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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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