Chapter 1CEO's report and outlook
Chief Executive Officer’s Report
In 2009, the APVMA launched the new Corporate Plan 2009–2012. It provides the direction for our activities over these three years and, as such, sets the framework for our Operational Plan 2009–2010. I am pleased to report the steps we have taken this year in the journey towards our goal: to enhance our reputation through promoting confidence, communicating our role clearly, working as a team with national and international government agencies to enhance regulatory efficiency, and enhancing the capability of our people and our systems.
Our activities during 2009-10 were focused on our core work, preparing for new initiatives associated with the reform agenda of the Council of Australian Governments (COAG), and finalising recommendations from the Australian National Audit Office (ANAO) audit report. Importantly, as the environment in which we operate is undergoing significant change, our emphasis remains to foster stability and resilience and to be responsive to our stakeholders’ needs and expectations while meeting our regulatory obligations.
We have previously reported against the three themes of stakeholder confidence, operational excellence, and informing policy. These remain a useful framework for considering our progress and achievements.
The new APVMA website was launched in November 2009. This is one of several strategies we are using to build and strengthen stakeholder relationships and to provide targeted and accessible information. We created two new information portals—‘Chemicals in the news’ and ‘Community questions’—that provide clear and factual information on current issues relating to pesticides and veterinary medicines (agvet chemicals). These initiatives aim to further enhance awareness of how our regulatory activities protect people, the environment and trade.
During 2009-10, we commenced a systematic spray drift review program. This marked a decade of effort to strengthen management of off-target risks from spray drift. The APVMA Operating Principles in Relation to Spray Drift Risk has been augmented with a new mathematical model for assessing bystander spray drift risk and the publication of new, enforceable spray drift control restrictions for product labels. Our spray drift mitigation program is one of the most thoroughly developed programs in the world. It is an example of our work in promoting confidence through consistent, predictable and transparent decision-making. The review program is designed to tighten controls on the way that more than two thousand products are used in Australia and to strengthen the protection of people, the environment and trade.
Last year, I reported that some core activities, such as delivering on registration timeframes, had been under intense pressure during 2008-09. Our focus for 2009-10 was to raise performance and foster stability within available resources and the operating environment. This time last year, we were dealing with major backlogs in work, particularly in the chemistry assessment area. The restructure of the Chemistry team, the establishment of a separate pharmaceutical chemistry capacity in the Veterinary Medicines Program, and the newly re-engineered and streamlined registration processes mean that the chemistry assessment work in progress is back on track and the backlog is no longer a concern.
Timeframe performance this year is similar to last year: some 82 and 88 per cent of applications were finalised within the required timeframe, for both the Pesticides and Veterinary Medicines programs respectively. Importantly, the number of applications finalised has increased considerably this year. Typically, 11 to 23 per cent more applications were finalised this year than last year. Of particular note is the increase in the number of decisions for new and innovative products.
During 2009–10, the APVMA worked with several overseas regulatory agencies in global joint reviews and work sharing of assessments for new pesticides. Global joint reviews deliver internationally peer-reviewed and consistent assessments and illustrate the benefits of a disciplined project management approach by both the applicant and the regulator. Typically joint reviews are completed with an elapsed timeframe that is 7–13 months less than the average elapsed timeframe for other similar applications. This is a true measure of success for a global approach to bringing new chemistry to Australia; and it is an example of how our engagement with other international government agencies for pesticide products can enhance efficiency.
2009–10 also brought major achievements in human resources management and information technology development. In July 2009, the APVMA implemented a new performance management system to foster a positive performance culture that focuses on outcomes rather than outputs, ensures greater transparency and consistency, and captures the Australian Public Service integrated leadership capabilities.
We were honoured to be short-listed as a finalist in the Excellence in eGovernment Award for 2010 for our implementation of the Electronic Application Registration System (EARS). This software provides online capabilities to applicants to submit and check the status of their applications for product registrations. Statistics gathered from EARS indicate that applications submitted using this software take an average 80 fewer days to approve than if submitted by other means.
During 2009-10, we continued to be actively involved in the Australian Government’s regulatory reform agenda, helping to inform Early Harvest and long-term reforms to improve the efficiency and effectiveness of our operations. Major advances in 2009-10 include:
- gaining agreement on how on-farm dairy cleansers should be regulated
- better defining the scope of chemicals the APVMA regulates and excluding certain products
- developing a new regulatory process for low-risk chemicals
- developing a suite of measures that simplify the administration of agvet chemicals
- implementing the remaining two of the six recommendations of the 2006 ANAO audit report.
The APVMA has continued to contribute to policy processes within other portfolios that are of relevance to the regulation of agvet chemicals. These include workplace labelling reforms, the reform to poisons scheduling arrangements, as well as policy considerations in the area of environmental labelling of chemicals progressed by the Environment Protection and Heritage Council. Internationally, the APVMA has made major contributions in harmonisation activities through the Organisation for Economic Co-operation and Development (OECD), the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and the Codex Alimentarious Commission.
I am indeed fortunate to have the support of a strong and cohesive Executive team to lead staff through these challenging times. This year, I am pleased to have welcomed a new member to the Executive team—Dr Allen Bryce joined the APVMA as new Program Manager, Veterinary Medicines Program in September 2009. My Advisory Board and Audit Committee have been invaluable in providing the organisation with experience, a fresh set of eyes on issues, advice and reassurance.
This annual report is the first step of ongoing activity to promote confidence, to communicate our role clearly, to work with national and international government agencies and to enhance the capability of our people and our systems. The pace has been fast, the pressures and expectations high, and the available resources limited. We have worked very hard to deliver on the APVMA operational plan this year.