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Focus on Regulation

Vedanta: UK Supreme Court takes the “straitjacket” off claims against parent companies in the English Courts

On 10 April 2019, the UK Supreme Court handed down its judgment in Vedanta Resources PLC and anor. v Lungowe and others [2019] UKSC 20; a long awaited decision on parent company liability and the jurisdiction of English courts over transnational torts. This blog sets out the key findings and practical implications of the judgment, with a particular focus on what it means for human rights related claims against multinationals and the policies and procedures which they adopt to address the risk of adverse human rights impacts associated with their overseas subsidiaries and supply chains. Continue Reading

Commerce Secretary Ross to FCC: Overbroad TCPA Rules Could Have a “Devastating” Impact on Federal Agencies and the 2020 Census

As we head towards 2020, it’s time once again for the decennial U.S. national Census – one of the broadest data collections that the United States federal government undertakes to learn more about its citizens, recalibrate Congressional districts, allocate public funding, and deliver critical public services. But the government’s ability to conduct the upcoming Census is under threat from an unlikely source – the Federal Communications Commission’s (FCC’s) interpretation of the Telephone Consumer Protection Act (TCPA). Continue Reading

Yesterday’s News, Again? MOE recently shut down 234 CEIs and CEPs?

Recently, a piece of news was published in many media outlets in China saying that the Ministry of Education (“MOE“) announced its termination of cooperation with universities of the U.K., the U.S., Australia and Canada. There are a total of 234 cooperative education institutions (“CEIs“) and cooperative education institutions (“CEPs“) involved.

It is not clear why this news was circulated again last week, but we note that the MOE notice cited in the news is a notice that was published by the MOE in June 2018, with a reference of “Jiao Wai Ting Han [2018] No. 39” (“MOE 2018 Notice“, see link). Also, the name list included in the news is actually the same listed in the MOE 2018 Notice.

We checked with the MOE regarding this news. One MOE official clarified that Continue Reading

Poland: Impact of a no-deal Brexit scenario on biocidal products’ data changes, and the validity of parallel import licences for medicinal products

The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques.[1]

The first Brexit related communique concerned changes to: data which was included within marketing permissions, data being made available on the market, and data concerning the use of biocidal products. The second concerned the impact of Brexit on the validity of parallel import licences.

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Germany: New guidelines for designating vegan and vegetarian products with meat related terms – Will food designations like “vegetarian salami” become soon inadmissible?

Vegan and vegetarian food is becoming more and more popular. However, as a lot of vegans and vegetarians are not willing to give up the taste of meat the demand for meat substitutes increases. Whether “vegan salami” or “vegetarian meatballs”, the fundamental question regarding the designation of those substitutes remains unclear so far: Is the current practice of designating them in the same way as the conventional meat products misleading consumers and should such designations be reserved for the “original”? Continue Reading

Study shows complexity and uncertainty of IoT regulation in Europe

A Hogan Lovells study comparing of regulatory requirements in the European Union, United States, and China shows the complexity and uncertainty of the regulatory framework relevant to Internet of Things (IoT) in Europe. The number of telecoms regulatory constraints affecting IoT in the EU is almost twice as high as in the United States and China. Federal Communications Commission (FCC) Chairman Ajit Pai compares the global race to 5G with World Cup football: “When it comes to 5G, we need to keep the playbook fresh and forward leaning.”[1]

Outdated regulations can slow IoT deployment. Our study shows that many regulations affecting today’s IoT were originally designed for human voice conversations. Continue Reading

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  Primarily, the proposed rule seeks additional information on sunscreen ingredients so that FDA can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and exposure, and evolving information about the potential risks associated with these products.  The proposal is for a final monograph on sunscreens, which would substantially amend the 1999 final rule on sunscreens that was stayed before its effective date. Continue Reading

Poland: New Medical Research Agency

On Monday, March 4, the President signed a bill on the establishment of a new institution, the Medical Research Agency (ABM).

The new Agency will be a specialized body of experts who will work on innovation in Polish medicine, focusing on areas related to oncology, haematology and rare diseases. The activities of the Agency will primarily consist in co-financing scientific research and development work as well as interdisciplinary projects, with particular emphasis on clinical, observational and epidemiological research. Moreover, the Agency will be able to initiate and carry out its own scientific research and development work and, additionally, to expand international cooperation.

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Budha Ismail Jam, et al, Petitioners v. International Finance Corporation

Introduction

On 27 February 2019, the Supreme Court of the United States (SCOTUS) held that International Organisations do not have absolute immunity under the International Organizations Immunities Act of 1945 (IOIA). This blog discusses the opinion of the Supreme Court. Continue Reading

Poland: official position of the competent authority on consequences for medical devices in the event of a no-deal brexit

On 1 March 2019[1], the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the medical devices.

It is announced that in the event of a “no-deal” Brexit, as from 30 March 2019, the United Kingdom will be considered a third country. In this case the following consequences will affect:

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