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Summary Basis of Decision Phase II: Posting of the Summary Report of External Consultations

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May 7, 2012

Our file number: 12-107151-457

Notice

The Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) are pleased to announce the release of the Summary Report of External Consultations on Phase II of the Summary Basis of Decision (SBD) project.

The SBD initiative was developed to increase the transparency of the drug and medical device regulatory review processes and to provide Canadians with improved access to information about authorized products. Phase I of the project was launched on January 1, 2005 with the publication of Notice of Decision and Summary Basis of Decision documents for new drug submissions for new active substances and a subset of class IV medical devices. An evaluation of Phase I of the project was conducted in 2008/2009 and the results were published in January 2010.

Following the evaluation, revisions were proposed for Phase II of the SBD project to reflect stakeholder comments. Consultation with stakeholders regarding these proposed changes took place at a meeting in Ottawa on November 3, 2011 and through an online consultation on the Health Canada website from October 19 to December 19, 2011. The consultations solicited feedback on demonstration versions of SBDs which illustrated the proposed revisions and on respondents' use of SBD documents.

The consultation report contains a summary of input obtained through the face to face and online consultations. Health Canada is reviewing feedback obtained and intends to launch Phase II in the summer of 2012. Prior to the launch of Phase II, a notice will be posted on the Health Canada website to advise stakeholders.

Questions or concerns related to the consultation report should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca

Table of Contents

1. Executive Summary

1.1 Face to Face Consultation

The following paragraphs provide a brief summary of the half-day face to face meeting held by the Therapeutic Products Directorate (TPD) on November 3, 2011.

  • A large proportion of stakeholders indicated that they had used the Phase I Summary Basis of Decision (SBD) documents.
  • Stakeholders responded positively to three examples of Phase II SBD web-based documents. The consensus seemed to be that the Phase II SBD represents an improvement in both transparency and usability.
  • Much discussion revolved around the proposed post-authorisation/post-licensing activity (PAA/PLA) tables and the stated intention to publish negative decisions in the table.
  • Discussion also took place regarding the language of the SBD documents and the intended target audience as well as the need to improve the visibility of the documents through education campaigns and other measures.
  • Although there was little variance across the range of responses, attendees indicated that publishing SBDs more quickly and expanding the number of products for which SBDs are published were the most important priorities for the future. Stakeholders also indicated that SBD coverage in the future should be prioritized to products with the highest potential risk as well as products intended for children.

1.2 On-line Consultation

The following paragraphs provide a brief summary of the on-line consultation through the Health Canada website from October 19 to December 19 2011.

  • Overall, there was support for a greater degree of transparency in the federal drug and device regulatory processes and for the information presented in the SBDs.
  • Stakeholders varied in their perspective regarding the level of usefulness of the information in the SBDs; many felt that more information, particularly regarding clinical trials, is necessary.
  • The proposed publication of negative decisions and withdrawals for subsequent submissions for products with market authorization received both support and criticism. Some supporters felt it was long overdue whereas some critics felt it was without regulatory support.
  • The level of language and intended audience were also continued themes; many respondents indicated that summaries in plain language would be helpful to further the use of the documents.

2. Introduction

This report provides a summary of consultations with external stakeholders regarding changes proposed for Phase II of the Summary Basis of Decision (SBD) Project. Input was gathered through a half-day consultation meeting with invited stakeholders held by the Health Products and Food Branch (HPFB) in Ottawa on November 3, 2011 and an on-line consultation conducted on the Health Canada website between October 19 and December 19 2011.

3. Background on the SBD Project

Before drug products or medical devices are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and its related Regulations.

The SBD project was initiated in 2003 as part of the transparency agenda of the Therapeutic Access Strategy. The Health Product and Food Branch is responsible for the review of drug products (pharmaceutical and biological) and medical devices; within the Branch, the Therapeutic Products Directorate (TPD) is responsible for implementing the SBD project. When instituted, the intent of the project was two-fold:

  • To increase the transparency of the drug and medical device regulatory review processes; and
  • To provide Canadians with improved access to information about authorized products.

Summary Basis of Decision documents:

  • outline the scientific and benefit/risk-based reasons for Health Canada's decision to authorize the sale of a product;
  • include regulatory, safety, effectiveness and quality (chemistry and manufacturing) considerations;
  • are targeted to informed consumers and health professionals interested in the basis for Health Canada's product-specific decisions for drugs and medical devices; and
  • reflect information available to the regulator at the time of authorization.

The key objectives of the SBD project were to provide a timely rationale as to why a product was approved, in a factual and objective manner and with a standardized format. In preparing the documents, Health Canada intended to provide as much information as possible about the scientific and regulatory reasons for the decision, while respecting the boundaries of confidential and/or proprietary information.

The SBD project was intended to operate with a phased approach and in 2005, after an in-depth consultation with stakeholders, Phase I was launched. At that time, the decision was made to publish SBD documents for all approved new drug submissions (NDS) for new active substances (NAS), (which included pharmaceutical and biologic drugs) and for a subset of class IV medical devices (those which have the highest risk).

The process to create SBD documents was in two steps: once a qualifying product was approved, technical writers worked to quickly draft a 'Notice of Decision' (ND) from the review information. The ND functioned as a short executive summary to provide overview information about why the product was approved. The goal was to post the information on Health Canada's website within six weeks of approval. The second step was to create the SBD document, which provides more detailed information about the benefit/risk assessment of the quality, safety and efficacy of the product in the context of the approval decision, and includes the information from the ND. The goal was to publish the SBD within five months of approval.

4. Phase II Proposals

In 2008, an evaluation of Phase I of the project was undertaken with internal and external components. Health Products and Food Branch staff involved in the drafting and publication of SBDs (including technical writers, reviewers, managers, etc.) were consulted for their feedback on the internal process to create SBD documents. A questionnaire (e-mailed to key stakeholders) and an online workbook on the Health Canada website solicited feedback from those outside government. Analysis of the results took place in 2009 and an evaluation report was published on the Health Canada website in January 2010. Feedback from stakeholders was generally positive and indicated a continued need for transparency in the decision making process but also pointed out that the SBDs lacked visibility on the Health Canada website and were not available until long after a product was approved.

As a result of the information obtain in the evaluation of Phase I, the Health Products and Food Branch reviewed the project and the Therapeutic Products Directorate (TPD)Footnote 1 developed a proposal for changes in Phase II. These changes include:

  • Streamlining existing SBD information, with an increased focus on the risk/benefit analysis that led to authorization of the product;
  • Eliminating the Notice of Decision as a separate document;
  • Reformatting the SBD to make it more user-friendly and web-based in a question and answer format;
  • Including a post-authorization/post-licensing activity (PAA/PLA) table (for drugs or devices respectively) that describes decisions issued by Health Canada after the initial authorization of the product. Proposed for inclusion in this table are submissions or applications for new uses for the product that were rejected, withdrawn or cancelled, in the interests of promoting safe use of the product; and
  • Adding subsequent entry biologic products (SEBs) to the scope of the SBD project.

5. Objectives and Approach

5.1 Objectives of the External Consultation

The changes proposed for Phase II were the subject of internal consultation within Health Products and Food Branch; specifically, feedback was solicited regarding the intention to revise and streamline the SBD documents and the plan to publish a post-authorisation activity /post-licensing activity table (the PAAT/PLAT). Once internal support was obtained, an external consultation was planned in order to get feedback from a variety of stakeholders regarding the proposed changes for Phase II.

The consultation was intended to explore:

  • Current and anticipated use of SBD documents;
  • Reactions to SBD Phase II proposals, including potential improvements to content and format; and
  • Priorities for future efforts.

To illustrate the changes proposed for Phase II, three SBD documents (one each for a drug, a biologic, and a medical device) were revised to reflect the new format.

5.2 The Approach

This consultation comprised two components. The first was a face to face meeting with key stakeholders held in Ottawa on November 3 2011. The second was an on-line consultation which took place between October 19 and December 19 2011. Each approach is explained in the following sections.

5.2.1 Face to Face Consultation

In early September, key stakeholders were sent email invitations to attend a half-day meeting to discuss the proposed changes to the SBD project for Phase II. Stakeholders were selected from the pharmaceutical, biologics and medical device representative industry groups, from national health organizations and patient groups with specialization in key illnesses and/or interest in the regulatory process, from researchers in the health product field and from health professionals and their association groups. Over 25 invitations were sent out with a final attendance number of 12 people, several of whom had participated in a previous consultation regarding the SBD project. The 12 attendees included representatives from industry groups, health and consumer organizations, academic researchers and health professionals.

The session was structured as follows (please see the Agenda in Appendix A):

  • Participants were given a presentation which included the history of the SBD Project including a summary of phase I, the evaluation and analysis that led to the phase II proposals.
  • An outline of the changes proposed for Phase II was demonstrated along with one of the revised SBDs so that participants could experience the changes as they would appear on the Health Canada website.
  • A facilitated session followed where participant opinions regarding the restructuring of the documents and streamlining of the context were solicited, along with their perspective on publishing information about subsequent submissions for approved health products, including where the decision on the subsequent submission was negative.
  • The participants were also canvassed regarding their perspective on potential future steps for the SBD project, including the publishing of information on negative decisions for health projects and the expansion of the scope of the SBD project to include other types of health products (such as generic drugs).

5.2.2 On-line Consultation

On October 19 2011, the three revised SBDs showcasing the proposed new format for Phase II were published on the Health Canada website along with a feedback document with five questions soliciting respondent feedback on the proposed changes (see Appendix B for questions). An additional question asking respondents to self-identify from a list of stakeholder groups was also included. The questions could be completed and submitted online, or via fax or mail.

A notice about the online consultation was sent out to a list of over 200 stakeholders via email and was also circulated by some of the attendees at the face to face meeting to their members. The notice and the website both indicated that the online consultation would accept responses from October 19 to December 19, 2011.

Twenty-nine responses were received during the on-line consultation period. Of the 29 received, one was blank except for the self-identification question and another was a compilation of 14 responses.

Table of responses received during the on-line consultation period
Stakeholder Type Number of submissions

Table 1 footnotes

Table 1 footnote 1

One respondent self-identified as part of a consumer/patient coalition and as an academic/researcher but was counted as the first group.

Return to table 1 footnote A referrer

Drug or Biologic Submission Sponsor / Industry Association 10
Concerned Citizen 2
Academic/ResearcherTable 1 footnote A 2
Medical Device Manufacturer 2
Healthcare Professional 14
Patient 1
Public Interest Group 2
Provincial Government 1
Other  
Health Charity 2
Patient Advocate 1
Consultant 1
Patient/consumer coalition 1
Trade Associations 2
Health Technology Assessment Organisation 1
Total responses 29
Total number of respondents 41

6. Results of Face to Face Consultation

6.1 Initial Reaction to Phase II Sample Documents

After the presentation of the proposed changes for Phase II and a walk-through of one of the revised SBD documents, stakeholders were asked to comment on the revisions and on their use of the current SBD documents (from Phase I). Those stakeholders (slightly more than half the 12 attendees) who indicated that they use the current documents stated that they were used primarily for risk information and details about clinical trials. Those who did not use the documents said they were unaware they were available, that they were hard to find on the Health Canada website and/or that the documents were not available soon enough after the product was approved. However, those who had been previously unaware of the SBD documents indicated that they did intend to use them now that they knew of their availability and location on the Health Canada website.

Reception to the demonstration of the revised SBD documents was generally positive. Meeting attendees stated that the reorganization of the documents into question and answer format and increased web functionality were improvements over the Phase I documents. Some concern was expressed regarding the following areas:

  1. Content: Some stakeholders indicated that the revised documents still did not contain enough detailed information about clinical trials including study participants, results and harms to truly allow consumers and health care providers to make informed choices. Information about pivotal studies and number needed to treat were also identified as important to include.
  2. Language: Stakeholders also had questions about the target audience for the documents since the language level was viewed as being technical and a barrier for some consumers. Other stakeholders indicated that in their view, they could act as intermediaries for consumers by using the information contained in the documents and conveying it in a simpler format.
  3. Releasing information about negative decisions: Some stakeholders were adamant that Health Canada did not have the regulatory authority to release any information about submissions which had negative decisions or were withdrawn during the submission process. These stakeholders questioned Health Canada's proposed publication of this information in the PAA and PLA tables and responded negatively to the stated intention of doing so to provide additional safety information for products which are currently on the market and may be used in ways other than those authorized.

Additionally, stakeholders asked for three immediate clarifications:

  1. There were questions regarding the frequency with which the SBDs will be updated to reflect the most recent activity on a particular product. Stakeholders want to be certain that the SBDs will be reliable sources of current information. In response, Health Canada indicated that, while regular updates are the intended approach, discussion was ongoing as to how the documents (notably the PAA and/or PLA tables) would be updated and new information included. However, new additions to the document would be indicated by date added so that users would be able to determine how recently an SBD had been updated.
  2. The type of information to be included in the proposed PAA/PLA tables was also a source of discussion. The proposals included specific examples of types of submissions/applications and decisions on which Health Canada was soliciting feedback such as Supplemental New Drug Submissions (SNDS) or amendments for new indications, fulfillment of conditions for products approved under the Guidance Document: Notice of Compliance with Conditions (NOC/c) etc. Participants were asked for their input as to the types of information which would most be of use to them.
  3. Following the concern about publishing information about negative decisions, industry representatives wanted to know if Health Canada planned to implement publishing information in the PAA/PLA tables prior to any changes through the regulatory modernization process. When informed that the intention was to include the PAA/PLA tables as part of Phase II with implementation planned for mid-2012, industry representatives indicated that this was unacceptable in their view. Their concerns included the commercial interests of companies to protect sensitive business information, that companies might be harmed if the public found out about rejected submissions and that publishing confidential commercial information might discourage companies from seeking market authorization in Canada. This sparked a lively debate among the group as stakeholders representing consumer interests and researchers suggested that information about the safety of products currently marketed in Canada should be made available to the public since there was no other way for Canadians to obtain this information. Some attendees provided actual examples of situations where harm had been caused as a result of the failure to share information considered 'confidential'. As part of the discussion, Health Canada indicated that for products currently on the market in Canada, providing information about subsequent submissions, including negative decisions, was within Health Canada's mandate to protect public safety through the regulatory process.

Much of the discussion related to the last point involved themes such as the balance of confidentiality and public safety, the potential harms to industry and the potential public safety benefits from publishing information about negative decisions and the reality of the off-label use of health products. No resolution was achieved between opposite points of view, however some participants indicated that education for the public about the risks of drug products might be an area which would benefit Canadians.

There were a number of other questions raised by the demonstration for Phase II:

  • Will over-the-counter medications (OTCs) be covered by SBDs? Health Canada indicated they will continue to be, if they are captured within the subset of SBD-eligible products [for example (e.g.) a new drug submission for a new active substance]. There are currently SBDs posted for OTC products under the Phase I project.
  • What will occur in the event that a prescription drug is switched to OTC status in the future? Health Canada responded that currently this situation is not within the scope of SBD-eligible products but it could be considered in the future.
  • Will existing SBDs be updated to reflect the Phase II Format? No, the intention is to implement Phase II for new submissions after a pre-determined date.
  • Would PAA/PLA tables be published for existing SBDs? As indicated, the intention is to implement Phase II for submissions authorized after the Phase II implementation date and the PAA/PLA would only be published for those products.
  • Will the SBD include information from foreign sources? Health Canada indicated that if the product authorization was at all based on the use of a foreign review, this fact will be captured in the SBD (as is currently the case in Phase I).
  • Will users be able to subscribe to an SBD and be subsequently informed automatically in the event of a change? Health Canada said that they were looking into the potential to use RSS feeds as a way of advising of the posting of new SBDs but the operational details of how to include updates to SBDs (such as in the case of the PAA table) had not been discussed.

6.2 Phase II SBD: Suggested Improvements

Participants were next solicited for their opinion regarding potential improvements to the Phase II SBD content and format and offered a number of suggestions.

Some stakeholders proposed that the SBDs should be written to be accessible to non-technical readers such as patients and consumers. This could include drafting companion documents in plain language, such as a summary, glossary or explanation of clinical trial concepts. This view was not unanimous, however, as other stakeholders countered that the SBD should be targeted primarily at health care providers and/or informed consumers (such as patient advocates) who would act as interpreters and advisors for patients and consumers. From this perspective, the SBDs should remain a detailed scientific document. In this context, Health Canada staff indicated that Part III of the Product Monograph (PM) contained information in a language targeted for most consumers and most participants agreed that ideally, the SBD should link directly to the PM. A further recommendation was that key information - approval status and approved indications should be prioritized within the SBD document. Some suggested that the SBD should avoid generalities and provide very clear statements. This includes specific percentages related to mortality and side effects/toxicity, and detailed information on the parameters of clinical trials used to support a new drug submission (e.g. eligibility criteria), especially when that information is not available elsewhere. Some of this information is available in the other sections of the PM (not Part III) and when advised of this fact, one participant indicated that in his view, the SBDs did not need to contain this level of detail if the information was readily available in the PM.

With regard to information sources, stakeholders said that information must be actively promoted if it is to be useful. Drawing on the example above of the PM, they noted that Part 3 of the PM, while carefully constructed for consumer use, is not generally distributed with prescription medications which are not in original packaging. This reinforced the suggestion that the SBD and PM documents be linked on the Health Canada website and precipitated another suggestion that Health Canada work with stakeholders (such as the Canadian Pharmacists Association's Therapeutics initiative or the Canadian Society of Hospital Pharmacists website) to encourage them to link with the SBD documents. Other stakeholders suggested that research is needed into how patients and health care providers use and understand about health products and specifically the type of information presented in the SBDs.

Health Canada was urged to undertake education efforts to help consumers understand the concept of risk with regard to medications so that they can make the best use of information contained in the product monograph and the Summary Basis of Decision.

6.3 Future Priorities

Within the context of limited resources at Health Canada, stakeholders were asked to prioritize four options for the future of the SBD initiative:

  • Expanding the number of products for which SBDs are published.
  • Expanding the types of decisions for which SBDs are issued.
  • Providing greater depth of information in SBDS, for the current scope of decisions/products.
  • Providing the same information as current SBDs, but in a more timely manner.

When stakeholders ranked these four options from one to four numerically, two options were slightly more favoured: providing information more quickly and expanding the number of products for which the SBDs are produced. Providing greater depth of information in the SBDs for the current scope and expanding the types of decisions covered by SBDs were slightly lower priorities respectively, however the range between the four choices was minimal. In expanding on their priorities for action, several participants affirmed that the priority for SBDs should be the most serious illnesses, products with the highest risks, and products authorized for use in children.

7. Results of On-line Consultation

As discussed under Approach, stakeholders were engaged by Health Canada online through the publication of three modified Phase II SBD documents, sample PAA/PAL tables, and a questionnaire containing five questions

  1. SBD documents explain how Health Canada came to a decision to authorize certain drugs and medical devices for sale. The documents include regulatory, safety, efficacy and quality considerations. Does the information as presented help you to understand how Health Canada came to a decision regarding a drug or medical device?
  2. For the first time, Health Canada proposes publishing a post-authorization activity table (PAA) for drugs and a post-licensing activity table (PLA) for medical devices, to accompany the SBDs. This table would include summaries of decisions made by Health Canada, following the initial decision to authorize a drug or medical device. Is this information useful?
  3. How will you use the information presented in the SBDs and PAA/PLA tables?
  4. Health Canada is considering expanding the scope of the SBD project in the future, to align with current international practices of publishing information on negative decisions and withdrawals for certain types of drug submissions and medical device applications. Please provide us with your thoughts.
  5. Do you have any other comments on the SBD project?

In addition, stakeholders were asked to select the category "which best describes your perspective" by choosing from a pre-established list as described in section 5.2.

As noted earlier, 29 responses were received during the consultation period from a variety of stakeholder groupsFootnote 2. One response was blank save for the group identification and another represented 14 separate responses which had been compiled into one response. The total number of respondents was therefore 41.

7.1 Question 1: Does the Phase II SBD Explain Health Canada's Decision?

SBD documents explain how Health Canada came to a decision to authorize certain drugs and medical devices for sale. The documents include regulatory, safety, efficacy and quality considerations. Does the information as presented help you to understand how Health Canada came to a decision regarding a drug or medical device?

Overall, there was support for the underlying concept which guides the Phase II SBD, specifically a greater degree of transparency in the federal drug and device regulatory processes and for the information presented in the SBDs. Participants were somewhat divided however regarding the usefulness of the information contained in the proposed Phase II SBD document with some requesting more information and others indicating that the information provided was not useful at all.

Several respondents indicated Health Canada should make a decision about the intended audience for SBDs, and tailor the SBD content accordingly. Respondents were divided over whether SBDs should be produced for the general public (and therefore indicated the language was too technical to be understood) or for a more informed audience (including health care professionals) (and therefore indicated a preference for detail and technical accuracy over plain language text). As in the face to face meeting, several stakeholders explicitly stated that the web-based SBD should be prominently linked to the Product Monograph (PM).

Some stakeholders who supported the SBD project indicated that even with the revised focus on benefit/risk planned for Phase II, additional information would be necessary to make the documents useful to them. Clinical trial results, including pivotal studies and the 'number needed to treat' as well as trials which were inconclusive or terminated early, were described as being critical to the ability to see whether a product would be suitable to recommend to their stakeholders or patients. Post-market requirements of manufacturers were also mentioned as useful to include. Additionally, some stakeholders, including some from industry, stated that they would welcome information about 'why' Health Canada came to their decision about the product including how risks and benefits were compared in order to make a decision.

Some industry stakeholders expressed disappointment that the Phase II does not reach the level of detail contained in the corresponding documents published by the European Union's European Medicines Agency (EMA) or the United States Food and Drug Administration (FDA).

7.2 Question 2: Usefulness of Post-Authorization / Post-Licensing Activity Tables

For the first time, Health Canada proposes publishing a post-authorization activity table (PAA) for drugs and a post-licensing activity table (PLA) for medical devices, to accompany the SBDs. This table would include summaries of decisions made by Health Canada, following the initial decision to authorize a drug or medical device. Is this information useful?

The PAA/PLA tables were generally endorsed by stakeholders as a logical and comprehensible way of presenting information about the lifecycle of a drug or device. The large majority of stakeholders believe the information this table will be useful not only for transparency but also to provide information that may be relevant to off-label prescribing.

The level of detail to be included in the PAA/PLA tables was the subject of many comments. Stakeholders felt that not every detail or event related to a drug product or device should be included in the tables but that the focus should be on including information as close to the time of a decision as possible. Doing so would allow Canadians to have the most accurate and up to date information about products. Some possible types of information suggested by respondents to include would be safety information, fulfillment of conditions for products which are approved with conditions and decisions about subsequent submissions and applications. Other respondents inquired as to whether Risk Management Plans (RMPs) or Periodic Safety Update Reports (PSURs) could be included as part of the PAA/PLA tables.

Many (but not all) industry stakeholders were of the opinion that the proposed PAA/PLA tables include information which Health Canada does not have the regulatory authority to release, specifically related to a submission/application which was rejected, cancelled or withdrawn. They expressed concern that the type of information proposed for publication could place sponsors or their products at a competitive disadvantage. Concern about release of information which they consider to be commercially sensitive was a recurrent theme in the submissions of industry stakeholders. They urged Health Canada to propose the necessary regulatory changes in advance of implementing Phase II of the SBD.

7.3 Question 3: Using the Phase II SBD Activity Tables

How will you use the information presented in the SBDs and PAA/PLA tables?

The potential use of the PAA/PLA tables varied between industry and other stakeholders.

Industry saw two primary uses for the information. The first was as a way to understand the paths that products have taken through the authorization process, the way Health Canada is evaluating products, and the way decisions are made. The second (perhaps related) use was for competitive intelligence.

Among other stakeholders, the most common use anticipated for the PAA/PLA tables was to understand any post-market requirements placed on products including clinical trials, and/or the submission of post-approval safety information. In other words, they expect to use the SBD as a source of information to help patients and health care providers to make good choices and decisions.

Furthermore, the PAA/PLA tables will serve the purpose of demonstrating transparency for stakeholders, so that they can track and evaluate the actions and decisions of Health Canada itself.

Finally, at least one respondent noted that the SBD documents may factor into discussions about coverage for some health products from provincial governments.

7.4 Question 4: Expanding the Scope of the SBD Project

Health Canada is considering expanding the scope of the SBD project in the future, to align with current international practices of publishing information on negative decisions and withdrawals for certain types of drug submissions and medical device applications. Please provide us with your thoughts.

There was considerable input from stakeholders on the question of which decisions should be the subject of SBD and which should not. There is general agreement that SBDs should be published:

  • Following market authorization approval of a new substance new drug submission (NDS), new (or subsequent entry) biologic or new device.
  • Following approval or rejection of market authorization of a supplemental new drug submission (SNDS) which proposed a new indication for a drug which market authorization already exists for another indication. (Appeals of rejections should have been completed first.)
  • Following the withdrawal of a product which received a Notice of Compliance with Conditions (NOC/c).

There is much less unanimity on the publication of SBDs for entirely new drugs and devices which are denied market authorization or are withdrawn by the sponsor before a decision is made by Health Canada. Some stakeholders indicated that while, for transparency reasons, SBDs should be available for products which are submitted but denied approval; they acknowledged that this was perhaps not an immediately attainable goal and that focusing on the timeliness of the current process was critical. Many respondents indicated that the publication of information on all submissions, including those for products which did not make it on the Canadian market because they were withdrawn or denied approval, was long overdue. Other stakeholders suggested that without insight into the new drug submissions which Health Canada rejects, it is difficult to identify what thresholds of risk and benefit the Department is using and whether it is being consistent. Finally, some stakeholders supported the publication of negative decisions as a way to provide patients with more information about the safety and effectiveness of drugs and devices particularly in cases of off-label use and where particular indications may be modified or rejected.

Other stakeholders, in contrast, strongly suggested that the publication of SBDs for such products would serve no purpose because the products in question would not be available to Canadians. As in the face to face consultation, there was also concern expressed about the competitive impact of disclosing information about products which had been rejected but may be resubmitted for authorization at a later date. Some stakeholders expressed concern that information about rejections or withdrawals could taint a product's image and/or provide competitors with critical information. Finally, other respondents again expressed their belief that information about rejected or withdrawn submissions and/or applications was confidential and outside of the scope of Health Canada's regulatory authority to disclose.

7.5 Question 5: Additional Comments

Do you have any other comments on the SBD Project?

When offered the opportunity to provide additional comments, most consultation participants simply restated or emphasized the point made earlier. However, a few new themes emerged, notably:

  • Non-industry stakeholders emphasized the need to publicize and promote the SBD as a resource for patients and health care providers.
  • There is a strong appetite among some non-industry stakeholders for access to detailed clinical trial information.
  • Among medical device manufacturers, some questioned the value of the SBD exercise in their sector, related to the assumption that patients rely on their physicians to choose medical devices on their behalf.

Appendix A: Agenda

Summary Basis of Decision Project Consultation on Proposals for Phase II November 3, 2011
Time Item Presenter
8:30 Welcome
Opening Remarks
Roundtable
Facilitator
Barbara J. Sabourin,
A/Director General,
Therapeutic Products Directorate
8:50 - Background on the Summary Basis of Decision (SBD) Project and overview of changes made to Phase II of the SBD Project
- Demonstration of pilot Phase II documents
Tasha Yovetich, Policy Analyst, Bureau of Policy Science and International Programs
and
Laura Johnson, Project Manager, Office of Business Transformation
9:20 Questions and clarifications on presentations Facilitator
9:30 Moderated discussion regarding proposal: Format, content and use
1) Are you currently accessing SBD information?
2) Will these documents be useful? How so?
3) Would other information on the review process be valuable?
4) What would you do to improve these documents?
5) How does this compare to other information available on the Internet or from other regulators?
All
10:30 Health break
Coffee, Tea
 
10:45 Moderated discussion regarding context and future directions
If Health Canada were in a position to increase its SBD level of effort; should we expend that effort on:
1) an expanded number of products covered?
2) an expanded set of or different types of decisions?
3) going more in depth on our current decisions and products?
4) providing the same information more quickly?
5) In light of Health Canada's limited resource set, what is the relative priority of each of the four options above?
All
11:45 Wrap-up Facilitator

Appendix B: E-Consultation Questions for Summary Basis of Decision (SBD)

  1. SBD documents explain how Health Canada came to a decision to authorize certain drugs and medical devices for sale. The documents include regulatory, safety, efficacy and quality considerations. Does the information as presented help you to understand how Health Canada came to a decision regarding a drug or medical device?
  2. For the first time, Health Canada proposes publishing a post-authorization activity table (PAA) for drugs and a post-licensing activity table (PLA) for medical devices, to accompany the SBDs. This table would include summaries of decisions made by Health Canada, following the initial decision to authorize a drug or medical device. Is this information useful?
  3. How will you use the information presented in the SBDs and PAA/PLA tables?
  4. Health Canada is considering expanding the scope of the SBD project in the future, to align with current international practices of publishing information on negative decisions and withdrawals for certain types of drug submissions and medical device applications. Please provide us with your thoughts.
  5. Do you have any other comments on the SBD Project?
  6. The category that best describes your perspective is:
    1. Federal government official;
    2. Provincial government official;
    3. Drug submission sponsor;
    4. Medical device manufacturer;
    5. Patient;
    6. Healthcare professional;
    7. Public interest group;
    8. Concerned citizen;
    9. Academic/researcher;
    10. Other (please specify).

Footnotes

Footnote 1

Whereas the Therapeutic Products Directorate is responsible for drafting the Summary Basis of Decisions (SBDs), it works closely with the Biologics and Genetic Therapies Directorate (BGTD) and the Medical Devices Bureau reviewers in the preparation of the documents.

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Footnote 2

It is worth noting that at least 4 responses in the online consultation were from participants whose organisation had been present at the face to face meeting and so were taking the opportunity to reaffirm their earlier expressed opinions.

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