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COVID-19 Update: World Health Organization Warns of Dangerous Phase

During a press conference on June 19, 2020, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus stated that “[t]he pandemic is accelerating” and that we are now in a “dangerous phase” where the virus is “spreading fast.”   June 22, 2020 saw the largest single day spike in cases, with 183,020 new cases worldwide.   In the … Continue reading

Arbitrating disputes in the pharmaceutical, life sciences and healthcare sector in the era of the COVID-19 pandemic

Introduction A signature feature of the last several months has been the scramble for masks, shields and gowns – personal protective equipment (PPE) – for doctors, nurses and other care workers. Governments have been focused on ensuring that health authorities, both public and private, have a sufficient supply of essential medical equipment (such as PPE … Continue reading

COVID-19 Update: U.S. and U.K. Issue Joint Alert Regarding COVID-19 Research Cyber Threat

The U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency and the U.K.’s National Cyber Security Centre issued a joint alert on Tuesday that advanced persistent threat groups “are actively targeting organizations involved in both national and international COVID-19 responses.”   This warning should be heeded by hospitals, health systems, pharmaceutical companies, and academic medical … Continue reading

COVID-19 Update: CDC says Spread of Coronavirus Virus “Inevitable”

On Tuesday February 25, 2020, Nancy Messonnier, director of the U.S. Center for Disease Control’s National Center for Immunization and Respiratory Disease warned in a call with reporters that “[u]ltimately we expect we will see community spread in the United States. It’s not a question of if this will happen, but when this will happen, … Continue reading

COVID-19 Update: Death Toll Surpasses 2,000

As of Thursday February 20, 2020, there have been more than 75,000 known coronavirus infections and over 2,000 deaths.  According to the Centers for Disease Control, there have been fifteen confirmed cases of the coronavirus in the United States, and there have been no deaths reported.  Deaths from the coronavirus have occurred in China, Iran, … Continue reading

COVID-19 Update: Over 60,000 Confirmed Cases

Earlier this week the WHO announced that COVID-19 would be the name for the disease caused by the coronavirus.  On Wednesday, China announced 14,840 new cases of the coronavirus after changing the way cases are confirmed to include where a test was negative but other methods such as symptoms and x-rays show evidence of the … Continue reading

U.S. Declares Coronavirus a Public Health Emergency

As of Monday February 3, the death toll of the Coronavirus had risen to 362 and there were over 17,300 known cases around the world.  The number of coronavirus deaths in China has now exceeded the severe acute respiratory syndrome epidemic in 2003.  There have been eight confirmed cases in the United States, with Massachusetts … Continue reading

WHO Deems Coronavirus Global Health Emergency and White House Announces Task Force

On January 30, 2020, the World Health Organization (WHO)  declared the coronavirus a global health emergency.  The coronavirus has now been identified in 18 countries and has infected 9,709 people. 213 people have died from the coronavirus.  Countries are beginning to evacuate citizens from China and the United Kingdom, Australia, South Korea, Singapore and New … Continue reading

Public Health Officials Try to Contain Coronavirus

Governments around the world are continuing to take steps to contain the spread of the coronavirus.  As of Monday morning, 2,744 people worldwide have become infected with the coronavirus and 80 people have died.  There have been five confirmed cases in the United States, with one case in Washington, Arizona, and Illinois, and two cases … Continue reading

U.S. Prepares for Deadly Coronavirus

Earlier this week the CDC confirmed the United States had its first case of a deadly new strain of coronavirus “2019-nCoV.”  The patient is from Washington state and was returning to the United States from Wuhan, China.  At least seventeen people in China have died from the coronavirus.   In a press release, the CDC stated … Continue reading

Informed consent principles in the UK

The English Court of Appeal in a June 2018 judgment confirmed the principles relating to informed consent in medical malpractice claims. A woman had been suffering painful, heavy periods and lower back pain, for which she sought medical advice. After being given various treatment options, she chose to undergo a total abdominal hysterectomy and bilateral … Continue reading

South African Health Products Regulatory Authority Board has been appointed

The Minister of Health has appointed the board members of the newly established South African Health Products Regulatory Authority (SAHPRA). This health agency is the successor to the Medicines Control Council (MCC) which for decades has been the only medicines regulator in South Africa. A well-resourced and streamlined regulator is seen as the first step … Continue reading

Ontario introduces legislation requiring disclosure of payments to physicians

Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations. The Health Sector Payment Transparency Act is one of several acts introduced by Bill 160. It will require manufacturers, wholesalers, marketing firms, and others … Continue reading

Ontario announces sales of recreational cannabis framework

On September 8th, Ontario announced its much-anticipated framework for the distribution and sale of recreational cannabis. This announcement makes Ontario the first province to outline a comprehensive response to the Federal government’s plan to legalize cannabis by July 2018. Ontario’s proposed approach largely mirrors the Province’s approach to the sale of alcohol and tobacco. Recreational … Continue reading

Australia: Improvements for GMP clearance

Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) has announced that it is planning improvements around Good Manufacturing Practice (GMP) clearance. As part of this, the TGA will be publishing an updated revision of the GMP clearance guidance document, and redesigning the current GMP Clearance application e-forms. GMP clearance is required for all medicines … Continue reading

US telemedicine industry players are pursuing opportunities abroad

Telemedicine has been rapidly expanding in the United States. Indeed, Texas recently passed legislation that gives Texas telemedicine providers more flexibility, including the ability to establish a physician-patient relationship in connection with telemedicine services without requiring an in-person visit. Business entrepreneurs are finding ways to expand telemedicine opportunities internationally as well. NBC News recently published … Continue reading

Ontario legislature clarifies mandatory privacy breach reporting requirements under the Ontario Personal Health Information Protection Act

In Ontario, the Personal Health Information Protection Act (PHIPA)[1] governs the collection, use and disclosure of personal health information within the health sector. The term “personal health information” is broadly defined in PHIPA and includes identifying information which is not strictly personal health information but is contained in a record containing personal health information. Health … Continue reading

The European Court of Justice lowers causation standard of proof, finds vaccine could cause multiple sclerosis absent hard science

In an opinion that could significantly lower the threshold for proof of general causation in product liability lawsuits if adopted elsewhere, on June 21, 2017, the European Court of Justice held that a court could find a vaccine “defective” and thus the cause of a disease, even where no medical research supported such a causal … Continue reading

Health Canada releases Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

Health Canada recently released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) – more commonly known as the “Plain Language Labelling Regulations.” As of June 13, 2017, the Plain … Continue reading

Impact of Brexit on marketing authorisation holders – new EMA and CMDh guidance

The European Commission and European Medicines Agency (EMA) have published a Q&A document (the EMA Q&A) concerning the legal consequences for marketing authorisation holders (MAHs) of centrally authorised medicines if the UK becomes a ‘third country’ after Brexit. The EMA Q&A provides further detail following the European Commission and EMA notice of 2 May 2017. … Continue reading

FDA / EMA parallel scientific advice principles published

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recently released an updated “General Principles” statement regarding the agencies’ parallel scientific advice (PSA) program for human medical products. The PSA program provides scientific advice and protocol assistance in parallel to sponsors. “Sponsor” refers to: in the US, the sponsor of an Investigational … Continue reading
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