Health, Pharmaceuticals & Biotechnology

The pharmaceutical and biotechnology sector is one of the most dynamic and fastest growing in Australia today. From small start-ups to large multinationals, the industry includes a diverse range of organisations, from some of the largest companies in the world today, to those which are not much more than an idea. The sector also embraces government and research organisations.

High profile, high impact

Deacons is the professional services firm most recognised by the pharmaceutical industry in Australia. Our pharmaceutical and biotechnology group is an active participant in the industry with a client portfolio that includes many local and international companies. We have played a key role in driving many industry issues including campaigning for the industry in respect of new legislation.

A hallmark of the industry is its heavy regulation, and understanding those regulations end to end, and how the whole jigsaw fits together is one of our key strengths.

All bases covered

Deacons knows the pharmaceutical and biotechnology industries, the legal principles applicable and the practical issues and problems. We take a holistic view of these matters and understand the context in which they occur.

Our expert lawyers provide clients with advice on all aspects of the law as it applies to the pharmaceutical and biotechnology industries including regulatory requirements, intellectual property, technology transfer agreements, licensing, clinical trial agreements and trade practices. In addition, we advise in related areas such as venture capital.

We are heavily involved in new aspects such as those around stem cells, and make an active contribution to the many and various dialogues around ethical issues in this area.

Our services

Pharmaceutical and biotechnology

• legislation: advice on industry specific legislation, especially the National Health Act, Therapeutic Goods Act (and related regulations, codes, orders and instruments – see further below), Gene Technology Act, Trade Practices Act and the various State Pharmacy Acts
• agreements: licensing, materials transfer, joint venture, distribution, co-marketing, confidentiality, acquisitions/mergers, technology transfer, research & development, shareholder, subscription
• pharma regulatory: Therapeutic Goods Act, gene technology, categorisation of products, clinical trials and guidelines, code of conduct, labelling, pharmacy regulation, privacy, scheduling, CMIs and Pis conduct of clinical trials: investigator agreements, consents, insurance, ethical guidelines, genetic testing
• intellectual property: patents, trademarks, copyright, confidential information, know how, litigation, licensing and technology, use of internet product liability: risk assessment and minimisation strategic advice, product recall advice and strategy, crisis management
• review of decisions: AAT, ADJR, Freedom of Information marketing and promotion: industry codes

Other areas of innovation, such as nanotechnology, allow us to draw on our broader technology base, including extensive skills in the IT and biotechnology platform areas.

General

• financing including venture capital
• privatisation and corporatisation including joint ventures, partnering arrangements
• property: leasing, redevelopment, planning approval, building and construction issues, property management
• taxation:125% R&D, co-operative research centres, withholding tax, division 10B, international tax
• transfer pricing: audit defence, internal documentation, contemporaneous documentation
• agreements: service provision, outsourcing, acquisition, trust deeds, maintenance services
• tender requirements
• employment and related law

Please call us if you would like to know more about how we can help you.

• Legal update: New .au Domain Name Transfer Policy from 1 June 2008

  In last month’s Legal Update on Upcoming Changes to .au Domain Name Transfer Policy we noted that the Australian domain name administrator (auDA) had approved an implementation plan for a new policy on the transfer on .au domain name licences. auDA has now confirmed that the new policy will take effect on 1 June 2008.

  18 Apr 08 Michael Park

• Legal update: New Guidance Note issued by the Takeovers Panel on equity derivatives

  On 11 April 2008, the Takeovers Panel (Panel) released Guidance Note 20 - Equity Derivatives (Guidance Note) outlining when, and in what circumstances, the use of equity derivatives may constitute unacceptable circumstances and require disclosure to the market.

  17 Apr 08 Robert Sultan, Shane Bilardi , Natalie Trezise

• Legal update: Upcoming changes to .au domain name transfer policy

  The Australian domain name administrator (auDA) recently announced that it has approved an implementation plan for a new policy on the transfer of .au domain names licences. (It is the exclusive licence to use the domain name that is transferred, rather than ownership of the domain name itself.) This announcement follows auDA’s earlier acceptance of the recommendation from the 2007 Names Policy Panel that the current policy be relaxed to allow a registrant to transfer its domain names for any reason.

  27 Mar 08 Michael Park , Ka-Chi Cheung

• Legal update: Market volatility - ASX and ASIC respond

  Sensing a growing controversy, the ASX and ASIC have issued a number of media releases in response to market concerns, reminding market participants of laws designed to protect the integrity of markets. This update discusses the ASX and ASIC statements in light of the current apparent market volatility.

  17 Mar 08 Tim Woodforde

• Legal update: ACCC releases new draft merger guidelines

  The ACCC recently published its 2008 Draft Merger Guidelines for consultation. These guidelines are intended to provide an explanation of the framework the ACCC will apply when considering whether a merger or a proposed merger could substantially lessen competition in a market. Guidelines such as these issued by the ACCC from time to time, provide a useful overview of polices and procedures applied by the ACCC when reviewing proposed mergers.

  4 Mar 08 Jyoti Singh and Chris Mitchell

• Newsletter: EBIT - May 2007

  Welcome to the May issue of EBIT (Emerging Business, Innovation and Tax). EBIT is an informative newsletter to be shared amongst your clients and colleagues. We provide this information to help you keep abreast of changes to legislation and to stay informed of recent cases and other developments. We hope you enjoyed this issue of EBIT and we look forward to bringing you more issues of EBIT in the future.

  24 May 07 Marcus O'Brien, Michael Tooma, Peter Norman , Angela Zhang, April Thomas

• Newsletter: EBIT - March 2007

  Welcome to the March issue of EBIT (Emerging Business, Innovation and Tax). EBIT is an informative newsletter to be shared amongst your clients and colleagues. We provide this information to help you keep abreast of changes to legislation and to stay informed of recent cases and other developments. In this issue we discuss unfair dismissal and permitted termination for a genuine operational reason. We look at copyright protection, and we review the revised exposure draft for the taxation of financial arrangements tax timing rules. We hope you enjoyed this issue of EBIT and we look forward to bringing you more issues of EBIT in the future.

  9 Mar 07 David Coombes, Greg Hipwell, Michael Serong, Gregory Wong , Evan Mentiplay, Annabele Nilsoon

• Newsletter: Enterprise – December 2006

  Welcome to the December issue of Enterprise. The last few months have seen the High Court confirm the validity of Work Choices, the Australian Fair Pay Commission hand down its first decision, the Award Review Taskforce present its reports on pay and classifications and award rationalization and some fine tuning of Work Choices largely to address employer concerns. This edition of Enterprise examines other important developments with a focus on the employer/employee relationship. We look at an employer failing to follow its own policies on termination, what is “acceptable alternative employment” in a redundancy situation, a protracted absence on sick leave and post-employment restraint. Owner drivers in Victoria and diplomatic employers round out our overview of the employment relationship. Our authors will be happy to hear from you if you need more depth than the space we have allowed them permits.

  8 Dec 06 Stuart Kollmorgen, Alan Grinsell-Jones, Jason Noakes, David Cross , Magda Marciniak, Carolyn Symons, Evan Mentiplay, Jessica Idotta, Olivia Hillier, Kristy Cassoff, Lindsey Kerr, Dan Pilmore, Jenny Thrum, Ashley Bozdag

• Newsletter: EBIT - December 2006

  Welcome to the December edition of EBIT (Emerging Business, Innovation and Tax). EBIT is an informative newsletter to be shared amongst your clients and colleagues. We provide this information to help you keep abreast of changes to legislation and to stay informed of recent cases and other developments.

  4 Dec 06 Michael Park, David Wilson , Ka-Chi Cheung, Stephen Clune

• Legal Update: Caution on use of Schemes of Arrangement

  The Victorian Supreme Court Yesterday issued a stern warning against complacency in the use of schemes of arrangement as a takeover mechanism. “The decision in Smith v Zenyth Therapeutics makes it clear that the statutory approval threshold (50% of members and 75% of votes) should not be assumed to be all that is required” said senior Melbourne partner Robert Sultan.

  16 Nov 06 Robert Sultan, Shaun Clyne