Explanation of advantages— Science Diplomacy

Status quo reliance on foreign icebreakers is unstainable — jeopardizes American commitment to Antarctica

Augustine 12 (Norman Ralph Augustine is a U.S. aerospace businessman who served as Under Secretary of the Army from 1975 to 1977. Augustine currently serves as chairman of the Review of United States Human Space Flight Plans Committee. Blue Ribbon is led by Augustine, but includes the US Antarctic Program’s members “NATIONAL SCIENCE FOUNDATION SUMMARY RESPONSE TO THE REPORT OF THE U.S. ANTARCTIC PROGRAM BLUE RIBBON PANEL” pg online at http://www.nsf.gov/geo/plr/usap_special_review/usap_brp/rpt/nsf_brp_response.pdf//hss-RJ)

The U.S. inventory of icebreakers relevant to McMurdo resupply operations is effectively limited to three USCG ships—the medium icebreaker Healy and two polar class icebreakers, Polar Sea and the Polar Star17. Healy, commissioned in 2000, participated in the McMurdo break-in mission in 2002/03. Healy is more ice-capable, albeit less maneuverable, than the Russian Vladimir Ignatyuk that successfully conducted the 2011/12 breakin under the very light ice conditions that prevailed prior to the arrival of Iceberg B15 in the McMurdo Sound area and again over the past two years. The Healy does not possess either the power or the maneuverability required for unassisted break-in operations in heavy, multiyear ice. In addition, Healy is typically fully engaged in Arctic science operations for its entire annual operating schedule (approximately 185 days per year) and is expected to be committed to such duties indefinitely into the future. Healy could, at least in principle, be made available as a backup vessel to assist another vessel with the break-in under exigency situations, or, if deemed in the national interest and other options are unavailable, to conduct the break-in at McMurdo under light ice conditions (much as it did for a fuel delivery to Nome, Alaska, in early 2012). The relevant studies assume that the Healy will eventually undergo a service life extension that would permit it to remain in operation for the foreseeable future. Polar Sea, commissioned in 1978, is in “commissioned, inactive” status and has been incapable of operating since May 2010, when it experienced an unexpected catastrophic failure of five of its recently refurbished engines. It is not decided whether the Polar Sea will return to active status. Polar Star, commissioned in 1976, is undergoing a $60 million service life extension that should provide an additional seven to ten years of operating life. Polar Star would not be available for operational icebreaking services until 2013/14 at the earliest, and is unlikely to be operational much past the 2020/21 season. At present, and perhaps again in the future, the USAP is in the position of being principally or totally reliant upon foreign sources for icebreaking support for the annual resupply. Additionally, it is not clear that the Swedish and Russian icebreakers used in recent years will be available in the future. This approach to resupply of U.S. operations in Antarctica is unsatisfactory in the long term. The lack of a U.S. capability to conduct the McMurdo break-in severely jeopardizes the U.S. commitment to its stated policies regarding the Antarctic Continent. As soon as possible, the break-in should again be supported by icebreaking services reliably controlled by the U.S. government, preferably an icebreaker owned and operated by the USCG.

And, US science presence is key — provides a stabilizing influence and maintains the integrity of the Antarctic Treaty

Augustine 12 (Norman Ralph Augustine is a U.S. aerospace businessman who served as Under Secretary of the Army from 1975 to 1977. Augustine currently serves as chairman of the Review of United States Human Space Flight Plans Committee. Blue Ribbon is led by Augustine, but includes the US Antarctic Program’s members “NATIONAL SCIENCE FOUNDATION SUMMARY RESPONSE TO THE REPORT OF THE U.S. ANTARCTIC PROGRAM BLUE RIBBON PANEL” pg online at http://www.nsf.gov/geo/plr/usap_special_review/usap_brp/rpt/nsf_brp_response.pdf//hss-RJ)

Setting aside the ambiguities associated with the federal budgeting process, logistics planning in Antarctica is complicated by the shortness of the season during which the continent can be reliably accessed for logistical purposes, nominally 21 weeks by air at McMurdo Station and 15 weeks at South Pole Station. Using U.S.-owned heavy icebreakers, McMurdo Station could be accessed by ship during about ten weeks each year. As these ships have become unavailable and less-powerful icebreakers are used, the time in which to accomplish resupply by sea has been reduced to the four-week annual sea ice minimum—a challenging and unreliable practice. In Antarctica, weather changes frequently and abruptly, necessitating contingency plans for most activities, particularly those in remote areas. The cost of energy is high and uncertain, and the behavior of the ice pack can hinder the delivery of energy and other critical supplies. During late 2011, a series of storms affecting harbor conditions left too little time for the McMurdo ice pier to thicken to sufficient strength, thus requiring deployment of a portable modular causeway system loaned by the Department of Defense (DoD). The Panel itself made the final landing of the season at the Sea Ice Runway, the airfield closest to McMurdo Station, before sea ice conditions deteriorated to the point that air operations had to be moved to a more solid but more remote location. At the Pegasus Runway, constructed on glacial ice, temperatures now rise more frequently to within a few degrees of the point where air operations are precluded. Long-term uncertainties abound. Some Antarctic research activity will continue to shift from relatively simple to more highly integrated research that requires more complex support. Further, the impact on the Antarctic region of greatly expanded tourism remains to be determined. Many nations do not participate in the Antarctic Treaty. Seven countries have made claims to parts of Antarctica that remain in abeyance while the Treaty is in force—pointing to the importance of maintaining an influential U.S. science presence as a stabilizing influence. Finally, climate change in Antarctica could significantly complicate future runway and ice pier construction and thereby impact both air and sea operations.

Enhancing polar ocean fleet solves — secures polar leadership

Sutley and Holdren 13

(Nancy H. Sutley John P. Holdren, Chair, Council on Environmental Quality Director, Office of Science and Technology Policy, Co-Chair, National Ocean Council Co-Chair, “National Ocean Council Federal Oceanographic Fleet Status report” pg online at http://www.whitehouse.gov/sites/default/files/federal_oceanographic_fleet_status_report.pdf//sd)

Reports by the National research Council (NrC, 2011b), the White House Office of Science and technology policy (augustine et al., 2012), and Members of Congress2 stipulate that the United States should provide heavy icebreakers to support u.S. interests at both poles. For example, Future science opportunities in the Antarctica and southern ocean (NRC, 2011b) identifies the continued strong logistical support of Antarctic science, specifically calling out the need to “maintain and enhance the unique logistical assets of the united States, including…research vessels with increased icebreaking capabilities, and heavy icebreakers for reliable resupply of the U.S. Antarctic program.” More and Better science in Antarctica through increased logistical effectiveness (Augustine et al., 2012) specifically called out the need to “restore the u.S. polar ocean fleet (icebreakers, polar research vessels, mid-sized and smaller vessels) to support science, logistics, and national security in both polar regions over the long term. (Follow through on pending action in the president’s FY2013 Budget request for uSCG to initiate the design of a new icebreaker.)” the report included as one of its actions items (action 4.1-3): “aggressively pursue the acquisition of a new polar research vessel with enhanced capabilities to ensure U.S. leadership in pursuing scientific endeavors in the Southern ocean.”

Ice breakers are key to year-round polar presence — that’s key to future Antarctic cooperative initiatives

Spotts 5

(Peter, staff writer for Christian Science Monitor, “Icebreakers - on thin ice ; It is a priority to shore up the old US fleet as research demands grow, scientists say” pg online at proquest//sd)

Yet the ships' importance is expected to grow as climate change turns the ocean at the top of the world into an arena where countries vie for control over new shipping lanes, oil and gas exploration, and other economic activities. In Antarctica, America's year-round presence fulfills treaty obligations and ensures that the US continues to have a strong voice in efforts to keep the continent a model of international cooperation. Globally, roughly 40 icebreakers crunch their way through polar ice. About half of those belong to Russia, says Anita Jones, a University of Virginia computer scientist and former Pentagon official who heads the panel. Meanwhile, the US's fleet of three heavy icebreakers is sailing along at half steam. The US has one modern vessel, the Healy, which began operating in 2000 and typically remains in the Arctic. The other two - the Polar Star and the Polar Sea - were built in the 1970s and are nearing the end of their design lives. The Polar Star was out of commission for the 2003-2003 Antarctic resupply run, which fell to the Healy - delaying research projects in the Arctic. Over the past year, the Polar Sea has been tied to a dock with serious engine problems. The US Coast Guard and the National Science Foundation (NSF) reportedly have scrapped enough money together to get the Polar Sea underway by next fall. But the US was forced to contract with a Russian icebreaker to open the resupply channel during the 2004-2005 season. The three icebreakers also serve scientist as floating labs for polar research. And those demands are set to grow. Arctic countries, including the US, are asking scientists to continue to monitor environmental change in the Arctic. Moreover, polar scientists from around the world are planning the International Polar Year, from 2007 to 2008, a monumental research effort at the top and bottom of the Earth. Over the long term, without modern icebreakers in our own fleet, it could be harder for US researchers to take part in international work, researchers say.

And, a new regulatory patent regime is uniquely key for effective Antarctic bioprospecting and biotechnology breakthroughs

Herber 2005, (Bernard P. Herber Department of Economics, University of Arizona, Tucson, Arizona, “Bioprospecting in Antarctica: the search for a policy regime”, [ http://journals.cambridge.org/download.php?file=%2FPOL%2FPOL42_02%2FS0032247406005158a.pdf&code=68461ef4a9373867d298f403f4d38dc7 ] , //hss-RJ)

One of the world’s most important and interesting growth industries, biological prospecting, commonly referred to as bioprospecting, has reached the continent of Antarctica and its surrounding ocean. This global industry involves the search for, and examination of, diverse biological resources, such as plants, animals, and micro-organisms, for commercially valuable biochemical and genetic resources (Connolly-Stone 2005). The industry may be viewed as a subset of biotechnology, that is, the application of biological sciences to industry and/or the environment (Farrell and Duncan 2005). The bioprospecting process overlays several stages of production, which range from discovery and sampling to subsequent research and development, manufacturing, and marketing (Jabour-Green and Nicol 2003; Farrell and Duncan 2005). Both pure academic research and industrial research, the latter with a commercial or profits objective, are involved in bioprospecting, and the interface between the two is often obscure. The simultaneous presence of these two, sometimes conflicting, objectives is integral to the analysis below as it pertains to Antarctica. Tropical rain forests and coral reefs have been a popular focal point for biological prospecting activities in this global industry. Important industry sectors involved in bioprospecting include agriculture, biotechnology, cosmetics, pharmaceuticals, and waste management. The global biotechnology industry consisted, in 2003, of 4,284 companies (3,662 private and 622 public) in 25 nations, generating $35 billion in annual revenues, and employing some 188,000 people. (United Nations University 2003). The development of commercial products from naturally occurring biochemical processes and genetic resources tends to be an expensive, long, and uncertain process. Moreover, such profit-motivated considerations are accompanied by significant ‘public goods’ traits in this complex industry. The subject of the present paper employs a definition of Antarctica that corresponds to the geographical area covered by the Antarctic Treaty System (ATS). This area encompasses the continent of Antarctica, surrounding islands, and the entire Southern Ocean to the south of the Antarctic convergence zone, the latitude of which varies between 45◦S and 60◦S (Hemmings, 2005). An increasing amount of scientific research on the biota (fauna and flora) of Antarctica, with bioprospecting implications, has recently been taking place (United Nations University 2003). There are two primary reasons for the current bioprospecting interest in Antarctica. Firstly the considerable absence of knowledge surrounding the Antarctic biota provides a unique opportunity to discover potentially valuable new organisms, and secondly the severe environ-mental conditions in Antarctica, such as extremely cold temperatures and extreme aridity and salinity, have caused the evolution of biota with unique characteristics for survival. In particular, the search for extremophiles, novel life forms capable of withstanding cold, aridity, and salinity, is receiving emphasis. The application of extremophiles is found in industrial processes such as lipsomes for drug delivery and cosmetics, molecular biology, the food industry, and waste treatment (United Nations University 2003,2005). Biotechnical and pharmaceutical companies, universities, and research institutes, often through consortia comprising a mixture of both private and public entit-ies, have undertaken bioprospecting projects in Antarctica (United Nations University 2003). As a result, it is difficult to make a clear distinction between pure ‘scientific research’ and ‘commercial activities’. In the meantime, commercial pharmaceutical companies have been asserting property rights to flora and fauna in Antarctica. More than 40 patents had been granted, as of 2004, worldwide on bacteria and other organisms found in Antarctica with, in that year, more than 90 additional patent applications pending in the United States alone (Stix 2004). Since a ‘positive’ correlation exists between biodiversity and the stability of ecosystems, while a ‘negative’ correlation exists between biodiversity and economic production, it must be concluded that the fragile ecology of Antarctica is extremely sensitive to activities such as unregulated bioprospecting that could disrupt its biodiversity in a significant manner (Spain 2005). While the present level of bioprospecting in Antarctica poses no such threat, the need for the formation of a comprehensive regulatory regime for Antarctic bioprospecting appears desirable given the future growth potential for this industry in Antarctica. An important facet of the discussion to follow is the interaction that exists between the above issues and the uniqueness of Antarctic governance. In the case of Antarctica, an entire continent is governed under an international treaty regime that does not possess sovereignty in its political body, even though the states that are members of this international governing body are sovereign in nature. This Antarctic governance regime, which grew out of the Antarctic Treaty of 1959 and subsequent measures, conventions, and a protocol (to be described below), is known as the Antarctic Treaty System (ATS). At the present time, 45 states, including all of the world’s major economic and political powers, are signatories to the Antarctic Treaty (Antarctic Treaty 1959). After this introduction, the paper turns to a demonstration of the ‘public good’ qualities of bioprospecting. This is followed by an examination of bioprospecting policy under both the Biological Diversity and Law of the Sea Conventions. The paper concludes with a detailed evaluation of the complex issues that confront efforts to establish a comprehensive bioprospecting policy regime for Antarctica.

And, Specifically the US Bayh-Dole patent model is key — fosters transparency, info sharing and promotes broader respect of other international conservation treaties

Oldham et al 2013, (*Dr Paul Oldham is an anthropologist who trained at Cambridge and the London School of Economics. Paul has worked with indigenous peoples in the Amazon and now specialises in biodiversity, intellectual property and emerging areas of science and technology. In partnership with Stephen Hall, Paul has pioneered methods for large scale patent analysis and visualisation involving biodiversity. Paul is a Visiting Research Fellow at the Institute of Advanced Studies, United Nations University, **Dr Stephen Hall is the Informatician and Web Developer for the team. He is an experienced software developer and researcher holding a PhD in Computing from Lancaster University. Stephen’s research interests include Big Data, Business Intelligence and new ways of web development. ***Dr Oscar Forero is an anthropologist who trained at Imperial College. Oscar has worked with indigenous peoples in the Colombian Amazon and has carried out projects focusing on community development and conservation in Mexico and Chile among other countries. Oscar specialises in participatory research methods and empowering communities using participatory mapping techniques. His research in Science and Technology Studies focuses on how techno-scientific innovation contributes to, or deters, the fulfilment of human rights and the design of Food Security strategies, “Biological Diversity in the Patent System”, [ http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0078737#pone.0078737-Lohan1 ] , //hss-RJ)

The implication of demands for disclosure of origin is that developing countries would receive a share of receipts when a patent involved a genetic resource or traditional knowledge originating from their country. The economics of intellectual property markets remain remarkably opaque. It is therefore unclear what the economic impact of transfers would be on wider markets and transfers within markets. The lack of clarity on the actual economic values of biodiversity and traditional knowledge related intellectual property and related products is a major problem. This lack of clarity creates a situation of expectations about the high economic value of biodiversity and traditional knowledge among ‘provider’ countries that is pitted against the fear of exposure to the economic costs of disclosure among ‘user’ countries. This leads to unconstructive shadow boxing between states. This is exacerbated by efforts on the part of some states to use debates at WIPO as a platform for securing reform of the TRIPS agreement. Some countries have taken the unilateral stance that a requirement for greater transparency on the origin of genetic resources and traditional knowledge in patent applications would promote respect for the Convention on Biological Diversity and legal certainty in access and benefit-sharing arrangements under the Nagoya Protocol. Increasingly both developing and developed countries are taking unilateral action to introduce disclosure requirements into their national patent laws [186]. The practical implication of the adoption of unilateral disclosure requirements by countries such as Brazil, India, China, South Africa, Norway and Switzerland among others is that disclosure of origin will increasingly become routine for companies and research organisations seeking to operate in these markets. However, piecemeal approaches are unlikely to be as efficient as a clearly defined international standard. It is important to recall that the fundamental purpose of the patent system is the disclosure of new and useful innovations that over time become freely available for wider use by the public. In our view it is reasonable to expect that patent applicants should state where they obtained the genetic resources and associated traditional knowledge that is material to an invention. This would have the additional advantage of improving long-term knowledge and understanding of the role of biodiversity and traditional knowledge in innovation. At the same time, increased transparency would contribute to creating conditions of trust in access and benefit-sharing by clarifying what is actually happening with genetic resources and traditional knowledge. In practical terms, much could be achieved by following the model for disclosure of federal funding in patent applications developed in the United States under the 1980 Bayh-Dole Act [186]. The Bayh-Dole system requires recipients of federal funding to include a “Statement Regarding Federally Sponsored Research and Development” setting out the source of federal funding and contract number at the beginning of a patent application. This model for disclosure has caused no reported difficulties in the patent system and could be readily adapted to improve certainty for countries that access and benefit-sharing laws are being recognized and respected. We propose that this model could be adapted as a Statement or Declaration on Access and Benefit-Sharing in patent applications involving genetic resources and associated traditional knowledge that are material to the claimed invention. Such a statement or declaration would include a reference to contracts, permits and an international certificate of compliance to clarify the terms and conditions under which materials and any associated traditional knowledge were obtained. In addition, the 1980 Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure requires patent applicants to deposit a sample of a microorganism with an International Depositary Authority (such as the American Type Culture Collection). Patent applicants routinely make such deposits and provide information on the accession number and origin of organisms as part of a patent application. A Budapest Treaty style model could also contribute to addressing the concerns of developing countries and improve the clarity of disclosure of the origin of genetic resources and associated traditional knowledge in patent applications. Proposals for potential sanctions for non-disclosure cover a spectrum from halting the processing of patent applications, to revocation of granted patents or sanctions outside the patent system such as fines. However, a more flexible approach to sanctions might focus on using existing levers in the patent system, such as patent application and renewal fee schedules or tax incentives, to create Adjustable Incentive Measures (AIMS) that reward certain types of behaviour while discouraging behaviour associated with misappropriation or biopiracy [189]. In short, there may be flexibilities in the patent system that can be used to promote compliance with the Nagoya Protocol and contribute to opening up biodiversity to research and development.

And, Antarctic bioprospecting is key to biotechnology and the pharmaceutical industry

Nicol 2004, (Professor Dianna Nicol started her academic career as a scientist, receiving a PhD from Dalhousie University in Canada in 1987. She started studying law after moving to Tasmania in 1992. She was admitted as a barrister and solicitor to the Supreme Court of Tasmania and the High Court of Australia in 1998 and spent some time in legal practice. She commenced work as an academic at the University of Tasmania in 2000 and was appointed as full Professor in 2009. Her teaching focuses on primarily on the interface between technology and the law, with particular focus on intellectual property law. The broad theme of her research in the law discipline is the regulation of biotechnology and human genetics. She is particularly interested in the commercialisation of genetic knowledge and patenting of genetic inventions. She is currently the lead chief investigator on two Australian Research Council funded projects, one on patenting of biotechnology inventions, the other on the role of law in the era of personalised medicine. She has served as Deputy Dean of the Law Faculty and she is currently Associate Dean, Research. At the end of 2011 she finished a five year tenure as Chair of the University’s Animal Ethics Committee, “Antarctic bioprospecting, benefit sharing and cooperation in Antarctic science”, [ http://www.antarctica.gov.au/about-us/publications/australian-antarctic-magazine/2001-2005/issue-6-autumn-2004/feature/antarctic-bioprospecting-benefit-sharing-and-cooperation-in-antarctic-science ] , //hss-RJ)

Antarctic ecosystems consist of diverse communities of organisms uniquely adapted to their extreme environment. One of the drivers of Antarctic science is to investigate this rich biodiversity. There is little doubt that knowledge of Antarctic biodiversity benefits humankind, because it allows us to better understand the world we live in and to make informed decisions about the future. It also offers other important benefits to society, not the least of which is the development of new medicines to treat human disease. Many of the unique chemicals produced by living organisms to assist them in their daily battle for survival also have valuable pharmaceutical properties. The process of tapping into the world's natural biological resources for healthcare and other purposes is known as bioprospecting. This process is also sometimes referred to as biodiscovery – at least at the early stage of exploration and initial sample collection. The potential for research on Antarctic organisms to contribute to the public good is well demonstrated by the following extract from a patent claiming an enzyme derived from krill and fish. The patent claims that this enzyme is useful in the treatment of: viral infections such as herpes outbreaks, fungal, bacterial or parasitic infections, including the primary and secondary infections of leprosy, colitis, ulcers, haemorrhoids, corneal scarring, dental plaque, acne, cystic fibrosis, blood clots, wounds, immune disorders including autoimmune disease and cancer. Patents such as this are the lifeblood of the biotechnology and pharmaceutical industries. A patent gives its owner, and anyone else who the owner permits, the right to use the invention for the life of the patent (usually 20 years) and to exclude others from using it. The trade-off to society is that the patent owner has to disclose the invention and the best method of performing it. The patent owner gets the benefit of a period of time when they are free from competitors in the market. But once the patent expires others are free to use the invention. The main argument justifying patents is that they encourage innovation: they provide the necessary incentive for patent holders to invest significant time and money in bringing their inventions to market. If a blockbuster drug results then the patent owner receives a windfall. However, there are many pitfalls on the long and winding road to market. For drugs, the usual figure for time from invention to market is 12-15 years and the estimated cost is $500-800 million, with only one in 5000 products actually making it to market. Hence, we can perhaps take it as read that, if we want new medicines, we have to have patents (although it must be acknowledged that some would, nevertheless, argue to the contrary). These costs of drug discovery do not even take account of the early pre-invention phase. For medicines based on natural products, samples have to be collected, isolated, characterised, and screened for pharmaceutical activity before drug-related patents can be filed. Each of these steps is expensive and risky and requires considerable skill. Despite these potential pitfalls on the road to product development, the importance of bioprospecting in the process of drug discovery is widely acknowledged and there is general support in industrialised countries for the development of a bioprospecting industry. The Convention on Biological Diversity (CBD) recognises, on the one hand, the enormous public benefit to be had from exploitation of natural resources and, on the other hand, the sovereign rights of countries to control access to their resources and to share in the benefits from their exploitation. The CBD and the associated Bonn Guidelines set up a system for facilitating and regulating bioprospecting by providing guidance to countries on how to deal with the three key issues of access, benefit sharing and technology transfer. The goal is not only to provide appropriate incentives for innovation, but also to acknowledge the sovereign rights of owners of natural resources to control access and share profits and technological developments.

And, the pharmaceutical industry is key to solve bio terrorism — new drugs are key

Pilch and Zilinskas 2005, (*A graduate of the University of Miami School of Medicine, Richard Pilch, M.D., joined the Center for Nonproliferation Studies at the Monterey Institute of International Studies in January 2002, where he now serves as the Scientist-in-Residence of the Chemical and Biological Weapons Nonproliferation Program. Dr. Pilch is a project manager for the Cooperative Biological Research program in Russia, and is co-writing a book on the dichotomous use of toxins as both therapeutic agents and weapons of war. He also maintains an interest in the medical and healthcare aspects of chemical, biological, and radiological threats, as well as the monitoring of biotechnological advances for possible offensive or defensive application. **Raymond A. Zilinskas, Ph.D. is director of the Chemical and Biological Weapons Nonproliferation Program, Center for Nonproliferation Studies, Monterey Institute of International Studies. In 1993, Dr. Zilinskas was a William Foster Fellow at the U.S. Arms Control and Disarmament Agency, which seconded him to the United Nations Special Commission to work as a biological analyst; as such, he participated in two biological warfare-related inspections in Iraq. He has since then worked for the University of Maryland Biotechnology Institute and a consultant to the U.S. Department of State and Department of Defense. He currently focuses on developing effective biological arms control, assessing the proliferation potential of the former Soviet Union’s biological warfare program, and meeting the threat of bioterrorism. He edited the book Biological Warfare: Modern Offense and Defense (1999), “Encyclopedia of Bioterrorism Defense”, [ http://onlinelibrary.wiley.com/book/10.1002/0471686786 ] , //hss-RJ)

The pharmaceutical and biotechnology industries play an important role in providing anti-infective drugs, vaccines, and biologicals (a category of pharmaceutical products consisting not of chemical agents like drugs and not of vaccines, but rather of products such as immunomodulators, interferons, and monoclonal antibodies, which are often produced in facilities similar to vaccine production lines since they are usually derived from tissue cultures or, in some cases, from organisms like modified Escherichia coli but are not classic vaccines) for use in responding to a bioterrorist attack. Research, development, and production programs initiated by the pharmaceutical industry will play a key role in providing new therapeutic agents for use against potential bioterrorist threats, and the industry will be an important element in determining future policies relating to bioterrorism defense. BACKGROUND In times of war and national catastrophes alike, the pharmaceutical industry has worked closely with governments and international agencies to ensure the greatest possible response capability to those in need. During World War II, for example, the pharmaceutical industry worked with u.s. government and university scientists to rapidly develop critical blood fractions that ultimately saved innumerable lives (Starr, 1998), while a similar joint project resulted in the greatly expedited development of penicillin (Hobby, 1985). When, following the September 11, 2001, attacks on the United States, President Bush declared war on terrorism, the pharmaceutical industry again volunteered to do what was needed in order to aid in the effort. Both the needs and the solutions have since proven to be much more complex than at any other time in history, however, and the industry is still, to some extent, in the process of determining what is expected of it in the post-September 11 era. Prior to 2001, the distinction between pharmaceutical industry policies relating to biological warfare (BW) and bioterrorism was unclear. Large pharmaceutical companies were interested in such issues as the genetic engineering of microorganisms and the stockpiling of antiinfective drugs and vaccines in anticipation of the use of biological agents as weapons. There was also an interest and concern about the proposed site inspection aspects of the Biological and Toxin Weapons Convention (BWC) verification protocol initiative. Attention to all of these issues was of a general nature except for the brief period prior to the Gulf War. Following September 11 and the subsequent use of Bacillus anthracis spores as a bioterrorist agent delivered via the U.S. postal system, however, the pharmaceutical industry’s attention became much more focused. POST-SEPTEMBER 11 PHARMACEUTICAL INDUSTRY RESPONSE It has been noted that the terrorist attacks of September 2001 using commercial aircraft as weapons produced varied reactions in the United States, including one that was neither directly nor logically connected to the attack: the overwhelming expression by several officials and experts that the next terrorist attack could well involve biological or chemical weapons (Leitenberg, 2002). The subsequent mailing of letters containing B. anthracis spores and the infections and deaths associated with this incident enhanced the feeling of vulnerability to this type of weapon, provoking a deluge of inquires from the press, trade groups, and government agencies (both legislative and executive branches) concerning the readiness of the pharmaceutical industry to respond to a bioterrorist attack on a larger scale. Specifically, demands were placed on the industry to define inventories and production and distribution capabilities of relevant antiinfective and wound healing drugs, vaccines, and biologicals. Requests were also submitted for details on drugs and vaccines in development, including time estimates of when these agents would be available for emergency use.  Accurate information on these issues was often difficult to obtain, because no individual or single department within larger pharmaceutical companies possessed the necessary data in the detail that was required. The disclosure of specific information on drugs in development further created legal and patent issues that required consultation and clarification. Regardless, it eventually became apparent that companies did not possess large stockpiles of those agents deemed necessary, and even when they did, distribution directly to the general public in many cases violated current laws and required expertise that did not exist. It soon became apparent that there was a need for a single communication body to speak for the pharmaceutical industry, and thus in October 2001, the Pharmaceutical Research and Manufacturers of America’s (PhRMA) Task Force on Emergency Preparedness was formed. Task Force on Emergency Preparedness Upon its creation, the Task Force established four initial priorities (PhRMA, 2001): • Each company was to designate a top scientist to serve on an industry/government working group to identify priority needs, gaps, and capabilities relevant to the pharmaceutical industry. • Each company with antibiotic capability was to provide data on its production capacity for antibiotics that might be effective against bioterrorism agents. • Information was to be provided about the ability of the industry to share laboratory capability in order to help analyze suspicious material for the presence of bioterrorism agents. • It was to be determined whether industry could be of assistance in the storage and distribution of needed therapeutics or vaccines. The Task Force, today, continues to provide a vehicle to address and better define exactly what is expected of the pharmaceutical industry in addressing public health needs in the face ofbioterrorism, and to establish practical policies in this area. The Impact of Legislation Legislation such as the House Anti-Terrorism Bill raised significant issues for the pharmaceutical industry. Although many potentially effective antiinfective drugs had demonstrated in vitro activity (low minimum inhibitory concentration) against potential bioterrorism organisms, the Food and Drug Administration’s (FDA) approved labeling for these drugs did not include treatment of infection by such organisms. This situation raised complex issues for government agencies charged with protecting public health within the bounds of current laws regulating prescription drugs, because success required promoting their off-label usage. In addition, legislation concerning the security of drug production and research and development (R&D) facilities for global pharmaceutical companies complicated employment and personnel reliability measures, particularly when aliens, foreign graduate students, and postdoctoral personnel were involved. Another significant issue concerned the cost of stockpiling patented drugs versus the less expensive generic version of these drugs, some of which were not available in the United States at that time because of patent restrictions. The pharmaceutical industry responded to these issues by making the necessary adjustments to ensure that adequate drugs would be available to address the needs of the public. CURRENT BIOTERRORIST AGENTS OF CONCERN Anthrax One of two diseases to receive the majority of attention from pharmaceutical and biotech industries is anthrax, its priority self-evident, given the events of fall 2001. Currently, the pharmaceutical industry is capable of both supplying adequate drugs for limited anthrax outbreaks and filling the needs of stockpiling programs integral to response efforts in a major incident. Distribution of stockpiled drugs remains an issue but falls outside the scope of responsibility of the pharmaceutical industry. The pharmaceutical industry is fully cooperating with government agencies to perform the necessary animal studies to increase the number of currently marketed drugs and drugs in development against anthrax. Within both the pharmaceutical and biotechnology industries, programs are also in place to develop improved vaccines and biological therapies for the future, and to ensure that adequate supplies of today’s drugs are available. Significant attention, particularly by the biotechnology industry, is being directed toward the development of rapid detection and diagnostic procedures using both environmental and human samples as well (Enserink, 2001). Smallpox Smallpox has received considerable attention from phar-maceutical and biotechnology industries as well (Enserink, 2002). Initially, priority was given to ensuring that ade¬quate stocks of the current vaccine were available to first vaccinate first responders as a preparedness measure and then vaccinate necessary populations in the event of an outbreak. The ultimate goal was to establish a capability to vaccinate the entire population of the United States if necessary. Several pharmaceutical companies bid on a one-year contract to produce the required amounts of the vaccine, which upon being awarded has led to the manu¬facture and stockpiling of enough vaccine to meet current public health needs. Research on improved vaccines is ongoing. The pharmaceutical industry is also cooperat¬ing with government agencies to expedite the search for antiviral drugs with activity against the smallpox virus. Ultimately, the potential consequences of a bioterrorist threat employing smallpox, although still significant, have in a very short period of time been significantly reduced. Other Potential Bacterial Threats Marketed drugs exist that are likely to be effective against those pathogens considered to be potential bacterial bioterrorist threats (for more information, please refer to the entry entitled ‘‘Centers for Disease Control and Prevention’s Bioterrorism Preparedness Program’’). However, the potential for use of highly resistant strains of these pathogens necessitates the continued development of new agents with novel mechanisms of action, a need consistent with current pharmaceutical industry drug discovery programs. Thus, the encouragement of the pharmaceutical industry to maintain these programs and develop new antibacterials appears to be a critical element of current approaches to preparedness. The development of new vaccines and biologicals is also critical to addressing the problem of drug-resistant bacterial agents of today and tomorrow. Potential Viral Threats Other Than Smallpox The need for the development of drugs against potential viral bioterrorism threats remains a serious problem. Most current antiviral drugs are not effective against select viral agents, making pharmaceutical and biotechnology industry research on new vaccines and other biologicals, such as those associated with the enhancement of host defense mechanisms, the best approach for the future (Fox, 2003a). Toxins One approach to responding to an anticipated bioterrorist threat is to focus research on neutralizing either a freestanding toxin (such as botulinum toxin) or the toxin produced by an infecting agent (such as lethal factor, or LF, of B. anthracis) rather than focusing on an antibacterial drug. This approach appeals to both biotechnology as well as large pharmaceutical companies since such biological products or antitoxin drugs not only fill a definite medical need but also allow for justification of the research investment. Research in this area is of particular interest since it bypasses the issue of drug resistance, which is the most limiting factor to the market value of both novel and classic antimicrobial drugs. Development of drugs directed against toxins, if successful, will yield a product with an extended market value. PHARMACEUTICAL INDUSTRY DRUG DISCOVERY PROGRAMS As noted, a vital approach to responding to highly resistant organisms in the future is the continued implementation of drug discovery programs to enhance the pipeline of novel agents. At present, however, a number of large pharmaceutical companies are in the midst of reducing or eliminating these programs because of practical concerns, namely, that the expenses pertaining to maintaining such a program and taking a single drug through development all the way to the market (average cost is about $800 million) are prohibitive (Gwynne and Heebner, 2003). Further, in large pharmaceutical companies, antiinfective programs must compete with other therapeutic areas for funding. When one considers that antiinfective drugs are only required for a short duration (days) whereas drugs from other therapeutic areas are often given to patients for years or even life, it is difficult to justify their development and production from a financial perspective. Thus, pharmaceutical companies honoring the commitment to their shareholders cannot, in the contemporary situation, pursue antiinfectives as a high priority, creating a void that will most likely be filled by small pharmaceutical and biotechnology companies in the immediate future (though it should be noted that many of the drugs being developed by these companies have come from lead compounds generated by the larger pharmaceutical companies). This is an issue that must receive the attention of policy planners when setting future priorities. ADDITIONAL PHARMACEUTICAL INDUSTRY INITIATIVES Most pharmaceutical companies with marketed anti-infectives have offered their drugs either free of charge or at cost to the government for use in an emergency situation. Several pharmaceutical companies have offered teams of scientists and laboratory space to conduct research, leading to solutions against potential microbial weapons as well. Other initiatives include a program coordinated by PhRMA in cooperation with the U.S. government, which involves the delivery by pharmaceutical company representatives of printed summary data on anthrax and smallpox to health care personnel in order to raise their awareness of these diseases and provide an informative source for related questions that these personnel may have. In addition to these programs, some pharmaceutical companies sponsor scientists from foreign countries to work at the Centers for Disease Control and Prevention (CDC) in Atlanta in order to develop skills for addressing bioterrorism in their respective countries. THE FUTURE The pharmaceutical industry will continue to play a significant role in providing therapeutic drugs against the most likely bioterrorist threat agents. However, there are significant gaps in the current therapies available for highly resistant bacteria and many viruses, and significant time, research, and money must therefore be invested to address these gaps. This will involve the continuing cooperation of the pharmaceutical and biotech industries with various government agencies, academic researchers, and private foundations. Incentives must be provided to conduct research in identified areas of need (Fox, 2003b), and new paradigms must be developed to evaluate drugs and vaccines that cannot be tested in human clinical trials to determine efficacy. New surrogate markers, such as animal or even in vitro models, will have to be accepted as indicators of efficacy as an incentive to develop some of these needed therapies (Friedlander et al., 1993). The pharmaceutical industry will continue to be an active participant in the dialog necessary to move forward in these areas in the years to come.

And, Bioterrorism is likely — terrorists are intent on attacking the US

Brooks 2/11/14, (Susan Wiant Brooks (born August 25, 1960) is an American politician who has been the United States Representative for Indiana's 5th congressional district since 2013. Brooks, a Republican, previously served as the United States Attorney for the United States District Court for the Southern District of Indiana from 2001 to 2007, this was her testimony in front of the Congressional Subcommittee on Emergency Preparedness, Response, and Communications Committee on Homeland Security, “Bioterrorism: Assessing the Risk”, [ http://homeland.house.gov/sites/homeland.house.gov/files/documents/02-11-14-Brooks-Open.pdf ] , //HSS-RJ)

“Today’s hearing is part of the oversight work this Subcommittee has and will be conducting on bioterrorism and the Department of Homeland Security’s biosurveillance capabilities. I was U.S. Attorney for the Southern District of Indiana during the anthrax attacks in 2001. These attacks killed five people and sickened more than 20 others. These attacks showed us both the physical and psychological impacts of a bioterrorism event and were a reminder that a small amount of a biological agent can have a large impact. In his 2003 report, “Catastrophic Bioterrorism – What is to be Done?,” Richard Danzig noted that the one gram of anthrax that was sent to Senator Leahy contained one trillion spores – an amount, that if effectively dispersed, could kill thousands of people and cause great economic damage. I don’t say this to be an alarmist. We must be aware of all the threats we face. I fear that over the course of time, people have lost sight of the potential impacts of such an attack and why we must be vigilant and prepared. Because of this, I think that this hearing is important – to again talk about this threat and what we are doing about it. In addition to this hearing, this Subcommittee is also doing several other activities surrounding bioterrorism and biosurveillance. At the request of Ranking Member Payne and myself, as well as the Chairman and Ranking member of the full Committee, the Government Accountability Office (GAO) is conducting a review of the National Biosurveillance Integration Center(NBIC) to determine whether the NBIC is working to its potential, providing value to Federal participants, and worthy of our vital security dollars. The Subcommittee is also continuing its oversight of the BioWatch Program, the Office of Health Affairs’ flagship program designed to detect aerosolized bioterror agents. BioWatch is at a crossroads. Members may recall that this Subcommittee requested a GAO review of the program in the 112th Congress, which was released in September 2012. Among its recommendations was that the Department complete an analysis of alternatives for the Generation-3 (Gen-3) system to determine whether this approach is the right way to go. The Institute for Defense Analysis completed this analysis and delivered the results to the Department late last year. It is my understanding that the Department is currently reviewing the AOA and considering options for the future of the program. I urge them, as I will discuss with Secretary Johnson when he appears before the Committee tomorrow, to thoughtfully consider the results of the AOA to determine the most appropriate path forward for the Program. I look forward to receiving testimony from the Department on this issue in the near future. As the foundation of this future work, we are meeting today to receive an update on the bioterrorism threat. And we know the threat is real. In testimony before this Subcommittee in the 112th Congress, former Senator Jim Talent, Vice-Chair of the WMD Commission, reminded us of the Commission’s finding that it was likely that there would be a WMD attack somewhere in the world by the end of 2013 and that, in their judgment, the attack was more likely to be biological. Bioweapons can be developed surreptitiously, transported with relative ease, and deployed insidiously over time. We have no reason to believe that the threat has changed since that testimony. In materials prepared for his appearance before the House Intelligence Committee last week, Director of National Intelligence James Clapper noted that the Intelligence Community remains focused on the “…proliferation of chemical and biological warfare-related materials, and development of WMD delivery systems.” In addition to nation-state actors, the Intelligence Community has also judged that al-Qaeda and its affiliates are intent on conducting CBRN attacks against the United States.1 So, I am pleased that we will be receiving testimony from a distinguished panel of witnesses to put this threat into perspective. I will note for the Members that we are planning to follow up this hearing with a classified briefing on the threat later this month. With that, I look forward to the testimony and our discussion this morning.”

Bioterrorism causes extinction

Steinbruner 97,(John Steinbruner — Senior Fellow at the Brookings Institute)1997, “Biological Weapons: A Plague Upon All Houses”, FOREIGN POLICY, //hss-RJ)

Although human pathogens are often lumped with nuclear explosives and lethal chemicals as potential weapons of mass destruction, there is an obvious, fundamentally important difference: Pathogens are alive, weapons are not. Nuclear and chemical weapons do not reproduce themselves and do not independently engage in adaptive behavior; pathogens do both of these things. That deceptively simple observation has immense implications. The use of a manufactured weapon is a singular event. Most of the damage occurs immediately. The after effects, whatever they may be, decay rapidly over time and distance in a reasonably predictable manner. Even before a nuclear warhead is detonated, for instance, it is possible to estimate the extent of the subsequent damage and the likely level of radioactive fallout. Such predictability is an essential component for tactical military planning. The use of a pathogen, by contrast, is an extended process whose scope and timing cannot be precisely controlled. For most potential biological agents, the predominant drawback is that they would not act swiftly or decisively enough to be an effective weapon. But for a few pathogens---ones most likely to have a decisive effect and therefore the ones most likely to be contemplated for deliberately hostile use--the risk runs in the other direction. A lethal pathogen that could efficiently spread from one victim to another would be capable of initiating an intensifying cascade of disease that might ultimately threaten the entire world population. The 1918 influenza epidemic demonstrated the potential for a global contagion of this sort but not necessarily its outer limit.

And, Biotech advances independently solves extinction

Trewavas, 2k – (Anthony Trewavas — Institute of Cell and Molecular Biology at the University of Edinburgh , “GM Is the Best Option We Have,” 6/5/2000, www.agbioworld.org/biotech-info/articles/biotech-art/best_option.html)

In 535A.D. a volcano near the present Krakatoa exploded with the force of 200 million Hiroshima A bombs. The dense cloud of dust so reduced the intensity of the sun that for at least two years thereafter, summer turned to winter and crops here and elsewhere in the Northern hemisphere failed completely. The population survived by hunting a rapidly vanishing population of edible animals. The after-effects continued for a decade and human history was changed irreversibly. But the planet recovered. Such examples of benign nature's wisdom, in full flood as it were, dwarf and make miniscule the tiny modifications we make upon our environment. There are apparently 100 such volcanoes round the world that could at any time unleash forces as great. And even smaller volcanic explosions change our climate and can easily threaten the security of our food supply. Our hold on this planet is tenuous. In the present day an equivalent 535A.D. explosion would destroy much of our civilisation. Only those with agricultural technology sufficiently advanced would have a chance at survival. Colliding asteroids are another problem that requires us to be forward-looking accepting that technological advance may be the only buffer between us and annihilation. When people say to me they do not need GM, I am astonished at their prescience, their ability to read a benign future in a crystal ball that I cannot. Now is the time to experiment; not when a holocaust is upon us and it is too late. GM is a technology whose time has come and just in the nick of time. With each billion that mankind has added to the planet have come technological advances to increase food supply. In the 18th century, the start of agricultural mechanisation; in the 19th century knowledge of crop mineral requirements, the eventual Haber Bosch process for nitrogen reduction. In the 20th century plant genetics and breeding, and later the green revolution. Each time population growth has been sustained without enormous loss of life through starvation even though crisis often beckoned. For the 21st century, genetic manipulation is our primary hope to maintain developing and complex technological civilisations. When the climate is changing in unpredictable ways, diversity in agricultural technology is a strength and a necessity not a luxury. Diversity helps seecure our food supply. We have heard much of the precautionary principle in recent years; my version of it is "be prepared

Icebreakers are key — only way to make Antarctic research feasible

White et al 11 – institute of Arctic and Alpine Research at the University of Colorado at Boulder (James W.C., “Future Science Opportunities in Antarctica and the Southern Ocean,” National Research Council, http://agdw.uh.edu/sites/agdw/files/docs/future_directions_2011.pdf)

Heavy icebreakers are a special class of surface ships that are essential to the conduct of science in Antarctica and the Southern Ocean, providing access for ocean and coastal research in heavy ice covered seas, and allowing fuel and supplies to reach research stations. They are complex, sturdy vessels that are inherently expensive. Icebreakers are discussed in more depth in Appendix D, with a brief summary provided here. Anticipated scientific research needs in Antarctica and the Southern Ocean will require the services of heavy icebreakers, not only to break ice and clear out harbors, but also to support research missions for less-capable polar research vessel ice breakers and act as helicopter platforms. In addition, scientific operations at McMurdo now totally rely on the annual resupply in late Austral summer of fuel and materials; this is done by transport ship and tanker and requires heavy ice-breaking capacity. There is a critical shortage of U.S. heavy icebreaking capacity in Antarctica and the Southern Ocean at this time. The two U.S. Coast Guard heavy icebreakers, Polar Sea and Polar Star, are more than 30 years old and have exceeded their service lives. The Polar Sea is to be decommissioned in 2011. The Polar Star is undergoing engine repairs and refitting needed to extend this ship’s service for a limited period; repairs are expected to be complete in 2013. As concluded by the 2007 NRC report Polar Icebreakers in a Changing World, the “operations and maintenance of the polar icebreaker fleet have been underfunded for many years” (National Research Council, 2007b). Other reports have discussed the need for the United States to have its own icebreaking capacity, including three previous NRC reports, a congressional analysis, and a Homeland Security audit (National Research Council, 2007b, 2011c, 2011e; O’Rourke, 2011; Richards, 2011). These documents conclude that there are strong national security and operational reasons for the nation to develop its own icebreaking capability. As stated in the Critical Infrastructure for Ocean Research and Societal Needs in 2030 (National Research Council, 2011c) report, “the nation should recover U.S. capability to access fully and partially ice-covered seas.” Based on the scientific research needs outlined in this report, the committee strongly supports the conclusion that the United States should develop sufficient icebreaking capacity, either on a national or international basis. Any arrangement should ensure that the U.S. needs in Antarctica and the Southern Ocean, for both research vessel support, and in particular the annual break-in supplying McMurdo, can be met by secure, reliable, and heavy icebreaking capacity.