Equitable market access

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The Vision in Brief:

Consumer Health Products Canada and its member companies are seeking a regulatory environment that ensures all products of a similar nature and health benefit are evaluated by the same criteria and innovation is rewarded. When this vision is achieved, consumers will have a wider selection of consumer health products from which to choose, and they can be confident that all of the products they see on the market are safe, of high quality, and do what they claim to do.

Summary:

Canada's consumer health products industry believes that the products it sells to Canadians must be safe, of high quality, and do what they claim to do. For this to occur, all health products sold on the Canadian market must be manufactured, tested, and evaluated according to specific criteria. These requirements should be set according to the safety profile of the product, as well as the health claims that are attributed to it. Unfortunately, this is currently inconsistent: while the requirements for evaluating some types of products have been updated, some are still being evaluated by inappropriate criteria.

This lack of regulatory inconsistency also creates inequities in product availability and selection. It creates artificially high barriers (and consequently, higher costs) for some products to come to the marketplace, while other products that do the same thing and are regulated by appropriate standards can come to market faster and at a lesser cost. Implementation of consistent regulations for all consumer health products would result in greater product availability and provide consumers with more selection.

In addition, Canada does not currently reward innovation in the consumer health products industry. As a result of the lack of incentives, the growth of the consumer health products market is more stunted here than in other countries that do encourage new research and development in self-care.

Ensuring equitable market access benefits everyone. The companies that develop and market the products benefit from having all products evaluated and marketed on a level playing field thereby supporting their endeavours to research potential new health benefits from their products and to develop and market new products. But most importantly, consumers will be better able to make informed decisions when selecting products to practice self-care and they will have more product choices.

The Vision in Detail:

In general, consumer health products are considered to be "lower-risk" products. However, all products have some risks associated with their use, even if the risk may only be limited to certain people or under certain conditions. Canada's consumer health products industry believes that all products that have a similar range of risks associated with them should be evaluated by the same criteria. This is called "risk-based regulation." Under risk-based regulation, consumer health products would not be subject to the same regulatory requirements as prescription medicines.

Many different types of products are labeled or advertised with health claims. Canada's consumer health products industry believes that when Canadians pick up a product in their local store with a specific health claim on it - regardless of whether they think of it as being an "over-the-counter medication", a "natural health product", a "cosmetic" or a "food" - they are assured that the claim has been evaluated by the same criteria as all the other products that have the same claim.

Innovation in consumer health products should be rewarded in order to encourage research and development. Currently, if a company develops an innovative new product or discovers a new use for an existing product, another company can also market a copy of that product or use the same claim. This is very discouraging for the company that put significant financial and human resources into the innovation. The consumer health products industry believes that innovative products and claims should be granted a period of exclusivity on the market.

The Solution:

Currently, natural health products are regulated by the newly created Natural Health Products Regulations, which were developed specifically for this type of product. While this type of consumer health product is being evaluated by modern and appropriate standards, all other consumer health products are still being governed by the same regulations as prescription drugs.

To provide consumers with optimal market access to all consumer health products, Consumer Health Products Canada is seeking changes at both the legislative and the regulatory levels. Specifically, CHP Canada is seeking:

  • regulations for consumer health products that are distinct from those for prescription drugs, thereby allowing the consistent regulation of all products intended for self-care;
  • amendments to the Food and Drugs Act that will support the shift to risk-based regulation;
  • the implementation of standard criteria for evaluating health claims for products, regardless of their form (ie., over-the-counter medication, natural health product, cosmetic, or food); and,
  • the implementation of a period of market exclusivity for innovative new consumer health products and new claims on existing products (including consumer versions of former prescription products, ie., "switched" products).

CHP Canada Success to Date:

  • Consumer Health Products Canada (formerly NDMAC) has provided evidence-based guidance on consumer health products and self-care to governments and healthcare organizations for more than 110 years.
  • CHP Canada recommendation that natural health products (a category of consumer health products) be regulated separately from prescription drugs was accepted.
  • CHP Canada provided evidence-based expertise and knowledge to Health Canada that it used to help develop the Natural Health Products Regulations (2004). 
  • Since the implementation of the NHP Regulations, CHP Canada has provided guidance to the Natural Health Products Directorate that has resulted in significant improvements in the product submission process.
  • CHP Canada was successful in having regulations amended to allow all consumer health products to make risk reduction and prevention claims for ailments - provided the claim is supported by appropriate evidence - that they previously were unable to make (2008).
  • For over 10 years, Consumer Health Products Canada has been lobbying the federal government to update the Food and Drugs Act and to develop appropriate regulations for the rest of the consumer health products category. In 2008, the federal government released its Food and Consumer Safety Action Plan, in which it committed to amend the Food and Drugs Act.

CHP Canada in Action:

  • CHP Canada has been meeting with parliamentarians and Health Canada staff to ensure that amendments to the Food and Drugs Act will provide for risk-based regulation and the development of regulations that will enable all consumer health products to be regulated appropriately.
  • The Association has been meeting with Health Canada and Industry Canada to encourage the government to agree to implement the regulatory changes that are necessary to provide innovative consumer health products and claims with a period of market exclusivity.
  • The Association has been meeting with the various departments within Health Canada that are responsible for evaluating different types of products to encourage the implementation of standard criteria for evaluating health claims for products, regardless of their form (ie., over-the-counter medication, natural health product, cosmetic, or food).