As artificial intelligence continues to reshape industries and transform the global economy, trade policy must evolve to keep pace and ensure equitable growth for all nations.” This is how Chat GPT, the viral artificial intelligence (AI) chatbot sensation that has dominated the media since late 2022, suggests starting an article about AI and trade.

Already back in 2018, McKinsey predicted AI would contribute USD 13 trillion to the global economy by 2030. Today, with news outlets increasingly reporting on AI and major tech giants such as Google, Microsoft, and Baidu all rushing to release their own chatbots, the policy relevance of AI for international trade is a contemporary reality.

At the intersection of trade policy and AI, the traditional view is that policy must get out of technology’s way. AI in this conception brings unbridled productivity if only trade barriers can be stemmed as the technology spreads from developed economies to the Global South. Under this view, also shared by the Organisation for Economic Co-operation and Development, policy recommendations include further liberalization of information and communication technology goods trade; lowering barriers to digital services trade; facilitating mode 4 delivery of services (presence of natural persons); and harmonizing data flow regulation. These policy recommendations would doubtlessly help the proliferation of AI technology in international trade, but they do not tell the whole story.

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Beyond merely providing an additional impetus to liberalize international trade, AI presents several policy gaps that current rules cannot address.

The rise of AI brings a familiar problem in the form of the goods–services distinction, which has proven difficult in the case of digital goods, for example. Although World Trade Organization (WTO) case law has shed some light on how to determine if a product is a good or a service, the WTO’s work program on electronic commerce—which was meant to settle the question more conclusively—is still being negotiated after 25 years. As AI is incorporated into more goods (think self-driving cars and AI robotics), it will become increasingly important to establish universal rules to determine whether General Agreement on Tariffs and Trade or General Agreement on Trade in Services (GATS) commitments dictate. The current patchwork that has emerged in the form of free trade agreements creates a fragmented landscape that is likely to boost the cost of trade.

Where AI can clearly be considered a service, other issues emerge. GATS market access commitments for certain professions including accounting, legal services, or medical services are often tied to certification requirements or legal personhood. This poses problems for AI systems such as legal tool Harvey or even Chat GPT (which recently passed the bar exam). Can such systems be said to have received education and training such that they are covered by GATS commitments? Similarly, where GATS commitments are based on legal personhood, does this exclude AI systems? Would this also be the case in a situation where a form of electronic or digital personhood is adopted for AI systems, as has been suggested in the European context?

Another GATS-related problem concerns the four modes of delivery: cross border, consumption abroad, commercial presence, and the presence of natural persons. These modes are ill-adapted to products that have AI embedded in them, like self-driving cars, smartphones, or medical devices. Such products create a market access issue for services trade, which, according to the GATS, is not supposed to be subject to tariffs. However, services that are embedded into goods are liable to tariffication because the value of the services is included in the cost of the final product for which a tariff is levied. Software bought online and delivered through mode 1 is not tariffed, for instance, yet the same software, when installed on an imported computer, will effectively be tariffed, given that the customs value of the computer includes the value of the software. This has led some to call for the addition of a 5th mode of services delivery, meant to capture the services content embodied in goods exports. In 2009, the European Union’s estimated mode 5 services exports amounted to EUR 300 billion. A 2017 study, meanwhile, suggested that multilateral liberalization of mode 5 trade could increase world trade by EUR 500 billion. Though some attempts have been made to include mode 5 facilitation in bilateral agreements, this has not been attempted at the WTO.

Lastly comes the issue of intellectual property. AI is producing graphics, poetry, and even music—all of which are the legal purview of intellectual property rights (IPR). In the context of international trade, it is the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that sets minimum standards for the protection and enforcement of IPR. Unfortunately, the TRIPS agreement does not define how to deal with AI-generated works, and individual members have taken different approaches in their domestic legislation, ranging from full protection of AI-generated works to a requirement of human creativity that effectively leaves such works unprotected. This patchwork is likely to become increasingly unsatisfactory as the share of intellectual property—both copyright and patents—generated by AI and traded across borders continues to rise.

A Job for the WTO?

As the only organization with a near-global mandate to regulate trade, the WTO seems like the logical place to forge agreements to deal with these policy gaps. The goods–services distinction, GATS professional certification issues, mode 5 services delivery, and IPR issues all situate themselves comfortably within one or several WTO committees and working groups. So, too, do the more traditional issues of ICT tariffs, services liberalization, and data regulation. Legislating at the WTO prevents international fragmentation and provides a rules-based system that stands in opposition to the might-makes-right approach that preceded the organization’s creation.

The suitability of the WTO must be considered in light of certain limitations, however. Chief among them is the pacing problem, a well-known phenomenon wherein technological innovation progresses too quickly for regulation to keep up. This issue is not unique to the WTO; it also exists in domestic legislative contexts. Even so, the fact that the WTO’s Joint Statement Initiative on e-commerce is finalizing texts on electronic signatures and spam in a world where AI, cryptocurrencies, non-fungible tokens, and blockchain technologies remain virtually unregulated illustrates the risk of relying exclusively on the WTO to legislate.

Secondly, the lack of universality regarding normative approaches to AI regulation also inhibits a multilateral solution. Indeed, AI regulation is intrinsically linked to questions of privacy, morality, and property that differ across cultures. Even markets with similar levels of development, such as the European Union and the United States, have taken radically different approaches to privacy and free speech (think the General Data Protection Regulation). This is all without considering the divergent national interest with regard to trade liberalization. Rich countries, which dominate the AI market, want to liberalize trade as much as possible. The calculus for poorer countries, where tariffs remain an important source of government budgets, looks starkly different.

These limitations notwithstanding, it appears unadvisable to let AI regulation develop exclusively in national or regional contexts. The policy issues detailed above require solutions, and multilateral solutions are preferable from a trade standpoint.

In the absence of hard law provisions, which have largely remained elusive in the WTO, the organization can still play an active role in this area. Soft law, informal rules, and norms can still be introduced in the WTO—as they have been for years—without relying on hard law. This would allow states to experiment with AI regulation in line with their economic, social, and moral objectives. Soft law approaches have proven successful in other international policy-making areas, and in the context of the WTO, could act either as a sort of greasing mechanism for the growing number of AI-impacting free trade agreements or, more ambitiously, as a halfway house, building toward hard law commitments in the future.

Timing is of the essence. With policy already lagging behind technology and the use of AI set to increase drastically in the real economy, some sort of international coordination is necessary. At a time when WTO reform is front and centre in the minds of many trade diplomats, an innovative approach to tackle the policy issues raised by AI could be an illustrative case in point of the organization’s continued value.

Whether or not states come together to regulate AI, it is clear that this technology is set to transform industries and trade patterns. Much like trade generally, AI will generate great economic growth but also painful labour market disruptions. Faced with the risk of worsening the digital divide by remaining inactive, policy-makers should make sure whatever solutions they arrive at contribute to creating a more sustainable and inclusive global economy.

Pascal Krummenacher is a trade policy professional and a former project officer at the World Trade Organization.

To read the full policy analysis, please click here.

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There are only two changes from the draft document reviewed in mid-March. The first is the most important and concerns the definition of “an eligible member.” Originally, footnote 1 consisted of the following – “For the purpose of this Decision, developing country Members who exported more than 10 percent of world exports of COVID-19 vaccine doses in 2022 are not eligible Members.” From public data, this language would have excluded China from being an eligible Member. In the footnote 1 forwarded to the Membership on May 3, there are two bracketed sentences, the second of which is what was in the earlier draft. The other bracketed option would make all developing countries “eligible Members” — “[For the purpose of this Decision, all developing country Members are eligible Members. Developing country Members with capacity to export vaccines are encouraged to opt out from this Decision.]” Should China opt out of the Decision, the resulting potentially eligible countries would be the same. The opt out language could also arguably get additional Members who have significant vaccine producing and exporting capacity to voluntarily opt out as well (e.g., India).

The second change is the bracketing of paragraph 3.(a) with an additional footnote indicating that “This paragraph is under further consideration as to whether to keep or delete.” The paragraph (which is unchanged from the earlier draft other than the addition of brackets) reads,

“(a) [With respect to Article 31(a), an eligible Member may issue a single authorization to use the subject matter of multiple patents necessary for the production or supply of a COVID-19 vaccine. The authorization shall list all patents covered. In the determination of the relevant patents, an eligible member may be assisted by WIPOʼs patent landscaping work, including on underlying technologies on COVID-19 vaccines, and by other relevant sources. An eligible Member may update the authorization to include other patents.]”

It was reported that China was pushing to be included in the small group discussions and took exception to the footnote 1 language which would exclude only it. Presumably the alternative bracketed language in footnote 1 is designed to address Chinaʼs concerns. However, it is less likely that the U.S. will accept a final package if China doesnʼt opt out of the decision.

Consistent with the earlier draft, the Decision, if adopted would remain in effect for either three or five years (numbers are bracketed alternatives).

Many NGOs have raised concerns about the lack of immediate coverage of therapeutics and diagnostics. Paragraph 8 continues to read, “No later than six months from the date of this Decision, Members will decide on its extension to cover the production and distribution of COVID-19 diagnostics and therapeutics.” Thus, a decision on coverage of therapeutics and diagnostics will occur, absent a change in language in the text, by the end of 2022, if the decision is adopted.

If the text is accepted by the WTO membership (or modified in ways acceptable to all), then there should be an agreed WTO response to the pandemic at the 12th Ministerial. For reasons noted in recent posts, the value of such a response will be more in the other aspects of the response (keeping markets open, limits on export restraints, transparency, etc.) than on the document dealing with access to vaccines via TRIPS actions. Nonetheless, an agreed response, including the vaccine TRIPS provisions, would be an important accomplishment in the current times.

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, Current Thoughts on Trade.

To read the full commentary from Current Thoughts on Trade, please click here. 

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To understand how COVID-19 has affected global trade in, and production of, vaccines, and to get a sense of where the main capacities to produce COVID-19 vaccines at scale might be found, we looked at global vaccine trade prior to the pandemic and estimated production worldwide, with two main results. First, pre-pandemic, the EU was the world’s largest producer of vaccines. Second, the pre-pandemic market for vaccine was divided into two spheres: rich countries are supplied by EU and US production capacity (with the latter mostly producing for itself), while India was the main producer for developing countries. China produced almost exclusively for its own market.

Evidence since the start of the pandemic indicates that, while broadly COVID-19 has not changed these production patterns, there have been modifications. China has become a major supplier of COVID-19 vaccines to developing countries, using its vaccines as political leverage and benefitting from the fact that the US has yet to export its production, while India has stated explicitly that it will prioritise its own population. In this context, with its substantial production capacity, the EU will play a major role as a global COVID-19 vaccine supplier as the world continues to tackle the pandemic.

The global vaccine trade pre-pandemic

Figure 1 shows the biggest vaccine exporters pre-pandemic (2017-2019). The EU27 as a bloc (ignoring intra-EU trade) was by far the largest exporter of vaccines to the world, both in terms of volumes (44% of total global exports) and value (60.3%). The larger share of value compared to volume indicates that the EU exported relatively more to markets where it could supply at higher prices, ie high-income countries (HICs). Figure 2 shows this: while the EU supplied 60% of the vaccines imported by HICs, it only supplied 12% of the vaccines imported by low-income countries (LICs). The US and the United Kingdom were the major revenue markets for the EU’s vaccines exports, representing 43.4% and 16.7% respectively of total EU revenues from export of vaccines. Taken together, LICs provided only 1.2% of EU revenues from vaccine exports (7.4% from lower-middle income countries, so 8.6% for LICs and lower-middle income countries), but absorbed 3.9% of volumes exported from the EU (33.2% for lower-middle income countries).

With a share of 22%, the US was the second largest exporter in value terms (though only one third of the EU size). But like the EU, the US pre-pandemic mostly exported to other HICs: it represented only 2% of volumes imported by LICs (Figure 2). For India, the opposite was the case. While India was the second-largest vaccine exporter in terms of volumes (24.7% of total global exports) it represented barely more than 2% of vaccines exports in terms of value. This huge discrepancy is linked to the fact that India exported virtually only to LICs, representing 80% of their vaccine imports by volume (Figure 2).

These trade patterns reflect a highly segmented market for vaccines, with HICs representing the bulk of revenues, while LICs represent the bulk of volumes. High-income producers (EU, US) sell vaccines to high-income countries, while India provides vaccines to low-income countries. This notable market segmentation is associated with the licensing practices of the pharmaceutical industry.

The largest life sciences companies by vaccine revenues are: GSK, Merck, Sanofi and Pfizer, which represent about 90% of global vaccine revenues. They license their patents to producers in LICs to produce and sell to LICs, reserving bodog poker review HIC markets for their own production or dedicated HIC licensees. In particular, the Serum Institute of India plays an outsized role as a licensee, supplying vaccines to low-income countries.

Estimating vaccine production capacities

To get a full picture of global vaccines supply patterns before the pandemic, we looked not only at the trade flows, but also at production capacities. In the absence of official data on global vaccine production, we estimated countries’ production volumes from the available trade data. For this, we first estimated internal demand. We looked at countries that are not producers (ie countries that export virtually no vaccines). For these countries, we assumed that their total demand for vaccines is equal to their imports. This gives a sense of what the ‘consumption’-based demand for vaccines is. Based on this approach, we provide a range of estimates. We computed the average imports per capita of non-producing countries and used this to compute demand for all countries. We also looked at the relationship between imports per capita and a ‘vaccine index’ based on the demographics and immunisation rates in the same non-producing countries. We computed estimates both with and without income-level segmentation by country. We then derived production estimates per country as the sum of our estimates of their demand and their net exports.

All estimates produce similar results and give a good sense of the scale of production volumes across the world. Table 1 sets out our estimated production volumes per country. Taken as a whole, the EU is the world’s largest producer of vaccines, closely followed by India, with estimates of around 15.5 million and 14.5 million kilogrammes of vaccines produced yearly, respectively. China with production in the realm of 8 million to 12 million kilogrammes comes in third place. The United States is in fourth place, but with considerably smaller production volumes of 4.5-5.2 million kilogrammes. Other countries with considerable vaccine production capacity are Indonesia, Japan, South Korea and Russia. No African or Latin American country has an estimated production capacity of more than 1 million kilogrammes.

Among vaccine producers, the EU pre-pandemic exported the greatest (estimated) volumes of the vaccines it produced, apart from South Korea, which also has a high export-intensity, but from only a small (estimated) production capacity. China, meanwhile, exported almost no vaccines before COVID-19.

Table 1: Range of estimates of yearly vaccine production (millions of kg, 2017-2019 data)

COVID-19 and the future of vaccine production

While it is tempting to draw conclusions from these numbers about the capacity to produce COVID-19 vaccines, there are couple of caveats. First, our data reflects production capacity in ‘normal’ times (2017 to 2019 averages) and for a broad spectrum of vaccines. It is unclear to what extent new capacity has been installed or how much this capacity has been adapted to produce COVID-19 vaccines at the required scale and speed. More importantly, vaccines pre-pandemic were produced with different technologies.

The leading western producers mostly produce vaccines using viral vector and/or protein technology. Older inactivated virus technology is mostly used in LIC production, most notably in China. For COVID-19, the two Chinese vaccines approved by the World Health Organisation use inactivated virus technology, while vaccines from Astra Zeneca and Johnson & Johnson use viral vector technology (this includes the Serum Institute, which licenses Astra Zeneca vaccines for supply to LICs). However, the vaccines from BioNTech and Moderna use a novel mRNA technology. At the start of the COVID-19 pandemic, it was unclear how much of the established vaccine production capacity could be quickly activated for COVID-19 vaccine production, particularly for the novel mRNA vaccines.

Data on COVID-19 vaccine production from Airfinity, a small private firm that specialises in COVID-19 data, shows the similarities and differences compared to the pre-pandemic situation (Figure 3). The biggest producers of COVID-19 vaccines are the same as the biggest vaccine producers before the pandemic (China, the US, the EU and India), but the ranking has changed.

A significant change can be observed in China’s vaccine policy. While China exported hardly any vaccines before the pandemic, it is now the largest exporter of COVID-19 vaccines. Chinese vaccines are mainly exported to a handful of LICs in central and South-East Asia, South America and North Africa. The US, meanwhile, is yet to export any COVID-19 vaccine, as it has prioritised vaccinating its own population first. India, which pre-pandemic was the main exporter of vaccines to LICs and could be a pivotal country for meeting LIC demand, is exporting but redirecting its capacity in order to meet local demand. Russia’s Sputnik V viral vector vaccine has received a lot of media attention, but Russia, although it is exporting more than usual, only plays a minor role in volume terms.

Figure 3: Production and exports of COVID-19 vaccines

Overall, the evidence shows that high-income vaccine producers (US, EU) have, in the pandemic, continued to produce for high-income countries (though the US currently produces only for itself). In the light of our data, it is unsurprising that keeping global vaccine markets open was less of a priority for the US than the EU, given the much greater pre-pandemic export intensity of EU vaccine production.

However, for LICs, India’s apparent big step back during the pandemic from its role of exporter could be bad news. Until now, India has been the major supplier to LICs. Interestingly, China (and Russia, to a smaller degree) has seized the opportunity to increase production and exports to LICs.

Outlook

The pressing question currently is how to increase the volume of COVID-19 vaccines available to the world and, more specifically, to low-income countries. The developing world until now has relied on India for vaccines. Can other suppliers and countries scale up in the face of India’s retrenchment in the face of the devastating COVID-19 wave in India in spring 2021? China has significantly increased its capacity and now exports massively to low-income countries, but will be constrained by the willingness of countries to take up China’s vaccines, which use the older inactivated virus technology. Even if the US changes policy and exports more of its unused capacity, this capacity is not so sizeable.

While much hope has been invested in patent waivers to increase production in LICs, it is unclear if such a policy will work in the short term, given how little experience producers have with mRNA vaccines (making even voluntary licensing deals difficult). Even for vaccines based on the old inactivated vaccine or viral vector technologies, further transfers of production know-how are needed.

This leaves the EU as the main supplier to the world, given its capacity to produce at scale the most sought-after COVID-19 vaccines. In addition, EU producers have a legacy of exporting, though mainly intra-EU or to other HICs. In the medium-term, partnerships with emerging markets will remain absolutely essential. Notable is the EU’s initiative to support the creation of vaccine production in Africa, including through mRNA manufacturing. In addition, since developing markets are not served by European manufacturers in the first place, there is little risk of harming EU industry.

Lionel Guetta-Jeanrenaud is working at Bruegel as a Research Assistant. He studied economics at the Ecole normale supérieure de Lyon, in France. Before joining Bruegel, Lionel worked as a research assistant at the Department of Economics of Harvard University.

Niclas Poitiers, a German citizen, joined Bruegel as a research fellow in September 2019. Niclas’ research interests include international trade, international macroeconomics and the digital economy. He is working on topics on e-commerce in trade as well as European trade policy in global trade wars. Furthermore he is interested in topics on income inequality and welfare state policies.

Prof Dr. Reinhilde Veugelers is a full professor at KULeuven (BE) at the Department of Management, Strategy and Innovation.  She is a Senior Fellow at Bruegel since 2009.  She is also a CEPR Research Fellow, a member of the Royal Flemish Academy of Belgium for Sciences and of the Academia Europeana. From 2004-2008, she was on academic leave, as advisor at the European Commission (BEPA Bureau of European Policy Analysis).  She served on the ERC Scientific Council from 2012-2018 and on the RISE Expert Group advising the commissioner for Research.  She is a member of VARIO, the expert group advising the Flemish minister for Innovation. She is currently a member of the Board of Reviewing Editors of the journal Science and a co-PI on the Science of Science Funding Initiative at NBER.

To read the full commentary from Bruegel, please click here. 

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That would be a scandal if it were true. But it is not. Access to new, firm-level supply-chain data reveals there has never been a US export “embargo” on materials needed to manufacture vaccines. In recent months, in fact, the Serum Institute and other Indian companies have significantly increased imports of vaccine materials from key suppliers in the United States, including Merck Millipore, Thermo Fisher, Cytiva, Pall, ABEC, Sartorius, and more.

On April 16, Adar Poonawalla, CEO of the Serum Institute, brought things to a head with a tweet. “Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up.” He was not alone in accusing the US government of using the Defense Production Act (DPA) to ban exports of supplies. Mahima Datla, the CEO of Biological E, another major Indian vaccine company, made similar public complaints. President Joseph R. Biden Jr.’s national security advisor, Jake Sullivan, responded that the United States would help by immediately sending emergency vaccine-making equipment to India.

There is, of course, enough blame to go around. Vaccines have not been equitably distributed worldwide. Vaccine equipment and materials are in short supply globally, and shortages may even temporarily get worse. The White House was slow to explain that the Defense Production Act was not being used as “an export ban or a de facto ban or an embargo or any restrictions on sales to any other outside clients or customers anywhere. Companies are able to export however they need.”

But there is something to be learned from the misplaced accusations of CEOs, if policymakers can raise their sights and focus on helping India and other countries now struggling to expand their immediate vaccine production capabilities. Policymakers should work to provide more transparency into the vaccine manufacturing supply chain to avoid these sorts of misperceptions. More important, they should use that information to partner with companies globally to identify and mitigate the worst of the input shortages before the shortfalls stop or slow down vaccine production. The supply chain data presented here can help.

What is Known About the Serum Institute, Biological E, and Vaccine Inputs

The Serum Institute has licensed technology to manufacture two vaccines—one from AstraZeneca in June 2020 and one from Novavax in July. The company secured funding from Gavi and the Bill & Melinda Gates Foundation in August and September to begin to scale up manufacturing that was at risk—i.e., before regulatory approval of the vaccines. In exchange, the Serum Institute agreed to supply hundreds of millions of doses to poor countries through the COVAX Facility over 2020 and 2021.

Manufacturing a vaccine is complex but can be separated into two basic stages (figure 1). The first involves making the drug substance and then formulating it into drug product. This requires capital equipment such as bioreactors and filtration pumps but also a continuous supply of “single use” (disposable) materials such as bioreactor bags, filters, and tubing, as well as chemicals and cellular and other raw materials known as “consumables.” Once done, a second facility takes shipments of the drug product and uses its assembly lines to squirt liquid vaccine into millions of tiny vials, adding caps and labels, and then packaging them up for distribution.

To manufacture the Novavax vaccine, for example, the Serum Institute procured massive new pieces of capital equipment in September, buying six 4,000 liter bioreactors that ABEC indicated were the “largest in the industry by a factor of two.” ABEC would manufacture the bioreactors and customized, single-use bioreactor bags “in its US and Ireland facilities to meet Serum Institute’s accelerated schedule.” (Nevertheless, ABEC is currently reporting a 16-18 week lead time for new shipments of its bags.)

The Serum Institute may have also repurposed legacy equipment already on hand, including to manufacture the AstraZeneca vaccine—which it has called Covishield. In the face of Poonawalla’s plea for more equipment, on April 26 the White House announced emergency shipments of “[Merck] Millipore filters that would have been used to manufacture AstraZeneca vaccine that will be used to manufacture the Covishield AstraZeneca vaccine [sic] serum.”

Equipment is likely in short supply globally, but there is no evidence to suggest a US “embargo” on Merck Millipore, ABEC, or any other company sending vaccine supplies to the Serum Institute (figure 2). Using S&P Global Market Intelligence Panjiva’s (Panjiva) data, which is based on Indian customs transactions, the Serum Institute received $25 million of imports from the United States between October 2020 and March 2021. This volume made up 22 percent of the Serum Institute’s imports from the world and was more than 30 percent higher than the prior six months.

A number of American-based vaccine equipment suppliers made shipments to the Serum Institute between October and March. In October and December, those 4,000 liter bioreactors arrived, reflecting $4 million of purchases from ABEC. Merck Millipore also shipped $3.7 million of goods, including filters; Cytiva and Pall sent a combined $3.3 million of exports, including disposable bioreactor bags. Serum also imported $2.1 million from Thermo Fisher and $600,000 from Sartorius.

The Serum Institute was not alone. Biological E has been preparing to manufacture two other vaccines—one from Johnson & Johnson (Janssen) as well as one from Dynavax and the Baylor College of Medicine. While Indian regulators have not yet authorized either for use, Biological E has had a technology agreement for each since August 2020.

Biological E shows similar buying patterns from US suppliers (figure 3). Between October and March, the vaccine manufacturer received $9 million of imports from the United States, 29 percent of its total imports and an increase of 220 percent (from $2.9 million) from the prior six-month period. Thermo Fisher shipped $3.6 million of those goods, including bioreactor bags, and $187,000 of the exports, including filters, were from Merck Millipore.

The existence of these US exports does not mean, of course, that all of the equipment and materials were to be used to make COVID-19 vaccines. (The Serum Institute and Biological E also manufacture other vaccines.) It also does not imply that these Indian manufacturers are still not missing critical parts or that supplies are not running short. Equipment shortages have been a problem throughout the pandemic, even impacting American vaccine companies. At one point Pfizer, for example, had to recycle individual filters two or three times to avoid running out.

American suppliers of vaccine equipment agree. In a Bloomberg interview in January, Chris Ross, CEO of Merck Millipore, indicated the company had been hit with “off-the-charts” demand for filtration devices and the single-use equipment that their clients needed to make COVID-19 vaccines.

Vaccine Manufacturers Globally May All Be Relying on the Same Few Suppliers

There are many causes of the equipment and raw materials shortages. But things may have been made worse because of how the supply chains for some of these vaccine manufacturers developed, creating a demand spike for the same materials from the same few companies at the same time.

Take the AstraZeneca vaccine’s global manufacturing network. The first stage is now being done by at least nine different companies in eight different countries (figure 4). The second stage happens in at least ten different facilities in nine countries.

Pall and Cytiva, a pair of subsidiaries under Danaher, are likely supplying at least some equipment for the AstraZeneca vaccine supply chain network. Pall was part of the original consortium the Oxford vaccine originators convened in early April 2020 that later expanded to include the AstraZeneca partnership. Clive Glover, Pall’s director for cell and gene therapy, described the equipment implications (of figure 3) with, “The need to standardize was a necessity for this project because there are more than 20 different sites manufacturing [the Oxford/AstraZeneca vaccine], each using the 50 or so consumables required for the manufacturing process. If each site had its own customized version, there would need to be more than 1,000 parts!”

Standardizing the AstraZeneca production process would have tradeoffs. A benefit of common equipment and materials would be the speed at which each new facility could scale up production of a consistent drug product. But the downside of standardization is it may concentrate—and lock in—demand for equipment into a limited number of suppliers. That is, bodog online casino the benefit of that speed and drug product consistency can only be realized if there is enough of the standardized equipment to go around.

The Serum Institute may face intense competition for equipment from many other sites in the AstraZeneca COVID-19 vaccine manufacturing network. Two US facilities—for Emergent BioSolutionsand Catalent—have had AstraZeneca production taking place under a DPA priority-rated contract since summer 2020, giving those plants earlier access to any US-based supplies that the Serum Institute might also need. This may explain how the US government was able to find Merck Millipore filters to share with the Serum Institute on April 26. Finally, demand for equipment to make the AstraZeneca vaccine was also likely coming from newly-tasked facilities in the Netherlands, Belgium, Australia, Japan, Argentina, and the two in the United Kingdom (see again figure 3).

A similar uptick in demand for common equipment likely affected the Serum Institute’s ability to scale up production for Novavax. Novavax has contracted at least seven other facilities to manufacture the drug product for its vaccine (figure 5). Two are in the United States, and at least one of them, FUJIFILM Diosynth Biotechnologies (FDB) in Texas, also appears to use equipment from Pall and Cytiva. The other Novavax facilities are in the United Kingdom (also a FDB plant), Czech Republic, Spain, Japan, and South Korea. In April, Novavax CEO Stanley Erck indicated some facilities were threatened by a global shortage of bioreactor bags, but he did not indicate which plants or which supplying companies were behind the shortfall. Finally, note that the Emergent BioSolutions plant also had the ABEC 4,000 literbioreactor in place prior to the pandemic. (Other COVID-19 vaccine efforts were reportedly also using ABEC equipment.) Thus, many facilities were likely competing with the Serum Institute for bags and other materials needed to make the Novavax vaccine.

The shortages were predictable, and under Operation Warp Speed, the US government at least attempted to address the problem. In October, it provided Cytiva $31 million to “expand manufacturing capacity in the company’s Massachusetts facilities and create duplicate capabilities in Cytiva’s Utah facilities to be complete in less than 12 months.” To help it scale up faster, Cytiva was also given priority access to input suppliers through an invocation of the Defense Production Act.

The US government subsidized Cytiva in part because it was “the primary supplier to many of the companies currently working with the U.S. government to develop COVID-19 vaccines” (emphasis added). But even if the subsidies to Cytiva were sufficient to expand the input capacity needed to satisfy American vaccine manufacturers, they were unlikely to have been large enough to satisfy the surge in global demand.

A New and Global COVID-19 Vaccine Supply Chain Policy is Needed

The challenge facing policymakers today is different from what it was six to twelve months ago. Then, US policymakers were focused on securing the American vaccine supply chain. At that point, which vaccines would receive regulatory approval remained unknown. Now, dozens of facilities making vaccines for Pfizer, Moderna, Johnson & Johnson, AstraZeneca (figure 3), Novavax (figure 4), and more have all been established globally. Furthermore, as the Indian trade data confirmed, these facilities have already formed relationships with critical equipment and raw material suppliers around the world.

Today, policymakers need to leverage information about those relationships to identify and resolve potential input shortages before they stop or slow the much needed expansion of COVID-19 vaccine production. Here are five steps explaining how to do so (figure 6).

1. Regularly survey the dozens of now-established COVID-19 vaccine production facilities about their critical inputs.[5] How much do they need, from which companies, from where are those being supplied, and on what time schedule? Furthermore, how customized is each input? (Is it truly unique to that supplier?)

2. Once that information has been collected for each facility, aggregate it up to the level of the input supplier. Determine how many bioreactor bags are needed from Cytiva versus Thermo Fisher. Establish how many filters are needed from Merck Millipore, etc.

3. Separately survey the major input suppliers identified in step 2. Cross-check whether each input supplier’s pending orders match the information from the vaccine facilities. Check other competing claims on that input production (from clients making products aside from COVID-19 vaccines), and establish whether their existing capacity can satisfy orders from COVID-19 vaccine facilities on time. Can Merck Millipore really meet the simultaneous new demand for filters from Serum Institute, the Novavax plant in Texas, and the AstraZeneca facility in the Netherlands? Will Cytiva have enough bioreactor bags to service all of the plants in their order book? If a plant really needed more of this particular piece of equipment or raw material, would Thermo Fisher have any spare capacity to provide it?

4. Identify potential input shortages. Whenever step 3 reveals a supplier as not having sufficient capacity to meet all of the demand on time, some sort of policy intervention is needed.

5. Determine whether the shortage is impacting a customized input, and tailor the policy response accordingly.

For customized inputs that no other equipment supplier can make, there are two possibilities. Policy should first incentivize the company to utilize its existing capacity more intensively, in a wartime-like-effort, running second, third, and weekend shifts.

If that resulting increase in production of equipment and materials remains insufficient, incentivize the capital investment necessary for that company to expand productive capacity to provide more of those customized inputs.

Even with current heightened demand, an input supplier may not have the private incentive to invest in new capacity if it perceives that demand as transitory. For example, a private company may perceive facilities manufacturing pandemic-specific equipment, such as huge bioreactors or their enormous single-use bags, as having limited utility once the health crisis is over and tens of billions of vaccine doses are no longer a global regularity. Society needs companies to make this capacity investment right now to save lives, and governments may have to pay for it with subsidies. The evidence is that the industry is making large capital investments. But without the policy intervention, private firms might not make the rightexpansions into pandemic-level capacity to address the public health crisis.

For inputs that are not customized, use the step 3 information to help find temporary alternative suppliers. Take advantage of the information on spare capacity collected by having surveyed the other input providers.

Even following this checklist, sometimes there will be no immediate way to resolve an input shortage. In this case, policymakers can use the information they have collected on global production to help ration and nudge supplies to where they can do the most public good. Nevertheless, the pace of vaccine production will slow.

Making Operation Warp Speed Global

US policymakers have arguably deployed elements of this five-step process during the pandemic on behalf of American vaccine makers through Operation Warp Speed and the Defense Production Act. And when vaccine facilities in other countries have run into equipment shortages, the US government has sometimes even stepped in to help, as with the Serum Institute in April as well as with CureVac in May. But the Indian experience showcases why the United States cannot and should not attempt to manage this five-step process alone. The worldwide nature of the pandemic, as well as the international supply chains characterizing vaccine production and input-providers, means that the coordinated and informed allocation of scarce supplies must take place through a more global lens.

These are some of the now practical and real-world reasons why Bown and Bollyky (2021) have called for a COVID-19 Vaccine Investment and Trade Agreement (CVITA). Coordinating public investment to expand critical inputs and raw materials is required simply because those vaccine supplies may be produced in one country (such as the United States) even though they are desperately needed by a vaccine manufacturer in another (such as India). In the face of input shortages, policymakers may need to step in and make hard decisions about how to best allocate those supplies on behalf of public health. But the public also needs to see those policymakers as making informed decisions.

Transparency in the global vaccine supply chain will also improve trust. That may heighten cooperation and be a reminder that, in the COVID-19 pandemic, we are all in this together.

Chad P. Bown, Reginald Jones Senior Fellow since March 2018, joined the Peterson Institute for International Economics as a senior fellow in April 2016. His research examines international trade laws and institutions, trade negotiations, and trade disputes. With Soumaya Keynes, he cohosts Trade Talks, a weekly podcast on the economics of international trade policy.

Chris Rogers joined S&P Global as part of the acquisition of Panjiva in 2018. His research covers international trade policy, logistics sector trends and analysis of industrial supply chains. Previously he worked as an international trade analyst at Bloomberg Intelligence after spending nearly 20 years covering the global energy industry as a sell-side analyst at institutions including JPMorgan and UBS.

To read the full commentary from the Peterson Institute for International Political Economy (PIIE), please click here. 

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My post of November 2 had raised a number of question presented by the proposed waiver:

” The proposal raises a series of questions that should be addressed to understand whether the waiver is appropriate. These questions include whether such a broad waiver request is appropriate or envisioned by Article IX:3 and 4 of the Marrakesh Agreement? Shouldn’t those requesting a waiver be required to demonstrate that the existing flexibilities within the TRIPS Agreement are inadequate to address concerns they may have? Can two Members request a waiver of obligations for all WTO Members? Can a waiver request be considered where the product scope is lacking clarity, and the uses/needs of the waiver are very broad and potentially open to differing views? To what extent is there a need for those seeking a waiver to present a factual record of actions being taken by governments, companies and international organizations to provide access to medical goods during the pandemic including to developing and least developed countries? bodog sportsbook review Shouldn’t those seeking a waiver identify the extent of existing licenses by major pharmaceutical companies with them or other WTO Members for the production of vaccines or therapeutics to address COVID-19?”

The supplemental information provided by South Africa identifies various patent pending matters and identifies what it describes as restrictive actions by some companies and some patent litigation by certain companies. As such the communication provides some information of possible relevance in examining the proposed waiver. However, there is little if any information provided on most questions that seem important to an informed discussion of the proposed waiver.

On November 27, Australia, Canada, Chile and Mexico filed a communication entitled “Questions on Intellectual-Property Challenges Experienced by Members in Relation to COVID-19”. IP/C/W/671. While the entire communication is embedded below, paragraphs 3 and 4 are copied below and present a framework for the consideration of the proposed waiver and seek factual answers to a series of questions which would help understand if there are in fact any significant barriers being confronted by WTO Members in addressing the pandemic.

“3. The co-sponsors of this communication remain of the view that these important, challenging, and complex issues merit further reflection and significant consideration, in order to identify any specific and concrete IP-related challenges faced by Members in addressing COVID-19. In addition, we take note that IP rights are one part of a broad discussion informing the availability and accessibility of treatments for COVID-19. Indeed, as the Doha Declaration on the TRIPS Agreement and Public Health emphasizes, the TRIPS Agreement itself is part of the wider national and international effort to address public health problems. With respect to COVID-19, this broader response includes significant investments through procurement mechanisms like the Access to COVID-19 Tools Accelerator and the COVAX Facility and Advance Market Commitment, as well as work within the WTO and elsewhere to safeguard and protect global supply chains.

“4. The co-sponsors of this communication are actively committed to a comprehensive, global
approach that leverages the entire multilateral trading system in place to supporting the research, development, manufacturing, and distribution of safe and effective COVID-19 diagnostics, equipment, therapeutics, and vaccines. The co-sponsors also reaffirm their support for the TRIPS Agreement, including the flexibilities it provides, and for the Doha Declaration on the TRIPS Agreement and Public Health. In this context, we invite consideration of how the existing legal framework under the TRIPS Agreement, including the flexibilities affirmed under the Doha Declaration on the TRIPS Agreement and Public Health, have operated thus far in the context of Members’ efforts to address the COVID-19 pandemic. We are also committed to fully understanding the nature and scope of any concrete IP barriers experienced by Members related to or arising from the TRIPS Agreement, and such that would constitute impediments to the fight against COVID-19. To that end, and with a view to facilitating a consensual, evidence-based approach, the co-sponsors of this communication therefore respectfully submit the following questions to Members for their consideration and response.”

The communication from Australia, Canada, Chile and Mexico then provides eight questions designed to develop a factual record of challenges faced on procurement of products, local production, compulsory licenses, as well as copyright-related challenges, industrial-designs-related challenges, and challenges from undisclosed information. The questions also include an inquiry as to “what specific legal amendments or actions would the proponents seek to enact for the prevention, containment, and treatment of COVID-19 that are not – or may not be – consistent with the TRIPS Agreement and its flexibilities?”

There is a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights scheduled for December 11 at the WTO. It is assumed that the only item on the agenda will be the consideration of the proposed TRIPS waiver submitted by India and South Africa and joined by four other countries. A recommendation should be forwarded to the General Council by December 31. While the proposed waiver may receive support from many WTO Members, it will be opposed by many as well as not justified and undermining the existing WTO TRIPS Agreement and built-in flexibilities. The communication from Australia, Canada, Chile and Mexico provides a possible path forward by seeking to gather factual information that would permit Members to identify what challenges actually exist and what existing tools are available for addressing the existing challenges so that the need for any waiver is limited to what is actually needed instead of being the very broad waiver proposal for all countries regardless of actual problems faced.

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, bodog poker review|Most Popular_Congressional

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The fifteen countries signing the RCEP are the ten ASEAN countries — Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam — and five others (Australia, China, Japan, New Zealand and the Republic of Korea). India had participated in negotiations but withdrew in late 2019. According to a CNN article, “The Regional Comprehensive Economic Partnership spans 15 countries and 2.2 billion people, or nearly 30% of the world’s population, according to a joint statement released by the nations on Sunday, when the deal was signed. Their combined GDP totals roughly $26 trillion and they account for nearly 28% of global trade based on 2019 data.” CNN Business, November 16, 2020, China signs huge Asia Pacific trade deal with 14 countries, https://www.cnn.com/2020/11/16/economy/rcep-trade-agreement-intl-hnk/index.html.

The Joint Statement released on the 15th is copied below.

Joint Leaders’ Statement on The Regional Comprehensive Economic Partnership (RCEP)

“We, the Heads of State/Government of the Member States of the Association of Southeast Asian Nations (ASEAN) – Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Viet Nam – Australia, China, Japan, Korea and New Zealand, met virtually on 15 November 2020, on the occasion of the 4th RCEP Summit.

We were pleased to witness the signing of the RCEP Agreement, which comes at a time when the world is confronted with the unprecedented challenge brought about by the Coronavirus Disease 2019 (COVID-19) global pandemic. In light of the adverse impact of the pandemic on our economies, and our people’s livelihood and well-being, the signing of the RCEP Agreement demonstrates our strong commitment to supporting economic recovery, inclusive development, job creation and strengthening regional supply chains as well as our support for an open, inclusive, rules-based trade and investment arrangement. We acknowledge that the RCEP Agreement is critical for our region’s response to the COVID-19 pandemic and will play an important role in building the region’s resilience through inclusive and sustainable post-pandemic economic recovery process.”

https://asean.org/joint-leaders-statement-regional-comprehensive-economic-partnership-rcep-2/

The agreement has twenty chapters some of which have annexes:

1. Initial Provisions and General Definitions
2. Trade in Goods
3. Rules of Origin
4. Customs Procedures and Trade Facilitation
5. Sanitary and Phytosanitary Measures
6. Standards, Technical Regulations, and Conformity Assessment Procedures
7. Trade Remedies
8. Trade in Services
9. Temporary Movement of Natural Persons
10. Investment
11. Intellectual Property
12. Electronic Commerce
13. Competition
14. Small and Medium Enterprises
15. Economic and Technical Cooperation
16. Government Procurement
17. General Provisions and Exceptions
18. Institutional Provisions
19. Dispute Settlement
20. Final Provisions

The full RCEP agreement and country schedules of tariff commitments can be found in English at the webpage for RCEP, https://rcepsec.org/legal-text/ as well as on various individual signatory web pages. See, e.g., the Australian Government, Department of Foreign Affairs and Trade, https://www.dfat.gov.au/trade/agreements/not-yet-in-force/rcep/rcep-text-and-associated-documents.

A summary of the agreement from the ASEAN webpage is embedded below. https://asean.org/storage/2020/11/Summary-of-the-RCEP-Agreement.pdf.

From the chapter titles, it is clear that the Agreement does not deal with issues such as labor or environment. While there is a chapter on trade remedies, a review shows no expanded rules on industrial subsidies – a matter of concern for many countries dealing with China. Similarly, under the competition chapter, the only reference (and it is indirect) to state-owned or state-invested enterprises is contained in Article 13.3.5 (“Article 13.3: Appropriate Measures against Anti-Competitive Activities”). “Each Party shall apply its competition laws and regulations to all entities engaged in commercial activities, regardless of their ownership. Any exclusion or exemption from the application of each Party’s competition laws and regulations, shall be transparent and based on grounds of public policy or public interest.” (Emphasis added).

RCEP Chapter 7, Trade Remedies

While subsequent posts will look at other aspects of the RCEP Agreement, this post looks at Chapter 7, Trade Remedies. For convenience, the chapter is embedded below.

Safeguard actions

Section A of Chapter 7 deals with RCEP safeguard measures. The RCEP safeguard measure is intended to be available for a transitional period that extends to a period that is eight years after the tariff elimination or reduction on a specific good is scheduled to occur. Relief can be in the form either of stopping tariff reductions or snapping the tariff back to the MFN rate at the lower of the rates applicable at the date of entry into force of the Agreement for the country in question or the MFN rate on the date when the transitional RCEP safeguard measure is put in place. There is a three year limit on relief, with a one year extension in certain circumstances. If relief is for more than a year, the relief provided is to be reduced “at regular intervals”. Relief is not available against imports from a RCEP party whose imports are less than 3% of total imports from the RCEP parties or if the RCEP party is a Least Developed Country. RCEP has three members who are Least Developed Countries (LDCs) according to the UN’s 2020 list – Cambodia, Laos and Myanmar. Compensation is required and if not agreed to, then the party subject to the RCEP safeguard “may suspend the application of substantially equivalent concessions” on goods from the party applying the safeguard. No compensation is required during the first three years of relief if there has been an absolute increase in imports. No compensation will be requested from an LDC.

RCEP countries preserve their rights under the WTO to pursue global safeguard measures. RCEP parties are not to apply both a RCEP safeguard and a global safeguard to the same good at the same time.

Antidumping and Countervailing Duties

Section B of Chapter 7 deals with antidumping and countervailing duties. While the Section starts by noting that parties “retain their rights and obligations under Article VI of GATT 1994, the AD Agreement, and the SCM Agreement,” the section adds clarity to notice and consultation requirements, timing of notice and information required for verification, maintaining a non-confidential file available to all parties and other matters. The biggest addition to parties rights and obligations is the acceptance of a “Prohibition on Zeroing” in dumping investigations and reviews. Article 7.13.

“When margins of dumping are established, assessed, or reviewed under
Article 2, paragraphs 3 and 5 of Article 9, and Article 11 of the AD Agreement, all individual margins, whether positive or negative, shall be counted for weighted average-to-weighted average and transaction-to- transaction comparison. Nothing in this Article shall prejudice or affect a Party’s rights and obligations under the second sentence of subparagraph 4.2 of Article 2 of the AD Agreement in relation to weighted average-to-transaction comparison.”

Considering the centrality of the WTO dispute settlement decisions on “zeroing” to the U.S. position on overreach by the Appellate Body, the actions of the RCEP parties to add the obligation contained in RCEP Art. 7.13 to their approach to antidumping investigations will almost certainly complicate the ability of the WTO to move past the impasse on the Appellate Body.

Conclusion

The RCEP Agreement is an important FTA in the huge number of such agreements entered by countries around the world. There will certainly be advantages for the RCEP countries from the regional trade liberalization and the common rules of origin adopted.

Pretty clearly, the RCEP has not dealt with some of the fundamental challenges to the global trading system from the rise of economic systems that are not premised on market-economy principles. While such issues can be addressed in the WTO going forward, the ability of China to get a large number of trading partners to open their markets without the addressing of the underlying core distortions from the state directed economic system that China employs suggests that the road to meaningful reform has gotten longer with the RCEP Agreement.

Nor have the RCEP countries chosen to include within the RCEP action on issues like the environment which are of growing importance to the ability to have sustainable development. Again while such issues can be addressed in the WTO, they are also being addressed in bilateral and plurilateral agreements by other countries and including some of the RCEP countries. Thus, RCEP is a lost opportunity for leadership by China on issues of great importance to its citizens and those of all RCEP parties.

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, bodog poker review|Most Popular_Congressional

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The waiver request was made part of the agenda of the Council for TRIPS agenda for its meeting on October 15-16. The WTO Secretariat provided a short press release on the TRIPS Council meeting. The discussion on the waiver proposal is quoted below.

Some 40 members engaged in a substantive discussion on a proposal submitted by India and South Africa for a temporary waiver of certain TRIPS obligations they said would facilitate an appropriate response to COVID-19. The proposal suggests a waiver for all WTO members on the implementation, application and enforcement of certain provisions of the TRIPS Agreement in relation to the “prevention, containment or treatment” of COVID-19. The proponents argued this would avoid barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of essential medical products.

The waiver would cover obligations in four sections of Part II of the TRIPS Agreement (https://www.wto.org/english/docs_e/legal_e/27-trips_04_e.htm) — Section 1 on copyright and related rights, Section 4 on industrial designs, Section 5 on patents and Section 7 on the protection of undisclosed information. It would last for a specific number of years, as agreed by the General Council, and until widespread vaccination is in place globally and the majority of the world’s population is immune. Members would review the waiver annually until its termination.

According to the proponents, an effective response to the COVID-19 pandemic requires rapid access to affordable medical products such as diagnostic kits, medical masks, other personal protective equipment and ventilators as well as vaccines and medicines. The outbreak has led to a swift increase in global demand, with many countries facing shortages, constraining the ability to effectively respond to the outbreak. As new diagnostics, therapeutics and vaccines for COVID-19 are developed, there were significant concerns about how these will be made available promptly in sufficient quantities and at affordable prices to meet global demand.

The proponents argued that many countries — especially developing countries — may face institutional and legal difficulties when using TRIPS flexibilities, including the special compulsory licensing mechanism provided for in Article 31bis (https://www.wto.org/english/res_e/publications_e/ai17_e/trips_art31_bis_oth.pdf ), which they saw as a cumbersome process for the import and export of pharmaceutical products. Now was the time for the WTO as an organization to rise up to the collective call for defeating the pandemic. The WTO would not succeed in its efforts to rebuild the COVID-19 affected economies unless it acts now to first save those lives that are going to build these economies. It is time for members to take collective responsibility and put people’s lives before anything else, they concluded.

While a number of developing and least-developed country members welcomed the proposal as a contribution to the discussion, many were still studying it in their capitals and asked for clarification on certain points, particularly regarding its practical implementation and the possible economic and legal impact of the waiver at national level. A number of developing and developed country members opposed the waiver bodog sportsbook review proposal, noting that there is no indication that intellectual property rights (IPRs) have been a genuine barrier to accessing COVID-19 related medicines and technologies.

While acknowledging that the sustained and continued supply of such medicines and technologies is a difficult task, they observed that non-efficient and underfunded health care and procurement systems, spiking demand and lack of manufacturing capacity are much more likely to impede access to these materials. In the view of these members, solutions can be legitimately sought within the existing IP system as the TRIPS Agreement provides enough tools and sufficient policy space for members to take measures to protect public health. The suspension of IPRs, even for a limited period of time, was not only unnecessary but it would also undermine the collaborative efforts to fight the pandemic that are already under way.

Given this range of positions, the Council chair, Ambassador Xolelwa Mlumbi-Peter of South Africa, said that the item would remain suspended as members continue to consider the proposal. Requests for waivers concerning WTO agreements must be submitted initially to the relevant council for consideration. Axer 90 days, the TRIPS Council has to submit a report to the Ministerial Conference. Given that the proposal was submitted on 2 October, the 90-day time-period expires on 31 December 2020. The TRIPS Council meeting will be reconvened on the item of the waiver proposal as appropriate before that date, the chair said.”

WTO, 20 October 2020, Members discuss intellectual property response to the COVID-19 pandemic, https://www.wto.org/english/news_e/news20_e/trip_20oct20_e.htm.

Waiver provisions in the WTO

Article IX:3 and 4 of the Marrakesh Agreement Establishing the World Trade Organization deal with waivers from obligations WTO Members have assumed.

Article IX- Decision-Making

“3. In exceptional circumstances, the Ministerial Conference may decide to waive an obligation imposed on a Member by this Agreement or any of the Multilateral Trade Agreements, provided that any such decision shall be taken by three-fourths of the Members unless otherwise provided for in this paragraph.

(a) A request for a waiver concerning this Agreement shall be submitted to the Ministerial Conference for consideration pursuant to the practice of decision-making by consensus. The Ministerial Conference shall establish a time period, which shall not exceed 90 days, to consider the request. If consensus is not reached during the time period, any decision to grant a waiver shall be taken by three-fourths of the Members.

(b) A request for a waiver concerning the Multilateral Trade Agreements in Annexes 1A or 1B or 1C and their annexes shall be submitted initially to the Council for Trade in Goods, the Council for Trade in Services or the Council for TRIPS, respectively, for consideration during a time-period which shall not exceed 90 days. At the end of the time period, the relevant Council shall submit a report to the Ministerial Conference.

4. A decision by the Ministerial Conference granting a waiver shall state the exceptional circumstances justifying the decision, the terms and conditions governing the application of the waiver, and the date on which the waiver shall terminate. Any waiver granted for a period of more than one year shall be reviewed by the Ministerial Conference not later than one year after it is granted, and thereafter annually until the waiver terminates. In each review, the Ministerial Conference shall examine whether the exceptional circumstances justifying the waiver still exist and whether the terms and conditions attached to the waiver have been met. The Ministerial Conference, on the basis of the annual review, may extend, modify, or terminate the waiver.”

Some questions from the waiver proposal

The waiver proposal put forward by India and South Africa is extraordinarily broad – covering all WTO Members for a broad range of products not clearly delineated, with the waiver of a broad array of TRIPS obligations without a demonstration of the relevance of the requests for some (e.g., copyright) for a potentially lengthy period of time.

The proposal raises a series of questions that should be addressed to understand whether the waiver is appropriate. These questions include whether such a broad waiver request is appropriate or envisioned by Article IX:3 and 4 of the Marrakesh Agreement? Shouldn’t those requesting a waiver be required to demonstrate that the existing flexibilities within the TRIPS Agreement are inadequate to address concerns they may have? Can two Members request a waiver of obligations for all WTO Members? Can a waiver request be considered where the product scope is lacking clarity, and the uses/needs of the waiver are very broad and potentially open to differing views? To what extent is there a need for those seeking a waiver to present a factual record of actions being taken by governments, companies and international organizations to provide access to medical goods during the pandemic including to developing and least developed countries? bodog sportsbook review Shouldn’t those seeking a waiver identify the extent of existing licenses by major pharmaceutical companies with them or other WTO Members for the production of vaccines or therapeutics to address COVID-19?

Historical usage of waivers have not been as broad as that requested by India and South Africa

Waivers are exceptional by their nature and Article IX:3 talks in terms of a waiver of some obligation for a particular Member, not the waiver of many parts of an agreement for all members. When one looks at waivers granted previously by the WTO, one sees a range of topics — many relate to time for Members to implement changes from updates of the harmonized tariff systems (for individual countries who sought the temporary waiver), some pertain to preferential arrangements between one Member and another or a group of Members and some pertain to waiver of deadlines or specific obligations for least developed countries. Two documents prepared by the WTO Secretariat show waivers granted or continuing in existence in 2019 and all waivers between 1995 AND 2015. The two documents are embedded below.

Thus, the present request for a waiver by India and South Africa doesn’t seem to comply with the literal terms of Article IX:3 of the Marrakesh Agreement or with the much more narrow scope of waivers typically considered. As reviewed above, the request would apply to all members, not just India and South Africa. The request also seems overly broad both in terms of products (not clearly defined), uses and provisions to be waived.

Existing flexibilities within the TRIPs Agreement

Because of the importance to all WTO Members of the health of their citizens, there has been a lot of focus and discussion within the WTO on the interface between intellectual property and public health. Under the original TRIPs Agreement and the subsequent amendment to the Agreement in 2005 that took effect as Article 31bis to the TRIPs Agreement in 2017, there is flexibility within the TRIPs Agreement for Members to deal with health emergencies including through compulsory licensing which can include the right to manufacture and export to developing and least developed countries who don’t have pharmaceutical manufacturing capabilities in-country. See TRIPs Agreement Article 31, Article 31bis and WT/L/641. The current language of Articles 31 and 31bis from the patent portion of the TRIPS Agreement are presented below.

Article 31 Other Use Without Authorization of the Right Holder

“Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

(a) authorization of such use shall be considered on its individual merits;

(b) such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;

(c) the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;

(d) such use shall be non-exclusive;

(e) such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use;

(f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;

(g) authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;

(h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;

(i) the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;

(j) any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;

(k) Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined axer judicial or administrative process to be anticompetitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;

(l) where such use is authorized to permit the exploitation of a patent (“the second patent”) which cannot be exploited without infringing another patent (“the first patent”), the following additional conditions shall apply:

(i) the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent;

(ii) the owner of the first patent shall be entitled to a cross-license on reasonable terms to use the invention claimed in the second patent; and

(iii) the use authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent.

Article 31bis

1. The obligations of an exporting Member under Article 31(f) shall not apply with respect to the grant by it of a compulsory license to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out in paragraph 2 of the Annex to this Agreement.

2. Where a compulsory license is granted by an exporting Member under the system set out in this Article and the Annex to this Agreement, adequate remuneration pursuant to Article 31(h) shall be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member. Where a compulsory license is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall not apply in respect of those products for which remuneration in accordance with the first sentence of this paragraph is paid in the exporting Member.

3. With a view to harnessing economies of scale for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products: where a developing or least developed country WTO Member is a party to a regional trade agreement within the meaning of Article XXIV of the GATT 1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (L/4903), at least half of the current membership of which is made up of countries presently on the United Nations list of least developed countries, the obligation of that Member under Article 31(f) shall not apply to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that Member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. It is understood that this will not prejudice the territorial nature of the patent rights in question.

4. Members shall not challenge any measures taken in conformity with the provisions of this Article and the Annex to this Agreement under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994.

5. This Article and the Annex to this Agreement are without prejudice to the rights, obligations and flexibilities that Members have under the provisions of this Agreement other than paragraphs (f) and (h) of Article 31, including those reaffirmed by the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2), and to their interpretation. They are also without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under the provisions of Article 31(f).”

The WTO Secretariat has a page on its website that discusses intellectual property and the public interest, https://www.wto.org/english/tratop_e/trips_e/trips_and_public_interest_e.htm , which reviews both flexibilities for Members in addressing public interest needs as well as current topics being discussed within the TRIPS Council. There also have been publications by the WTO Secretariat, WIPO and WHO on flexibilities in accessing medical technologies. See, e.g., WTO, WIPO and WHO, Promoting Access to Medical Technologies and Innovation, SECOND EDITION, https://www.wto.org/english/res_e/booksp_e/who-wipo-wto_2020_e.pdf . And on October 21, 2020 the WTO held a technical workshop on health, trade and intellectual property in addressing COVID-19. See 21 October 2020, WTO workshop on health, trade and intellectual property: an integrated approach to COVID-19; https://www.wto.org/english/news_e/news20_e/heal_21oct20_e.htm. There is a lengthy combined PowerPoint presentation available from the webpage which was used in the workshop.

Thus, there can be no doubt that the WTO TRIPS Agreement provides significant flexibility to Members to address health emergencies. The waiver proposal from India and South Africa doesn’t review any actual efforts to utilize the flexibilities but just opines that Members won’t be able to effectively utilize them. Such an approach should not be acceptable for such far-reaching requests as the proposal from India and South Africa.

Ongoing efforts by governments, companies and organizations to make medical goods available to developing and least developed countries

Strangely missing from the waiver request submitted by India and South Africa is any mention of the global efforts underway to ensure access to medical goods and vaccines and therapeutics as approved.

There have been various fundraising efforts in 2020 to provide the necessary wherewithal to organizations focused on developing vaccines for global distribution or focused on the distribution of medical goods, vaccines and therapeutics globally.

CEPI and GAVI in coordination with the WHO have extensive efforts underway, including access to large manufacturing capacity for approved vaccines within the pool of vaccines being developed and included in the CEPI portfolio.

In addition, some private companies involved in manufacturing vaccines under development have licensing arrangements with certain producers for distribution to developing and least developing countries. Some companies have made access to the drawings of their medical equipment available to any company wishing to produce the equipment.

Thus, it is hard to understand a need for a broad waiver when there are considerable international cooperation and substantial vaccine capacity available for some of the vaccines in late-stage testing. The WTO membership deserves to have a full compilation of developments and existing actions to facilitate access to medical supplies for developing and least developed countries. The India and South Africa waiver proposal provide none of the relevant information.

While it is not the purpose of this post to develop the full factual record, I provide below some links which supply some information on ongoing developments. See The Guardian, October 20, 2020, India at heart of global efforts to produce Covid vaccine, Country plays central role in development, manufacture, and possible distribution of potential vaccines, https://www.theguardian.com/world/2020/oct/20/india-at-heart-of-global-eworts-to-produce-covidvaccine  (“A deal has already been struck for the Serum Institute of India, based in the city of Pune, to produce 1bn doses of the the Oxford/AstraZeneca vaccine, seen as the forerunner in the vaccine race.” “Johnson and Johnson, whose Covid-19 vaccine is also in phase 3 clinical trials, has struck a deal with the Indian pharmaceutical company Biological E to produce up to 500m doses if successful.” “Bharat Biotech, a Hyderabad-based pharmaceutical company, has a deal to manufacture 1bn doses of Washington University’s intranasal vaccine, now in clinical trials, and Indian pharmaceutical giant Dr. Reddy’s has a deal to do a phase 2/3 human trials in India of Russia’s controversial Sputnik vaccine and then produce 100m doses. There are also at least a dozen indigenous vaccines being developed within India. ” “Poonawalla of the Serum Institute said that ‘50% of whatever quantity we manufacture will be kept for India and the remaining will go to low- and middle-income countries.’”).

GAVI, the Vaccine Alliance, October 15, 2020, COVID-19 SITUATION REPORT #19, https://www.gavi.org/sites/default/files/covid/Gavi-COVID-19-Situation-Report-19-20201015.pdf (“COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. Gavi is coordinating the development and implementation of the COVAX Facility, the global procurement mechanism of COVAX. The COVAX Facility will make investments across a broad portfolio of promising vaccine candidates (including those being supported by CEPI) to make sure at-risk investment in manufacturing happens now. Gavi is also coordinating the development and implementation of the Gavi COVAX Advance Market Commitment (AMC), the financing instrument that will support the participation of 92 low- and middle-income countries and economies in the COVAX Facility.

The goals of the COVAX Facility and AMC include:

❖ to support the largest actively managed portfolio of vaccine candidates globally

❖ to deliver 2 billion doses by the end of 2021

❖ to offer a compelling return on investment by delivering COVID-19 vaccines as quickly as possible

❖ to guarantee fair and equitable access to COVID-19 vaccines for all participants

❖ to end the acute phase of the pandemic by the end of 2021”).

CEPI, October 21, 2020, bodog casino CEPI expands global manufacturing network, reserving manufacturing capacity for more than 1billion doses of COVID-19 vaccines, https://www.gavi.org/vaccineswork/cepi-expandsglobal-manufacturing-network-reserving-manufacturing-capacity-over-1-billion-doses  (“CEPI signs agreements with Biofabri (Spain) and GC Pharma (Republic of Korea) to reserve vaccine manufacturing capacity for more than 1 billion doses of COVID-19 vaccines designated by CEPI. CEPI’s strategic investments in vaccine manufacturing at facilities around the world will support the COVAX goal to produce 2 billion doses of safe and effective vaccine by the end of 2021.”).

Conclusion

There is no doubt that the COVID-19 pandemic presents a global health crisis. In response to the crisis there have been activities within the WTO to minimize restrictions on the movement of medical goods and a workshop looking at the interface of trade, intellectual property and public health to help Members address internal needs. The TRIPS Agreement has various flexibilities to permit Members to address health challenges. At the same time there have been extraordinary efforts by many governments, companies and international organizations to cooperate both to develop vaccines and therapeutics but also to speed up manufacturing and work towards equitable distribution of medical goods. Leading pharmaceutical companies have already entered into licensing arrangements to provide billions of doses of vaccines when approved to developing and least developing countries. GAVI and CEPI in coordination with the WHO are working on supporting various vaccine development, securing manufacturing capacity and raising funds to permit broad distribution of vaccines and other products to countries in need and others who have contributed to the group effort.

So factually, it is hard to understand the waiver request filed by India and South Africa. Against a backdrop of how waivers have been used in the past and the lack of a demonstration that existing flexibilities won’t provide acceptable answers, the waiver proposal also is deficient in terms of legal justification. The proposal is not justified, is too broad both in terms of product coverage, Members who would be given waivers, and the range of TRIPS provisions that would be waived for some number of years.

These are serious problems with a proposal that requires TRIPS Council action and referral to the General Council by the end of the year. Thus, the TRIPS Council should recommend against acceptance of the waiver proposal put forward by India and South Africa.

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, bodog poker review|Most Popular_Congressional

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First, there is geopolitics and national security. Digital technologies allow foreign powers to hack industrial networks, conduct cyber-espionage, and manipulate social media. Russia has been accused of interfering in elections in the United States and other Western countries through fake news sites and the manipulation of social media. The US government has cracked down on the Chinese giant Huawei because of fears that the company’s links to the Chinese government make its telecoms equipment a security threat.

Second, there are concerns about individual privacy. Internet platforms are able to collect huge amounts of data on what people do online and off, and some countries have stricter rules than others to regulate what they can do with it. The European Union, for example, has enacted fines for companies that fail to protect the EU residents’ data.

Third, there is economics. New technologies give a competitive edge to large companies that can accumulate enormous global market power. Economies of scale and scope and network effects produce winner-take-all outcomes, and mercantilist policies and other government practices can result in some firms having what looks like an unfair advantage. For example, state surveillance has allowed Chinese firms to accumulate huge amounts of data, which in turn has enabled them to corner the global facial recognition market.

A common response to these challenges is to call for greater international coordination and global rules. Transnational regulatory cooperation and anti-trust policies could produce new standards and enforcement mechanisms. Even where a truly global approach is not possible – because authoritarian and democratic countries have deep disagreements about privacy, for example – it is still possible for democracies to cooperate among themselves and develop joint rules.

The benefits of common rules are clear. In their absence, practices such as data localization, local cloud requirements, and discrimination in favor of national champions create economic inefficiencies insofar as they segment national markets. They reduce the gains from trade and prevent companies from reaping the benefits of scale. And governments face the constant threat that their regulations will be undermined by companies operating from jurisdictions with laxer rules.

But in a world where countries have different preferences, global rules – even when they are feasible – are inefficient in a broader sense. Any global order must balance the gains from trade (maximized when regulations are harmonized) against the gains from regulatory diversity (maximized when each national government is entirely free to do what it wants). If hyper-globalization has already proved brittle, it is in part because policymakers prioritized the gains from trade over the benefits of regulatory diversity. This mistake should not be repeated with new technologies.

In fact, the principles that should guide our thinking on new technologies are no different from those for traditional domains. Countries may devise their own regulatory standards and define their own national security requirements. They may do what is required to defend these standards and their national security, including through trade and investment restrictions. But they have no right to internationalize their standards and try to impose their regulations on other countries.

Consider how these principles would apply to Huawei. The US government has prevented Huawei from acquiring American companies, restricted its operations in the US, launched legal proceedings against its senior management, pressured foreign governments not to work with it, and, most recently, banned US companies from selling chips to Huawei’s supply chain anywhere in the world.

There is little evidence that Huawei has engaged in spying on behalf of the Chinese government. But that does not mean that it will not do so in the future. Western technical experts who have examined Huawei’s code have been unable to rule out the possibility. The opacity of corporate practices in China could well obscure Huawei’s links to the Chinese government.

Under these circumstances, there is a plausible national security argument for the US – or any other country – to restrict Huawei’s operations within its own borders. Other countries, including China, are not in a position to second-guess this decision.

The export ban on US companies, however, is harder to justify on national security grounds than the ban on Huawei’s US-based operations. If Huawei’s operations in third countries pose a security risk to those countries, their governments are in the best position to assess the risks and decide whether a shutdown is appropriate.

Moreover, the US ban confronts other countries with severe economic repercussions. It creates significant adverse effects for national telecoms companies like BT, Deutsche Telekom, Swisscom, and others in no fewer than 170 countries that rely on Huawei’s kits and hardware. Perhaps worst hit are poor countries in Africa that are overwhelmingly dependent on the company’s cheaper equipment.

In short, the US is free to close its market to Huawei. But US efforts to internationalize its domestic crackdown lack legitimacy.

The Huawei case is a harbinger of a world in which national security, privacy, and economics will interact in complicated ways. Global governance and multilateralism will often fail, for both good and bad reasons. The best we can expect is a regulatory patchwork, based on clear ground rules that help empower countries to pursue their core national interests without exporting their problems to others. Either we design this patchwork ourselves, or we will end up, willy-nilly, with a messy, less efficient, and more dangerous version.

Dani Rodrik is a Professor of International Political Economy at Harvard University’s John F. Kennedy School of Government and is the author of Straight Talk on Trade: Ideas for a Sane World Economy.

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