Trade Agreements

The U.S., E.U., and key trading partners are negotiating an Anti-Counterfeiting Trade Agreement (ACTA). ACTA is one of several major new initiatives seeking, in part, to protect drug monopolies under the guise of fighting counterfeits. Much like a counterfeit, ACTA misrepresents its true ingredients to the public.

In a new fact sheet, Essential Action outlines some key concerns ACTA may pose, focusing on access to medicines. Then we recommend basic principles the United States and other countries should follow if they decide to continue participating in ACTA negotiations.

The concerns outlined in the fact sheet are:
- ACTA will keep medicine prices high
- ACTA threatens the generics industry
- ACTA fails to adequately address public health & safety concerns
- ACTA’s draft text is secret
- ACTA enforces private monopolies at public cost

Download a .pdf version of the fact sheet here: ACTAFactsheet.pdf
Download a .doc version of the fact sheet here: ACTAFactsheet.doc

Today, Essential Action submitted comments to the Canadian government concerning the proposed Anti-Counterfeiting Trade Agreement (ACTA), focusing on the public health priority of ensuring access to safe and affordable medicines to people around the world, regardless of income or wealth.

Download a .pdf version of the comments here: EssentialActionACTAcommentsCanada.pdf

Download a .rtf version of the comments here: EssentialActionACTAcommentsCanada.rtf

A summary of the comments, plus a text version of the complete comments (minus the citations) can be read in the continuation of this post.

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IP-Watch
By David Cronin

BRUSSELS - India’s status as a top world supplier of generic medicines could be threatened by a free trade agreement its government is negotiating with the European Union, a new study has concluded. Separately, the World Customs Organization has abandoned its intellectual property rights enforcement group, replacing it with a non-policymaking information committee.

A draft of the proposed agreement, available here [1], put forward by EU officials recommends that it should incorporate a wide range of intellectual property issues. According to Carlos Correa, a professor in the University of Buenos Aires, at least two of the provisions in the draft could hamper access to affordable medicines for developing countries.

In an analysis of the accord, Correa concluded that it could require India to forbid the manufacture of generic versions of patented drugs for up to five years after the patents in question expire. While the official rationale behind the EU’s proposal is that such an extension would offer compensation for the time it has taken the patent-holder to obtain marketing authorisation for a particular drug, Correa argued that it would have adverse consequences for the poor as it would delay the reduction of drug prices.

Another provision would offer protection to test data submitted for the approval of branded medicines for a certain length of time (the precise duration has not yet been specified by EU officials). In effect, this would bar makers of generic drugs from using that data.

Until now India has been opposed to introducing such a form of data exclusivity, Correa noted, adding that the EU recommendations go beyond the scope of the key international IP law: the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.

The question of access to medicines was one of the main issues debated at a public meeting held in Brussels on 10 June, organised by several consumer and health action groups.

Peter Maybarduk from the Washington-based organisation Essential Action said that a number of studies have estimated that the costs of medicines can fall by between 40 percent and 80 percent once generic versions of patented drugs become available. Despite the health benefits associated with this reduction, he complained that a number of governments from industrialised countries have been pursuing an “enforcement agenda” which places greater emphasis on the profits of corporations than on public needs.
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In May 2009, twenty-six U.S. consumer, development, HIV/AIDS, public health and religious groups, including Essential Action, Act UP Philadelphia and New York, Africa Action, CPATH, Forum on Democracy and Trade, Global AIDS Alliance, Health GAP, the Interfaith Center on Corporate Responsibility, Knowledge Ecology International and Oxfam America, released a common platform on trade-related intellectual property and access to medicines issues. The document broadly outlines the common policy agenda these groups are pursuing in the areas of access to medicines, innovation and transparency.

You can download the platform here: IP-MedsPlatformMay2009.pdf

You can download a list describing the organizations that endorsed the platform (including contact persons) here:
OrganizationalDescriptionsofPublicHealthGroupsforUSTR-May13.pdf

Read a text version of the platform in the continuation of this post.
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FOR IMMEDIATE RELEASE
September 15, 2008

For more information contact:
USA: Robert Weissman, director, Essential Action +1 (202) 387-8030, (Mobile) +1 (202) 360-1844, rob@essential.org

Australia: Kimberlee Weatherall, Lecturer, TC Beirne School of Law, The University of Queensland and Board Member, Australian Digital Alliance, (Mobile) +61 4 0376 2544, k.weatherall@law.uq.edu.au

Canada: Michael Geist, Canada Research Chair in Internet and e-commerce Law, University of Ottawa, (Office) +1 (613) 562-5800 ext. 3319, mgeist@uottawa.ca

Korea: Byoung-il Oh, Korean Progressive Network Jinbonet, (Tel) +82-2-774-455, (Mobile) +82-19-213-9199, antiropy@www.jinbo.net


Secret Counterfeiting Treaty Public Must be Made Public, Global Organizations Say

More than 100 public interest organizations from around the world today called on officials from the countries negotiating Anti-Counterfeiting Trade Agreement (ACTA) -- the United States, the European Union, Switzerland, Japan, South Korea, Canada, Mexico, Australia and New Zealand -- to publish immediately the draft text of the agreement.

Secrecy around the treaty negotiation has fueled concerns that its terms will undermine vital consumer interests.

Organizations signing the letter include: Consumers Union, Electronic Frontier Foundation, Essential Action, IP Justice, Knowledge Ecology International, Public Knowledge, Global Trade Watch, U.S. Public Interest Research Group, IP Left (Korea), Australian Digital Alliance, The Canadian Library Association, Consumers Union of Japan, National Consumer Council (UK) and Doctors without Borders’ Campaign for Essential Medicines.

Based on leaked documents and industry comments on the proposed treaty, the groups expressed concerns that ACTA may:

+ Require Internet Service Providers to monitor all consumers' Internet communications;

+ Interfere with fair use of copyrighted materials;

+ Criminalize peer-to-peer electronic file sharing; and

+ Undermine access to low-cost generic medicines.

"Because the text of the treaty and relevant discussion documents remain secret, the public has no way of assessing whether and to what extent these and related concerns are merited," say the public interest groups in their letter.

Worsening the problem is the perception that industry lobbyists have access to the text and are influencing the negotiations. "The lack of transparency in negotiations of an agreement that will affect the fundamental rights of citizens of the world is fundamentally undemocratic. It is made worse by the public perception that lobbyists from the music, film, software, video games, luxury goods and pharmaceutical industries have had ready access to the ACTA text and pre-text discussion documents through long-standing communication channels."

"Why in the world are trade negotiators keeping the treaty a secret?" asks Robert Weissman, director of Essential Action. "Are they worried about counterfeiters influencing the negotiations? What possible rationale is there for secrecy -- other than to lock out the public? Intentionally or not, a treaty to prevent unauthorized copying may easily go too far, and undermine important consumer interests. That's why it is so important that this deal be negotiated in the light of day."

Essential Action is a public health and corporate accountability group located in Washington, DC.

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The list of signers and additional quotes from groups signing the letter is available on the continuatio of this post, or as downloadable rtf at:

ACTA-signon.rtf

ACTAquotes.rtf

The United States, the European Union, Japan, South Korea, Canada, Mexico, Australia and New Zealand are now negotiating a new treaty known as the Anti-Counterfeiting Trade Agreement (ACTA).

The text of what they are negotiating remains secret, but there's a lot to be worried about. An over-reaching treaty in this field could require Internet Service Providers (ISPs) to monitor all consumers' Internet communications, interfere with fair use of copyrighted material and undermine access to low-cost generic medicines, among many other dangers.

Does the proposed ACTA contain provisions that would result in these harmful effects?

There's no way to know, because the treaty text remains secret. There is no legitimate rationale for such secrecy, which denies people around the world an opportunity to comment on and influence the negotiations.

Essential Action is asking organizations and individuals from around the world to sign on to a letter to ACTA negotiators, asking that they immediately make public the draft text of the treaty. The text of the letter, with initial signatories, is below.

If you would like to sign the letter, please send your name, affiliation (if any), city/country and email address to Sarah Rimmington of Essential Action at: . Please specify if you are signing in your individual capacity or on behalf of an organization. **Please note: Our deadline for accepting signatures is Wednesday, August 20, 2008.**

On March 21, Essential Action submitted comments to USTR on a proposed anti-counterfeiting treaty.

The comments argue that background information on the treaty conflate the concepts of counterfeiting, "piracy" and infringement. "An agreement based on, or reflecting, such a conflation of distinct concepts is likely to be overly broad, proscribing behavior that cannot correctly be identified as counterfeiting and that is not necessarily detrimental to the public interest." As regards medicines, the proper focus should be on public health -- in the context of the broader problem of substandard medicines -- rather than on counterfeiting

The comments argue that Big Pharma should be obligated to disclose publicly information it has on fake pharmaceuticals.

The comments also point out that the key market incentive for medicines counterfeiting is the high price of patented medicines, and that efforts to make medicines available at marginal cost will reduce counterfeiting incentives.

An rtf formatted version of the comments is available here: EssentialActionACTAcomments.rtf.

The text of the comments follows on the continuation.

An interview with Essential Action's Sarah Rimmington on global access to medicines aired on WRVU 91.1 FM in Nashville Tennessee on January 7, 2008.

In the interview with Project Question’s Lonnie Atkinson, Sarah explains how international trade agreements governing patent rules and the brand-name pharmaceutical industry work to restrict the introduction of low-cost generic copies of life-saving drugs in the developing world. The widespread lack of generic versions of many life-saving treatments is a significant contributing factor to the limited access poor people in developing countries have to them.

You can listen to the entire interview here.

October 30, 2007
For Immediate Release
For More Information, contact: Robert Weissman, Essential Action, (202) 387-8030

In response to a request from Senator Edward Kennedy and Representative Henry Waxman, the Government Accountability Office today has issued a report on U.S. trade policy and access to medicines.

The GAO report highlights in some detail the many ways that the Bush administration has violated the Doha provision in the 2002 Trade Promotion Authority legislation. The Act designated respecting the Doha Declaration on the TRIPS Agreement and Public Health as a principal negotiating objective related to intellectual property.

"It is time for the Bush administration to stop defending Big Pharma's interests in extended patent monopolies, at the expense of public health," says Robert Weissman, director of Essential Action, a Washington, D.C.-based organization that aims to expand access to essential medicines. "The life-and-death consequences are just too high."

"A new policy should have advancing public health, rather protecting large corporate contributors, as its starting point," said Weissman. "From there, it's easy to see what to do: promote generic competition — including but not limited for the AIDS drugs that the President's own AIDS program is purchasing — stop pushing for higher patent and drug monopoly standards in developing countries, and explore new ways to promote both innovation and affordability."
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For Immediate Release
For more information, contact:
Robert Weissman, Essential Action, 202-387-8030 (o), 202-360-1844 (cell), rob@essential.org
Asia Russell, Health GAP, 267-475-2645, asia@healthgap.org
Brook Baker, Health GAP, 617-373-3217, b.baker@neu.edu

Comment and Analysis on Revised Intellectual Property and Access to Medicines Provisions in Peru and Panama Trade Agreements
Essential Action and Health GAP

The final Peru and Panama texts incorporate the terms of the earlier "concept paper" negotiation between the House Ways and Means Committee and the U.S. Trade Representative, for better and worse, with few changes. Our statement on the conceptual deal is available here.

It remains the case that the Peru/Panama trade deals will leave patients worse off than they would be with no agreement. The agreements enhance monopoly protections for medicines beyond those required under the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), and will worsen public health.

These revised trade agreements are less bad than the original versions, in some notable ways. If the deals are adopted — and we hope they are not — it will be important that Peru and Panama aggressively incorporate in their implementing legislation (and subsequent revisions) the flexibilities that have been added thanks to the negotiating efforts of the Ways and Means Committee.
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