Proposed fees for natural health products: International analysis
Health Canada's regulatory regime is not directly comparable to those of other countries. However, it is important for us to be aware of and understand how other regulators treat natural health products (NHPs) when setting up a cost-recovery regime in Canada.
Health Canada looked at 4 regulators:
- European Medicines Agency (EMA) (English only)
- Australia's Therapeutic Goods Administration (TGA) (English only)
- United States' Food and Drug Administration (U.S. FDA) (English only)
- United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) (English only)
It is difficult to make international comparisons given the differences in how health services are funded in different countries, how each country defines NHPs and the cost-recovery approach they use. In Canada, we define NHPs as substances that are naturally occurring and are used to restore or maintain good health. Other countries use various definitions, and may include or exclude certain ingredients, products or usages.
For example, in the U.S., most herbal medicines are considered dietary supplements and are not evaluated before being marketed. There are also no U.S. FDA-approved products labelled as homeopathic. The FDA published a draft guidance on complementary and alternative medicines (English only) in 2007 (last updated in May 2020) outlining how it regulates various products.
In Australia, therapeutic products are classified based on level of risk, so NHPs may be subject to the same requirements as non-prescription drugs depending on their risk categorization.
In the European Union (EU), most herbal medicines are considered to be drugs, though they are not centrally authorized. Typically, herbal medicines have been in use before the EMA was created (central authorization is only for new medicines) and would have been authorized at the national level for each EU country. Companies seeking market access for traditional herbal medicines in EU member states need to follow national procedures and pay any applicable fees in those jurisdictions, although they may submit a request for scientific opinion and pay a fee through the centralized process:
Fees may also vary depending on the claims made or the type of marketing authorization chosen.
For example, in Australia, "listed medicines" are not eligible to make any health claims. However, a claim to prevent, alleviate or cure a serious form of a disease, ailment, defect or injury will automatically incur a high-risk categorization regardless of ingredients:
- differences among listed/assessed listed/registered medicines (English only)
- listed medicines are defined as not required to be TGA-assessed before being sold in the market
- thus, they are not eligible for any health claims
- health claims (English only)
In EU member states, different fees apply depending on whether the company is seeking to market the product on a national level or in other partner countries as well:
- Guide to fees for human products (refer to section 1.9) (English only)
- applying the codes in the Guide to the associated excel file returns the application prices of new homeopathic products
Fees for site licensing also vary due to other factors. However, for our international comparison, we focused on fees for manufacturing sites, as this information was readily available.
Overall, compared to other jurisdictions where a given NHP is considered a drug, the fees proposed by Health Canada are lower. Where a given NHP is not regulated as a health product or is unregulated, the fees proposed by Health Canada are higher. For example, the European Commission considers most herbal products to be drugs and has correspondingly higher levels of oversight and fees. Several other jurisdictions also have measures to support small businesses. For example, in the United Kingdom, companies meeting their small business definition qualify for 25% to 50% fee reductions and payment deferrals (English only).
The EMA also waives some fees for micro businesses:
Table 3 summarizes regulatory frameworks and fee ranges across jurisdictions (conversion rate as of December 7, 2022. For a more detailed comparison, consult Annex C.
Health Canada (proposed) | Australia/TGA | United Kingdom/MHRA | European Union/EMA | United States/FDA | |
---|---|---|---|---|---|
Product classification | Class I, II, III Separate from drugs or foods |
From listed (low risk), assessed listed, to registered (high risk) medicinesFootnote 1 | From dietary supplement to prescription medicine | From food supplement, herbal medicine, to drug | From dietary supplement to drug |
Product licensing fee | $1,124 to $58,332 | Listed and assessed listed products: $1,229 CAD ($893 + $451 AUD) Registered products: $38,433 CAD ($3,047 + $38,988 AUD) |
$856 CAD (£517) to $8,290 CAD (£5,006) (homeopathic to new drug application) | $0 to $449,520 CAD (€313,200) (marketing authorization application) | $0 (up to $823,706 CAD or $633,620 USD for comparable productsFootnote 2) |
Annual product fee | $542 | $1,094 CAD ($1,200 AUD) to $1,440 CAD (1,580 AUD) |
$126 CAD (£76) to $4,021 CAD (£2,428) based on product classification (periodic homeopathic/herbal to standard) | $0 to $161,035 CAD (€112,200) based on product classification (maintenance of a marketing authorisation) | N/A |
SL fee | $4,784 | Initial fee of $766 CAD ($841 AUD) + variable inspection cost (manufacturing licences) |
$303 CAD (£183) to $5,205 CAD (£3,143) (NOPFootnote 3 to standard licence application) | $34,015 CAD (€23,700) + variable inspection cost | $21,921 to $32,880 CAD ($16,119 to $24,178 USD) (monograph drug facility fee)Footnote 4 |
Annual site fee | $6,921 to $40,071 | $4,507 CAD ($4,945 AUD) (annual charges for manufacturing licences) |
$775 CAD, (£468) (periodic manufacturing licence) | Up to $31,575 CAD (€22,000) (from Ireland) (annual fee major site) | |
Fee reduction | First NHP product application free for small business, 25% to 50% reduction thereafter 25% to 50% reduction also applies to SL applications and amendments and right to sell |
Annual product fee deferred until product sold on market 50% annual licence fee reduction for small businessesFootnote 5 |
25% to 50% fee reduction for small business and payment deferralsFootnote 6 | 40% to 100% fee reduction for micro and small businesses,Footnote 7 orphan drug fee reductions and payment deferrals for inspection and marketing authorizationFootnote 8 | N/A |
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