The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines.
In October 2020, the UK Government made changes to the regulation of medicines for COVID-19 and influenza. The regulations set out changes for the temporary authorisation of medicines (including COVID-19 vaccines) and allow the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to set conditions for that authorisation.
The challenges of the past year have underscored the importance of life sciences to a dramatic degree. With countries worldwide now distributing vaccines that were developed in record time, COVID-19 has also made plain the value of investing in technological and scientific solutions that can reshape the world and improve health outcomes.
The pandemic has particularly accelerated investments in the digital health space, as a significant share of everyday life has migrated to computer screens by necessity. So what does this mean for the sector going forward?
Writing for MPO Magazine, McDermott partner Steve Bernstein shares five themes to watch in the digital health sector, including what life sciences developers and investors should know about the current deal-making landscape.
On March 10, 2021, US Congress finalized and passed the American Rescue Plan of 2021 (ARPA), the latest COVID-19 relief package that largely tracks President Joe Biden’s initial $1.9 trillion proposal. The ARPA extends unemployment insurance benefits and provides direct $1,400 stimulus payments to qualifying Americans, but it also makes several important health policy-related changes. These include providing funding for vaccine distribution and testing to combat the COVID-19 pandemic, making policy adjustments to the Medicaid program, facilitating health insurance coverage and providing more money for healthcare providers. The final bill also makes two narrowly focused technical Medicare payment changes.
This summary highlights notable health policy provisions of the final bill.
A recent poll in the United Kingdom revealed there was a high level of support among managers for making COVID-19 vaccines mandatory for staff returning to work, with half of the respondents believing office access should be restricted for those who refused to get a vaccination on non-medical grounds. But what are the legal, ethical and privacy issues of such measures?
In an interview for BBC World News, McDermott partner Carole Spink discussed employer-related vaccine considerations.
On March 19, 2021, California Governor Gavin Newsom signed SB 95, significantly expanding California’s COVID-19 Supplemental Paid Sick Leave (CSPSL). This latest legislation now requires any California employer with more than 25 employees to provide CSPSL in addition to regular paid sick leave offered.
Effective March 12, 2021, all New York State employers are required to provide employees with paid time off (PTO) to receive a COVID-19 vaccine at the employee’s regular rate of pay.
Progressive Democrats in the US Senate are hoping to use a streamlined process that needs just 50 votes to approve a COVID-19 relief package that includes billions in new funding for vaccines and other supplies. But some experts are already casting doubt on that plan.
STAT spoke with nine current and former congressional staffers and budgetary experts, including McDermottPlus consultant Rodney Whitlock, on the possibility of public health funds receiving approval through the budget reconciliation process.
Last year ended as an unprecedented and historic year, with far-reaching effects across diversity, equity and inclusion, employment practices and workplace standards. In a recent article for International Law Office, partners from McDermott’s Employment group highlight what changes are expected in 2021 and how these may affect employers and employees.
Can employers make COVID-19 vaccination mandatory?
Yes, with some exceptions. Experts say employers can require employees to take safety measures, including vaccination. That doesn’t necessarily mean an employee would get fired if they refuse, but they might need to sign a waiver or agree to work under specific conditions to limit risk.
With vaccine rollout underway in the United States, McDermott partner Michelle Strowhiro outlines considerations for employers in a recent article for The Associated Press.
The Democrats have control of all three levers of power—the Senate, the House and the presidency—for the first time since the early years of the Obama administration.
How will President Biden use this new concentration of power to shape healthcare policy?
A recent article in Medscape outlined seven key healthcare actions that Biden could pursue, with McDermottPlus consultant Rodney Whitlock weighing in.
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