PM+: Managing the environmental impact of animal pharmaceuticals
What is the best way to address societal and political concerns about the impact of pharmaceuticals on the environment? IFAH-Europe's Managing Director Roxane Feller explains.
Veterinary medicines are produced in a wealth of different formulations, such as creams, tablets, injectables and premixes.
These can be administered to help treat diseases or ailments in animals in a range of ways: by drinking, eating, injecting, and applying on the skin to name a few.
As a result of the use of medicines, it is possible for their residues to find their way into the environment.
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The risk to the environment associated with each of these products varies greatly, as it is determined by a combination of the nature of the active substance(s) in the medicine, and the level of exposure to the environment (which is determined by its form and use).
The EU institutions are currently in the process of revising the legislation on veterinary medicines, and the new European commission proposal aims to ensure the safety of these medicines, for the user, animal patients, consumers and the environment as a whole.
An environmental safety assessment of every veterinary medicine has been compulsory in the EU since 1992 as part of its overall marketing authorisation application, but questions have been raised about how the system can be improved to ensure greater protection of the environment.
We at IFAH-Europe are actively participating in the discussion on how best to address societal and political concerns about the impact of pharmaceuticals on the environment. We must advise caution when reviewing the best instruments to reach this goal.
It has been suggested that the use of a monograph system, which collates existing data on the fate and effects of active substances, may be a useful tool; yet monograph systems are resource-intensive to develop and maintain.
They present a number of practical problems that would need resolving, specifically who will carry the burden to draft each monograph, approve it, determine its rules, uses and its ownership, not to mention how the system will be funded and enforced.
Furthermore, monographs only serve to gather data on active substances. It is essential that policymakers recognise that an environmental risk assessment must be inherently linked to a medicinal product and its patterns of use, not just the active substance contained within.
That is why it might be better to publish the key environmental data from each product assessment in the public assessment report, so that this data can be used by anyone.
This solution firstly avoids the problems associated with developing monographs, and secondly has the benefit of bringing together both the data on the active substances and the data on the intended patterns of use (the 'exposure'). Both these elements are necessary for an environmental risk assessment.
There is a concern that introducing monographs may have an additional unintended detrimental effect.
By having to stick to a single set of data, any incentive for a veterinary medicines developer to go beyond these minimum requirements for a product under development will be removed.
Some companies carry out more innovative studies, or additional studies of higher quality with a broader scope.
By opting for a monograph system, we run the risk that it will actually offer a lower degree of environmental protection.
Ultimately we must ask ourselves the question: does it solve the problem we have set out to resolve?
Can the proposed system cope with the reality that many existing active substances are used by multiple companies, including those in the human medicines and biocides sectors?
The animal health industry is certain that a monograph system is not the answer, and we welcome further discussions to find a suitable solution for the veterinary medicines market.
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