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Senior Associate Sarah Bryden and Law Graduate Leesa Vanmali examine the recent decision in Selim v Lele, where the Full Federal Court of Australia dismissed a constitutional challenge to the validity of the Professional Services Review Scheme

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We examine the latest chapter in a case involving workers exposed to traumatic events; New South Wales planning policy changes for housing for senior and disabled people; and recent Australian Taxation Office rulings regarding the GST and retirement villages

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In this edition: Partner Dr Trevor Davies and Law Student Elizabeth Sarofim report on the recent decisions of the New South Wales and Victorian governments to lift their four-year moratoria on the commercial cultivation of GM canola

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In this edition: Partner Dr Trevor Davies provides an overview of the proposed changes to the patent rules governing the prosecution of patent applications in the United States, and of the recent legal challenge to the implementation of the rule changes

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In this edition: Since early 2005, AAR Biotech News has been closely monitoring the Advisory Council on Intellectual Property's recommendation regarding patents and experimental use in Australia. Partner Dr Trevor Davies and Lawyer Ollie Evans provide a further overview of the proposed amendments to the Patent Act 1990 (Cth) to include an experimental use exemption

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In this edition: Lawyer Rachel Darvey reports on the recent introduction of the Therapeutic Goods Amendment Act 2007 and how it impacts on the transition period for medical devices

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In this edition: Patent attorney and lawyer, Dr Rob Silberstein, provides an overview of contributory infringement in relation to patents in Australia, including a historical jurisprudential and legislative account of the issues raised by this vexed area of law

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We look at a case of anti-competitive conduct by doctors; the first set of standards issued by the Queensland Health Quality and Complaints Commission; and a question of discrimination in the provision of medical services

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In this edition: Partner Sarah Matheson and Articled Clerk Adel Mohamed provide a brief overview of follow-on biologics and the regulatory frameworks in the United States of America, Europe and Australia established to regulate this emerging class of therapeutic products

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In this edition: Senior Associate Matt Ireland and Law Graduate Pat Crisp examine due diligence as it relates to the biotech industry

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In this edition: Partner Dr Trevor Davies and Trade Mark Lawyer Lara Gun outline the issues for trade mark adoption and protection

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In this edition: Technical Assistant Dr John Landells provides an overview of recently released Federal Government policy requiring all government agencies to establish and implement plans for the management of intellectual property

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In this edition: Lawyer Jacqueline Goodall reports on the outcome of three recent decisions by the federal Privacy Commissioner on the protection of health information under privacy law

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In this edition: Lawyer Adrian Coras provides an overview of some of the commercialisation strategies available to biotechnology companies

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We report on the duty owed by employers where workers are exposed to traumatic events; the right to access one's own health information; the meaning of 'exceptional circumstances' when applying the 80/20 rule; the extent of the duty to warn patients pre-surgery; and when a surgical procedure amounts to battery

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In this edition: Partner Dr Robert Smyth, of US law firm Morgan Lewis & Bockius LLP, and Allens Arthur Robinson Patent Attorney Dr Kathryn Sunn provide an overview of a recent US Patent and Trademark Office notice on restriction requirements in patent applications containing nucleotide sequences

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In this edition: Patent Attorney and Lawyer Dr Rob Silberstein provides an overview of the grace period provisions under the patent laws of various Australian and overseas jurisdictions and discusses a range of related patents issues

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In late March 2007, the Department of Health and Aging released an exposure draft of the Therapeutic Products Bill 2007 (Cth). This is the first in a series of new laws that will significantly change the way therapeutic products are regulated in Australia and New Zealand by setting up a joint trans-Tasman scheme. Lawyer Przemek Kucharski summarises key aspects of the Scheme and the Bill

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In this edition: Privacy Commissioner's biometrics recommendations in response to ALRC privacy review

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In this edition: Partner Dr Trevor Davies and Law Graduate Matt Vitins provide an outline of the recent Issues Paper released by the Advisory Council on Intellectual Property on its review of the enforcement of Plant Breeder's Rights in Australia

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In this edition: Partner Dr Trevor Davies and Technical Assistant Dr John Landells provide an overview of bio-prospecting of Australia's genetic heritage, including a review of Australia's new regulatory regime for controlling access to its natural resources

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In this edition: The operative provisions of the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 (Cth) commence on 12 June 2007. Partner Sarah Matheson and Articled Clerk Adel Mohamed provide a brief overview of changes brought about by the amending legislation that affects the status of therapeutic cloning in Australia

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In this issue we examine the role of the Professional Services Review; final and binding determinations made under the Medical Practice Act 1994 (Vic); recent amendments to stem cell legislation; and the treatment of a child without parental consent

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A new food descriptors guideline issued by the Australian Competition and Consumer Commission, coupled with two recent investigations by the ACCC regarding misleading packaging of food items, highlight the need for food manufacturers to be careful of the claims made on their packaging. Partner Belinda Thompson and Lawyer Alexander Gelis report

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In this edition: Recent decisions concerning the law relating to patent term extensions for pharmaceutical patents may raise concerns for patentees. Partner Trevor Davies and Lawyer Jonathan de Ridder explain

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In this edition: Partner Sarah Matheson and Lawyer Emma Stacey provide a jurisdictional comparison of the 'springboarding' exception to patent infringement

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In this issue we look at the issue of witness immunity; a duty of care case; medical record ownership; and new or amended legislation

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In this edition: Partner Peter Allen and Lawyer Sean Massingham provide an overview of the upcoming provisions for the taxation of capital gains made by foreign residents set out in the Tax Laws Amendment (2006 Measures No. 4) Bill 2006

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In this edition: Partner Trevor Davies and Technical Assistant John Landells provide a jurisdictional comparison of the patentability of methods of treating humans

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In this edition: Partner Peter Allen and Paralegal Karla Drinkwater provide an outline of the Federal Government's scheme encouraging eligible Australian companies to increase their research and development activities by providing tax incentives

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In this edition: Patent Attorney and Lawyer Dr Rob Silberstein provides an outline of some of the available grants and concessions offered and/or supported by Australian State and Territory governments

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In this edition: Lawyer Dominic Nguyen provides an update on the proposed introduction of an experimental use exemption in Australia. Since early 2005, Biotech News has been closely monitoring the Advisory Council on Intellectual Property's recommendations regarding patents and experimental use in Australia and, in particular, an amendment to the Patents Act 1990 (Cth) to include an experimental use exemption. IP Australia has now released a public consultation paper on ACIP's recommendations

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In this edition: Patent Attorney and Lawyer Dr Rob Silberstein provides an outline of some of the available grants and concessions offered and/or supported by the Australian Federal Government

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In this issue we look at changes to the Queensland health system, the Community Services Obligation funding pool for pharmaceutical wholesalers and distributors, and a case concerning a parental dispute over the appropriate disposal of their deceased daughter

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In this edition: Special Counsel Karin Clark and Lawyer Andrew Ailwood provide an outline of the recent changes to the Privacy Legislation Amendment Bill 2006 (Cth) and its impact on genetic information

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In this edition: Lawyer Andrew Gun provides an outline of the recent changes to the Therapeutic Goods Advertising Code 2006, and the regulation of cosmetic chemicals with regard to antibacterial skin products

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We look at changes to country-of-origin food labelling that could cost the Australian food industry $60 million, the mandatory introduction of iodine and folic acid fortified foods and an industry report on the fatty acid content in infant formula products

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In this edition we celebrate AAR Biotech News' fifth anniversary. Patent Attorneys Dr Kathryn Sunn and Dr Rob Silberstein and Patent Attorney and Partner Dr Trevor Davies provide an outline of the important news, changes and topics that we have covered over the past five years

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In this edition: Patent attorney, Dr Kathryn Sunn, provides an outline of the first of three consultation phases on the proposed joint therapeutic products regulatory regime for Australia and New Zealand

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In this edition: Special Counsel Karin Clark, Senior Associate Jacky Mandelbaum and Articled Clerk Matt Zaba discuss the changes introduced by the Therapeutic Goods Amendment Act (No.1) 2006

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We look at the High Court's decision on 'wrongful life', access issues to information for assisted reproductive technology recipients and the UK Lillywhite case

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In this edition: Partner Richard Hamer and Lawyer Eloise Curry discuss recent developments in GM food regulation and labelling requirements

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In this edition: Special Counsel Karin Clark and Lawyer Tanya Vaysman discuss the privacy implications associated with developments in technology that provide for genetic and health data linkage

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In this edition: As reported in the previous edition of Biotech News, the Intellectual Property Laws Amendment Bill 2006 was introduced into the House of Representatives on 30 March 2006. Senior Associate Jonathan Gottschall and Patent Attorney Anthony Selleck outline the major amendments proposed by the Bill in relation to patent rights

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In this edition: AAR Partner Sarah Matheson and Law Clerk Fiona Galbraith discuss the relaxation of requirements in relation to the submission of patent certificates as part of an application to register many types of therapeutic goods in Australia

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In this edition: AAR Articled Clerk Martin Hecht and Partner Michael Dowling review current issues in the pharmaceutical patent area

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In this edition: AAR patent attorney and lawyer Dr Rob Silberstein reviews the recent report on the agriculture and food sector and GM Moratoriums in Australia

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We look at whether PPPs could help alleviate the infrastructure crisis in Queensland Health; the recommendations of the Lockhart Review on embryo research legislation; the court assessing a doctor's standard of care in relation to the Trade Practices Act; and an update on the AB v Attorney-General of the State of Victoria case

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In this edition: AAR lawyer Andrew Gun and partner Sarah Matheson review the recent report on regulation of cosmetic chemicals in Australia

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In this edition: AAR Partner Maryjane Crabtree provides an invaluable product liability checklist for the biotechnology industry

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We look at the issue of the law and rapidly changing reproductive technologies; the complexity of medical treatment for children; patent requirements for therapeutic goods; court review of a medical board decision; medicine pricing; a doctor's duty to explain the available treatment options and; a patents loophole being closed

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In this edition: AAR Senior Associate Caroline Ryan discusses the recommendations of the Final Report on Patents and Experimental Use in Australia released by the Advisory Council on Intellectual Property

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We look at an American Bill that could stop obesity law suits; a series of changes to the Australia New Zealand Food Standards Code; a move by McDonald's to disclose nutritional information; and a Federal Court decision that indicates Australia is not to become a 'resting ground for bad patents'

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In this edition: Senior Associate Caroline Ryan overviews the Consultation Draft for the National Framework for the Development of Ethical Principles in Gene Technology

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In this edition: Senior Associate Lorien Beazley looks at the new sanctions (including criminal sanctions and personal liability for officers) planned for manufacturers of therapeutic goods who breach the therapeutic goods regulatory regime

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In this edition: Patent attorneys Dr Kathryn Sunn and Dr Rob Silberstein report on the recent NSW AusBiotech Conference held on 1-2 September 2005 at the Powerhouse Museum, Sydney

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In this edition: Senior Associate Caroline Ryan outlines the recent Federal Court decision that held Mayne's chemotherapy cancer drug infringed an Australian patent owned by Pfizer subsidiary, Pharmacia Italia

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In this issue: we look at a Victorian court's orders to release a patient's medical file involving an abortion; an update on the legislation regarding human embryos and prohibition on human cloning; amendments to aged care legislation; the new national online Australian clinical trials registry; an analysis about whether Cattanach v Melchoir could be repeated in 2005; and extending doctors' fiduciary duties to include disclosures of adverse events could be repeated in 2005; and extending doctors' fiduciary duties to include disclosures of adverse events

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In this edition: Senior Associate Lorien Beazley provides an overview of ClubBio2005: Fever at the Frontline

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In this edition: Lawyer Clare Cunliffe reviews the Australian Health Minister's Advisory Council's new draft model for the scheduling of drugs and poisons in Australia.

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In this edition: Senior Associate Caroline Ryan provides an overview of the APVMA's Guidelines for the Registration of Biological Agricultural Products.

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In this edition: Partner Sarah Matheson and Lawyer Caroline Ray outline the Term of Reference for the Review of the operations of the Gene Technology Act 2000 and the Intergovernmental Agreement.

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A number of the recommendations made in the Privacy Commissioner's review of the private sector provisions of the Privacy Act 1988 will impact on organisations or individuals in health-related fields and those accessing health-related services. Partners Catherine Parr, Peter Jones and Cameron Price and Articled Clerk Martin Hecht look at the main findings of the review.

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In this edition: The existing pharmacy location rules and their oversight by the Australian Community Pharmacy Authority, which were due to expire on 30 June, will now continue until 31 December 2005. Michael Dowling discusses.

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In this edition: Lawyer Tanya Vaysman and Senior Associate Caroline Ryan outline the key recommendations of the Review of the Australian Arrangements for Clinical Trials and Access to Unapproved Therapeutic Goods.

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In this edition: Partner Philip Kerr and Lawyer Clare Cunliffe discuss the implications for Australian patent law of a recent Federal Court decision by Justice Merkel in relation to the validity and alleged infringement of Queens University's patent for the treatment of skin cancer and other skin lesions by photodynamic therapy.

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We look at new privacy legislation in NSW, direct-to-consumer prescription advertising, changes to the PBS, health warning labels for alcohol, pharmacist misconduct, and we review the Private Patients' Hospital Charter

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In this edition: Senior Associate Caroline Ryan gives an overview of the regulatory framework for the assessment and registration of pesticides and veterinary medicines in Australia

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In this edition: Partner Andrew Wiseman and Lawyer Clare Cunliffe look at recent cases on employee inventions and identify some common pitfalls encountered by employers

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Lawyer Andrew Cameron and Partner Peter James discuss the NHRMC's submissions to the current review of Australia's privacy regime

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Recent developments in the McDonald's litigation in the US have revived the hopes of prospective participants in class actions against fast food manufacturers and sellers for the alleged adverse health effects of their products. Partner Peter O'Donahoo and Lawyer Chris Peadon discuss the prospect for similar claims in Australia

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Senior Associate Caroline Ryan discusses basic commercialisation strategies for research

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AAR Senior Associate Caroline Ryan provides an overview of the Options Paper on Patents and Experimental Use in Australia, released for discussion purposes by the Advisory Council on Intellectual Property.

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We look at a national standard on communication for dealing with adverse events in health care; changes to the Victorian Mental Health Act; the ACCC's prescription to doctors for good practice; and a review of the Commonwealth Insurance Contracts Act

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In a recent case, the Australian Federal Court held the practice of patent 'evergreening' is not allowable in Australia. In this edition, Patent Attorney Anthony Selleck and Partner Dr Trevor Davies review a recent case and consider its implications on protecting inventions.

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In this edition, Patent Attorney Kathryn Sunn and PTA Partner Dr Trevor Davies review Australia's premier biotechnology conference, AusBiotech 2004 'Going Global', held in Brisbane earlier this month.

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We look at 'widely accepted' medical practice in terms of medical negligence; anti-competitive behaviour against Australian doctors in NZ; a case that clarifies medical treatment versus palliative care; exclusive services referrals in NSW hospitals; and medical confidentiality in the face of litigation

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In this edition, AAR Lawyer Anne Donaldson reviews the meeting of World Intellectual Property Organization delegates that examine proposals for the protection of traditional knowledge and folklaw

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In this edition, AAR Partner Philip Kerr and AAR Lawyer Clare Cunliffe look at the proposed scheme to introduce a trans-Tasman therapeutic goods authority

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In this edition, AAR Lawyer Alexia Mayer and AAR PTA Partner Dr Trevor Davies provide an overview of the Australian Law Reform Commission's report, Genes and Ingenuity: Gene Patenting and Human Health

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In this issue: Interested parties only have a few more days in which to send a submission on new Government food labelling guidelines. We look at the potential impact of a new Ministerial Council guideline relating to health claims on food labelling and also, what our major political parties have said they will do in relation to food issues, if elected

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In this edition, Partner Philip Kerr and Lawyer Clare Cunliffe look at the details and the effect of the US Free Trade Implementation Act 2004 (Cth) as it applies to therapeutic goods

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Our feature article this edition: Lawyer Alison Rush summarises the objectives of the Biodiscovery Act 2004 (Qld) and discusses how the new regulatory scheme will operate in practice.

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Our feature article this edition: Patent Attorney Dr Kathryn Sunn reviews a recent Australian Patent Office decision providing an interpretation of what constitutes a 'human being' and 'biological processes for the generation of human beings' with regard to exclusion for patenting purposes

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We report on new legislation for those with complex welfare needs; mental illness and a medical duty of care; Health Connect privacy and confidentiality issues; the new MedicarePlus safety-net arrangements and patients' rights to refuse treatment

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Our feature article this edition: Lawyer Anthony Selleck examines a recent appeal of the European Patent Office decision to allow disclaimers within patent specification as a means to overcome prior art to obtain an European patent

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Our feature article this edition: we assess the rights to Intellectual Property developed between employer and employee and how contractual arrangements and policies provide the required IP protection

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Our feature article this edition: we review the legal issues that surround the regulation of scheduled drugs

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We look at some current issues surrounding the growing problem of obesity

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Our feature article this edition: Lawyer Clare Cunliffe and Partner Dr Trevor Davies discuss the laws governing the agricultural cultivation of genetically modified crops in Australia.

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Our feature article this edition: the ASX has recently drafted the Code of Best Practice for Reporting by Biotechnology, Medical Device and other Life Sciences Companies to govern biotechnology reporting methods. Lawyer Mark Malinas provides an overview of the proposed framework and impacts on listed Biotechnology companies.

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Welcome to AAR's update on food legislation, policy, news and cases. Feature articles: The rise of obesity, mortality and life-insurance premiums; CoOL news from Food Standards Australia New Zealand

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Our feature article this edition: we discuss a recent US Federal Court of Appeal case which highlights the difficulties universities and early-stage researchers may experience in obtaining commercially-valuable patent coverage

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Our feature article this edition: How broadly can an invention be claimed as tangible IP? AAR Lawyer Anthony Selleck reviews recent proceedings that highlight the importance of patent claim disclosure in protecting the intellectual property it encompasses

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In this issue we report on the NSW Court of Appeal's rejection of a 'wrongful life' claim, gene patenting, proposed changes to the Disability Discrimination Act, the impact of the US-Aust Free Trade Agreement on the health sector and, the ACCC's continued monitoring of health funds.

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Our feature article this edition: Transfer pricing, intellectual property and advanced pricing agreements: we consider how business taxpayers can protect themselves

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Our feature article this edition: Business Development Lawyer Anne Donaldson highlights AAR's contribution to the upcoming Australian Innovation Festival: a series of free seminars for technology commercialisation companies

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Our feature article this edition: After several years of negotiation and consultation with the therapeutic goods industry, the Australian and New Zealand Governments have formally agreed to establish a single trans-Tasman therapeutic goods agency, following the model of Food Standards Australia New Zealand. Partner Annette Hughes and Articled Clerk Susannah Downie look at the new regime and its likely impact

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Partner Richard Hamer and Law Clerk Tom Reid examine the potential changes the Australia-United States Free Trade Agreement will have on the pharmaceutical industry

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Our feature article this edition: Intellectual property is a class of specified intangible asset that qualifies as a depreciating asset under the tax legislation and for which a deduction may be available. According to press reports, an Australian pathology company has claimed their patient records as "intellectual property" for the purpose of claiming a tax deduction under the capital allowances provisions.

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Our feature article this edition: AAR Senior Associate Caroline Ryan provides an overview of Discussion Paper 68: Gene Patenting and Human Health, released by the Australian Law Reform Commission as part of the current Inquiry into the impact of patenting genetic materials and related technologies on research and healthcare

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Our feature article this edition: Recent claims of successful human cloning and ever advancing research tools and techniques prompt international bodies to continually review human cloning and associated stem cell research legislation. Lawyer Melissa Foong compares current legislative measures enforced by different jurisdiction

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Welcome to AAR's update on food legislation, policy, news and cases. Feature articles: The US-Australia Free Trade Agreement; Fast food marketers spared the force of law; and 'Booze' biscuits spark public outrage

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Our feature article this edition: Australia proposes a US style 'ANDA' scheme to deal with patent disputes between the originators of new medicines and generic manufacturers, if the recent US Australia Free Trade agreement is implemented. It also proposes to speed PBS listing of new medicines

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The recently announced agreed text of the Free Trade Agreement between the United States and Australia has major implications for the sectors of the Australian economy and society that focus on intellectual property, telecommunications, media, entertainment and electronic commerce. Partner Paul Zawa and Senior Associates Raani Costelloe, John Dieckmann and Rachel Nemes report.

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We look at issues of the regulation of embryo experimentation; medical indemnity changes; medical implant communication systems; misleading advertising in the health industry; and the regulation of scheduled drugs

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Welcome to AAR's update on food legislation, policy, news and cases. Feature articles: Non-culinary herbs in food, the issues of bioterrorism, and tougher NSW food legislation

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Our feature article this edition Amendments to US patent laws enacted as part of the US Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Medicare Drug Act) on 8 December 2003 will have implications for both originator and generic pharmaceutical companies in the US marketplace. Title XI of the Medicare Drug Act

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Our feature article this edition is the final article in our series on research collaborations, Lawyers Grant Howden and Sarah Murray and Articled Clerk Wei-Ee Cheah consider the tax implications of biotechnology research collaborations

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Our feature article this edition is part three of our series on research collaborations, lawyer Anne Donaldson discusses strategies to commercialise the fruits of the collaboration

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Our feature article this week is a report from Senior Associate, Lorien Beazley on last week's ClubBio2003. ClubBio is an annual conference for the Queensland biotechnology industry. Under the theme Passion, People & Products and at the Gold Coast last Friday the industry reflected on the last 12 months

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In this issue: we look at the issues of patient confidentiality and the duty of care of health professionals; the review of the Insurance Contracts Act; the ACCC's continued focus on misleading advertising in the health sector; the inaugural Health Services Advisory Committee; the ACCC's stance on genetic testing; and the government's national strategy for online information management in the health sector

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Our feature article this week is the second in a series that looks at structuring research collaborations in Australian biotechnology. In this edition Lawyer Jacky Mandelbaum looks briefly at the structure of research collaboration agreements and in detail at the protection of intellectual property rights

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Our feature article this week is the first in a series that looks at structuring research collaborations in Australian biotechnology. In this edition Partner Tony Pyman and Lawyer Tamsin Hone consider the advantages and disadvantages of two alternative collaboration structures: incorporated joint ventures and unincorporated joint ventures

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Welcome to AAR's update on food legislation, policy, news and cases. Feature article: From junk food to junk lawsuits

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Our regular roundup of developments in this fast-moving industry. Feature article: Following recent changes to the Therapeutic Goods Act which widened the definition of therapeutic goods under the Act, lawyer Clare Cunliffe and partner Guy Foster discuss the regulatory process in relation to therapeutic goods and the claims that can be made in relation to therapeutic goods

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Our regular roundup of developments in this fast-moving industry. Feature article: Lawyer Alice Hume looks at the amendments to the Therapeutic Goods Act 1989 which provide clarity and certainty for manufacturers, consumers and regulators at the food-medicine interface

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Our regular roundup of developments in this fast-moving industry. Feature article: Senior Associate Jeff Bergmann makes some observations on the GTG DNA patent controversy

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We look at the issues surrounding the regulation of online pharmacies, the legislation relating to age of consent to medical treatment, the obligation of medical practitioners to provide advice about alternative therapies, how to define medical negligence, and the role of the Therapeutic Goods Administration

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Our regular roundup of developments in this fast-moving industry. Feature article: Senior Associate Duncan Bucknell considers the recent US decision in Madey v Duke regarding the defence to patent infringement of non-profit experimental research, and the Australian implications of the decision

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Welcome to our pharmaceutical law update - this page gives you a summary of the latest significant amendments to the CommonwealthTherapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990

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Welcome to AAR's update on food legislation, policy, news and cases. Feature: Is fast food the new tobacco?

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Our regular roundup of developments in this fast-moving industry. Feature article: Articled Clerk Tom Reid examines the recently released final version of the Australian Law Reform Commission report Essentially Yours: The Protection of Human Genetic Information in Australia, and how it deals with some of the issues raised during its drafting.

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Welcome to AAR's update on food legislation, policy, news and cases. Feature: Organic and GM Foods - Food Regulations Conference

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Our regular roundup of developments in this fast-moving industry. Feature article: AAR takes a look at the upcoming launch of Australia's new National Neuroscience Facility, to be celebrated by a week of activities in Melbourne under the banner of "Brain and Mind: Innovate. Integrate. Inspire"

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Our regular roundup of developments in this fast-moving industry. Feature article: Senior Associate Lorien Beazley and Partner Dr Trevor Davies were in Washington D.C. for Bio 2003

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Our regular roundup of developments in this fast-moving industry. Feature article: Pharmaceutical innovation is stimulated and protected, primarily, by the patent system. However, there are a number of sui generis regimes operating alongside the patent system which provide different forms of protection specific to pharmaceutical products. Lawyer Jonathan de Ridder considers the reach and limitations of one of those sui generis regimes: data exclusivity

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Our regular roundup of developments in this fast-moving industry. Feature article: Clare Cunliffe, Robert Cooper and Richard Hamer look at recent changes to the Therapeutic Goods Act

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Our regular roundup of developments in this fast-moving industry. Feature article: Tom Fotheringham discusses some of the ethical considerations encountered when conducting clinical trials. The article considers the ethical scrutineering of the Human Research Ethics Committees and the balance that must be struck between the desire to satisfy sponsors while also discharging the responsibility to report adverse results

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We update you on the ACCC's focus on health fund advertising; new communication standards for health professionals; the extended right of persons suffering 'pure psychiatric injury'; potential litigation for food addiction in the US; new medical indemnity insurance reforms; and the balance between patent rights and universal access to pharmaceuticals

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Our regular roundup of developments in this fast-moving industry. Feature article: Rebecca Sadleir considers two of the principal types of commercial relationship that a biotech company may enter into. The article discusses the benefits of a licence or collaboration and examines the principal commercial and legal terms that each type of agreement should contain

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Our regular roundup of developments in this fast-moving industry. Feature article: Rebecca Sadleir examines the circumstances in which a biotech company will be subjected to due diligence and when it is necessary. Rebecca also outlines some of the key areas of a due diligence review, with a focus on IP rights, and gives some practical pointers in dealing with common issues

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Our regular roundup of developments in this fast-moving industry. Feature article: If you engage a researcher to conduct research and development, you should be wary of conflicts of interest, as Alex Fleming explains

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Our regular roundup of developments in this fast-moving industry. Feature article: Fast track procedures and orphan drug programs are effective ways for stimulating research into neglected diseases. Penny Holloway and Dorothy Pawlukowski outline the features of the fast-tracking and orphan drug approval procedures of the USA, EU and the current position in Australia

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Our regular roundup of developments in this fast-moving industry. Feature article: This edition we have a special report from Bruce Roberts, a Managing Director of Roberts Mitani Aqua Partners, LLC

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Our regular roundup of developments in this fast-moving industry. Feature article: Recently, the WTO declared support of every country's rights to protect public health and promote access to medicines for all. However, on 20 February 2003, a draft resolution to allow developing countries access to generic pharmaceuticals to address public health problems was rejected. AAR Lawyer Kate Beattie reports

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Our regular roundup of developments in this fast-moving industry. Feature article: AAR Lawyer Erica Davis and AAR PTA Partner Dr Trevor Davies discuss the terms of reference of the ALRC's new inquiry into Intellectual Property Rights Over Genetic Materials and Genetic Related Technologies announced on 18 December 2002

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We update you on the Draft National Privacy Code, an important UK court ruling on a third-generation contraceptives case, an ALRC inquiry into gene patents, what the Daniels v ACCC ruling will mean for in-house counsel, and a round-up of new and amended health legislation

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Our regular roundup of developments in this fast-moving industry. Feature article: AAR Lawyer, Kirraley Bowles, provides a summary of the principal provisions of the Prohibition of Human Cloning Act 2002

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Our regular roundup of developments in this fast-moving industry. Feature article: Rachael Patterson discusses the Medical Indemnity Bill 2002, introduced into Federal Parliament late last year

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Senior Associates Gerry Cawson and Judith Taylor from our private equity team consider the new tax concessions relating to venture capital investments in Australia

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Our regular roundup of developments in this fast-moving industry. Feature article: Special Counsel Karin Clark provides an updated review of the integration of Federal and state laws into health privacy practice

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This issue of Biotech News contains two feature articles relating to biotech patent issues. The first discusses Astra's successful High Court appeal last week on the 'obviousness' of its Losec patent. The second summarises the current status of general issues arising in the patentability of medical treatments

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We look at the recommendations of the National Review of the Law of Negligence, issues surrounding the patentability of methods of medical treatment, the ALRC report on the use of genetic information, the effect of the new privacy legislation on the private sector, advertising and health funds, and the issue of medical indemnity insurance reform

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Our regular roundup of developments in this fast-moving industry. Our feature article: Lawyer Kate Beattie looks at the options open to you if you want to amend your patent after it has been granted

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Our regular roundup of developments in this fast-moving industry. Our feature article: Lorien Beazley discusses last week's ''ClubBio 2002 - Biotechnology with a Twist'' conference, held in Coolum on Queensland's Sunshine Coast

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Our regular roundup of developments in this fast-moving industry. Our feature article: the new Biotechnology Centre of Excellence has received much publicity of late, but what does it really tell us about new kinds of strategies and opportunities for research enterprises? Johanna Gibson discusses the issues

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Our regular roundup of developments in this fast-moving industry. Our final feature on the recent Australian Law Reform Commission Discussion Paper (DP 66) covers three important areas - insurance, employment and privacy

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We look at a series of health-related issues including an overseas perspective on PPPs and the NCP's review of pharmacies

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When the Therapeutic Goods Administration approves a therapeutic drug, is its decision immune from challenge? Until recently, the TGA thought so. Senior Associate Patrick Sands and Lawyer Cynthia Cochrane review a recent case where public safety concerns entitled a competitor to challenge that immunity

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Partner, Lionel Hogg and Liam Prescott look at new goods tampering crisis management guidelines, Lawyer Karin Clark reviews the new privacy legislation, Senior Associate Alex Feltham and Liam Prescott look at the new Queensland Government biotech code of conduct; and Senior Associate Emma Marsh reviews the ACCC's report to the Senate on health funds

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We explain how the Federal Government expects Public Key Infrastructure to improve the flow of information while maintaining security and confidentiality. We also consider moves afoot for the corporatisation of general practitioners and examine how the ACCC made a stand against unconscionable conduct

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We look at some of the potential legal issues behind recent media reports of doctors allegedly refusing surgery for patients who smoke. We highlight some of the do's and don'ts in health advertising so that you won't fall foul of the ACCC and Health Care Complaints Commission. We also look at the new privacy legislation that comes into effect on 21 December 2001

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We ask whether insurance companies should be able to change the terms of your cover based on genetic tests, and look at the ACCC's latest report, which says consumers still aren't getting enough information on health insurance

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The ACCC has targeted the health industry over the last few years, but good strategic planning can keep the consumer watchdog happy. Our article on e-Health shows how medical providers need to anticipate legal hurdles

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With high demand putting pressure on health services, we examine whether a UK-style partnership between the private and public sectors is a viable solution. And as e-health takes off, we highlight the pitfalls health providers may face in their quest to capitalise on opportunities

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John Baartz discusses two recent NSW decisions. The first relates to the duty of hospitals to persuade patients not to leave the hospital until they are treated. The second discusses the consequences of failing to warn patients of post-operative risks.