Topic: International

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Global health trends impacting the regulation of food and beverage labels

As global rates of obesity and related diseases continue to rise, consumers around the world are becoming more health conscious, and are expecting their food products to reflect their desire for healthier options. A recent Nielsen Global Health and Wellness Survey found that, of the 30 000 people across 60 countries surveyed, 49% consider themselves … Continue reading

Health Canada releases draft guidance documents for consultation related to good manufacturing practices and drug establishment licensing

On January 18, 2017, Health Canada released five draft guidance documents for consultation relating to good manufacturing practices and drug establishment licensing. The consultation period is open until April 18, 2017. Read the full update in Norton Rose Fulbright’s Pharma in brief – Canada.… Continue reading

Australia – TGA consults on software as a medical device

The Therapeutic Goods Administration (TGA) has opened consultation on the use of software as a medical device (SaMD) as part of the International Medical Device Regulators Forum working group (IMDRF Working Group). The IMDRF Working Group comprises a number of clinical evaluators of medical devices and is seeking views on questions relating to the clinical … Continue reading

Australia – Gene Technology Regulator commences review into Gene Technology Regulations

The Australian Gene Technology Regulator has commenced a technical review of the Gene Technology Regulations (Regulations), which underpin the regulation of a range of gene technologies and genetically modified organisms. The review is aiming to ‘provide clarity about whether organisms developed using a range of new technologies are subject to regulation’ and to ‘ensure that … Continue reading

New device guidelines published in China

On 21 September 2016, the Department of Medical Device Supervision of the China Food and Drug Administration (CFDA) published the Guidelines to Medical Device Manufacturers for the Quality Control and Release of Finished Products (Draft for Public Comment) (the Guidelines). The comment period expired on 30 September 2016 and the final version of the Guidelines … Continue reading

Medical technology initiatives announced in Health Minister’s budget speech

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

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

Australia – ehealth amendments

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

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

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

Germany: New healthcare reforms 2015

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

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

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

Norton Rose Fulbright launches 2015 litigation trends annual survey

We recently released our 2015 litigation trends annual survey, the 11th overall and the most extensive in its history. More than 800 corporate counsel representing companies across 26 countries were polled on disputes-related issues and concerns. Click here to read our press release, and click here to see Law360’s extensive coverage. Survey respondents – primarily … Continue reading

Joint venture developments in chinese hospital market

Two recent joint ventures demonstrate potential opportunities for health care providers to expand into the Chinese market. The first venture involves Raffles Medical Group, a large Singapore-based health care provider, collaborating with Shanghai LuJiaZui (Group) Co, Ltd., a China real estate developer, to build a 400-bed, full-service hospital in the New Bund International Business District … Continue reading

China: new healthcare reform 2020

China recently announced a new five year road-map for reform of its healthcare sector. The National Planning Guideline for the Healthcare Service System (2015–2020) is the first comprehensive five-year blueprint targeting keys areas for development by 2020. Faced with the challenge of insufficient resources and poor quality of service in the sector, the reform of … Continue reading

Chinese government introduces new regulations to enable private investment in senior care

Earlier this year, the Chinese government introduced further regulations setting out a framework for private investment in senior care. With the 60 and over population in China expected to reach 300 million by 2025, senior care is becoming a pressing issue as demand in China increases. Investors interested in China’s senior care market can learn … Continue reading

Pharma in Focus – reforming class actions for pharmaceutical claims

The issue of reforming class actions for pharmaceutical claims is highlighted in this opinion piece by Partner Toby Biddle on the Vioxx litigation. This article was originally published by Pharma In Focus and is reproduced with permission. Vioxx case highlights class action difficulties A decade of litigation over MSD’s Vioxx (rofecoxib) may prompt reform around … Continue reading
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