Proposed fees for veterinary drugs master files – Consultation comments

Flavine North America, Inc.

As a 26 year veteran of the veterinary pharmaceutical API industry, I would like to comment on the proposal to implement fees for veterinary MFs. As an agent and distributor for various small to medium sized API manufacturers, Flavine North America, Inc. has faced this same question in the USA. As you are probably aware, we do not have MF fees for veterinary drug APIs in the USA. Flavine supports a good many veterinary drug product companies with APIs for both companion animals and food animals. Our primary clients are generic companies rather than pioneer companies.

Unfortunately, many of the products for animals have rather limited sized markets and generic companies can consider the potential return on investment too limited to invest in a drug registration. The drug product sponsor will likely be expected to cover the cost of the API MF fees, which only adds to the overall cost of development. This compounds the issue and leaves certain products without competition and pet parents and farmers with only the high cost pioneer drug. Alternatively, should a product be attractive for a drug product company to consider for generic development and approval, the share of the business for the API manufacturer is typically a small percentage. Should the drug sponsor be unwilling to pay the MF fee as well as the API producer, there will be lesser or perhaps no API options given the small API business opportunity resulting in no generic approvals.

In general, I would expect that with a MF program in place for veterinary APIs, API companies may rather focus development and regulatory resources on the more profitable human drug market. In my role in the AH segment of the pharma market, we are always faced with API companies rationalizing product development / R&D resources. There are many more larger and more lucrative products in the human health drug market and we struggle to get API companies that primarily support the human drug market to allocate resources for smaller veterinary new product development. MFs fees will only make the veterinary market less attractive.

Anonymous

I would like to provide a few comments related to the proposed updates to the fee structure to align with human drugs.

1. As a small animal health company in Canada these added costs are another challenge to bring certain products to the market. As there are many products being lost every year in the animal health market this creates another hurdle to register products and initiate/maintain dossiers for this smaller market. Not sure why/how Health Canada can justify these fees for the veterinary market? Potential phase in approach would be helpful. Or is there a way to harmonize our DMF with the other regulatory bodies?
2. Also setting up CESG access is very time consuming/costly. Some companies like ours do not have the resources/technical ability to complete. Option to still use sharing applications?

Member of the Public

I am concerned that, by adding a fee for filing veterinary drugs, that veterinary care may become more expensive. Already, pet parents can not afford the care they need for their loved ones. Please do not make veterinary care, which is in shortage, more expensive. Please also phase out the animal laboratory testing of veterinary drugs by the end of the decade. There are cruelty free ways to test medicines.

Anonymous

1. Fees: The proposed fees due to be implemented January 2024 are the same as those for human master files. In the past Health Canada fees have always recognised the difference in revenue between the veterinary and human industries and no justification has been given for this proposed increase, without even a phased-in approach. Particularly for smaller companies, the cost of regularly updating the master files will now be prohibitive. The fee increase should be clearly justified for the veterinary industry and phased in over several years at least.
2. CESG: Considering the small size of the veterinary market in Canada, the effort to set up CESG access for a veterinary drug product supplier seems excessive, will Health Canada offer any support to smaller companies who do not have the technical resources to do this?
3. DMF updates: Could the process to update the DMF be more aligned with that of other agencies, the US CVM for example?