What does Modernization mean?

Governments routinely make changes to their regulatory frameworks (legislation and regulation) to address minor issues or to reflect new policy. This approach provides a temporary fix but is not sustainable for the future. Modernization will involve a comprehensive review, with emphasis on work that will deliver the clearest value to Canadians and the health care and food safety systems, as well as greatest efficiency by cutting through unsustainable administrative requirements. Modernizing the health product and food frameworks will result in an efficient, sustainable, transparent and flexible system, including common principles that apply across product lines.

What is Legislation and Regulation?

Legislation refers to laws, called Acts, which are enacted by Parliament, the legislative arm of government. There is also subordinate legislation (for example, Regulations or Rules) where parliament delegates its law-making powers to other bodies. For example, the enabling legislation would state that a minister, an administrative agency or, the Governor in Council (Cabinet) has the power to make regulations.

Regulations are the rules issued by the Governor in Council to carry out the intent of statutes (Acts or legislation) enacted by the Government of Canada. They are instruments of legislative power and have the force of law.

Regulations contain more specific information and requirements than Acts. These can include definitions, licensing requirements, performance specifications, exemptions, forms and other details.

For more information regarding the making of Acts and Regulations in Canada visit the " Guide to Making Federal Acts and Regulations (2001)"

What is the Current Regulatory System for Health Products and Food?

The following statutes and rules provide a framework for Health Canada to regulate health products and food in Canada:

Legislation:

• Food and Drugs Act

Regulations:

• Food and Drug Regulations
• Medical Devices Regulations
• Safety of Cells, Tissues and Organs for Transplantation Regulations
• Natural Health Products Regulations
• Processing and Distribution of Semen for Assisted Conception Regulations
• Blood Regulations

What are the Drivers for Change?

The environment in which Health Canada undertakes its regulatory activities for health products and food is influenced by several key drivers:

• New and emerging science, medicines and technologies
• Globalization
• Emerging public health threats and needs
• Sustainability and appropriateness of the regulatory system
• Need to Support science-based review functions
• International Alignment and Best Practices
• Public demand for greater transparency and openness
• Calls for Patient-Centred Approach and Involvement
• Alignment with Health Care and Food Safety Systems
• Need for Improved Information Systems
• Government initiatives: Regulatory Cooperation Council (RCC) and the Red Tape Reduction Commission (RTRC)

The regulatory frameworks were developed at different points in time, and although some are fairly modern, others are not, and it has become increasingly difficult for Health Canada to respond efficiently and effectively to these drivers. In particular, the Food and Drugs Act and many sections in the Food and Drug Regulations include provisions established in the 1960s. The need to update and revitalize the frameworks has become paramount.

More information regarding current drivers for change for health products may be referenced: "Trends and Drivers".

What are the Objectives for Regulating Health Products and Food?

• Protect the public from sale and advertising of unsafe products
• Support the safe use of products by transparently providing the information needed to help Canadians make informed decisions about their health
• Align lifecycle and regulatory system with health care and food safety systems
• Maintain appropriate and proportional regulatory oversight
• Incorporate international best practices 
• Support science and technology innovation
• Ensure regulatory and operational sustainability and foresight

What is the Plan to Achieve these Objectives?

Developing a Sustainable and Effective Plan

Regulatory Roadmap for Health Products & Food

Health Canada's Roadmap is a strategy to produce a sustainable regulatory future that meets the objectives of protecting the Canadian public from the sale and advertising of unsafe food and health products, and supporting the safest consumption of food and use of health products.

The Roadmap provides the vision to transform nearly a dozen current frameworks for food and health products of various ages and regulatory approaches into an efficient, transparent, and comprehensively aligned regulatory system that contributes directly to the safety of Canadians and the benefits they gain from food and health products.

The three main pieces of the Roadmap describe where we are, where are we going and how we will get there.

What has been accomplished so far?

Initial Development - Progressive Licensing Project

• Recognizing the need to reset the legislative and regulatory framework for drug products, Health Canada initiated the Progressive Licensing Project to assess areas for improvement and consult with relevant stakeholders including industry, end users and the public.

Regulatory Development

• Building on the work and consultations accomplished through the Progressive Licensing Project, Blueprint for Renewal, Technical Discussions, and others, Health Canada is now in a position to proceed with its plan to sequence and prioritize regulatory projects. This is an important task that requires careful consideration and planning, so that the transition from the existing to modernized frameworks will occur seamlessly, with minimal disruption to the regulatory process.

What activities are currently underway?

The regulatory frameworks for health products and food are being updated. Continue to monitor progress and provide your thoughts and insights by signing up to receive updates, and by checking back on consultations underway.