pacific Partnership (TPP) is a massive package of proposed new economic rules for the Asia-Pacific region (including the US), heavily influenced by corporate priorities through the Office of the United States Trade Representative (USTR) and under negotiation right now.  You might not have heard of it, but if it’s eventually signed, its secret texts will affect your life. At the TPP negotiations’ official stakeholder briefing May 13th outside Dallas, USTR announced that the nine TPP country Chief negotiators together had just awarded a prize to the first negotiators to finalize their chapter: rules on small and medium enterprises (SMEs). Meanwhile, negotiators of chapters that are taking time for review and input are now getting a little punishment. For example, intellectual property negotiators who have been appropriately scrutinizing proposals that would transform their countries’ laws regarding generic medicines, internet freedom and much more, have reportedly been dragged before the assembled Chiefs more than once to face pointed questions about what’s taking so long. USTR is driving this new tactic, which even the US Chief Negotiator described as a more “heavy-handed approach.” Apparently USTR thinks this is a good thing.  But it comes at the expense of the “high-quality” agreement the parties expressly seek. Ordinarily the sort of proposals under discussion would be subject to serious debate in national legislatures; open to public comment and academic study....

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Colombian Court: Abbott Labs’ AIDS Drug Pricing Abuse Violated Health Rights

Both sides appeal in ongoing civil society lawsuit for compulsory license A Colombian administrative judge has ruled that Abbott Laboratories and the Ministry of Health threatened and violated collective rights to public health by maintaining the price of an HIV medicine above the reference price, flouting a government order. The court’s decision is a groundbreaking condemnation of Big Pharma pricing abuses and a precedent for health rights in Colombia. The decision arises from a lawsuit filed by health groups seeking a compulsory license on lopinavir + ritonavir (LPV/r), marketed by Abbott as Kaletra and Aluvia. A compulsory license would introduce cost-cutting generic competition with Abbott’s patent-based monopoly. The decision, technical documents and brief histories of Colombia’s ongoing access campaign are now available here, and a printable PDF of this backgrounder is available here. The Decision and Case The February 29, 2012 decision by Administrative Court 37 of Bogotá finds that Abbott violated a 2009 government pricing order and directs the Ministry of Health to initiate procedures for sanctions against Abbott (potentially including financial penalties). The court states that Abbott abused its dominant market position by pricing its essential medicine 350% higher in Colombia than in neighboring countries (about $3500 compared to about $1000). This harmed the sustainability of Colombia’s health system and violated “public administrative morality.” According to the court, “mercantile utility and patent ownership” does not justify “disobeying...

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