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 ...
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 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 ...
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 ...
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" ...
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 ...
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 ...
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 ...
CRIMINAL Counterfeit VaccinesBy Andre Augusto Mendes Machado and Mariana Murad Leiva Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes" ...
As we near the second year of the COVID-19 pandemic, trademark maintenance deadlines in 2021 create new obstacles for registrants. To maintain a federal trademark registration, registrants must periodically file an affidavit of use under Section 8, swearing that the mark is in use in commerce or that the registrant has an acceptable excuse for nonuse. Recent office actions show that the U.S ...
Introduction On 21 January 2021 a new royal decree was published in the Official Gazette which has temporarily extended occupational doctors' role in combating the COVID-19 pandemic in the workplace ...
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 ...
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 ...
A change in administrations from Republican to Democratic usually ushers in increased enforcement, regulation and strategic initiatives. Most of the Trump regulations and initiatives will likely be scrapped where possible. They will be replaced by rules and guidance documents that have been held in abeyance during the previous administration, as well as numerous new initiatives ...
Welcome to the Life Sciences & Healthcare Newsletter, a publication prepared by our multidisciplinary team dedicated to the Healthcare industry, under the coordination of partners Lior Pinsky and Renata Fialho de Oliveira. INSURANCE ANS establishes operating rules for electronic administrative proceedings, effective as of end of March 2021 Andrea Piccolo Brandão In accordance with Decree No. 8,539, of Oct. 08, 2015 ("Dec ...
Two federal cases in the Northern District of Ohio recently reached very different conclusions on whether the state’s COVID-19 shutdowns of restaurants permit valid claims for business interruption insurance coverage. Reviewing essentially the same facts and policy provisions, one court found for the insurer, holding no coverage to exist. The other found for the policyholder, awarding coverage. The opposite results will no doubt lead to further upcoming appellate activity in Ohio ...
Coming to Grips with Hospital Price Transparency – DC Circuit Rejects American Hospital Association’s Effort to Invalidate Price Transparency Requirements Rule Since 2010, Section 2718(e) of the Public Health Service Act has required hospitals to establish and publish annually “a list of the hospital’s standard charges for items and services provided by the hospital ...
It's that time of year again – CLE Compliance season! With the impact of COVID-19, we know many of our clients have found it challenging to meet their annual CLE requirements. Bradley is pleased to offer you a complimentary, online CLE addressing key topics with thought-leading speakers from inside and outside of Bradley. This CLE program includes 1 ethics hour and 2 general hours ...
With the Universal Community Testing Programme for COVID-19 detection by the Hong Kong Government and temperature screening in the workplace, the collection and use of biometric data (such as DNA samples, fingerprints and facial images) have raised concerns among the public. In August 2020, the Privacy Commissioner (PC) has updated its guidance note on how data users should collect and use biometric data in compliance with the Personal Data (Privacy) Ordinance (Guidance Note) ...
On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries ...
