ISP - FDA (English)
STATEMENT OF AUTHORITY
INSTITUTO DE SALUD PÚBLICA DE CHILE
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA), is authorized under 21 C.F.R. § 20.89 (Code of Federal Regulations of the United States related to “Communications with foreign government officials”) to disclose non-public information to Instituto de Salud Pública de Chile (ISP) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
ISP understands that some of the information it receives from FDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. ISP understands that this non-public information is shared in confidence and that FDA considers it critical that ISP maintain the confidentiality of the information. Public disclosure of this information by ISP could seriously jeopardize any further scientific and regulatory interactions between FDA and ISP. FDA will advise ISP of the non-public status of the information at the time that the information is shared.
In Chile, the access to Government Administration information is a right that it is regulated by Law 20,285 of 2008, which establishes that the public function is exercised with transparency, so that it permits and promotes the knowledge of procedures, contents and decisions taken in the exercise of it. Consequently, under the principle of transparency of the public function, acts and resolutions of the organs of state administration, its foundations, the documents that directly and essentially support and supplement them, and the procedures used for their issuance are public. Similarly, the information developed with public funds and all other information held by the organs of government is public, regardless of format, medium, creation date, source, categorization or processing.
Law 20,285 establishes exceptions to disclosure of information held by the State Administration, so that all or part of accurate and specific information can be declared secret or confidential in exceptional cases indicated in the same Law. Pursuant to these exceptions ISP has the right to deny access to non-public information provided to ISP in confidence by FDA.
Therefore, ISP certifies that it:
- has sufficient powers not to disclose non-public information provided in confidence to ISP by FDA to third parties and has the capacity to protect information as undisclosed information in accordance with, Industrial Property Act 19,039 and Decree 107 of 2010, of the Ministry of Health, which provides mechanisms for the protection of "undisclosed" data by ISP;
- has the authority to protect from public disclosure non-public information provided in confidence to ISP by FDA, according to the provisions of Article 21, Law 20,285, which establishes that access to all or part of information may be denied when public access thereto or communication, or knowledge thereof affects the national interest, especially if it relates to public health;
- will not publicly disclose non-public information provided by FDA without prior 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 that the information no longer has non-public status;
- will promptly inform FDA of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from ISP. If such judicial or legislative mandate orders the disclosure of FDA provided non-public information, ISP will take all appropriate legal measures in an effort to guarantee 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 Government of Chile’s laws or regulations, or to any relevant policies or procedures that would affect ISP’s ability to honor the commitments in this document.
Information obtained by ISP from a source other than the FDA is excluded from this Confidentiality Commitment.
This Commitment will take effect when signed by ISP and will continue to be in effect until terminated by ISP on 30 days written notice to the FDA except that all non-public information received by ISP from FDA will continue to be covered by this Commitment.
Signed on behalf of ISP:
________/s/_________ Date: 3/19/2012
Mrs. María Teresa Valenzuela Bravo M.D.
Instituto de Salud Pública de Chile
Av. Marathon 1000, Ñuñoa – Santiago
Casilla 48 Correo 21
Tel: +56 (2) 5755 101
Fax: +56 (2) 575 5667