Tag archives: international

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

Ontario introduces legislation requiring disclosure of payments to physicians

By Ian Trimble (CA) and Sara Zborovski (CA) on October 6, 2017 Posted in International

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

US telemedicine industry players are pursuing opportunities abroad

By Elise LeGros (US) on August 15, 2017 Posted in International, Regulatory

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

Pain and suffering includes mental anguish from medical negligence (Austria)

By Sandra Sithole (ZA) on September 22, 2016 Posted in International

In March 2016, the Austrian Supreme Court granted an award for pain and suffering to a patient for mental strain after a piece of broken scissors was left in his body following a surgery despite the fact that the claimant had not suffered any physical pain.… Continue reading

Australia trials “Health Care Homes”, a new model of primary health care

By Rohan Sridhar (AU) on August 15, 2016 Posted in International

Australia is set to trial a new model of primary health care based on the successful “Health Care Homes” programs in Canada and the United States. Australia’s version of the Health Care Homes scheme was proposed in broad terms in December 2015 by the Primary Health Care Advisory Group, in its Better Outcomes for People … Continue reading

U.S. Food and Drug Administration announces new partnership with Canadian Food Inspection Agency on food safety

By Sara Zborovski (CA) and Jillian Hyslop (CA) on June 13, 2016 Posted in FDA & Food Safety

Summary On May 4, 2016, the U.S. Food and Drug Administration (FDA) signed a “systems recognition arrangement” with the Canadian Food Inspection Agency (CFIA) and Health Canada recognizing the comparability of the U.S. and Canadian food safety systems. This is only the second time that the FDA has recognized a foreign food safety system as … Continue reading

Medical technology initiatives announced in Health Minister’s budget speech

By Nerushka Bowan and Rakhee Bhikha on June 7, 2016 Posted in International

The use of technology in the health sector is on the rise. The intersection of these two industries leads to interesting legal questions relating to digital risk, including big data analytics, data security and privacy. In his budget speech on 10 May 2016, Minister Aaron Motsoaledi discussed the following interesting medical technology initiatives being undertaken … Continue reading

Australia: Review of pharmaceutical reimbursement rules

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on May 24, 2016 Posted in International

Background On 25 April 2015, the Minister for Health announced a review of the Guidelines (Guidelines) for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), the body that recommends which products should be reimbursed by Government, and for how much. The Minister said the review sought to ensure that the PBAC Guidelines are “consistent … Continue reading

Times, they are a-changin’ – new country of origin food labeling system effective 1 July 2016

By Frances Drummond (AU) and Alyson Poole (AU) on May 6, 2016 Posted in FDA & Food Safety

Summary From 1 July 2016, new country of origin labeling requirements will become a reality in Australia, with a new food labeling system commencing under the Australian Consumer Law. The implementation of the new system will have a two year transition period. From 1 July 2018, the new system will be mandatory and something which … Continue reading

Tapping into China’s medical devices industry: Ten things to know

By Yi Wang (CN) on March 15, 2016 Posted in International

Our newly released guide shares the top ten things to know about tapping into China’s medical devices industry. The guide provides an overview of the regulatory regime for medical devices in China and the top issues that foreign investors and manufacturers should consider when entering the China market.… Continue reading

Consumer claims under Canada’s patent regime foreclosed

By Randy Sutton (CA) on February 1, 2016 Posted in International

In Low v. Pfizer Canada Inc. the British Columbia Court of Appeal accepted Pfizer’s argument that the Canadian patent regulatory regime does not provide the basis for a civil action by consumers based on alleged breaches of the patent regime. The Court found, in relation to a claim pertaining to Pfizer’s Viagra, that the patent … Continue reading

Australia – ehealth amendments

By on January 5, 2016 Posted in International

As part of the Australian Government’s digital health agenda, the Health Legislation Amendment (eHealth) Act 2015 (the Act) has recently been assented to. The personally controlled electronic health record (PCEHR) system was launched in July 2012. eHealth records are an online summary of an individuals’ health information. The individual controls what is included in the … Continue reading

Australia – New twist in the battle between the Commonwealth and originator pharma

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on September 1, 2015 Posted in International

What it means: The Commonwealth’s desire to pursue damages pursuant to the usual undertaking seems firmly entrenched. Pharmaceutical patent holders need to consider this prior to commencing infringement actions. The Commonwealth seems to be guarded regarding the potential success of its two initial claims against originators. The Commonwealth of Australia’s ongoing battle with originator pharma … Continue reading

Australia – Inquiry into Intellectual Property Arrangements

By on September 1, 2015 Posted in International

The Australian Federal Treasurer, Joe Hockey, recently announced that there will be an inquiry into Australia’s intellectual property arrangements. The inquiry, to be conducted by the Productivity Commission, the Australian Government’s independent research and advisory body, will examine the balance between promoting competition and protecting intellectual property in Australia, taking into account our international trade … Continue reading

Push for industrial hemp for human consumption in Australia grows

By on August 26, 2015 Posted in FDA & Food Safety

State and Federal Tasmanian Members of Parliament have stepped up the pressure on the Federal Government to allow production of industrial hemp for human consumption. In Australia, the National Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) includes the genus Cannabis as a ‘Prohibited Substance’, except as processed hemp fibre containing 0.1 per … Continue reading

Germany: New healthcare reforms 2015

By Heiko Bertelmann (DE) and Felix Dinger (DE) on August 19, 2015 Posted in International

Germany is currently undergoing substantial legislative changes in the healthcare sector. While the current Government had announced these reforms already in its coalition agreement 2013, it is only now beginning to act on them. Although not part of an overall masterplan, the various elements aim towards building a more compliant, digitalized and patient-focused German healthcare … Continue reading

FSANZ calls for submissions on GM soybean

By Bernard O'Shea (AU) on August 3, 2015 Posted in FDA & Food Safety

Food Safety Australia New Zealand (FSANZ) has opened submissions into a request by Monsanto Australia (Monsanto) to market (but not cultivate) food based on a genetically modified soybean line, MON-87751. MON-87751 has been genetically engineered to express two proteins, which provide protection from feeding damage caused by particular insects. The GM soybean would be cultivated … Continue reading

Australian Government begins second awareness campaign for Health Star Rating

By Bernard O'Shea (AU) on July 31, 2015 Posted in FDA & Food Safety

The Australian Government has begun further awareness raising for its multi-million dollar Health Star Rating (Health Star) system. The Health Star system aims to aid in the education of Australians regarding their food choices, through a complicated 5 star rating system. The Health Star system awards points to foods based on their protein, fibre and … Continue reading

Australian – Stock and Pet Food Regulation

By Bernard O'Shea (AU) on July 31, 2015 Posted in FDA & Food Safety

The Australian Government recently made substantial amendments to the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations)[1]. These amendments were intended to reduce the impacts of regulation on low risk stock food and pet foods, and are estimated to save $7.8 million per year in regulatory costs. The Government has now released a … Continue reading

Australian Parliament introduces food import and export bills

By Bernard O'Shea (AU) on July 30, 2015 Posted in FDA & Food Safety

The Australian Parliament has recently introduced two suites of bills, relating to charges for the import of food into, and export of food out of, Australia. The Export Charges (Collection) Bill 2015, Export Charges (Imposition – General) Bill 2015, Export Charges (Imposition – Excise) Bill 2015 and Export Charges (Imposition – Customs) Bill 2015 (collectively … Continue reading

As Germany clamps down on health sector corruption, is Australia next?

By on July 30, 2015 Posted in International

Corrupt pharmacists, physiotherapists, doctors and care workers could face up to five years imprisonment if found guilty of corruption or bribery, according to a new law being introduced by the German government. This week, German Chancellor Angela Merkel’s Cabinet signed off on the anti-corruption plan presented by the German Justice Minister. Some commentators say that … Continue reading

Australia – new country of origin food labelling regime

By Bernard O'Shea (AU) on July 29, 2015 Posted in FDA & Food Safety

In a surprise announcement, Australian Prime Minister Tony Abbot announced on 21 July 2015 the new labelling regime, earlier than expected. This announcement follows a large public survey on the issue of country of origin food labelling, which had almost 18,000 responses. In a press conference, along with the Hon. Ian Macfarlane, Minister for Industry … Continue reading

City of Toronto launches controversial food safety pilot program

By Jenna de Jong (CA) on July 28, 2015 Posted in FDA & Food Safety

The City of Toronto recently launched a pilot program that allows individuals to anonymously report suspected cases of food poisoning to Toronto Public Health. The program, which Toronto has dubbed “GastroBusters”, allows residents to anonymously report the details of their illness online or by telephone. Opponents of the GastroBuster program have pointed out that the … Continue reading

New procedural rules for Canada Agricultural Review Tribunal reflect competing needs of flexibility and predictability in administrative proceedings

By Jenna de Jong (CA) on June 5, 2015 Posted in FDA & Food Safety

New rules have come into force for the Canadian Agricultural Review Tribunal (the “Tribunal”). In Canada, certain decisions affecting the food industry have been delegated to quasi-judicial administrative tribunals. Administrative tribunals have been created for the purpose because they facilitate the appointment of decision-makers with expertise in the subject area, and they facilitate more informal … Continue reading