Two of the most common questions we get from our clients are ‘why does the APVMA take so long?’ and ‘why is it so expensive’?
The APVMA is the national regulator for ‘agricultural chemicals and veterinary medicines’. The legislative definition of an agricultural chemical product is so broad that captures everything from crop protection products, to dairy cleansers, wood preservatives and swimming pool sanitisers. As a result, the APVMA is required to regulate a lot of different products, each with their own risks. In the 2018/2019 year they received 2878 applications for new or variations to products, active constituents, and permits; and finished with 1202 active applications. While many of the minor variations and label approvals can be done within weeks or a few months, the more complicated products that require a technical assessment take anywhere from 8 to 18 months if correct, or 12-25 months or longer if there is additional information required.
The reasons for these long timeframes are many, however it essentially comes down to resources and expertise. The APVMA has struggled to meet timeframes for these longer-term technical applications for many years. As a result, there has always been a large backlog of applications to assess and assessments for some applications will not start for months after the application has been accepted. While the APVMA has introduced many time-saving policies and procedures (e.g. notifiable variations and use of international assessments), resourcing and experience within the organisation are critical to its abilities to function effectively. With increased expertise, the APVMA will be more able to appreciate actual risks and mechanisms to mitigate risks to suitably low levels. This can negate the need to request additional data or information. It takes at least 12 months to train a scientifically skilled person to be a reasonably competent regulatory scientist and risk evaluator. Frequent turnover of staff requires extensive resourcing for training and makes it very difficult to keep knowledge within the organisation.
With respect to resourcing, the APVMA is nearly 100% funded (aside from recent relocation funding) by fees and levies from the companies that supply the regulated products. The APVMA sets fees based on Government agreed principles that are based on a user pays system, although not all costs are passed on at the beginning. Simple applications are charged at 100% of the cost to service them, while more expensive technical applications are charged at approximately 40% of the cost to service them. The 60% difference and other activities of the APVMA (e.g. chemical review and compliance enforcement) are covered by the levy on the wholesale value of product supplies. More information is available here.
For the APVMA to increase its resources and expertise, they will need to charge more via either application fees or levies. The alternative is to make massive and significant changes to the entire regulatory system, such that the work of the regulator is reduced, enabling more resources to focus on the remaining application assessments. Given the current legislation, this is simply not possible, or in the interest of the wider public.
So what can you do to give your application the best chance of the quickest pathway through the regulatory maze? You make the correct application type and the best it can be to reduce the likelihood of recategorisation or additional questions being asked by the regulator. The good old days of just throw it in and the APVMA will tell us what to do are far behind us. Our experienced team of consultants at DTS will always attempt to make the application as correct and easy to follow as possible, thereby making the APVMA’s job easier and the best chance of early success.