Ensuring safety, quality, and efficacy

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Vision in Brief:

Consumer Health Products Canada and its member companies are seeking a marketplace where all marketers of consumer health products adhere to legislative and regulatory requirements that are consistent and appropriate to consumer health products. When this vision is achieved, consumers will be assured that the products they buy for self-care are safe, effective, and of high quality.

Summary:

Trust and confidence in Canada's consumer health products is founded on providing Canadians with products that are safe, effective, and of high quality. Members of Consumer Health Products Canada are the leaders in the industry and they got this way by manufacturing, importing and selling products that not only meet the government's requirements, but also meet voluntary standards of the industry.

CHP Canada is lobbying the government to increase Health Canada's resources to provide more effective compliance and enforcement of the current legislated and regulated requirements to help increase consumer trust in the industry. A longer term goal is to ensure that the actual requirements being applied to consumer health products are appropriate to the benefits and risks associated with these lower risk products. By eliminating inappropriate requirements, the regulators should have more resources to put towards truly ensuring that consumers can trust the safety, quality and efficacy of the consumer health products they use.

Innovative energies and the drive to expand the self-care options available to consumers stimulates research and industry growth, but at tremendous cost. Industry is seeking some innovation incentives that cost the government and the public nothing, but help the innovator to obtain a reasonable return on investment: CHP Canada is seeking an appropriate period of time between the approval of innovative consumer health products and the entry of competing products based on the innovator's research.

Vision in Detail:

Companies that manufacture, package, label, import or test consumer health products must adhere to the Food and Drugs Act and either the Food and Drug Regulations (for over-the-counter medications) or the Natural Health Products Regulations1 to ensure safety, quality, and efficacy of the products. Companies that demonstrate they meet good manufacturing practice (GMP) requirements are granted an Establishment License (for over-the-counter medications) or a Site License (for natural health products), both of which are issued by Health Canada and renewed on a regular basis.

In addition, all consumer health products sold in Canada must have valid product licenses which are issued by Health Canada. These licenses require the brand owner to prove that the products are safe and do what the company claims it will do (ie., efficacy). Products that have undergone a full pre-market assessment and been approved will have a government-approved number on the label (ie., a DIN number for over-the-counter medications and an NPN or DIN-HM for NHPs).1

While CHP Canada's member companies are leaders in the industry who meet and exceed these regulatory requirements, it is still necessary to have a watchdog to safeguard all the health products to which Canadians have access. The Health Products and Food Branch Inspectorate ensures the uniform, efficient, and effective enforcement of the requirement for all Canadian establishments, and any foreign establishments providing health products to the Canadian market, to comply with the Food and Drug Regulations and/or the Natural Health Products Regulations.

Since 2004, natural health products have been regulated by the Natural Health Products Regulations, which were developed specifically for this type of product. While this type of consumer health product is being evaluated by risk-appropriate standards, all other consumer health products are still being governed by the same regulations that apply to prescription drugs. While CHP Canada's members adhere to the legislated and regulatory requirements currently in place, they recognize that precious resources are being used to comply and enforce artificially high requirements on these lower risk products.

Before a product is granted a DIN or NPN license, it is fully evaluated to ensure safety, quality and efficacy; however, it is generally recognized that all health products have risks and benefits. The maintenance and enhancement of health and safety is a responsibility that is shared between government and industry, consumers, healthcare professionals and their respective associations: all parties work together to report and monitor adverse reactions, and assess the actions that are necessary to reduce the likelihood of further adverse reactions. CHP Canada emphasizes that actions must depend on the nature, the seriousness and the frequency of the reaction, as well as on the intended use of the health product, the benefit obtained from its use versus the risks and the availability of alternative therapies.

Research and innovation leads to improved health outcomes: Consumer Health Products Canada members are continually working to provide Canadians with new and innovative self-care products, which can range from a completely new product to making modifications to well-established products to provide consumers with more choice (eg., new indications, flavours, dosage forms, etc). It also includes switching some prescription drugs to over-the-counter/NHP status for conditions that can be managed through the practice of self-care. Innovative energies and the fundamental need to prove efficacy, stimulates growth of the industry and the research community, but at tremendous cost. Industry is seeking an appropriate period of time between the approval of the innovative consumer health product and when second entry products would be permitted to enter the market, to allow the sponsor to obtain a reasonable return on investment.

Many of the products our members market have been widely available for decades and have earned the trust that their customers have in them by not only complying with the legislative and regulatory requirements, but by going the extra mile. Over the years, CHP Canada has put in place a number of voluntary initiatives that can further enhance the safety of their members' products, including the labelling program for significant changes to products, guidelines for providing poison control information, labelling of non-medicinal ingredients, and tamper-evident features for packaging (which was eventually incorporated into regulations).

1NOTE: On August 4, 2010, Health Canada implemented a new regulation to manage a situation whereby a resource problem has led to a large number of natural health products being in backlog to be reviewed. The Natural Health Products (Unprocessed Product License Applications) Regulations will provide a temporary exemption (and number beginning with "EN") to permit NHPs, for which a product license application has been filed with Health Canada, but the assessment has not been completed, to be legally sold on the market. The exemption number will stay in effect until the application(s) is withdrawn or is processed and a decision to issue or refuse a license is made. These regulations will be repealed 30 months after coming into force (ie., February 2013).

The Solution:

To ensure that consumers will be assured that the products they buy for self-care are safe, effective, and of high quality, Consumer Health Products Canada is seeking changes at both the legislative and the regulatory levels. Specifically, CHP Canada is seeking:

  • enforcement of compliance with the Food and Drugs Act, Food and Drug Regulations, and the Natural Health Products Regulations1;
  • 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;
  • implementation of incentives to reward consumer health products companies for developing innovative new consumer health products and new claims on existing products (including consumer versions of former prescription products, ie., "switched" products); and,
  • CHP Canada emphasizes that post-market evaluation of products must be evidence-based and actions must depend on the nature, the seriousness and the frequency of the adverse reaction, as well as on the intended use of the health product, the benefit obtained from its use versus the risks and the availability of alternative therapies.

CHP Canada Success to Date:

  • Consumer Health Products Canada has provided evidence-based guidance on consumer health products and self-care to governments and healthcare organizations for more than 110 years.
  • CHP Canada's 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), including Good Manufacturing Practices, site and product licensing requirements, adverse reaction reporting, etc.
  • CHP Canada developed voluntary guidelines for a labelling program for significant changes to products, as well as for providing product information to poison control centres.
  • CHP Canada's voluntary initiatives for labelling of non-medicinal ingredients, and tamper-evident features for packaging were incorporated into regulations.
  • 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 is also providing Health Canada with its expertise on the components that would be necessary in a new regulatory framework for over-the-counter medications, including such things as innovation incentives for the consumer health products industry.
  • The Association is developing a research and policy paper outlining the benefits to consumers and the Canadian healthcare system of supporting innovation in switch initiatives.