STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM SWEDISH MEDICAL PRODUCT AGENCY (MPA) NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHAREDBYTHE UNITED STATES FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA) is authorized under 21 C.F.R. § 20.891 to disclose non-public information to Swedish MPA regarding FDA-regulated drugs, including pre- and post-market activities, as appropriate, as part of cooperative law enforcement or cooperative regulatory activities. FDA is further authorized under section 708(c) of the Federal Food, Drug, and Cosmetic Act2 to share with a foreign government, as it deems appropriate and under limited circumstances, certain types of trade secret information.
The Commissioner of Food and Drugs has certified MPA as having the authority and demonstrated ability to protect trade secret information from disclosure. FDA therefore may provide MPA with certain types of trade secret information at FDA’s discretion and upon request by MPA, based on the following certifications.
MPA understands that some of the information it receives from FDA may include non-public information exempt from public disclosure, such as commercially confidential information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. MPA understands that this non-public information is shared in confidence and that it is critical that MPA maintains the confidentiality of exchanged non-public information. Public disclosure of exchanged non-public information by MPA could seriously jeopardize any further scientific and regulatory interactions between MPA and FDA and thus disclosure may jeopardize Sweden’s relations and cooperation with FDA. FDA will advise MPA of the non-public status of the information at the time that the information is shared.
Therefore, MPA certifies that it:
- has the authority to protect from public disclosure such non-public information provided to MPA in confidence by FDA;
- will protect the non-public information in accordance with Swedish laws as well as the policies and procedures permitted by those laws, including relying on any relevant provision or provisions in Sweden’s Public Access of Information and Secrecy Act that would protect FDA-provided non-public information in the event that such information is requested;
- will not publicly disclose such FDA-provided non-public information without the written authorization of the owner of the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from FDA providing that the information no longer has non-public status unless public disclosure is required pursuant to the Swedish law;
- will protect trade secret information that FDA may provide from disclosure unless and until MPA is in possession of a written permission for disclosure by the sponsor of the information provided by FDA, or alternatively of a declaration from the Commissioner of Food and Drugs of a public health emergency under section 319 of the Public Health Service Act that is relevant to the information unless public disclosure is required pursuant to the Swedish law;
- with respect to trade secret information concerning the inspection of a drug facility, has the authority to otherwise obtain such information and will use such FDA-provided information only for civil, administrative regulatory purposes in the context of its mission;
- will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from MPA. If such judicial or legislative mandate requires disclosure of FDA-provided non-public information, MPA will take all appropriate legal measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and
- will promptly inform FDA of any changes to the MPA’s laws, or to any relevant policies or procedures, that would affect MPA’s ability to honor the commitments in this document.
MPA understands that FDA-provided information may come to it from the European Medicines Agency (EMA) and/or the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) as a result of the Cooperation Agreement between EMA and the EU Member States Regulatory Authorities. MPA will protect such FDA-provided non-public information from public disclosure to the same extent that it will protect non-public information provided to it directly by FDA.
This confidentiality commitment is not intended to create any legal obligations of any nature, either in domestic or international law.
The alterations and amendments to this confidentiality commitment shall be made by mutual consent of the parties in writing. This commitment will become effective upon FDA's signing of a similar commitment and will remain effective until cancelled by MPA or FDA upon 30 days written notice. In the unlikely event that this confidentiality commitment is cancelled, MPA will continue to protect any FDA-provided non-public information under the terms of this confidentiality commitment.
Signed on behalf of MPA
Catarina Andersson Forsman
Dag Hammarskjölds Väg 42
751 03 Uppsala, Sweden 02
1 - United States Code of Federal Regulations, Title 21, section 20.89.
2 - United States Code, Title 21, section 379(c).