On March 24, 2009 Health Canada issued the finalized version of the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations (the “Guidance Document”). A draft version of the Guidance Document was initially released on June 25, 2007.
The Guidance Document does not reference Health Canada’s recently proposed regime for subsequent entry biologics, which was announced on March 27, 2009 and is presently subject to a 60-day comment period. Health Canada’s proposed draft guidance document for subsequent entry biologics was discussed in a March 31, 2009 Pharma in brief.
HEALTH CANADA GUIDANCE DOCUMENT ON DATA PROTECTION - KEY PROVISIONS:
The Guidance Document is only applicable to qualifying innovative drugs that received an NOC on or after June 17, 2006. The Guidance is substantially similar to the draft version circulated in 2007, but does seek to clarify the eligibility of innovative drugs, including combination drugs, the marketing status of innovative drugs, as well as Health Canada’s general review process. The key provisions are outlined below:
- New and significant data capable of supporting a grant of data protection is characterized as “those clinical trials which provide the evidence to determine the efficacy, properties and conditions of use of the drug (eg. Pivotal trials)”.
- Drugs containing variants of a medicinal ingredient approved on the basis of comparative studies against drugs which have already been approved, are not eligible for data protection.
- Where the significance of a clinical trial is in question, the Office of Patented Medicines and Liaison (“OPML”) will consult with the relevant review bureau.
- In a new section on combination drugs, where at least one ingredient is an innovative drug for which a data protection term is still in effect, examples are provided to clarify data protection eligibility for combination drugs.
- Manufacturers applying for data protection now also have the option of submitting their supporting information in section 1.2.4 – Patent Information in Module 1 of the NDS as per the Guidance for Industry: Preparation of New Drug Submissions in the CTD format .
- Data protection applications for combination drugs, where at least one drug is an innovative drug, must state whether data protection for the innovative drug should be applied to the combination product.
- The OPML will notify manufacturers in writing that qualification for data protection is being assessed. The results of assessments will be entered into the Therapeutic Product Directorate’s Drug Submission Tracking System, which can be accessed by the manufacturer.
- The marketing status of the DIN of innovative drugs will be confirmed by consulting the Drug Product Database maintained by Health Canada.
- Where marketing status is questionable, the manufacturer will be contacted in writing and given ten days to provide proof of marketing status in Canada.
- Data protection will continue to be provided when there has been a newly-issued DIN due to a change in manufacturer for so long as the drug continues to be marketed by the new manufacturer. The new manufacturer should inform the OPML as soon as possible regarding change in manufacturer status.
- An innovative drug that is re-introduced to the market will receive data protection from any subsequent entry submissions for the remainder of the original data protection term.
- If the OPML determines that marketing requirements for an innovative drug have not been met, a subsequent manufacturer will be allowed to file its submission and obtain an NOC, even if the innovative drug is subsequently marketed again under its term of data protection.
- Sponsors may discuss the suitability of pediatric clinical trials for obtaining the six month extension by contacting the appropriate review bureau as per the Guidance for Industry: Management of Drug Submissions.
- The Sample Pediatric Study Evaluation Checklist, originally found in the draft version of the Guidance Document, has been omitted in the finalized version of the Guidance Document.
- Inquiries regarding a particular listing on the Register of Innovative Drugs should be sent to the OPML. The OPML will attempt to respond to all inquiries within 30 days of receipt.
- Inquiries to the OPML on the listing of an innovative drug will be confirmed to both the originator of the inquiry and the innovative company of the drug in question.
- Inquiries of this nature cannot be marked as ‘confidential’.
- The OPML will provide the results of the assessment to both parties and will provide 30 days to each party to make representations.
- The Guidance Document is effective as of March 30, 2009.
CHALLENGE TO DATA PROTECTION REGULATIONS IS ONGOING:
The constitutional validity of the October 5, 2006 amendments to the data protection provisions in the Food and Drug Regulations is being challenged by Apotex Inc. and the Canadian Generic Pharmaceutical Association in judicial review applications before the Federal Court. Eli Lilly Canada Inc. and Canada’s Research-Based Pharmaceutical Companies were granted leave to intervene in these proceedings. In December 2008, Mr. Justice Mandamin heard both challenges to the data protection regime and reserved his decision. To date, no decision has been rendered.
LINK TO THE GUIDANCE DOCUMENT: