ARCHIVED - Food and Drugs Act Liaison Office (FDALO) - Report on Activities (March 2008 - March 2010)

Health Canada
2010

Executive Summary

Over the past two years, the Food and Drugs Act Liaison Office (FDALO) has:

• given a voice to stakeholders who have had difficulty being heard by the department;
• helped staff build competencies in better managing difficult relations with stakeholders;
• promoted openness and transparency in the regulatory process; and
• provided feedback on trends to contribute to the continuous business improvement of regulatory processes under the Food and Drugs Act.

This report presents an overview of FDALO's activities during its first two years in operation and sets out key objectives for the way forward.

Table of Contents

• Mandate of the Food and Drugs Act Liaison Office
• Background
• Number of Cases
• Geographic Origin of Cases
• Nature of Issues
• Referrals in Information Seeking Cases
• Work Units Involved in Complaints Cases
• Sample Cases
  • Marketing to High Risk Groups Without a Licence (Policy Issues)
  • Recall of a Seasonal Product (Communications and Procedural Issues)
  • Adverse Reaction to a Therapeutic Product (Policy Issues)
  • Product Stopped at the Border (Communications Issues)
  • Overwhelmed by a Recall (Interpersonal and Procedural Issues)
  • Inter-directorate Facilitations (Communications Issues)
• Who has been using Our Services?
• What Stakeholders Told Us They Want
• Our Role in Strengthening Departmental Response to Stakeholder Concerns
• Improving Our Services to External Stakeholders
• The Way Ahead
• Conclusion

Mandate of the Food and Drugs Act Liaison Office

To receive complaints, concerns or enquiries about alleged acts, omissions, improprieties and/or broader systemic problems on matters pertaining to the Food and Drugs Act, and to listen, offer options, facilitate resolution, make recommendations or otherwise examine the issues impartially.

Background

• The Food and Drugs Act Liaison Office (FDALO) was officially launched in March 2008.
• It is part of the Public Affairs, Consultation and Communications Branch (PACCB) of Health Canada.
• The role of the Office is to act as a neutral and impartial resource to help resolve disputes, preferably in the early stages, between regulatory staff and stakeholders using alternative dispute resolution processes.
• It promotes openness and transparency in the regulatory process and provides feedback to Health Canada senior management on trends and patterns in complaints to assist with the continuous improvement of the regulatory process.

Number of Cases

From March 2008 - March 2010, the Food and Drugs Act Liaison Office opened 346 cases and closed 329 of them; 17 cases remained active. FDALO has also met its service standard of responding to enquiries within 1 business day in 93.1% of the cases.

Geographic Origin of Cases

The following pie chart details the geographic origin of cases received. The 73 cases marked "unknown" capture individuals who contacted us via email or phone, but did not disclose their location.

Nature of Issues

The following table details the types of cases that have been received by the Food and Drugs Act Liaison Office. The analysis includes 329 closed cases. Our cases can be generally divided into two categories: Information Seeking cases and Complaint Cases. Information-Seeking seeking cases generally involve the stakeholder being unable to locate a policy or contact person and counts for 76% of our cases. Complaints cases, or cases that require FDALO intervention according to our core services of mediation, facilitation and coaching represents 24% of our cases.

We have also divided the cases in each category according to 5 general themes that we have observed. Those themes are communication issues, interpersonal issues, procedural issues, policy issues and general questions about our office.

Note: A case can fall into more than one category and/or theme.

Since September 2009, we are getting fewer "information seeking cases" and more "complaints cases" and we are attributing this, in part, to the fact that we have updated our web site to contain information and links to commonly used resources, notably Canada Vigilance and Health Canada General Information line, Canadian Food Inspection Agency (CFIA) and the Inspectorate.

Table: Nature of Issues for Closed Cases

Referrals in Information Seeking Cases

The following pie chart details the work units to which we referred individuals seeking information or a contact person within Health Canada. A single case may have been referred to more than one work unit.

Work Units Involved in Complaints Cases

The following pie chart details which work units were involved in resolving complaint cases. These are cases that required FDALO intervention according to our core services of mediation, facilitation and coaching. A single case may have involved more than one work unit.

Sample Cases

Marketing to High Risk Groups Without a Licence (Policy Issues)

Scenario

• An importer began marketing a natural health product to pregnant women before receiving a licence for the product.
• Health Canada's Inspectorate asked the importer to stop selling the product and conduct a warehouse-level recall. The importer complied.
• The importer was not aware that he could not market to "high-risk groups" before obtaining a licence for this natural health product.

Resolution

• Our Office provided a third-party perspective for the importer, and while he still could not market his product without a licence, he felt that his concerns were understood.
• He asked if FDALO could expedite his licence application, and accepted when he was told it couldn't as it would be unfair to other companies in the licensing queue.
• Our Office spoke to the industry association that the importer belonged to. It agreed to promote this particular provision of the law to its members so that others would avoid a similar fate.
• The importer considered his options, including returning the imported product.

Recall of a Seasonal Product (Communications and Procedural Issues)

Scenario

• A business owner came to FDALO after Health Canada requested that he stop sale of his seasonal product.
• He was concerned that the time frame for obtaining permission to sell the product would cause him to miss a key deadline and would jeopardize his business.
• The business owner was very upset and felt that his only option was to make a public appeal to escalate the issue.
• His Member of Parliament's office referred him to FDALO for assistance.

Resolution

• Working one-on-one with the business owner, the FDALO advisor helped him identify various constructive options for resolving the issue.
• With support from our Office, the business owner was able to successfully communicate directly with Health Canada and resolve the issue to his satisfaction.

Adverse Reaction to a Therapeutic Product (Policy Issues)

Scenario

• An individual had an adverse reaction to a therapeutic product. She was concerned about reporting mechanisms to capture such information and wanted to ensure that a similar incident did not happen to another person. This complex issue involved several levels of government and jurisdictions.

Resolution

• The FDALO advisor worked one-on-one with the individual to identify the key issues for her. The advisor also contacted the relevant officials at Health Canada for clarification.
• Once the issues were clearly defined, the individual was able to get the information that she was seeking from Health Canada. She learned that the department was already making the changes that were important to her.
• Our Office was also able to help the individual identify and follow-up with the other jurisdictions involved in this case, which helped diminish her frustration that "Health Canada was not doing anything to help."
• The person was pleased with the intervention and the fact that Health Canada was already addressing her concerns.

Product Stopped at the Border (Communications Issues)

Scenario

• A citizen tried to import a therapeutic product for personal use when Health Canada denied entry of the product into the country.
• Health Canada originally informed him that he would soon receive written notification of the status of the shipment.
• He waited several weeks without receiving any further communication from the department and was becoming anxious about the money he had paid for the product.
• He did not know where to turn for assistance until he found FDALO on the Health Canada Web site.

Resolution

• With the citizen's permission, FDALO contacted a Health Canada regional representative to obtain information about the file.
• We received clarification that the citizen's product had been seized, along with many others suspected of being counterfeit products. The volume of seizures was causing a delay in communicating with all the affected parties.
• The citizen appreciated being informed of the cause of the delays and, with the information, decided to obtain a reimbursement from the credit card company he had used to purchase the product.

Overwhelmed by a Recall (Interpersonal and Procedural Issues)

Scenario

• A Health Canada inspector requested that a business stop the sale of a product, based on information, including a third-party complaint, that the product posed a risk to health. The inspector asked the business owner to provide further information about the product.
• The business owner felt mistreated by how the situation was handled and was preparing to take legal action against the department.

Resolution

• FDALO obtained the perspectives of both the business owner and the Health Canada inspector and worked with both parties to clarify expectations and negotiate mutually acceptable time frames for the business owner to provide further information to the department.
• Once these expectations were clarified, the business owner felt that she would be able to meet the reporting requirements. She felt empowered and that her concerns were now being taken into consideration by Health Canada.
• The inspector appreciated being informed of the issue and being able to work directly with the business owner to resolve the issue before it escalated.

Inter-directorate Facilitations (Communications Issues)

Scenario

• Following a FDALO presentation, some Health Canada employees invited our Office to facilitate a preparatory meeting for staff from 3 different directorates.
• They were experiencing difficulty in coordinating and prioritizing an issue important to a stakeholder association that they were going to meet with in a few weeks. The stakeholder was becoming frustrated at the apparent lack of coordination on the issue within Health Canada. The staff from the 3 directorates wanted to arrive at a unified approach to address the issue.

Resolution

• FDALO staff facilitated an inter-directorate meeting and provided procedural leadership allowing the staff to identify solutions that addressed the complexity of the issue and to arrive at a unified approach.
• The staff from the 3 directorates communicated their individual concerns, suggested potential contributions, and made commitments to have tasks completed in time for the stakeholder meeting.
• The staff reported being ready for the meeting and that the stakeholder association was pleased with the meeting's outcome.

Who has been using Our Services?

Regulated parties who can be described as individuals or small businesses are the majority of users of the Food and Drugs Act Liaison Office's services.

Some examples include the following:

• Stakeholders with concerns related to natural health products and compliance and enforcement issues.
• Small companies who run into difficulty with the regulatory process due to a lack of knowledge or understanding (for example, importers, exporters, manufacturers, retailers).
• Parties who are not familiar with the department's structure or with the law and regulations, and who find it difficult to manoeuvre through the system without assistance (for example, citizens whose imported products are stopped at the border).
• Employees requesting assistance in trying out new or different approaches to managing difficult stakeholder relations.

What Stakeholders Told Us They Want

Our systemic analysis of FDALO cases has allowed us to provide Health Canada with the following feedback from the stakeholders' perspective. Stakeholders have expressed that they want:

• More timely responses to their concerns and complaints.
• Easier access to Health Canada information or personnel.
• To be respectfully educated on their regulatory responsibilities in a way that allows them to comply.
• A forum to voice their concerns or disagreements and feel like their perspective has been heard.
• To understand the rationale for evidence-based decisions.
• A clear understanding of how and by whom their objection to a decision will be reviewed (transparency in reconsideration processes).
• Assurance of fair and consistent application of the regulations across directorates and regions (predictability in their dealings with Health Canada).
• Consultation processes that are open and transparent and reflect input from stakeholders.

Our Role in Strengthening Departmental Response to Stakeholder Concerns

Reporting

• FDALO reports on trends and systemic issues for senior management consideration and further action.

Training

• We enhance staff competencies in effectively managing stakeholder relations through case management assistance and training.

Consultation with Staff on Difficult or Complex Files

• Facilitate intradepartmental meetings on "hot issues" and lessons learned.
• Serve as a resource for staff who manage challenging stakeholder situations--provide assistance with letter writing, clarifying issues and so on.

Program Integration

• Work with Health Canada's various regulatory work units to streamline case management approaches.

Improving Our Services to External Stakeholders

To ensure FDALO services are accessible, we have:

• revised all our communications materials to make them more user-friendly and to clarify our services.
• conducted outreach with departmental staff across the country and various stakeholder associations.
• updated our Web site--we now appear on Health Canada's main page under "How to get involved."

The Way Ahead

Over the next year FDALO's work objectives are the following:

• Continue outreach to a broader segment of stakeholders.
• Roll out stakeholder relations training across the department.
• Work to improve and strengthen complaints resolution processes with Health Canada's regulatory branches.
• Formalize our operating procedures so that they can be shared with Health Canada staff and stakeholders.
• Continue to offer feedback to Health Canada on issues of importance to stakeholders to allow for system-wide improvements.

Conclusion

The first 2 years of operation have been very active, with many lessons learned that will guide future decisions.

Our neutral and impartial perspective has allowed us to assist close to 350 stakeholders in navigating the regulatory system, and to resolve issues between Health Canada and its Food and Drugs Act stakeholders.

Our key contribution will be to offer feedback to the department that will contribute to system-wide improvements for all stakeholders, small and large, thereby improving openness, transparency and accountability in the regulatory system.

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