Canada's Patented Medicine Notice of Compliance regulations: balancing the scales or tipping them?
Bibliographic record
Abstract
BACKGROUND: In order to comply with the provisions of the North American Free Trade Agreement, in 1993 the Canadian federal government introduced the Patented Medicine Notice of Compliance Linkage Regulations. These regulations were meant to achieve a balance between the timely entry of generic medicines and the rights of patent holders. The regulations tied the regulatory approval of generic medicines to the patent status of the original brand-name product. DISCUSSION: Since their introduction the regulations have been a source of contention between the generic and the brand-name industry. While the regulations have generated a considerable amount of work for the Federal Court of Canada both sides dispute the interpretation of the "win rate" in the court cases. Similarly, there is no agreement on whether multiple patents on single drugs represent a legitimate activity by the brand-name industry or an "evergreening" tactic. The generic industry's position is that the regulations are being abused leading to the delay in the introduction of lower cost generic products by as much as 8 years. The brand-name companies counter that the regulations are necessary because injunctions against the introduction of generic products are frequently unavailable to them. The regulations were amended in 2006 and again in 2008 but both sides continue to claim that the regulations favour the other party. The battle around the regulations also has an international dimension with interventions by PhRMA, the trade association representing the United States based multinational companies, arguing that the regulations are not stringent enough and that Canada needs to be placed on the U.S. Priority Watch List of countries. Finally, there are multiple costs to Canadian society as a result of the NOC regulations. SUMMARY: Despite the rhetoric there has been almost no empiric academic research done into the effect of the regulations. In order to develop rational policy in this area a number of key research questions have been formulated.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.022 | 0.054 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.017 | 0.015 |
| Scholarly communication | 0.019 | 0.006 |
| Open science | 0.005 | 0.003 |
| Research integrity | 0.024 | 0.016 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".