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The politics of the UK life sciences sector is currently a little complicated by national and international events, not least is the potential judicial review being sought by the Association of the British Pharmaceutical Industry (ABPI), and the not so small matter of Brexit. The Science and Technology Committee announced on the 20 July that it is undertaking an inquiry into life sciences and the industrial strategy, could it bring a new perspective on UK life sciences?
The UK parliament has, as part of its checks and balances, a number of Select Committees who report on Government departments as well as broader economic affairs. Their reports prompt at the very least reflection on the part of the Government, all the way through to changes in the way things are done.
The Science and Technology Committee is a Lords Select Committee. That means that they don’t shadow the work of a specific Government department, but instead look into specialist subjects. The Committees previous inquiries have covered antimicrobial resistance, closing the Science Technology Engineering and Maths (STEM) skills gap, EU regulation of the life sciences, genomics and genome-editing, industrial strategy for science, research and innovation, the implications and opportunities for science and research from the UK leaving the EU and a whole host of other topics that are directly relevant to the pharmaceutical industry.
The Committee has just launched a new inquiry, this time to look into life sciences and the Industrial Strategy.
The inquiry will look at what can be learnt from the 2011 UK Life Sciences Strategy. Lessons will try to be gleaned to inform how to measure the success or otherwise of the new strategy. This includes the life sciences sector deal that will be developed as work on a life sciences report is finalised, as part of the wider UK Industrial Strategy. Although not explicitly stated, relevant too should be the impact of Innovation, Health and Wealth, also launched in 2011. An evaluation exists and there are good reasons to learn from it.
Within the 2011, and then re-launched 2013, UK Life Sciences Strategy were proposals that subsequently turned into the Early Access to Medicines Scheme (EAMS). EAMS can give products an early regulatory opinion before formal licensing and give patients access earlier than would otherwise be the case. This has already been looked at through the Accelerated Access Review (AAR) – Strategy&PWC specifically looked at it as part of commissioned work – and it’s just been boosted by
to support small and medium sized companies (it will still be up to non-SMEs to self-fund).
The inquiry will also look at public procurement and how it can be a stimulus for innovation. This is timely as the UK won’t be bound by EU procurement law once it exits the EU.
There is also a question about who should be responsible for implementation and who they should be accountable to. This is likely to be linked to the inquiry’s last question about whether Government should appoint a dedicated Life Sciences Minister. George Freeman previously held that post, but the post itself was ‘shared out’ when Prime Minister Theresa May changed things around when she took up her position. Lord O’Shaughnessy in the Department of Health and Lord Prior in the Department of Business, Energy and Industrial Strategy, now share responsibilities relating to life sciences.
Just to ensure that there is plenty for the inquiry to consider, it also includes a question on the regulatory framework and how it might be changed or improved after Brexit in order to support life sciences.
The inquiry comes at an interesting time. The UK life sciences sector is not only working through the implications of Brexit, but there is also the potential for a Judicial Review of the National Institute for Health and Care Excellence (NICE) decisions to introduce a new budget impact test. This will allow NHS England to negotiate a deal if a new medicine has a budget impact of over £20 million in any of the first three financial years post launch. That would apply even when the National Institute for Health and Care Excellence (NICE) says that the drug is cost-effective. Concerns have been raised about whether changes like this make the UK less attractive for research.
Government and industry are also either about to start, or perhaps have just started, negotiating on a successor to the Pharmaceutical Price Regulation Scheme (PPRS). The PPRS is the voluntary scheme that indirectly regulates pricing of branded medicines. There has always been a debate about how far pricing and reimbursement affects research decisions, but it’s likely that a tougher PPRS will do little to encourage industry.
What the Committee says won’t necessarily shape Government policy, but the current Government does need to strike the right balance about enabling innovation and getting the best deal for taxpayers. The Committee may have bring a new perspective to that conundrum.
The Committee has issued a call for evidence with the deadline for written submissions on the 15 September 2017. There are 18 detailed questions ranging from how to encourage investors to how the UK should be involved with the European Medicines Agency (EMA) post Brexit.
There will likely be quite a few responses and much that stakeholders will be able to draw on as there have been a whole host of reports in recent months including the Governments own analysis (Strength and Opportunity 2016, Life Sciences Competitiveness Indications), industry’s own or commissioned analysis (Building Something Great: UK’s Global Bioscience Cluster 2016, the UK Drug Discovery Landscape, the Economic Contribution of the UK Life Sciences Industry, the Changing UK Drug Discovery Landscape, Assuring the Interests of the UK in Global Pharmaceuticals – What Role Does the EU Play?) plus reports from others (the Role of EU Funding in UK Research and Innovation, and the Impact of Collaboration: The Value of UK Medical Research to EU Science and Health). The challenge for those responding will be how to fit all the issues and evidence into the preferred 8 page submissions.
Next will be public hearings and a report from the Committee is expected in Spring 2018.