Animal Health Products

Documents - Workshop September 2007

Issue Statement - Animal Health Products

ISSUES STATEMENT– ANIMAL HEALTH PRODUCTS

1. The approval of new drugs in Canada is a very slow and complex process.
   The regulatory framework is the biggest obstacle to innovation and competitiveness within the industry (Canadian Animal Health Institute and the International Fertilizer Industry Association Report 2007). Regulations increase development time and costs. The animal drug approval system as a whole needs to be streamlined so that the entire approval process, from application to approval, will proceed faster.
   
   
2. Canada’s regulatory framework is not harmonized with the United States.
   The quality of scientific risk assessment by Canadian regulatory agencies is ranked below that of the United States (US) and Australia. Extended Canadian approval times (beyond those in the US) reduce the competitiveness of Canadian animal health product companies.
   
   
3. Canada’s regulatory framework does not limit the use of non-approved drugs or guard against the inappropriate application of approved drugs.
   Current regulations allow farmers, pharmacists and feed mills to import active pharmaceutical ingredients. The inconsistent enforcement of regulations results in the use of pharmaceutically active ingredients as medication in feed and water on farms and in large production systems.
   Health Canada considers the use of prescription and over-the-counter drugs, in a manner not in accordance with the product label, as extra-label drug use (“off-label”).1 The Canadian Veterinary Medical Association (CVMA) recognizes that approved drugs are not necessarily available for all animal species or for all diseases, justifying extra-label use under the supervision of a licensed veterinary practitioner.
   When food animals are treated “off-label”, product withdrawal periods and maximum residue limits, established for the originally intended species, may not be the same. The prescribing veterinarian assumes the responsibility of determining appropriate drug withdrawal times.2 Extra-label drug use in production animals also has the potential to promote the development of antimicrobial resistance.
   
   
4. Regulations do not exist for functional foods, nutraceuticals and biotech productions.
   Gaps in the regulations can occur when the responsibility for the approval of new classes of innovative compounds, such as functional foods, nutraceuticals and biotech productions falls to more than one agency, or when a product is not considered to be a food or a drug in the traditional sense. New classes of biologics with therapeutic claims, such as bacteriophages and nutraceuticals, and functional foods with medicinal properties require clear procedures for their approval process. Confusion often delays bringing potentially useful products to market.
   
   
5. The ability of the animal health products industry to respond to future needs is limited, as result of the lack of investment and incentives in research and innovation, as well as the current regulatory system.
   Innovation often requires major investments in scientific research. A phenomenon also occurs in the industry referred to as “technology spillover” or the importing of intellectual property developed outside of Canada. Canada’s regulatory system is considered the biggest obstacle to innovation. Timeliness and predictability are critical to business planning. Canadian companies are challenged by the slow and unpredictable approval process.
   
   
6. There is a perceived risk that drug and biological residues may be present in animal products and the environment.
   Food animals are given a variety of products to treat and prevent disease, and to increase feed conversion rates and to promote growth.  The presence of these drug residues (if not used appropriately) in consumable animal products, are a public health concern.
   
   
7. Post market surveillance of approved animal drugs and biologics is an industry responsibility.
   An adverse drug reaction (ADR) is any unintended reaction to a drug, which includes noxious side effects, sensitivity reactions, toxicity and atypical failure.3 Surveillance of a drug once it reaches the market helps to identify other ADRs, ADRs that may occur infrequently, are specific to certain breeds or species, are related to animal age and interactions with other drugs, or that may not have been observed in clinical trials.  The degree of ADRs, along with the frequency of similar reports, can lead to changes on product labelling, the recall of a particular lot of drug product, the complete removal of a drug from the market, or no intervention.3 
   Once a drug has been approved for sale in Canada, the manufacturers themselves are responsible for post-market surveillance, to monitor the continued efficacy and safety of the product in both animals and their potential food products.3 There are no regulations requiring veterinarians to report suspected adverse drug reactions to the Veterinary Drug Directorate (VDD) or to drug manufacturers, but this process is strongly encouraged because they are usually the first to document clinical abnormalities.3
   
   
8. Drug resistant strains of bacteria, parasites and viruses are increasing at a greater rate than new drugs can be discovered and developed.
   Since the 1950’s, natural and synthetic antimicrobials (substances that can kill or slow the growth of bacteria, viruses, parasites or fungi) have been used in veterinary medicine to treat and prevent infections, or to increase feed conversion rates and promote growth in production animals.4
   The economic advantage of the antimicrobial treatment of food animals and its routine practice, favours the survival of drug-resistant strains of disease-causing organisms.5   Once a micro-organism has become resistant to a drug, it may continue to thrive because of limited alternative treatment options. Subsequent infections caused by this drug-resistant pathogen may be more severe and occur with increasing frequency. If this pathogen infects humans, either by direct contact or through contaminated food products, it may significantly impact health care costs (i.e. Avoparcin).4,5  Despite the surveillance and concern for antimicrobial resistance in Canada, the threat of antimicrobial resistance continues to increase at a greater rate than the discovery of new drug products.