Medico Legal & Pharmaceutical Law

Debating drug pricing, regulation and industry transparency

Pharma lawPharmaceutical companies, law firms, government departments, associations and consultants convened at the Sydney Harbour Marriott on 29th and 30th May 2014, for the 7th Annual Pharmaceutical Law Conference.

Over this jam-packed two-day event, discussion centred on a selection of pivotal issues impacting the industry including pharmaceutical law reforms, Intellectual Property, evaluation of the competitive landscape and industry transparency.

Opening the event, Professor Robyn Ward, Clinical Associate Dean of the Lowy Cancer Research Centre and Member of PBAC, gave an insightful overview of some of the challenges faced in making reimbursement decisions including the difficulties of interpreting preliminary evidence, co-dependency and assigning value to improved health outcomes.

Following on from this discussion migrated to particular areas of reform in pharmaceutical law, including patent-term extensions, led by Shelston IP and access to New Presentations, led by Claire Willmott, Legal Counsel at Roche Products.

A panel discussion centred on the patent eligibility of life sciences (including both Methods of Medical Treatment and Genetic subject matter) was a notable highlight of the Intellectual Property session, with different sides of the argument being proffered by Grant Shoebridge of Shelston IP, Nigel Lokarn of K& L Gates, Lisa Taliadoros of Jones Day and Dr Berndatte Tobin of the Plunkett Centre for Ethics. Following on from the much-publicised Apotex vs Sanofi-Aventis Australia case, several key areas of dispute were raised including the distinguishing between discovery and invention and whether it is possible to make isolated elements patentable in what is now a very-complex natural world.

Building on the debates of Day One, Friday’s discussion focused predominantly on the competitive landscape of the Australian pharmaceutical industry (with inputs from some of the regulators) and a focus on the challenges of industry transparency.

drugpricingProfessor John Skerritt led the keynote session as National Manager of the TGA, and offered some interesting perceptions around the evolution of the regulators role as medicine usage patterns change, the importance of international regulatory convergence and the ways in which regulators are increasing their engagement with patient groups.

A second panel of experts hotly contested the Australian drug pricing system and the means by which it is a system that can be sustainable. Led by a panel made up of lawyers, industry associations and regulators, a number of new issues were raised including questions as to who is best qualified to make up PBAC and whether specialists are actually necessary when the focus should be on general health outcome.

Discussion culminated in a series of presentations focused on the challenges and benefits of achieving industry transparency. Key themes emerging included anti-false claims, abuse of dominance, updates on Privacy Law and Business Conduct compliance. Evidently achieving greater transparency within the industry will take some time but developments are being made and solutions being provided.

We would like to thank all the speakers for putting together a really exciting program this year, and for our active audiences who encouraged heated discussion throughout! We look forward to the advancements and new themes of discussion that the 2015 conference will bring and hope to see you there.


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