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Progressive Licensing - Mock Framework Exercises Summary

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Regulatory Planning - May 28, 2007
Standard Licensing - May 29, 2007
Provisional Licensing - May 30, 2007
Post-Licensing - June 11-12, 2007

To ensure that Health Canada is capable of maintaining and enhancing its reputation as a science-based and reliable regulator, the Progressive Licensing Project was initiated to develop a drug regulatory system for the future. The Progressive Licensing Project is an initiative of the Blueprint for Renewal, a long-term policy framework that will help inform the development and implementation of a plan to improve the drug regulatory system.

In developing this framework, Health Canada has been following a pathway of early engagement with key stakeholders from all parts of the healthcare system. As part of the engagement path, Health Canada initiated five days of meetings to explore and test a mock framework with all sectors of the healthcare system, from primary users of the regulations (the Health Canada science review staff and the drug industry), to those impacted by the decisions taken by Health Canada (prescribers, payers, patients, etc.).

The five days of meetings covered the entire life-cycle of regulations: the pre-market development and planning; the licensing decision and entry on to the market; and the post-licensing period when drugs are being used by patients and consumers.

Pre-Licensing Discussions

Two main proposals were advanced and discussed among participants: pre-filing meetings, and life-cycle management plans. With respect to pre-filing meetings, discussions were centered around the types of information that are necessary, the participation at these meetings, the types of meetings (whether for advisory purposes, or binding decisions), and the role of international harmonization.

Discussions concerning the life-cycle management plans touched on their flexibility, the possible workload and resource implications, and accountability and transparency issues. In general, the ideas of good planning around the drug and the regulatory filing were well received.

Licensing

The two days surrounding the licensing decision of the regulator were divided up into a discussion around the standard licence, and a discussion around the possibilities of having a "provisional" licence for drugs quite far outside of the norm.

The discussion on the standard licence touched on a number of various subjects, including the information requirements for a licence, the use of rolling reviews where information could be submitted in batches, the assessment of the benefit-risk profile, and international harmonization. The role of the licence itself (as something that confers a right to sell, versus as a mechanism to convey information) was discussed, and how the licence could communicate information to the public and prescribers. The enforcement of the requirements for a licence was also explored.

The second topic in the licensing section was the idea of a "provisional" licence. Topics raised by participants included the consideration of a committee to review drugs eligible for provisional licensure (what the composition of this committee could be, whether it could include patient groups, whether this was a burden, and how well the committee could examine the acceptability of risk), the data requirements for provisional licensure, whether a provisional licence was a cumbersome process, and the criteria for eligibility of drugs for this process.

Discussed at length was the idea of a provisional licence itself, and the merits of a single pathway process versus a dual pathway, where a separate process exists for approving this subset of exceptional drugs.

Post-licensing

There was general support for the idea of post-market commitments and activities. Some of the issues discussed included the ability to harmonize globally with other regulators, the performance and adherence to post-market activities by generic drug companies, the thresholds of risk, and the collection of information and the parties involved in the collection. The idea of clarification and consistency among the different levels of government was raised, as was the limitations of database studies.

A patient-centered approach was advanced by numerous parties, and a focus on patient health outcomes, not just relating to the post-licensing stage but as an underlying common theme to the entire framework.

Risk Management Plans were discussed, and issues about flexibility in both the requirements and the frequency were raised, as was the possibility of increased regulatory burden brought about by safety reporting to the entire industry. Clarification of roles and responsibilities in the management of risk was highlighted as an area for further work. Pharmacovigilance and risk minimization activities were discussed, and in general there was much support for a system with flexibility. Challenges were brought forward in the reporting of adverse reactions, and the inclusion of patients into the reporting was highlighted.

In discussing risk communications, participants brought forward the need for inclusion of the prescribing community in the framework development. Some other topics relating to communication of risk that were discussed were having consistency between English and French, keeping a focus on the patient, and advisory committees on risk communication (their scope and composition). There was general support for the proposals put forward by Health Canada in the area of post-market activities.

The final topic discussed was the re-evaluation of drugs by the federal regulator at different stages in their life-cycle - concern was voiced over the potential increased resources necessary, and where the information to re-evaluate would come from, and who would be involved. The idea of fixed dates versus flexible dates for both the timing and length of review was discussed, as was the issue of international harmonization of timing.

In general, participants were supportive of the Progressive Licensing Project, and hopeful that the end product would begin to address issues in the present drug regulatory system. There were a few concerns that were expressed by numerous participants at varying times during the five days, which included the potential for increased regulatory burden; the maintenance of focus on the end-users of the system - patients; and the need to ensure that the interaction between the federal authorities and provincial decision makers is well understood.

On the whole, participants were pleased with the organization of the five days and the development process, and the fact that they were being included at an early stage.