Topic: International

Marketing class actions: a new frontier for medical products

By Toby Biddle (AU) and Helen Macpherson (AU) on June 5, 2017 Posted in International

A new type of product claim is emerging in the Australian class action market; one which has been part of the US class action landscape for many years. Unlike previous product class actions where the safety of the product was typically in issue, the new product claims focus on statements/ representations made in the marketing … Continue reading

FDA / EMA parallel scientific advice principles published

By on June 1, 2017 Posted in International, Regulatory

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

European Union’s new medical device regulations come into force

By on May 25, 2017 Posted in International, Regulatory

Today, 25 May 2017, two new Regulations come into force in the European Union: the Medical Device Regulation (MDR) which replaces two EU Directives on general medical devices and active implantable medical devices; and the In Vitro Diagnostic Medical Devices Regulation (IVD MDR) which replaces the EU Directive on IVD medical devices. Now begins a … Continue reading

Formula milk suppliers targeted by Singapore competition authority

By Wilson Ang on May 25, 2017 Posted in International

On 10 May, the Competition Commission of Singapore (CCS) published a market study report on formula milk supply to babies, infants and young children in Singapore. The CCS commenced its review of the formula milk market in October 2015 due to the sharp increase of formula milk prices in Singapore in recent years, a trend … Continue reading

Recent European developments in mHealth regulation

By on May 18, 2017 Posted in International, Regulatory

In this briefing we cover recent regulatory developments for mobile health (mHealth) in the European Union and set out a summary of the current framework. mHealth is a sub-segment of electronic health (eHealth) and covers medical and public health practice supported by mobile devices. It especially includes the use of mobile devices for health and … Continue reading

Mandatory kilojoule labeling – Victoria, Australia

By on May 18, 2017 Posted in FDA & Food Safety, International

The Victorian Government has introduced the requirement that all major Victorian food outlets and supermarket chains must display kilojoule contents on their menus. The Food (Kilojoule Labelling Scheme and Other Matters) Amendment Act 2016 will, from May 2018, require large chain food businesses and large chain supermarkets to display: the average kilojoule content of standardised, … Continue reading

Medical assistance in dying in Canada: one year later

By Melissa Perry (CA) on April 27, 2017 Posted in International

Since the Canadian federal government introduced legislation governing medical assistance in dying (“MAiD”), the provinces and territories, which are responsible for the delivery of health care services in Canada, have adopted a variety of processes and procedures to deal with requests for MAiD. However, some questions and issues which have arisen with the legalization of … Continue reading

Canadian Government looks to Supreme Court of Canada for opinion on the constitutionality of the Genetic Non-Discrimination Act

By on April 26, 2017 Posted in International

In March 2017, Parliament gave third reading to Bill S-201, also known as the Genetic Non-Discrimination Act. The Genetic Non-Discrimination Act was introduced as a Senate bill by now-retired Liberal Senator James Cowan in December 2015 to ensure that fear of genetic discrimination did not prevent Canadians from deciding to proceed with genetic testing which … Continue reading

Court upholds Health Canada decision requiring additional information ‎on certain Apotex drugs manufactured in India

By Ian Trimble (CA), Kristin Wall (CA) and Sara Zborovski (CA) on April 6, 2017 Posted in FDA & Food Safety, International

The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s decision to require additional information from Apotex as part of its submissions for certain drugs manufactured in India by Apotex affiliates. Read the full update here.… Continue reading

NICE to fast-track more medicine approvals but wider changes do not impress industry

By on March 23, 2017 Posted in International, Regulatory

The National Institute for Health and Care Excellence (NICE) produces guidance in a number of forms including technology appraisals. Technology appraisals are recommendations on the use of medicines and treatments within NHS England. The recommendations are based on a review of clinical and economic evidence. NHS England is legally obliged to fund medicines recommended by … Continue reading

European and US regulators’ agreement on mutual recognition of inspections of medicines manufacturers

By on March 10, 2017 Posted in International, Regulatory

In the European Union (EU), inspections of medicines manufacturing sites are carried out by national competent authorities from EU Member States. Each year, EU competent authorities and the US Food and Drug Administration inspect many manufacturing sites in the EU, US and elsewhere in the world, to ensure compliance with Good Manufacturing Practice (GMP). EU … Continue reading

New NHS England conflict of interest guidelines

By on March 2, 2017 Posted in International, Transparency

NHS England has published new guidelines on managing conflicts of interest. The guidance will come into force on 1 June 2017. It will be applicable to Clinical Commissioning Groups, NHS Trusts and NHS Foundation Trusts, and NHS England. The guidance covers common situations which can give rise to risk of conflicts of interest including gifts, … Continue reading

The UK Government’s Brexit White Paper and its impact on the life sciences sector

By on February 7, 2017 Posted in International

On February 2, 2017, the Government published a White Paper on its plan for exiting and achieving a new partnership with the EU. The White Paper expands upon Prime Minister Theresa May’s speech on January 17, 2017. We have previously written about the speech and earlier developments (The UK government’s Brexit plan and its implications for Life Sciences). See … Continue reading

Global health trends impacting the regulation of food and beverage labels

By Georgina Hey (AU) and Isobel Taylor (AU) on February 3, 2017 Posted in FDA & Food Safety, International

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

By Jillian Hyslop (CA) and Sara Zborovski (CA) on February 1, 2017 Posted in FDA & Food Safety, International

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

The UK Government’s Brexit plan and its implications for life sciences

By Huw Evans (UK) on January 19, 2017 Posted in International

On January 17, 2017, Prime Minister Theresa May delivered her much anticipated speech on the UK Government’s plan for exiting the EU. Continued membership of the EU’s single market and full membership of the customs union have both been explicitly ruled out. The plan for achieving a new partnership between the UK and the EU … Continue reading

Australia – TGA consults on software as a medical device

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on November 16, 2016 Posted in International

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

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

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

By Yi Wang (CN) on October 14, 2016 Posted in International

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

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

Withdrawal of life support from child in his best interests (UK)

By Sandra Sithole (ZA) on September 21, 2016 Posted in International

The mother of a 2-year old child who suffered grave injuries in a road traffic accident appealed against the court order obtained by the grandmother to withdraw all respiration and to treat the child only with pain relief, sedation and nursing as appropriate.… 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

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