1. Pharmaceutical market players mostly deal with two regulators These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices. 2 ...
On 23 June 2023, the Council of the European Union adopted its eleventh package of restrictive measures against Russia, which supplements those discussed in our previous newsflashes_. This latest package aims to tackle the circumvention of previously adopted sanctions and also adds additional restrictions ...
Thirteen years after the filing of the initial complaint, the First Circuit recently revived a False Claims Act (FCA) suit, reversing the district court and holding a relator can be an “original source” without participating in or having contemporaneous knowledge about the alleged fraud. See United States ex rel. Banigan v. PharMerica, Inc., 950 F.3d 134 (1st Cir. 2020) ...
The Department of Health and Human Services (HHS) has opened up another $20 billion in funds to help hospitals and healthcare providers deal with the financial impacts of treating COVID-19 patients. The new funding round was opened on April 25 and is intended to compensate providers without regard to payer mix and to provide assistance based on March and April 2020 lost revenues ...
The Budget. The 83rd Texas Legislative Session convened on January 8th with news of a better-than-anticipated revenue estimate, an unusually high number of new and second-term legislators, and less controversy and fanfare than observers have come to expect at the start of the biennial, 140-day process. In mid-March, only days before the bill became due, lawmakers passed and the Governor signed legislation to fill the $4 ...
Flu season is in full swing. with the Center for Disease Control (CDC) confirming over 155,000 positive U.S. cases of influenza since Sept. 29, 2019. Simultaneously, the coronavirus COVID-19 has spread rapidly across China, with at least 70,000 confirmed cases, including 15 confirmed cases in the United States. In response, employers need to be prepared to assist employees in staying safe and complying with potential quarantines. Beginning Feb ...
Dinsmore’s Government Relations team was involved in several significant legislative initiatives affecting the health care sector during the 2019 regular session of the West Virginia legislature. Most notably, Dinsmore was involved in the passage of HB 2010, relating to foster care ...
The Government Accountability Office (GAO) recently issued its Annual Report to Congress, which provides statistics concerning bid protest filings for Fiscal Year (FY) 2020, including the number of protests filed and sustained. The chart below, included in GAO's Annual Report, summarizes this information. Click here to view the summary table As shown above, most of the data points remained constant from the prior year ...
As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020 ...
The outlook for the year ahead is uncertain with the effects of post-Brexit rules to contend with and COVID-19 continuing to restrict the way we live and work. We look at what the year may have in store for the construction industry. COVID-19 There is no doubt that the pandemic has caused challenges for the construction industry and is likely to have a significant impact into 2021 ...
In recent years, license-in/out transactions have become the most common way for innovative drugs and medical devices (including medical aesthetics) companies to collaboratively develop and commercialize medical products and related technologies. According to public information, in China, the total amount and number of investment and financing in life sciences sector have witnessed a significant decline from 2021 to 2023, with the investment amount being only a quarter of that in 2021 ...
We have recently seen reports about the unbelievable amount of pressure on the NHS, including inaccessibility to GPs; a high degree of emergency admissions; and bed-blocking within hospitals where vulnerable patients cannot be discharged safely. These factors have exacerbated the pressure on our healthcare system to almost unprecedented levels. Medical technologies or MedTech could be the way forward to ease some of the pressure ...
As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform ...
The U.S. Court of Appeals for the Second Circuit on March 13 issued a highly consequential decision in U.S. Securities andExchange Commission v. Rashid, interpreting and applying the mental state for liability of investment advisers under the Investment Advisers Act. Over a strong dissent, the court reversed a finding of liability of the defendant investment adviser under basic principles of negligence law, and in doing so, provided a road map for future enforcement actions under the act ...
On Aug. 31, 2012, the United States Court of Appeals for the Second Circuit issued its decision in In re Charter Communications Inc., (2d Cir. Aug. 31, 2012), expressly adopting an abuse of discretion standard for reviewing equitable mootness determinations ...
The glacial pace at which the federal government has implemented cannabis policy–particularly in light of the rapid evolution of cannabis laws at the state level–is at the same time predictable and frustrating to those seeking a measure of certainty ...
When not conducted carefully, internal investigations cancause more harm than good. Deciding to investigate a suspected problem is onlythe first of several key determinations. The responsible executive must planand execute the investigation deliberately to avoid self-inflicted harm. Anorganization can protect itself—while still conducting an investigation that isconfidential, full and fair—only by carefully thinking about how best touncover the alleged wrongdoing or compliance issues ...
The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...
In the recent decision of Abdul Malek Bin Mohamed v MISC Bhd dated 17 June 2020 [Award 840 of 2020], the Industrial Court recognised that the tenure of service of an employee in an organisation does not shield the employee from having to render satisfactory performance at the level required by the Company. The Industrial Court upheld the dismissal of an employee for poor performance after 32 years of service ...
As U.S. hospitals and health clinics continue preparing for novel coronavirus (COVID-19) patient surges, federal regulatory agencies are developing resources to help health care providers comply with myriad regulatory requirements. In this context, the U.S ...
On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site). Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa ...
On June 15, 2022, the Supreme Court of the United States released its long-awaited decision in American Hospital Association v. Becerra in which it unanimously held that the United States Department of Health and Human Services (HHS) overstepped its statutory authority by cutting 340B-related reimbursement to hospitals ...
Nearly 106,000 Americans are currently on waiting lists for donor organs and 17 die each day while waiting. The holy grail for rising to meet this demand and end this suffering will be the ability to “print” the organs, muscles, and tissues from individually grown cells, lowering the need for human donors and the complicated and sometimes unbearable stress that goes along with donor wait lines ...
