Commercial Eyes holds a unique place as trusted advisers in the Australian pharmaceutical and medical device industries. We are often asked for advice in navigating the market forces that affect how our clients conduct their businesses. So, here are the top 5 hot topics our clients are seeking advice on in 2013.
1. The Federal Election
The Prime Minister’s announcement in January of the next Federal Election was quickly followed by the promise “not to start the nation’s longest election campaign.” While the intention of the announcement is to enable business to plan the year ahead, it is becoming more evident that all we can really plan based on this announcement is our annual leave. How can the pharmaceutical and medical device industry plan for the rest of 2013 and beyond the MOU when all polls suggest we will possibly have a new government? And even if the government is returned in September, we could expect a completely different front bench, possibly a new health minister and a new parliamentary secretary for health.
2. A government looking for savings
Sustainability of the PBS will continue to be a hot topic for discussion in 2013 and well into 2014. Price disclosure will continue to drive prices down, while market access delays should be expected for new medicines. It is clear this government is looking for savings and the PBS is an obvious target. Despite unified calls from industry for ‘no change to the PBS in the 2013 Budget’ and the fact that government has agreed to “no new pricing initiatives” under the MOU, there is still concern around the influence of central government agencies in proposing changes between the Budget and MOU expiry.
The Pharmaceutical Patents Review seeks to evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry. Asked to consider whether there is evidence that the patent system is being used to extend pharmaceutical monopolies, the review has highlighted the different approach to patents by the industry peak bodies Medicines Australia and GMiA. Commercial Eyes expects significant changes to the Australian patent system to come out of this review.
The number of rolling reforms at TGA will continue to be hot topic for anyone involved in Regulatory Affairs in 2013. Despite falling over at its first attempt, the joint Australian and New Zealand regulatory agency ANZTPA is scheduled to commence in 2016. Combine this massive change with proposed changes to labelling and packaging and other ongoing TGA Blueprint reforms and we could end up with a more challenging regulatory system to navigate.
Pricing is possibly the single issue that will perpetually be on this list. The industry is facing a commercial squeeze that hasn’t been experienced in Australia before, and is unlikely to let up in 2013. Greater pressure from PBAC for lower prices will lead to market entry challenges for new medicines and will force companies to consider if launch in Australia is financially feasible. Meanwhile, the generics industry, already feeling the squeeze from price disclosure, will see ongoing price erosion that will almost certainly lead to decisions around withdrawal of unprofitable products form the market.