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 ...
The manufacturer of the official facemask for the Brazilian Football Confederation filed a court action against an e-commerce company, accusing it of offering similar items allegedly manufactured by third parties. The manufacturer of the official facemask for the men’s and women’s teams of the Brazilian Football Confederation (CBF) filed a court action against an e-commerce company, accusing it of offering similar items allegedly manufactured by third parties ...
The U.S. Environmental Protection Agency has announced its temporary policy regarding environmental enforcement activities during the COVID-19 pandemic. The policy is retroactive to March 13, 2020, and will apply for the foreseeable future, until seven days after EPA gives notice that the policy will terminate. The policy applies to actions for which EPA has federal enforcement authority ...
The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released an interim final rule on October 29, 2020, delaying the implementation of the information blocking rule under the 21st Century Cures Act (Information Blocking Rule) ...
On 30 January 2020, the World Health Organization (WHO) declared that the outbreak of novel coronavirus or COVID-19 constituted a Public Health Emergency of International Concern (PHEIC). The COVID-19 is a respiratory illness caused by a new coronavirus which first originated in Wuhan, Hubei Province, China, the death toll from which has reportedly surpassed 1,000 on mainland China, while confirmed infections have passed 40,000 globally ...
A new regulation has been issued by the Minister of Health, namely Regulation of the Ministry of Health No. 1010/MENKES/PER/XI/2008 regarding the Registration of Medicines (“Regulation 1010/2008”). Regulation 1010/2008 revokes previous Ministry of Health Regulation No. 949/Menkes/Per/VI/2000. Under Regulation 1010/2008, a medicine to be distributed in Indonesia must first be registered before a Distribution License (Izin Edar) can be applied for ...
Referring to Newsletter Issue No. 12 in relation to the Health Bill, the new Health Law No. 36 of 2009 was finally issued on 13 October 2009. Under the Health Law, mothers must breastfeed their babies exclusively from birth until 6 months old. It is expected that family members, the Government, Regional Governments and communities will support lactating mothers by providing time and space for them to breastfeed their babies in work places and public areas ...
Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...
We are increasingly being asked: “Is it more likely that individuals rather than companies will be prosecuted under the new Health and Safety Offences Act 2008?”. The new Act, which came into force in January 2009, did not introduce any further duties on either organisations or individuals, but it did dramatically increase the penalties that can be imposed for breaches of existing health and safety legislation ...
Dinsmore employment law attorney Alyson St. Pierre authored an article for The Indiana Lawyer regarding a recent Indiana law that does not automatically grant religious exemptions from COVID-19 vaccinations and instead allows employers to investigate the validity of religious exemption requests. An excerpt is below ...
Due to the active spread of coronavirus infection COVID-2019, the Russian authorities, at both the federal and regional levels, are taking significant measures to ensure the self-isolation of citizens. These measures include increasing the liability for violation of measures for preventing the spread of coronavirus infection, which caused adoption of a number of legislative acts. 1 ...
“It is a treasured value in humanity … that no parent would want her child to grow up thinking that she (the child was) a mistake." - Justice Choo Han Teck In 2010, a Chinese woman, trying to conceive a child with her Caucasian husband, underwent an in vitro fertilisation (“IVF”) procedure at a clinic. Like the previous time she bore a child through IVF at that clinic in 2006, no third party’s gametes were meant to be used ...
In recent years, the Department of Justice, the FDA and the FBI have stepped up enforcement of the Food Drug and Cosmetic Act’s (FDCA) drug importation, distribution and misbranding requirements particularly with respect to high-priced and difficult-to-obtain drugs used in cancer treatment. Recently, these efforts suffered an unexpected setback in the Sixth Circuit following the United States’ decision to abandon its prosecution against an East Tennessee Oncologist and his wife ...
MP Dr Liam Fox provided his support to a draft bill recently placed before parliament focusing on individuals with Down’s Syndrome. He has been working on the bill with a Down’s Syndrome Association in Portsmouth. If the draft bill passes through parliament and receives royal assent, the Down’s Syndrome Act will come into force. Its focus is on improving provision for those with Down’s Syndrome which includes education, health, social care and employment ...
On Dec. 22, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.[i] CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19 ...
Can a patent be infringed even if the patented product is not manufactured, assembled, or even used? Indeed, such infringement is possible. In fact, this is known as the theory of inducement of infringement. Naturally, acts of ?inducement? must meet certain conditions before inducement of infringement can be found. The Federal Court of Appeal recently clarified these conditions ...
On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the personalized medicine and genetics industry. The personalized medicine industry seeks to revolutionize patient care by using genetic sequencing and testing to predict disease likelihood, severity, progression, and/or treatment response ...
The currently unstoppable strong spread of COVID-19 and the resulting restrictions on public life, such as quarantine measures and curfews, which are imposed in EU Member States and worldwide and which are sometimes very drastic, are also increasingly impairing the ability to work and communicate. In the meantime, various IP Offices have also reacted to this. 1 ...
MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020 ...
In light of the COVID-19 National Health Emergency, U.S. Citizenship and Immigration Services (USCIS) introduced temporary policies related to H-1B-sponsored physicians who are completing their three-year J-1 waiver service commitment requirements. The temporary policies relate to full-time work requirements and the ability of J-1 waiver-approved physicians to provide telehealth services ...
On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310 ...
St. Luke’s Health System’s 2012 acquisition of Saltzer Medical Group, Idaho’s largest independent multi-specialty physician practice group, violated federal and state antitrust laws according to a U.S. District Court holding issued on Friday, January 24, 2014. The Court ordered divestiture of the practice. The FTC and the Idaho Attorney General filed the Complaint seeking to block the sale on March 12, 2013. In response, St ...
Hunton & Williams announced today the launch of its new website — the Hunton & Williams Health Care Reform Center, huntonhealthcarereform.com ...
