Review of Access to New Medicines

6.5 How the transparency of SMC has improved and what further opportunities there are for patient and clinician engagement

6.5.1 Feedback from all stakeholders confirmed that SMC and its processes are more transparent. Easily understood information is available from a number of sources and the contribution of Patient Group Partners and the Public Involvement Network were both singled out for particular praise. It was felt that engaging with SMC was still complex and potentially arduous but there were sources of support and the processes felt facilitative.

6.5.2 The move to hold meetings in public was felt to be a significant step in improving transparency but several stakeholders felt there had been one particular adverse consequence, namely the introduction of decision making by secret ballot. Under previous arrangements SMC's decision making had been by discussion and consensus building moderated by the meeting's chair although even then there had been occasions when a show of hands had been necessary. It was felt by some who expressed a view that consensus building was preferable to voting but it was recognised that there may be challenges in achieving this in an open public forum. It was suggested that this might be done in closed session at the conclusion of the public meeting.

6.5.3 This issue has clearly been the subject of much deliberation by SMC and its stakeholders in the course of introducing the new approach. The arrangements currently in place appear to take account of balancing a number of issues including optimising the transparency of discussion at SMC, protecting the confidentiality of individual members of SMC in relation to voting, and respecting the pharmaceutical industry's concerns in relation to the commercial implications of the timing of the announcement of SMC decisions. Nonetheless given the level of concern expressed in the process of gathering information for this review there would be merit in reviewing the position.

6.5.4 It was also commented that although SMC meetings were now held in public they represented only part of a longer process which includes NDC and in some instances PACE which, in common with SMC voting, continue to held in closed session.

6.5.5 Several stakeholders, most notably patients and the pharmaceutical industry, made pleas for greater transparency in relation to decision making. This ranged from voting in public, publishing the outcome of voting and developing a decision making framework document. The inclusion of a section in the Detailed Advice Document ( DAD) which outlined how the evidence was considered was suggested but it was recognised that where this had been done elsewhere it had been a complex and labour intensive process. It was felt however that SMC might explore the experience of NICE in this regard.

6.5.6 The handling of information that was deemed "commercial in confidence" was also felt to be a barrier to transparency. It results in documents being submitted which contain sometimes significant amounts of information which has been redacted at the request of the submitting pharmaceutical companies. This is then felt to hamper understanding of the issues. The challenge going forward will be for pharmaceutical companies to make submissions that minimise the use of commercial in confidence data and thus their requests for redaction of the contents of submissions.

6.5.7 Both patients and the pharmaceutical industry asked for greater transparency in relation to decision making when medicines were not recommended, in part to aid with better quality resubmissions where feasible. There was a particular plea to better understand the contribution of the PACE statement to the overall decision.

6.5.8 As highlighted above there was general satisfaction with PACE as having made a good start but there were a number of suggestions on how it might be further developed and improved and these have already been discussed in Section 6.2 above.

Recommendations

13 Review SMC's processes in relation to decision making by secret ballot.

14 Minimise the inclusion of commercial in confidence information in SMC submissions.