In a move which might best be described with the understatement “well, about time…”, the UK’s cross-parliamentary select committee on health took the initiative of launching a major public consultation – into the thorny problem of access to medicines during and after Brexit.
The inquiry, launched on 21 September, is focused on highlighting key points-to-consider over new regulatory arrangements which will need to be set in place, in order to guarantee safe and effective provision of medicines, medical devices and related products for UK patients and the general public, during the course of the UK’s “divorce proceedings” transition period towards leaving the EU, and afterwards when the country goes it alone. It will welcome submissions from patient groups, healthcare providers and staff, academics and industry representatives. The fact that this constructive move follows more than a year of frustrating almost-silence from government on any details of the pharma industry’s future regulatory relationship with Europe should probably be forgiven, in the light of it happening at all – in an almost-timely manner.
The story so far…
Despite the submission of numerous reports on this and closely related topics to government, compiled by the pharma industry itself, by NGOs and by outside analysts, some dating from before the referendum – including a specific section in the high-profile Accelerated Access Review late last year – the Department of Health has so far been vague on future plans for pharma. In particular, the knotty problem of the future relationship between the UK’s national drug regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), and its EU counterpart the European Medicines Agency (EMA), has not been ironed out – beyond statements that the relationship will be “positive.” However, since the invocation of Article 50, time is now pressing for an answer. The Association of the British Pharmaceutical Industry (ABPI) and other prominent agencies have highlighted that it is an imperative for adapted drug regulations to be set in place from the official exit date of 29 March 2019 – in order to guarantee that medicines, devices and related products will continue to be provided safely and efficiently to UK patients.
Focus of the select committee’s consultation
The committee, chaired by Dr Sarah Wollaston MP, has stressed that the main purpose of the new inquiry will be to provide “certainty” to patients, the National Health Service (NHS) and the UK life sciences industry over the post-Brexit regulatory landscape. In practical terms, this has to include any transition period required for amending regulations, and the committee has noted that it should also encompass any implications for the future of medical research and development, both in the UK and Europe. With this relatively broad remit, contributing parties have been invited to highlight particular opportunities, risks and trade-offs which they feel may be involved in the process. Written submissions to the consultation may focus on any or all of the topics below, or others which come to mind relating to the impact of Brexit on healthcare.
Key considerations likely to arise for UK life science companies, healthcare services and regulatory bodies as a result of Brexit, and actions necessary to minimise or eliminate any adverse impact on patients and the public, and to maximise service enhancement opportunities which may come up.
Alternative arrangements which could be introduced post-Brexit for the regulation of medicines, medical devices and related products, highlighting potential opportunities, risks and trade-offs.
Timing required to facilitate a smooth transition to new arrangements, including the possibility of moving directly to new arrangements post-29 March 2019, or a requirement for an interim period with transitional arrangements.
Effects of EU withdrawal on the UK’s role in influencing international standards in life sciences in the future.
Arrangements required to ensure safe, effective and timely supply of medical radioisotopes, over the short, medium and long term.
Implications for medical research and development, including timely patient access to new medicines, technologies and other medical innovations developed within or outside the UK, with points to consider for enhancement of potential opportunities, and avoidance or mitigation of any adverse consequences in this area.
The consultation period is still running – with a closing date of 26 October. Submissions to the inquiry (up to 3,000 words) may be sent via the health select committee’s website here. This will be followed by public hearings in November and December 2017, and a formal report.
A kick in the right direction?
So – how will this inquiry make any difference, considering that many of the answers to its questions have already been examined at length in numerous reports from the industry over the last few months? The key distinction, perhaps, is that it comes from the House of Commons Health Select Committee, rather than the Department of Health (DH). The select committee is a cross-party group, with the governmental role of scrutinising the activities of the DH and its associated public bodies. Significantly, the current chair of the select committee, the Conservative MP Sarah Wollaston, is a trained physician, who has on occasion been sharply critical of the DH, over issues such as NHS underfunding during recent reforms, and the use of statistics. In this context, it would seem likely that Dr Wollaston will push for as realistic and practical a report as possible, highlighting the most crucial real concerns of the pharma and medtech industries, and of the healthcare sector and patients, at this key stage in negotiations. And although there is no guarantee the advice will be followed by the government, the resulting report is likely to highlight proposed solutions of practical value, and pointers towards the most important pitfalls to avoid.
However, yes, it has now been well over a year since the verdict of the Brexit referendum. So indeed, it would appear more than a little late in the day to be launching such an inquiry – although there is absolutely no doubt that it has been welcomed already by the industry and health service providers. In contrast, the DH’s responses to the numerous detailed reports and industry submissions on this topic (particularly the Accelerated Access Review) thus far have remained relatively vague – simply voicing general support for the industry, but avoiding disclosure of any actual detail on specific options which will be preferred. The most pressing issue, the necessary relocation of the EMA regulatory body from its current site in London, is due for a decision by the European Council in November – but there is no inkling of what the UK’s future relationship with this body will be, or how many of the current staff will choose to move to the new location. Perhaps the outcome of this consultation will be to give a far-from-gentle push in the direction of much-needed clarity – at this crucial moment, while there is still time to address any opportunities or major risks before the exit deadline looms.