Government needs to act now and present its vision for the sector post Brexit. This includes protecting the research ecosystem from uncertainty so that inward investment is not threatened, access to the EU regulatory framework, preserving the single market for medicines and to facilitate access to the people skills that are essential to the delivery of medicines to patients in the UK.
The European Medicines Agency (EMA) is currently responsible for Marketing Authorisations (MA) covering all 31 countries in Europe (including EEA countries). A MA submission for the UK alone will require the same level of company resource and will attract a lower priority in comparison. The UK could therefore be downgraded in the global launch sequence for new medicines. This would have negative consequences for patients, clinical research and the economy.
The UK’s medical research charities play an increasingly important role to make the country an attractive place to invest. The members of the Association of Medical Research Charities (AMRC) fund £1.6bn worth of research per year and increasingly in a more strategic way involving commercial collaborations. For example, Myeloma UK has a number of such collaborations with more in the pipeline.
The depth and breadth of world-class clinical science supported via the NIHR in England is enormous. It has pioneered successful new models of industry/academia/NHS collaboration such as the Translational Research Partnerships programme, and put in place several organisational measures to help industry navigate what is undoubtedly a complex environment.
Stakeholders need to collaborate on measures to drive alignment between research programmes that generate data for market authorisation with the requirements of UK Health Technology Appraisals.
A new UK value framework for better research should be developed.
UK academics should be incentivised to design Innovative clinical trials in partnership with industry to generate UK-facing regulatory standard data.
New flexible approaches to pricing and patient access schemes should be designed.
The time between regulatory approval, HTA and adoption by the NHS should be shortened.
In order for the PPRS to fully meet its stated goals the 2019 PPRS should include:-
A New Medicines Fund, sponsored by continued industry rebates, that would pay for, inter alia, all new medicines launched during the period of the Scheme plus all medicines prioritised under NHS England Commissioning Prioritisation and would obviate the need for the NHS affordability criteria and the NICE QALY threshold for Highly Specialised Technologies (HST).
The PPRS ‘Taper’ should be restored, with a higher exemption threshold of £10m and applied to companies up to £40m in annual turnover.