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On September 15, 2021, CMS published a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule (“MCIT/RN Rule”), which was published on January 14, 2021 and was set to take effect on December 15, 2021.  The MCIT/RN Rule would have created a pathway to provide…

 On January 21, 2021, the European Commission opened two public consultations on the review of the EU Blood Directive and the EU Tissues and Cells Directive.  Both Directives are more than fifteen years old, and their implementation diverges widely across the member states.  The rules on human blood and tissue gain increasing importance for…

A growing number of African countries have begun to ease COVID-19 related regulatory restrictions. Some countries, such as Kenya, Rwanda, and Senegal resumed international flights in August, while other countries like South Africa and Nigeria are only now opening their borders. For a continent that slipped into recession for the first time in a quarter

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On 10 September 2020, the German Federal Social Court (Bundessozialgericht – “BSG”) has issued an important decision with significant impact on the drug pricing and reimbursement system. It ruled that a pharmaceutical company can file a direct legal action against the early benefit assessment in the so-called AMNOG process. This was not possible so far.

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Drug manufacturers have responded to the COVID-19 pandemic by adopting measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, some have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and mitigating associated risks to product

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The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). President Trump initially had announced the MFN executive order during his July 24, 2020 press conference highlighting four separate executive orders aimed at drug pricing. However,…

On August 15, 2020, the Minister of Cooperative Governance and Traditional Affairs (COGTA) announced the extension of the national state of disaster. The national state of disaster was declared under Government Gazette No 43096 of 15 March 2020 (and extended by Government Gazette Nos 646 of June 5, 2020 and 765 of July 13, 2020),

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