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Scottish Medicines Consortium
Sponsor company attendance at meetings
Information for Sponsor Companies
Introduction
In October 2013, the Scottish Government published its response to the Health and Sport
Committee inquiry into access to new medicines. This recommended that the Scottish
Medicines Consortium (SMC) should:
“…invite the manufacturer of the new medicine under consideration to give evidence at their
main SMC appraisal meeting, in order to address any outstanding questions that SMC
members have and highlight any outstanding issues of which they believe SMC should be
aware prior to its advice being published.”1
The Scottish Medicines Consortium (SMC) will invite sponsor companies to attend SMC
meetings when one of their products is being considered (as a full submission or
resubmission) from November 2014. The applicant company representatives will be
expected to respond to specific queries regarding the submission and be able to provide
clarification on any outstanding issues.
This document outlines:



how the new process will work
timelines for the new process
revised letter templates and registration form for the new process
How will the new process work?
Company representatives will be invited to attend a meeting where a full submission or
resubmission for one of their products is being considered. There is no obligation for the
company to attend and non-attendance will not prejudice the review.
SMC will invite the company to attend SMC committee meetings from November 2014. We
will be able to accommodate a maximum of two company representatives for each medicine
under consideration. The role of the company representatives will be to respond to specific
inquiries and/or comment on any matters of factual accuracy as directed by the SMC Chair.
SMC meetings routinely consider between 5-7 full submissions. Company representatives
will be invited to participate in the meeting at the point where their product is under
discussion. As we are unable to specify timings for individual product discussions in
advance, the company representatives will be invited to sit in the public gallery until the
Chair invites them to participate in the appraisal of their product, returning to the gallery after
their product has been assessed.
NB: Sponsor companies who provide two representatives to attend the meeting will
not be granted additional places in the public gallery.
1
The Availability of New Medicines for Patients in Scotland (April 2013), Prof. Phillip Routledge, p32
In the event of a closed
will normally be asked
they may be asked to
respond to questions
company’s submission.
session being required within the meeting, company representatives
to leave the meeting room although at the discretion of the Chair
remain in the room for this part of the discussion to specifically
from committee members about confidential information in the
Company representatives will sit at the committee table when their submission is under
discussion. There will be a maximum of two representatives from the company who should:
1. Be an employee of, or be acting on behalf of the sponsor company and ideally have
been directly involved in the development of the company’s submission
2. Have detailed knowledge of the product under consideration and be able to engage
effectively with the SMC committee
3. Have a comprehensive understanding of SMC submission and decision making
processes
4. Be able to comment accurately on the product’s
a. Comparative efficacy
b. Comparative safety
c. Clinical effectiveness
d. Cost effectiveness
5. Agree to be bound by the terms and conditions of SMC’s existing confidentiality
policy regarding medicines under assessment.
Company representatives will have the option of leaving the venue at the next natural break
in the agenda (either a closed session or tea break). They will receive a briefing prior to the
SMC meeting and upon arrival at the meeting venue, and may be asked for feedback
following their attendance. A member of SMC staff will be on hand to coordinate all aspects
of the sponsor company’s attendance.
At the time of the SMC meeting the NDC has considered in detail the evidence submitted by
the company and the company has had the opportunity to respond with clarification, further
analysis and comments on any weaknesses identified. SMC will consider NDC’s preliminary
recommendation together with clinical expert opinion, patient group contributions and, where
relevant, the output of a Patient and Clinician Engagement (PACE) meeting. There is no
requirement for members to repeat the detailed discussion held at NDC. The company
response to the NDC preliminary recommendation is included in the meeting papers and
reflected in the presentation given by the SMC team to committee members before the
medicine is discussed.
SMC members will consider NDC’s preliminary recommendation and seek clarification of
any outstanding clinical or cost-effectiveness issues, consider the company response to the
preliminary recommendation and take into account societal issues. The sponsor company
delegates will be invited to respond and provide clarification of any outstanding issues.
Members will vote after the discussion and the recommendation which will subsequently
announced to members only in a closed session at the end of the meeting.
The presence of representatives from the sponsor company provides a further opportunity
for members to raise any outstanding points about the clinical and cost-effectiveness
evidence that they feel the company has not adequately addressed in their submission or in
the company comments after NDC. New evidence from the company is not admissible at
this stage in the process. Company representatives should be aware that there may be no
need for questions, if the submission is straightforward and there are no outstanding issues.
Company representatives will not be participants in the discussion on the
submission. All questions for company representatives should be directed through
the Chair and the company will be invited to respond at the Chair’s discretion.
Members should not ask the company to answer questions that directly refer to
commercial in confidence information, e.g. value of Patient Access Schemes, but they
may ask the company about outstanding issues in relation to the clinical, economic or
budget impact information within the submission or supporting documentation.
SMC members with personal non-specific interests are prohibited from taking part in the
product discussion and vote. Those members with a personal non-specific interest will also
be prohibited from asking the sponsor company questions via the SMC chair.
SMC meeting minutes will contain the names of the companies in attendance, but not the
names of the individuals.
Timeline for companies at meetings
The sponsor company will receive an invitation to attend the SMC meeting within their
scheduling confirmation letter (Appendix 1) which will include the deadline for company
representatives to register for the meeting. Companies should complete and return the
“SMC committee attendance reply form” (Appendix 2) within 7 days of receiving the draft
NDC advice for the medicine under assessment.
Appendix 1: Change to scheduling confirmation letter
Dear
Your submission to the Scottish Medicines Consortium for DRUG has been scheduled for the New
Drugs Committee (NDC) meeting on Tuesday dd Month 2014.
The draft advice from NDC will be emailed to you on Friday dd Month 2014 and submitted to the
Scottish Medicines Consortium (SMC) for a final decision on Tuesday dd Month 2014.* This will
allow you to feedback any comments regarding the draft advice prior to the SMC meeting.
If you have not already confirmed in your submission, please could you keep us informed of the date
on which marketing authorisation is received, and the launch date (or date that the product is made
commercially available to NHS Scotland).
Subject to confirmation of these dates, advice will be issued in confidence to NHS Boards and ADTCs
across Scotland on Friday dd Month 2014 and published on the SMC website on the afternoon of
Monday dd Month 2014. If you have not confirmed that your product will be licensed and launched
prior to Friday dd Month 2014 we will withhold the advice, in confidence, until we receive the
necessary confirmation.
From November 2014, two company representatives may attend the SMC meeting at which your
product will be considered. Please see the attached Information for Sponsor Companies Document
for more information. Company representatives should:
1. Be an employee of the company or be acting on behalf of the company, and ideally have been
directly involved in the development of your submission
2. Have detailed knowledge of the product under consideration and be able to engage effectively
with the SMC committee
3. Have a good understanding of SMC processes
4. Be able to comment accurately on the product’s:
Comparative efficacy
Comparative safety
Clinical effectiveness
Cost effectiveness
5. Agree to be bound by the terms and conditions of SMC’s existing confidentiality policy regarding
medicines under assessment/
If you wish to take up this invitation please complete and return the attached form by Friday dd
Month 2014 to [email protected]
Please note that sponsor companies who provide two representatives to attend the SMC
meeting will not be granted additional places in the public gallery.
*If a PACE meeting is requested the process will add an additional 1-3 months onto the assessment
timelines.
If you require any further information please do not hesitate to contact me.
Kind regards
Appendix 2: SMC committee attendance reply form
Scottish Medicines Consortium
Committee attendance reply form
SMC meeting on Tuesday DD Month Year
Organisation
Please enter the name of your organisation here
Complete the following boxes with the details of the representatives who will be attending
the Committee Meeting:
Representative 1
Name
Job title or role
Company (if different from
above)
E-mail address
Representative 2
Name
Job title or role
Company (if different from
above)
E-mail address
Please use the following box to indicate whether the representatives have any special needs
we should be aware of (for example, if a hearing loop is required):
Please complete this form and return to [email protected] by DD Month Year.