Letter from Health Canada to Germany with respect to the sharing of confidential information

Exchange of Letters constituting an arrangement between the Health Products and Food Branch of Health Canada and the Paul-Ehrlich-Institut of Germany with respect to the sharing of confidential information

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Professor Dr. Klaus Cichutek
President
Paul-Ehrlich-Institut
Federal Institute for Vaccines and Biomedicines
Paul-Ehrlich-Str. 51-59
63225 Langen
GERMANY

Dear Dr. Klaus Cichutek:

The Health Products and Food Branch (HPFB) of Health Canada and the Paul-Ehrlich-Institut of Germany, as the respective authorities involved with and responsible for the regulation of therapeutic products and consumer safety in Canada and Germany (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, biological medicinal products.
2. Strengthen communication between the Participants and enhance their ability to protect and promote the health and safety of the populations of their respective countries 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.

The Participants understand that this Arrangement will not compromise their respective responsibilities, nor does it create legally binding obligations on either Participant or between them to share information with each other.

The Participants understand 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. The Participants will advise one another of the confidential status of the information at the time it is shared. As such, the Participants understand this information will be shared in confidence, and will be shared in accordance with the laws of their respective countries as well as the policies and procedures permitted by those laws. The Participants 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 the sharing of confidentiality information relates to the purposes of this Arrangement and such disclosure or use is in accordance with the laws of their respective countries as well as the policies and procedures permitted by those laws.

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 the purposes of 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.

The Participants will make all reasonable efforts to inform each other of any action taken 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 it from any subsequent disclosure that is not authorized by the judicial, legislative or other authority.

The Participants will make all reasonable efforts to inform each other of any changes to the laws, policies or procedures of their respective countries that may affect their treatment of confidential information obtained from the other Participants.

The Participants will protect the confidentiality of information in accordance with the laws of their respective countries 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 them be protected according to the laws of their respective countries from unauthorized use and disclosure.

The Participants will make their request for information to their respective contact points in charge of the administration of this Arrangement. The Participants designate the following as their respective contact point for matters relating to this Arrangement: (a) for HPFB, the Director of International Affairs of the Policy, Planning and International Affairs Directorate and (b) for the Paul-Ehrlich-Institut, the Coordinator of the International Relations.

This Arrangement will become effective at the date of the last letter from one Participant to the other setting out this Arrangement. 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 the laws of their respective countries as well as the practices and procedures permitted by those laws.

We look forward to concluding this Arrangement and for allowing the sharing of confidential information and continued cooperation between HPFB and the Paul-Ehrlich-Institut, in the best interests of public health.

This letter and the letter by the Paul-Ehrlich-Institut will constitute this Arrangement, signed in the English and French languages, each version being equally valid.

Yours sincerely,

Paul Glover
Assistant Deputy Minister
Health Products and Food Branch

May 25 2011