On 7 August 2019 the Federal Administrative Court annulled a Federal Office of Public Health (FOPH) order that had limited the price increase of a medicinal product on the list of specialities to two years. The product manufacturer had requested a price increase under Article 67(2) of the Healthcare Insurance Ordinance (SR 832.102), having incurred higher costs following the loss of two suppliers ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
Is your business affected by counterfeiting? If so, you are not alone. A newly released study shows that almost all intellectual property dependent companies listed on the NASDAQ OMX Stockholm 30 Index have been affected. Moreover, most expect that the problem will continue to grow. Better political support is required to stem this development, but companies already have several weapons available to use against the counterfeiters ...
Counterfeiting continues to make the news. Locally, we’ve just had a report of a R10 million bust in the Vereeniging area, during which fake soaps, shampoos, clothing and bags were seized, and seven suspects from Malawi, Mozambique and China (no surprises there), were taken into custody.But we are increasingly getting reports of counterfeiting in product areas that go way beyond the traditional stomping ground of FMCG and luxury goods ...
The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
Appeared in Lone Star Express, a puclication of the Lone Star Chapter of the Healthcare Financial Management Association, September 2002. The recent reports of corporate fraud, improper accounting practices, and mismanagement have resulted in new legislation and stock exchange standards for publicly-traded corporations. In order to restore confidence in the nation’s financial markets, President George W ...
By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...
The recent accounting frauds and corporate scandals have many in-house counsel, as well as directors and officers, re-examining their responsibilities, obligations, and potential liabilities. New legislation, SEC regulations, stock exchange listing standards and public, media and shareholder scrutiny are imposing new or expanded processes for corporate accountability, financial reporting and business practices ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
INFARMED and the DGS have published a set of guidelines for manufacturers and wholesale distributors of medicinal products for human use. The aim of these guidelines is to ensure supply to the domestic market and, at the same time, to prevent the spread of Covid-19 and protect the employees of these operators ...
In some areas, intellectual property will experience a period of slowdown in activity, at least in the near future. We look at this in more detail below. However, this does not mean mandatory registration of industrial property will come to a halt because, with many bodies, including the Portuguese INPI (National Institute of Industrial Property), registration is done online ...
In some areas, intellectual property will experience a period of slowdown in activity, at least in the near future. We look at this in more detail below. However, this does not mean mandatory registration of industrial property will come to a halt because, with many bodies, including the Portuguese INPI (National Institute of Industrial Property), registration is done online ...
The rapid spread of the new Coronavirus (SARS-CoV-2) and the Covid-19 pandemic have led to a very significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), and there was insufficient supply to meet existing needs during the state of emergency and the period that will immediately follow it ...
INFARMED has published a set of exceptional measures – which will remain in force during the period of risk to public health – to be adopted by sponsors, clinical trial sites, and research teams, to guarantee the safety, protection and rights of clinical trial subjects.It has also defined INFARMED’s evaluation of trials intended to treat or prevent the new Coronavirus disease (SARS-CoV-2) as a priority ...
EUIPO On 16 March 2020, the Executive Director of the European Union Intellectual Property Office (EUIPO) has issued Decision No EX-20-3 extending all time limits expiring between 9 March 2020 and 30 April 2020, that affect all parties before the Office, to 1 May 2020. In principle, the new deadlines will not be communicated to the parties on a case-by-case basis ...
Introduction The recent spread of the coronavirus around the world is justifying significant concern among senior living operators and raising questions about how to prepare for and respond to the possibility that the disease will affect residents, staff, and visitors. This concern is exacerbated by the fact that seniors tend to be more vulnerable to such communicable diseases and live in close quarters with others at the community, sharing meals and participating in group activities ...
Coronavirus Digest no. 4 Patents and other intellectual property rights 1. Patents Moderna reveals that it may not hold the patent rights for the vaccine against Covid-19, because it was not the first to file the patents. This came after the US National Institute of Health claimed co-ownership of the rights to this vaccine. Read more here ...
Due to the worrying evolution of the epidemiological situation currently afflicting the country, Presidential Decree no. 276/20 of 23 October 2020 has been enacted to update the preventive and control measures for the spread of COVID-19. Overall, there is a strengthening of the previous preventive measures established in Presidential Decree no. 256/20, of 8 October 2020 ...
World: The COVID-19 pandemic has prompted all destinations worldwide to introduce restrictions on travel, research by the World Tourism Organization (UNWTO) has found. This represents the most severe restriction on international travel in history and no country has so far lifted restrictions introduced in response to the crisis. Following up on previous research, the latest data from the United Nations specialised agency for tourism shows that 100% of destinations now have restrictions in place ...
At Patterson Belknap we continue to diligently monitor the outbreak of the COVID-19 coronavirus and assess the potential legal and business issues that may arise relating to the virus. The situation is fluid, and best practices and guidelines are evolving in real time. We are closely monitoring the situation as it unfolds, and share our latest perspectives on the legal issues relating to COVID-19 below ...
During the outbreak of the coronavirus (COVID-19), nursing home safety is a top priority, since most of the residents are at a higher risk of getting sick from the virus.[1] To help control and prevent the spread of the virus in nursing homes, the Centers for Medicare & Medicaid Services (CMS) provided additional guidance on March 13, 2020 ...
According to the Council Regulation (EC) No 6/2002 on Community designs (CDR), you can protect a design without registering it. But here is the catch: the unregistered design must be new and have an “individual character”. So, what is individual character? A recent court case gives insight. It specifically addresses the fashion industry, but the ideas are useful for any company that does not register all of its designs ...
