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Export Controls Pharmaceutical Industry

Goodwin

The BIOSECURE Act and Its Potential Implications

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Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

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This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

The Volkov Law Group

Navigating Recent BIS Changes to the EAR: A Practical Primer for the Medical Device and Product Industry

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Among other things, on May 19, 2023, the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) issued a sweeping new set of restrictions that collectively operate to deter the Putin Regime from acquiring...more

Morgan Lewis

How China’s Detailed Human Genetic Resources Rules May Impact Multinational Life Science Companies

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China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 98

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This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 95

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This regular update (no. 95 | 9 January 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 91

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This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion....more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 86

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This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. ...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 80

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COMPETITION & STATE AID - State Aid - European Commission adopts Temporary Crisis Framework to support economy in context of Russia's invasion of Ukraine - On 23 March 2022, the Commission adopted a Communication on a...more

Jones Day

Covid-19 Key EU Developments, Policy & Regulatory Update No. 78

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COMPETITION & STATE AID - State Aid - European Commission publishes first Report on implementation of Recovery and Resilience Facility - On 1 March 2022, the Commission published its first Report to the European...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 73

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COMPETITION & STATE AID - Competition - Commission publishes Competition Policy – 2021 at a glance. On 22 December 2021, the European Commission published its Competition Policy – 2021 at a glance. ...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.72

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COMPETITION & STATE AID - Competition- European Commission expresses views on IAG’s (aborted) intended acquisition of Air Europa, including in light of impact of COVID-19 restrictions - On 16 December 2021, the...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 71

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COMPETITION & STATE AID - Competition - Executive Vice President and Competition Commissioner Margrethe Vestager speaks at U.S. Chamber of Commerce's Transatlantic Business Works Summit. ...more

Jones Day

COVID-19 KEY EU Developments, Policy & Regulatory Update No. 70

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COMPETITION & STATE AID - State Aid - European Commission adopts revised Guidelines on State aid to promote risk finance investments- On 6 December 2021, the Commission published its Communication on Guidelines on...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.69

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COMPETITION & STATE AID - State Aid - European Commission publishes revised Communication on State aid rules for Important Projects of Common European Interest (IPCEI). On 25 November 2021, the Commission published a...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 68

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COMPETION & STATE AID - European Commission adopts Communication on a Competition Policy Fit for New Challenges - On 18 November 2021, the European Commission adopted a Communication on a Competition Policy Fit for New...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory update No.67

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COMPETITION & STATE AID - European Commission comments on transatlantic relations in post-pandemic world, including building resilient supply chains - On 12 November 2021, Executive Vice-President and Competition...more

White & Case LLP

House Republicans Introduce Bill to Renew 2015 Trade Promotion Authority Law and Establish New Negotiating Objectives for...

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On July 27, Reps. John Joyce (R-PA) and Jim Banks (R-IN) introduced legislation that would establish new US trade negotiating objectives for the pharmaceutical sector, in the context of a broader renewal of the trade...more

Morgan Lewis

EU Imposes Authorization Requirements for COVID-19 Vaccine Exports

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In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force...more

Dechert LLP

Election 2020: President Biden’s Potential Impact on Business

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Now that it appears Joseph R. Biden Jr. has won the presidency, it’s time to take a serious look at the Democratic Party platform and how a Biden administration will likely impact business....more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 7 In This Month's E-News: July 2020

Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more

Polsinelli

COVID-19 Challenges Medical Equipment Supply Chains

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The COVID-19 pandemic is significantly disrupting international trade as global and domestic supply chains grapple with declining trade volumes and inadequate supplies of medical goods, including personal protective equipment...more

Hogan Lovells

FEMA releases exceptions to rule prohibiting exports of PPE – exports to Canada and Mexico are excluded and other important...

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On 17 April the Federal Emergency Management Agency (FEMA) released significant exceptions (effective Friday 17 April, but to be published on 21 April) to FEMA's temporary final rule prohibiting exports of certain personal...more

Cozen O'Connor

FEMA Issues Further Guidance on PPE Exports

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In an Alert published on April 10, we discussed temporary restrictions that the Federal Emergency Management Agency (FEMA) had placed on the export from the United States of certain personal protective equipment (PPE). ...more

Polsinelli

FEMA Issues Restrictions on PPE Exports Due to COVID-19 Pandemic

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On April 10, 2020, the U.S. Federal Emergency Management Agency (FEMA) published a Temporary Final Rule as part of its response to the COVID-19 pandemic.  The Temporary Final Rule allocates certain scarce or threatened...more

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