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  • Vote NO on Fast Track

    This moment could not be more important. Our years of work against the Trans-Pacific Partnership (TPP) are boiling down to this moment.

    Hours ago, U.S. Representative Dave Camp and Senator Max Baucus introduced a bill for Congress to grant President Barack Obama Fast Track trade authority. If Congress approves this bill, it will give away its constitutional authority to protect us from the numerous threats posed by the TPP.  

    Write now and demand that your representative commit to you in writing to vote “no” on Fast Track.

    If the Fast Track bill passes, the TPP could be signed before Congress votes on it. Then the deal could be rushed through Congress with no amendments and limited debate. Fast Track trade authority is how Clinton and Bush passed the WTO, NAFTA, CAFTA and other disastrous “trade” deals.

    The TPP would empower foreign corporations to sue governments in international tribunals if a country implements environmental, public health or other public interests policies that undermine corporations’ “expected future profits.” It would create new incentives to offshore more American jobs.

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  • How a Free Trade Agreement Threatens Your Health and the Health of the People You Care About

    Reshma Ramachandran and David Carroll warn that the Trans-Pacific Partnership will trample over access to affordable medicines. They drafted this article for PLOS:

    Last month, Wikileaks posted the complete Intellectual Property (IP) Chapter of the secretly-negotiated Trans-Pacific Partnership Agreement (TPP) confirming public health advocates’ worst fears of the agreement’s impact on patients worldwide. The TPP is the largest free trade agreement to date between the United States and 11 other countries (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam) comprising over 40 percent of global GDP. This landmark agreement is expected to “set the standard for 21st century trade agreements going forward.” While free trade agreements are designed to lower barriers for the importation and exportation of goods between countries and strengthen the global economy through mechanisms such as lowered tariffs, the TPP goes far beyond past traditional trade regulations with the inclusion of over 20 chapters on a variety of non-trade related issues including domestic food safety, health, labor, environmental policies. Two of these chapters on investment and intellectual property will have far reaching consequences on the public health of populations worldwide. The TPP has been shrouded in secrecy, with only the negotiators and an “advisory committee” of over 700 industry representatives allowed to read drafts of the agreement. Even congress and congressional staffers have been barred from examining drafts of this far-reaching agreement.

    Since the previous leak of the IP Chapter in 2011, several professional and civil society organizations including Doctors Without Borders, American Association of Retired Persons, Public Citizen, and the International Federation of Medical Students Associations have sent letters and presented at the closed-door negotiating rounds to the United States Trade Representative (USTR) expressing concerns that the proposed provisions patients will severely restrict access affordable, innovative medicines. The Wikileaks posted text revealed that the USTR and Obama Administration have decided to aggressively prioritize the interests of multinational pharmaceutical and medical companies over patients worldwide and at home. In fact, according to emails submitted to Intellectual Property-Watch under the Freedom of Information Act, the USTR has actively solicited the input of industry groups, giving them special access to the negotiating text while consumer and health groups have had to resort to requesting special meetings with negotiators. The USTR is also one of the best examples of a revolving door between government and industry. Since the turn of the century, at least a dozen USTR officials have taken jobs with companies that favour stronger copyright and patent protection. Peter Maybarduk, Director of Public Citizen’s Global Access to Medicines Campaign, described meetings with US negotiators as, “…a complex diplomatic exercise, it’s not like a frank exchange of information about what is actually happening.”

    Indeed, the recently leaked TPP chapter reflect these corporate interests as evidenced by the still-included provisions. In the text, the USTR has proposed a number of provisions that will further strengthen patents and data exclusivity for pharmaceuticals. Such provisions will bar the entry of generic competition into the market allowing for brand-name drug companies to retain their monopoly market and set drug prices at exorbitantly high prices. These provisions include:
    • Lowering patent standards allowing for “evergreening” or the granting of patents for newer forms of existing medicines including new formulations or minor modifications even in the absence of a therapeutic benefit
    • Mandating that surgical, therapeutic, and diagnostic methods must be patented making medical practitioners in TPP member states liable for infringement and restricting their choices for treatment
    • Imposing data exclusivity on all pharmaceuticals, including biologics with the minimum period for this class to be set at 12 years (despite the fact that the White House is publicly in favor of a 7 year data exclusivity period and the FTC has stated that there is no need for any data exclusivity period at all) thereby not allowing drug safety regulators from accessing clinical data to grant market approval for generic and biosimilar drugs
    • Adjusting patent term periods to account for “unreasonable delays” including patent prosecution periods ranging from two years to more than four years extra further delaying generic drug entry into the market
    • Adjusting patent term periods for regulatory approval periods allowing for patent extensions for both new pharmaceutical products as well as methods for producing or using new pharmaceutical products halting any potential innovation
    • Linking patent status and drug marketing approval causing drug regulatory authorities to take on the additional task of early patent enforcement, allowing for bogus patents to be a barrier to generic drug registration

    Such proposals go beyond current U.S. and international law including the World Trade Organization’s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Additionally, the TPP has the potential to jeopardize millions of lives in the participating countries by driving up the costs of medicines significantly. Even in the United States, there has been a public outcry from physicians regarding the high cost of medicines. Earlier this year, over 100 oncologists came together to write a perspective piece in the journal Blood calling the prices of brand-name cancer drugs “astronomical, unsustainable, and perhaps even immoral.” The United States health care system has in fact greatly benefited from the entry of generic competition. On May 9, IMS Health released a report entitled Declining Medicine Use and Costs: For Better or Worse?, which found that many Americans had forsaken much needed doctor visits, medicines, and other treatments as they struggled to afford health care. In light of this, it is appalling that U.S. negotiators would continue to push provisions that would further exacerbate the cost burden of healthcare for patients not only abroad, but at home.

    The week following World AIDS Day, trade ministers will convene again in Singapore as a potential “end game” to the negotiations planning on making large trade-offs on various trade topics including copyright, Internet issues, and medicines in order to make a grand announcement that they “have a deal” by the end of the year. Despite opposition from both civil society and other TPP governments, the USTR is aggressively pushing the participating countries to accept these dangerous IP provisions during this meeting to finalize the agreement. The USTR recently claimed that the “United States is a leading voice for strong [intellectual property rights] protections and for access to medicines for the world’s poor, including in developing country [Trans-Pacific Partnership] partners”. These good intentions are admirable but are overshadowed by the actions of the USTR, as it continues to trade away health and true innovation to cater to Big Pharma profits. To keep the promise of an AIDS-Free Generation and the ability to provide access to affordable medicines, the trade ministers must put a stop to these harmful provisions at the upcoming Singapore meeting.

    If you want to make a difference, you can write or tweet to USTR Michael Froman and tell him to stop attacking access to lifesaving medicines here. Organisations can write too and feel free to use our recently sent letter as a template.

    Reshma Ramachandran is a joint medical and public policy student at Alpert Medical School at Brown University and Harvard Kennedy School. David Carroll is a medical student at Queen’s University Belfast. They can be found on Twitter @reshmagar and @davidecarroll.

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  • Physicians and Scientists-in-Training Push for Access in TPP Negotiations

    According to recently leaked text of the Intellectual Property Chapter of the Trans-Pacific Partnership (TPP), the United States and other governments are prioritizing multinational corporate profits over patients and consumers around the world including their own citizens. The American Medical Student Association (AMSA), Australian Medical Student Association, International Federation of Medical Students’ Associations (IFMSA), IFMSA-Quebec, Student Global AIDS Campaign (SGAC), and Universities Allied for Essential Medicines (UAEM) today sent a letter to TPP negotiators urging them to ensure that all TPP provisions provide future patients access to evidence-based and effective medicines and procedures rather than forcing us, as practitioners, to compromise our medical professionalism and the quality of care we are able to provide our patients.

    On November 13, 2013, WikiLeaks released the entire consolidated negotiating text for the Intellectual Property (IP) Chapter of the TPP. These organizations, representing pharmacists, biomedical researchers, and physicians-in-training from countries participating in TPP negotiations, expressed their concerns regarding the chapter text stating “the proposed provisions will severely restrict access to affordable medicines, access to knowledge, and access to responsible innovation.”

    This week, TPP negotiators are meeting in Salt Lake City to further negotiate the Intellectual Property Chapter provisions. The organizational letter calls for the following:

    • Removal of dispute resolution provisions that will compromise any of the safeguards found in the WTO TRIPS Agreement that allow governments to use its flexibilities to protect public health within their borders
    • Removal of any provisions that would lower the global standards for earning patents including “evergreening” or use of minor modifications of existing drugs to extend market exclusivity
    • Removal of any provision to provide data exclusivity for biologics
    • Exemption from patent infringement of diagnostic, therapeutic, and surgical procedures similar to 35 USC 287(c) allowing for medical practitioners to be immunized from a suit particularly when the machine, manufacture or composition of matter itself is not patented
    • Removal of any provision such as patent term adjustments for patent prosecution or regulatory periods that would delay entry of generic drugs into the market, thereby restricting access to affordable medicines.
    • Removal of patent linkage provisions that would cause drug regulatory authorities to take on the additional task of early patent enforcement, allowing for bogus patents to be a barrier to generic drug registration.

    Even if you're not a negotiator, you can still take action to make sure that the TPP prioritizes patients over profit. Click here to join Doctors Without Borders in sending letters to the United States Trade Representative Michael Forman and to spread the word about the TPP's harmful provisions with some sample Tweets and Facebook posts.

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  • Exclude tobacco from the Trans Pacific Partnership

    The U.S. Trade Representative intends to introduce a proposal on tobacco at negotiations to create the Trans Pacific Partnership (TPP), a trade agreement among 12 nations, at meetings in Brunei this week. The proposal capitulates to multinational tobacco corporations, jeopardizing the nation's health and economic welfare.

    Tobacco companies have recently accelerated their use of trade rules to attempt to delay and reverse tobacco control measures that limit marketing in the U.S., Australia, Uruguay, Norway, and Ireland. Trade rules grant corporations rights to contest nations' public health and other policies. Countries that lose trade challenges face stiff financial penalties, payable to the complaining corporation.

    Public health and medical advocates in the U.S. and abroad have urged the USTR to exclude tobacco control protections from trade challenges under the TPP. The USTR informally floated a policy in 2012 that could create a "safe harbor" for some tobacco control regulations. Many legal and medical experts noted that tobacco companies could easily exploit the remaining substantial loopholes.

    But the tobacco industry marshaled opposition claiming that the U.S. proposal might actually reduce tobacco use, tobacco-related deaths, and tobacco sales. Other corporations backed up Big Tobacco, expressing concern that addressing the uniquely lethal effects of tobacco in trade agreements could set a precedent for reining in their own practices. On Aug. 15, USTR announced it would not advance that proposal.

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  • AMSA Testifies On TTIP Negotiations

    Yesterday, AMSA National President Dr. Nida Degesys testified in front of the Office of the United States Trade Representative.

    Below are some of her comments that were submitted on behalf of the organization regarding the Administration’s intention to enter into negotiations for the Transatlantic Trade and Investment Partnership (TTIP) Agreement.

    As physicians-in-training, we believe that trade agreements should promote public health and access to medicines. For this reason, we urge the exclusion of any and all intellectual property provisions as well as any tobacco and alcohol provisions in the TTIP. Finally, we demand full transparency in the negotiations.

    First, during our medical training, we witness firsthand how access to affordable medications is critical in preventing unnecessary deaths due to both infectious and non-communicable diseases. Unfortunately, it appears that recent free trade agreements (FTAs) including the Australia-United States FTA and Korea-United States FTA as well as the current Trans-Pacific Partnership Agreement (TPP) negotiations compromise this access by imposing unprecedented TRIPS-plus IP provisions. These provisions have the potential to jeopardize millions of lives in participating countries by granting monopoly protections to pharmaceutical companies, which significantly drive up the costs of medicines. Even in the United States, there has been an outcry from the physician community regarding the high cost of medicines. Just last month, over 100 oncologists agreed that the prices of brand-name cancer drugs is “astronomical, unsustainable, and perhaps even immoral.” The United States health care system has greatly benefitted from generic competition......It is unacceptable that cost as a result of this agreement will become a barrier to access and ultimately, a healthy life.

    On behalf of more than 35,000 physicians-in-training, we implore you to ensure that any TTIP agreement ensures our future patients are able to access evidence-based and effective medicines and procedures rather than forcing us to compromise our medical professionalism and the quality of care we provide our patients.

    To ensure the TTIP does not compromise access to medicines AMSA is urging the following:

    • Prohibition of “evergreening” or use of minor modifications of existing drugs to extend market exclusivity;
    • Exemption from patent infringement of diagnostic, therapeutic, and surgical procedures similar to 35 USC 287(c); 
    • Rejection of any provision to provide data exclusivity for biologics;
    • Removal of intellectual property as an actionable “investment” allowing pharmaceutical and medical device companies to skirt domestic regulation and overturn national public health legislation; and
    • Preservation of existing national pharmaceutical benefit schemes such as the Pharmaceutical Benefits Board in Sweden, Pharmaceutical Price Regulation Scheme in the United Kingdom, and the Veteran Health Administration in the United States.

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