Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of developing a broad drug importation program. Instead, the working group’s remit was specifically limited to considering potential
OFAC issues press release for a Finding of Violation
German Minister of Economics suggests revising EU and German merger control regulations to enable the creation of European champions – and keeps FDI options on the table to prevent acquisitions by non-European players
On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. A potentially important condition to one of the key proposed changes specific to new drugs is that it would be available only for
With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before (see our previous blog posts here and here), significant news broke on December 7, 2018, regarding a newly implemented pilot centralized drug procurement program (the “program”) that will have significant ramifications for global pharmaceutical companies.
In 2015, the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee that conducts national security reviews of foreign investments, maintained a heavy case load, reviewing 143 transactions, according to CFIUS’s recently published annual report to Congress.
On August 21, 2017, the Department of Commerce (Commerce) and the Office of the United States Trade Representative (USTR) issued a request for public comment on the impact of government procurement provisions of U.S. trade agreements on U.S. manufacturers and suppliers. Prompted by President Trump’s “Buy American and Hire American” Executive Order (E.O.), the request seeks to understand how domestic preference laws affect participation of U.S. manufacturers and suppliers in the Federal procurement process.
Ahead of a Constituent Assembly that could re-write the Venezuelan Constitution and dissolve state institutions, the U.S. Treasury Department’s Office of Foreign Assets Control has designated 13 current and former Venezuelan government officials.
On July 17, the Department of State communicated to Congress that Iran remains in compliance with its obligations under the Joint Comprehensive Plan of Action (JCPOA), the nuclear agreement reached over Iran’s nuclear program by the world’s major powers that went into effect in January 2016.
On June 7, U.S. Treasury Secretary Steven Mnuchin said publicly that Congress should pass legislation to amend the authorizing statute for the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee that conducts national security reviews.
On Thursday, May 18, U.S. Treasury Secretary Steven Mnuchin waded further publicly into efforts on Capitol Hill to amend the authorizing statute underlying the Committee on Foreign Investment in the U.S. (CFIUS), a U.S. Government interagency committee that conducts national security reviews. Munchin reportedly told a gathering of business executives at the U.S. Chamber of
Congressional efforts to reform the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee that conducts national security reviews, continue apace. This week saw the introduction of bipartisan legislation in the U.S. Senate that would (i) give federal agriculture and food officials permanent representation on CFIUS and (ii) amend the statute to allow the Committee to consider agriculture and food-related criteria when reviewing transactions that could result in control of a U.S. business by a foreign person.
Lawmakers in both the U.S. House of Representatives and Senate are examining ways to restrict Chinese investment in the United States by reforming national security reviews conducted by the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee.
The future of the Border Adjustment Tax (BAT) proposal, a critical element of the House Republican tax reform plan, is in doubt after signs of Republican opposition in the Senate emerged last week. Senator David Perdue (R-GA) became the most prominent Republican to overtly criticize the BAT, expressed in a Dear Colleague letter to his
On January 19, 2017, the U.S. Commerce Department’s Bureau of Industry and Security (“BIS”) issued several amendments to the Export Administration Regulations (“EAR”) to implement the India-U.S. Joint Statement of June 7, 2016, recognizing the U.S. and India as Major Defense Partners, and making certain technical changes regarding Hong Kong’s Import and Export (Strategic Commodities)
On December 2, 2016, President Obama blocked a Chinese-owned German company, Grand Chip Investment GmbH (“Grand Chip”), from acquiring the U.S. business of German company Aixtron SE (Aixtron), a semiconductor equipment manufacturer with a U.S. subsidiary headquartered in Sunnyvale, California.
The Internet of Things (“IoT”) connects markets and supply chains around the world. Industry, governments and consumers around the world are embracing IoT technologies to improve research and public policy, to accelerate service delivery and to monitor global development programs across healthcare, agriculture, natural resource management, climate, and energy sectors. Industry experts project that between
The incoming Trump administration’s approach to foreign direct investment (FDI) in the United States and to national security reviews conducted by the Committee on Foreign Investment in the United States (CFIUS) is difficult to predict. Mr. Trump has criticized certain foreign investments in the United States, but his trade-related critiques have focused largely on U.S. free trade agreements and the loss of U.S. manufacturing jobs to foreign countries.
This month Hogan Lovells partners Amy Roma and Ajay Kuntamukkala presented at the International Nuclear Law Association’s (INLA’s) Annual Congress in New Delhi, India. They presented on the Iranian Nuclear Deal and implications for U.S. businesses.
After the UK Brexit referendum of 23 June the implications on the political, economic and legal relations between the UK and the EU have been discussed from many angles. But what about one of the main pillars for the successful integration of the European Single Market: State aid law? Does the end of EU membership
The Department of Energy (DOE) recently published its revised Part 810 Guidance on compliance with the amended Part 810 Regulations on nuclear export controls (10 C.F.R. Part 810). The 2015 amendments to the Part 810 Regulations represented the first comprehensive updating of DOE nuclear export control policy since 1986.
Pursuant to the North Korea Sanctions and Policy Enhancement Act of 2016’s requirement that the Secretary of the Treasury determine whether North Korea is a jurisdiction of primary money laundering concern, on May 27, 2016, the U.S. Treasury’s Financial Crimes Enforcement Network (“FinCEN”) found that the Democratic People’s Republic of Korea (“DPRK” or “North Korea”)
On March 2, in the wake of recent nuclear and ballistic missile tests, the United Nations Security Council adopted a far-reaching sanctions resolution against the Democratic People’s Republic of North Korea. UN Security Council Resolution 2270 targets Pyongyang’s nuclear weapons and ballistic missile programs with a set of sanctions that the U.S. proclaimed the strongest imposed by the Security Council in two decades.
In 2014, the Committee on Foreign Investment in the United States, a U.S. Government interagency committee that conducts national security reviews of foreign investments, reviewed nearly 50% more transactions than it did in 2013, according to CFIUS’s recently published annual report to Congress. The dramatic increase likely reflects a combination of factors, including an increase in cross-border M&A activity, transactions involving sensitive industries or acquirers, and parties continuing to make filings with CFIUS across a broad range of industries.