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AgVetLink February 2003

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Update: draft PAR operational policy

Background

The ACVM Group received a number of submissions in the pre-consultation phase of the development of the prescription animal remedy (PAR) operational policy from the New Zealand Veterinary Association (NZVA), the Veterinary Council of New Zealand (VCNZ) and the National Animal Ethics Advisory Council (NAEAC).

The draft was circulated to NZFSA business groups, MAF Biosecurity business groups and the Ministry of Health as part of the internal process. In addition to this, ACVM Group and NZFSA staff attended several meetings where the issues were discussed, and we received written comments from a number of organisations.

Some of the comments provided have been used to make improvements to the original draft policy circulated at the last AVMAC meeting and are reflected in the version that has now gone out for public consultation (available at http://www.nzfsa.govt.nz/acvm/publications/discussion/operational-policies/index.htm). The other comments will be considered along with submissions from the public consultation process.

At present the ACVM Group is in discussion with the Commerce Commission regarding their concerns about the potential for restrictive trade practices, and these will be considered as part of the consultation process.

Definitions

One of the most important changes in the current draft policy is to include working definitions for 'veterinary consultation' and 'immediate or direct care'. The ACVM Group has included the definitions that are used in the VCNZ Code of Professional Conduct for Veterinarians. Both the NZVA and the VCNZ have suggested that the definition of immediate or direct care should be tightened and have noted that several overseas jurisdictions adopt the Royal College of Veterinary Surgeons definition for direct care which states that:

(a) the veterinary surgeon must have been given responsibility for the health of the animal or herd in question by the owner or the owner's agent; 

(b) responsibility must be real and not nominal; 

(c) the animal or herd must have been seen immediately before prescription and supply; or 

(d) recently enough or often enough for the veterinary surgeon to have personal knowledge of the condition of the animal or current health status of the herd or flock to make a diagnosis and prescribe; 

(e) the veterinary surgeon must maintain clinical records of that herd/flock/ individual.

What amounts to 'recently enough' would be a matter for the professional judgement of the veterinary surgeon in the individual case.

The ACVM Group is aware that such a definition could cause changes in current practices in a few specialised areas. This is possibly at odds with our desire to, as far as possible, allow current practices to continue providing ACVM Act risks can be managed. We are discussing this with the Commerce Commission, and we are interested in comments from respondents on this point.

It has also been suggested that the risk management process would be made more robust if the definitions had some legal effect. In the short term it would appear that this could be done by way of approval of a code of practice. In the longer term it may be more effective to amend the ACVM Act (and/or the Veterinarians Act) to provide additional regulation making powers. This has been advised to the NZFSA Policy Group for consideration.

Operational procedures

NZVA has also suggested that risk management would be improved by a 'legal definition' of operational procedures. The ACVM Group agrees and has proposed a standard based on one already used (see page 5).

Trade in veterinary medicines

A number of concerns in this area have been expressed although the ACVM Group has made efforts to stress that we are not advocating change but are allowing for legitimate practices. The ACVM Group, after hearing the initial concerns in this area, proposed the code of practice for trade in PARs to add some robustness and controls.

It has been suggested that there would continue to be risks posed by new entrants to the trade in PARs that do not exist at present even given the powers provided by the ACVM Act to register (and to de-register) traders. While we don't expect there to be many new entrants, there is a potential to handle this concern in the implementation process. For instance, existing traders could be included on the register at no cost on the basis that they are operating in business as usual mode. New entrants could be subject to a positive compliance programme of audits for a period of time in a 'confidence building' period. In this case there would be a cost for new entrants but no additional cost of compliance for anyone currently operating in the business.

We are interested in the views of AgVetLink readers to this proposal.

Other concerns

While the ACVM Group is not advocating or forcing changes in the

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