Regardless of the type of therapeutic good you commercialise – original brand medicine, generic medicine, biological or medical device – we all share the common challenge of operating in a heavily regulated market. Therefore the role of the TGA in approving these products for market entry and maintaining marketability is paramount for commercial success in the pharmaceutical and medical device industry. In this Industry Insight we see how the TGA’s Blueprint reforms stack up and look at the impact on industry.
Following several major reviews in 2011, the Government released TGA Reforms: a blueprint for TGA’s future in December of that year. The Blueprint, as it was nicknamed, outlined initiatives covering a range of TGA activities grouped into 4 themes; communication and stakeholder engagement; complementary medicines; medical devices; and advertising and promotion of therapeutic products. A detailed plan to implement the Blueprint initiatives was released in July 2012 describing how the reforms would be delivered.
For industry, this came with a fee increase. Implementation over a four year period was expected to cost $11.7 million, with $2.3 million expected to be spent in 2012-13. In line with the TGA’s full cost recovery model, industry was required to foot the bill for the implementation of Blueprint reforms. The impact on industry was a blanket fee increase of 2% in addition to the 3.6% indexation increase.
Are the KPI’s being met?
Imbedded in the blueprint was a commitment to report on progress every six months – the first released in February 2013. This report card showed that of the 48 blueprint recommendations, 11 had been completed at 31st December 2012.
But is that sufficient for industry? Was the 2% fee increase spent wisely? Some quick calculations reveal that around 20% of the budget was spent completing around 20% of the activities. However, a closer look at the achievements reveals that there is still much work to be done. For example, whilst the publication of the TGA External Communication and Education Framework: Priorities and Projects 2013-15 does address Transparency Review Recommendation 3, it is only a framework for describing how TGA will communicate with consumers and engage with stakeholders. Whilst the TGA claims that activity has been completed for the purpose of reporting against KPIs, the actual communication and engagement is yet to occur.
Areas that still require implementation will affect industry
Despite this first report card showing TGA is on track to complete the majority of recommendations by their due date, challenges lie ahead with a small number of recommendations experiencing potential completion delays. While these delays may be out of the TGA’s hands, they are not insignificant. Of most impact to Eye Spy readers is the proposal for changes to the labelling and packaging of medicines to address consumer safety risks arising from Transparency Recommendation 14. Consultations on this topic have delivered varied responses from stakeholders and the issue of equal prominence of a medicine’s brand name and active ingredient could be a compromise that industry will need to make. Discussions between TGA and stakeholders are ongoing and although it seems to make sense that any changes be implemented alongside the joint regulatory agency ANZTPA, a revised Therapeutic Goods Order could be drafted as early as 30th June 2013.
Another year, another fee increase
Following the 2% increase in 2012, many were expecting another ‘blueprint fee’ to be added to the indexed fee increase announced during the most recent TGA bilateral meetings with industry. Whilst this expectation was not realised when the fee increase of 2.9% was announced, it is important to remember that this increase is over the larger increase from last year. Therefore, the industry is in fact going to be funding the Blueprint initiatives forever.