Author: Pinky Mazumder
From September 28th to October 28th 2017, the Therapeutic Products Directorate (TPD) of Health Canada held an online consultation on five proposed initiatives to promote in the approval process for prescription pharmaceuticals. Although majority of responses were from the drug and medical device industry (37 out of 52 responses), the consultation also received responses from health professionals and patient groups (15 out of 52 responses). The following article summarizes the responses to the consultation on the proposals for drug product transparency.
Proposal 1 - “Publishing a summary document that would explain Health Canada’s decision for certain prescription generic drug submissions”
Majority of respondents agreed that a summary decision for second person submissions should be available. Many respondents also thought that it would be useful to be provided with Health Canada’s evaluation of the data submitted and “all relevant information” relating to the approval or rejection of the submission. Industry respondents believed that this information would further their business interests by increasing their understanding of the relevant regulatory requirements. Non-industry respondents also deemed such information to be useful as it would better inform and educate the public on generic drug products.
Proposal 2 – “Publishing a list of submission for prescription generic drugs that have been submitted to Health Canada for review”
Nearly all respondents indicated that a list of generic product submissions would be useful as it would help the industry plan for drug shortages and provide competitive intelligence. Non-industry respondents said that this may better inform patients and physicians about potential treatment options. However, majority of industry respondents also agreed that disclosure of the submission of a generic drug product just before market authorization would not provide the sponsor with enough time to adjust forecasts. A few respondents also said that such transparency would disclose the competitive landscape.
Proposal 3 – “Expanding the scope of the current Regulatory Decision Summary initiative to include approved submissions for new routes of administration, dosage forms and strengths”
Many of the industry respondents and non-industry respondents did not align in their opinion of this proposal. Nearly half of industry respondents did not find this proposal to be useful as such product information would already be disclosed in the Product Monograph whereas some industry respondents also said that such information about competitors would help plan business decisions. On the other hand, 100% of non-industry respondents found this proposal to be helpful.
Proposal 4 – “Adding company (sponsor) name to entries on the Submission Under Review (SUR) List”
Majority of industry respondents agreed that adding the sponsor name to the list would assist regulatory intelligence however a few respondents also noted that this may serve as a disadvantage to their own strategic marketing position as it may disclose pipeline information. However, majority of non-industry respondents agreed that this proposal would be useful and would help them directly contact sponsors for product availability information.
Proposal 5 – “Adding the submission ‘class’ to entries on the SUR list”
Both the majority of the industry and non-industry respondents agreed that this would be an useful initiative as it would provide the industry with regulatory intelligence information. However, many industry respondents mentioned that disclosure of the submission class would not serve any benefit for the public. On the other hand, non-industry respondents said that this information could provide knowledge of additional treatment options and could lead to better patient care. It should also be noted that many industry respondents suggested that such transparency initiatives should apply to both generic and innovator drug products.
For more information on the responses to the consultation on the proposals for Prescription Drug Transparency, please see the Health Canada report cited in the Reference section below.
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Reference
Health Canada What We Heard – Proposals for prescription drug transparency https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/what-we-heard-proposals-prescription-drug-transparency.html