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Consumer & Public Health Groups, State Legislators Ask Congress To Oppose Biogenerics Proposal

July 20, 2009

Dear Senator or Representative,

Congressional consideration of healthcare reform has two overriding goals: expand health coverage to the uninsured, and contain costs. It is widely understood that the first goal cannot be achieved absent success with the second objective.

It is therefore vital that Congress take steps to lower the price of the most expensive drug treatments, rather than aid Big Pharma and the biotech industry's ability to price gouge consumers and the government. For this reason, we urge you to support the Promoting Innovation and Life Savings Medicines Act, H.R. 1427 and reject attempts to pass other biologics legislation that will leave affordable care out of reach.

UAEM, AMSA and Essential Action Demand AAU Rescind Support of Excessive Data Exclusivity

Download a PDF of the letter
Download a PDF of the press release

July 14, 2009

Robert M. Berdahl
President
American Association of Universities
1200 New York Avenue, NW, Suite 550
Washington, DC 20005

RE: June 3, 2009 AAU Endorsement of Eshoo-Inslee-Barton Follow-on Biologics Bill

Dear Dr. Berdahl,

Coalition Launches Statement on the Right to Research

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UAEM is a part of a coalition of student groups that today launched a statement on the right to research by improving open access to research. You can read the statement and press release at http://www.righttoresearch.org/.

Student Statement on The Right to Research

Scholarly knowledge is part of the common wealth of humanity.

Unfortunately, not everyone has access to the scholarly literature, despite advances in communications technology. The high cost of academic journals restricts access to knowledge; in some fields, prices can reach $20,000 for a single journal subscription1 or $30 for an individual article.2 Despite these high prices, authors of scholarly articles are not paid for their work. The profits from these publications go solely to the publishers of the journals. A vast amount of research is funded from public sources – yet taxpayers are locked out by the cost of access.

Learning and inquiry are impeded when scholars lack access to fellow researchers’ work, and when students lack access to the work of scholars before them.

AAU ONCE AGAIN ENDORSES LEGISLATION THAT WILL IMPEDE ACCESS TO AFFORDABLE BIOLOGIC DRUGS

Download a pdf of the press release

Download the April 16, 2009 UAEM letter to AAU

Read the November 12, 2008 AAU response to our initial letter

Read our original October 15, 2008 letter to AAU

Read AAU's June 10, 2008 endorsement of the Eshoo-Barton legislation

Read AAU's May 2, 2008 comment on the legislation

Contact: Eleanor Blume
Phone: (781) 640-7750
Email: eleanor dot blume at gmail dot com

For Immediate Release

AAU ONCE AGAIN ENDORSES LEGISLATION THAT WILL IMPEDE ACCESS TO AFFORDABLE BIOLOGIC DRUGS

UAEM CALLS ON AAU TO WITHDRAW SUPPORT

The Association of American Universities (AAU) has once again endorsed legislation, (newly numbered H.R. 1548 in the new Congress), that would impede access to lower-cost follow-on biologics such as vaccines and cancer treatments. The AAU previously declined to withdraw its endorsement from H.R. 5629 of the previous Congress, the “Pathway for Biosimilars Acts,” following a call to do so from Universities Allied for Essential Medicines (UAEM). The new bill, as with the previous one, would effectively increase the length of patents on biologic drugs by allowing market registration data exclusivity of up to 14.5 years, delaying the onset of cheaper follow-on biologics while inhibiting patent challenges and impeding access to these essential medicines. This is in contrast to the normal five years of market registration data exclusivity currently in place for small-molecule drugs. Alternative legislation proposed by a bi-partisan group from the House and Senate includes more reasonable terms of data exclusivity is now available.

UAEM has argued that this obviously commercially-motivated provision is not in line with the non-profit mission of the university.

UC PRESIDENT YUDOF CONTACTS ALMOST 400 UAEM SUPPORTERS IN ADVANCE OF MARCH 12th MEETING

Almost four hundred of UAEM-UC's supporters, from Japan to Uganda, and Pakistan to Palo Alto, received a letter from University of California President Mark Yudof on March 2, 2009, in response to their letters urging the adoption of a Global Access License policy for the UC's medical innovations.

President Yudof's letter, described previous examples of innovative licensing practices at the UC, and reiterated his invitation for UAEM to present its

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  • INDIAN GOVERNMENT MAINTAINS ANTI-ACCESS POSITION REGARDING PUBLICLY-FUNDED RESEARCH

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    The controversial Protection and Utilization of Public Funded Intellectual Property Bill, set to threaten access to medicines and future innovative research

    Berkeley, CA – Despite appeals from Universities Allied for Essential Medicines (UAEM), and other public interest groups, the Indian government has refused to modify a secretly drafted legislation that would govern the patenting of the results of publicly funded-research including publicly-funded medical research.

    UAEM CALLS ON INDIAN GOVERNMENT TO RECONSIDER LEGISLATION REGARDING THE PATENTING OF PUBLICLY-FUNDED RESEARCH

    in

    UAEM CALLS ON INDIAN GOVERNMENT TO RECONSIDER LEGISLATION REGARDING THE PATENTING OF PUBLICLY-FUNDED RESEARCH

    Legislation Threatens Access to Medicines and Future Innovative Research

    November 6, 2008

    Berkeley, CA - Universities Allied for Essential Medicines (UAEM), an international student advocacy group, today called on the Indian government to reconsider legislation that would govern the patenting of the results of publicly funded-research including publicly-funded medical research. The goals of the legislation are unclear and as currently written, the bill would likely harm access to medicines and impede the ability of scientists to conduct innovative research.

    Proponents of the Indian bill claim it will help India to commercialize publicly-funded research by encouraging research institutions to seek patents. UAEM today issued a white paper raising questions about the impacts of university patenting in the United States under the Bayh-Dole Act while offering analysis of the Indian bill. The Indian bill is modeled after the Bayh-Dole Act of 1980, which encouraged research institutions to seek patents and commercialize discoveries made through publicly-funded research. While patenting has risen since the passage of Bayh-Dole, it has also expanded into areas of basic research where patents prevent other research from using basic tools to conduct life-saving research.

    10 Nobel Laureates: Archbishop Desmond Tutu Signs the PCS

    1984 Nobel Peace Prize recipient Archbishop Desmond Tutu signed the Philadelphia Consensus Statement on Thursday, joining the call for universities to take action. Tutu signed the PCS after meeting with University of after meeting with University of Michigan UAEM members.

    You can read more about this important show of support below in the University of Michigan-UAEM press release.

    Archbishop Tutu joins 9 other Nobel laureates in calling for change on our university campuses.

    UAEM Calls on AAU to Withdraw Endorsement of Eshoo-Barton Follow-on Biologics Bill

    Contact: Sam Houshower
    Email: houshower [at] berkeley [dot] edu

    For Immediate Release

    UAEM URGES AAU TO WITHDRAW ENDORSEMENT OF ESHOO-BARTON FOLLOW-ON BIOLOGICS BILL

    Universities Allied for Essential Medicines (UAEM) today called on Robert M. Berdahl, President of the Association of American Universities (AAU), to withdraw its recent endorsement of H.R. 5629, the "Pathway for Biosimilars Acts," which includes a term of exclusivity for market registration data that would effectively increase the length of patents on biologic drugs by up to 14.5 years. This is in contrast to the normal five years of market registration data exclusivity currently in place for small-molecule drugs. Biologics include critical medicines such as insulin and most vaccines, as well as many of the most exciting new treatments that are emerging for conditions such as cancer and autoimmune disease.

    The additional exclusivity terms in H.R. 5629 will allow drug companies to keep the price of medicines high by delaying the onset of the generic competition that makes medicines affordable to most people. For example, generic competition has in recent years brought the cost of HIV/AIDS treatment from $15,000 per patient per year to $99 today, making the treatment of millions in developing countries possible. The current cost of brand biologics puts them out of the reach of many. For example, daclizumab, a biologic drug used to prevent organ transplant rejection, costs around $6,300 for a single course of therapy. UAEM argues that universities, as non-profit institutions with a mission to advance knowledge for the global public good, should not take a position that increases the commercial returns on biologic drugs at the expense of access.

    Ethan Guillen, Executive Director of UAEM, said, "There is obviously a need for a pathway for generic biologics but this is not it. The AAU needs to explain why nonprofit universities think the desperately poor around the world, not to mention American consumers, should have to wait over a decade to be able to buy affordable, life-saving generic vaccines."

    Presidential Candidates Pledge Support for Fighting Neglected Diseases

    FOR IMMEDIATE RELEASE
    Contact: Anjali Dalal
    Monday, Sept 29, 2008
    anjali [dot] dalal [at] yale [dot] edu

    Presidential Candidates Pledge Support for Fighting Neglected Diseases

    Barack Obama Builds Upon Support for Making Low-Cost Medicines Available in Developing Countries

    Berkeley, CA – At the Clinton Global Initiative Thursday, United States presidential candidates Senator John McCain and Senator Barack Obama highlighted the importance fighting neglected diseases in developing countries. Obama in particular signaled the importance of access to medicines and his campaign released a statement saying that as president, he will "ensure that medications for malaria, AIDS, tuberculosis and neglected tropical diseases developed with U.S. taxpayer dollars are available at low costs in developing countries." Ensuring low-cost access to life-saving medicines in developing countries through open licensing and patenting strategies is a key goal for Universities Allied for Essential Medicines (UAEM).

    The statement expanded on Obama's previous support for "the adoption of humanitarian licensing policies that ensure medications developed with U.S. taxpayer dollars are available off-patent in developing countries." It reinforced the Democratic Party's similar embrace of off-patent availability in its national platform.

    Making publicly-funded medicines available off-patent can allow the makers of generic pharmaceutical companies to produce and sell drugs in developing countries. This approach represents little to no loss for companies as the patented medicines are too expensive for those in developing countries to purchase. Universities, which are responsible for much of the basic research that makes new drugs possible, have tremendous power to insist upon open licenses that will ensure that their research benefits the public interest.

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