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FREE TRADE IN MEDICINES AND SUPPLIES IS THE HEALTHIEST APPROACH

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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.

__________________________________________________________________

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.

medical equipment

Guide to Preparing Medical Equipment for Shipping

Shipping medical equipment is inseparable from diverse challenges shippers have to face and overcome to orchestrate and eventually conduct the process without any difficulties. The most common challenges refer to the efforts to provide these items with utmost security through each and every stage of the process. Should any of the items get damaged or destroyed, the party in charge will have to deal with costly repairs or, even worse, complete replacement of the item.

The most viable solution lies in preparing medical equipment for shipping properly so as to minimize the chances of an accident. Here is what you have to bear in mind before you start negotiating shipping terms.

Evaluation prior to packing

What inevitably precedes the process of packing and preparing medical equipment for shipping is a thorough evaluation. This step is necessary because these items vary considerably in terms of size, shape, fragility, and weight. Consequently, to be able to complete the task efficiently and successfully, one has to know precisely the type and amount of equipment that is to be shipped.

Medical equipment should be handled with the utmost care and by experts who possess the expertise, experience, and appropriate equipment to respond to the demands of the task accordingly. An amateur cannot understand the delicacy of the process, which further results in increasing the risks of damage or even destruction to some of the medical equipment during the shipping process.

Tailored packing is crucial

While ordinary packing supplies will undeniably be suitable for some medical equipment, there are those items that require using custom-built crates or specific packaging solutions for impeccable security. The above-mentioned evaluation, hence, proves to be crucial for this purpose. Once you know exactly the size of items and when you analyze those which are awkwardly-shaped or extremely heavy, you will be able to request engineering of the crates that guarantee protection from abrasion, shock, moisture, temperature change, and vibration.

What packing supplies are necessary?

When preparing medical equipment for shipping, using specialized packing materials is a must. Understandably, for some pieces of equipment, you can use standard cardboard or plastic boxes, but generally, the most sensitive pieces require the already mentioned custom-built crates for excellent protection. In addition, using premium-quality cushioning materials is the strategy you need when eliminating any chances of damage is what you strive for.

If you opt for maritime shipping after analyzing the pros and cons of this decision, looking for vapor barrier packaging solutions becomes inevitable. In these circumstances, it is of utmost importance to use moisture and vapor-proof packaging to prevent corrosion on metal surfaces that can seriously harm the functionality of the equipment.

Professional assistance is mandatory when preparing medical equipment for shipping

There are numerous, respectable companies in the shipping industry that offer their impeccable service to various clients. Regardless of the airfreight vs. sea freight dilemma you might be experiencing, there is no place for questioning your decision to hire professionals for this task. However, to be able to monitor the process and assess the quality of the service you get, it is critical to get an insight into the usual practice when preparing medical equipment for shipping is in question.

Conduct detailed research before you find the shipping company you can trust. You need one which employs genuine professionals who know how to pack diagnostic, surgical and lab equipment, CT scanners, lasers, X-ray devices, and MRI machines. They need to be reliable and competent to dismantle these pieces of equipment, secure all the parts, pack, and, finally, load these into a shipping container. Online reviews are a good starting point for your search. Requesting free no-obligation cost estimates can help you know what budget you will need for this endeavor.

Obtain insurance

An essential step in the process of preparing medical equipment for shipping is getting the proper insurance by all means. No matter how well the preparations have been conducted, there is always a risk of unforeseen accidents that might endanger the safety of equipment in the shipping process. Concerning the value of the items you want to ship, obtaining proper insurance must not be neglected. It is important to be entitled to a reasonable compensation should some of your pieces of equipment get damaged or destroyed on the way to their final destination. This is the only solution that guarantees you peace of mind and the knowledge that you have covered all the potential scenarios of the upcoming shipping process.

Preparing medical equipment for shipping requires time

Time is what you need to handle each task with utmost commitment and undivided attention and finally prepare medical equipment for shipping well enough. Starting well in advance means an opportunity to reconsider some decisions before you make them final. If you understand how delicate this process is, you will understand how important it is to bring all the potential difficulties to a minimum. Professional assistance is the core of this process because you need the expertise to complete the process successfully.

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Ian Miller has devoted his time to studying shipping industry challenges and he frequently writes articles on this subject for companies such as Four Winds Bahrain. Ian has cooperated with many shipping companies and is now writing a study on the effects of technology on the shipping industry.

pancreas

First-of-its-Kind Bio-Artificial Pancreas on Track for Type-I Diabetes Cure

Imagine a world where those living with Type 1 Diabetes, a chronic illness affecting more than 60 million adults globally, no longer had to deal with regular blood glucose monitoring, daily insulin injections or life-threatening nighttime hypoglycemic events, but instead could eat, exercise and sleep worry-free. That’s the kind of future an up-and-coming breakthrough technology is on track to creating.

Beta-O2 Technologies, a privately held biomedical company headquartered in Israel with research and industry affiliates across the U.S., is working to deliver a first-of-its-kind bio-artificial pancreas as a safe, effective and long-term cure for the disease. With preliminary animal trials showing promising results for its second generation breakthrough device, called Bio-artificial Pancreas (ßAir), the company is planning to begin human clinical trials within the year.

“We have strong pre-clinical evidence to prove the safe operation of our device on animals,” said Beta-O2 CEO Amir Lichter, noting that the second generation ßAir is performing well in ongoing animal studies. “It’s an enormous achievement that is paving the road for human trials.”

Measuring approximately 2.5 by 2.5 inches, ßAir is made of titanium. It has two components: a macrocapsule that contains pancreatic cells and an oxygen tank equipped with an external port, so patients can easily refresh oxygen levels weekly. Once implanted under a patient’s skin, it becomes a natural source of insulin, sensing blood glucose levels and delivering insulin as required.

While there are a couple of other artificial pancreatic solutions being explored by different industry players, Beta-O2’s disruptive technology is the only bio-artificial pancreas to incorporate an active oxygen supply, necessary to keep the pancreas cells in the implanted device functional and viable over the long term. Other solutions are demonstrating limited success because they rely on a patient’s bloodstream to deliver enough oxygen to keep the transplanted cells viable, which is problematic, Lichter explained.

“Pancreas cells (islets) are extremely delicate,” he said. “We solve the problem by proactively supplying oxygen through an external source, providing a superior solution.”

Lichter said the beauty of the Beta-O2 solution — which holds 10 global patents for its exclusive immune protection capabilities and oxygen supply mechanisms — is that it’s very generic, meaning “it can contain cells from a human donor, cells from the pancreas of a pig, or cells derived in a lab from stem cells.” Other advantages are that Beta-O2’s bio-artificial pancreas does not require a patient to take intensive immunosuppression therapies after implant due to its protective encapsulation capabilities, and the device can quickly be retrieved from a patient if necessary due to malfunction or other health concerns, he explained.

U.S. affiliates helping to bring product to market

Beta-O2 is currently collaborating with several U.S.-based pharmaceutical companies and academics, including researchers from Harvard University, MIT, University of Virginia and Cornell University, to further enhance the ßAir oxygen supply and its ability to measure glucose levels and secrete insulin once implanted. The company is also in negotiations to solidify its collaboration with several stem cell providers as it looks to secure an additional $15 million in investment funds to support its aggressive go-to-market strategy.

“The active oxygen supply used by Beta-O2 is currently the best and most advanced technique for maintaining viability and function of large numbers of pancreatic islets (or stem cell-derived islets) in an encapsulation transplantation device,” said Clark K. Colton of the Department of Chemical Engineering at MIT and Beta-O2 Scientific Advisory Board member.

Calling the Beta-O2 device a “next-gen treatment option,” Dr. José Oberholzer, Professor of Surgery, Biomedical Engineering and Experimental Pathology at the University of Virginia and Beta-O2 Scientific Advisory Board member, explained that “after years of insulin injections and ‘closed-loop’ insulin pumps and glucose sensors, patients will finally have access to a biological device solution to treat the most brittle forms of diabetes. The Beta-O2 device is the only implant that has shown reproducible results in humans with diabetes, with measurable insulin production originating from human islet cells within the device without the need for recipients to take any immunosuppressive drugs.”

An earlier safety trial involving four patients in Sweden, supported by New York-based JDRF (Juvenile Diabetes Research Foundation), successfully demonstrated that Beta-O2’s device is fully safe for use. No side effects were observed in patients who carried the device for up to 10 months, and the cells remained viable and functional.

Now, current animal trials underway at Beta-O2 are focused on extending the life of functional cells even further, with promising early results showing that rats implanted with ßAir are maintaining normal glucose levels.

“With tangible evidence that we can maintain the viability and functionality of our cells for a long duration in rats, which have an immune system very similar to humans, we are looking forward to moving ahead with our second round of human clinical trials,” Lichter said, noting that the company aims to be first to show that implanted biological pancreatic cells can successfully achieve normal blood sugar levels in diabetic patients without the need for immunosuppression therapy.

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About Beta-O2 Technologies Ltd. (www.beta-o2.com)

Beta-O2 Technologies Ltd. is a biomedical company developing a proprietary implantable bioreactor, the ßAir, for the treatment of Type 1 Diabetes. ßAir is designed to address the main problems of the otherwise successful procedures in which islets of Langerhans (i.e. pancreatic endocrine cells) are transplanted in diabetic patients, such as the need for life-long immunosuppressive pharmacological treatment and limited functionality of the transplanted islets over time due to an insufficient oxygen supply. Beta-O2 investors include SCP Vitalife Partners, Sherpa Ventures, Aurum Ventures, Pitango Venture Capital, Saints Capital, Japanese and Chinese private investors.

Special Report: How to Keep Shipments Moving Forward During a Global Health Emergency

Delayed start to the new year
The coronavirus outbreak has prompted an official global health emergency that is severely affecting business operations not only in China but also around the globe. With any kind of widespread health outbreak, global importers and exporters are dealing with unpredictable logistics concerns that require a proactive approach to keep business running as usual.

It’s important to note that any cargo from the Wuhan, Hubei Province (the origin of the outbreak), and other quarantine zones, are restricted from leaving the province, which includes full container loads (FCL), less than container loads (LCL), as well as air freight. There will also be delays in factories re-opening, and a reduction of exports from China due to Wuhan residents not returning to work until February 17th, 2020 and other municipalities extending Chinese New Year until February 9th, 2020, including:

-Shanghai Municipality

-Chongqing Municipality

-Jiangsu Province

-Zhejiang Province

-Guangdong Province

-Fujian Province

The latest in air and ocean travel

In general, there has been an increased reduction in travel in and out of China. In areas where travel is permitted, strict health checks are causing significant delays at main air and ocean terminals, to ensure the safety of all travelers and workers. While the Wuhan port is closed, the other ports continue to operate. We also continue to see several airlines canceling flights in and out of China which can have an impact on cargo capacity.

Below are important considerations that will help keep your supply chain moving and better navigate any shipping challenges associated with the latest travel restrictions and schedule shifts.

Assessment of inventory levels

Having an accurate assessment of your inventory is expected, but it’s important to understand how restrictions on imports from China will impact your current inventory and regular shipping cadence. Look ahead to determine if the demand for your product may change in the next few weeks and if you have a need for expedited shipping. Starting those conversations now and establishing a plan are important as air capacity falls due to canceled passenger flights and higher demand.

Planning ahead in production

There are numerous variables to consider when planning for production. Working through these with a supply chain expert will help you be prepared and proactive as the uncertainty around the virus continues.

-What will production look like and has there been any discussion with the vendors and factories?

-How are existing inventories compared to sales projections?

-What plans are in place in case there is a shortage of workers in China or the demands are not being met within a specific window of time?

-Has there been a discussion about how the backlog will be addressed?

Backup sourcing options

When there is any kind of delayed start to production, keeping up with the workload poses a challenge, and so you may need to consider backup sources. Backup sourcing options are not always easy to find and keeping up with the sheer demand and quality controls can be a challenge. Connecting with a global supply chain expert to vet reliable options is important to ensure success.

While we may not know how long this global health emergency will last, C.H. Robinson’s global network of experts are dedicated to helping you get your shipments where they need to be. We continue to closely monitor the situation and provide updates through our client advisories as needed.

genetic testing

Global Genetic Testing Market to Hit $25 Billion by 2025

Genetic Testing Market is expected to exceed USD 25 billion by 2025. Growing incidences of genetic diseases coupled with the rising availability of advanced genetic tests will augment the industry growth.

Increasing awareness regarding the availability of genetic tests should escalate the genetic testing market growth throughout the forecast years. Industry players implement several promotional activities that raise awareness amongst the people. Moreover, due to increasing internet penetration in developing economies, individuals are becoming aware of the benefits of early diagnosis of genetic diseases. Above mentioned factors should surge the industry growth. However, the high cost of genetic testing may affect industry growth to some extent.

The unprecedented growth pace of the genetic testing market is rather evident from 23andMe’s recent launch of a grant program as a part of its Genotyping services for the research platform. A significant market contributor globally, through this invention, aims at promoting research studies with the intent to increase the revenue shares in the upcoming years. This trend itself bears testimony to the fact that the chief market players are opting for strategic moves to strengthen their position in the global genetic testing market share.

A business vertical of high repute, thriving extensively on personalized medicines, genetic testing market as of today stands as one of the outpaced, profitable industry spheres there is. Endorsed by the availability of technologically sound gene diagnosing kits and elevating cognizance regarding the use of personalized medicines, the commercialization potential of the genetic testing industry has surged immensely in the past few years.

Speaking of the test type spectrum, the carrier testing segment has stood tall during the past few years and is likely to develop at an appreciable pace during 2019-2025. For the records, the carrier testing segment accounted for USD 460 million in 2018. These tests find large scale use among couples to determine the chances of having a child with genetic disorders.

Also, they focus on detecting the probability of a healthy person carrying mutated genes. These factors have prompted healthcare professionals to recommend required treatments for the individuals comprising mutated genes thereby adding an impetus to genetic testing market trends.

North America’s genetic testing market will foresee over 10% growth throughout the forecast years. Increasing prevalence of genetic diseases will prove beneficial for regional growth. Cystic fibrosis, sickle cell anemia, thalassemia, and other genetic disorders affect millions of individuals in the U.S. annually that should spur the demand for upgraded genetic tests. Moreover, favorable regulatory scenario for genetic tests will further positively influence regional growth.

Companies are undertaking several initiatives to add innovations in the genetic testing market. Additionally, industry players such as 23andMe, BGI, BioMerieux, Cepheid, Counsyl and others have implemented several strategic initiatives such as mergers, acquisitions and product launches for gaining competitive advantage. For instance, in October 2016, 23andMe announced the launch of a grant program as part of its Genotyping Services for Research platform. The program is aimed at promoting research studies and obtaining proposals in which 23andMe experience is likely to garner more customers. This strategy will enhance 23andMe’s business grow

Source: https://www.gminsights.com/industry-analysis/genetic-testing-market,m

vaccines

Report: Global Vaccines Market

The U.S. vaccine market is anticipated to experience growth of 8.9% CAGR during the forecast timeframe. The high adoption rate of vaccines to reduce the incidence of infectious diseases along with several initiatives undertaken by government by increasing immunization rates and recommendations should stimulate business growth.

Japan’s vaccine market will grow significantly over the coming years to reach over USD 6.0 billion by 2025. Introduction of the routine vaccination program in October 2016 leading to the introduction of numerous important and routine vaccines having a higher rate of administration as compared to voluntary vaccines should drive the Japan vaccine market.

Increasing demand for preventive vaccines, the rising number of people suffering from infectious as well as non-infectious diseases globally will drive the vaccine market over the forecast timeframe. Increasing government funding for vaccine development will further boost industry growth.

Widespread routine vaccination programs and numerous initiatives undertaken by governments to encourage vaccine administration especially in developing and underdeveloped countries will positively impact industry growth. Growing awareness about reduced mortality due to immunization should propel vaccines industry growth over the forecast period.

High adoption of new vaccines coupled with technological advancements should stimulate business growth. Moreover, a strong product pipeline of leading companies such as Merck, Novavax, Emergent BioSolutions will lead to industry expansion over the coming years. However, high costs associated with transportation and storage of vaccines will limit the vaccines market growth to a certain extent over the foreseeable future.

Each time a nation is hit by an epidemic wave, children are one of the groups that take the deadliest hit. According to the Centers for Disease Control and Prevention, 1 or 2 of every 1,000 children who are diagnosed with measles die. During the nation’s recently witnessed measles outbreak, around 92 percent of children received a combination vaccine that prevents measles, rubella, and mumps. Immunization programs prevent and protect toddlers and infants from dangerous complications and failing to vaccinate may certainly put them at risk for fatal diseases. This has escalated the demand for vaccines for kids, which has subsequently influenced the growth curve of the vaccines market from the pediatric populace.

As per estimates, vaccines industry size from the pediatric age group is set to witness a CAGR of 9.1% over 2019-2025, given the high vulnerability of kids to infectious diseases along with the increasing implementation of pediatric immunization programs.

Driven by the ongoing pace of urbanization and the rising awareness regarding the potential dangers a pandemic can inculcate, the global vaccines industry is gaining increased attention. According to a new research report by Global Market Insights, Inc., the overall vaccines market size is anticipated to surpass $70 billion by 2025.

Some of the major market players involved in the global vaccines market are Merck, AstraZeneca, Johnson & Johnson, Novartis, Bristol-Myers Squibb, Abbott, Sanofi Pasteur, GlaxoSmithKline, Pfizer, Emergent BioSolutions, CSL, Astellas Pharma and Novavax. Firms are focusing on product launch to fortify their product base and market reach over the coming years.

Source: Global Market Insights, Inc.

diabetes

Global Diabetes Care Devices Market Report

The revenue graph of the diabetes care devices market has been witnessing considerable momentum in recent years owing to the increasing usage of self-monitoring blood glucose and insulin delivery devices. Obesity, smoking, genetic mutations, a sedentary lifestyle, unhealthy diet have led to an escalation in the number of diabetes patients. The occurrence of diabetes is gradually rising, such that more than 1 in every 10 adult individuals or 12.2% of the U.S. population aged 18 years or older is affected with it. Diabetes is considered as the seventh leading cause of death.

According to WHO, 422 million adults globally are diabetic patients, 1.6 million deaths are directly attributed to diabetes each year and 1 in 3 adults aged over 18 years is overweight and 1 in 10 is obese. In essence, all these statistics demonstrate the rapid growth in the number of diabetic patients which has driven the growth prospects of the diabetes care devices industry. According to a research report by Global Market Insights, Inc., the revenue portfolio of the diabetes care devices market will exceed USD 41.5 billion by 2025.

Diabetes is increasing among adults as well as children due to the prominence of an indolent lifestyle. In 2016, 41 million infants and young children were reported to be obese or overweight, 124 million children and adolescents were obese which counts to be a tenfold increase in the last four decades and nearly 1 in 5 children and adolescents are overweight or obese. Obesity is the primary cause which has led to the prevalence of diabetes as almost everyone prefers to enjoy an unhealthy lifestyle without realizing the significance of physical wellness. As per the Pan American Health Organization (PAHO), around 305,000 people died due to type 2 diabetes in America in the year 2014.

Increasing count of deaths due to diabetes has intensified the sales of diabetic care devices. The latest technologies and devices are being preferred over traditional techniques due to their ability to deliver accurate results. Launched recently, Senseonics’s Eversense Continuous Glucose Monitoring (CGM) system is one such unique and revolutionary device. Termed as the first implantable device to measure glucose level, Eversense CGM has received approval from the U.S. Food and Drug Administration (FDA) which is being touted as a groundbreaking step forward in the dynamic diabetic management world.

The device uses a unique light-based technology to send glucose level data to an app on cell phone, warning patients about their rising or dropping glucose level. It can be worn up to 90 days which is impressive as Dexcom and Medtronic’s sensor technology can be used for up to 10 days only. Eversense CGM is one of many innovations unveiled by medical device makers to check on diabetes and demonstrates the enormous growth opportunities being opened up for the diabetes care devices industry.

Numerous innovations in the healthcare sector have ensured that several options and product ranges are available to keep a check on diabetes. Many of these are in the pipeline and are awaiting regulatory approval. For instance, a ready-to-use glucagon emergency pen by Xeris Pharmaceuticals is awaiting regulatory approval from FDA depending upon the meeting in June 2019. Apparently, there are a number of devices in the early production phase or are seeking FDA approval – a factor that would benefit the growth prospects of diabetes care devices market.

Moreover, myriad studies are being carried out today to find out new approaches to manage diabetes. For instance, the Juvenile Diabetes Research Foundation (JDRF) is a non-profit organization which offers funding to cure type 1 diabetes (T1D). The organization has invested over $2.2 billion in research funding since its inception. A T1D patient Lindsey Redepenning is a commendable example of recovery through Medtronic 670g Artificial Pancreas hybrid closed-loop system developed with the contribution of JDRF. Implantation of artificial pancreas is a new technology that effectively helps in curing T1D by releasing insulin in with changing blood glucose levels in a similar way to a human pancreas.

In a nutshell, rising number of R&D investments and consistent efforts of non-profit organizations like JDRF will propel diabetes care devices market share. Additionally, the launch of technologically-superior and highly efficient blood glucose measuring devices is likely to assist the diabetes care devices market in registering exponential growth in the times to come.

Source: Global Market Insights

ups flight forward

UPS Flight Forward Boasts First-Ever Part 135 Standard Certification

Drones continue to make news headlines with the latest announcement from UPS Flight Forward, Inc. confirming the first-ever government-approved Part 135 Standard certification awarded by the FAA earlier this week. This certification – which is known as the highest level, supports the UPS subsidiary to further opportunities in drone deliveries including operating drones beyond the visual line of sight (BVLOS).

“This is history in the making, and we aren’t done yet,” said David Abney, UPS chief executive officer. “Our technology is opening doors for UPS and solving problems in unique ways for our customers. We will soon announce other steps to build out our infrastructure, expand services for healthcare customers and put drones to new uses in the future.”

UPS Flight Forward deployed the first BVLOS drone delivery to WakeMed’s hospital in Raleigh, North Carolina shortly after receiving the certification. The government-exempted BVLOS flight was carried out by Matternet’s M2 quadcopter. UPS partnered with drone creator Matternet earlier this year to expand supporting healthcare delivery operations specifically for WakeMed’s hospital campus. These operations further reiterate the demand for efficient, speedy deliveries for the medical industry and its patients.

“UPS Flight Forward is benefitting from our knowledge as one of the world’s leading airlines. The Flight Forward organization is building a full-scale drone operation based on the rigorous reliability, safety, and control requirements of the FAA,” Abney said.

The Part 135 Standard certification carries significant advantages with minimal restrictions to UPS, such as no limits on the scale of operations, unlimited numbers of drones and remote operators, cargo weights exceeding 55 pounds, and more. By obtaining this certification, common barriers associated with drone deliveries are eliminated.

“This is a big step forward in safely integrating unmanned aircraft systems into our airspace, expanding access to healthcare in North Carolina and building on the success of the national UAS Integration Pilot Program to maintain American leadership in unmanned aviation,” said U.S. Secretary of Transportation Elaine L. Chao.

drugs

WHAT TODAY’S USMCA DEBATE HAS TO DO WITH THE DRUGS OF TOMORROW

The political winds seem to be blowing in favor of a Congressional vote on the U.S.-Mexico-Canada Free Trade Agreement (USMCA) yet this fall. But before they vote, some Members of Congress want to talk over a few issues with the Trump administration’s negotiators. They are pressing the administration to lower intellectual property protections for the U.S. biopharmaceutical industry because they say the agreement’s provisions protecting original data generated by pharmaceutical inventors will drive up the price of prescription drugs.

Their arguments strike a political nerve but don’t offer a complete picture of this complex and evolving industry. The USMCA debate reflects a domestic difference in views. While the United States works to develop its regulatory framework for newer drugs, many other markets are further behind. As important as it is, the issue of data protection for biologic drugs is not well understood. We’ll try to cover the top lines.

Pieces of the Intellectual Property Puzzle

For American innovators of biopharmaceuticals, gaining access to overseas markets requires not only securing regulatory approvals; the policy environment must also be conducive to marketing their products, which includes a value-based approach to pricing, procurement, reimbursement policies – and intellectual property protections.

There are various facets to the intellectual property (IP) protections needed to incentivize massive investments in pharmaceutical innovation and to enable the recovery of those costs once a drug is commercialized. Patents are part of the package and so is the protection of proprietary data, the issue at the fore in discussions about USMCA.

These protections are particularly important to American companies. The intellectual property attached to 57 percent of the world’s new medicines was created in the United States. That’s no accident. Research and development activities flourish in countries where IP frameworks are well developed and enforced.

70% drug dev

What is Data Protection?

To achieve marketing approval from a regulatory oversight agency such as the U.S. Food and Drug Administration and its counterparts in other countries, innovator pharmaceutical companies submit data on the outcomes of their research and years of clinical trials demonstrating the drug is effective and safe. The cost and risks of developing the original data and product fall to the inventor.

When a generic producer or producer of a “biosimilar” seeks approval, they are often afforded the short cut of relying on the inventor’s data. To ensure a balance between incentivizing drug discovery and development while also providing opportunities for lower-cost copies to become available, the inventor’s data may be protected for a period of time against disclosure to generic or biosimilar producer. During this time, any competitor is free to undertake their own data and seek marketing approvals on that basis.

For How Long?

Provisions on data protection are not new in domestic regulations or in trade agreements. Since the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in 1995, World Trade Organization (WTO) members have agreed not to disclose clinical data submitted to regulatory authorities to obtain marketing approval for pharmaceutical products, thereby protecting such data “against unfair commercial use”.

Negotiators of the TRIPS Agreement contemplated specifying that data protection should be no less than five years, but ultimately refrained from including a specific timeframe, leaving it to the discretion of WTO members in their national regulations. NAFTA, which took effect in 1994, provides a minimum of five years.

Enter a New Type of Drug

The timing of these provisions is relevant to the debate today. The TRIPs and NAFTA provisions apply to new “chemical entities,” meaning small molecule drugs – that is, most drugs on the market to date. These types of drugs are capable of being replicated through chemical synthesis to make generic drugs. For this reason, regulators tend to agree that requiring duplicate data from generics would be an inefficient use of resources and unnecessary testing of patients, as long as the generic product is proven “bioequivalent” to its reference product.

Biologics are newer medicines. They are large, complex molecules that are made from living cells to produce the required proteins. This manufacturing process is vastly more complex. A follow-on product is not identical, but rather structurally similar and thus called a “biosimilar”. An exact replica is not possible, and patients cannot automatically be switched from a biologic to its biosimilar without risk of adverse effects.

Given the differences between biologics and small molecule drugs, they are regulated differently, and the IP protections have been applied differently. Biologics are largely defined by their manufacturing processes and regulatory approval of biosimilars does not require identity with the reference product, so biologics must often rely only on process patents versus a product patent. Innovator companies argue a longer term of data protection is needed to bridge the differences in patent protection or to offset the lack of patent protections in some countries, while allowing them to recover the increased cost of generating the original data.

New Trade Provisions for Biologics

Given the longer innovation cycle and the increased cost and complexity of biologics, many governments have provided longer periods of data protection for biologics than for small molecule drugs.

In the United States, the Biologics Price Competition and Innovation Act signed into law by President Obama in 2016, provides for a 12-year period of regulatory data protection for biologics. American companies have sought the same standards from trading partners.

With new agreements in the WTO largely stalled, the focus of trade negotiations over the last decade has shifted to bilateral and regional trade agreements where provisions are often more detailed and tailored. In negotiations toward the Transpacific Partnership Agreement (TPP), the United States pushed for 12 years, but agreed to eight years for biologics from the date of first marketing approval and allowed flexibility in how data protections could be administered. When the United States withdrew from the TPP, the remaining members suspended the relevant provisions.

In the USMCA, American biopharmaceuticals again did not get everything they wanted. Canada and Mexico do not have to match the United States in providing 12 years but agreed to increase the duration of data protection to 10 years from the current standard of five years in Mexico and eight years in Canada.

10 years in USMCA

Why Push Trading Partners to Increase Data Protections?

Beyond North America, the so-called “pharmerging” markets (generally the large developing countries) are growing faster than the stable developed markets. China is by far the largest emerging market for pharmaceuticals. In many developing countries, patent systems are weak or poorly enforced. Regulatory data protection provides some buffer against IP exposure, making it viable and more attractive for companies to introduce their products in that market.

Less data protection and lack of enforcement diminish the potential for U.S. exports. It also leaves the door open for competitors to access unprotected U.S. data without the originator’s authorization. Trade agreement obligations help guard against the unfair commercial use of proprietary data and expand the degree of IP protections in global markets, which is a precursor to greater diffusion of innovative drugs to patients worldwide.

Back to the Core Concerns – Availability and Costs to Patients

Critics of USMCA’s provisions argue data protections keep the prices of biologics high by delaying the introduction of biosimilars. The first biosimilar product was approved in the U.S. market in March 2015. By March 2019, 18 had been approved. Many experts suggest biosimilars have lagged in the U.S. market due to slower changes to the U.S. regulatory system and patent litigation as the industry goes through the same growing pains it did with generic regulation.

As well, drug development is an inherently expensive and risky business, characterized by high failure rates. On average, the process of discovery and commercialization takes 10-15 years at a cost of $2.6 billion. Less than 12 percent of drug candidates make it all the way from lab to patient.

Because of the complexity and high fixed costs required to develop the capacity to manufacture biosimilars, it takes eight to 10 years for biosimilars to come to market, there are fewer entrants than is the case with generics, and the cost savings realized are 10 to 30 percent off the brand, versus an average of 80 percent achievable by generics. Considering the length of time normally required to achieve safe and reliable production of biosimilars, the data protection period in USMCA is unlikely to be a cause of undue delay in getting them to market. Data protection terms are also often less than the remaining patent term.

Your Loss is My Gain

The prominent healthcare research firm, IQVIA, forecasts the biopharmaceutical industry stands to lose $121 billion between 2019 and 2023 as periods of market exclusivity end. Eighty percent of that impact, or loss for innovators, will be in the U.S. market as nearly all of the top branded drugs will have generic or biosimilar competition.

IQVIA says competition among biosimilars is on a path to grow three-times larger in 2023 than it is today. If that’s so, savings over branded biologics could produce approximately $160 billion in lower spending just over the next five years, even as overall spending on biologic drugs grows.

This is part of the business cycle of the pharmaceutical industry and why the innovators maintain strong pipelines because they have limited exclusive time in the market before competitors arrive. That’s good for patients. The data protections in USMCA are not likely to materially impact this cycle or spending. When Canada and Japan lengthened their duration of data protection, drug spending as a percentage of GDP remained nearly flat.

ME losses

Reason for Optimism

Biologics are called the drug of tomorrow. They comprise nearly 70 percent of the innovation pipeline which includes some 4,500 drugs in development in the United States and another 8,000 globally.

Breakthrough products are expected for cancer treatments, autism and diabetes. This is great news, but specialty and niche products tend to come at a higher price so spending may increase as these new drugs enter the market. According to IQVIA, average spending on the brand versions will nonetheless decline from 8.2 percent of the U.S. market to 6.7 percent, a demonstration there’s a healthy market for originals and copies.

There would be no copies without the originals, which is why pharmaceutical regulatory and legal frameworks are full of public policy trade-offs to strike a balance that will support return on innovation while not impeding the availability of affordable drugs. As we make scientific progress, the systems that include IP protections must evolve to accommodate new types of drugs, new capabilities in data analytics and clinical practices, and even changing business models. Not doing so can imperil the pace of progress at precisely the moment when breakthroughs are on the horizon.

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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 fourteen years as an Adjunct Professor at Georgetown University’s Master of Science in Foreign Service program.

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

DACHSER India Branches Boast CEIV Pharma Certification

DACHSER’s Mumbai and Hyderabad branches are among the few companies in India to receive the prestigious Center of Excellence for Independent Validators in Pharmaceutical Logistics certification  recognizing exemplary operations in transporting Life Science and Healthcare (LSH) products. Such products are both temperature and time-sensitive, requiring meticulous, accurate, and high standards in monitoring and handling to ensure product quality.

“Congratulations to DACHSER India on their CEIV Pharma certification. The time and temperature sensitive nature of pharmaceutical products means the highest standards are needed to make sure product integrity is maintained for such shipments,” said Vinoop Goel, IATA’s Regional Director for Airports and External Relations, Asia-Pacific. “With India being a major supplier of pharmaceutical products, DACHSER India’s CEIV Pharma certification will give pharmaceutical companies confidence and assurance that their cold-chain logistics requirements are being met.”

Difficult to obtain, the CEIV Pharma certification is earned by companies implementing efficient, safe, and excellence in transporting LSH products. Currently, DACHSER’s Hyderabad branch is one of two companies in the region to boast the accreditation. Through a strenuous audit ensuring compliance among all all facilities, equipment, operations and staff, DACHSER applied for the certification with the goal of adding to its already extensive history in handling pharma products.

“Obtaining the CEIV Pharma certification is an important milestone for DACHSER India. It emphasizes our continued focus for providing highly reliable logistic services to our valued customers in the LSH segment”, said Huned Gandhi, Managing Director, Air & Sea Logistics for the Indian Subcontinent. “Quality and efficiency have always been the cornerstones for our success and our teams are extremely proud to receive this accreditation from IATA.”
“By way of CEIV certification at our Mumbai and Hyderabad branches, DACHSER India has made a big step forward to further enhance its operational and technical competencies in serving our LSH customers,” concluded Zarksis Munshi, Head of Air Freight, Air & Sea Logistics India Subcontinent.