News Releases

FOR IMMEDIATE RELEASE

Following are comments from representatives of consumer, health and medical student groups, following the wholesale addition of the brand-name industry backed Eshoo-Barton-Inslee approach to generic biologic drugs by House Republican party leadership in their health care amendment, “The Affordable Health Care for America Act,” released today:


“It’s disappointing that the Republican Party which purports to be the party of free markets has decided to lend its support to a pro-monopoly, anti-competition, anti-innovation biogenerics proposal.” Robert Weissman, President, Public Citizen, (202) 588-1000, rweissman@citizen.org


"Today, it is unfortunately apparent that across party lines, special interest politics rather than evidence-based policies have prevailed. The democrats’ provisions on lifesaving biologic medicines—accepted verbatim by the Republicans today-- contradicts the major objectives of health reform—to contain health care costs and expand access to health care." Laura Musselwhite, medical student, Duke University, and member of www.AffordableMedsNow.org campaign of the American Medical Student Association (AMSA) and Universities Allied for Essential Medicines (UAEM), 336-908-6635, laura.musselwhite@gmail.com


"The Republican health care bill allows insurance companies to continue to deny people coverage for pre-existing conditions. Of course they whole-heartedly approve of the Eshoo biologic drugs amendment -- in both cases, it's corporate profit over human life. Your own personal death panel becomes the size of your bank account." Jane Hamsher, co-founder, Public Option Please (POP), (202) 248- 3155, firedoglake@gmail.com Join POP in the fight for affordable biologic medicines at http://publicoptionplease.com/home/.


“It looks like the only thing the Democrats and Republicans agree on relating to health care reform is the adoption of a generic biologic drugs proposal that will perversely block price-lowering generic competition. Unfortunately, this kind of bipartisanship will keep affordable versions of drugs like Roche-Genentech’s $48,000 per year blockbuster cancer treatment Herceptin out of American patients’ hands for far too long, or perhaps forever.” Sarah Rimmington, Attorney, Essential Action, Access to Medicines Project, (202) 422-2687, srimmington@essentialinformation.org Essential Action is a member of the www.AffordableMedsNow.org campaign.


"Perhaps we'd have greater bipartisan attention paid to access to affordable medicines for patients if the American people could afford to match the $1 million a day Pharma is spending on lobbying Congress. Members of Congress need to look at the evidence and fix the flawed provisions supported by Representative Eshoo and others to allow a true pathway for generic biologics." Ethan Guillen, Executive Director, Universities Allied for Essential Medicines, (775) 287-2553, ethan.guillen@essentialmedicine.org UAEM is a member of the www.AffordableMedsNow.org campaign.


"These days Washington, DC is a one party town, when it comes to influence from big Pharma. The Republicans had a chance to demonstrate that competition can protect consumers and businesses. Instead they opted for highly regulatory barriers to competition." James Love, director, Knowledge Ecology International (KEI) (202) 361-3040, james.love@keionline.org KEI is a member of the www.AffordableMedsNow.org campaign.


"At a time when we are hoping to reform health care by bringing costs down and improving patients' access to treatment and care, I am disappointed to see GOP leaders adopt Rep. Eshoo's language for biologic drugs. This language will in effect extend pharmaceutical companies' high monopoly pricing via prolonged periods of market exclusivity, and paradoxically stifle innovation by enabling easy renewal of these long monopolies." Saira Alimohamed, student, Alpert Medical School of Brown University, and Chair of the Global Health Committee, American Medical Student Association (AMSA). (443) 803-7403 or Saira@brown.edu or Global.Chair@amsa.org AMSA is a member of the www.AffordableMedsNow.org campaign.


“I am shocked at the ability of the pharmaceutical industry to buy what it wants from Congress. The inclusion of a biogenerics proposal that will in fact block most generic biologic drugs from coming to market in the Republican healthcare bill underscores how policy-making in Washington these days is less about patient's needs, and more about serving the interests of the pharmaceutical industry.” Malini Aisola, Senior Research Advisor, Knowledge Ecology International, (202) 332-2670, malini.aisola@keionline.org KEI is a member of the www.AffordableMedsNow.org campaign.


"These most recent developments in health care 'reform' are extremely troubling. I am very worried for the future of America's healthcare system if the only productive compromise our representatives can make is to throw in this same biogenerics proposal, with its same lack of foresight or concern for patients' rights." Eric Emilio-Gerrit Butter, student, UNC Gillings School of Global Public Health, Duke Institute for Genome Science and Policy, and member of Universities Allied for Essential Medicines (UAEM), (607) 759-5959, egbutter@gmail.com UAEM is a member of the www.AffordableMedsNow.org campaign.

FOR IMMEDIATE RELEASE
September 28, 2009

Contact: Sara Crager, MD PhD, Yale University, and member, Universities Allied for Essential Medicines (UAEM)
Phone: (203) 444-4805 Email: sara.crager@yale.edu

Contact: Ethan Guillen, Director, Universities Allied for Essential Medicines (UAEM)
Phone: (775) 287-2553 Email: ethan.guillen@essentialmedicine.org**


CURRENT PROPOSALS IN HEALTHCARE REFORM BILLS WILL BLOCK MOST GENERIC BIOLOGICS

Student and consumer groups, Universities Allied for Essential Medicines (UAEM) and the American Medical Student Association (AMSA), supported by consumer groups Essential Action and Knowledge Ecology International, are today calling on Congress to create a real pathway for the production of generic biologics. Current proposals for generic biologics or “follow-on biologics” in Senate and House versions of healthcare reform legislation that purport to create such a pathway will actually block production of most generic biologics, which -- if the current proposals are improved in critical ways -- could save $71 billion or more in the first decade alone.

The organizations involved support healthcare reform now, but urge Congress to fix this serious challenge to future affordable access, both here and abroad, which could also create tremendous savings for the healthcare system.

To engage and educate consumers and patients from across the United States
in the fight for affordable medicines, UAEM and AMSA have launched a website, http://www.AffordableMedsNOW.org

FOR IMMEDIATE RELEASE

Following are comments from consumer, public health and student groups, state legislators and experts following today’s House Energy & Commerce Committee vote to add the Eshoo-Barton-Inslee generic biologics (biogenerics or biosimilars) amendment to America’s Affordable Health Choices Act of 2009.

Sarah Rimmington, Attorney, Essential Action, Access to Medicines Project, Tel: (202) 387-8030 or Cell: (202) 422-2687, srimmington@essentialinformation.org
"The biogenerics proposal adopted today torpedoes the objective of health care cost containment. The Eshoo proposal only offers the illusion of price-lowering generic competition for biotech drugs like Roche-Genentech’s $72,000 per year cancer treatment Herceptin. By making cheap and easy tweaks to old biologic drugs, Big Pharma will be able to obtain near perpetual monopolies and keep affordable biogenerics from pharmacy shelves several decades after their patents expire.

It’s hard not to wonder if the $1 million per day Big Pharma and Biotech spends lobbying influenced today’s vote.

But it’s not too late. Congress can stop Pharma from continuing to price gouge the American public by fixing the biogenerics proposals on the floor of the House and Senate. President Obama can demand changes before signing a health care bill into law We can’t afford for them not to."


Larry McNeely, Health Care Advocate, US PIRG (Public Interest Research Group), (202) 546-9707 x 303, lmcneely@pirg.org
“The biologics measures passed today are nothing more than a bailout for Biotech and Pharma.”


Joana Ramos, MSW , Director, Washington Coalition for Prescribing Integrity and cancer survivor, Seattle, WA (206) 229-2420, jdr@ramoslink.info
“Patient and their families need relief from the exorbitant, and ever-escalating prices, being charged for biologic medicines. Medical innovations are of no value without access. Limiting the period of marketing exclusivity to 5-7 years for these new drugs is an important first step to solving the problem.

Almost every week my colleagues and I work with, or seek help for, not only the uninsured, but increasingly also insured patients facing food insecurity, evictions, foreclosures on their mortgages, bankruptcy, and even relapse and untimely death just because of the price of biologic drugs. In one recent case, an insured college student with rheumatoid arthritis had a flare-up so severe that he had to be hospitalized, after his 6-month co-pay grant for Kineret from an assistance program ended. Because it took several more months for him to be able to get into a new program, his parents, members of the squeezed middle class, then had to put the monthly co-pays of $650 for Kineret on their credit card during the wait. They now struggle with that debt plus the close to $10,000 of the "patient responsibility" portion of the hospital bills, plus insurance premiums that have almost doubled since 2006. Patients with RA are thought to need these drugs for the rest of their lives.

Compared to many biologic cancer drugs however, Kineret is a "bargain," at some $1400/month. Drugs like Herceptin and Tykerb run in the multiple thousands of dollars per month, and 4-figure co-pays are common.”

We are deeply disappointed by the decision of the House Committee on Energy and Commerce to adopt the BIO and PhRMA-backed amendment on generic biologics. Instead of opening the door to less expensive generic drugs and the potential for enormous savings to patients and healthcare providers, including federal and state governments, this amendment will insure that BIO and PhRMA companies can charge monopoly prices for a minimum of 12 years. The proposal that passed today will also make it much easier for brand companies to wait until the eleventh hour to make minor changes to old biologics, and then renew the 12 year marketing monopoly an unlimited number of times.

Neither the brand industry nor the supporters of the amendment have ever credibly explained why the manufacturers of brand biologics should be entitled to a guaranteed 12 years of exclusivity, which is in effect 12 years of monopoly prices, when the patent system has been adequate to protect innovation in every other industry. They have also never explained why 12 years of exclusivity is appropriate for the manufacturers of biologics, when since 1984 the manufacturers of chemical drugs have thrived with five years of exclusivity.

We are also disappointed that the majority of the Committee ignored the recent study of the Federal Trade Commission, which concluded (1) that there is no basis for granting biologics manufacturers 12 years of exclusivity and (2) that there is no evidence that their patents are weaker than the patents on chemical drugs. There are many competing studies on this subject, but the FTC is independent and unbiased and has deep expertise in laws pertaining to patents and competition.

We can only conclude that the Committee’s action reflects the continuing influence and power of Big Pharma, which has made adoption of the Eshoo-Barton amendment a high priority. We pledge to fight on the floor of the House and Senate and in every other forum that is available for a viable generic biologic program which will allow the Food and Drug Administration to approve generic biologics once valid patents have expired. If meaningful changes cannot be made, then we urge Congress to drop the generic biologics amendment from healthcare reform legislation.
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Today, Essential Action along with the National Women's Health Network, Community Catalyst, Breast Cancer Action, National Legislative Association on Prescription Drug Prices (NLARx), Knowledge Ecology International (KEI), American Medical Student Association (AMSA) and Universities Allied for Essential Medicines (UAEM) sent a letter to Members of Congress to oppose legislative proposals for the approval of generic biologic drugs that contain excessive periods of data exclusivity or other unnecessary and significant barriers to generic biologic competition.

"Our nation is experiencing massive healthcare costs during an economic crisis," says the letter. "Increasing the availability of generic biologics will be a critical element of a comprehensive and necessary health care cost containment strategy, and will provide Americans affordable choices in their healthcare. If the wrong legislation passes on this critical issue there will be no generic biologics and patients and a teetering healthcare system will continue to pay the price."

The letter indicates that the proposal that recently passed the Senate Health Committee, as well as a proposal being floated by Representative Anna Eshoo in the House of Representatives propose excessive amounts of data exclusivity and other unacceptable bureaucratic obstacles to timely, price-lowering generic competition for biologics.

You can read the complete letter in the continuation of this post.
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For Immediate Release
July 16, 2009

***Statement of Sarah Rimmington, Attorney, Essential Action, Access to Medicines Project***
For more information contact Sarah Rimmington at (202)387-8030 or (Cell) (202)422-2687
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"Big Pharma is today salivating at the prospect of hijacking the healthcare reform process to enhance its ability to price gouge the American public.

As the House Energy and Commerce Committee meets to mark up healthcare legislation, it is expected to consider an amendment from Representatives Eshoo and Barton to authorize generic competition for biotech drugs. Currently, there is no regulatory process for approval of generic versions of this class of pharmaceuticals, known as "biologics." Biologics make up roughly half of the most important new medicines, including many or most cancer drugs.Unfortunately, rather than creating robust price-lowering competition, the Eshoo/Barton approach would establish extended monopoly protections -- exceeding the monopolies already conferred by patents -- and a series of needless bureaucratic hurdles for approval of generics.

President Obama has signalled that in a spirit of "generous compromise" the pharmaceutical industry should be given seven years of monopoly protection for clinical test data -- effectively prohibiting generics from entering the market for seven years after a drug goes on the market. The Eshoo/Barton proposal would establish a monopoly period of 14.5 years, and possibly longer. The Federal Trade Commission has concluded that no extra monopoly period is needed to promote innovation or ensure a fair return to brand-name biotech or drug companies.

President Obama's healthcare reform effort has two goals: to expand coverage for the uninsured, and to control healthcare costs. The Eshoo/Barton proposal would torpedo the objective of healthcare cost containment. The bottom line is simply this: If the Eshoo/Barton approach is adopted, consumers and the government will pay many tens of billions of dollars more in drug costs than needed. Such a windfall for a Big Pharma is something that neither consumers nor the government can afford."
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Essential Action is a public health and corporate accountability group. Our Access to Medicines Project has worked on U.S. and global access to medicines issues for more than a decade. The project focuses on patent and related barriers to generic competition.

Today, Essential Action along with eight other civil society organizations, sent a letter to the World Health Organization Expert Working Group on R&D financing (EWG) to express concerns and make suggestions regarding issues of transparency and balance, conflict of interest and substantive outcomes. The expert working group, which is meeting today in Geneva, was created as the third stage of a longer process to address important flaws in the current system of financing medical R&D. The EWG follows the work of the WHO Commission on Intellectual Property Rights, Innovation, and Public Health (CIPIH) and the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The overall objective of these initiatives has been to reform and change the current system of R&D financing.

Download a .pdf version of the letter here: ngos2ewg_30jun2009.pdf

You can read a text version of the letter below the jump.
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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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Essential Action, Knowledge Ecology International (KEI), Oxfam America,
AU Program on Information Justice and Intellectual Property (PIJIP),
Forum on Democracy and Trade, Health GAP (Global Access Project)

FOR IMMEDIATE RELEASE | April 30, 2009
Contact Information for each organization accompanies quotations below

Today, the US Trade Representative (USTR) released its annual "Special 301 Report," identifying countries it views as denying "adequate and effective protection of intellectual property rights." Despite committing to the World Trade Organization's TRIPS flexibilities meant to encourage access to low-cost generic medicines, the United States regularly singles out countries for pro-health policies that are TRIPS compliant in the Special 301 Report. The report is based on comments submitted to USTR, most of which come from businesses holding copyrights and patents. The pharmaceutical industry's trade association submits detailed comments each year, which USTR draws on extensively. (To view all the comments received by USTR for the 2009 report, see www.regulations.gov).

Public health and consumer groups had hoped the Obama administration would turn a new page and recognize the right of countries to take TRIPS-compliant measures that increase access to medicines, and thus are disappointed that this year's report mirrors not only Big Pharma's demands, but the policies previously pursued by the Bush administration.
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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