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10 Facts about America's EITC-eligible Tax Filers


Researchers from the Brookings Metropolitan Policy Program have released new Earned Income Tax Credit (EITC) data from the IRS on federal individual income tax filers. The interactive data are available for all ZIP codes, cities, counties, metropolitan areas, states, state legislative districts, and congressional districts in the U.S. Users can also find new MetroTax model estimates of the EITC-eligible population in 2012 based on the latest American Community Survey data.

From the 2012 MetroTax model, here are 10 facts about EITC-eligible tax filers

• 71.1 million people live in tax units that are eligible
• 31.1 million children live in eligible households
• 72.8% of eligible filers speak English
• 50.9% are white
• 36.1% received food stamps at some point in the last year
• 25.8% are married filing jointly
• 13.2% have earned a bachelor’s degree or higher
• The median adjusted gross income is $13,638
• 12.7% of eligible filers work in the retail trade industry
• 13.6% work in office and administrative occupations

Read the blog post by Jane Williams and Elizabeth Kneebone to learn more and also visit the EITC interactive.

Authors

  • Fred Dews
     
 
 




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Connecting EITC filers to the Affordable Care Act premium tax credit


     
 
 




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Public attitudes on US manufacturing

The manufacturing sector in United States continues to play a significant role in our nation’s economic life, creating valuable jobs at a time when the economy is undergoing major changes. In the face of rising automation, rapidly evolving technology, and an ongoing trade war, debates surrounding the manufacturing industry, its workforce, and its economic effects…

       




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Brookings survey finds 58% see manufacturing as vital to US economy, but only 17% are very confident in its future

Manufacturing is a crucial part of the U.S. economy. According to the U.S. census, around 11.1 million workers are employed in the sector, and it generates about $5.4 trillion in economic activity annually. Yet this area currently faces significant headwinds. The June IHS Markit Manufacturing Purchasing Managers Index fell to its worst reading since 2009…

       




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Highlights: How public attitudes are shaping the future of manufacturing

The manufacturing industry has been a significant part of the U.S. economy for decades, but it now faces critical challenges with the emergence of automation and other technologies. Recently, Governance Studies at Brookings hosted the eighth annual John Hazen White Forum on Public Policy to discuss the future of manufacturing, as well as a new…

       




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Adjusting to China: A Challenge to the U.S. Manufacturing Sector


Policy Brief #179

During an "exit interview" with the Wall Street Journal, departing National Economic Council Director Lawrence Summers argued that history would judge the United States based on how well we adjust to China’s emergence as a great power, economically and politically. In the face of China’s progress, America’s manufacturing sector faces major challenges in becoming and remaining competitive and our choice of national economic policies will affect how well we meet those challenges. It is essential that the U.S. trade deficit not balloon as the economy recovers. There is scope to expand our exports in services and agriculture, but improving the competitiveness of U.S. manufacturing is vital.

The U.S. Trade Deficit: Background

Components of the Trade Deficit. The U.S. trade deficit in goods and services was just under $700 billion in 2008—4.9 percent of Gross Domestic Product (GDP). However, the deficit in goods trade was nearly $835 billion, which was partially offset by a $136 billion surplus in services trade. The latter surplus has grown consistently over a range of service types and has important potential to expand. Going forward, we can assume this surplus will remain around one percent of GDP. But services trade surpluses alone cannot solve the U.S. trade deficit problem, because of persistent large deficits in goods trade.

Very important are deficits in the energy sector. In 2008, petroleum products accounted for $386 billion of the total trade deficit (2.7 percent of GDP). reducing energy imports (and consumption) is a significant challenge for the U.S. economy, and with global energy demand continuing to rise and supply constrained, oil prices are more likely to rise than fall. The U.S. bill for imported oil is unlikely to fall below 2.7 percent of GDP for years to come.

In future, for overall U.S. trade in goods and services to be balanced, non-energy products (that is, manufactured and agricultural products) would have to achieve a surplus of around 1.7 percent of GDP. Added to the one percent services surplus, the two would balance out the almost unavoidable petroleum deficit.

Obviously, elements in this rough calculation could shift, for better or worse, but if the U.S. economy is to achieve a more balanced growth path, the competitive position of U.S. manufacturing must improve sharply.

Growth of the U.S. Trade Deficit. In 1999, the U.S. economy was experiencing strong growth and low inflation, but the trade deficit in manufactured and agricultural products was high—$262.5 billion—and concentrated in four broad industry categories. The largest deficit was in plastic, wood and paper products ($62 billion). Transportation equipment—from autos to aerospace—was close behind ($61 billion), followed by textiles and apparel ($52 billion) and computers and electronics ($44 billion). Only two categories had trade surpluses: chemicals at more than $9 billion and agriculture at $4 billion.

By 2008, the trade deficit had risen to $400 billion, an increase of $138 billion or nearly 52 percent in nominal terms. The deficit in computers and electronics accounted for nearly half of the overall increase in the trade deficit (48 percent, a $66 billion increase). Two other industries had large deficit increases: plastic, wood and paper products; and textiles and apparel. By contrast, agricultural products contributed an additional $27 billion to a small 1999 surplus. And transportation equipment reduced its trade deficit by nearly $12 billion. Chart 1 illustrates how the increase in the U.S. goods trade deficit (excluding oil) was distributed by segment between 1999 and 2008.

Rising Imports from China

Simply put, the United States runs chronic trade deficits and China runs trade surpluses because we spend more than we produce, and they do the opposite. The U.S. trade deficit with China in manufactured and agricultural products was already large in 1999—$68.6 billion or 26 percent of the nation’s total trade deficit. By 2008, it had increased to nearly $268 billion. The story of the increasing U.S. trade deficit from 1999-2008—apart from oil—is the explosion in the deficit with China.

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Computers and electronic products account for much of the increase in U.S. imports from China. In 2008, China exported $108 billion in these products to the United States, up from less than $19 billion in 1999. Beyond this sector, Chinese exports to the United States have grown strongly pretty much across the board. Although the United States exports agricultural products to China, there is a large return flow of processed and labor-intensive food products. And, while Chinese textile and apparel imports have risen, U.S. demand for Chinese goods in this category has grown only modestly as other emerging economies have become major clothing exporters.

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The Nature of Chinese Exports. On a visit to China early in 2010, I heard a memorable speech declaring that the United States is exploiting China. The Chinese perception is based on where profits land. For example, a 2009 survey by Greg Linden, Kenneth Kraemer and Jason Dedrick of the University of California suggests that Apple, Inc. sells iPhones or iPods for several hundred dollars, most of them “made in China,” but the Chinese producer and Chinese workers receive just under four dollars apiece. The retail price of the 2005 video iPod was $299, the wholesale price $224 and the factory price $144.56. The largest part of the factory price ($101.40) came from Japanese components, with U.S. companies other than Apple supplying $14.14 in components and many different suppliers providing other small components. The final assembly and checking is done in China for $3.86, while Apple’s estimated gross margin is $80 per unit sold at wholesale, plus a portion of the retail margin through its Apple online and retail stores.

These same researchers deconstructed the value of a 2005 Hewlett-Packard Notebook PC, which sold at retail for $1,399 and had a factory cost of $856.33. Intel and Microsoft received a total of $305.43 for each computer sold, while the assembly and checking done in China netted $23.76— only 1.7 percent of the retail price. China’s massive export boom in computers and electronics derives from the fact that it is a very good place to assemble electronic products that clearly benefit U.S. companies’ profits. However, China’s policymakers want change; they are determined to attempt to obtain more of the value added of the goods their citizens assemble.

The place of China as a supplier to the United States is further illuminated in the forthcoming book Rising Tide: Is Growth in Emerging Economies Good for the United States? by Lawrence Edwards and Robert Lawrence, who have taken a detailed look at the “unit values” of traded products, particularly U.S. exports and imports. Detailed trade data identify specific classes of products and provide total dollar value and number of physical items sold in each class. For example, the data report the value of electric motors exported by China to the United States, along with the number of motors, which allows a calculation of the price per motor. If a country is selling motors for electric shavers or toys, the unit value will be small; if the motors are for large capital goods, the unit value will be high.

Edwards and Lawrence find a striking result for China, one that also applies to other emerging economies. It turns out that unit values in the same product categories are hugely different. China sells low unit value products to the United States, and the United States sells high unit value products around the world. These price differentials are so great, in fact, they suggest the United States and China are not really competing. They are making completely different things. Perhaps even more surprising, over the past several years, there appears to be no tendency for the unit values to converge. This contradicts the hypothesis that China is successfully moving up the technology or “value ladder.” Instead, U.S. competitors are Europe and Japan.

Although the volume of Chinese exports to the United States has soared, in high-tech, as we saw, it is assembling components originating elsewhere and, in other industries, it is making primarily low value products, such as toys and children’s clothing— market niches where the U.S. would not be expected to be competitive.

China and Multinational Companies

When China emerged from the Cultural Revolution and started on a path to become a productive and market-oriented economy, it faced massive educational, technological and business hurdles. Competent scientists, engineers and managers had been exiled and “re-educated.” Heroic efforts were needed to catch up to developed nations’ economies. Asian precursors such as Japan and Korea had faced their own catch-up challenges, taking advantage of the global market in capital goods to help them, and China followed their lead. Unlike the others, China encouraged direct foreign investments and required partnerships with domestic businesses. These relationships provided not only financing, but also the business and technology skills of global corporations and sped development of Chinese companies.

Germany provides a fascinating case study of the benefits and perils of a strong relationship with China. Spiegel Online notes that the most important driving force behind the current German economic upswing is its exports of sophisticated capital goods to China. German companies find, however, that the Chinese demand access to their industrial know-how. German businesses are reluctant to offend their Chinese customers, but deeply concerned about the loss of intellectual property. Beijing does not want merely to catch up to German companies—its goal is to surpass them. It has already done so in the manufacture of solar panels, by subsidizing research into solar technology. China exports perhaps 70 percent of its output of solar panels, about half of which goes to Germany, where demand is heavily subsidized by the German government. In electricity generation, Beijing invited Western companies to build power plants jointly with domestic Chinese partners. Now the Chinese are upgrading the plants with their own technology, based on what they learned through the German company Siemens and the French company Alstom.

A 2010 study by James McGregor of APCO sharply criticizing Chinese industrial and technology policies provides additional examples of China’s determination to leverage Western technology. Notably, China is expected to spend $730 billion on its rail network by 2020, with about half being used to expand high-speed passenger lines. This level of capital spending is irresistible for European producers. The China National Railway Corporation (CNR) invited Siemens to bid on a $919 million contract to build 60 passenger trains for service between Beijing and Tianjin. Siemens built the first three, but the remaining 57 were built in China by CNR, using 1,000 Chinese technicians Siemens had trained. In March 2009, Siemens announced an agreement for it to build 100 additional high-speed trains to serve Beijing-Shanghai, but China denied such an agreement ever existed. Siemens ultimately received a contract for $1 billion in components, but $5.7 billion went to CNR, which built the trains.

In the long run, China favors its own producers. It brings in foreign companies at the launching of an industry, then uses government procurement to advance the market share of Chinese companies and, eventually, to shut out competition. This strategy has allowed it to build on foreign companies’ expertise, develop domestic champions and raise the technological level of its economy and exports. Because of its large and rapidly growing market, China can pressure foreign companies to partner with Chinese companies, allowing their employees to learn managerial and technical skills. Over time, China has somewhat loosened formal requirements for foreign companies to accept partners, but the strategy of technology and skills transfer remains very much in force.

Developing countries naturally learn from best practices world-wide; indeed the 19th century economic history of the United States includes considerable technology transfer from Britain and the rest of Europe. Nevertheless, companies that have invested heavily to develop new technologies and efficient processes cannot afford to simply allow China to free-ride on their efforts. Yet many Chinese leaders make it clear they are on a mission to acquire the best technology, using their size and growth as a way to obtain it.

A December 23, 2010 New York Times editorial noted this strategy, saying, “[I]ntellectual property misappropriation cannot be a government policy goal, especially in a country the size of China, which can flood world markets with ill-begotten high tech products.” The editorial acknowledged some U.S. progress at the World Trade Organization, but urged our government to be “more vigilant and aggressive” against intellectual property losses.

Helping U.S. Manufacturers Adjust to China

U.S. exports of manufactured goods reached $952 billion in 2009 and grew strongly in 2010. The goal of increasing exports substantially is feasible, given favorable economic conditions and policies. It may even be possible to bring some off-shored production back to the United States, a possibility some manufacturers have been exploring, in order to remediate cost, quality and delivery problems. But first, policymakers must recognize that:

  1. Today’s trade deficit is not a technology problem. The U.S. economy simply must become a more attractive place to develop and manufacture new products. The best ways to do this are to balance the budget and lower the marginal tax rate on corporations. Our trade problem is that U.S. companies develop innovative products but choose not to manufacture much of their value here. One chronic reason is that the value of a dollar has been too high, making U.S. production too expensive. If the U.S. saved more and balanced the federal budget, that problem would take care of itself. This would require global exchange rate adjustments including an increase in the real exchange rate of the renminbi, although economic forces will force this to happen without the need for U.S. political action. In addition, the U.S. corporate tax rate is higher than that of other countries, encouraging overseas investments. Both of the recently announced deficit reduction plans provide blueprints for balancing the budget and lowering corporate tax rates.
     
  2. Technology may become a problem in the future. The United States should work with the European Union, Japan and multinational companies to develop a uniform code of conduct to protect technology and patents when emerging market companies work with multinationals. Government sanctions that would draw the United States into direct conflict with China are inadvisable, and the World Trade Organization (WTO) has limited effectiveness. Thus, multinational corporations should take the lead and refuse to work with foreign entities that demand access to and misuse proprietary technology. They should be fully informed of past unacceptable practices and the policies and behavior they should expect before entering new markets. If companies nevertheless reveal their technology as the price of market access, that is their choice.
     
  3. Policymakers must work with the private sector to identify and reduce barriers to U.S. exports. The expansion of U.S. exports will be in industries such as advanced manufacturing, electronics, aerospace and medical devices. These industries will require new technologies, capital, R&D and skilled labor. There is a strong case for support of technology development through direct funding, improved tax treatment of R&D, increased access to capital and a reduced marginal corporate tax rate. Skill shortages appear to be another important barrier to expansion. Improving the U.S. education and training system in science, math, engineering and technology is a long-term national priority. Furthermore, as recommended by Brookings vice president Darrell West, easing restrictions on H-1B visas to prioritize high-value immigrants with technology expertise is an obvious policy fix with immediate benefits.
     
  4. The policy debate must focus on the right issue, and not be drawn down blind alleys. Indicators that the U.S. economy is falling behind must be evaluated carefully. For example, A 2007 National Academy of Sciences study, Rising Above the Gathering Storm, reviewed a range of such indicators. It noted that China is building 50 chemical plants, whereas the United States is building one; and computer chip fabrication plants are being built in China (and elsewhere in Asia), but not in the United States. However, the lack of U.S. investment in these sectors may not be a reason for concern. It can be difficult to operate either bulk petrochemical or chip fabrication plants profitably over the long run, and they create few jobs.
     
  5. Companies should focus on innovation and cost reduction and avoid dragging policymakers and themselves along time-wasting tangents. Endless discussions took place during the Clinton administration about how Fuji was competing unfairly with Kodak, whereas the real challenge to Kodak was not Fuji but digital technology. Currently, the World Trade Organization is assessing appeals from the European Union (EU) and the United States regarding its decision that the EU unfairly subsidized Airbus to the detriment of Boeing. Whatever the merits of the arguments in the parties’ six years of legal wrangling over this issue, Boeing’s future success may depend more on how well it solves problems with the new 787, now several years behind schedule, and whether it can make its factories leaner and more productive.

Conclusion

Expanding manufactured exports is a key to our nation’s global competitiveness and reduced trade deficits. Recovery in manufacturing will help employment and the revival of local economies. Competition from emerging economies, especially China, means that innovation in products and processes will be essential to maintaining U.S. leadership. While emerging economies are important markets for U.S. manufacturers, these exchanges should not become opportunities to misappropriate U.S. companies’ intellectual property. U.S. policymakers must create a climate that fosters growth in manufacturing while protecting U.S. innovation and technology.

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Image Source: © Brian Snyder / Reuters
      
 
 




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The Comprehensive Patent Reform of 2011: Navigating the Leahy-Smith America Invents Act


Policy Brief #184

The Leahy-Smith America Invents Act (AIA) approved in September 2011 constitutes the most significant overhaul of the American patent system in decades. This policy brief examines some key patent law changes and studies mandated by the legislation, and provides recommendations for companies on successfully navigating the new landscape. [Editor's Note: the legislation was signed into law by President Obama on September 16, 2011.]

Perhaps most notably, the new law will move the United States away from a “first to invent” system and closer to the “first to file” approach used in much of the rest of the world. Other important changes include a new proceeding in the U .S. Patent and Trademark Office (PTO) for third-party challenges to the validity of a recently issued patent, an expanded mechanism for a third party to provide information to the PTO that could be used to narrow or eliminate claims in a pending patent application being prosecuted by a commercial rival, and the introduction of a new, broadly applicable patent infringement defense based on prior commercial use.

RECOMMENDATIONS
  • Under the “first to file” provision of the AIA, companies should be more careful when producing pre-filing disclosures for venues such as conferences and trade shows, with the understanding that under the AIA those disclosures may play a much larger role than in the past with respect to patentability of the associated IP.
     
  • Under the AIA, rights to an invention prior to a filing date will depend more on the history of relevant disclosures and less on nonpublic, internal company documents such as laboratory notebooks. All companies—large and small—should consider how to modify their procedures for protecting, evaluating, and filing patents on their inventions accordingly.
     
  • The AIA provides a grace period during which inventors can disclose their invention without losing the right to patent it, but leaves uncertainty regarding the definition of “disclosure”. Companies should carefully monitor case law and PTO actions that will undoubtedly help clarify this issue in the coming years.
     
  • Companies should reevaluate the extent and manner to which they use provisional patent applications to preserve IP rights.
     
  • In light of the increased number of mechanisms available to challenge the validity of pending and issued patents, companies engaged in patent prosecution should reconsider the tradeoffs of performing their own thorough prior art searches during patent prosecution. By finding and disclosing relevant prior art to the PTO, companies may reduce the likelihood that the disclosed prior art will be used successfully against them in future validity challenges.

 

 

In addition, there are several other aspects of the AIA that do not change patent law, but may have far reaching consequences. For example, an AIA mandated study by the Government Accountability Office promises to furnish vitally important information on the economic impact of patent litigation by non-practicing entities, and will almost certainly influence future patent legislation. Under the AIA, the hurdles small businesses face in protecting their patents internationally will also receive attention through a PTO study.

It will take many years to develop a mature body of case law and legal scholarship on the full impact of the AIA. What is clear today is that it will profoundly impact the ways that patents are filed, prosecuted, and litigated in the coming years. Companies and other entities that retool their patent strategies to address these changes will be in a much stronger position to maximize the value of their intellectual property (IP) portfolios.

First Inventor to File

One of the most significant components of the AIA concerns the move from a first to invent system to a first to file system. Under this provision, which takes effect 18 months after the AIA is enacted into law, an inventor may win the race to create the invention but lose the race to file the corresponding patent application, and thus lose the right to patent the invention.

However, the AIA includes an important exception in the form of a grace period allowing an inventor or others who obtained information from the inventor to make disclosures regarding the invention in advance of filing a patent application, as long as the application is filed within one year after the first disclosure. Some form of grace period has been a feature of the U.S. patent landscape since the 19th century, and allows an inventor time to examine the commercial practicability of the invention, engage in discussions with potential partners and customers and secure the resources necessary to draft a patent application.

The inclusion of both first to file language and a grace period in the new patent law creates what could amount to a hybrid between first to invent and first to file. For example, in the case of two inventors who independently disclose the same invention immediately following its conception, both the pre-AIA “first to invent” law and the post- AIA “first to file” law can favor the earlier discloser, who is by definition the earlier inventor if the disclosure is truly immediate. However, in the absence of disclosure in advance of a patent filing, pre-AIA law favors the earlier inventor, while the AIA “first to file” provision will favor the earlier filer.

As a result, under the AIA inventors and the companies that employ them must think much more carefully about how to manage pre-filing disclosures. Put simply, silence can be costly. To the extent that a company remains quiet about an invention while contemplating whether or not to pursue patent protection, it stands exposed to the possibility of losing the right to do so if a competitor files first. A company wishing to avoid this risk faces the additional challenge that the AIA does not specifically define what constitutes “disclosure” sufficient to preserve patentability. The use of provisional patent applications, which offer advantages including a more formalized way to document the dates and content of disclosures than activities such as presentations at trade shows, should also be reevaluated in light of the AIA.

Some companies may find themselves targeted by competitors’ disclosures engineered specifically to foreclose patent opportunities. To reduce vulnerability to such attacks, companies can engage in preemptive “defensive” disclosures, but must be mindful of the impacts of these disclosures on their own patent filing deadlines.

In addition, employees engaged in intellectual property creation can be made aware that there is an increased need to pursue timely steps to secure patent protection on new inventions. Internal company systems for documenting, reporting, and rewarding innovations can be modified to better match the provisions of the AIA. Companies should also consider the budgetary impact of the AIA in terms of the amount and timing of expenditures.

It is important to recognize that the AIA leaves substantial differences between the patent laws in the United States and those in other countries. For example, unlike in the United States both pre- and post-AIA, in Europe an inventor’s own public disclosures in the year prior to a patent filing can be invalidating prior art. To the extent that for financial or other reasons a company needs to defer filing a U.S. patent application to a future date, in one sense the systems have actually moved farther apart. This is due to what amounts to a newly incentivized option to buy some measure of protection in the U.S. by disclosing in advance of a filing at the cost of losing patentability in Europe. This requires careful consideration of disclosure plans.

Best Mode and Invalidity

The AIA does not alter the requirement that a patent application must “set forth the best mode contemplated by the inventor of carrying out” the invention. However, somewhat paradoxically, for proceedings commenced on or after the date of its enactment, the AIA eliminates the alleged failure to follow this requirement as grounds for asserting invalidity.

This change has the potential to alter a fundamental compact between an inventor and the government that is at the core of the patent system, which grants a patent holder the right to exclude others from practicing an invention in exchange for disclosing the best mode contemplated by the inventor. The AIA eliminates the failure to make this disclosure as grounds for asserting invalidity. Some inventors may view this as creating an incentive to intentionally withhold information on how to best carry out an invention.

Supplemental Examination

The AIA creates a new supplemental examination procedure, effective one year after enactment, allowing a patent owner to request that the PTO perform a supplemental examination to “consider, reconsider, or correct information believed to be relevant” to a patent. Subject to certain exceptions, this process can prevent a patent from being “held unenforceable on the basis of conduct” relating to this information.

The supplemental examination provision is particularly relevant to inequitable conduct allegations that are frequently raised by defendants in patent litigation. Defendants often try to identify information relating to the prosecution of patents that have been asserted against them that, in their view, indicates inequitable conduct rendering the patents unenforceable. Supplemental examination provides a way for a patent owner to preemptively attempt to inoculate a patent against such allegations.

Pre-Issuance Submissions

Beginning one year after the AIA is enacted, third parties will have the option of providing pre-issuance submissions of prior art accompanied by “a concise description of the asserted relevance of each submitted document” to the PTO in connection with a pending application. Such submissions can be used, for example, to attempt to prevent or hinder the issuance of a patent that the submitting party views as detrimental to its interests. However, to the extent that a patent examiner finds the arguments provided through a pre-issuance submission unconvincing, the resulting patent might actually be strengthened, not weakened.

Prior Commercial Use Defense to Infringement

Since 1999, alleged infringers of business method patents have had access to a “prior use” provision that can constitute a defense against infringement, provided certain conditions are met. For patents issued on or after the date of enactment of the AIA, the prior use defense can be applied, subject to certain exceptions, to patent infringement claims covering a much broader range of subject matter “consisting of a process, or consisting of a machine, manufacture, or composition of matter used in a manufacturing or other commercial process.”

Post-Grant Review Proceedings

Post-grant review proceedings are conducted through the PTO in order to reconsider alreadyissued patents, and can lead to the confirmation, cancellation, withdrawal, or modification of patent claims. T he phrase “post-grant review” is sometimes used to broadly refer to multiple types of post-grant proceedings including the ex parte and inter partes reexaminations available under pre- AIA patent law, and sometimes to more narrowly refer to a specific new review option created by the AIA (in fact, in the AIA itself the phrase is used in both the broad and narrow meanings).

Under pre-AIA patent law, a requester wishing to initiate an ex parte or inter partes reexamination provides the PTO with one or more published prior art references and an explanation why those references, in the view of the requester, raise a “substantial new question of patentability.” The PTO can either grant or deny the request; if the request is granted, an ex parte reexamination proceeds without any further input from the requester (unless the requester is the patent owner), while in an inter partes reexamination the requester participates during the reexamination process.

Both types of reexaminations have proven to be highly effective ways for third parties to challenge the validity of issued patent claims, often in tandem with or as a lower cost alternative to challenges adjudicated through the Federal court system and the International Trade Commission. According to data released by the PTO in June 2011, 92% of the requests for ex parte reexamination filed since the proceeding was introduced in the 1980s have been granted, and fewer than one quarter of patents subject to ex parte reexamination have emerged without any claim changes or cancellations. Inter partes reexamination was introduced in 1999; since then 95% of inter partes reexamination requests have been granted, and only 13% of patents subject to inter partes reexamination have survived with all claims confirmed.

The AIA leaves ex parte reexamination in place, but a year after enactment will replace inter partes reexaminations with “inter partes review” proceedings adjudicated by a newly renamed Patent Trial and Appeal Board within the PTO. The pre-AIA threshold to grant an inter partes reexamination of a “substantial new question of patentability” will be replaced with a higher threshold requiring that the PTO find a “reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition.” This higher standard will also be applied to inter partes reexaminations filed during the transition period immediately following enactment of the AIA and preceding the shift to inter partes review. Inter partes review requests must be filed no earlier than nine months (and in some cases longer) after the grant or reissue of the patent being challenged.

Additionally, the AIA creates a new “post-grant review” process through which a petitioner who is not the patent owner can request the cancellation as invalid of one or more claims of a patent granted or reissued within the previous nine months. The PTO can authorize a post-grant review if the information presented by the petitioner, “if not rebutted, would demonstrate that it is more likely than not that at least one of the claims challenged in the petition is unpatentable.” Under the AIA this threshold can be satisfied not only using traditional invalidity arguments based on settled law, but also by a petition that raises “a novel or unsettled legal question that is important to other patents or patent applications.” This language amounts to an invitation to address “novel or unsettled” legal questions through the PTO, raising a number of issues relating to respective roles the courts and the PTO will play in resolving them.

For companies engaged in or threatened with patent litigation or those that simply want to launch a pre-emptive strike at patents held by a competitor, post-grant review introduces a new way to challenge patents. The AIA contains estoppel and other provisions intended to prevent a requester from having two bites at the apple by challenging a claim in both a PTO post-grant (or inter partes) review and a civil action or International Trade Commission proceeding. However, in some circumstances these provisions may turn out to be largely toothless, since patent cases often involve multiple defendants who form joint defense groups and engage in coordinated attacks on patent validity. There is nothing in the AIA preventing one defendant from challenging claim validity through a post-grant or inter partes review and another from simultaneously or later asserting invalidity of the same claims in the federal court system or at the International Trade Commission.

The AIA also expressly provides that, starting one year after enactment, statements by a patent owner filed in a federal court or with the PTO regarding claim scope can be cited to the PTO for consideration in ex parte, inter partes, and post-grant review proceedings to determine claim meaning.

Other Provisions

In addition to codifying many changes to patent law, including those described above, the AIA contains other provisions that will likely have a significant impact on the operation of the PTO and on future patent legislation. Several of these provisions are discussed below.

Fee Diversion

One of the most controversial aspects of the patent reform debate has pertained to the practice of fee diversion, which arises because the PTO takes in an amount in fees that exceeds its appropriation. The Senate version (S. 23) of the AIA passed in March 2011 provided for the creation of a fund that would have allowed the PTO roll over excess funds into future fiscal years. However, in the House version (H.R. 1249) passed in June 2011 that became the template for the final legislation, this provision was removed and replaced with a newly established “Patent and Trademark Fee Reserve Fund” to be held in the treasury and into which excess fees will be deposited. This approach does not cleanly put the fee diversion issue to rest, and the details of how the reserve fund will be managed in future years remain unclear.

Studies Mandated by the AIA

The AIA mandates several studies, including one to be performed by the Government Accountability Office to examine the “consequences of litigation by non-practicing entities, or by patent assertion entities,” to gather data, among other things, on the volume of litigation, the number of cases found to be without merit, the costs to patent holders, licensees, licensors, and inventors, the economic impact of this litigation, and the “benefit to commerce, if any, supplied by non-practicing entities or patent assertion entities that prosecute such litigation.”

“Non-practicing entities” and “patent assertion entities” are terms that are sometimes used to describe companies that have little or no business other than the assertion of patents. Patent litigation involving these entities has grown significantly in recent years, in large part due to the potential for large judgments and settlements. The GAO study provides an opportunity for an unbiased examination of a significant aspect of the litigation environment, and is likely to produce information that will be valuable in drafting future patent legislation.

The AIA also mandates that the PTO perform a study on international patent protections for small businesses. T he financial burden of obtaining international patent protection is particularly heavy for small companies due to the combined costs of performing many different country-specific filings. As a result, many small companies either avoid foreign filings altogether, or perform foreign filings only for a small subset set of countries and only for the patents that they believe to be the most valuable. A goal of the AIA-mandated study is to determine whether to recommend establishing a loan or grant program to help small businesses defray the costs associated with international patent protection.

It is likely the study will conclude that such a program would be beneficial to small businesses, but it is just as likely that implementing it will prove to be extremely difficult in the current budgetary environment. However, the study may influence future patent legislation in the United States and abroad, and may be useful in multilateral discussions regarding international patent protection.

Conclusion

The AIA will reshape how United States patents are obtained, challenged, and valued in acquisition, licensing, and litigation settlement discussions. Companies that overhaul their intellectual property strategies in light of the provisions of the AIA will be in a better position to maximize the value of their patent portfolios and to strengthen their options in patent litigation matters.

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Organizing for Success: A Call to Action for the Kansas City Region

Though possessing much economic strength, the Kansas City region faces stark barriers to its long term competitiveness, including a limited capacity for innovation, unfocused growth, and wide racial disparities. This paper—in conjunction with two companion papers delving into the region's economic assets and its life sciences economy—examines how Kansas City can overcome these challenges.

 

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Facilitating Antibacterial Drug Development


Event Information

May 9, 2012
8:30 AM - 2:30 PM EDT

Saul/Zilkha Rooms
Brookings Institution
1775 Massachusetts Avenue NW
Washington, DC 20036

As the prevalence of drug-resistant bacteria continues to rise, there is a pressing need for new drugs to combat infections by these organisms. However, research and development in this area has slowed, creating a public health concern that we lack the drugs necessary to treat multi-drug resistant infections. Challenges to promoting antibacterial drug development may be scientific, methodological, regulatory, or economic in nature.

On Wednesday, May 9, 2012, the Engelberg Center for Health Care Reform convened an expert workshop, "Facilitating Antibacterial Drug Development,” that explored solutions to methodological and regulatory challenges that could make the development process more efficient. This meeting brought together diverse multi-stakeholder experts—including medical product developers, health care professionals, researchers, patient advocates, representatives of the U.S. Food and Drug Administration, and other groups—to explore the following issues:

  • Existing paradigms for antibacterial drug development;
  • Novel approaches to further antibacterial drug development, including use of pharmacokinetics and pharmacodynamics, Bayesian methods, innovative clinical trial designs, new data sources, alternate clinical endpoints, and new regulatory tools; and
  • Short- and long-term opportunities to advance the antibacterial drug development enterprise through collaboration among stakeholders, improved regulatory science, and other means.

For more information on FDA’s Antibacterial Drug Development Task Force, click here.

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Brookings Council on Antibacterial Drug Development Meeting #1

Event Information

August 30, 2012
9:00 AM - 2:00 PM EDT

Falk Auditorum
The Brookings Institution
1775 Massachusetts Avenue, NW
Washington, DC 20036

As part of ongoing cooperative work with the U.S. Food and Drug Administration, the Engelberg Center for Health Care Reform has formed a council to bring together expert perspectives on the challenges facing antibacterial drug development. Designed to include representatives from academia, patient advocacy groups, industry, providers, and government agencies, the Brookings Council on Antibacterial Drug Development (BCADD), will convene twice a year to discuss pressing issues in the treatment of infectious diseases and potential steps to address them.  

The first BCADD meeting, held on August 30, 2012, brought stakeholders together to discuss the following:

  • Ongoing antibacterial initiatives at FDA and the Clinical Trials Transformation Initiative
  • Statistical and methodological approaches that could be harnessed to improve the efficiency of antibacterial drug development
  • Balancing benefit-risk and uncertainty considerations with public health needs
  • Next steps for council action

For more information on FDA’s Antibacterial Drug Development Task Force, click here.

Event Materials

       




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Incentives for Change: Addressing the Challenges in Antibacterial Drug Development

Event Information

February 27, 2013
9:00 AM - 4:00 PM EST

Falk Auditorium
Brookings Institution
1775 Massachusetts Avenue NW
Washington, DC 20036

As part of an ongoing cooperative agreement with the U.S. Food and Drug Administration (FDA), the Engelberg Center for Health Care Reform at Brookings has formed the Brookings Council on Antibacterial Drug Development (BCADD) to identify steps to address the major technical, regulatory, and financial barriers impeding antibacterial drug development. At the first meeting of the BCADD, stakeholders emphasized the importance of concentrating on discrete policy and program areas to revitalize the antibacterial drug development enterprise.

BCADD convened a diverse group of stakeholders, including FDA officials, industry and biotech representatives, payers, providers, clinicians, and academic researchers Wednesday, February 27, 2013, to discuss two of the economic challenges facing antibacterial drug development:

  • Better understanding the potential role of incentives in drug discovery and development; and
  • Identifying potential reimbursement models that can support both stewardship and expanded investment for antibacterial drug products.
Antibacterial development has moved slower than other therapeutic areas in part due to the challenges of achieving a return on investment under the current reimbursement system. New models are needed to incentivize research and development of antibacterial products and to separate reimbursement from unit sales in order to help preserve the effectiveness of existing and new antibacterial drugs. The workshop’s objectives are to support the development of pragmatic proposals for the larger stakeholder community to consider.

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Modernizing Antibacterial Drug Development and Promoting Stewardship

Event Information

February 7, 2014
9:00 AM - 2:30 PM EST

The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

Antibacterial drug resistance is a global public health threat poised to worsen due to the combination of the inappropriate use of existing drugs and a marked decline in innovative antibacterial drug development. In order to tackle this problem, stakeholders must consider comprehensive strategies that address both drug development and stewardship.

On February 7, the Engelberg Center for Health Care Reform convened an expert workshop, “Modernizing Antibacterial Drug Development and Promoting Stewardship” to explore a two-pronged approach to combating antibacterial drug resistance that includes: 1) the development of pathogen-focused antibacterial drugs that target the most serious public health threats; and 2) stewardship efforts for all antibacterial products in order to preserve their utility. Participating stakeholders included experts from the drug development and health care industries, the clinical community, government, and academia. These stakeholders shared their insights on potential frameworks and evidentiary considerations for pathogen-focused drug development, and efforts underway to promote the appropriate use of commonly used antibacterial drugs in the ambulatory care setting.

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Reinvigorating the Oral Antibacterial Drug Development Pipeline

Event Information

November 20, 2014
9:00 AM - 2:30 PM EST

Saul Room and Zilkha Lounge
The Brookings Institution
1775 Massachusetts Avenue, NW
Washington, DC 20036

Antibacterial drugs are a critical component of the nation’s public health armamentarium, and have saved millions of lives by preventing and treating a range of bacterial infections. However, antibacterial drug development has been hampered by challenges unique to the antibacterial drug market, which have stifled innovation and left patients and providers with fewer options to treat increasingly resistant infections. One consequence of the dwindling antibacterial drug pipeline has been a reduction in effective oral antibacterial drug treatment options, which are particularly important in the ambulatory and transitional care contexts. Recent proposals to re-invigorate the antibacterial pipeline are geared towards serious infections treated in the inpatient setting, which may lead to a greater focus on intravenous therapies. However, addressing both current and future needs in the infectious diseases space will require a balanced mix of both oral and parenteral antibacterial drugs.

In cooperation with the U.S. Food and Drug Administration (FDA), the Engelberg Center for Health Care Reform at Brookings held an expert workshop on November 20, 2014, to identify the most promising strategies to support oral antibacterial drug development. Participating stakeholders included experts from the drug development and health care industries, the clinical community, government, and academia. These stakeholders shared their insights on potential regulatory, scientific, and economic strategies to reinvigorate the oral antibacterial drug pipeline. 

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The future of global manufacturing

Today’s rapidly evolving manufacturing technologies including artificial intelligence, advanced robotics and the "internet of things"—often referred to as “Industry 4.0” technologies—are poised to reshape the global manufacturing landscape, with important consequences for the traditional role of manufacturing in economies’ structural transformation, growth, and job creation. As we explore in our chapter in the just-published book…

       




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Can schools commit malpractice? It depends.

Recently seven students attending public schools in Detroit sued the state of Michigan in a Federal district court. Shortages of materials, not having skilled teachers, and poor conditions of their school buildings had deprived them of access to literacy, which, they argued, is essential in order to enjoy the other rights enumerated in the Constitution. …

       




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Webinar: Public health and COVID-19 in MENA: Impact, response and outlook

The coronavirus pandemic has exacted a devastating human toll on the Middle East and North Africa (MENA) region, with over 300,000 confirmed cases and 11,000 deaths to date. It has also pushed the region’s public healthcare systems to their limits, though countries differ greatly in their capacities to test, trace, quarantine, and treat affected individuals. MENA governments…

       




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Keep independent Israeli action on the table


While Israeli and Palestinian interests are best served by a negotiated two-state state solution, the peace plan that Sam Bahour proposed in his February post disregards Israel's demographic and security concerns and is tantamount to a Palestinian veto on a negotiated solution. His insistence on the right of return for Palestinian refugees and rejection of security limitations on Palestinian sovereignty in effect asks Israel to become a binational state while creating a militarized Palestinian state alongside it. Bahour rejects the notion of unilateral action, but his case only reinforces my belief that Israel may need to act independently to protect its interests.

The logic behind the Clinton parameters and President Obama’s peace plan was that in return for the creation of a Palestinian state, Palestinian refugees would relinquish their claim to Israel; the hope was that this would allow for the "two states for two peoples" to exist side-by-side. Yet Bahour rejects compromise on the refugee issue as the forfeiture of “basic components of statehood and basic principles of Israeli-Palestinian peace that are enshrined in international law.” Any peace agreement that both establishes a Palestinian state and recognizes the rights of millions of Palestinians to enter Israel would hasten the end of Israel's Jewish identity.

Israel's interest in the creation of a Palestinian state is also built upon the assumption that a sound agreement would improve its security rather than threaten it. To this end, Israel has called for a demilitarized Palestinian state, and this has been echoed by the United States, France, the Czech Republic, the European Union, and Australia’s Labor Party. Even Mahmoud Abbas accepted the premise of demilitarization, saying, “We don’t need planes or missiles. All we need is a strong police force.” Nevertheless, Bahour’s piece declares any limitations on the sovereignty of Palestine unacceptable. For Israel, a peace deal that grants one’s adversaries access to more deadly weaponry would be absurd.

Bahour argues that my strategies for reaching a two-state solution are doomed because they do not meet the "mutual interests" of the parties to the conflict, but his plan does not offer incentives for Israel to make peace.

Bahour argues that my strategies for reaching a two-state solution are doomed because they do not meet the "mutual interests" of the parties to the conflict, but his plan does not offer incentives for Israel to make peace. His proposal not only fails to improve Israel's situation in any tangible sense, but further endangers it. Rejectionist Palestinian positions like Bahour's (and Abbas's recent dismissal of Biden's initiative) would veto the two-state solution as a means to move towards a single binational state. That is precisely why Israel may need to act independently to keep a two-state solution viable.

Authors

  • Amos Yadlin
     
 
 




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The situation in Gaza requires immediate action


As the two-year anniversary of the last round of conflict in Gaza approaches, the inhumane conditions to which 1.8 million Palestinians are being subjected threaten to reach boiling point by the summer months, when the lack of access to water and electricity - available for a maximum of eight hours a day - combined with the oppressive heat and the lack of a reconstruction progress, could exacerbate frustrations, culminating in a new cycle of violence.

Despite the relative calm since the August 26, 2014 ceasefire between Israel and Hamas, there have been more than 20 serious incidents that involved incursions, air raids, and missile exchanges with 23 Palestinians killed in the Gaza Strip since December 2015.

As antagonistic verbal exchanges between Hamas and Israel continued over the past few months, scenes of rising violence in the West Bank and Jerusalem - seemingly outside the control of Hamas and the Palestinian Authority (PA) - started to further fuel people's frustration, thus adding to the volatility of the situation.

Reconstruction of Gaza

The Israeli/Palestinian question has become notorious for the international community's inaction.

Nevertheless, the reconstruction of Gaza is one area where action is not only possible but is also badly needed from both strategic and humanitarian perspectives.

The estimates for how much construction has been completed vary depending on the source, and range from about 17 percent (3,000) of the approximately 18,000 homes destroyed or severely damaged in July/August 2014 according to the UN Office for the Coordination of Humanitarian Affairs; to 9 percent by the World Bank, or to "nothing" by the average Gazan.

Regardless of the exact figure, the fact remains that more than 75,000 people remain displaced across Gaza as a direct result of the July/August 2014 war, a problem made worse by insufficient funding.

There are many factors to explain the slow progress. Chief among them is the continued Israeli blockade; the underlying cause of all the wars in Gaza since Israel’s unilateral withdrawal in 2005.

Egypt's refusal to open the Rafah border crossing without the presence of the PA, along with the Palestinians' inability to activate a unity government, makes the situation even worse.

However, one controversial factor that has received little attention is the UN's Gaza Reconstruction Mechanism (GRM).

The GRM is a complicated system of surveillance intended to: "a. Enable the GoP to lead the reconstruction effort; b. Enable the Gazan private sector; c. Assure donors that their investments in construction work in Gaza will be implemented without delay; d. Address Israeli security concerns related to the use of construction and other 'dual use' material" (UN, October 2014).

By attempting to be both the humanitarian and the jailer at the same time, the UN has fast become the recognizable face of the blockade.

Moral legitimacy

Two years into the reconstruction process, it is now clear that the GRM not only poses difficulties for the people of Gaza seeking to rebuild their homes - as it forces them to wait for a long time before they receive any construction materials - but also, more importantly, erodes the moral legitimacy of the role of the United Nations in Gaza.

For more than 70 years, the UN in Gaza has been associated largely with the work of the United Nations Relief and Works Agency for Palestine Refugees in the Near East (UNRWA).

While the Palestinian people have come to accept that the UN cannot resolve their problems, they still expect that it should at least attempt to take an impartial position, and on occasions adhere to its own values by acting as a witness and speaking up against the atrocities that Palestinians face.

With the GRM, the role of the UN changed. The humanitarian imperative that the UN clings to as it delivers aid in the occupied Palestinian territory is no longer neutral.

In fact, in order to facilitate the flow of construction material under the GRM, the UN is increasingly seen as favoring the status quo and siding with the one with power - Israel.

Arguably, among the four main objectives behind the establishment of the GRM, the one related to Israel's security interest seems to take precedence all the time.

Under the current arrangements, a person seeking construction materials must first go to the GRM administrator to be placed on a list. Once their name reaches the top of the list, the Israeli Coordinator of Government Activities in the Territories (COGAT) must approve of the request before the distribution of any materials. The process between COGAT and the GRM can take weeks.

The sight of UN personnel in armored vehicles accompanying sacks of cement (to ensure delivery and use as proposed) incenses the population of Gaza, as they view this practice as the UN placing a higher value on the protection of construction commodities than on human life.

Complex politics of occupation

The inability of the GRM to engage the local population has alleviated tensions over the past two years. During the conception of the GRM, the civil society of Gaza did not participate in the formation of policies governing the distribution of reconstruction materials.

Only the United Nations, the Israeli government, and the PA devised the plan to rebuild Gaza. Due to their pre-determined position to deny Hamas any opportunity of engagement, the process effectively resulted in excluding citizens and civil society organizations, which was a big mistake.

Nickolay Mladenov and other senior UN officials understand well that the GRM has fallen victim to the complex politics of occupation and resistance.

It is being used every day to punish or "incentivize" Hamas and/or to frustrate any possibility of reaching an understanding between Gaza and the West Bank.

It has also provided a fig leaf to the Egyptian President Abdel Fattah el-Sisi which allowed him to close his borders while pursuing a doomed-to-fail securitization agenda in Sinai.

Its lack of effectiveness has also provided many donors with the excuse to not honor their pledges, thus compounding the suffering.

In short, the situation in Gaza requires immediate action. Regardless of whose fault it is that the GRM has not been able to alleviate the suffering of the people of Gaza, it seems appropriate for the United Nations to admit to the failure of the mechanism and even to withdraw its services.

In fact, a walkout by the UN from administering the crossing and use of construction material is not only the right thing to do morally, but might also force constructive action from Israel, EU governments, the Gulf states, and the US as well as Hamas and the PA.

Given the security concerns in Iraq, Syria, Egypt, and elsewhere, the international community would not stand by and allow for a complete meltdown in Gaza.

The alternative is to continue to deny the reality of the mechanism and to watch the grievances of Palestinians in Gaza reaching an unresolvable level that explodes into another violent round of conflict, worse than the last.

This piece was originally published on Al Jazeera English.

Authors

Publication: Al Jazeera English
Image Source: © Mohammed Salem / Reuters
      
 
 




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Health policy 101: How the Trans-Pacific Partnership will impact prescription drugs


For the last several years, the US government has been negotiating a free-trade agreement known as the Trans-Pacific Partnership (TPP) with 11 other countries across the Asia-Pacific and Latin American regions, which could have major impact on the pharmaceutical market.  When finalized it will be the largest free-trade agreement in history, impacting up to one-third of world trade and roughly 40 percent of the global gross domestic product. The deal has attracted a fair share of criticism from a wide range of groups, including concerns over proposed regulations for biologic drugs in participating countries. Specifically, critics are concerned about the length of data exclusivity granted to the companies that hold the patents on these drugs. Below is a primer on biologics and how they are being addressed in the TPP.


What are biologics and biosimilars?

Biologic drugs include any therapy derived from a biological source; a group which includes vaccines, anti-toxins, proteins, and monoclonal antibodies. Because they are typically much larger and more structurally complex than traditional ‘small-molecule’ drugs, they are also more difficult—and much more costly—to develop and manufacture. Biologics are also among the most expensive drugs on the market, costing an average of 22 times more than nonbiologic drugs. Avastin, a cancer drug, can cost more than $50,000 a year, while the rheumatoid arthritis drug Remicade can cost up to $2,500 per injection.

Given these high costs, there is substantial interest in encouraging the development of biosimilars, a term used to describe follow-on versions of an original biologic. Estimates of the potential cost savings vary substantially, but some have predicted that competition from biosimilars could reduce US spending on biologics by $44 to $66 billion over the next ten years.  In the European Union, biosimilars have been on the market since 2006, and a 2013 analysis found that, for the 14 biosimilars on the market, the average price discount was about 25 percent. By 2020, the overall cost savings are projected to total $16-$43 billion.

After the Affordable Care Act (ACA) was passed in 2010, the US Food and Drug Administration (FDA) developed an accelerated approval pathway for biosimilars, modeled after the pathway used for the approval of small-molecule generics. In order to meet the criteria for biosimilarity, the drug must share the same mechanism of action for the approved condition of use, and there must be no clinically significant differences between the two drugs in terms of purity, safety, or potency. FDA recently approved its first biosimilar, Zarxio, which is a copy of the oncology drug Neupogen.

What issues are being raised over data exclusivity in the US?

Under current FDA regulations, biologic drugs are granted 12 years of data exclusivity following approval. During this period of exclusivity, the FDA may not approve a biosimilar application that relies on the data submitted as part of the original biologic application. This form of temporary monopoly is distinct from patent protection, which is granted well before approval and is not related to clinical data.  Data exclusivity does not prevent another company from generating the data independently, but drug companies are unlikely to go to the considerable (and costly) effort of replicating a full course of clinical trials for a drug that is already on the market. (Though biosimilars may need to undergo some additional clinical testing under current FDA regulations, the amount of data required to support approval would certainly be less than what is required for an original biologic approval.)

The 12-year exclusivity period for biologics was established in the ACA following intense debate, and has continued to attract criticism. (By contrast, the period of data exclusivity is just five years for small-molecule drugs.) Supporters argue that given the greater cost and difficulty of bringing a biologic to market a longer period of exclusivity is necessary to incentivize innovation. Others argue that the resulting restrictions on competition keep drug prices unnecessarily high, inevitably putting a strain on the health system and keeping potentially life-saving drugs out of reach for many patients.

How would the TPP affect data exclusivity?

For the 11 countries besides the U.S. that are involved in the TPP, current data exclusivity protections range from zero (Brunei) to eight years (Japan). Under the Obama Administration’s current proposal, participating countries would increase those periods to match the US standard of 12 years. Curiously, this proposal directly contradicts the administration’s ongoing domestic efforts to lower the period of data exclusivity. Since the ACA passed, the Obama administration has repeatedly proposed reducing it to seven, arguing that this would save Medicare $4.4 billion over the next decade. Some have noted that, once the 12-year period is enshrined in the TPP, it will become significantly more difficult to change it through the US legislative process. Furthermore, imposing US standards on the 11 member countries would inevitably restrict competition at the global level, and many patient advocacy and international humanitarian organizations have argued that doing so would undermine the efforts of US global health initiatives like the Vaccine Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which rely on price competition to manage program costs.

It is unclear whether the US will be successful in its efforts. There have been reports that the issue of data exclusivity has become a significant point of contention, and the US delegation may seek to compromise on its demands. It may, for example, negotiate exceptions for the poorer countries involved in the negotiation, as the Washington Post notes. However, the details of the negotiations are largely confidential, which makes it challenging to assess the possibilities, their relative advantages, or how the US Trade Representative (which is leading the US negotiations) is balancing the need to ensure adequate incentives for innovation with the need to control drug costs and facilitate patient access to potentially life-saving therapies.

Editor's note: Elizabeth Richardson, a research associate in the Center for Health Policy, contributed to the research and writing of this post. 

       




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Promoting continuous manufacturing in the pharmaceutical sector


Event Information

October 19, 2015
9:00 AM - 4:00 PM EDT

The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

Over the past decade, drug shortages and product recalls in the U.S. have occurred at unprecedented rates, limiting patient access to critical medicines and undermining health care. A majority of these shortages and recalls have been due to manufacturing quality issues. In response to these problems, and as part of its ongoing efforts to ensure a continuous supply of high-quality pharmaceuticals in the U.S., the U.S. Food and Drug Administration (FDA) is pursuing a range of strategies designed to improve the flexibility, reliability, and quality of pharmaceutical manufacturing. Among these strategies is the promotion of new manufacturing technologies, including continuous manufacturing. Continuous manufacturing offers several important advantages over current approaches to manufacturing and has the potential to significantly mitigate the risks of quality failures. At present, however, these technologies and processes are not widely used by the pharmaceutical industry, and there remain a number of barriers to their broader adoption. In collaboration with a range of stakeholders, FDA is currently exploring ways in which it can help to address these barriers and facilitate the uptake of new manufacturing technologies.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held a workshop on October 19 entitled “Promoting Continuous Manufacturing in the Pharmaceutical Sector.” This workshop provided an opportunity for industry, academia, and government partners to identify the major barriers to the adoption of continuous manufacturing, discuss regulatory policies and strategies that could help to address those barriers, and explore approaches to improving public and private sector alignment and collaboration to promote the adoption of continuous manufacturing.

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How US military services are responding to the coronavirus and the pandemic’s impact on military readiness

On this special edition of the podcast, four U.S. military officers who are participating in the 2019-2020 class of Federal Executive Fellows at Brookings share their expert insights about the effects that the coronavirus pandemic is having on the readiness of their respective services, and how their services are responding to the crisis. http://directory.libsyn.com/episode/index/id/14065544 Brookings…

       




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Africa in the news: COVID-19 impacts African economies and daily lives; clashes in the Sahel

African governments begin borrowing from IMF, World Bank to soften hit from COVID-19 This week, several countries and multilateral organizations announced additional measures to combat the economic fallout from COVID-19 in Africa. Among the actions taken by countries, Uganda’s central bank cut its benchmark interest rate by 1 percentage point to 8 percent and directed…

       




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COVID-19 and debt standstill for Africa: The G-20’s action is an important first step that must be complemented, scaled up, and broadened

African countries, like others around the world, are contending with an unprecedented shock, which merits substantial and unconditional financial assistance in the spirit of Draghi’s “whatever it takes.” The region is already facing an unprecedented synchronized and deep crisis. At all levels—health, economic, social—institutions are already overstretched. Africa was almost at a sudden stop economically…

       




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Mobile Technology’s Impact on Emerging Economies and Global Opportunity


Event Information

December 10, 2014
10:00 AM - 12:00 PM EST

Falk Auditorium
Brookings Institution
1775 Massachusetts Avenue, N.W.
Washington, DC 20036

Register for the Event
Webcast Archive:


Advances in mobile technology have transformed the global marketplace, especially in emerging economies. How has mobile technology changed economic progress in emerging economies? Who has benefited and why? How can emerging economies further take advantage of the mobile revolution to propel growth? Which challenges and decisions do policymakers currently face?

On December 10, the Center for Technology Innovation hosted an event to discuss mobile technology’s role and potential future in developing economies as part of the ongoing Mobile Economy Project event series. A panel of experts discussed what is needed to ensure that emerging mobile economies continue to grow, and how intellectual property, spectrum policy, and public policies contribute to sector development.

Join the conversation on Twitter using #TechCTI

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Transcript

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Unmanned aircraft systems: Key considerations regarding safety, innovation, economic impact, and privacy


Good afternoon Chair Ayotte, Ranking Member Cantwell, and Members of the Subcommittee. Thank you very much for the opportunity to testify today on the important topic of domestic unmanned aircraft systems (UAS).

I am a nonresident senior fellow in Governance Studies and the Center for Technology Innovation at the Brookings Institution. I am also a National Fellow at the Hoover Institution at Stanford, and a professor at UCLA, where I hold appointments in the Electrical Engineering Department and the Department of Public Policy. The views I am expressing here are my own, and do not necessarily represent those of the Brookings Institution, Stanford University or the University of California.

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Authors

Image Source: © Mike Segar / Reuters
     
 
 




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Contemplating COVID-19’s impact on Africa’s economic outlook with Landry Signé and Iginio Gagliardone

       




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Turning back the Poverty Clock: How will COVID-19 impact the world’s poorest people?

The release of the IMF’s World Economic Outlook provides an initial country-by-country assessment of what might happen to the world economy in 2020 and 2021. Using the methods described in the World Poverty Clock, we ask what will happen to the number of poor people in the world—those living in households with less than $1.90…

       




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The Global Compact on Refugees and Opportunities for Syrian refugee self-reliance

       




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Are you happy or sad? How wearing face masks can impact children’s ability to read emotions

While COVID-19 is invisible to the eye, one very visible sign of the epidemic is people wearing face masks in public. After weeks of conflicting government guidelines on wearing masks, the Centers for Disease Control and Prevention (CDC) recommended that people wear nonsurgical cloth face coverings when entering public spaces such as supermarkets and public…

       




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Taxing mobile phone transactions in Africa: Lessons from Kenya

Abstract Taxation on mobile phone-based transactions and on airtime has been introduced in Kenya and is spreading to other African countries. Some countries in sub-Saharan Africa view mobile phones as a booming subsector easy to tax due to the increasing turnover of transactions and the formal nature of such transactions by both formal and informal…

       




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Figure of the week: Taxing mobile transactions in Kenya

This week, the Africa Growth Initiative at Brookings published a new policy brief, “Taxing mobile phone transactions in Africa: Lessons from Kenya.” The brief discusses the limited ability of increased tax rates on mobile money transactions and mobile phone airtime to raise a significant amount of new tax revenue. According to the brief, these taxes…

       




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The troubling impact of America’s opioid epidemic on student learning

Today, the Brown Center on Education Policy is releasing a new report on one of the unexplored effects of the opioid crisis: the link between the opioid epidemic and the educational outcomes of children in hard-hit areas. Written by Rajeev Darolia and John Tyler, the report suggests a need to be aware of the potentially…

       




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Global solutions to global ‘bads’: 2 practical proposals to help developing countries deal with the COVID-19 pandemic

In a piece written for this blog four years ago—after the Ebola outbreaks but mostly focused on rising natural disasters—I argued that to deal with global public “bads” such as climate change, natural disasters, diseases, and financial crises, we needed global financing mechanisms. Today, the world faces not just another global public bad, but one…

       




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Funding the development and manufacturing of COVID-19 vaccines: The need for global collective action

On February 20, the World Bank and the Coalition for Epidemic Preparedness Innovations (CEPI), which funds development of epidemic vaccines, cohosted a global consultation on funding the development and manufacturing of COVID-19 vaccines. We wrote a working paper to guide the consultation, which we coauthored with World Bank and CEPI colleagues. The consultation led to…

       




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Hard times require good economics: The economic impact of COVID-19 in the Western Balkans

Like in other parts of the world, the Western Balkans are suffering a heavy blow as the novel coronavirus spreads. Governments are sending people home, and only a few businesses are allowed to operate. What began as a health shock has required a conscious—and necessary—temporary activity freeze to slow the spread of infection, leading to…

       




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Turning back the Poverty Clock: How will COVID-19 impact the world’s poorest people?

The release of the IMF’s World Economic Outlook provides an initial country-by-country assessment of what might happen to the world economy in 2020 and 2021. Using the methods described in the World Poverty Clock, we ask what will happen to the number of poor people in the world—those living in households with less than $1.90…

       




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How COVID-19 is changing law enforcement practices by police and by criminal groups

The COVID-19 outbreak worldwide is affecting not just crime as I explained last week, but also law enforcement: How are police responding to COVID-19 and its knock-on effects on crime? What effects does the pandemic have on criminal groups and the policing they do? Where have all the coppers gone? Globally, police forces are predominantly…

       




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Around the halls: Brookings experts on the Middle East react to the White House’s peace plan

On January 28 at the White House, President Trump unveiled his plan for Middle East peace alongside Israeli Prime Minister Benjanim Netanyahu. Below, Brookings experts on the peace process and the region more broadly offer their initial takes on the announcement. Natan Sachs (@natansachs), Director of the Center for Middle East Policy: This is a…

       




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Turning back the Poverty Clock: How will COVID-19 impact the world’s poorest people?

The release of the IMF’s World Economic Outlook provides an initial country-by-country assessment of what might happen to the world economy in 2020 and 2021. Using the methods described in the World Poverty Clock, we ask what will happen to the number of poor people in the world—those living in households with less than $1.90…

       




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Congressional oversight of the CARES Act could prove troublesome

On March 27th, President Trump signed the CARES Act providing for more than $2 Trillion in federal spending in response to the COVID-19 crisis. Overseeing the outlay of relief funding from the bill will be no easy task, given its size, complexity and the backdrop of the 2020 election. However, this is not the first…

       




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Scaling Up: A Framework and Lessons for Development Effectiveness from Literature and Practice

Abstract

Scaling up of development interventions is much debated today as a way to improve their impact and effectiveness. Based on a review of scaling up literature and practice, this paper develops a framework for the key dynamics that allow the scaling up process to happen. The authors explore the possible approaches and paths to scaling up, the drivers of expansion and of replication, the space that has to be created for interventions to grow, and the role of evaluation and of careful planning and implementation. They draw a number of lessons for the development analyst and practitioner. More than anything else, scaling up is about political and organizational leadership, about vision, values and mindset, and about incentives and accountability—all oriented to make scaling up a central element of individual, institutional, national and international development efforts. The paper concludes by highlighting some implications for aid and aid donors.

An annotated bibliography of the literature on scaling up and development aid effectiveness was created by Oksana Pidufala to supplement this working paper. Read more »

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Taking Development Activities to Scale in Fragile and Low Capacity Environments


EXECUTIVE SUMMARY

Fragile states present one of the greatest challenges to global development and poverty reduction. Despite much new learning that has emerged from within the development community in recent years, understanding of how to address fragility remains modest. There is growing recognition that donor engagement in fragile states must look beyond the confines of the traditional aid effectiveness agenda if it is to achieve its intended objectives, which include statebuilding, meeting the needs of citizens, and managing risk more effectively. Current approaches are constrained by relying heavily on small-scale interventions, are weakened by poor coordination and volatility, and struggle to promote an appropriate role for the recipient state.

Scaling up (i.e., the expansion, replication, adaption and sustaining of successful policies and programs in space and over time to reach a greater number of people) is highly relevant to fragile settings, both as an objective and as a strategic approach to development. As an objective, it reinforces the logic that the scale of the challenges in fragile states demands interventions that are commensurate in purpose and equal to the task. As a strategy, it encourages donors to identify and leverage successes, and to integrate institutional development more explicitly into projects and programs. In addition, scaling up can assist donors in addressing the priority areas of improved project design and implementation, sustainability and effective risk management.

Successful scaling up in fragile states almost certainly occurs less often than is possible and does not always involve a systematic approach. Donors should therefore look to more systematically pursue scaling up in fragile states and evaluate their performance with specific reference to this objective. This can be done by incorporating relevant elements of a scaling up framework into operational policies, from strategy development through to program design and monitoring.

Contrary to expectations, there are compelling examples of successful scaling up in fragile states. While the conditions prevailing in fragile states create serious obstacles in terms of “drivers” (the forces that push the scaling up process forward) and “spaces” (the opportunities that need to be created, or potential obstacles that need to be removed for interventions to grow), and in terms of the operational modalities of donors, these can be overcome through the careful design and delivery of programs with a clear focus on creating scaling up pathways, and through close partnership and sustained engagement of governments, communities and foreign partners.

Case study evidence suggests that the pathways taken to reach scale in fragile states demand different approaches by donors. Donors need to adopt greater selectivity in determining which areas or sectors for scaling up are justified—a strategy that has also assisted some donors in managing risk. More investment and time are required in upfront analysis and building the evidence for successful scaling up pathways. In some cases, donors require longer time horizons to achieve scale, although demand from government or beneficiaries has sometimes forced donors to move immediately to scale, allowing little or no time for piloting. Regardless of the pace of scaling up, donors that were most successful were engaged early and then remained engaged, often far beyond the replication phase of scaling up, to increase the likelihood of interventions being sustained. Other common characteristics of successful scaling up were simple project design and a focus on the institutional aspects of the scaling up pathway.

Case studies also point to the crucial role of drivers in moving the scaling up process forward in fragile states. Proven ideas and practical models have often been picked up in fragile states, contrary to the expectation that actors may be less responsive to recognizing and acting on the utility of promising results. Leaders undoubtedly have a role to play in supporting scaling up, although there are clear dangers that must be avoided, including avoiding the perception that donors are picking (political) winners by nominating leaders, and tying the survival of projects too closely to the fortunes of a leader’s political career. Incentives were found to be one of the most important drivers in fragile states, and there is a good case to be made for donors introducing new inducements, greater transparency or similar reforms to strengthen the role incentives play. Finally, and in contrast to the standard scaling up framework, community demand was found to be an important driver in many fragile states, both in demanding the expansion of small-scale projects and by facilitating the community’s own resources to support the scaling up process.

The greatest challenge to scaling up in fragile states is the limited spaces these environments provide. This is especially the case in respect to those spaces which concern aspects of governance: political, institutional and policy spaces. When working in fragile states, donors must recognize that spaces for scaling up are almost always more constrained, but look for ways to expand upon them. Some of the most successful examples of scaling up used creative approaches to build space quickly or used existing capacity to the fullest possible extent. Also relevant are the lessons of robust analysis, greater realism and cost control. The case studies confirm the importance of two additional spaces in fragile states. For example, security space often imposed horizontal obstacles to scaling up which could not realistically be overcome while ownership space served as a good indication of the perceived legitimacy of the scaling up process and the likelihood that interventions would be sustained longer term.

Case studies also affirm the importance of emphasizing robust project design and implementation, and the close linkages between the scaling up agenda and the role of risk management and sustainability in fragile states. While sustainability presented a significant problem for many of the projects and programs reviewed, a more focused approach around scaling up may assist donors in addressing sustainability concerns. This would entail adopting a longer-term perspective beyond the immediate confines of any individual project, looking for available drivers and supportive spaces, and focusing on effective implementation and consistent monitoring and evaluation (M&E). Any intervention introduced on a small scale that scores well in sustainability serves as a possible candidate for scaling up.

Similarly, many of the methods used by donors for managing risk—an emphasis on analysis, scenario planning, realism and making use of specialized aid instruments—are equally relevant for supporting scaling up in fragile countries. A persuasive argument can be made that the adoption of a more explicit scaling up approach by donors can form part of a risk management strategy in fragile states. Scaling up can enable donors to more ambitiously tackle development risks without allowing institutional and project risks to grow unchecked. Ultimately, a donor approach that combines good risk management and scaling up requires strong leadership and well-aligned incentives.

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Image Source: © Beawiharta Beawiharta / Reuters
      
 
 




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The SECURE Act: a good start but far more is needed

In December, while public attention focused on impeachment, the most extensive retirement legislation in more than a decade was passed and signed into law. Spearheaded by House Ways and Means Chairman Richard Neal (D-MA), the SECURE Act of 2019 was three years in the making and designed to raise the level and security of retirement…

       




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Tackling the Mortgage Crisis: 10 Action Steps for State Government

Introduction

During 2006, the United States saw a considerable upswing in the number of new mortgage defaults and foreclosure filings. By 2007, that upswing had become a tidal wave. Today, national homeownership rates are falling, while more than a million American families have already lost their homes to foreclosure. Across the country, boarded houses are appearing on once stable blocks. Some of the hardest hit communities are in older industrial cities, particularly Midwestern cities such as Cleveland, Detroit, and Indianapolis.

Although most media attention has focused on the role of the federal government in stemming this crisis, states have the legal powers, financial resources, and political will to mitigate its impact. Some state governments have taken action, negotiating compacts with mortgage lenders, enacting state laws regulating mortgage lending, and creating so-called “rescue funds.” Governors such as Schwarzenegger in California, Strickland in Ohio, and Patrick in Massachusetts have taken the lead on this issue. State action so far, however, has just begun to address a still unfolding, multidimensional crisis. If the issue is to be addressed successfully and at least some of its damage mitigated, better designed, comprehensive strategies are needed.

This paper describes how state government can tackle both the immediate problems caused by the wave of mortgage foreclosures and prevent the same thing from happening again. After a short overview of the crisis and its effect on America’s towns and cities, the paper outlines options available to state government, and offers ten specific action steps, representing the most appropriate and potentially effective strategies available for coping with the varying dimensions of the problem.

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  • Alan Mallach
      
 
 




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The unemployment impacts of COVID-19: lessons from the Great Recession

Efforts to stop the spread of the novel coronavirus—particularly the closure of nonessential businesses—are having an unprecedented impact on the U.S. economy. Nearly 17 million people filed initial claims for unemployment insurance over the past three weeks, suggesting that the unemployment rate is already above 15 percent[1] —well above the rate at the height of…

       




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Life after coronavirus: Strengthening labor markets through active policy

Prior to the COVID-19 crisis, the growing consensus was that the central challenge to achieving inclusive economic prosperity was the creation of good jobs that bring more workers closer to a true “middle-class” lifestyle (Rodrik, 2019). This simple goal will be hard to meet. The lingering effects of the coronavirus crisis will add to the…

       




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Action implications of focusing now on implementation of the post-2015 agenda


The consequences of the global financial crisis still ripple through the international system after the initial surge in global economic cooperation and governance immediately following the crisis. The ultimate effects have been that, while some elements of the international system of institutions have gotten stronger, the system as a whole is now seen as weaker, fractured, and driven more by geopolitical conflict than by institutional norms and frameworks.

The issue is how to move the global policy agenda forward in such a way that substantive progress induces institutional strengthening. The next two years offer new opportunities for creating a positive symbiosis between policy advance and systemic improvements.

I. The U.N. global agenda

The United Nations global agenda has three tracks that relate to each other and provide opportunities to pull the world together around an integrated, comprehensive strategic vision for the world’s people and strengthen the international system in the process.

The first track is the elaboration of a sustainable development agenda for each and all countries, not just developing countries, but advanced industrial economies and emerging market countries too. This effort is already well underway and will result in a summit of global leaders in September 2015 at the U.N. General Assembly (UNGA) in New York. This process entails a set of Sustainable Development Goals (SDGs) for 2030 to be developed and affirmed by and for all countries, and which succeed the Millennium Development Goals (MDGs) that culminate in 2015 and applied only to developing countries. This post-2015 goal-setting process will provide the substantive, cross-cutting, multidimensional agenda for the next 15 years. It is simultaneously a social, economic, and environmental agenda that relates goals to each other in functional terms requiring coordination among public and private sectors, ministries, civil society groups, and international institutions.

The second track is the financing for development (FFD) track, which goes well beyond reliance conceptually and practically on foreign aid or official development assistance as in the past. FFD for the SDGs includes a focus, first and foremost, on domestic sources of finance beyond government revenues. FFD is engaged in searches for innovative sources of finance, private sector mobilization of resources, creative market incentives and mechanisms, initiatives by civil society organizations, and development of entrepreneurial and small- and medium-size business opportunities that address global issues. This effort resulted in a global leaders meeting in Addis Ababa, Ethiopia in July of 2015 that reached agreement on the major thrusts for mobilizing resources for the post-2015 agenda (Kharas and MacArthur (2014)).

The third track is the global climate change negotiations currently under way to achieve a global agreement on the United Nations Framework Climate Change Convention (UNFCCC), which will result in a global summit in Paris in December of 2015. While these detailed negotiations on climate are a separate track, it is clear that the sustainable human development trajectories being put forward in the post-2015 agenda impact and are crucially affected by the efficacy of the climate change arrangements worked out in the UNFCCC agreements in 2015.

Whereas these three tracks operationally are going forward separately, the substantive aspects of each track affect and are affected by the content of the other two. The ultimate convergence of these three streams of activities and actions will have to occur in the beginning of 2016 at the global, regional, and national levels if the implementation phase is to be successful. A business-as-usual approach will not be satisfactory if at the global level, for example, the international institutions are unable to coordinate their work, or if at the national level ministries remain within their “silos” of sectoral expertise and responsibility.

Synergies exist between goal areas that cannot be realized without coordination across sectors and institutions, impacting goal achievement (see OECD 2014 PCD). A systemic approach is necessary at all levels to address the global challenges identified in the post-2015 agenda.

II. The G-20 summits for 2015 and 2016

A major opportunity presents itself in terms of providing impetus, momentum, and leadership for these large work streams and their convergence by linking the G-20 presidency of Turkey for 2015 with the G-20 leadership of China in 2016. Turkey and China working together in tandem within the G-20 Troika over the next two years to explain, support, and sustain the mobilization effort toward the post-2015 agenda could be a major contribution to it but also strengthen the global system of international institutions in the process. For the Turkish G-20 summit, scheduled to take place in November 2015 in Antalya, between UNGA in New York in September and the UNFCCC in Paris in December, Turkey could use part of its G-20 summit to have the leaders of the world’s largest advanced and emerging market economies explain to the world the nature, importance, and relevance of the SDGs to domestic concerns and priorities of ordinary people.

A weakness of G-20 summits thus far has been that G-20 leaders have become trapped by finance ministers’ issues and discourse and have failed to connect with their publics on larger issues of direct concern to people everywhere. The post-2015 agenda provides an opportunity for G-20 leaders to lead their people in understanding how global efforts relate to domestic conditions and why dealing only domestically with issues will not suffice to advance the human agenda where the global interface is extremely palpable. G-20 leaders, under Turkey’s leadership, could step out beyond the technical jargon of finance ministries and central banks, as important as those issues continue to be, and directly address the longer-term, fundamental conditions that affect the lives and livelihoods of all people. They would thereby strengthen their own leadership profile internally by explaining the global dimensions of domestic issues as means of creating public support for the sustainability issues in the post-2015 agenda.

Past experience with the International Development Goals (IDGs) of the 1990s and the Millennium Development Goals since the early 2000s  demonstrates that linking the goal-setting effort to the implementation phase yields powerful results by capturing the political momentum of the goal setting phase and carrying that energy forward directly into implementation efforts. If Turkey and China were to work together in 2015 and 2016, thereby bridging the goal-setting year in 2015 to the beginning of the implementation phase in 2016, they could provide the catalytic leadership and continuity that would maximize the staying power of the momentum from one phase to the next.

China, for its G-20 summit preparations in 2016, could focus on developing a road map, in concert with the other countries and international organizations and especially with the United Nations, that would explicitly keep alive the activities, groups, and initiatives manifested in the goal-setting phase into the next phase of implementation beginning in 2016. These combined efforts by Turkey and China could jump-start societies focusing on accelerating efforts to transform their societies by mobilizing policies and resources for highly related goal areas of direct benefit to their people.

The immediate effects of coordinated sequential efforts by Turkey and China in their respective G-20 years to advance the post-2015 agenda would be to strengthen the relationship between the G-20 and the United Nations on the agenda itself and to strengthen the G-20 summits by having leaders lead on issues of central concern to their people, strengthening the G-20 as a leadership forum in the process. For these results to occur, Turkey and China would need to begin to work together now to develop concordance in their individual efforts and initiate activities that would benefit greatly by beginning now and running through 2016 and beyond.

Accelerating implementation: Several initiatives could be undertaken now that would set up the dynamics for accelerated implementation in 2016 and beyond.

  • National strategies for achieving the SDGs: Encourage countries to adapt and adopt the SDGs to their respective priorities and social, political, and cultural contexts through deliberate decision processes and wide societal engagement.
  • The role of parliaments: Bring parliamentarians and parliaments into the goal-setting process so that they are aware of the legislative, regulatory, and budgetary implications of the post-2015 agenda.
  • The role of domestic ministries: Bring finance ministers and other domestic ministries and agencies together with foreign ministers in the goal-setting year to set in motion mutually involved functional relationships and operational guidelines to enhance implementation across sectors.
  • The G-20 as broker and mobilizer: The G-20 could act as a broker between the International Monetary Fund (IMF), World Bank, World Trade Organization (WTO), Organization for Economic Cooperation and Development (OECD), and regional development banks and the U.N. and its agencies to assure not just coordination but more intensive interactions that would be designed to accelerate the mobilization of resources and as well as policies and private sector activities that would enhance implementation.
  • The policy role of the OECD: The strong, substantive role of the OECD in G-20 summits on issues high on the G-20 agenda—such as structural reform, tax base erosion, development, environment, energy, employment, and social issues—position the OECD to continue to provide important substantive inputs to the G-20 in 2015 and 2016. The OECD would enhance the relationship of its 34 members with G-20 emerging market economies by OECD involvement in both the G-20 and the U.N. post-2015 agenda.
  • Financial stability and the SDGs: Encouraged by the G-20 summits, the IMF, the Financial Stability Board, and the OECD could work together to integrate the financial regulatory reform agenda into the post-2015 U.N. process by clarifying the linkages between financial stability, regulatory reform, and incentives for long-term private investment in infrastructure (crucial to all the SDGs) and in productive activities which generate greater employment and growth.
  • Multi-stakeholder participation in implementation: G-20 summits can facilitate multi-stakeholder processes for engaging civil society, labor, private sector, religious, academic, and expert communities not only in the G-20 summits, as is the current practice, but also in the post-2015 agenda and its implementation, connecting societal leaders with the SDG agenda.

III. The overarching importance of a single global agenda

If these efforts to bring together a wide cross-section of domestic and international agencies, public and private sector leaders, stakeholders, and civil society actors are to translate into actions that are meaningful to the lives and livelihoods of people, a single set of goals is essential. The lesson learned from the IDG-MDG experience was that the tendency to differentiate roles by identifying different institutions with different sets of goals was real. The United Nations had inadvertently put forward the Millennium Declaration at the September 2000 U.N. General Assembly that had “millennium targets” which were similar but not identical to the International Development Goals (IDGs). The IDGs had been developed in the mid-1990s by OECD development ministers and subsequently were endorsed by the World Bank, the IMF, the U.N. and the OECD. In fact, in 2000, for the first time ever, the heads of those four institutions signed, and the institutions themselves published, a joint report, A Better World For All: Progress towards the International Development Goals.

Despite the appearance of unity and in part because there was a lack of concordance between the Millennium Declaration Targets (MDTs) and the IDGs, there was a moment in March 2001 when it looked like there might be a decisive divergence between the U.N. and the Bretton Woods institutions, with the U.N. taking the lead on the MDTs and the World Bank and IMF taking the lead on the Poverty Reduction Strategy Process (PRSPs), leaving the IDGs marginalized altogether. This potential division of labor was thwarted by a decision to reconcile the differences between the MDTs and the IDGs by forging the Millennium Development Goals (MDGs), which embodied the principal elements of both. The MDGs surfaced and were endorsed by the Monterrey Summit on Financing for Development in March of 2002, keeping the major global institutions on the same page with bilateral donors and the same path moving toward achieving the MDGs in 2015.

Most people who know about the MDGs think their origins began at the U.N. in the year 2000. It is an often overlooked fact that the MDGs only came forward in 2002 to bridge the potential divide between the Bretton Woods institutions and the United Nations. If that divide had occurred, it would have been disastrous from a goal setting-goal implementation point-of-view. This history is quite important to bring forward into public light now because it illustrates divisive dangers that currently lurk under the surface threatening unity if not squarely addressed.

From the perspective of prioritizing implementation, the truth is that multiple sets of goals blur the strategic vision, fail to communicate direction, weaken effective leadership, and encourage special pleading for differentiated interests instead focusing on the common, public interest. The U.N. has the lead role in global goal setting and has strengthened its own role in the global system in recent years. However, looking forward now to the SDG implementation phase, a danger might be that the Post-2015 agenda could be seen as the creature and captive of the United Nations, whereas it must be fully endorsed and internalized within the global system of international institutions as a whole. For that to happen, it would be necessary to move now, during the goal-setting year, to include all the relevant international and domestic actors that are crucial to the implementation phase of the post-2015 agenda.

The implications of including the post-2015 agenda in the G-20 summits in 2015 and 2016:

  • It would make clear to relevant publics and actors that this set of global goals is universal, applicable to advanced countries, emerging market economies, and developing countries; it is not a “development agenda” but a “sustainability agenda,” which is broader, more strategic, and higher on the policy agenda of most countries.
  • It would make clear the inextricable dynamics between domestic priorities and global goals; the SDGs are not foreign policy objectives or aid targets for development; they are domestic priorities affected by global impacts and generating global spillovers that need to be managed, not neglected.
  • It would make the incorporation of finance ministers and domestic ministers with foreign ministers, along with international institutions, an imperative, rather than a utopian, ideal.
  • It would make obvious the need to have a wide range of international institutions dealing with health, labor, education, women, climate, and the environment on the same page with the United Nations and the Bretton Woods institutions working together toward the SDGs.
  • It would link the need for multi-stakeholder participation in goal setting to the goal implementation phase to mobilize support, policies, and resources but also to reveal and work on the interconnectedness of the goals themselves taken as a whole. 

Hence, the critical imperative is that there be a single narrative, a single set of goals, for all the domestic and global players to relate to, affirm, and implement. Otherwise, a fractured global order will produce lower-yield outcomes, and competition among priorities, sectors, and actors will result in poorer goal performance than would be possible with an integrated, concerted approach where all actors are working toward the same ends.

IV. Possible G-20 Actions by Turkey and China

Turkey has developed a process for the G-20 summit scheduled for November 14-15, 2015 in Antalya. Implementation, inclusion, and investment—the three “I’s”—are the overarching themes already established. The three “I’s” ties are tightly tied to the Australian G-20 outcomes—implementing action plans to achieve the incremental growth target of an additional 2 percentage points of GDP by 2018; including lower-income people in growth and lower-income countries in the global economy; and investing in infrastructure.

Each of these priorities is supportive of and compatible with the post-2015 agenda, even though they are not yet directly addressed to it. A decision by Turkey to include the post-2015 agenda in the 2015 G-20 would be easily achieved by cross-walking the SDGs over to and into the three “I’s” and vice versa. The central priority of the post-2015 agenda is, after all, “implementation.” The overarching meaning of the six elements of the post-2015 agenda (dignity, prosperity, justice, partnership, planet, and people (U.N. SG Synthesis Report December 2014)) is their impact on “inclusion.” And “investment” in infrastructure is crucial to all of the 17 SDGs.

The three pillars for Turkey’s 2015 agenda are: (i) strengthening the global recovery and lifting potential growth (the 2 percent target); (ii) enhancing resilience (financial regulatory reform]; and (iii) buttressing sustainability. Clearly, the third pillar on sustainability opens the door for the incorporation of the post-2015 agenda into the Turkey G-20, if Turkey wishes to do so. And the other two pillars fully support the sustainability agenda and are linked to it, or need to be.

For China, the post-2015 agenda presents a unique opportunity for the Chinese government to seize on a global agenda that has specific, strong, and visible links to the domestic concerns of the Chinese people. China could use the 2016 G-20 summit both to provide international leadership for global cooperation and to demonstrate the connection of global issues to domestic conditions through their impact and spillover effects. Because the post-2015 agenda is a universal agenda, by prioritizing it in its G-20 summit, China would be embracing the multiplicity of its own identity as a developing country but also as a dynamic emerging market economy that is destined to eventually play a global leadership role equivalent to advanced countries.

Furthermore, China seems intent on being a competitive nation in various spheres while at the same time being cooperative in others. The G-20 summit presidency for China in 2016 provides China with an opportunity to strengthen its role in international cooperation by being ambitious in the reach of its agenda for the G-20 in 2016, by its conduct as a member of the G-20 Troika for the next three years, and as the host government for the G-20 in 2016. By choosing to support Turkey in its consideration of incorporating the post-2015 agenda in the G-20 summit in 2015 and by China itself addressing the implementation issues in 2016, China would be reaping the demonstrably higher-yield gains generated by linking the SDG goal-setting phase in 2015 to the implementation phase in 2016.

Integrating the three tracks of SDG goal setting, financing for development, and progress on climate change actions is complementary but complex. While challenging, China has sufficiently high stakes in the outcomes of all three of these tracks to have a national interest in leading a global effort over the next three years to energize the convergence of agendas and institutional mandates necessary to generate bigger outcomes for people everywhere, including in China.

V. Results: Strengthening global governance and leadership

What follows from the analysis here is that the decision to include the post-2015 agenda in the Turkey and China G-20 summits would be a choice about the substance but also about the process of global economic governance, in which the G-20 has a leadership role. To do so in the way outlined here, would:

  • Strengthen the global system of international institutions by bringing them together around a single comprehensive, integrated sustainability agenda;
  • Create synergies between the United Nations and the other international institutions rather than identifying the post-2015 agenda with the U.N. alone and relying unnecessarily on the U.N. for its implementation;
  • Connect G-20 leaders with a broader human and planetary agenda beyond economics and finance, which in turn would connect G-20 leaders with their publics as they visibly address the domestic concerns of their people in their global context; and
  • Strengthen the role of the G-20 in global economic governance by putting the G-20 out in front as a broker among stakeholders, a catalytic coordinator of relevant domestic and international actors, and a leader on behalf of the concerns, lives, and livelihoods of people.

Selected References

Colin I. Bradford (2002), “Toward 2015: From Consensus Formation to Implementation of the Millennium Development Goals. Issues for the Future: The Implementation Phase”, Development Economics Department (DEC), The World Bank, December 2002.

Colin I. Bradford (2014), “The Changing World Economy and Global Economic Governance”, power point presentation at the Korean Delegation seminar “The OECD and Global Governance”, OECD, Paris, December 11, 2014.

Colin I. Bradford (2014), “Global Economic Governance and the Role of International Institutions”, Second High-level Policy Forum on Global Governance:  Scoping Papers, UNDP Beijing China, 22 October 2014.

Colin I. Bradford (2015), “Governance Innovations for Implementing the Post-2015 Sustainable Development Agenda: Conference Report”,  Brookings Institution, Washington, D.C., March 30, 2015.  http://www.brookings.edu/~/media/Events/2015/03/30-post-2015-sustainable-development-agenda/330-PostReportFinal.pdf?la=en   

Ye Yu, Xue Lei and Zha Xiaogang (2014), “The Role of Developing Countries in Global Economic Governance---with a Special Analysis on China’s Role”, Second High-level Policy Forum on Global Governance:  Scoping Papers, UNDP Beijing China, 22 October 2014. Authors are from the Shanghai Institutes of International Studies.

Homi Kharas and John McArthur (2014), “Nine Priority Commitments to be Made at the UN’s July 2015 Financing for Development Conference in Addis Ababa, Ethiopia,” October 2014. http://www.brookings.edu/research/papers/2015/02/united-nations-financing-for-development-kharas-mcarthur

OECD (2014), “Policy Coherence for Development and the Sustainable Development Goals”, Paris: OECD, 10 December 2014, prepared for the 8th Meeting of the National Focal Points for Policy Coherence for Development (PCD) held at the OECD on 17-18 December 2014. 


 

      
 
 




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All Medicaid expansions are not created equal: The geography and targeting of the Affordable Care Act

Summary Craig Garthwaite, John Graves, Tal Gross, Zeynal Karaca, Victoria Marone, and Matthew J. Notowidigdo study the effect of the Affordable Care Act Medicaid expansion on hospital services, with a focus on the geographic variations of its impact, finding that it increased Medicaid visits, decreased uninsured visits, and lead the uninsured to consume more hospital…

       




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Transparent Governance in Latin America’s Extractive Industries


Event Information

November 4, 2014
2:00 PM - 3:45 PM EST

Falk Auditorium
Brookings Institution
1775 Massachusetts Avenue, N.W.
Washington, DC 20036

Register for the Event

During the past decade, an abundance of wealth in minerals and hydrocarbons in Latin America and the Caribbean has translated into substantial revenues and macroeconomic growth. However, operations in the extractive sector have also led to significant challenges, such as corruption, negative social outcomes and environmental impacts.

On November 4, the Latin America Initiative and Energy Security Initiative at Brookings, with the Inter-American Development Bank (IDB), hosted a discussion on governance and institutional capacity in the extractive sector in Latin America and the Caribbean, drawing on findings from the publication Transparent Governance in an Age of Abundance: Experiences from the Extractive Industries in Latin America and the Caribbean, published by the IDB. Edited by Malaika Masson and Juan Cruz Vieyra, the book presents transparency as a central element to bolster governance quality and state legitimacy in the context of an increasingly demanding citizenry.

 Join the conversation on Twitter using #LatAmResources

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Why IT companies lead on proactive climate action


In the months leading up to the 2015 United Nations climate change conference in Paris starting November 30, global businesses have pledged to do their part for proactive climate action. To "capture and catalyze" these commitments, the UN Framework Convention on Climate Change, in conjunction with the government of Peru, launched the Non-State Actor Zone for Climate Change (NAZCA). NAZCA is an online portal that showcases commitment to action by companies, investors, cities and subnational regions to address climate change. To date, more than 2,000 companies—from Baosteel Group Corporation to Exxon Mobil Corporation to Taiwan Semiconductor Manufacturing to Wal-Mart Stores, Inc.—have made voluntary commitments to reduce emissions, increase energy use efficiencies and invest in renewable energy sources.

IT sector stands out 

Proactive action by businesses to combat global climate change is not new. Over the past decade, businesses have increasingly engaged in voluntary climate action to share best practices, network, promote market mechanisms, and set greenhouse gas emission reduction targets. Despite this, not all businesses are eager participants. My recent paper on the role of the Global 500 companies in transnational climate governance shows that, after controlling for political economic and institutional factors at the country level, global businesses operating in the information technology (IT) sector are twice as likely as other firms to engage in proactive climate action. Next to the consumer staples sector, the IT sector has the highest share of global companies engaging in proactive climate action compared to the energy, health care, industrials, materials and utilities sectors.

Among the notable IT companies worldwide that have taken proactive climate action, including public disclosures of their carbon emissions, are Apple Inc., Google Inc., Hitachi, Ltd., LG Innotek, Microsoft Corp., Ericsson and Telefonica.

There are several reasons why IT companies are in a better position than other corporations to play a proactive role in climate change mitigation. First, IT companies, as a sector, tend to be wealthier, not only in terms of asset holdings but also profitability. They also employ a larger number of workers than other companies. Large and well-endowed corporations are better able to afford the costly investments necessary for deploying renewable energy and for undertaking carbon emissions management. According to my findings, wealthy corporations that employ a large number of workers have two to four time higher odds of proactive climate action than companies with smaller asset holdings and employee base.

Complementary capabilities

Second, my research also shows that, more often than not, when a company demonstrates a commitment to sustainability through complementary capabilities and competencies, namely investments in environmental R&D and/or certification with the ISO 14001 environmental management standard, the odds are higher that the company also engages in voluntary climate action and carbon disclosure. For example, a larger share of companies in the IT sector (75 percent) are certified with the ISO 14001 environmental management standard than Global 500 companies excluding IT (54 percent). A similar pattern, albeit less pronounced, is also true of investments in environmental R&D by IT companies compared to other global companies (56 percent versus 48 percent).

Wealth endowment and complementary capabilities aside, IT companies are more likely than other Global 500 companies to have an in-house managerial- or executive-level sustainability officer. Close to half of all IT companies have formally created a position of a vice president of sustainability or a chief sustainability officer compared to about 40 percent of other global businesses. These in-house champions of sustainability policies and initiatives play a critical role in helping to align corporate vision and allocate the necessary resources toward sustainability efforts.

Among the world’s largest companies by revenue, Apple Inc. (rank 15th) is a leader in proactive climate action: Apple has pledged to "maintain 100% renewable energy in datacenters… [and] maintain carbon neutrality of purchased electricity for U.S. corporate facilities achieved in 2014 through renewable energy purchases and onsite generation and procurement." In 2014, Apple hired Lisa Jackson, a former administrator of the U.S. Environmental Protection Agency as its vice president of environmental, policy, and social initiatives, reporting directly to CEO Tim Cook. Along with Jacky Haynes, Apple’s senior director of social and environmental responsibility who specializes in supplier responsibility, Jackson has brokered a relationship with the Beijing-based Institute of Public & Environmental Affairs to train Apple facilities workers as part of Apple’s new Environmental, Health, and Safety Academy and to proactively publish emissions data of Apple’s supplier facilities in China. By committing to voluntary climate action, Apple and other corporations signal to consumers that they are socially responsible companies, not only to preempt public scrutiny but to gain an advantage in the "market for virtues."

Apple and Microsoft Corp. are the only two private sector entities that earned the U.S. Environmental Protection Agency (EPA)’s Green Power Partner of the Year award in 2015, which recognizes leadership in green power use and overall strategy and impact on the green power market.

Other IT companies, such as Autodesk, BT, Infosys, Salesforce and SAP have recently joined forces with Aviva, IKEA, Starbucks, Walmart, Marks and Spencer, Johnson & Johnson, among others, as part of RE100, a collaborative initiative of businesses, to set long-term target on powering their operations entirely with renewable energy.

Living up to promises

The fact that so many companies are recognizing the dangers of climate change and setting ambitious climate action goals is laudable. The biggest challenge will be seeing that they live up to their promises, especially given the voluntary nature of initiatives such as NAZCA. To thwart greenwashing, national governments and global governance organizations have an important role to play to keep the IT sector and other businesses accountable. The first step that NAZCA has taken is to invite "partnerships with others who would…make assessments of this type." A significant next step would be to publish guidelines and best practices for third-party monitoring and verification in order to strengthen the link between pledges for proactive action and ultimate follow-through by corporations. IT companies, as leaders in proactive climate action, should be at the forefront of working to establish best practices for adherence to voluntary commitments for mitigating global climate change.

Image Source: © Steve Marcus / Reuters