Encouraging international trade

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Vision in Brief

Consumer Health Products Canada and its member companies are seeking an environment that supports and encourages international trade and harmonized standards for the consumer health products sector. When this vision is achieved, Canadians will have greater access to new innovations that are occurring around the world in self-care and will enjoy greater assurance of the safety, quality and efficacy of imported consumer health products.

Summary

As is the case in many industries, most of Consumer Health Products Canada's member companies operate on a global level, importing and exporting products around the world. As such, ensuring that Canadian regulatory requirements are aligned with those of our trading partners plays an important role in assuring that Canadian companies have access to foreign markets and that Canadian consumers have access to a wide range of safe and effective consumer health products from around the world.

CHP Canada urges Health Canada to ensure that it applies sound regulatory practices and standards to the consumer health products industry that are aligned, whenever possible, with international norms to facilitate international trade. It also creates a wide variety of efficiencies which will benefit consumers around the world.

The sharing of knowledge on a global scale also opens new opportunities to make advancements in self-care. Canada currently lags behind most of its major trading partners in bringing new and innovative products for self-care to its citizens. Greater support for innovation is needed.

Canada has worked with a number of jurisdictions, most notably the European Union and the United States, to establish mutual cooperation in scientific and regulatory areas. However, the regulatory authorities of Canada's main trading partner, the United States, have not yet been able to agree with Health Canada upon mutual recognition agreements in some areas. This is an impediment to importing and exporting consumer health products between the two countries, which can increase costs and reduce innovation in self-care.

Vision in Detail

Given that most of the Consumer Health Products Canada's companies operate on a global level, ensuring that Canadian regulatory requirements are aligned with those of our trading partners plays an important role in assuring that Canadian companies have access to foreign markets and that Canadian consumers have access to a wide range of safe and effective consumer health products from around the world.

  • Strong relations and dialogue with international counterparts at both the government and the industry levels is important in achieving program objectives in an increasingly complex regulatory world. International involvement is a means of actively:
  • leveraging resources and knowledge;
  • ensuring application of sound regulatory practices and standards which are aligned, whenever possible, with international norms;
  • strengthening and facilitating existing mutual cooperation with international jurisdictions in scientific and regulatory areas;
  • addressing the challenges of globalization, new technologies and timely approval of new medicines; and,
  • assessing potential risks associated with health products marketed in Canada.

Health Canada has a long history of cooperation with its international counterparts and organizations. Its engagements have taken many forms ranging from informal information exchanges to multilateral harmonization initiatives. Through the World Self-Medication Industry, Consumer Health Products Canada and the other associations that represent the consumer health products industry in countries around the world work together to provide expertise to their respective governments to help ensure that regulatory practices and standards are aligned with international norms.

Health Canada and its counterparts in the U.S. and the EU have arrangements in place that allow them to exchange information as part of their regulatory and scientific processes, both before and after a health product has been approved. The potential benefits of this exercise include accelerated access of patients and animals to new and innovative health products as well as resource savings and improved regulatory performance and safety as a result of the involvement of the best regulatory expertise from both sides.

Canada is also a participant to Mutual Recognition Agreements (MRAs), covering drug/medicinal products Good Manufacturing Practices (GMP), with the regulatory authorities of Australia, European Community, New Zealand and Switzerland. This means that each country has assessed the GMPs of each of the other jurisdictions and deemed them to be equivalent. Bottom line: if Health Canada has issued a Canadian company an Establishment License (indicating that it meets Canadian GMPs), then it can more easily export products to other countries with whom Canada has an MRA. This relationship is reciprocal. This significantly reduces redundant testing and regulatory oversight, thereby enabling companies to make consumer health products more quickly available to their consumers and at a significantly lower cost.

Actually, many of CHP Canada's member companies manufacture to a higher standard than is required. CHP Canada pointed out to Health Canada that the MRA specifies that Canadian companies exporting products must have valid Establishment Licenses and the products must have Certificates of Pharmaceutical Product (CPP). When the new Natural Health Products Regulations came into effect, they required companies to hold a Site License with their own GMP requirements. Most of CHP Canada's members were already manufacturing to GMPs for drugs so the Association was able to gain the government's approval to allow NHP companies that either used to hold an Establishment License or still do, to receive Certificates of Pharmaceutical Product for their products enabling them to continue exporting their natural health products to MRA countries.

However, while Canada has made tremendous strides in supporting self-care through its agreements with some of the country's major trading partners, the regulatory authorities of Canada's main trading partner, the United States, have not yet been able to agree upon a mutual recognition agreement for Good Manufacturing Practices with Health Canada. This is an impediment to importing and exporting consumer health products between the two countries, which can increase costs and reduce innovation in self-care.

For all the other advances in support of international trade and efficiencies, Canada is also lagging behind our major trading partners - notably the European Union and the United States - in setting a regulatory climate that rewards innovation in the consumer health products industry. Regulatory barriers and the lack of incentives stifle innovation in this industry. As a result, Canadians do not have access to some of the self-care products that are available in other countries, Canada is missing out on potential economic benefits to the healthcare system, and it is failing to attract R&D investors to Canadian industries.

The Solutions

Health Canada and the U.S. FDA need to set up a mutual recognition agreement for GMPs to facilitate trade between these two major trading partners. Health Canada needs to also ensure that sound regulatory practices and standards are applied consistently and that they are aligned, whenever possible, with international norms to further support trade.

CHP Canada recommends that innovation incentives be put in place for industry innovators as a reward for being leaders in developing new and innovative consumer health products for Canadians.

CHP Canada Success to Date

  • Enabling manufacturers to continue exporting their natural health products to MRA and PIC/s countries by gaining agreement from the Health Products and
  • Food Branch Inspectorate to issue Certificates of Pharmaceutical Product (CPPs) for NHPs manufactured in facilities with Establishment Licenses. (2007)
  • CHP Canada's recommendations concerning a batch certification scheme for drug/medicinal products under the framework of Mutual Recognition Agreements were accepted thereby reducing redundant testing and costs.
  • CHP Canada has had much success in ensuring Health Canada's policies and guidances are aligned with international norms thereby facilitating international trade.

CHP Canada in Action

CHP Canada is encouraging Health Canada and the U.S. FDA to set up a mutual recognition agreement for GMPs to facilitate trade between these two major trading partners.

  • CHP Canada is working collaboratively with Health Canada to ensure that evidence-based decision making is applied when evaluating the activities of regulatory authorities in other jurisdictions.
  • CHP Canada is lobbying Health Canada to include innovation incentives for the consumer health products industry in a modernized consumer health products regulatory framework.
  • 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.