Increase in penalties for non-compliance
On 12 March 2014 substantial amendments to the Privacy Act come into effect. The new laws are backed by a significant increase in penalties for non-compliance of up to $1.7 million and new investigative powers are given to the Information Commissioner.
PBS spending and sustainability
Government decisions on health spending and the Pharmaceutical Benefits Regime (Australia's government reimbursement system) have been battered with criticism this year, from industry analysts, innovators and generics alike.
In contrast to the weak IPO market in 2012, 2013 has proven to be a fruitful year for biotech IPOs, with the rising share market providing encouragement to biotech sellers (and in particular, private equity sellers) to launch, and buyers showing greater interest. The combined market capitalisation of ASX-listed life-science companies rose 29 per cent over one year to September 2013.
 PwC Bio Forum Quarterly Review 2013.
New High Court authority for failure to warn cases
In Wallace v Kam  HCA 19, the High Court held that a medical practitioner was not liable for physical injury sustained by a patient as a result of an inherent risk materialising in a medical procedure, in circumstances where the patient would have undergone the procedure even if they had been warned of the risk that ultimately eventuated.
One of the significant developments in the employment space this year was the passing of legislation (the first of its kind) to create a bullying specific jurisdiction. From 1 January 2014, workers (meaning employees, contractors, trainees, students and volunteers) who are being bullied in a business run by a company, will be entitled to seek relief from the Fair Work Commission (FWC). If the FWC is satisfied that bullying has occurred and that there is a risk that it will continue, it can make any order it considers appropriate to prevent the bullying. Although this power is very broad, it does not include the power to order the payment of any pecuniary amount (ie financial compensation).
Compliance (incl. bribery & corruption)
Raising the Bar
Significant amendments to Australia's patent laws took effect in April 2013 with the commencement of a number of long awaited reforms introduced by the Intellectual Property Amendment (Raising the Bar) Act. The reforms are intended to create a more robust Australian patent system and bring Australian laws into step with other key patent jurisdictions.
India – Ranbaxy USA Inc: $500 million criminal sanction and civil settlement
In May 2013, Ranbaxy USA Inc. pled guilty to three charges under the Food, Drug and Cosmetic Act (FDCA), and and four charges of knowingly making material false statements to the Food and Drug Administration.
China – GSK: ongoing bribery and corruption investigation
Regulatory / Transparency
In July 2013, allegations surfaced that GSK engaged in bribery and corruption in China, with authorities alleging that GSK funnelled up to USD$492 million through travel agencies to facilitate bribes to doctors and officials to boost its drug sales. The bribery is alleged to have occurred over a six-year period beginning in 2007.
Medicines Australia Code of Conduct – Transparency initiative
When the last version of the Medicines Australia Code of Conduct was approved in 2012, the ACCC requested that further measures be implemented in respect of transparency with benefits provided to healthcare professionals. In August 2012 Medicines Australia established a broad-based Transparency Working Group (TWG) to develop measures and policies to further enhance transparency of payments and other transfers of value between the pharmaceutical industry and healthcare professionals.
ANZTPA expected to begin in 2016
During 2013 there have been numerous developments towards the creation of ANZTPA, a single Australian and New Zealand regulator of therapeutic goods. In June 2013, the National Manager of the Therapeutic Goods Association (TGA), Dr John Skerritt, outlined an eight point list for the TGA in the lead up to 2016, which is when ANZTPA is expected to begin. Dr Skerritt's list included further aligning with Medsafe New Zealand, being a science-based regulator that made consistent findings based on legislation, and ensuring better communication with the industry and customers.
Topics: Australia, Bullying, Compliance, Healthcare, IPO, Patents, Privacy Laws
Published In: General Business Updates, Health Updates, Intellectual Property Updates, Labor & Employment Updates, Privacy Updates