What We Heard - Proposals for prescription drug transparency
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Introduction
This report presents a summary of responses to the Therapeutic Products Directorate's consultation on proposals for prescription drug transparency. The consultation was held online between September 28 and October 28, 2017.
The purpose of the consultation was to seek input on five proposals related to drug product transparency initiatives. The consultation was open to the public, health organizations, industry, and other interested stakeholders.
The input received will inform the work that Health Canada is doing to update and expand its current transparency initiatives. The first two proposals are designed to improve transparency of generic drug submissions (Abbreviated New Drug Submissions, or ANDSs). The other three proposals relate to changes to existing transparency initiatives for drug submissions.
The consultation document explained each of the five proposals and respondents were asked to respond to specific questions related to each one. The proposals included:
- Publishing a summary document that would explain Health Canada's decision for certain prescription generic drug submissions;
- Publishing a list of submissions for prescription generic drugs that have been submitted to Health Canada for review;
- Expanding the scope of the current Regulatory Decision Summary (RDS) initiative to include approved submissions for new routes of administration, dosage forms and strengths;
- Adding company (sponsor) names to entries on the Submissions Under Review (SUR) List; and
- Adding the submission 'class' to entries on the SUR List.
Who provided feedback?
In total, Health Canada received 52 responses to the consultation document. Of the 52 respondents, 37 were from industry, which includes pharmaceutical, biotechnology and medical devices companies, as well as industry associations and other; and 15 were from non-industry which includes health professionals, patient groups/associations, provinces, the general public and other.
Qualitative descriptors such as "majority", "many", "several", "some", and "few" have been used throughout the report to describe the stakeholders' comments.
What did stakeholders say?
Proposal 1 - Publishing a summary document that would explain Health Canada's decision for certain prescription generic drug submissions
Overall, 90% of respondents said that summaries of decisions on prescription generic drug submissions would be useful. This proposal was seen as useful by 92% of industry and 87% of non-industry respondents.
For which submissions, or for what types of decisions would this information be useful? Specifically, what information would be useful to you, within such a summary?
Industry
- The majority of those that responded said decision summaries should be written for all ANDS (generic submissions) for positive and negative decisions including cancellations and withdrawals.
- Almost half of those that responded said it would be useful to have "all relevant information" regarding the rationale for Health Canada's decision to approve or reject a generic drug submission. Several also mentioned it would be useful to have Health Canada's evaluation of the data submitted.
- A few respondents indicated that information about submissions that are out of the ordinary would be useful. A few respondents also provided examples of the type of information that Health Canada could include in the summary document (e.g. justification for using a foreign reference product, decision making that uses information from other jurisdictions, decisions for complex dosage forms, and decisions that deviate from published guidance). A few respondents stated that it would be useful to know when the active ingredient is not identical to the reference product.
- A few respondents also suggested that Health Canada explain which studies are done with the reference product and which are done with the generic product.
- In addition, several respondents stated that the information disclosed should be consistent with the transparency requirements of the Protecting Canadians from Unsafe Drugs Act and should be the same for all products addressed by this Act.
Non-Industry
- The majority that responded said decision summaries should be written for all generic submissions for positive and negative decisions.
- Several respondents stated that a summary of the rationale for Health Canada's decision to approve or reject a generic drug submission would be useful as well as information regarding whether the generic product was the same as the reference product.
- A few respondents stated that it would be useful to understand ways in which the generic product was different to the reference product (e.g. inactive ingredients, formulation or labeling).
How would you use this information if Health Canada began providing it? Please explain why this information would not be useful to you.
Industry
- Several respondents described how the summaries would help their business interests (e.g. predictability of the Canadian market, inform business decisions/strategies, provide a competitive advantage, product development).
- Several others indicated that the information could help to improve submission quality through better understanding of regulatory requirements, what is considered in the review and the type of studies or data needed.
- Several respondents said that transparency in the form of a decision summary would allow health care bodies/industries to better anticipate and manage drug shortages.
- A few respondents said that summaries of decisions for prescription generic drug submissions would not be useful to them (e.g. decision making regarding treatment options does not involve identifying other companies that sell the same product).
Non-Industry
- Several respondents said that the information could be used to inform or educate patients and families, either by patients themselves or by patient groups and health professionals. For example, the information would enable an understanding of all available information about a prescribed product. It could also assist in making informed decisions when switching from a brand drug to a generic, improve treatment compliance and monitoring, and help explain why a generic is or is not available in Canada.
- A few mentioned other ways they would use the information (e.g. advocate for patients, inform their policy work and funding decisions).
What is the potential impact of this transparency measure on you or your organization? Please provide any additional feedback you have about this proposal.
Industry
- Nearly half of those that responded said the proposal would provide knowledge or understanding of Health Canada's process and requirements regarding the basis of approval and decision making for generic drugs.
- Many of those that responded said this initiative should be implemented in order to align transparency of generic product submissions with those of innovator products.
- Several respondents said the impact would be minimal or none.
- Several respondents said that creating decision summaries for generic submissions could negatively affect their business interests. For example the proposed initiative:
- Could be detrimental to, or have a significant negative impact on, competitiveness (with associated financial and/or legal implications) by revealing business strategies;
- Provides an opportunity for competitors to have information that would allow them to develop and register the same product or create negative promotional activities; and
- Could affect the reputation of a company.
- A few respondents mentioned that the impact would be a better ability to plan business decisions.
- A few respondents said that depending on what information was part of the decision summary document, there could be concerns about confidential business information or trade secrets.
Non-Industry
- The majority of those that responded said the proposed measure would give them a better understanding or awareness of Health Canada decisions and processes for generic drugs.
- Several respondents said the information would allow them to better advocate on behalf of their patients.
Proposal 2 - Publishing a list of submissions for prescription generic drugs that have been submitted to Health Canada for review
Overall, 96% of respondents said that if Health Canada began publishing a list of submissions for prescription generic drugs that have been submitted to Health Canada for review, this would be useful to them. This proposal was seen as useful by 95% of industry and 100% of non-industry respondents.
If Health Canada began sharing information as described above for generic submissions (ANDSs) before market authorization would this information be useful to you? If not, please explain why this information would not be useful to you.
Industry
- The majority of those that responded said the information would be useful in determining the availability of a drug and upcoming treatments in a given therapeutic area. It would also allow for better planning for drug shortages.
- The majority of those that responded also said that transparency related to the filing of generic submissions would provide competitive intelligence, could influence strategic decisions on filing, and would help innovator companies plan for the impact of generics on their branded products.
- Some respondents indicated that the information would be useful to consumers and provinces in terms of making them aware of potential options for treatment.
Non-Industry
- Several respondents said that the information would allow better advocacy decisions and would inform patient groups, physicians and patients about potential new/additional treatment options.
When would this information be more useful to you? Why?
Industry
- The majority of those that responded said the information that would be most useful is when a submission is accepted into review.
- The majority of those that responded also stated that generics should be subject to the same transparency requirements as innovative products. Furthermore, they indicated that the transparency of the submission when accepted into review in combination with the transparency of the Patent List and patent expiry dates is important and relevant information for stakeholders.
- Many of those that responded also said the information would be helpful in preparing for the impact of the generic drug on a branded product and in better anticipating and managing drug shortages.
- A few respondents stated that the information, while helpful to competitors, would be disadvantageous to the sponsor of the submission. The information would offer visibility and greater predictability of the market landscape for a product thus facilitating business decisions and planning based on market share.
Non-Industry
- The majority of those that responded said that the information would be useful when a submission is accepted into review. A slightly lesser number of respondents indicated that the information would be useful when the submission is close to being approved or rejected by Health Canada.
- A few respondents mentioned that the information would facilitate timely advocacy on behalf of patients.
What is the potential impact of this transparency measure on you or your organization? Are those impacts different depending on the timing of the release of the information? Please provide any additional feedback you have about this proposal.
Industry
- The majority of those that responded indicated that the timing of the release of information is important. Disclosure just prior to final approval would not allow sufficient time to adjust forecasts and avoid a drug shortage or the unnecessary destruction of stock.
- Many of those that responded said there was no direct positive or negative impact related to the proposal. However the proposal would align requirements for innovator and generic manufacturers.
- A few respondents mentioned that the information would disclose the competitive landscape and may impact business decisions and planning for filing of new products.
- In terms of additional feedback, the majority of those that responded stated that transparency initiatives should be applicable to all therapeutic products, generic and innovator, to allow healthcare professionals and patients to make fully informed decisions regarding treatments. Furthermore, many that responded said that all generics under review should be included.
Non-Industry
- A few respondents mentioned that the proposed measure would provide useful information regarding treatment options that may be cheaper.
Proposal 3 - Expanding the scope of the current Regulatory Decision Summary (RDS) initiative to include approved submissions for new routes of administration, dosage forms and strengths
Overall, 65% of respondents said that expanding the scope of RDSs to include approved submissions for new routes of administration, dosage forms and strengths, as described in the consultation document would be useful to them. This proposal was seen as useful by 51% of Industry and 100% of non-Industry respondents.
How would you use this information if Health Canada began providing it? Please explain why this information would not be useful to you.
Industry
- A slight majority of those that responded said an expanded scope to include new routes of administration and new dosage forms would be useful as it would help to evaluate market potential and establish regulatory strategies. However, many also stated that this information is already currently available in the Product Monograph and that additional disclosures would further increase resource needs at Health Canada for little public benefit.
- Many of those that responded stated that the most relevant information is why a drug was approved or why a submission was rejected or cancelled.
Non-Industry
- The majority of those that responded said the information would be useful to inform decisions on treatment/therapies for patients and inform patients on the availability of therapies.
- A few respondents commented that the information would be useful to inform new routes of administration that are better suited to a patient's need.
What is the potential impact of this transparency measure on you or your organization? Please provide any additional feedback you have about this proposal.
Industry
- Many of those that responded commented on the impact of disclosure requirements on Health Canada resources and questioned the value of the additional transparency measures.
- Some respondents mentioned that the information provided on competitors would be useful for business decisions and planning.
- A few respondents indicated the impact to their organization would be limited or minimal.
- In terms of additional feedback, many of those that responded said the proposal would have very little added value from a patient safety perspective.
Non-Industry
- Many of those that responded said the information would lead to better informed patients and health care providers as well as better options for patients.
Proposal 4 - Adding company (sponsor) name to entries on the Submission Under Review (SUR) List
Overall, 73% of respondents said adding the company (sponsor) name to entries on the current Submissions Under Review List would be useful to them. This proposal was seen as useful by 70% of Industry and 79% of non-Industry respondents.
How would you use this information if Health Canada began providing it? Please explain why this information would not be useful to you.
Industry
- The majority of those that responded indicated they would use the information to provide insight on competitors' regulatory activities and to inform business decisions and planning.
- Some of those that responded stated that the information would not provide added value.
- A few respondents said the addition of the company information would be disadvantageous to their strategic positioning in the market place.
- A few respondents mentioned that in many cases the information is already publically available via an internet search.
Non-Industry
- Some respondents said the information would give them the ability to contact a company directly for information concerning product availability and access programs.
What is the potential impact of this transparency measure on you or your organization? Please provide any additional feedback you have about this proposal.
Industry
- Many of those that responded mentioned that this transparency measure would provide information about the submissions that competitors have filed and would facilitate better planning. Conversely this would also reveal pipeline information to competitors.
- Some respondents commented that this transparency measure could increase direct calls to companies for investigational products that are currently under review and could impact resourcing in companies.
- Additional comments provided by respondents included:
- Many of those that responded made the general comment that transparency requirements should be applicable to generic and innovator therapeutic products. They also indicated that the information provided by the expansion of this existing transparency initiative would provide very little public benefit from the perspective of drug safety.
- A few respondents expressed concern given potential cost/resources requirements and recommended an assessment of the impact/value of this proposal prior to expansion.
Non-Industry
- Comments received from respondents regarding this question were varied. Feedback received included:
- Support for the transparency measure as it would make advocacy decisions more informed, allow assessment as to whether patients will have access to new drugs, and facilitate proactively contacting companies with questions surrounding product pipelines. By adding this information it would also promote accountability through transparency.
- It would be useful to add additional information such as target disease and indication, as well as dosage form and route of administration.
Proposal 5 - Adding the submission 'class' to entries on the SUR List
Overall, 86% of respondents said that the addition of submission 'class' to entries on the current Submissions Under Review List would be useful to them. This proposal was seen as useful by 84% of Industry and 93% of non-Industry respondents.
How would you use this information if Health Canada began providing it? Please explain why this information would not be useful to you.
Industry
- The majority of those that responded said the information would provide regulatory intelligence and competitive information.
- A few respondents said that the information is not useful and does not provide additional value, particularly to the general public due to the complexity of submission types.
- A few respondents indicated that the information would be useful to understand what types of submissions/treatments are filed for less common submission types i.e. submissions filed under the Notice of Compliance with Conditions (NOC/c) and Submissions Relying on Third Party Data guidance documents.
- A few respondents commented that the information would increase awareness to treatment timelines and could impact business decisions regarding demand planning and the marketing of products.
Non-Industry
- Many of those that responded said this information would aid in advancing decision making options for patient care (e.g. availability and approximate timing of availability of product).
- A few respondents were interested in knowing more about extraordinary use, priority review and NOC/c submissions for treatment options, as well as additional guidance to health care practitioners.
What is the potential impact of this transparency measure on you or your organization? Please provide any additional feedback you have about this proposal.
Industry
- The majority of those that responded said the disclosure of this information would provide more knowledge to competitors. For example, regulatory insight into another organization's pipeline and development strategies which in turn may impact product planning.
- Some respondents said the information would be useful for the marketing of products which have a demand, as well as for providing knowledge on how companies file drug submissions for specific molecules (i.e. Submissions Relying on Third Party Data).
- Additional comments included:
- Many of those that responded made the general comment that transparency requirements should be applicable to generic and innovator therapeutic products. They also indicated that the information provided by the expansion of this transparency initiative would provide very little public benefit from the perspective of drug safety.
- A few respondents expressed concern given potential cost/resources requirements and recommended an assessment of the impact/value of this proposal and existing transparency initiatives prior to expansion.
Non-Industry
- A few respondents said that having early awareness of products that are being reviewed by Health Canada could lead to better patient care.
Next steps
We would like to thank all respondents for providing comments on these proposals. Feedback received will inform recommendations for next steps. Interested parties and stakeholders will be informed via a posting to the Government of Canada website as to the next steps for each of the five proposals (including implementation details, where applicable) in Spring 2018. You can follow the What's New - Drug Products page for more information.