RISK ANALYSIS: THE SCIENTIFIC BASIS FOR THE REGISTRATION OF VETERINARY DRUGS

Animal health products make valuable contributions to society by protecting and preserving the health of animals. As companion animals have come to play a more important role in the everyday lives of humans, animal health products have been able to extend the length and quality of life for our pets. Animal health products also have played a key role in assisting food producers in providing an adequate amount of safe and healthy animal protein products for an expanding world population.

Risk analysis is the most effective method for measuring the risks that might be associated with animal health products and balancing them against the benefits of the products. The animal health industry, through IFAH, strongly supports the use of scientifically based risk analysis as a basis for making public policy decisions about the approval and use of animal health products.

IFAH's mission is to promote a predictable, harmonised, science-based and innovative market place for the provision of quality animal medicines, vaccines and other animal health products, and so contribute to a healthy and safe food supply and to a high standard of health and welfare for animals and people. As such, and in accordance with IFAH's mission, one of the animal health sector's major attributes is the requirement that any new veterinary drug must be subject to a stringent, scientific and objective review, the decision making process associated with which being based on risk analysis.

What is Risk Analysis?

Risk analysis means a process consisting of three interconnected components, namely risk assessment, risk management and risk communication. IFAH stresses that the difference between ‘hazard' (being the agent having the potential to cause an adverse effect) and ‘risk' (being a function of the probability of an adverse effect and the severity of that effect, consequential to a hazard) should be well differentiated and understood.

Risk assessment means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. It should be targeted to a specific product use to facilitate the making of appropriate decisions. Risk assessment takes into consideration risk/benefit, as opposed to risk alone. As such, this process should include an objective balance reflecting the merits of use versus non-use of a product.

Risk management means a process, distinct from risk assessment, undertaken by the authorities of weighing policy alternatives in consultation with interested parties, considering the result of risk assessment. In addition to the options of allowing or disallowing the approval of a particular product, risk management measures could include label restrictions that limit use.

An alternative to making risk management decisions based on risk assessment is the application of precaution. The use of precaution may be considered in situations where there is a need for making a policy decision, the risk involved is serious or perhaps irreversible and there is a lack of full scientific certainty. The application of precaution should not be used as a reason for postponing decision. Regarding animal health products, it is anticipated that the use of precaution will be quite rare. Licensed veterinary medicinal products have passed an independent scientific assessment. Post-marketing surveillance is set up to capture any unexpected harmful effects of a product. Based on this, the probability of scientific uncertainty associated with licensed veterinary drugs should be low. Therefore, it is anticipated that the application of precaution should be a very exceptional option to be used in our sector.

On the rare occasions when precaution is applied, several principles should be observed:

1) Precautionary decisions are not permanent and should always be subject to reconsideration as science and technology develop.

2) Precautionary decisions should involve a high degree of transparency, clear accountability, and full and meaningful public involvement.

3) Precautionary measures should be proportional to the potential severity of the risk being addressed and to society's chosen level of protection.

4) Precautionary measures should be non-discriminatory and consistent with measures taken in similar circumstances.

Risk communication means the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk related factors and risk perceptions, among risk assessors, risk managers, consumers, the academic community and other interested parties, taking due consideration of legally binding confidentialities. In any event, all stakeholders and interested parties must be in a position to fully understand the decision making process and the requirements that must be met. Risk communication must be pro-active, transparent and objective.

The use of risk assessment allows authorities to make informed decisions about the proper use of animal health products that are necessary to treat and prevent diseases in animals. Risk analysis provides a scientific method for measuring risks and implementing measures to protect the public from that risk. IFAH strongly supports risk analysis and encourages its use by authorities that regulate animal health products.

3 November 2005