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COVID-19 Trade Update: FEMA Implements Export Controls for PPE as CBP Issues Guidance Restrictions

PPE

COVID-19 Trade Update: FEMA Implements Export Controls for PPE as CBP Issues Guidance Restrictions

On April 3, 2020, President Trump issued a Presidential Memorandum directing the Department of Homeland Security, through the Federal Emergency Management Agency (FEMA), to utilize the Defense Production Act to restrict the export of scarce domestic materials being used to respond to the spread of COVID-19, including certain personal protective equipment (PPE).

Effective Tuesday, April 7, FEMA implemented this Order through a Temporary Final Rule (the TFR) that restricts U.S. exports of five specific categories of PPE products that were previously designated by the Department of Health and Human Services (HHS) as “scarce or threatened materials.”

U.S. Customs and Border Protection (CBP) has since issued its own internal guidance on the TFR that provides further detail on the scope of the restrictions as well as key exclusions for certain U.S. exporters.

The TFR differs from traditional U.S. export control regulations, such as those administered by the U.S. Departments of Commerce and State, in that there is no licensing system in place and FEMA’s determination is not based on the proposed end-use or end-user of the product – rather, FEMA will assess all U.S. exports of designated PPE materials and reallocate those products domestically as required. Because FEMA is not an agency that traditionally administers U.S. export control regulations, it is critical for manufacturers, suppliers, and distributors of PPE products and related medical materials to be aware of the specific articles impacted by the TFR, the scope of the restrictions, the timeline for implementation, consequences for non-compliance, and the potential for expanded product coverage.

PPE Export Restrictions Overview

The TFR providing for PPE export restrictions is effective as of April 7, 2020 for a period of 120 days. The TFR designates five of fifteen categories of materials previously identified as “scarce or threatened materials” by HHS. In particular, the subject restricted PPE materials are the following:

-N-95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;

-Other Filtering Facepiece Respirators (e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100), including single-use, disposable half-mask respiratory protective devices that cover the user’s airway (nose and mouth) and offer protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181;

-Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;

-PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials; and

-PPE gloves or surgical gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such gloves intended for the same purposes.

Before any shipments of the above-listed PPE materials can be exported from the U.S., CBP will temporarily detain the shipment so that FEMA can determine whether to:

-Prohibit the export and return the shipment for domestic use;

-Utilize the Defense Product Act (DPA) to issue a “rated order” for the materials (a priority contract or order placed in support of a national defense program under the DPA); or

-Allow the export of part or all of the shipment.

In making its determination, FEMA may consider the following factors:

-The need to ensure that scarce or threatened items are appropriately allocated for domestic use;

-Minimization of disruption to the supply chain, both domestically and abroad;

-The circumstances surrounding the distribution of the materials and potential hoarding or price-gouging concerns;

-The quantity and quality of the materials;

-Humanitarian considerations; and

-International relations and diplomatic considerations.

Scope and Exemptions

On April 9, 2020, CBP issued an updated internal guidance memorandum (CBP Internal Guidance) to its field operators to clarify key definitions and general exceptions to the PPE export restrictions provided for in the TFR.

First, CBP highlights that the focus of the TFR is on “commercial quantities” of PPE exports, currently defined as shipments valued at $2,500 or more and containing more than 10,000 units.

The CBP Internal Guidance then lists the following export circumstances that are excluded from the FEMA restrictions:

-Exports to Canada or Mexico;

-Exports to U.S. government entities such as U.S. military bases overseas;

-Exports by U.S. Government agencies;

-Exports by U.S. charities;

-Exports by critical infrastructure industries for the protection of their workers;

-Exports by the 3M Company;

-Express or Mail Parcels that do not meet the “commercial quantity” definition above;

-In-transit shipments.

However, it is important to note that as of April 16, the Internal CBP Guidance on exclusions for the TFR has not been formally published in the Federal Register or elsewhere by CBP, and may be subject to additional revisions in its final form.

Practical Advice and Next Steps

All U.S. manufacturers, suppliers, and distributors of PPE materials or other products designated by HHS as “scarce or threatened” (the relevant HHS guidance can be found here) that are considering exporting their products for sale need to have a comprehensive understanding of the FEMA TFR and applicable export restrictions. Expect additional CBP and/or FEMA guidance in the near future with refined definitions, clarifications as to how the exclusions will be administered, and further details on how product definitions will be determined. It may be the case that additional products identified by HHS as “scarce or threatened” in connection with the fight against the spread of COVID-19 will be added to the list of restricted products for exports, including portable ventilators and certain drug treatment products that contain chloroquine phosphate or hydroxychloroquine HCl. Additional export, exporter, or product-based exclusions may be issued in the finalized published FEMA/CBP guidance as well.

In the meantime, U.S. exporters of PPE products can expect delays at CBP ports around the country as FEMA and CBP develop and implement the TFR and related policy guidance. If you have any questions about the TFR, the impact of the TFR on exports of PPE products, or whether a particular product or proposed export is covered by a CBP exclusion, please contact a member of Baker Donelson’s Global Business Team.

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Alan Enslen is a shareholder with Baker Donelson and leads the International Trade and National Security Practice and is a member of the Global Business Team. He can be reached at aenslen@bakerdonelson.com.

Julius Bodie is an associate with Baker Donelson who assists U.S. and foreign companies across multiple industries with international trade regulatory issues. He can be reached at jbodie@bakerdonelson.com.

masks

Global Imports of Breathing Appliances and Gas Masks Recorded the Highest Growth Before the COVID-19 Pandemic

IndexBox has just published a new report: ‘World – Breathing Appliances And Gas Masks – Market Analysis, Forecast, Size, Trends And Insights’. Here is a summary of the report’s key findings.

Global Trade of Breathing Appliances and Gas Masks  2013-2018

In 2018, the amount of breathing appliances and gas masks exported worldwide totaled $1.7B (IndexBox estimates). The total export value increased at an average annual rate of +5.5% over the period from 2013 to 2018; the trend pattern remained relatively stable, with only minor fluctuations being recorded throughout the analyzed period. The most prominent rate of growth was recorded in 2018 when exports increased by 15% year-to-year. In that year, global breathing appliances exports reached their peak.

Exports by Country

The U.S. ($375M), Germany ($332M) and the UK ($279M) were the countries with the highest levels of exports in 2018, together accounting for 57% of global exports. These countries were followed by France, China, Poland, Australia, Taiwan, Chinese, Canada, Russia, South Korea and Mexico, which together accounted for a further 27%.

Poland experienced the highest rates of growth with regard to the value of exports, among the main exporting countries over the period under review, while exports for the other global leaders experienced more modest paces of growth.

Export Prices by Country

In 2018, the average breathing appliances export price amounted to $64,941 per tonne, going up by 6% against the previous year. Over the period from 2013 to 2018, it increased at an average annual rate of +5.1%. The growth pace was the most rapid in 2017 when the average export price increased by 14% year-to-year. Over the period under review, the average export prices for breathing appliances and gas masks reached their maximum in 2018 and is expected to retain its growth in the immediate term.

There were significant differences in the average prices amongst the major exporting countries. In 2018, the country with the highest price was France ($109,043 per tonne), while Mexico ($12,629 per tonne) was amongst the lowest.

From 2013 to 2018, the most notable rate of growth in terms of prices was attained by Russia, while the other global leaders experienced more modest paces of growth.

Imports by Country

In value terms, the U.S. ($232M), Germany ($187M) and Canada ($96M) appeared to be the countries with the highest levels of imports in 2018, with a combined 30% share of global imports. The UK, France, Australia, China, Denmark, the Netherlands, South Korea, Chile and Indonesia lagged somewhat behind, together accounting for a further 27%.

Denmark recorded the highest rates of growth with regard to the value of imports, among the main importing countries over the period under review, while imports for the other global leaders experienced more modest paces of growth.

Import Prices by Country

The average breathing appliances import price stood at $61,064 per tonne in 2018, growing by 2.7% against the previous year. Over the last five-year period, it increased at an average annual rate of +2.7%. The most prominent rate of growth was recorded in 2014 when the average import price increased by 8.7% year-to-year.

There were significant differences in the average prices amongst the major importing countries. In 2018, the country with the highest price was Australia ($85,291 per tonne), while Indonesia ($26,559 per tonne) was amongst the lowest.

From 2013 to 2018, the most notable rate of growth in terms of prices was attained by Australia, while the other global leaders experienced more modest paces of growth.

Source: IndexBox AI Platform

humanitarian

ECONOMIC SANCTIONS EXEMPT HUMANITARIAN TRADE

Ailing Relations

Iran has been among the worst affected countries from COVID-19, having emerged as an early hotspot outside China. As of April 7, there were an estimated 62,589 confirmed cases with over 3,800 deaths. Iran’s cases appear to have peaked in late March, but exact numbers are unknown due to the secretive nature of its totalitarian regime. Other countries throughout the Middle East began reporting cases in late February and continue to battle spread of COVID-19 due to travel linked to Iran.

U.S. offers of assistance were rejected by Iran’s Supreme Leader Ayatollah Ali Khamenei, who said publicly on March 22, “You might give us a medicine that would spread the disease even more or make it last longer.”

According to the U.S. State Department, the United States has offered more than $100 million in medical assistance to foreign countries, including to the Iranian people, and reports that Iranian health companies have been able to import testing kits without obstacle from U.S. sanctions since January. The U.S. government has urged Iranian leaders to be more truthful about its efforts to contain the virus.

Iran assistance

Humanitarian Trade Exemptions

U.S. economic sanctions against Iran include a general exemption for U.S. exports of agricultural commodities, food, medicines and medical devices to Iran and an authorization process to obtain licenses for a specific list of medical supplies and equipment not covered under the general exemption. Such licenses are usually given for one year.

The U.S. government recently reinforced its messaging that sanctions are directed at the Iranian regime, stating: “[Sanctions] are not directed at the people of Iran, who themselves are victims of the regime’s oppression, corruption, and economic mismanagement.”

A 2019 Congressional Research Service report suggests U.S. sanctions have limited access by the Iranian population to “expensive Western-made medicines such as chemotherapy drugs,” due to a lack of bank financing for such transactions and that the limited supplies that exist have gone to elites.

Role of Financing

Between 2018 and 2019, overall U.S. trade with Iran went from small to very small under tightened sanctions. In 2018, U.S. exports to Iran were valued at $425.7 million. In 2019, U.S. exports had decreased 82 percent to $73.1 million.

Underlying that decrease in trade, even of humanitarian-related goods and services, reflects a tendency toward over-compliance by banks and multinational firms that avoid transactions with Iran to minimize possible violations of U.S. sanctions. Doing so, even inadvertently, could cut off their access to vital U.S. financial markets. The U.S. government has also explicitly cited concerns about the Iranian regime’s abuse of humanitarian trade to evade sanctions and launder money.

To close these loopholes, in October 2019 the Treasury Department announced a new payment mechanism “to facilitate legitimate humanitarian exports to Iran.” The measure restricts the role of the Central Bank of Iran in facilitating humanitarian trade, which the U.S. government views as financing terrorism. It also imposes rigorous reporting requirements to thwart diversion of funds intended for humanitarian use.

By late February 2020, as the COVID-19 medical crisis unfolded in Iran, the U.S. Treasury Department issued a general license authorizing certain humanitarian trade transactions involving the Central Bank of Iran while also approving the use of a Swiss financial channel to finance such transactions.

The Swiss Humanitarian Trade Arrangement (SHTA) enables Swiss-based exporters and trading companies in the food, pharmaceutical and medical sectors to access a secure payment channel with a Swiss bank to guarantee payments for their exports to Iran. Novartis was the first Swiss company to send medicine for use in cancer treatments. Germany, France and Britain have also used this new channel to offer a $5.5 million package to Iran to help fight the coronavirus.

exemptions in sanctions

Trade in Food and Medicine

Much has been written recently about governments restricting exports and otherwise increasing the cost of traded medical supplies during the pandemic.

For two decades now, the Trade Sanctions Reform and Export Enhancement Act of 2000 (TSRA) has ensured that each U.S. country-based sanctions program provides for trade of agriculture, medicine and medical devices under a broad humanitarian exemption. This is intended to limit potential adverse effects on civilian populations who are not the target of sanctions.

The United Nations Security Council maintains 14 active sanctions programs that also include humanitarian exemptions driven by the belief that a supportive and healthy citizen population is necessary to achieve improvements in a sanctioned regime.

Recently, the United Nations Security Council approved a humanitarian exemption to sanctions against North Korea (DPRK) requested by the World Health Organization for diagnostic and medical equipment to address COVID-19. The United States supported this decision.

Exemptions Thwarted by Totalitarian Regimes

The health impacts of embargoes are difficult to isolate and quantify. They may not become apparent until years after resource shortages occur. Domestic production challenges can also play a role. For example, Iran produces 97 percent of its medicines locally, but a third of these drugs rely on active ingredients that are imported, according to the head of Iran’s Food and Drug Organization.

Although humanitarian trade exemptions are intended to mitigate shortages of essential supplies, totalitarian regimes are known for putting their goals before the needs of their citizens. The negative impacts of sanctions are often compounded by inequitable distribution or outright theft of essential goods and ongoing civil conflicts.

In any case, it’s difficult to know the net effect of sanctions and humanitarian trade exemptions because data on key indicators of health effects are often missing or unavailable from embargoed regimes. However, it is clear that enabling trade in essential goods like food and medical supplies has served a role in health diplomacy for decades.

During her career in international trade and government affairs, the author worked with pharmaceutical and medical device manufacturers to navigate U.S. sanctions policies and requirements.

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Sarah Smiley is a strategic communications and policy expert with over 20 years in international trade and government affairs, working in the U.S. Government, private sector and international organizations.

This article originally appeared on TradeVistas.org. Republished with permission.

cargo

GLOBAL CARGO IS LEAVING ON A JET PLANE

With the ongoing threat of COVID-19, airlines have seen a precipitous drop in passenger travel and are focused on the possibility of a voluntary or mandated halt to U.S. passenger flights. In response, major carriers are finding ways to keep flying during the global health crisis.

American Airlines and United Airlines, for example, have offered their passenger aircraft for charter cargo flights. Even in normal times, the lower deck of passenger aircraft carries cargo to maximize the utilization of space. With the sharp scale-back in passenger travel, however, the companies are offering dedicated cargo runs to deploy their assets and replace revenue while helping to keep supply chains moving and facilitate the shipment of essential goods.

Attention All Passengers:

Many air travelers don’t realize that it’s not just their own and fellow travelers’ luggage that checked in for their flights. The big passenger airlines generally have a lot of available space in their bellies. With operating costs covered by passenger tickets, the airlines often generate supplemental revenue by carrying packages, freight or mail for the U.S. postal service on board passenger flights.

In turn, cargo shippers secure relatively cheap space and can get goods close to their ultimate destination given the dense network of airports serving passenger flights around the world. Even logistics players like UPS and FedEx partner with passenger airlines, particularly in emerging markets where trade volumes may not justify the deployment of their own regularly-scheduled aircraft. Technology tools enable precise coordination to ensure goods off-loaded from a freighter aircraft make their departure on a passenger aircraft and vice versa.

Cargo split

The trend is taking off. The International Air Transport Association (IATA) has been cited as estimating the split between cargo carried by passenger airlines and freighter aircraft at 60/40 and forecasts that will grow to 70/30 in the coming years.

In 2018, American Airlines moved 2 billion pounds of cargo and raised $1 billion of cargo revenue despite not operating cargo aircraft. Airlines based in Asia such as Korean Air and Cathay Pacific do have freight fleets, but still carry more than half of their cargo in the bellies of passenger aircraft. McKinsey has noted that with the expansion of the major Middle Eastern passenger carriers and new aircraft designs with large belly-cargo configurations, the belly capacity of Middle Eastern carriers flying into Europe in 2016 equaled the capacity of more than 100 weekly Boeing 777 freighter flights.

Open Skies

“Open Skies” agreements governing the transport of people, pallets and packages are designed to enable market forces to guide decision-making about routes, capacity, and pricing. Critically, Open Skies agreements also provide both passenger and cargo flights unlimited market access to partner markets and the right to fly to all intermediate and beyond points. The United States now has Open Skies agreements with over 100 partners around the world, including both bilateral agreements and two multilateral accords. So-called fifth freedom rights – also called beyond rights – are a core element of Open Skies agreements, permitting a carrier to fly to a second country, offload passengers and cargo, pick up new passengers and cargo, and continue on to a third country.

Over 100 Open Skies

While Open Skies agreements provide benefits to both passenger and cargo carriers, cargo carriers to a large extent fly international packages and freight themselves, while passenger carriers utilize codeshare agreements and worldwide alliances. The different business models and complex tie-ups can produce a divergence in interests. A prominent example was the dispute between the “Big Three” U.S. passenger carriers – American, Delta, and United – and the governments of the United Arab Emirates (UAE) and Qatar, who the carriers alleged were providing billions of dollars in subsidies and other benefits to their state-owned carriers: Emirates, Etihad, and Qatar Airways. Among other serious concerns, this raised red flags about subsidized fifth freedom operations (e.g., Newark-Athens-Dubai) and the potential for their expansion, negatively impacting U.S. passenger airline service to the Middle East and India.

U.S. Airlines for Open Skies, a coalition that included FedEx, Atlas Air, the Cargo Airline Association and JetBlue (which has a code-sharing agreement with Emirates), opposed the call of the Big Three for restricted Gulf fifth freedom rights (a violation of the U.S.-UAE and U.S.-Qatar Open Skies agreements if restricted involuntarily). The cargo carriers expressed concern that challenges to the Open Skies accords with Qatar and the UAE put at risk the fifth freedom rights that cargo carriers depend on for their complex global networks. They discounted the view that the U.S. could breach passenger fifth freedom rights without setting a dangerous precedent for the equivalent all-cargo rights.

The dispute was ultimately resolved in 2018 through U.S. government agreements with the Qatar and UAE governments under which the parties acknowledged that government subsidies adversely affect competition and committed to financial transparency and business on commercial terms.

Air Cargo Players

In the Upright Position for Takeoff

As passenger carriers step up to support cargo at this extraordinary time, you may not know that from 1997-2001, UPS also ran passenger operations. For a period of years, the company had contracts with tour companies and cruise lines to offer vacation flights as well as charters for college and pro sports teams, politicians, the press corps and others. In under four hours, a 727-100QC could be ready to carry 113 passengers. See here for the UPS Quick Change process.

Air cargo capacity is critical at this time of crisis and the airlines’ role is deemed a critical infrastructure industry by the Centers for Disease Control and Prevention (CDC). American Airlines reports that its recent cargo-only charter carried medical supplies, mail for active U.S. military, and telecommunications equipment and electronics to support people working from home. United’s wide-body charter cargo flights are likewise getting critical goods into the hands of businesses and people in need. Stakeholders across the cargo and passenger industries look forward to a post-pandemic era where all can return to their respective roles in transporting people and cargo globally, described well by United’s slogan “Connecting People. Uniting the World.”

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Leslie Griffin is Principal of Boston-based Allinea LLC. She was previously Senior Vice President for International Public Policy for UPS and is a past president of the Association of Women in International Trade in Washington, D.C.

This article originally appeared on TradeVistas.org. Republished with permission.

ustr

USTR Considers 301 Tariff Exemption Requests for COVID 19 Medical Supplies

As the country faces the global health crisis caused by the COVID-19 outbreak, recent announcements by the Office of the U.S. Trade Representative (“USTR”) signal the possibility of some relief from special tariffs on imports from China. Since July 2018, as reported previously here, the Trump Administration has imposed tariffs under Section 301(b) of the Trade Act of 1974 on nearly all U.S. imports of Chinese goods, including medical supplies that are now in high demand because of the outbreak.

USTR based the tariffs on its findings in an investigation of China’s acts, policies, and practices related to technology transfer, intellectual property, and innovation. There have been four rounds of tariffs, broadening the scope of products that are affected. With each round, USTR allowed requests for exclusion of particular products that are not adequately available in the United States.  Prior to the most recent announcements, the opportunity to request exclusions from any or all of the four lists had lapsed, but USTR continued to consider whether to grant requests that had already been filed but remained outstanding.

National priorities have changed as the COVID-19 outbreak in the United States has worsened, increasing the need for medical supplies. On March 25, USTR published a notice of the opportunity to request additional exclusions for products expected to be helpful in responding to the crisis.

Requests can be made through the online portal regulations.gov, but the window closes June 25, 2020, unless extended. Requests “specifically must identify the particular product of concern and explain precisely how the product relates to the response to the COVID-19 outbreak. For example, the comment may address whether a product is directly used to treat COVID-19 or to limit the outbreak, and/or whether the product is used in the production of needed medical-care products.” Decisions will be made on a rolling basis. Any responses to exclusion requests should be submitted within three business days after a request is posted.

In addition, USTR states that it has been prioritizing, in consultation with the U.S. Department of Health and Human Services, the processing of previously filed exclusion requests “addressed to medical-related products related to the U.S. response to COVID-19,” granting approximately 200 separate exclusions on March 10, 2020, March 16, 2020, and March 17, 2020. Products excluded in this manner have included medical masks and other personal protective products.

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By Matthew R. Nicely, Joanne E. Osendarp, Eric S. Parnes, Dean A. Pinkert and Julia K. Eppard at Hughes Hubbard & Reed LLP

supplies

FREE TRADE IN MEDICINES AND SUPPLIES IS THE HEALTHIEST APPROACH

What Does Trade Have to Do with the Pandemic?

pandemic is a type of epidemic, wherein an outbreak of a disease not only affects a high proportion of the population at the same time, but also spreads quickly over a wide geographic area.

As the novel coronavirus jumped continents, governments in countries yet unaffected or with low incidence rates moved to prevent “importing” the virus through individual travel. Simultaneously, governments acted to create diagnostic kits and treatments for those with the virus – all praise our frontline healthcare workers.

Unfortunately, what could worsen the situation is a policy practice that seems to be infectious. More than 20 governments are banning the export of needed supplies, a prescription for shortages and higher prices. What the crisis also lays bare is that key countries and many important healthcare products remain outside a WTO agreement that would otherwise enable duty-free trade in the medicines and supplies we need on a regular basis.

Pandemic Proportions

In the history of pandemics, there has been none more deadly than the infamous Bubonic Plague which took 200 million lives in the mid-14th century, wiping out half the population on the European Continent. The pathogen spread through infected fleas carried by rodents, frequent travelers on trading ships. The practice of quarantine began in the seaport of Venice, which required any ships arriving from infected ports to sit at anchor for 40 days — quaranta giorni — before landing. Two centuries later, Small Pox took 56 million lives. In the modern era, some 40 to 50 million succumbed to the Spanish Flu of 1918 and HIV/AIDS has claimed 25-35 million lives since 1981.

For perspective, and not to minimize its severe toll, the number of fatalities from novel coronavirus will likely exceed 10,000 by the time of this writing. COVID-19, as it is currently known, is a reminder that we live with the ongoing threat from many types of both known infectious diseases like cholera, Zika and Avian flu, as well as diseases yet unknown to us. Although we can more rapidly detect, contain and treat epidemics, diseases now travel at the speed of a person on board an international flight. Our cities are bigger and denser, further enabling rapid transmission.

Pandemic Prepping Includes Trade

Because we are interconnected, we share the health risks, but we can also problem-solve as a global community. Scientists in international labs share insights to identify viruses, swap guidance on how to conduct confirmatory tests, and quickly communicate best practices for containment.

Outside times of crisis, global trade in health-related products and services has laid the foundation for faster medical breakthroughs through international research and development projects, and by diversifying the capability to produce medical supplies, devices, diagnostics and pharmaceuticals.

Innovation thrives in the United States like nowhere else. Yet, no single country, not even the United States, can discover, produce and distribute diagnostics, vaccines and cures for everything that ails us — or invent every medical intervention that improves the productivity and quality of our lives.

One Quarter of medicines have tariffs

A Dose of Foresight

As the Uruguay Round of multilateral trade negotiations were drawing to a close in 1994, a group of countries representing (at the time) 90 percent of total pharmaceutical production came to an agreement. Each government would eliminate customs duties on pharmaceutical products and avoid trade-restrictive or trade-distorting measures that would otherwise frustrate the objective of duty-free trade in medicines.

The WTO’s Pharmaceutical Tariff Elimination Agreement, which entered into force on January 1, 1995, is known as a “zero-for-zero initiative” to eliminate duties reciprocally in a particular industrial sector. Signed onto over subsequent years by the United States, Europe’s 28 member states, Japan, Canada, Norway, Switzerland, Australia and handful of others, the agreement initially covered approximately 7,000 items that included formulated or dosed medicines, medicines traded in bulk, active pharmaceutical ingredients (APIs) and other chemical intermediaries in finished pharmaceuticals.

Signatories agreed to expand the list in 1996, 1998, 2006 and 2010 so it now covers more than 10,000 products. Tariffs were eliminated on a most-favored-nation basis, meaning it was extended to imports from all WTO members, not just parties to the agreement.

Maintenance Drugs

Though an important start, the agreement has not been updated in a decade. Trade in products covered by the WTO agreement has risen from $1.3 trillion in 2009 to $1.9 trillion in 2018. Yet, some 1,000 finished products and 700 ingredients are not covered under the agreement, leaving pharmaceutical trade subject to hundreds of millions in customs duties. With China and India increasing manufacturing over the last decade, the value of global trade included in duty-free treatment decreased from 90 percent in 1995 to 81 percent in 2009 to 78 percent in 2018.

It is challenging to chart trade statistics and tariffs on health-related products, particularly since many chemical ingredients have both medical and non-medical uses. Here we have attempted to reproduce tables developed by the WTO in 2010, but we do not include a large number of chemicals that have general use whose tariff lines were not enumerated in the WTO’s analysis.

Health Product Import Shares

In 2010, the European Union and the United States together accounted for almost half of all world imports of health-related products. Europe has become a much larger importer while U.S. imports have decreased slightly as a percentage of global imports. Imports by many big emerging markets including Brazil, Mexico, China, India and Turkey, have increased along with their purchasing power. These countries benefit from zero duties when importing from countries that signed on to the WTO Pharmaceutical Trade Agreement.

Health Product Export Shares

On the export side, Europe dramatically increased its share of global exports while the United States dropped across the board compared to 2010, particularly in medical products and supplies. China shows significant growth in exports of inputs specific to the pharmaceutical industry – including antibiotics, hormones and vitamins – as well as medical equipment including diagnostic reagents, gloves, syringes and medical devices. India also increased its exports of all types of pharmaceuticals, particularly ingredients, but did not drive up its share across all types of exported health-related products. China and India would benefit from zero duties without having to reciprocate for exports from countries that signed on to the WTO agreement.

That said, according to the trade data, China and India still only account for 5.4 percent of global exports in health-related products covered by the agreement. Therefore, simply expanding membership to include these countries is not sufficient to enlarge duty-free trade – the number of tariff lines covered by the agreement would also need to expand to capture a significant portion of traded healthcare products.

Emerging Market Pharm Trade

Tariffs as a Symptom

The final price of a pharmaceutical is determined by many factors that differ by country. Costs and markups occur along the distribution chain from port charges to warehousing, to local government taxes, distribution charges, and hospital or retailer markups. Tariffs may seem a relatively small component of the final price, but the effect is compounded as all of these “internal” costs accumulate and they are symptomatic of complex regulatory systems.

A 2017 study by the European Centre for International Political Economy determined that tariffs on final prices add an annual burden of up to $6.2 billion in China. In Brazil and India, tariffs on medicines may increase the final price by up to 80 percent of the ex-factory sales price. Imported pharmaceuticals are at a clear disadvantage and patients bear the burden in cost and diminished availability.

Side Effects

According to the U.S. International Trade Commission, the U.S. pharmaceutical industry historically shipped bulk APIs from foreign production sites to the United States before formulating into dosed products. After the WTO agreement, it became viable to import more finished products duty-free. Over the years, a failure to add more APIs to the duty-free list reinforced this trend. The U.S. Food and Drug Administration also allows firms to import formulated products prior to receiving marketing approval to prepare for a new product launch but does not allow bulk API importation before market approval.

The urgency to accrue adequate supplies and treatments for COVID-19 has reignited a debate on U.S. over-reliance on China and India for antibiotics, among other medicines. What if factories must close? What if China and India withhold supplies? If raw materials and ingredients are derived in those countries, would the United States be able to ramp up domestic production? The White House is considering incentives and Buy America government procurement requirements to stimulate demand for U.S. production and in the meanwhile has temporarily reduced tariffs on medical supplies such as disposable gloves, face masks and other common hospital items from China.

20 Countries Ban Medical Exports

A Cure Worse Than the Disease

Removing barriers to trade in essential products is a healthier approach than imposing restrictions that could exacerbate potential shortages.

Nonetheless, some 20 countries have announced a ban on the export of medical gear – masks, gloves, and protective suits worn by medical professionals. They include Germany, France, Turkey, Russia, South Korea, India, Taiwan, Thailand and Kazakhstan.

Governments generally do maintain national stocks of critical items to enable manufacturers to ramp up production in cases of health emergencies or address unexpected gaps in their supply chains. But when major producers withhold global supply, importing countries face shortages and higher prices. Dangerously, India’s trade restrictions go beyond medical gear to restrict export of 26 pharmaceutical ingredients. India, however, relies heavily on APIs imported from China for their medicines, much of it originating from factories in Hubei province where the outbreak emerged.

Bans tend to beget more bans, potentially wreaking havoc on pharmaceutical and medical product supply chains, making it more difficult for healthcare workers to stem spread of the virus. Poorer countries with already fragile and underfunded healthcare systems are left in an even more vulnerable position.

A Test for Public-Private Collaboration

Instead of export restrictions, governments can expedite purchase orders and otherwise support industry efforts to ramp up production for domestic and global use. Most global manufacturers are operating at several times their usual capacity since the initial outbreak in China. Private labs are utilizing high-throughput platforms to conduct more tests faster but require trade in the chemical reagents needed to start up and run the tests.

Biopharmaceutical firms are applying their scientific expertise to accelerate the development of a vaccine and treatments for COVID-19. They are reviewing their research portfolios, investigating previously approved medicines that have potential to treat the virus, and donating approved investigational medicines to the global research effort. Internationally, scientists are collaborating through a Norway-based nonprofit called the Coalition for Epidemic Preparedness Innovations on COVID-19 vaccine development. They know that the more options, the better – most drug candidates will not get through all three phases of clinical trials.

Recovery

Epidemic diseases evolve and they do not respect borders. Treating them, as well as the myriad chronic diseases and other ailments that affect us more routinely, requires new and adapted medical technologies arising from innovation made widely available through trade.

While there’s nothing inherently wrong with providing incentives to encourage domestic production, it should not come at the expense of free trade in health-related products. Tariffs should be eliminated on life-saving medicines and their ingredients. Governments must impose restrictions on exports temporarily and only when absolutely necessary. In this way, openness in trade will help promote the recovery of both our health and our economies.

Many thanks to economist and contributor Alice Calder for running all the trade numbers in this article. Full data tables may be accessed here.

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Andrea Durkin is the Editor-in-Chief of TradeVistas and Founder of Sparkplug, LLC. Ms. Durkin previously served as a U.S. Government trade negotiator and has proudly taught international trade policy and negotiations for the last fifteen years as an Adjunct Professor at Georgetown University’s Master of Science in Foreign Service program.

Alice Calder

Alice Calder received her MA in Applied Economics at GMU. Originally from the UK, where she received her BA in Philosophy and Political Economy from the University of Exeter, living and working internationally sparked her interest in trade issues as well as the intersection of economics and culture.

This article originally appeared on TradeVistas.org. Republished with permission.

wellness medical bed market

Report: Medical Bed Market

The global geriatric population is on the rise with the population aged over 65 years set to outnumber children under the age of 5 years over the coming years. Older people are generally more susceptible to infectious or chronic ailments, mostly due to age-related deterioration of the immune system. This vulnerability to various health risks including contagious and chronic diseases, as well as injuries associated with falls and physical disabilities is likely to add impetus to the global medical bed market.

The surge in the occurrence of chronic ailments is also causing a rise in hospitalizations for accurate and effective patient care. This upsurge in tandem with rising disposable incomes and rapid healthcare infrastructure advancements are promoting the widespread acceptance of medical beds on a global scale.

Several favorable healthcare policies and mandates have been enacted to ensure the availability of proper and effective medical care to those in need. For instance, in March 2017, the Indian government released a healthcare reform that requires healthcare facilities to have a minimum of 2 beds per 1000. This means there will be nearly 2,623 beds over the coming decade, including new as well as replacement beds.

Elderly population growing at a rapid pace

The older generation, or the “baby boomers”, account for a large chunk of the global population, and rising. In 2019, the number of individuals over the age of 65 years was recorded at nearly 703 million. This number is set to double by 2050 to reach 1.5 billion.

Most frequent users of the Emergency Department or ED services are elderly people suffering from one or more chronic ailments. Common maladies associated with old age include cataracts and vision deterioration, hearing loss, back, neck pains and osteoarthritis, diabetes, cardiovascular conditions, dementia, and depression, among others. As a result of this, the demand for effective and adequate emergency services has been growing extensively of the past year, proliferating the requirement for efficient healthcare equipment, including medical beds.

The growing elderly population has also brought about the establishment of dedicated geriatric healthcare facilities like Athulya Assisted Living, the brainchild of Karthik Ramakrishnan. The facility, located in Chennai, is considered a premium assisted living center and features myriad advanced healthcare provisions including sophisticated ECH machines, assisted medical beds as well as trained healthcare staff.

Rising occurrences of chronic ailments and subsequent rise in hospitalizations

The rapid expansion of the elderly population is also leading to a higher prevalence of chronic health conditions such as diabetes, cancers, cardiovascular ailments, stroke, and respiratory ailments. This increase is likely to assert pressure on healthcare systems to be able to provide adequate care and treatment to these patients.

In 2017, emergency department visits from patients suffering from at least one chronic condition accounted for nearly 60% of the cumulative annual visits, incurring an expenditure of nearly $8.3 billion.

Furthermore, over 90 million U.S residents suffer from at least one chronic condition, with seven out of 10 individuals succumbing to a chronic ailment. These numbers indicate a strong need for effective medical equipment including sophisticated medical beds.

While there are several healthcare systems put in place for the treatment of acute medical issues, many facilities are not equipped to deal with chronic ailments and long-term care. Given the prolific rise of chronic disease cases, medical bed industry players are taking consistent efforts towards developing revolutionary healthcare solutions geared towards long-term treatment.

The emergence of new healthcare technologies

For hospitalized patients, hospital bed security is characterized by sporadic visits from nurses and doctors. Due to this, any potential decline in the patient’s clinical condition may go unnoticed for a period of time, causing a delay in treatment administration and increasing the risk of mortality or morbidity.

However, in recent times, many up and coming technologies are coming into existence, designed to combat this issue and mitigate risks associated with hospitalization.

In fact, the digital healthcare sector is expected to hit $536.6 billion by 2025.

One of the most prominent advancements in the medical bed industry is brought forth by Hill-Rom, a multinational medical technologies provider and the foremost hospital bed producer in the world. Hill-Rom has unveiled a new technology called EarlySense, designed to integrate with Hill-Rom’s Centrella Smart+ bed platform and provide continuous, contact-free monitoring solutions including heart and respiratory rate sensing and analytics system.

Additionally, a new study published in an American Society for Microbiology journal has revealed that using copper as a component in ICU medical beds would harbor an average of 95% less bacteria than conventional beds, ensuring low-risk levels among hospitalized patients.

Source: https://www.gminsights.com/industry-analysis/medical-bed-market

First-of-its-Kind Brain Health Supplement Aims to Improve Cognition, Memory

America’s newest brain health supplement may come in a small capsule, but according to scientific studies, its benefits could be huge. Sophrosyne, a first-of-its-kind breakthrough product launched this month, has a unique combination of four mind-boosting ingredients clinically proven to improve cognition and memory.

“This is great news for seniors and anyone looking to sharpen their memory, and also for military veterans or athletes who may experience frequent hits to the head,” said Dr. Daryl Rhys Jones, a top neuroscientist formerly with the Mayo Clinic and current CEO of Jonescientific, who led the development of Sophrosyne after years of research and testing. “With its unique mix of ingredients present at clinically active doses, there is nothing as effective as Sophroshyne on the market.”

In fact, no other known brain health product in the U.S. has been developed by a neuroscientist – an expert in the development and function of the nervous system, including the brain. Dr. Jones – who has done extensive research on Alzheimer’s and Chronic Traumatic Encephalopathy (CTE) – and his team scientifically evaluated hundreds of ingredients for their memory and cognition-building properties and produced the supplement using what they found to be the four most effective ones: withania somnifera, curcumin, bacopa monnieri and hericium erinaceus.

What sets these ingredients apart? Here’s a breakdown from Dr. Jones:

Withania somnifera. This plant – commonly known as Indian ginseng, Ashwagandha or winter cherry – has been proven to regenerate damaged brain cells.

Curcumin. A natural chemical produced by some plants, featuring antioxidant properties, this ingredient has shown to help maintain a healthy environment within the brain by removing unwanted proteins. An 18-month UCLA human clinical trial confirmed that consuming 180 mg of curcumin per day led to significantly enhanced memory and focus.

Bacopa monnieri. In at least four randomized, double-blind, placebo-controlled human trials, this herb has been demonstrated to enhance cognition and memory, and decrease the rate of forgetting newly-acquired information. It was shown to prevent the breakdown of neurotransmitters essential for cognition and memory.

Hericium erinaceus. Also known as Lion’s mane due to its unique appearance, this medicinal mushroom has been found to increase levels of peptides essential for the survival of brain cells. In a 16-week double-blind, parallel-group, placebo-controlled human trial, a high dose of this ingredient was found to improve cognitive function in seniors.

“Our research shows that these four nootropic (cognitive enhancing) ingredients, consumed in a daily capsule, deliver the most impressive results in improving cognition and memory compared to any other supplement available on the market,” said Dr. Jones, who cautions against taking other brands of supplements with a large ingredient list, due to the danger of losing the protective effects of a product that likely contains only minimal amounts of each ingredient crammed into one capsule.

A daily dose of Sophrosyne contains science-backed, clinically active doses of 500 mg of withania somnifera, 180 mg of curcumin, 300 mg of bacopa monnieri and 500 mg of hericium erinaceus.

For more information, please visit: Www.jonescientific.com