The Centers for Medicare & Medicaid Services (CMS) recently issued a new rule modernizing the “Stark Law” regulations. The rule aims to advance value-based care and ease the regulatory burden on physicians. Most of the reforms are effective January 2021; however, the rule includes important changes to how physician group practices may share profits that take effect next year ...
Digemid authorized Pfizer the second conditional sanitary registration of the COVID-19 vaccine manufactured in the United States. A total of 4 vaccines authorized by the Peruvian health authority are added to this registry ...
Decree-Law 36/2021, which amends Decree-Law 176/2006 of 30 August ("Medicines Statute"), was published on 19 May. The new Decree-Law introduces a ban on the advertising of discounts on the price of medicines subject to medical prescription that are reimbursed by the National Health Service ("NHS") or that contain narcotic or psychotropic substances ...
The world is in an upheaval now with the pandemic raging for over a year. The discussions and decisions that probably would never have been made a few years ago are being made today in the interest of the greater good and the public at large. When Bill Gates expressed his reservations against lifting IP protection on vaccine patents, it left the world reeling and his comments understandably criticised by experts and laymen alike ...
In Markit Systems (Pty) Limited v Fulcrum Group (Pty) Limited, the Gauteng Local Division of the High Court held that the customer was within its rights to cancel an agreement it had with a service provider because the parties had not been able to agree on the scope and details to be included in the schedule to the agreement ...
The third wave of COVID-19 is now spreading all over Thailand. The rise in confirmed numbers of cases and deaths has been reported by the Centre for the COVID-19 Situation Administration (“CCSA”). In response to the outbreak, the Ministry of Public Health announced a vaccination plan which ultimately aims to reduce the spread of COVID-19 infections by having around 50 million people (roughly 70% of the population) in Thailand vaccinated by the end of the year ...
We would like to inform you that the Russian President has signed amendments to Article 1360 the Civil Code of the Russian Federation ('Russian Civil Code'), in terms of providing compulsory licenses to use an invention, utility model or industrial design ('patent rights') on 30 April, 2021. The amendments came into force on 11 May, 2021 ...
The health crisis has not eased the tensions between the management and the trade unions of the Belgian National Orchestra (“BNO”). The pandemic has even caused an additional outbreak of ‘fever’, which even a Brussels Court of Appeal ruling on 7 May 2021 will probably not be enough to ‘cure’... At issue is the fate of musicians' rights to reproductions and broadcasts of their performances ...
The European Council has just adopted a new dual-use regulation. The new dual-use regulation is a recast of the current dual-use regulation and aims, among other things, to modernize European export controls in a number of areas. The regulation is directly applicable in all EU Member States and is expected to enter into force in 2021. In this Insight, Plesner's export control specialists outline the main changes resulting from the new dual-use regulation ...
More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021 ...
The COVID-19 pandemic has exposed the difficulties in reacting at European level to a major health crisis and the intention of the European Commission is to respond more effectively to future problems in the area of health. As a result, it is currently conducting an initial assessment of possible legislative changes in the area of medicinal products for human use ...
As an employer, are you obliged to search personal devices, personal email accounts and/or personal social media accounts belonging to employees or others such as trustees or non-executive directors when responding to a data subject access request (DSAR)? Many employers will now be familiar with undertaking a ‘reasonable and proportionate’ search when responding to an employee’s DSAR under Article 15 of the UK GDPR ...
Earn-outs are a commonly used payment mechanism in overseas and cross-border M&A transactions. Through earn-outs, transacting parties can set flexible metrics to adjust the buyer’s payment obligation and thereby allocate the risks and benefits between the buyer and seller ...
A recent study by the UK Advertising Standard’s Authority (ASA) has found that the majority of social media influencers are (still) breaking consumer and advertising laws. The ASA’s report, “Influencer monitoring report (March 2021)” (the ‘Report’) was undertaken as part of the ASA’s commitment to have more impact online, as well as be more proactive in their regulation and demonstrates its increased monitoring function ...
Gennex Media LLC, a customizable product online marketplace, and its sole officer and shareholder Akil Kurji, have agreed to an FTC consent decree resolving allegations the company falsely claimed its Brandnex novelty products were “Made in USA,” “USA MADE,” and “Manufactured Right Here in America!” when, in many instances, they were wholly imported from China ...
Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether ...
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 ...
On February 25, 2021, the Ministry of Health and Social Protection issued Resolution 223 of 2021 (the “Resolution”) to update the general biosecurity measures set for the management of Covid-19 in Colombia. The main novelties included in this regulation are mentioned below: 1. Scope The Resolution extended the scope of the general biosecurity measures to all "social and economic activities carried out by individuals" ...
Asset tokenisation is poised to tear down the high barriers to luxury investments. Imagine you are a whisky aficionado. Having witnessed rare Scotch trounce many investments over the past 10 years, you are eager to jump on the bandwagon. It is, after all, a complementary way to fund an expensive hobby; according to industry watcher Rare Whisky 101’s Rare Whisky Icon 100 Index, UK auction prices of 100 iconic collectors’ bottles have almost quadrupled since 2012 ...
In connection with the adoption of a new law on the ethical treatment of clinical trials of medical devices, the Folketing has made a number of changes to the rules on the affiliation and financial support of pharmaceutical and medical companies to healthcare professionals. The amendments will enter into force on 26 May 2021 ...
Behind every video game, there is intellectual property (IP) which is worth protecting to optimize monetisation of the game. As discussed in Studios and designers: Are you sure that you own the intellectual property rights to your video games, the first step for studios and designers is to make sure that they own all IP rights on the video game ...
FINANCIAL SERVICES BNM announces new funds for SMEs On 5 February 2021, Bank Negara Malaysia ("BNM") announced: an additional RM2 billion for the Targeted Relief and Recovery Facility (“TRRF”); the establishment of a RM200 million Disaster Relief Facility (“DRF”) 2021. TRRF The TRRF was a facility announced in the Budget 2021, established to assist eligible SMEs in the services sector ...
LAW OF 26 FEBRUARY 2021 AMENDING THE LAW OF 27 JULY 1991 ON ELECTRONIC MEDIA AND IMPLEMENTING DIRECTIVE (EU) 2018/1808 (THE "AUDIOVISUAL MEDIA SERVICES DIRECTIVE") The law of 26 February 2021 amending the law of 27 July 1991 on electronic media (the “Electronic Media Law”) and implementing the Audiovisual Media Services Directive was adopted on 26 February 2021 to implement (faithfully) the so-called Audiovisual Media Services Directive ...
In September 2020, a team of MIT researchers published a paper in the IEEE Open Journal of Engineering in Medicine and Biology, testing the hypothesis that coronavirus carriers—even asymptomatic ones—could be accurately detected using artificial intelligence (AI) based on only a phone recording of a forced cough.If this hypothesis is correct, the COVID-19 test can be accessible to people worldwide ...
