Bernard O'Shea (AU)

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Australia – TGA updates the Therapeutic Goods Advertising Code

The TGA has issued an updated Therapeutic Goods Advertising Code (New Code). The New Code regulates advertising of therapeutic goods to consumers. Only certain therapeutic goods can be advertised to the public. The New Code seeks to ensure that permitted advertising provides consumers with accurate and balanced information concerning the quality, safety and efficacy of … 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: Regulator considers permitting the sale of food derived from low THC hemp seeds

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on August 22, 2016 Posted in FDA & Food Safety

Food Standards Australia New Zealand (FSANZ) is calling for submissions in response to its draft variation of the Food Standards Code that would permit the sale of foods derived from low tetrahydrocannbinol (THC) hemp. The proposal follows a request by the Australia and New Zealand Ministerial Forum on Food Regulation (Forum) for FSANZ to consider … 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

Australia – nicotine and therapeutic goods

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on May 11, 2016 Posted in FDA & Food Safety

A recent Australian case (http://www.austlii.edu.au/au/cases/cth/FCA/2016/394.html) has touched on the tricky area of nicotine containing products, this time in the guise of product known as the Voke Inhalator, which contained 0.43mg of nicotine in a pressurised inhalation can. The supplier of the product was seeking to register the product as an OTC product, but our regulator, … Continue reading

TPP and biologics – a battleground in Australian elections

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on May 10, 2016 Posted in FDA & Food Safety

The Australian Labor Party has flagged the data exclusivity provisions of the Trans Pacific Partnership Agreement (TPP) as a major issue ahead of our now confirmed July date for an Australian election.… Continue reading

Australian TGA on cyber security

By Bernard O'Shea (AU) on April 4, 2016 Posted in FDA & Food Safety

In a timely note, the March 2016 edition of the Medical Devices Safety Update, put out by the Australian Therapeutic Goods Administration, highlights medical device cyber security as a key issue. Interestingly, this comes shortly after the release by the FDA of its draft guidance in relation to “Post Market Management of Cyber Security in … 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

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

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

Australia – Country of Origin Labelling developments

By Bernard O'Shea (AU) on May 8, 2015 Posted in FDA & Food Safety

Prompted by the frozen berries Hepatitis A scare, Agriculture Minister Barnaby Joyce and Industry Minister Ian Macfarlane have been asked by Prime Minister Tony Abbott to prepare a cabinet submission on reforms to country-of-origin labelling laws. Mr MacFarlane has promised major changes to Australia’s food labelling laws in the wake of the frozen berries scare, … Continue reading

Food safety newsletter – April 2015

By Brandon Crisp (US) and Bernard O'Shea (AU) on April 30, 2015 Posted in FDA & Food Safety

The monthly newsletter will provide a quick overview of legal issues affecting food safety, including the enactment of new statutes and regulations and significant case law developments, in the US and abroad. In this issue: World Health Organization announces food safety awareness initiative Chipotle goes GMO-free Tyson to phase out antibiotics in chicken Breast milk … Continue reading

Australia – Warning: Imported Food Ahead

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

On 2 March 2015, minority independent Federal Member, Bob Katter, introduced into the Australian Parliament the Imported Food Warnings Labels Bill 2015. This Bill seeks that all imported food products carry the label: Warning: Imported Food. This food has not been grown or processed under Australian health and hygiene standards and may be injurious to … Continue reading

Representative McDermott urges RAC appeal fix

By Mark Faccenda (US), Frances Drummond (AU), Nick Abrahams (AU), Bernard O'Shea (AU) and Jackie O'Brien (AU) on March 26, 2014 Posted in Regulatory

On March 18, 2014, Representative Jim McDermott (D-Wash.) sent a letter to US Department of Health and Human Services (“HHS”) Secretary Kathleen Sebelius “express[ing] concern about the backlog of appeals pending with the Office of Medicare Hearings and Appeals (“OMHA”)” and making recommendations for the improvement of the recovery audit contractor (“RAC”) audit appeals process. … Continue reading

Privacy – Mandatory breach notification coming to Australia

By Nick Abrahams (AU) and Bernard O'Shea (AU) on March 26, 2014 Posted in International, Regulatory

With many Australian organisations still coming to grips with recent changes to their privacy laws, legislation to mandate notification of privacy breaches is back on the agenda. Amongst other aspects, the recent changes introduced significant fines and increased the scope for liability if personal information is exported. This has forced organisations to review their privacy … Continue reading

Australian patents – exception for manufacture for export

By Jackie O'Brien (AU), Frances Drummond (AU) and Bernard O'Shea (AU) on March 26, 2014 Posted in International, Regulatory

In a move that has been threatened for some time, legislation has been introduced into the Australian parliament to create a further exception to the patentee’s rights. This will allow for the manufacture of patent protected medicines in Australia where the products are going to be exported to address a public health issue either in … Continue reading