Drug Monopoly Enforcement A...

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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The TransAtlantic Consumer Dialogue (TACD), Health Action International (HAI) and Knowledge Ecology International (KEI) hosted a public meeting on the issue of intellectual property rights enforcement in Brussels on Wednesday, June 10th.

Every day we hear about counterfeiting and piracy and about anti-counterfeiting and new enforcement initiatives of governments and industry. HAI, KEI and TACD presented two panels that challenged the direction and rationale of several of these intellectual property rights initiatives, including EU regulation 1383 on border measures and the proposed "Anti-counterfeiting" trade agreement (ACTA). The enforcement of private intellectual property right claims is a complex and important area of public policy that touches on issues such as personal privacy, civil rights, freedom, social and economic development, among others.

European Union leaders and the United States government are currently engaged in efforts to shape global norms for the enforcement of copyright, trademarks, patents and other intellectual property rights. These discussions are taking place in multilateral, plurilateral, bilateral and unilateral fora. Such policies raise concerns because of the delicate balance between on the one hand rights and exceptions, put in place by the international copyright and patent law "acquis", and on the other hand public health principles such as access to medicines.

Speakers at the event represented consumer and public health organisations from both sides of the Atlantic: Médecins Sans Frontières (MSF), KEI, Essential Action, Electronic Frontier Foundation (EFF), HAI, The European Consumers Organisation (BEUC) and the Brazilian Permanent representation to the European Union, as well as respondents from DG-Trade and DG-Internal Market & Services. The diverse audience included representatives from pharmaceutical, seed, and software companies, the US Chamber of Commerce, academic experts, European Commission officials, members of the European Parliament, journalists, public health groups, consultants, business and civil society organisations.
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The global "intellectual property" enforcement agenda poses profound risks for consumers in the U.S. and around the world in many ways. The risks include privacy and transparency issues and threats to access to medicines in the U.S. and the developing world.

Essential Action and other public health and consumer groups have identified several particular risks posed by the pharmaceutical monopoly enforcement agenda on access to medicines. They include:

- risks for global access to medicines and other public costs,
- how the enforcement agenda misleads policymakers and confuses public debate,
- the actual relationship between drug quality, the enforcement agenda, and counterfeit medicines,

To learn more about the the access to medicines concerns as well as to review some policy recommendations , download an Essential Action powerpoint introduction to the pharmaceutical monopoly enforcement agenda here: IPenforcementagenda.ppt

By Peter Maybarduk
The Wall Street Journal
Letter to the Editor

Roger Bate correctly identifies the danger to patients posed by substandard medicines ("China's Bad Medicine," op-ed, May 5). But his article tends to confuse public health and patent and trademark concepts.

One reason this matters is poor drug quality is a much bigger public health problem than just fakes.

Another is that brand-name drug companies, unfortunately, are exploiting public fear of fakes to reinforce patent monopolies -- in some cases demanding public officials treat generic competitor drugs as "counterfeits" that may infringe patents and should be subject to the same aggressive seize-and-destroy tactics applied to fake medicines. Dutch authorities' recent seizure of legitimate generics (which Merck requested be destroyed), in transit to treat HIV/AIDS in South America, is an example.

Whether a drug infringes a patent is an entirely separate inquiry from whether a drug is substandard or otherwise unsafe. Public policy should be careful to maintain this distinction, as overzealous government efforts to anticipate patent infringement can limit access to affordable and lifesaving generic medicines. They can also leave taxpayers footing the bill to protect drug firms' monopolies.

Peter Maybarduk
Essential Action Access to Medicines Project
Washington, D.C.
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By Peter Maybarduk
Foreign Policy
Letter to the Editor
November/December 2008

Roger Bate (“The Deadly World of Fake Drugs,” September/October 2008) correctly identifies the serious threat to patient safety that substandard counterfeit medicines pose. But one of his prescriptions— that health professionals consider sacrificing broad public access to treatment in favor of purchasing more expensive brand-name drugs—is bad medicine indeed.

Bate, a resident fellow of the American Enterprise Institute, failed to disclose that his organization receives substantial funding from brand-name pharmaceutical companies, including Eli Lilly and Company Foundation, Bristol-Myers Squibb Foundation, and Pfizer. Bate is also a fellow at the Institute of Economic Affairs, which employs on its board of trustees a former chairman of SmithKline Beecham and a current member of GlaxoSmithKline’s board of directors.

Brand-name pharmaceutical companies stand to benefit substantially from some of Bate’s proposals. For example, he claims humanitarian groups must choose between “expensive, safe drugs that treat fewer patients, or cheaper drugs that might not work.” This false dichotomy excludes the many affordable generic medicines that have undergone rigorous testing at the World Health Organization and other major drug regulatory authorities.
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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.**

The nations of the world are considering a resolution on Counterfeiting at this week's World Health Assembly in Geneva. Essential Action has produced a briefing note urging three specific changes to the resolution as pre-conditions for its adoption.

Essential Action recommends:

1. The Counterfeiting Draft Resolution should cite the role of high medicine prices in promoting pharmaceutical counterfeiting.

2. The Counterfeiting Draft Resolution should emphasize the need for companies to disclose information they have concerning counterfeits.

3. The Counterfeiting Draft Resolution should address counterfeiting as a public health problem. Anti-counterfeiting measures requiring the cooperation of health agencies should focus specifically and exclusively on the dangers and harms posed to the public by counterfeit goods. The WHO’s anti-counterfeiting work should be driven by the need to protect
public health, not intellectual property.


The full text of the briefing note is available following continuation of the post in html, and here as an rtf document: EA_Note_WHA_counterfeit_resn.rtf
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Intellectual Property Watch

25 April 2008
Rise Of Enforcement Priorities Reflected In Annual USTR IP Report

By William New

The annual United States government report aimed at boosting global protection of US intellectual property rights and discouraging investment in errant nations this year again took sharpest aim at China and Russia, but also raised the alert on Thailand in part for its use of permitted compulsory licensing for public health, on health and safety risks of counterfeit products such as medicines, on internet piracy, and on a global treaty against counterfeiting.