AVPA/Development of a National Regulatory Framework for Agricultural and Veterinary Chemicals
From Poultry Hub
Development of a National Regulatory Framework for Agricultural and Veterinary Chemicals
Report of a meeting between Ben Wells and the consultants Roger Rose and Nick Sheppard
The Council of Australian Governments, (COAG,) has asked for a report by first half of 2010 with a proposal for a single national framework to improve the registration and regulation of agricultural and veterinary chemicals.
On Monday 31st August 2009 I spoke with the two consultants putting the report together. They had already received submissions from a range of stakeholders which was a foundation for comment on behalf of APVMA.
We support a national registration scheme and would also like a national registration for veterinarians. The consultants took this on board although it is outside the frame of reference.
One stakeholder had suggested a limitation on the right of veterinarians to prescribe off label. APVMA already has a mechanism to do this by putting on a label restraint which the veterinarian cannot override. This power does not need strengthening.
It had also been suggested that we have compulsory reporting of adverse experience to APVMA. This is worth support however I made the qualification that there is an unequal balance of influence between the practitioner making the report and the power of the large manufacturer and that APVMA needs to do more than simply seek a response from the manufacturer.
There was a suggestion that APVMA perform safety testing rather than rely on registrant’s data. This was not supported as APVMA is a regulator and not a researcher and replicating work in Australia would do no more than increase costs and slow the process.
A suggestion was supported that Border controls be introduced to ensure that when registered chemicals are imported they come from the same source as the product registered. We have had instances where substituted products have been sold at a lower potency than the registered product.
However, a related suggestion was not supported that requested a single approval of actives with QC taking responsibility for individual product quality. This conflicts in intent with the paragraph above and is essentially allowing piggy backing of generic products that are very useful in lowering prices, but which must be able to show equivalent safety and efficacy as the original research product.
A suggestion to apply the same food safety requirement to imported and local products was strongly supported.
A suggestion had been made to “address the minor use issue.” This was mainly aimed at crop chemicals but it was emphasised in some detail that for veterinary products, and especially vaccines, a minor use permit allowed products to be available to small markets that could not justify a full registration cost and were very valuable to our industry.
The consultants had canvassed all stakeholders which clearly included consumer and some single interest groups. As a result there were suggestions that APVMA adopt a precautionary principle, consider the impact of chemical usage on the community and associated costs to the health system, encourage registration of “soft” products and to listen and act upon community concerns with respect to chronic illnesses such as Multiple Chemical Sensitivity.
It was strongly pointed out that the precautionary principle had been used in the EU to over ride a specific recommendation of their top scientific community that one in feed antibiotic was quite safe and posed no risk to human health. It was nevertheless banned on the precautionary principle resulting in a massive use of the human therapeutic, amoxicillin.
It was submitted that whilst community concerns are valid, all decisions of APVMA should be science based, and neither on a precautionary principle nor a vested interest. The analogy was drawn with the campaign to stop mass vaccination of children which vaccination has been proven to be safe and very effective. This campaign is not based on good science and we would not like to see a similar campaign develop against agricultural and veterinary chemicals. We support science based contrary views but strongly urge that APVMA be preserved as a solely science based regulator.
