Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives.  In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing.  Meanwhile, the Energy and Commerce Committee (E&C) held a hearing regarding implementation of biosimilars.  While all the attention will be on the former, the latter was more important, especially for participants in the biosimilar space.

First, the OGR Committee was a media show built around the flamboyant Shkreli.  Shkreli took the 5th when given the opportunity to testify and later tweeted – after being excused from the hearing for refusing to answer any of the Members questions – that the Committee Members were ‘imbeciles’.  The tone of the hearing was very aggressive towards drug pricing and what were described as unsavory business practices. Members were also critical of the FDA generic drug programs.  However, Member interest in strengthening the program to bring competition to the marketplace was clear. Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the FDA,  stated that funds collected as a result of the Generic Drug User Free Amendments (GDUFA) helped expedite the review process and that by October there will be a 10-month review process on all new applications. The Senate HELP Committee held a hearing last week on reauthorization of GDUFA, which will expire next year, and this bipartisan interest, coupled with the prescription drug cost crisis, could lead to increased resources for the FDA review process. Beyond some public shaming of specific drug companies, there was little suggestion of substantive action on drug pricing.

Second, the E&C Committee was less about drug pricing, but more so about the ability of manufacturers to get new biosimilar products to the market. Notably, Committee Members on BOTH sides of the aisle were critical of CMS for trying to price biosimilars more like generic drugs and categorize different products under a single billing code.  They said the CMS ruling undermines the intent of the Biologics Price Competition and Innovation Act of 2010 (BPCIA) by removing incentives for a robust marketplace. Biologics make up a $200 billion market, so the consequences of policy decisions are significant. Members were also critical of delays in approving more biosimilars and issuing guidance on product labeling. Rep. Frank Pallone (D-NJ) asked if additional appropriations would address these problems, to which Dr. Woodcock replied that she’s more concerned the FDA will be unprepared for a rapid expansion of the biosimilar market.

While 2016 may be devoted to campaigning against drug prices, the Committees responsible for the regulatory regimes for drugs are still very focused on preserving the ability of manufacturers to successfully bring drugs to the market.  That is a much bigger deal than the plethora of Martin Shkreli smirks you will be subjected to in the media.

©1994-2016 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Department of Commerce Releases Fact Sheet on EU-U.S. Privacy Shield

As we reported yesterday, the United States and the European Commission have reached a political agreement on a new framework for transatlantic data flows, referred to as the EU-U.S. Privacy Shield.  The U.S. Department of Commerce (“Commerce”) released a fact sheet yesterday to coincide with the announcement of the agreement.

The fact sheet includes a series of bullet points listing ways in which the Privacy Shield (1) “significantly improves commercial oversight and enhances privacy protections,” and (2) “demonstrates the U.S. Commitments to limitations and safeguards on national security.”  On the first point, Commerce states that “EU individuals will have access to multiple avenues to resolve concerns,” including alternative dispute resolution at no cost to individuals.  In addition, Commerce “will step in directly and use best efforts to resolve referred complaints” using a “special team with significant new resources.”  On the second point, the fact sheet references President Obama’s executive actions to enhance privacy protections and oversight relating to U.S. government surveillance activities.  Finally, Commerce states that “the United States is making the commitment to respond to appropriate requests” regarding U.S. intelligence activity, in a manner that is consistent with national security obligations.

Continued International and Domestic Coordinated Focus on Money Laundering

On February 1st, the U.S. Drug Enforcement Agency (DEA) announced an unspecified number of arrests of Hizballah money launderers, including Mohamad Noureddine. stack of moneyThese arrests followed the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) designation of Noureddine pursuant to its counterterrorism authority. The OFAC press release for this designation identifies Noureddine as a key Hizballah money launderer. According to OFAC,  Noureddine and his company Trade Point International S.A.R.L. established a money laundering network across Asia, Europe, and the Middle East that provides bulk cash shipping and black market currency exchange services for those seeking to hide their ill-gotten gains.

Hizballah International Financing Prevention Act of 2015

Irrespective of the detention of Noureddine, foreign financial intuitions that knowingly facilitate or conduct significant financial transactions for Trade Point International S.A.R.L. may have their U.S. correspondent or payable through accounts severed. OFAC has this authority under Section 102 of the Hizballah International Financing Prevention Act of 2015, which authorizes secondary sanctions on Hizballah.

Lebanese Canadian Bank

The arrests stem from  interagency  investigations of the Lebanese Canadian Bank (LCB). U.S.  law enforcement agencies have a long history with this now defunct Hizballah-linked bank.  In February 2011, the U.S. Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN) issued a Notice of Proposed Rulemaking to exclude  LCB from the U.S. financial system, finding that the bank is of “primary money laundering concern.”  In response to this action, the Banque du Liban revoked LCB’s banking license in September 2011. The bank’s remaining assets and liabilities were then sold to Societé General. Two years later, LCB entered into a $102 million settlement agreement to resolve a civil forfeiture and money laundering lawsuit filed by the U.S. Attorney for the Southern District of New York.  FinCEN withdrew  its Notice of Proposed Rulemaking in September 2015, on the basis that LCB no longer exists.

Coordinated Effort to Combat Money Laundering

The success of the ongoing money laundering investigation and recent arrests were possible because of the cooperation and coordination among the following international and domestic agencies:

  • DEA Philadelphia, DEA Miami, DEA Newark, DEA New York

  • DEA Special Operations Division and DEA Bilateral Investigative Unit

  • DEA country offices in Europe

  • DEA country offices in Bogota and Cartagena, Colombia

  • S. Customs and Border Protection National Targeting Center

  • S. Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN)

  • S. Department of the Treasury’s Office of Foreign Assets Control (OFAC)

  • Various French, German, Italian and Belgian law enforcement agencies

  • EUROPOL

  • EUROJUST

Like the LCB investigation before it, yesterday’s arrests will likely lead to additional U.S. and international actions against money launderers around the world.

ARTICLE BY Jeremy P. Paner of Holland & Hart LLP

Copyright Holland & Hart LLP 1995-2016.

Agreement Reached on New EU-U.S. Safe Harbor: the EU-U.S. Privacy Shield

On February 2nd, 2016, the European Commission and U.S. Government reached political agreement on the new framework for transatlantic data flows.  The new framework – the EU-U.S. Privacy Shield – succeeds the EU-U.S. Safe Harbor framework (for more on the Court of Justice of the European Union decision in the Schrems case declaring the Safe Harbor invalid, see our earlier post here).  The EU’s College of Commissioners has also mandated Vice-President Ansip and Commissioner Jourová to prepare the necessary steps to put in place the new arrangement.

The EU-U.S. Privacy Shield

According to the Commission press release, there will be several new elements to the EU-U.S. Privacy Shield, as compared with the invalidated EU-U.S. Safe Harbor framework.  For instance, in addition to subjecting participating U.S. companies to certain as-yet unspecified safeguards, the Privacy Shield will include:

  • An annual joint review of the program performed by the European Commission and U.S. Department of Commerce – to which European data protection authorities will be invited – to ensure its proper functioning.  This will include a review of access by U.S. intelligence agencies to EU-originating data.

  • Enhanced rights of redress for European data subjects, including (i) subjecting U.S. organizations to firmer deadlines when responding to complaints, (ii) allowing EU citizens and EU data protection authorities to refer complaints to the U.S. Department of Commerce and the U.S. Federal Trade Commission, (iii) establishing, as a last resort, a new binding alternative dispute resolution mechanism to resolve complaints that will be voluntary and free to data subjects, capable of issuing binding injunctive orders, and subject to judicial review consistent with the U.S. Federal Arbitration Act, and (iv) creating a new “Ombudsperson” within the U.S. State Department to handle complaints – channeled through EU Member State representatives – that relate to U.S. intelligence agencies’ access to data.  Disputes relating to human resources/employee data will remain subject to an alternative process that entails somewhat closer involvement of EU data protection authorities, similar to the current Safe Harbor.

Moreover, it is reported that the U.S. Director of National Intelligence will confirm by official letter to the EU that U.S. intelligence agencies do not engage in “indiscriminate mass surveillance” of data transferred under the new arrangement.

The Privacy Shield is expected to retain or enhance many of the elements contained in the original Safe Harbor framework, including substantive commitments made by U.S. companies on such matters as furnishing appropriate notices to EU citizens, maintaining the security of transferred data, and tightened restrictions on onward transfers.  The precise nature of these obligations is not yet known, but will become clearer in the weeks ahead.

Next steps

The EU College of Commissioner’s has mandated Vice-President Ansip and Commissioner Jourová to, over the coming weeks, prepare a draft Decision declaring the U.S. to ensure an adequate level of protection.  The adoption of such a Decision by the Commission must follow a “comitology” procedure which will involve:

  • a proposal from the Commission;

  • an opinion by EU Member States’ data protection authorities and the European Data Protection Supervisor (“EDPS”), in the framework of the Article 29 Working Party;

  • an approval from the “Article 31 Committee”, composed of representatives of Member States, under the comitology “examination procedure”;

  • the formal adoption of the Decision by the College of Commissioners;

  • at any time, the European Parliament and the Council may request the Commission to maintain, amend or withdraw the adequacy decision on the grounds that its act exceeds the implementing powers provided for in the Directive.

The effect of such a Commission Adequacy Decision is that personal data can flow from the 28 EU countries and three EEA member countries (Norway, Liechtenstein and Iceland) to the U.S. without any further safeguards being necessary.

Commissioner Jourová hopes for the new arrangement to be in force in approximately 3 months’ time.  The U.S. Government, in the meantime, will make the necessary preparations to put in place the new framework, monitoring mechanisms, and new Ombudsperson.

Tomorrow (February 3rd, 2016), Commissioner Jourová will attend the plenary meeting of the Article 29 Working Party to discuss the role of the EU data protection authorities under the EU-U.S. Privacy Shield.  The U.S. Department of Commerce is, in parallel, planning further briefings about the text.

EEOC Proposes Rule Requiring Employers to Disclose Pay Data on EEO-1 Forms and Key Recent Pro-Employee Changes in New York State’s and New York City’s Employment Laws and Regulations

EEOC EEO-1 Form Pay Data Requirement Raises Risks for Management

In a proposed regulation announced on January 29, 2015, the U.S. Equal Employment Opportunity Commission set forth changes that would require federal contractors and all other private-sector employers throughout the nation of more than 100 employees to report wage and salary data on their annual EEO-1 Forms. This new rule would mandate that such employers disclose compensation ranges and hours worked on their EEO-1 Forms, which already must contain data on employees’ gender, ethnicity, and race.

The Commission’s plans to require management to submit this data is part of the Obama Administration’s aggressive efforts to enforce the federal Equal Pay Act and other fair employment statutes and to promote pay equity in the workplace. Complying with the new regulation would require employers to spend substantial additional time and resources in gathering compensation information, which often involves many variables, and then organizing it into the format that the EEOC will mandate. Reporting this data to the EEOC would give the U.S. Government data without context and may lead to burdensome Commission investigations and enforcement actions based on misunderstandings of incomplete compensation information. Further, even though EEO-1 data enjoys some protections, the confidential status of employers’compensation information will now be vulnerable either to Freedom of Information Act requests or to kind of hacking attacks to which the federal government, with its antiquated IT systems in agencies such as the EEOC, has already suffered.

In sum, employers in New Jersey, New York, and around the country would become subject to higher EEOC scrutiny of their payroll practices, would face more Commission inquiries and litigations, would have to expend additional resources to complete EEO-1 Forms, and would need to live with a higher risk that their competitors will be able to obtain the confidential compensation data that the new rule would require management to submit each year to the EEOC.

Key Pro-Employee Changes in New York State and New York City Employment Laws and Regulations

New York State and New York City made significant changes in their labor and employment laws and regulations last year and this month. The NYS Legislature enacted, and Governor Cuomo signed, key revisions to laws that affect management throughout New York State. Mayor de Blasio and the City Council expanded local laws that further burden employers in the City. These important developments include:

A. New York State Women’s Equality Agenda

The Women’s Equality Agenda that went into effect on January 19, 2016 significantly amended New York State’s sex discrimination, sexual harassment, and equal pay laws to afford women greater protection in the workplace. These new statutes promoting gender equality in New York State include provisions that:

1. Amend New York State’s Equal Pay Act to require that an employer which pays lower wages to women than to men, for a job of equal skill, effort, and responsibility, demonstrate that such disparity is due to a bona fide factor other than sex, such as education, training, or experience, and that the difference in pay is job related and consistent with business necessity.

2. Make it unlawful for employers, in general, to prohibit employees from discussing or disclosing their wages — a new provision which affects both women and men.

3. Significantly increase the penalties for New York State Equal Pay Act violations by allowing employees to recover liquidated damages of three times (300%) the unlawfully unpaid wages, in addition to making the employee whole by requiring payment of the unpaid wages.

4. Allow a court to award attorneys’ fees to a prevailing plaintiff in sexual harassment and other sex discrimination actions.

5. Add familial status as a protected class under the New York State Human Rights Law. This new provision applies equally to men and women who are parents or guardians.

6. Expand the New York State Human Rights Law’s coverage of sexual harassment claims to all employers, including employers of from one to three employees who were not previously covered.

7. Require employers to provide reasonable accommodation for pregnancy-related medical conditions.

B. New NYS and NYC Protections for Transgender Individuals

1. Earlier this month, the New York State Division of Human Rights adopted regulations that make discrimination on the basis of a person being transgender unlawful under the New York State Human Rights Law. These regulations also prohibit harassment of transgender persons and require New York employers to reasonably accommodate employees who have been diagnosed with a “gender dysphoria” medical condition.

2. On December 21, 2015, the New York City Commission on Human Rights issued new enforcement guidelines on discrimination against transgender individuals, which the New York City Human Rights Law prohibits. The guidelines provide for penalties of up to $250,000 for violations that are found to be willful, wanton, or malicious.

C. New NYC Protections for Caregivers

1. The New York City Council has amended the New York City Human Rights Law to include caregiver as a protected class. The new local legislation, which Mayor de Blasio signed on January 5, 2016, defines caregivers as persons who provide direct and ongoing care for a minor child or a care recipient, such as a relative or individual with a disability who resides in the caregiver’s household. This amendment will go into effect on May 4, 2016.

© Copyright 2016 Sills Cummis & Gross P.C.

Uber-Complicated: Insurance Gaps for Rideshare Vehicles Can Create Uncertainty for Passengers and Drivers

Many of us have come to enjoy the convenience of summoning a ride via our Smartphones with a rideshare service company such as Uber, Lyft, or Sidecar.  However, significant issues exist over whether rideshare vehicles have adequate insurance coverage to compensate people injured in accidents involving those vehicles.

If one is injured by a Greyhound bus, for example, there is little question that Greyhound likely would have adequate insurance to cover any injuries and likely would have sufficient resources to compensate the injured party even without insurance.

By contrast, if one is injured by a rideshare driver, there are several potential obstacles to securing adequate compensation.

First, the rideshare company may classify the driver as an independent contractor instead of an employee, meaning that the company will not accept responsibility for the driver’s actions.  Second, even if the rideshare company accepts responsibility, the company’s insurance may not provide coverage, as discussed below.  In that event, the injured party is left to rely on the driver’s insurance, which also may be inadequate and may even exclude coverage for rideshare-related accidents.

The independent contractor issue has been litigated in numerous states with different outcomes.  Uber currently is facing two class action lawsuits in California related to this issue: Ghazi v. Uber Technologies, Inc., et al., No. CGC-15-545532 (Superior Court of California, County of San Francisco) and O’Connor v. Uber Technologies, Inc., et al., No. CV-13-3826 (U.S. District Court for the Northern District of California).[1]

Even if rideshare companies accept responsibility for a driver’s conduct, the companies typically have provided only limited insurance for their drivers.  Specifically, rideshare companies typically have not provided coverage in the following two periods: (1) when the rideshare app is turned off, or (2) when the app is turned on but no passenger is in the vehicle.

But, a horrific accident involving an Uber vehicle helped to start changing this dynamic.  Uber was sued in 2014 in California after a driver struck and killed a child during period (2) above, when he had his app turned on but had not yet picked up a passenger.  The case is captioned Liu v. Uber Technologies Inc., et al., No. CGC-14-536979 (Superior Court of the State of California, County of San Francisco).

California and other states recently have started requiring rideshare companies to maintain some coverage for their drivers in period (2), but that coverage is limited.  The companies typically provide contingent liability coverage with $50,000 per person/$100,000 per accident bodily injury coverage, but this insurance typically pays only for losses not covered by the driver’s personal policy.

And, even when rideshare company coverage is in place, insurers have relied on certain insurance policy exclusions in an effort to avoid paying claims.  One insurer is currently making such arguments in the coverage dispute with Uber over the Liu settlement See Evanston Insurance Co. v. Uber Technologies, Inc., No. C15-03988 WHA (U.S. District Court for the Northern District of California).

If a rideshare company’s commercial insurance is inadequate to fully compensate an injured party, that person is left to rely on a driver’s personal insurance.  But the driver’s insurance may be of no help because personal auto policies often contain an exclusion (the “livery exclusion”) for accidents occurring during commercial use of the vehicle, such as when a driver is transporting a passenger for hire.

Recently, there has been some effort in the insurance industry to close the insurance gaps discussed above, particularly during period (2), when a rideshare driver is using a mobile app but has not yet picked up a passenger.

In March 2015, the National Association of Insurance Commissioners adopted a white paper on insurance coverage for rideshare companies titled “Transportation Network Company Insurance Principles for Legislators and Regulators.”  The paper recommends that rideshare companies provide full coverage for period (2) or that drivers purchase individual commercial coverage during that period.

Similar to California, legislatures in Colorado, Illinois, and Virginia have passed laws requiring rideshare companies to offer full insurance during period (2).

In addition, some insurance companies are offering products to rideshare drivers to protect them in the event that rideshare companies’ commercial insurance does not pay.  For example, Geico (in Maryland and Virginia) and Progressive (in Pennsylvania) are offering individual commercial insurance to rideshare drivers that has lower rates than most commercial insurance.  USAA (in Colorado and Texas) offers a commercial insurance policy to rideshare drivers for an extra $6 to $8 per month.  Erie Insurance (in Illinois and Indiana) has removed an exclusion from personal auto policies purchased with a “business use” designation such that rideshare drivers now may be covered.

Overall, many options are emerging to provide additional insurance coverage on rideshare vehicles for the benefit of passengers and other third parties at all stages of the transportation process – from the time a rideshare driver turns on the app through the transport of a passenger.  Passengers, drivers, and affected third parties should continue to monitor these developments to make sure they are adequately protected.

© 2016 Gilbert LLP

[1] One consequence of the driver being classified as an independent contractor is that rideshare companies do not have to provide worker’s compensation insurance for a driver’s on-the-job injuries.  The Ghazi case addresses whether Uber drivers actually are employees and thus Uber must provide worker’s compensation insurance.

Automated Retail: Stores without Staff, but Not Without Issues

For many, air travel is required for business while for others it is used for pleasure. As millions of people are hustling through airports to make their flights, some may have taken a moment to stop to shop at one of the many staffless stores that are opening in airports. These staffless stores, which are often referred to as automated retail, sell goods that range from electronics such as headphones and chargers to cosmetics and clothing.

The staffless store phenomena is not limited to just airports as there is an increasing trend towards using these retail outlets in shopping centers throughout the country. We wrote on this new trend back in August of 2014 when the focus was on brick and mortar stores without staff, such as fitness centers and mattress stores. The 2016 version of staffless stores are a hybrid of the traditional kiosks/carts and a vending machine. They are typically similar in size to a vending machine but are situated in locations comparable to that of a traditional kiosk or inside of department stores. While branded in a manner similar to a kiosk, these automated outlets allow the retailer to avoid the cost of staffing the location.

The staffless store offers landlords and tenants a number of positive opportunities. For example, by offering tenants a lower cost way of penetrating a new market and giving landlords a way to increase revenues through the use of spaces that cannot be utilized effectively with traditional kiosks or carts. It can also introduce new retailers that otherwise would not be willing to incur the operating expense of having employees. Establishing the retailer in the Center initially through the use of an automated retail operation could also lead to later expansion opportunities with that retailer.

A landlord and tenant will often document the relationship for a staffless store by using a traditional kiosk or specialty lease form. However, there are a number of items that the parties should review when documenting the relationship. Some of those items include:

  • Many kiosk leases include operational and staff requirements so any language requiring a certain number of staff at the location or staff attire needs to be addressed.

  • Kiosk or cart leases often require that the kiosk/cart be adequately stocked with merchandise. While this requirement may still be applicable, the retailer needs to confirm that it has an adequate inventory monitoring process or software to ensure that the automated retail machine does not run out of product.

  • The exchange/refund policy may need to be modified to address the fact that retailer personnel will not be present to make any exchange of product.

  • The use of Center gift cards to pay for goods should be addressed in the Lease and by the automated retailer.

  • Confirming that the insurance requirements for the tenant are appropriate given that there will not be staff located at the leased premises. The indemnification provisions should also be carefully reviewed for accuracy given the facts of a given situation.

©2016 von Briesen & Roper, s.c

2015 Union Membership Rate Relatively Stable Despite New NLRB Election Rules

national labor relations boardDespite the National Labor Relations Board’s “quickie election rules,” the percentage of unionized workers in the private sector remained stable during 2015, according to the Bureau of Labor Statistics of the U.S. Department of Labor: 6.7% of private-sector workers were in unions in 2015, up from 6.6% in 2014. Not surprisingly, public-sector workers had a much higher union membership rate: 35.2%.

According to the report, men had a higher union membership rate than women: 11.5% versus 10.6%. In addition, the percentage of African-American workers who were union members was greater than Caucasian workers.

New York (24.6%), Alaska (22.8%), and Hawaii (21.8%) had the highest unionization rates, whereas South Carolina (2.2%), Mississippi (3.7%), and Utah (3.7%) had the lowest.

The report found the median weekly earnings of nonunion workers were lower than the median weekly earnings for unionized workers ($776 per week versus $980 per week). The report, however, recognizes that this comparison may not be valid because the “comparisons of earnings in [the] release are on a broad level and do not control for many factors that can be important in explaining earnings differences.” Indeed, this is likely the case.

Jackson Lewis P.C. © 2016

Travel to the United States in 2016: The Year of Fear – Restrictions on the Visa Waiver Program (VWP) ESTA

On January 21, 2016, the United States began implementing changes under the Visa Waiver Program Improvement and Terrorist Travel Prevention Act of 2015.

Nationals of Visa Waiver Program countries who have traveled to or been present in Iran, Iraq, Sudan, or Syria on or after March 1, 2011, will no longer be able to participate in the Visa Waiver Program.  In addition, nationals of Visa Waiver Program countries who are also nationals of Iran, Iraq, Sudan, or Syria will not be able to participate even if they have not visited or been present in those countries. 

There will be limited exceptions for individuals who are traveling on behalf of international organizations, regional organizations and subnational governments on official duty; who are there on behalf of a humanitarian NGO on official duty; or are journalists traveling for reporting purposes.  Certain individuals traveling to Iran for legitimate business-related purposes following the conclusion of the Joint Comprehensive Plan of Action of July 2015 and other individuals traveling to Iraq for legitimate business related purposes may be exempt as well.

Currently, thirty-eight (38) countries are participants in the Visa Waiver Program:

Andorra

Hungary

New Zealand

Australia

Iceland

Norway

Austria

Ireland

Portugal

Belgium

Italy

San Marino

Brunei

Japan

Singapore

Chile

Republic of Korea

Slovakia

Czech Republic

Latvia

Slovenia

Denmark

Liechtenstein

Spain

Estonia

Lithuania

Sweden

Finland

Luxembourg

Switzerland

France

Malta

Taiwan**

Germany

Monaco

United Kingdom*

Greece

The Netherlands

Individuals impacted may still travel to the United States as visitors for business or pleasure, if they successfully complete the normal process for applying for a non-immigrant visa at a United States Embassy or Consulate, as others who are not nationals of Visa Waiver Program countries, regularly do.  However, there certainly is concern that there will be backlogs and delays associated with the visa application process.

The Year of Fear

The real question which yet remains unanswered is precisely how will this change be implemented.  Customs and Border Protection (CBP) of the United States Department of Homeland Security advises that it will be modifying its Visa Waiver Program (ESTA) questionnaire to identify individuals who might be ineligible and provide them an opportunity to explain why an exemption might be applicable.  How such applications will be processed and assessed remains unknown.

In addition, it is not clear how implementation will take place with reference to those individuals who are already ESTA Visa Waiver Program participants.  The inference is, that they will be notified, perhaps by e-mail, but it is unclear.  Accordingly, it would make sense for those, who are subject to these new restrictions, to be prudent and simply and proactively apply for visas at appropriate American Embassies or Consulates, or at the very least, reach out to CBP.  The CBP website is www.cbp.gov and the CBP Information Center can be reached at www.cbp.gov/contact.

Canadians and Americans

Canadians are generally visa exempt but do not participate in the Visa Waiver Program, and accordingly these provisions are not applicable to them.  Of course, the United States imposes no  restrictions with reference to United States citizens, but one can anticipate that there might be in the coming months, restrictions or, backlash, or reaction from other countries.

More to Come – Passport Restrictions

Beginning April 1, 2016, passports must be electronic  and fraud resistant, and contain additional biographic and biometric information not previously required.  In addition to being machine readable, passports must contain an electronic chip that stores biographic data, biometric identifier, a digital signature and a unique chip identification number.

In addition, Visa Waiver countries by October 1, 2016  must have the capability to validate passports at key points of entry with heightened ability to screen travelers.

So what does the rest of 2016 hold for us?  It looks like it will be a battle between those forces that would like to see this be a year of hope, as compared to those who will settle for it being a year of fear.  Each has a legitimate agenda.  We are a compassionate country that  wants to present a welcome face to visitors, business persons, refugees and those in need.  But, on the other hand, we certainly do have much to fear from those who would be very happy to take advantage of our benevolence and of our open society to do harm.

Ultimately, I think our security concerns will predominate, but hopefully, we will find a sensible balance and equilibrium as time goes by.

US Treasury and Commerce Departments Announce New Changes to Cuba Regulations

On January 25, 2016, the US Treasury Department’s Office of Foreign Assets Control (OFAC) and the US Commerce Department’s Bureau of Industry and Security (BIS) announced new changes to existing US sanctions on Cuba, including OFAC’s Cuban Assets Control Regulations (CACR) and BIS’s Export Administration Regulations (EAR). These changes expand allowable financing for certain authorized exports, allow more flexibility in a number of sectors to export to Cuba, permit air carriers to serve customers in Cuba and further liberalize travel rules. These new regulatory changes may constitute the most that President Obama can do to liberalize trade and travel with Cuba in the absence of congressional legislation to lift the embargo in whole or in part.

Authorized Export Transactions

Amendments to the CACR and EAR to increase support for the Cuban people and facilitate authorized exports include the following:

  • The CACR have been amended to remove financing restrictions for most types of authorized non-agricultural exports. (OFAC is required by statute to maintain the existing limitations on payment and financing terms for the export and reexport of agricultural commodities and agricultural items). Permissible payment and financing terms for authorized non-agricultural exports and reexports now include payment of cash in advance, sales on open account, and financing by third-country financial institutions or US financial institutions.

  • OFAC expanded an existing general license to authorize certain additional travel-related transactions directly related to market research, commercial marketing, sales or contract negotiation, accompanied delivery, installation, leasing, or servicing in Cuba of items consistent with the export or reexport licensing policy of the Department of Commerce, provided that the traveler’s schedule of activities does not include free time or recreation in excess of that consistent with a full-time schedule.

  • BIS now will generally approve license applications for exports and reexports of telecommunications items that would improve communications to, from, and among the Cuban people; certain agricultural items not eligible for a license exception, including insecticides, pesticides, and herbicides; and items necessary to ensure the safety of civil aviation and the safe operation of commercial aircraft engaged in international air transportation.

  • BIS ended its policy of denial and now will consider on a case-by-case basis license applications for exports and reexports of items to meet the needs of the Cuban people, including exports and reexports for such purposes made to state-owned enterprises and agencies and organizations of the Cuban government that provide goods and services to the Cuban people. Exports and reexports eligible for this licensing policy include items for: agricultural production; artistic endeavors (including the creation of public content, historic and cultural works and preservation); education; food processing; disaster preparedness, relief and response; public health and sanitation; residential construction and renovation; public transportation; and the construction of infrastructure that directly benefits the Cuban people (e.g., facilities for treating public water supplies and supplying energy to the general public).

Travel

OFAC has expanded several existing allowable travel categories to facilitate travel to Cuba, including the following:

  • OFAC will authorize travel-related and other transactions directly incident to professional media or artistic productions of information or informational materials for exportation, importation, or transmission, including the filming or production of media programs (such as movies and television programs), music recordings, and the creation of artworks in Cuba by persons that are regularly employed in or have demonstrated professional experience in a field relevant to such professional media or artistic productions.

  • OFAC is expanding the general license for travel-related and other transactions to organize professional meetings or conferences in Cuba. The existing general license authorized only attendance at such meetings or conferences.

  • OFAC is authorizing by general license travel-related and other transactions to organize amateur and semi-professional international sports federation competitions and public performances, clinics, workshops, other athletic or non-athletic competitions, and exhibitions in Cuba.  OFAC is also removing requirements that US profits from certain events must be donated to certain organizations and that certain events be run at least in part by US travelers.

Conclusion

These changes to the regulations offer important changes and will allow for additional market opportunities for US businesses looking to enter the Cuba market. Still, the embargo is in place, and US companies should proceed with caution to ensure full compliance with all existing US and Cuban laws.

© 2016 McDermott Will & Emery