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. The decision therefore significantly broadens the legal redress possibilities of pharmaceutical companies under the German drug pricing and reimbursement regulation.…

Global Policy Watch

South Africa Eases COVID-19 Restrictions

By Mosa Mkhize & Shivani Naidoo

September 28, 2020

On September 16, 2020, President Cyril Ramaphosa announced that South Africa would move from Alert Level 2 to Alert Level 1 of Risk Adjusted Strategy as of midnight on September 20, 2020. This is in part in response to the relatively low levels of infections and the government led interventions to combat the spread of COVID-19. While South Africa has confirmed over 650,000 infections and has suffered 15,000 deaths, recent data illustrates that the number…

Global Policy Watch

The Week Ahead in the European Parliament – Friday, September 25, 2020

By Sebastian Vos

September 25, 2020

Next week, Members of the European Parliament (“MEPs”) will gather in Brussels for committee and political groups’ meetings. Several interesting debates are scheduled to take place. On Monday, the Committee on the Environment, Public Health and Food Safety (“ENVI”) will have an exchange of views with Commission Vice-President Frans Timmermans on the 2030 Climate Target Plan. The MEPS from ENVI are proponents of stepping up the EU’s climate ambition and have called for binding targets…

Global Policy Watch

How Can Corporations Support the Voting Process?

By Derek Lawlor

September 25, 2020

In the midst of the COVID-19 pandemic, voting in the 2020 general election is likely to look different than we have seen in recent times. Election officials across the country are working through in-person voting and vote-by-mail procedures and individual voters are deciding how best to cast their ballots. At the same time, many corporations are recognizing this unprecedented situation and are asking how they can help support the voting process. This alert discusses the…

Global Policy Watch

China Issues Regulations to Advance Implementation of Its “Unreliable Entity List”

By Christopher Adams, Yan Luo, Ashwin Kaja & Zhijing Yu

September 23, 2020

As tensions continue to rise between China and the United States, the Chinese government has taken a step forward in actualizing the “Unreliable Entity List,” first announced by China’s Ministry of Commerce on May 31, 2019, following the addition of Huawei and affiliates to the U.S. Commerce Department’s “Entity List.” Now, as the U.S. government pursues restrictions on Chinese technology services providers, including social media apps, the Ministry of Commerce has issued new Regulations on…

Global Policy Watch

California Mandates COVID-19 Supplemental Sick Leave for Larger Employers

By Carolyn Rashby & Michelle Barineau

September 23, 2020

California Governor Gavin Newsom has signed Assembly Bill (AB) 1867, to create COVID-19 supplemental paid sick leave (CPSL) requirements for employers with 500 or more employees, filling a gap left by the federal Families First Coronavirus Response Act (FFCRA) which applies only to employers with under 500 employees. The new law also codifies existing supplemental paid sick leave requirements for certain food-sector workers that were implemented in April under California Executive Order E.O. N-51-20.AB 1867…

Global Policy Watch

DOL Revises FFCRA Regulations in Response to Federal Court Decision Invalidating Parts of the FFCRA

By Lindsay Burke, Carolyn Rashby & Teresa Lewi

September 23, 2020

On September 11, 2020, the U.S. Department of Labor (“DOL”) issued revised regulations to clarify certain rights and employer responsibilities under the paid sick leave and expanded family and medical leave provisions of the Families First Coronavirus Response Act (“FFCRA”). The revisions were made in response to a recent decision of the U.S. District Court for the Southern District of New York (“SDNY”), which invalidated certain provisions of the FFCRA regulations. The FFCRA, which we…

Global Policy Watch

The Week Ahead in the European Parliament – Friday, September 18, 2020

By Sebastian Vos

September 18, 2020

Next week, Members of the European Parliament (“MEPs”) will gather in Brussels for committee meetings. Several interesting debates are scheduled to take place. On Monday, MEPs of the Foreign Affairs Committee (“AFET”) will have an exchange of views with China’s Ambassador to the EU, Ming Zhang. It is likely that MEPs will discuss the outcomes of the EU-China summit of September 14, 2020, and pose critical questions regarding, for example, the ongoing negotiations on a…

Global Policy Watch

UK: new “world-leading” deforestation and ecosystem supply chain law

By Daniel Feldman, Sinéad Oryszczuk, Hannah Edmonds-Camara, Atli Stannard, Paul Mertenskötter & Summreen Mahween

September 18, 2020

The UK Government recently announced that it is developing legislation that would make it illegal for large businesses operating in the UK to use certain commodities that have not been produced in line with local laws, and require in-scope companies to conduct due diligence to ensure that their supply chains are free from illegal deforestation and ecosystem change. A failure to comply could result in significant fines (the precise levels of fines are yet to…

Global Policy Watch

FDA Releases Guidance on Resuming Normal Drug and Biologics Manufacturing Operations During COVID-19

By Thomas Cosgrove, Paula Katz, Grant Dixon & Cory Trio

September 17, 2020

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 safety and quality.In light of these challenges, the U.S. Food and Drug Administration (FDA) released a guidance document on September…

Global Policy Watch

Key Public Policy Developments Around the World

Blog Authors

German court extends legal redress options for pharma companies in the drug pricing and reimbursement system

South Africa Eases COVID-19 Restrictions

The Week Ahead in the European Parliament – Friday, September 25, 2020

How Can Corporations Support the Voting Process?

China Issues Regulations to Advance Implementation of Its “Unreliable Entity List”

California Mandates COVID-19 Supplemental Sick Leave for Larger Employers

DOL Revises FFCRA Regulations in Response to Federal Court Decision Invalidating Parts of the FFCRA

The Week Ahead in the European Parliament – Friday, September 18, 2020

UK: new “world-leading” deforestation and ecosystem supply chain law

FDA Releases Guidance on Resuming Normal Drug and Biologics Manufacturing Operations During COVID-19

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