Letter from Irish Medicines Board to Health Canada with respect to the sharing of confidential information

Exchange of Letters constituting an arrangement between the Irish Medicines Board and the Health Products and Food Branch of Health Canada and the Healthy Environments and Consumer Safety Branch of Health Canada with respect to the sharing of confidential information

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Ms. Meena Ballantyne
Assistant Deputy Minister
Health Products and Food Branch, Health Canada
5th Floor, Graham Spry Building, 250 Lanark Avenue
Ottawa, Ontario
K1A 0K9

Mr. Paul Glover
Assistant Deputy Minister
Healthy Environments and Consumer Safety Branch, Health Canada
6th Floor, 269 Laurier Avenue West
Ottawa, Ontario
K1A 0K9

Dear Ms. Ballantyne and Mr. Glover:

The Irish Medicines Board (IMB) and the Health Products and Food Branch (HPFB) of Health Canada, along with the Healthy Environments and Consumer Safety Branch (HECSB) of Health Canada, as the respective authorities involved with and responsible for the regulation of therapeutic products and consumer safety in Ireland and Canada (hereinafter referred to as "the Participants"), have recognized the need to enhance their relationship with increased cooperation, by means of an exchange of letters (the "Arrangement"), in respect of the sharing of confidential information. The purpose of this arrangement is to:

1. Recognize that each Participant has jurisdiction over specific products and defines those products differently. Collaboration under this Arrangement is intended to cover all products regulated by, and common to, the Participants and to permit meaningful collaboration between them. This may include, but is not limited to, medicinal products and medical devices.
2. Strengthen communication between the Participants and enhance their ability to protect and promote the health and safety of their respective populations in carrying out their respective mandates.
3. Facilitate increased and accelerated access to safe, effective and high quality products as well as provide improved regulatory performance and safety as a result of the involvement of the best regulatory expertise from both countries.

This arrangement will not compromise the regulatory authority of either Participant to carry out their respective responsibilities, nor does it create legally binding obligations on either Participant or between them to share information with each other.

Each Participant understands that information exchanged between them may include confidential information that is not in the public domain in the country of the Participant providing the information. Participants will advise one another of the confidential status of the information at the time it is shared. As such, each Participant understands this information will be shared in confidence, and will be shared in accordance with the laws as well as the policies and procedures permitted by those laws applicable to the respective Participant. Each Participant will make every reasonable effort to prevent:

1. the public release of confidential information that has been shared for the purposes set out in this Arrangement; and
2. any other release of this information for purposes not set out in this Arrangement.

The Participants understand that confidential information may be shared with, or used by, the other Participant, or shared with the third parties set out in the next paragraph below without the prior written consent of the individual or entity to whom the information relates so long as this relates to the purposes contemplated in this Arrangement and such disclosure or use is in accordance with the laws as well as the policies and procedures permitted by those laws applicable to the respective Participant.

The Participants understand that information provided by one Participant to the other may be shared with that Participant's employees, agents or contractors who:

1. Require the information solely for work purposes in respect of this Arrangement,
2. Will only use that information for purposes contemplated by this Arrangement.
3. Will have a legally enforceable obligation, such as, but not limited to, an employment contract, an agency agreement, confidentiality contract or other document that permits those persons to use the information for the purposes of this Arrangement and requires them to protect the confidentiality of the information in accordance with the laws that are applicable to the Participant who receives the information.

The Participants will consult with each other on each occasion where there is a request for public disclosure or disclosure to third parties other than those set out in the preceding paragraph of confidential information received from either Participant.

Each Participant will make all reasonable efforts to inform the other of any effort made pursuant to a judicial, legislative or other authority to obtain confidential information that has been provided by one Participant to the other Participant. If public disclosure is required pursuant to such authority, the other Participant will make all reasonable efforts to ensure that the information is disclosed in a manner that protects the information from any subsequent disclosure that is not authorized by the judicial, legislative or other authority.
Each Participant will make all reasonable efforts to inform the other Participant of any changes to their respective laws, policies or procedures that may affect their treatment of confidential information obtained from the other Participant.

Each Participant will protect the confidentiality of information in accordance with their respective laws as well as the policies and procedures permitted by those laws. The Participants consider it crucial to the sustainability of this Arrangement and future cooperation that confidential information shared between their respective agencies or branches be protected according to the respective laws from unauthorized use and disclosure.

The Participants will make their request for information to designated officers responsible for the administration of this Arrangement within their own agency or branch. The Participants designate the following as their respective contact point for matters relating to this Arrangement: (a) for HPFB of Health Canada, the Director of International Affairs of the Policy, Planning and International Affairs Directorate; (b) for HECSB of Health Canada, the Director of Consumer and Clinical Radiation Protection Bureau, and (c) for IMB, the Director of Finance and Corporate Affairs.

This Arrangement will become effective at the date of the exchange of letters. The Participants may amend this Arrangement at any time, in writing, upon their mutual consent. Either Participant may terminate this Arrangement by giving a written 30 days notice to the other Participant. Upon termination of this Arrangement, the Participants will continue to protect confidential information from unauthorized disclosure and use in accordance with their respective laws as well as the practices and procedures permitted by those laws.

We look forward to adopting this Arrangement and for allowing the sharing of confidential information and continued cooperation between IMB and HPFB and HECSB, in the best interests of public health.

Yours sincerely,

Pat O' Mahony,
Chief Executive,
Irish Medicines Board

Oct 14 2010