Frequently Asked Questions - Paediatric Expert Advisory Committee

1. What will the Paediatric Expert Advisory Committee do?
2. Why is this Committee needed and how will it improve paediatric health?
3. Why a focus on pregnant and nursing women?
4. How will the Committee's advice be used by Health Canada?
5. What kinds of issues will the Committee provide advice to Health Canada on?
6. Doesn't Health Canada already have this expertise on staff?
7. How does this Committee differ from other external committees Health Canada has established?
8. How did Health Canada seek nominations for the Committee?
9. How were members assessed and how were Paediatric Expert Advisory Committee members selected?
10. Do members of the Paediatric Expert Advisory Committee get paid for their service?
11. What is the process for reappointment?
12. How will Health Canada address potential conflict of interest situations with Committee members?
13. How can I find out more about Paediatric Expert Advisory Committee?

The Paediatric Expert Advisory Committee and its Focus

Q1: What will the Paediatric Expert Advisory Committee do?

The Committee will provide Health Canada with broad strategic advice on children's (aged 0 to 18 years) and maternal health and safety issues related to the regulation of health products and food. Its focus will include health products and food issues affecting pregnant and nursing women as these may impact fetal development or the health of a nursing child.

The Committee will provide a forum for the exchange of information, ideas and opinions between external experts and Health Canada on a range of child and maternal health and safety policy issues, from food and nutrition to drug and vaccine safety and the safety and effectiveness of other health products.

Issues that the Committee will look at will span the health product lifecycle, from the discovery, testing and approval of products to monitoring their safety and effectiveness once they are on the market.

Q2: Why is this Committee needed and how will it improve paediatric health?

It is now understood that children have unique health and safety issues and respond differently than adults to health and food products. Currently, many products are not designed specifically for use in children and may not have sufficient information on the label to guide paediatric use.

Relevant clinical information on how health products and food may affect the health of children, and pregnant and nursing women, is essential to aiding decision-makers who share in the responsibility to protect and promote child health and safety. The Committee will help guide Health Canada on ways forward to close this information gap.

Q3: Why a focus on pregnant and nursing women?

The Committee will include a focus on health products and food issues affecting pregnant and nursing women as these may impact fetal development or the health of a nursing child.

Paediatric Expert Advisory Committee - Impact

Q4: How will the Committee's advice be used by Health Canada?

The Paediatric Expert Advisory Committee will function as an advisory body on broad strategic issues, not a decision-making body. Health Canada will take the Committee's advice into consideration as the Department seeks to advance work on paediatric and maternal issues related to health products and food.

The Committee will report to the Assistant Deputy Minister of the Health Products and Food Branch, which is responsible for the regulation of health products such as pharmaceuticals, medical devices, biologics and natural health products.

Q5: What kinds of issues will the Committee provide advice to Health Canada on?

The Committee will be asked to provide expert advice on broad strategic issues relating to children's and maternal health and safety issues related to health products and food throughout the health product life cycle. These could include:

• how to strengthen and promote paediatric and maternal information related to health products, food and nutrition;
• opportunities within Canada's regulatory framework to encourage safe and ethical paediatric clinical trials;
• partnerships and linkages within Canada and internationally in the field of paediatrics; and
• strengthening post-market surveillance, including how to increase the reporting of adverse reactions.

Q6: Doesn't Health Canada already have this expertise on staff?

Strengthening access to authoritative information to ensure the safety and effectiveness of health products used in children, pregnant and nursing women requires careful thought and collaboration of many partners, including international regulators, provinceritories, industry, health care providers, and consumer and patient groups.

The Committee will allow Health Canada to assemble a varied group of expertise as it seeks to advance work on paediatric and maternal issues related to health products and food.

The membership of the Committee reflects a blend of expertise, knowledge and experience as well as a balance of representation from different sectors including healthcare professionals, patients, consumers, academia and industry.

Q7: How does this Committee differ from other external committees Health Canada has established?

The Paediatric Expert Advisory Committee specifically focuses on broad strategic issues affecting child and maternal health. The Committee will provide advice on issues that fall under the mandate of Health Canada's Health Products and Food Branch, and will not address questions on specific health product or food that are scientific or technical in nature.

Should advice be needed on specific health products or class of products, Committee members may be asked to join a one-time expert committee which would be supplemented with additional scientific expertise. The Paediatric Expert Advisory Committee may also be asked to review and provide paediatric advice to other specialized committees.

Health Canada has established a number of scientific and expert advisory committees to provide advice and recommendations on a range of regulatory and health issues. For more information, please visit the advisory committees established by Health Canada.

Selection process for the Paediatric Expert Advisory Committee

Q8: How did Health Canada seek nominations for the Committee?

Health Canada held a rigorous nomination and selection process for the Committee with the goal of bringing together a diverse group of committed individuals who reflect a balance of representation from different sectors of the Canadian public.

A targeted nomination call letter was sent to approximately 150 organizations and was also posted on the Health Canada Web site. These organizations were chosen based on their areas of paediatric expertise and experience. They were also invited to share the nomination call package widely with others. As well, Health Canada distributed the information through existing stakeholder networks and encouraged the sharing of this information.

Seventy-nine highly qualified nominations were received as a result.

Q9: How were members assessed and how were Paediatric Expert Advisory Committee members selected?

Candidates were required to submit detailed information demonstrating their:

• Expertise and experience relevant to the Committee's mandate;
• Interest in and commitment to children's and maternal health and safety issues related to health products, food and nutrition;
• Expertise and experience with children's age groups: newborn (pre-term and term), infants and toddlers, children, adolescents; and,
• Previous committee experience.

Successful nominees were required to obtain government security clearance and declare their affiliations and interests. The Committee Chair was appointed by the Assistant Deputy Minister, Health Products and Food Branch, and was invited to provide input to the final membership, which was also appointed by the Assistant Deputy Minister.

The Committee's composition reflects a balanced representation from different sectors including healthcare professionals, academics, patients, consumers and industry. Committee membership also aims to reflect a balance of age, gender, people with disabilities, and regional, cultural and official language representation.

Q10: Do members of the Paediatric Expert Advisory Committee get paid for their service?

All members will serve on the Committee on a volunteer basis and receive no remuneration for their service. However, members will be entitled to reimbursement of travel, accommodation, meal and incidental expenses incurred in relation to their attendance at Committee meetings in accordance with the Treasury Board's Travel Directive and Hospitality Policy.

Q11: What is the process for reappointment?

Initial Committee members may serve a three-year term. Membership will be reviewed on a regular basis by the Chair and Executive Secretary. The Assistant Deputy Minister of the Health Products and Food Branch may consider extension(s) to the individual's term to a maximum of six consecutive years. Members who wish to continue for an additional term will be considered at the recommendation of the Chair to the Assistant Deputy Minister of the Health Products and Food Branch based on the quality of their performance.

Q12: How will Health Canada address potential conflict of interest situations with Committee members?

The Committee reports to the Assistant Deputy Minister, Health Products and Food Branch as an advisory body, not a decision-making body. Health Canada will take the Committee's advice into consideration as the Department seeks to advance work on paediatric issues related to health products and food.

Successful candidates for membership were required to complete a statement of affiliations and interests as a condition of serving on the Committee.

In addition, members will be required to submit annual statements of affiliations and interests to the Committee Secretariat. It will be incumbent upon members to update their statements in writing, should their personal situation change.

When the Committee meets, members will be asked to provide information on any relevant affiliations or interests depending on the issue under discussion.

Committee members are also expected to conduct themselves in an appropriate manner and the use of their positions cannot be reasonably construed to be for their private gain or that of any other person, company, or organization.

For more information

Q13: How can I find out more about Paediatric Expert Advisory Committee?

For more information on the Committee and other Health Canada paediatric initiatives, visit Office of Paediatric Initiatives.