Animal Health Products

Documents - Workshop September 2007

Issue Template - Animal Health Products

Animal Health Products Working Group

This working group is comprised of partners that are committed to research, manufacture and distribution of quality animal drugs and biologics1 in Canada. Canadian Animal Health Institute (CAHI) members and partner companies represent a high percentage of manufacturers and distributors in Canada and lead the working group. They are a national voice for the animal health pharmaceutical and biologic industry. For additional information, please visit CAHI’s website at the following address: http://www.cahi-icsa.ca/.

DEFINITION – Animal Health

The state of a living organism, species or population which can sustain biological functions to preserve its own integrity. 

• The definition of animal health includes animal welfare.

The working group can work with this definition. More specific comments include:

• Subjectivity of the terminology-raised questions (e.g. preservation of integrity within modern production systems).

DEFINITION – Animal Welfare

• General consensus was that animal welfare should be considered in the context of animal health.
• To optimize the contributions of animals in modern production systems and in all other sectors, animal welfare should be a priority.

ISSUES to the animal health products working group

Key Industry issues:

1. The regulatory framework for the approval of new drugs in Canada is burdensome and out of synch with other countries.
2. Canada’s regulatory framework is not harmonized with the United States.
3. Canada’s regulatory framework does not satisfactorily limit the use of non-approved drugs through special import provisions and inappropriate use of active pharmaceutical ingredients.
4. There is a regulatory void for classes of substances, such as functional foods, nutraceuticals and biotech products.
5. The ability of the animal health products industry to respond to future needs is limited because of the lack of investment/incentive initiatives in research and innovation.
6. Government decisions and communications involving industry are often unclear, too risk adverse, not harmonized among departments and agencies and often made in isolation of industry consultation.

Drug Issues identified by the NAHS Team in consultation with other sectors

1. There is the possibility of drug and biologic residues in food animal products through the use of non-approved products and extra-label use.
2. The reporting of adverse drug reactions (ADRs) is recommended but not mandatory.
3. The threat of antimicrobial resistance continues to increase at a rate greater than the discovery of new drugs.

PROPOSED NAHS OUTCOMES

The working group is in general agreement with the following NAHS objectives:

1. Protect Canadians from animal-related health risks.
2. Strengthen domestic and international confidence in the integrity of Canada’s animal health, environment protection and food safety systems.
3. Minimize the economic, social and environmental consequences of animal diseases.
4. Sustain the health of animal populations by maintaining their viability and genetic diversity
5. Reduce animals’ exposure to disease.
6. Continue to improve the quality of life for animals.
7. Protect ecosystem health through prudent animal health practices.
8. Develop an integrated governance system to mitigate animal health risks.

Addition:
9.  Improve Canada’s regulatory framework to ensure current and future animal health issues can be addressed in a fair and timely manner.