British American Business Council of Greater Philadelphia

Since 2017, the FDA approved more than two dozen new therapies with roots at Penn Medicine — almost half of which are first-in-class for their indications. Becoming a hub for drug research and development took a lot more than luck.

The news reached Abramson Cancer Center (ACC) Director Robert Vonderheide, MD, DPhil, at 11 a.m. on August 30, 2017. It was official: That morning, the U.S. Food and Drug Administration (FDA) approved a Penn Medicine-developed personalized cellular immune therapy.

Six hours later, Vonderheide was standing atop a coffee counter in the atrium of the Perelman Center for Advanced Medicine, addressing hundreds of jubilant faculty and staff members who had gathered for a now-iconic “flash mob” celebration of the milestone. Carl June, MD, and a team of scientists, physicians, and other dedicated staff had together turned a dream of using patients’ own immune cells to treat their cancer, into a reality.

Vonderheide called the discovery “a 20-year overnight sensation.” It would be a defining moment for Penn’s identity as a place that incubates and brings to life some of the most transformative modern medical advancements.

The FDA approval of chimeric antigen receptor (CAR) T cell therapy didn’t happen at Penn Medicine by chance. Nor did the others that followed. Since that day, other medical innovations and research that had been underway at Penn Medicine directly influenced at least two dozen more FDA approvals granted to cancer drugs and other medical technologies — giving the stamp of safety and effectiveness needed for these treatments to be widely available to patients outside of clinical trials. Eleven of the medical advancements documented to date represent the first FDA approvals in their classes: eight under cancer, two under gene therapy, and the revolutionary mRNA technology that powers COVID-19 vaccines around the world.

Penn Medicine faculty may lead this crucial work at different points across the continuum of discovery, from conducting pivotal discovery science in the lab which leads to licensing of compounds and technologies by commercial partners, to leading clinical trials of new therapies initially developed outside of Penn.

The list of Penn-linked FDA approvals is growing with each passing year, and for good reason. Science has shifted toward more discoveries based on the underlying mechanism of disease, especially in new cancer drug discovery. Through a particularly robust clinical trial and commercialization infrastructure, Penn has further worked to smooth every part of the path from idea to implementation. And to ensure that state-of-the-art treatments reach the patients who need them, Penn Medicine teams have also kept focus on equity and access during clinical trials and after therapies are approved.

In the long view, Penn’s emergence as a hub for medical advancements that lead to drug research and development is a credit to both the culture and strategic choices going back decades, says Jon Epstein, MD, executive vice dean and chief scientific officer in the Perelman School of Medicine.

“Our leadership has been judicious about investing in a broad portfolio across a pipeline of development that might take 20 or 30 years,” Epstein says. “People here embrace a no-risk, no-reward approach — they aren’t afraid to take the long view and realize you have to back many different ideas to end up with just a few breakthrough therapies.”

Reducing Barriers to Translational Research

Hiring Carl June — whose belief that the immune system could be trained to fight cancer was derided by naysayers — in 1999 is one of the risks Epstein references. At the time, nobody predicted June’s work would change the entire trajectory of cancer care.

June began studying CAR T cell therapy in cancer in the late 1990s, and as signs of success grew, so did the breadth of collaborators at Penn Medicine and Children’s Hospital of Philadelphia (CHOP) who brought the method into clinical trials. It would take nearly two decades to achieve FDA approval of the therapy in 2017 as a treatment for advanced acute lymphoblastic leukemia. The groundbreaking technique involves taking T cells — part of the immune system — from a patient’s blood and engineering them to produce CARs before reinfusing them into the body. These new receptors latch onto unique antigens on the patient’s tumor cells, killing them. Marketed by Novartis as Kymriah, the first CAR T cell therapy has proved lifesaving for many patients whose cancer has relapsed or failed to respond to other therapies. It has since garnered two additional approvals from the FDA to treat other forms of cancer.

Similar stories have played out on campus over and over. Jean Bennett, MD, PhD, and Albert Maguire, MD, were also “risky” hires whose ambitions vexed skeptics when they joined Penn’s Scheie Eye Institute in 1992. But their determination and decades of work from basic science through to clinical trials at Penn and CHOP, paid off; in December 2017, less than four months after approving CAR T, the FDA approved the married team’s treatment for a rare form of congenital blindness called Leber congenital amaurosis. Marketed as Luxturna, the therapy restores patients’ eyesight by injecting a corrective gene directly into their eyes via a viral vector. It was the nation’s first commercialized gene therapy — a term that encompasses a collection of techniques to modify a patient’s DNA — for a genetic disease.

Eighteen months later, approval followed for Zolgensma, a gene therapy using a viral vector developed in the lab of James Wilson, MD, PhD, director of Penn’s Gene Therapy Program and Orphan Disease Center, and studied in trials at CHOP, to correct spinal muscular atrophy — the number one genetic cause of infant mortality.

And in the most ubiquitous novel advance tied to Penn Medicine, in August 2021 the FDA gave its first full approval to an mRNA-based COVID-19 vaccine, which uses technology discovered more than 15 years earlier by longtime research partners Drew Weissman, MD, PhD, the Roberts Family Professor in Vaccine Research, and Katalin Karikó, PhD, an adjunct professor of Neurosurgery.

Recruiting faculty who dream big is essential to drug development, but there are other reasons Penn Medicine has connections to so many cutting-edge therapies. Among the top, says Vonderheide, is a strategic emphasis on translational research and eliminating barriers between laboratories and the clinic.

“Even our building design reflects that value. If you stand in the lobby of the Perelman Center for Advanced Medicine, you’re within 100 yards of the labs where discoveries are being made, the clinics where clinicians are designing clinical trials and patients are getting therapies, and the offices where executives are working out financial models,” he says. “We’re a unified, integrated system committed to making science real for patients.”

Financial investment from the health system is key to moving discoveries toward the clinic and helping more patients, Epstein adds, citing the Perelman School of Medicine’s Clinical Cell and Vaccine Production Facility — where cell and gene biotherapeutics are manufactured to meet regulatory standards — as an example.

“The health system invested in what was only basic research at the time to build the good manufacturing practices facility that is necessary to produce things like CAR T cells safely so they can be put back into humans,” he says. “Facilities like that cost a lot, and most medical schools can’t afford them. But at Penn Medicine we integrate our clinical and research missions intentionally, for the sake of the patients who don’t have the best clinical options today. We can’t afford not to invest back into ongoing scientific discovery.”

Expanding New Categories of Therapies Pioneered at Penn

The FDA approval of a drug doesn’t mean its development ends, particularly in young and still-unfolding categories like cell and gene therapy and mRNA technology. Research around the world has proliferated in these new realms, where Penn Medicine faculty are still striving to push the science forward.

While CAR T cell therapy has revolutionized treatment for hematologic malignancies, researchers are still striving to use it successfully against solid tumors; getting the treatment to penetrate solid masses is one challenge, and it is harder to find unique antigen proteins to target on solid tumor cells. Faculty members are examining ways to overcome these limitations, such as delivering CAR T cells regionally and testing multivalent CARs, which simultaneously bind to multiple targets.

Researchers are also pursuing universal “off-the-shelf” versions of CAR T, which would spare patients from having to donate their own T cells for engineering — saving precious time while ensuring an abundance of high-quality cells to work with. And many are studying CAR T therapy in conditions other than cancer — including Epstein, who is evaluating CAR T cells’ ability to treat fibrosis, which can affect any organ and is a major driver of heart failure.

In terms of gene therapy, most activity to date has tackled rare diseases, but some faculty are on a mission to change that — like cardiologist Kiran Musunuru, MD, PhD, MPH, ML, director of the Genetic and Epigenetic Origins of Disease Program. Musunuru is applying the gene editing technology CRISPR to fight the leading cause of death worldwide: cardiovascular disease. He has found that modifying genes in the liver can permanently reduce a person’s cholesterol levels and protect against heart attack and stroke. Currently in a clinical trial in New Zealand and the U.K., this single shot could eventually work as a heart disease “vaccine.”

And when it comes to mRNA, “we’re working on every imaginable infectious disease,” says Weissman, who back in 2005, alongside Karikó, discovered how to modify mRNA so it could be used safely and effectively in vaccines and therapeutics. Even before COVID-19 struck, Weissman’s lab group had set up mRNA vaccine clinical trials for herpes, HIV, and influenza. The many avenues they are currently exploring include a universal flu vaccine that covers all 20 known subtypes of influenza virus and an all-in-one “pan-coronavirus” vaccine that would be effective against any new variants yet to emerge.

People suffering with a broad range of life-threatening illnesses today hold onto hope that tomorrow will bring a new therapy that will save their life. Across Penn Medicine, researchers are focused on developing new medicines to address their unmet needs.

“With Penn at the forefront, the application of these first-in-class therapies to a broader array of other diseases is just around the corner. Penn Medicine’s scientific impact — and the worldwide attention it commands — have never been greater,” says J. Larry Jameson, MD, PhD, executive vice president of the University of Pennsylvania for the Health System and dean of the Perelman School of Medicine. “It is a tremendous point of pride that innovation born within our laboratories is being deployed to save lives across the world, and we are committed to fostering breakthroughs that will continue to redefine medicine as the 21st century unfolds.”

More About Penn Medical Advancements Leading to FDA Approvals

The Path from Innovation to Implementation. Penn’s infrastructure in both supporting clinical research and forging commercial partnerships smooths the way from idea to approval.

Why New Cancer Treatment Discoveries are Proliferating. The approval of CAR T cell therapy ushered in a new era for cancer treatment.

Putting Biomedical Research Advances Within Reach. Treatments and vaccines are only useful in the hands of the people who need them.

Moving to a new country is exciting. But it may also be daunting as it requires many new undertakings, such as finding a place to live or opening a bank account, which can quickly become time-consuming and frustrating. Unsurprisingly, many leave the often complex financial and legal matters for a later date. The cost of doing so, however, can be high. To save time and hardship, Cross Border Financial Planning USA has put together 10 financial matters to consider when moving to the US. Whilst this brochure focuses on the intricacies of moving from the UK to the US, many of the same or similar principles apply when moving to the US from other countries.

1. Reporting and paying tax

In the UK, most people only pay tax through the Pay As You Earn (PAYE) system, whereby tax is automatically deducted from their pay cheque and often there is no need to file a tax return. Although the US tax system is also Pay As You Earn, most people are still required to file a tax return each year and it is the individual’s responsibility to make sure they do so. Another difference is that the UK tax year runs from April 6th to April 5th, whereas the US tax year follows the calendar year from January 1st to December 31st.

2. Investments

The most popular UK-based investments, such as exchange traded funds (ETF’s) and mutual funds, are likely to be treated as Passive Foreign Investment Companies (PFICs) by the US tax authority – the Internal Revenue Service (IRS). In the UK, it is very common to see ETFs and mutual funds held inside an Individual Savings Account (ISA) because an ISA is tax-free in the UK. In the US, however, the IRS does not recognize the tax-free status of an ISA and, as such, ETFs and mutual funds are taxed very inefficiently in the US and are complex investments to file on a US tax return.

For those who move back to the UK, a similar concept applies to US-based ETF’s and mutual funds. Unless they hold UK-reporting status or are held in an appropriate account, the gains will be subject to UK income tax when you return, rather than the more favorable capital gains tax rates. To avoid potential issues down the line, it is important to understand how an investment is taxed in both the US and UK, and make appropriate changes based on your current and future residence.

3. Maintaining Property in the UK

For many people, the move to the US will not be permanent, either by their own choice or because their visa will not allow it. It is therefore common for people to maintain a property in the UK and rent it out. If you receive rental income from your UK property, this will be assessed for UK tax. This income also needs to be declared on your US tax return, and the double taxation treaty should allow you to use foreign tax credits to mitigate the risk of paying tax twice. If you sell your UK property whilst a resident in the US, then it is likely that you will be required to submit a non-resident Capital Gains Tax return to HMRC within 60 days of selling the property.

4. Reporting Foreign Assets

Having a bank account in both the UK and the US is useful for those who travel between the two, but try to keep things simple by consolidating. If the aggregate values of your non-US bank accounts exceed $10,000 at any point in the year, you will need to file each account via the Foreign Bank Account Report (FBAR), and because this is an IRS requirement, there are significant penalties for failing to file.

There is an additional US annual reporting requirement for all foreign financial assets where the total value of these assets exceeds $50,000 at the end of the year, or $75,000 at any time during the year for individuals. These are the thresholds for US residents, which double for married couples.

5. Be Smart on Currency

Transferring money straight from your UK bank to your US bank is often the easiest option, but almost never the best option. Utilizing a reputable currency broker or online currency company may be cheaper. Traditional banks often lack transparency, advertising zero fees or commissions, yet failing to make it clear how much they are making on the conversion rate itself.

6. What to do with pensions and retirement plans

It is easy to forget about retirement accounts, but second to a person’s home, retirement accounts are often the next largest asset that a person owns. It is important not to neglect accounts left behind in the UK, and it’s equally important to be aware of the options available in the US. Understanding how these accounts will be treated if you leave the US will help provide a better outcome in the future.

7. Rebuilding your credit score from scratch

Unless you have a poor credit score in the UK and are happy to be leaving it behind, starting fresh can be irritating. Not only can this work against you when a landlord reviews your application, but it can take years to build your score back to an equivalent level. The knock-on effect could still be felt several years later when applying for a mortgage. The most common complaint is the chicken and egg situation – you apply for a credit card to start building a credit score, but the credit card company rejects the application because you have no credit score. There are some banking and credit institutions that operate in both the UK and the US who will use your UK credit history when reviewing your US application, so that may be a good place to start. You can find out more information about how the US credit score system works at www.usa.gov/credit-reports.

8. Wills and Trusts

If you have a will or power of attorney in the UK, check whether they will still carry out your wishes as intended, and whether they need updating. It will sometimes be necessary to have a will in both the UK and the US. The same is true for trusts, and in some cases, a trust in one country will be treated very differently in the other. For example, a UK trust can be brought into the US tax system if a trustee or

beneficiary becomes a US taxpayer. Similarly, a simple living trust in the US can become a UK resident trust if you return to the UK. Advice is key in this area before making any decisions about restructuring or making changes.

9. Estate Planning

Estate taxes and inheritance taxes are different in both countries, and in the US, you have the additional complication of different state rules. At the federal level, the 2023 estate allowance is $12.92 million. A married couple who are both US citizens and long-term residents can protect $25.84 million from federal estate taxes. The unlimited marital deduction also enables any amount to be passed to a spouse free from federal estate taxes. In situations where one of the spouses is still deemed to be UK domiciled, which is not the same as being UK resident, the rules can be much less generous.

The estate allowance in the UK is far lower than in the US. In 2023, the allowance is £325,000 per person, with the potential to increase to £500,000 where a primary residence is passed onto children and grandchildren, as well as your estate being worth less than £2 million. Understanding domicile is key to understanding UK/US estate planning because it impacts not just which assets are liable to estate tax, but also whether you are liable for any estate tax at all.

10. Seek advice if you are unsure

When moving countries there are many considerations over and above finding a place to live and adapting to a new environment. In some instances you may be able to find the answers yourself, but if you are unsure, work with professionals who have experience working with cross-border families. Living, earning, and investing in different countries may add a layer of complexity, but effective planning often presents financial opportunities.

Cross Border Financial Planning USA LLC is an investment adviser located and registered in Pennsylvania. Registration of an investment adviser does not imply any specific level of skill or training and does not constitute an endorsement of the firm by the State of Pennsylvania. Cross Border Financial Planning USA LLC only transacts business in states in which it is properly registered or is excluded or exempted from registration. A copy of Cross Border Financial Planning USA LLC’s current written disclosure brochure which discusses among other things, Cross Border Financial Planning USA LLC’s business practices, services, and fees, is available through the SEC’s website at: www.adviserinfo.sec.gov.

Prior to making an investment decision, please consult with your financial advisor about your individual situation. Any mention of a particular security or type of security is not a recommendation to buy or sell that security. Investing involves risks including the possible loss of capital. Changes in tax laws or regulations may occur at any time and could substantially impact your situation. Cross Border Financial Planning USA are not tax or legal advisors, and you should discuss any tax or legal matters with the appropriate tax or legal professional.

Written By: Ragini Subramanian

There are many things that attract people to relocate to the U.S. and, by the same token, many U.S. citizens are lured to other jurisdictions. What is often forgotten is how the U.S. Treasury taxes U.S. citizens and green card holders who travel outside U.S. borders to live or work—temporarily or permanently—in foreign jurisdictions.

Impact on Income and Estate Taxes

U.S. citizens are subject to income tax in the U.S. on their worldwide income as well as U.S. tax return and foreign information return filing requirements. The country they call home—temporarily or permanently—after they leave the U.S. may also impose income tax on some of the same income that is taxed by the U.S.

A relief from double taxation is available in the U.S. either in the form of a foreign tax credit to offset taxes payable in the U.S., taking advantage of the foreign income exclusion provisions of the U.S. tax code, or availing double-tax relief afforded under a tax treaty between the U.S. and the foreign jurisdiction that is now the home. However, all this may not be as simple as it sounds:

• The availability of a foreign tax credit may be limited (i.e., due to a smaller ratio of foreign source income to the U.S. source income, the foreign country tax rate is higher than that in the U.S., or the foreign tax is not eligible for foreign tax credit).
• One may not meet the strict parameters of the foreign income exclusion rules (i.e., does not have a closer connection to the foreign country, does not meet the parameters of the tax home test, does not meet a continuous period of 330 days presence in a foreign country, or they are not present in the foreign jurisdiction for any period of 12 months).
• No treaty exists between the U.S. and a given foreign country (e.g., U.S. and Hong Kong), or the existing treaty does not provide relief from double taxation for a particular item of income. Contributions to a retirement plan of an employer of a foreign country often fall under this.

What about transfer taxes, such as lifetime gifts and estate taxes upon passing. While there are several avenues to avoid double taxation with respect to income tax, there are not many options regarding gift tax or estate taxes. A U.S. citizen is subject to gift and estate taxes in the U.S. no matter where the U.S. citizen lives, works, gives away property or passes away. The country of residence’s gift, transfer or estate tax rules may also impose a gift or transfer tax. There are a far greater number of income tax treaties than there are gift and estate tax treaties between the U.S. and foreign countries that provide relief from double taxation. By the same token, fewer countries have gift or estate tax laws similar to those in the U.S. In many instances, gifts to close relationships—such as parents, children, brothers and sisters—are not subject to transfer taxes. That, however, does not take away the fact that the U.S. gift and estate tax laws remain applicable.

Therefore, it is very important to evaluate the income, gift and estate tax implications if you and your spouse have chosen to retire to another nation or if you are relocating to another country for a career opportunity.

Does Relinquishing Your U.S. Citizenship or U.S. Residency Make Sense?

You may think, forget it, I will just give up my U.S. citizenship or my green card to get away from the U.S. tax system. However, while this may work in some cases, it will not be the right option in all instances. If you are a U.S. citizen or considered a long-term resident of the U.S. and (1) meet a certain net worth threshold of more than $2 million, not inflation adjusted; (2) meet a tax liability threshold for 2022 average net income tax liability for the five tax years immediately before expatriation of not more than $178,000, inflation adjusted; or (3) simply do not or cannot certify that you are fully compliant with all applicable U.S. tax laws, you are considered a “covered expatriate” under a U.S. tax regime popularly known as the “exit tax.” With respect to certain assets, a covered expatriate is taxed in the U.S. before leaving the U.S. on the gain—after excluding up to $767,000 for 2022 plus inflation adjusted—as if the assets were sold at fair market value as of the date of expatriation. Other assets (e.g., pension plan, education savings plan) are taxed at the election and subject to a complex set of rules as of the date of expatriation or when income is received after a person leaves the U.S. In the latter case, the person may remain subject to tax in the U.S. and specific tax return filing requirements only on that income source and any other income source that may be considered U.S. source. The mistake many people make is returning to the U.S. after relinquishing their U.S. citizenship or green card and reestablishing U.S. tax residency, which places them back at square one.

The exit tax may not be that bad, but in the absence of proper planning, relinquishing your U.S. citizenship or green card can have other tax implications. The gift and estate tax exemption is lost if you forsake your citizenship. The exemption is $10 million, inflation-indexed ($12.06 million in 2022) for the years 2018 through 2025. Instead, you’re limited to a nonresident exemption of just $60,000. A 40% gift tax after only a $15,000 annual exclusion on gratuitous transfers of tangible property (e.g., cash, U.S. real property) located in the U.S. can make gift giving more expensive. The sale of U.S. real property located in the U.S. requires additional compliance under the U.S. Foreign Investment in Real Property Tax Act of 1980. A partnership interest in the U.S. partnership or foreign partnership deriving income in the U.S. may subject a nonresident to a multitude of tax withholding regimes depending on whether the partnership is engaged in passive activity or in an active trade or business in the U.S. It may also generate tax return filing requirement in the U.S.

Make Informed Decisions

Your assets and estate plan can be subject to a significant impact immediately and as you plan for the future if you move abroad. Before going overseas, consult with your tax professional about your plans and the tax implications.

International Products Corporation (IPC) produces and markets specialty chemical products with emphasis on precision cleaners and assembly lubricants. IPC serves an international market with customers in the commercial, industrial, government and academic sectors. It reaches these markets through a combination of distributors, direct-sales and internet marketing. Currently, new products aimed at the consumer market are being developed. IPC also serves as a supplier of private-label products.

Founded in 1923, the company has been owned by Charles E. Granito since 1981. Rapid growth from 1981 to 1989 enabled the firm to move from Trenton, NJ, to a new custom-designed facility in Burlington, NJ, in 1990. On a four-acre site, this 20,000 ft2 building incorporates marketing, research, processing, packaging and warehousing functions that are key to IPC’s operations. Extraordinary steps were taken to make this facility safe for employees and the environment, and to assure that products made there meet the highest standards of quality. The on-site laboratory is equipped to expand quality and analytical work, allow for research on new and improved products and assist customers with technical testing.

In 1984, IPC opened IPCW, Inc., a subsidiary in the UK. IPCW distributes product for IPC throughout the European market. IPC also has distributors in China, India, Korea, Japan and Taiwan.

The full-line of precision cleaning products includes its flagship concentrated cleaner, Micro-90®. The line includes biodegradable, alkaline, acidic, neutral and enzyme cleaning products for a broad range of industries and applications. These include cleaning of labware, filter membranes, medical devices, pharmaceutical equipment and precision parts. All are registered with NSF as A1 cleaners.

P-80® Temporary Rubber Lubricants are unique formulated products for assembly of rubber and soft plastic parts (belts, bushings, grips, grommets, hoses, o-rings, seals) for the automotive, agricultural, appliance, aerospace, marine, pump and tool industries to name a few.

IPC is committed to making products that are water-based and to replace solvent and petroleum-based cleaners and lubricants. IPC avoids use of known carcinogens and hazardous chemicals, only using materials found on TSCA and EINESCS inventories. IPC maintains a ZERO discharge policy including wastewater, emissions and hazardous waste. And no product is considered highly toxic or corrosive. It is policy to keep abreast of environmental regulations such as removal of flame-retardants and certain metals (cadmium, mercury, chromium and lead) in products. IPC is an ISO-Certified Company.

IPC is an essential business.  Company operations have been continuous throughout the COVID-19 pandemic. Disinfecting surfaces to kill traces of microbes and disease is a critical concern right now. A common misconception is that simply disinfecting a surface is enough to sanitize it. This is not the case, cleaning and disinfecting are both important parts of a thorough sanitizing process. IPC’s products clean parts and surfaces first, allowing for proper sterilization after.

What is Cleaning? Cleaning refers to removing all dirt and soils from a surface. Detergents are used to clean surfaces. “Cleaning is the complete removal of…soil using appropriate detergent chemicals under recommended conditions.”

What is Disinfecting? Disinfecting refers to destroying or killing any germs, microbes or bacteria that are present on the surface. Disinfectants are used to accomplish this task.  “A disinfectant is a product which kills microbes without employing a soil removal action.”

Why do both? Surfaces must be properly cleaned prior to disinfecting. Removing traces of dirt, debris, and dust primes surfaces and equipment for disinfection. Soils can harbor germs and bacteria. Disinfection becomes less effective if surface soils are present.

What happens if I disinfect without cleaning? If a surface is disinfected before it is cleaned, the remaining soils can still contribute to the growth of harmful microbes and lead to further contamination. The residual soils may also serve as a barrier, preventing the disinfectant from reaching the surface and doing its job. Lingering soils on the surface may affect the active chemicals in a disinfectant, impacting their efficiency. If the surface is thoroughly cleaned first, and validated for cleanliness, the disinfection step becomes much more effective.

What are the steps for proper cleaning and disinfecting?

1. Remove large debris
2. Surface rinse with potable water
3. Clean with a specialty detergent like Micro-90® or Micro® Green Clean
4. Rinse thoroughly with potable water
5. Disinfect
6. Rinse again
7. For regulated industries, validate the cleaning process

Contact IPC’s product specialists for more information about hard surface cleaners for manufacturing and laboratory applications.

Free product samples are available for testing. Request a sample for testing.

201 Connecticut Drive
Burlington, NJ 08016, USA
IPCW, Inc.
238 Green Lane
Green Lane Business Park
London SE9 3TL UK
www.ipcol.com

President Biden, Brexit and what’s next for British-American Business Council

[British-American Business Council (BABC) Board Member and KPMG U.S. Principal Paul Harnick recently joined KPMG U.S.-U.K. Corridor Leader Howard Wiener and KPMG U.K.’s Michelle Quest for a discussion on the potential impact of the new U.S. administration’s policies and Brexit on BABC members’ business.]

Paul: What is the Biden administration’s proposed tax plan and what could it mean to a BABC member business?

Howard: During his campaign, Biden emphasized the need for certain policy changes, including infrastructure, clean energy, domestic manufacturing, rebuilding U.S. supply chains, housing, racial inequities, childcare, elder care and health care. To offset the costs of these goals, President Biden proposed changes to the Tax Code. President Biden’s campaign tax proposals were brief and high level. A few of the highlights affecting businesses and individual investors include:

• Increase the top statutory corporate income tax rate from 21% to 28%
• Create a new 15% corporate minimum tax on global book income of $100 million or more
• Increase the tax rate on certain foreign income from 10.5% to 21%. Increase individual tax rates to 39.6% and tax capital gains and dividends for individuals with over $1 million in income at ordinary income rates

Over the coming months, we can expect additional proposals, as well as refinements to proposals, to be made. With Democratic control of the House of Representatives and effective control of the equally split Senate, Democrats are in control of the U.S. legislative agenda. However, whether, and to what extent, tax legislation will be passed is far from certain. As a general matter, Senate filibuster rules require 60 votes for legislation to be considered for a vote, and convincing at least 10 Republicans to vote with the Democrats will be an extremely tall order. It’s important to note, though, that special “budget reconciliation” procedures allow some types of legislation, including tax legislation, to move through the Senate by only a majority vote without being subject to a filibuster. Yet, even in this scenario, the Democrats would need all 50 Democratic senators to agree to any legislation. This effectively leaves every Democratic senator with the power to veto any proposal. Given the broad spectrum of political philosophy among Democratic senators, one could expect negotiations and compromise around any proposals made by President Biden.

Paul: Can we expect a change in U.S. trade policy under a Biden administration?

Howard: Joe Biden has made clear that any trade deal between the U.S. and U.K. must be contingent upon respect for the Good Friday Agreement and prevent the return of a hard border. Given the current economic climate and uncertainty around the pandemic, it is unlikely that a U.K./U.S. trade deal will be done quickly. However, we can expect there will be further efforts to improve the U.K./U.S. economic relationship in the coming months and a deal in 2022 looks possible. More generally, there are not expected to be major trade liberalizations under a Biden presidency. The last few years have seen the U.S. taking a much harder stance on its trade relationship with China. This has been bipartisan.  Although the tone will likely change, many of the concerns of the Trump administration with respect to China are shared by President Biden and the Democratic Party.

Paul: Shifting to our other topic today – Brexit. Michelle, what has been the outcome?

Michelle: Since the U.K. voted in a national referendum to leave the European Union (EU) in 2016, businesses that operate between the U.K. and the EU have faced a significant level of uncertainty. Negotiations between the U.K. and EU ended in agreement on Christmas Eve to conclude the EU/U.K. Trade and Cooperation Agreement. The agreement now governs the economic and trading relationship between the U.K. and the EU.

The fact that an agreement was reached will be welcomed by many BABC members as it provides more certainty. However, businesses need to be aware that the agreement will not result in a static relationship between the U.K. and the EU. The agreement sets up a significant governance structure which will negotiate and determine how the agreement will be implemented. In particular, issues around financial services and data adequacy will be subject to further discussion. Furthermore, there is an automatic review of the agreement every five years.

Paul: What has been agreed?

Michelle: The agreement might be described as “skinny.” It focuses predominantly on goods, with most U.K. and EU goods not subject to tariffs or quotas.

There is little in the agreement for services. The provisions do not go much beyond existing EU practice, and, as a result, there will be challenges for service businesses to trade between the EU and the U.K.

Many citizens’ rights issues had already been covered in an earlier agreement and EU citizens living in the U.K. have until the end of June 2021 to secure their rights. BABC member businesses with mobile workforces need to be aware of the impact as the agreement ends the ‘freedom of movement [of people]’ between the U.K. and the EU.

Certain regulated sectors no longer have “passporting” rights, such as businesses operating in the pharmaceutical and financial services sectors.

Paul: What is the customs impact?

Michelle: The process at the U.K. and EU border has fundamentally changed. Customs declarations are now required on either side of the border and businesses will have to put further preparations in place, including holding registrations and having the data to support these declarations.

While the agreement means duty- and quota-free access to both markets, this applies only for goods that meet specific rules of origin. BABC member businesses should assess the impact of the rules of origin.

There are specific impacts from a customs perspective for Northern Ireland (NI). Customs duty will be due on British goods “at risk” of movement to the Republic of Ireland. A new UK Trader Scheme has been introduced.

Paul: What are the tax implications?

Michelle: The U.K. no longer has access, or needs, to comply with EU tax directives. In some cases, this may lead to additional taxation on certain transactions (for example, some inbound payments may be subject to withheld tax in the paying jurisdiction). The U.K. is no longer implementing DAC6 (the mandatory reporting rules) to the same extent as continuing EU members. U.K. implementation has been limited to one of the five categories (relating to information exchange and beneficial ownership).

The agreement contains provisions for coordination of social security. U.K. nationals travelling, working or living in the EU (and vice versa) will retain entitlements to some benefits. Cross-border workers and employers will only be liable to pay social security contributions in one state at a time.

Paul: What tax implications should BABC members be particularly aware of?

Michelle: There are several provisions in the U.S.-U.K. tax treaty favorable to U.K.-headed companies that require a party to be a resident of an EU member state. Ownership structure where U.K. companies have availed themselves to such provisions must be reviewed. Although there is hope that the U.S. and U.K. will negotiate amendments to account for Brexit, given the myriad of priorities announced by the Biden administration, any changes would not be expected in the short term.

Furthermore, in certain circumstances, consideration of the Limitation of Benefits clause of U.S. treaties may be necessary even where the payer or recipient is not a U.K. resident.

Paul: What is the impact on the U.K.’s economic outlook?

Michelle: KPMG estimates that with a trade deal between the U.K. and EU, U.K. GDP growth in 2021 could total 6.1%. If the U.K. had left the EU without an agreement, KPMG estimates U.K. GDP growth would have been lower, at 3.3%.

Paul: Are there any other impacts?

Michelle: The impacts of the U.K. leaving the EU are wide-ranging and the information we have covered during our discussion only briefly touches on a few of them. Given that the relationship between the U.K. and EU will not be static, businesses should follow developments, particularly in the coming months as the agreement is being implemented.

By Huw Beverley-Smith (London), Nate Bolin (Washington D.C.), Christopher Jefferies (London), David Kay (Chicago) and Remy Nshimiyimana (Philadelphia)

The United Kingdom (U.K.) left the European Union (EU) on 31 January 2020. Under the U.K.- EU withdrawal agreement, a transition period will end on 31 December 2020 (unless it is extended). During the transition period the U.K. will continue to participate in the single market and customs union and will otherwise be treated as if it were still an EU member state. For its part, the United States (U.S.) has shown strong interest in strengthening ties with the U.K on trade and a host of related regulatory and national security issues, many of which have strong bipartisan support in the U.S. Congress.  As a result, a possible U.S.-U.K. trade agreement is likely to be a priority for the U.S. regardless of the outcome of the upcoming November 2020 presidential election.

For the U.K. Government, the end of the transition period is politically symbolic, and it has been reluctant to extend it. Although the negotiations between the EU and U.K. are continuing remotely, the coronavirus pandemic has significantly increased uncertainties. The economic impact of the shutdown of the U.K. economy in order to fight the coronavirus could be substantial and could potentially change the U.K. Government’s stated position and political calculations going forward. If the deadline were not extended and the U.K. were to reach the end of the transition period with no trade deal, the relationship would revert to World Trade Organisation rules. U.K. businesses would then be required to deal with the double shock of the coronavirus shutdown, as well as a complete overhaul to the terms in which they operate.  The EU is facing challenges as well, since fighting the coronavirus pandemic is testing its resources and the cohesion between Member States.

The timing of the end of the transition period is significant since it will influence the U.K.’s relationships with countries outside of the EU, including the U.S. Although the U.K. can negotiate their future trading relationships, the agreements cannot come into force before the end of the transition period without the agreement of the EU.

Global Britain Strategy

The U.K. already has more than 40 trade agreements with 70 countries around the globe through its former membership of the EU. These include significant trading partners such as Canada, Japan and Singapore. During the transition period, the agreements continue to apply as they did. However, the U.K. is working to replicate these agreements on a bilateral basis so that they will continue to apply after the transition period. As of December 2019, the U.K. has succeeded in replicating the agreements that cover 8.3% of its current trade, with countries such as Switzerland, South Korea and the European Economic Area countries (Norway, Iceland and Liechtenstein).

The U.K. Government has also announced its intention to seek new trade agreements with the U.S. New Zealand, Australia and an updated agreement with Japan. The intention is to negotiate these in tandem. From the U.K.’s perspective this gives a great opportunity to ensure the maximum benefits from each trade agreement as the different territories can be played off against one another. The EU negotiating teams, for example, will know that if the EU were to increase trade frictions, then there would be scope for the U.K. to allow other negotiating partners freer access to the U.K. and so disrupt EU trade and businesses.

The U.K. has recently held a public consultation on its future global tariffs policy and an announcement on what this will be is expected shortly. Once set, this new U.K. global tariff (UKGT) will cover any imports coming into the U.K. from anywhere in the world where there is no free trade agreement in place and will be the baseline for any bilateral negotiations with countries seeking a better deal.

In addition to the UKGT, some countries may want to see what the U.K.’s relationship with the EU will be before determining what they think they can achieve in a trade agreement. A further potential obstacle is that some modern trade agreements have clauses that ensure that anything offered to a third country in a new agreement must be given to the party to an existing trade agreement, if it is more beneficial. For instance, if Japan were to offer the U.K. better terms in their new bilateral arrangement, there are provisions in the existing EU – Japan agreement that require Japan to offer the EU the same terms as they offered the U.K.

Global U.S. Strategy

Under President Trump, the United States has shifted its trade strategy from broad-based multilateralism to more limited, bilateral agreements with key trading partners – as exemplified by the president’s decision to withdraw from the multilateral Trans-Pacific Partnership (TPP) on his third day in office and the conclusion of new or revised trade agreements with Japan, South Korea, Canada, and Mexico.  These agreements and related aspects of the trade policy agenda announced annually by the Office of the U.S. Trade Representative (USTR) have received wide-spread bipartisan support – a notable contrast to the reception of other planks in the president’s “America First” agenda.

Against this backdrop, the negotiation of a bilateral agreement with the U.K. – the world’s fifth largest economy and key U.S. ally – is a logical and important next step.  Moreover, it is likely to remain a top trade priority regardless of the winner of the November 2020 presidential election.  Indeed, a U.K.-U.S. bilateral trade agreement is widely seen by policy makers on both sides of the political divide as a vital bridgehead to strengthen the U.S.-U.K. alliance while increasing leverage on the EU to eliminate some historic and well-entrenched U.S.-EU trade irritants – such as agricultural policies, regulatory standards, and the on-going Boeing-Airbus trade disputes.

The U.K.- U.S. Relationship

Outside of the U.K.’s relationship with the EU, the U.K.- U.S. relationship is arguably the U.K.’s most important. According to the U.K. Government, total U.K.- U.S. trade was valued at £220.9 billion ($274.3b) in the past year which amounted to 19.8% of both countries’ exports. Although nearly half of the U.K.’s trade went to the remaining EU27 countries, making the EU as a whole the U.K.’s largest trading partner, the U.S. is the U.K.’s largest bilateral trading partner.

Depending on one’s point of view, there are differing scenarios for what comes next in the U.K. – U.S. relationship. Some analysts question whether an agreement with the U.S. could be negotiated without knowing the outcome of the EU negotiations. Conversely, others claim that because of the historical ties, the “special relationship,” and the cultural similarities in trade approaches, a trade deal could be concluded quickly. Already, there are signs that both current governments continue to favour the latter approach, with U.S. and U.K. negotiators continuing to press forward with early-stage discussions despite the disruptions caused by the coronavirus pandemic.

Adding to the complexity are the differing views within the U.K. and U.S. on what a trade agreement should achieve. Many businesses (especially from an American perspective) see a trade agreement as an opportunity to enhance American businesses’ access to the U.K. market, and to align the U.K.’s regulatory regime to the U.S. rather than the ostensibly more onerous EU rules.

For instance, the contrary views can be seen through recent public discourse in the U.K. centred around the transatlantic differences in product and food standards. The production process for chicken has been a symbolic example for the British public, but this debate could be around anything from the types of chemicals used in food production, to the use of GMOs in agriculture, and the testing of medical devices. Another politically sensitive issue is the extent to which the U.K.’s National Health Service (NHS) could be opened up to American pharmaceutical and other medical companies. The British public have indicated that they would like little to no access given to American business. Some American Members of Congress have also raised the situation with the border between Northern Ireland and the Republic of Ireland as a potential stumbling block to the future U.K. – U.S. relationship.

For these reasons, the U.K. could be placed in a difficult position and the scope for the U.K.’s pivot towards U.S. regulatory standards may be limited. However, this debate may be somewhat irrelevant to U.S. and U.K. businesses who also have operations in the EU. The so-called “Brussels Effect,” (where a company will adopt one set of standards and harmonize upwards to the highest standard (usually the EU’s because they generally are the most stringent) for their operations globally, may in practice, displace any regulatory changes in a trade deal. The theory of the Brussels Effect (a variation on the California Effect which describes the shift of regulatory standards relating to the environment, consumer products and other areas) is that there is little incentive for a company working in multiple jurisdictions to have differing standards for each place they operate. It is more efficient to comply with the most stringent and sell that product or service everywhere. The effect is seen clearly in the global application of the General Data Protection Regulation (GDPR), where some American companies apply GDPR standards to their American operations, even though they are not legally required to do so.

This isn’t to say that the U.K. will stay aligned to the EU, because the more they do, the more chance that difficulties that have prevented an agreement in the past U.S.-EU trade negotiations that took place from 2013 to 2016, could resurface in the U.S.- U.K. context.

The U.K.’s Negotiating Objectives

In early March 2020, on the day that talks between the U.K. and EU on their future relationship got underway, the U.K. Government released their negotiating objectives for the U.S. agreement. In their objectives, the Government states that they believe a Free Trade Agreement (FTA) would increase trade with the U.S. by £15.3 billion over the 15 years after the FTA comes into force. They also say that it will deliver a £1.8 billion boost to U.K. workers’ wages, as well as lowering prices on consumer goods.

The U.K. Government wants to focus on potential gains for the 30,000 Small and Medium-sized Enterprises (SMEs) across the U.K. that are already trading with the U.S., and to open new opportunities for other British SMEs. The U.K. Government says that the U.S. currently levies £451 million in tariffs on U.K. exports each year.

To achieve these gains, the U.K. Government wants to secure liberalisation of tariffs on a mutually beneficial basis (taking into consideration the U.K.’s agriculture industry) and will also seek to reduce technical barriers by removing trade restrictive measures in goods (while upholding safety standards).

The Government also says they want to reduce regulatory obstacles to facilitate market access, and also increase their trade in services by ensuring market access and fair competition for U.K. services exporters. They highlight the free flow of data (while upholding the U.K.’s standards of personal data protection) as a particular goal in this area.

A trade dispute settlement mechanism will also be negotiated to promote compliance with the agreement. However, the objective on this point is still extremely vague. This is likely because the investor-state dispute settlement mechanism was one of the most difficult topics in the EU-U.S. negotiations between 2013 and 2016. As such, the U.K. Government is trying to avoid creating too much controversy with the U.S. Government before the talks even begin.

They have stated clearly in their objectives that the NHS will never be on the table in negotiations. They are adamant that the NHS (including its pharmaceutical procurement system) cannot be opened up to the private sector, whether they are from overseas or domestically based. The U.K. Government also says that it will ensure high standards for both consumers and workers, as well as keep high standards on environmental protection, animal welfare and food standards.

Overall, on their own economic modelling, if these objectives are achieved with all tariffs and half of non-tariff barriers being eliminated, the U.K. Government projects that U.K. GDP will increase by around 0.16%. That is the best-case scenario, and in real money terms this is a significant figure. However, from the obstacles set out above, much will depend on which path the U.K. will decide to go down.

The U.S.’s Trade Objectives

The Trump Administration notified Congress in October 2018 that the President intended to negotiate a trade deal with the U.K. after it left the EU. In their negotiating objectives the Office of the U.S. Trade Representative (USTR) took as a template the recently-concluded U.S.-Canada-Mexico Agreement (USMCA) – the successor to NAFTA – which USTR has described as a “model” for future U.S. trade agreements.  Features of USMCA that are reflected in the U.S. negotiating objectives include specific limitations on operations of “state-owned enterprises” – which are included not because Canada, Mexico or the U.K. have significant state-owned enterprises, but as a bulwark to the growing presence of Chinese State-Owned Enterprises on the global stage and as investors in each of these countries.   Reducing so-called “non-tariff barriers” such as certification standards, testing requirements, and other regulatory practices is another key U.S. objective in the U.S.-U.K. negotiations.  For example, the U.S. wants to eliminate practices that are perceived to unfairly decrease U.S. market access for agricultural goods, especially the non-tariff barriers that they believe discriminate against U.S. agricultural goods. Promoting “greater regulatory compatibility” to reduce burdens within the agricultural sectors, as well as commitments for trade in agricultural products developed through biotechnologies are also on the agenda.  Beyond simply expanding bilateral trade, many in the U.S. view this objective as an important fulcrum to gain leverage over the EU in future U.S.-EU negotiations concerning the EU’s own regulatory requirements, such as the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) system.

Trade in services is another important element of the objectives, particularly the financial services market. USTR wants to expand market opportunities for U.S. financial services suppliers, by opening up the conditions of the financial services trade and improving the transparency and predictability of the U.K.’s regulatory procedures. The U.S. seeks to ensure that the U.K. does not impose restrictions on cross-border data flows that require the use of local computing facilities. This will tie into wider agreements relating to data management, given the U.K.’s current commitment to GDPR and ensuring the protection of its citizens’ data. Similarly, the U.S. is pressing the U.K. to scrap proposed taxes on digital services.

USTR would also seek standards for pharmaceuticals and medical devices that ensure government regulatory reimbursement regimes are transparent, procedurally fair and non-discriminatory. They would like full market access for all U.S. pharmaceutical and medical products. As mentioned in earlier sections, this is likely to be a sticking point in negotiations, given the U.K. government’s position on this.

The objectives also include specific provisions relating to Intellectual Property, competition policy, environmental and labour protection. In essence, these seek reciprocal rights or that minimum standards are upheld. In some cases, such as labour and environmental laws, the US is seeking to enforce standards that are currently similar or indeed even higher in the U.K. In the case of Intellectual Property and competition law, there is already some level of reciprocity and operation of international frameworks independent from any specific bilateral arrangements that to some extent provide for much of what is sought.

Similar to the recently-concluded USMCA dispute resolution mechanism, USTR is seeking to ensure that the U.S. and U.K. Governments retain control of disputes and can promptly address situations where they believe decisions made by the dispute resolution panel are wrong.

The Future Relationship

The U.K. is entering an unprecedented new era. The U.K. Government is working on nearly every relationship it has around the globe to prepare for the moment the EU treaties cease to apply to it. This can be an opportunity to redefine the U.K.’s position, however, it is not without its challenges and risks. As the U.K. negotiates its new relationship with its EU partners, the U.K. – U.S. relationship will take on even more importance.

Trade negotiations in the new post-Brexit era have moved beyond the economics of GDP and tariffs. Achieving a trade agreement with the U.S. has become a politically symbolic goal for the U.K. Government. They will be keen to achieve an agreement in order to show that they can move beyond the EU structures. For its part, the U.S. views a bilateral trade agreement as a means to sustain and strengthen ties with its close ally and a lynchpin of future relations with the Continent.  Therefore, a U.K.-U.S. agreement is likely to remain a priority for the both governments. However, with the addition of the coronavirus pandemic on the plate of governments on both sides of the Atlantic, the outcome and timeframe are impossible to predict with certainty, as is the question whether the U.K. and U.S.’s negotiating stances will have hardened.