“It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry”. These were Theresa May’s words on the Prime Ministerial campaign trail in July 2016, and they were echoed last week in a leaked government document listing pharma as a high priority industry in the wake of Brexit.
In a few weeks the Prime Minister will trigger Article 50 amidst ever present NHS financial pressures and an increasing scrutiny on the affordability of medicines.
Given the life sciences industry is one of the most highly regulated sectors in the world, it is no surprise that much of the discussion about Brexit has focused on the key regulatory issues. Despite increasing pressure not to quit the European medicines regulator, Jeremy Hunt revealed his cards at a recent select committee hearing, admitting he doesn’t expect the UK to continue as a member of the European Medicines Agency once it leaves the EU, instead seeking a “relationship” with the EMA after Brexit.
The nature of this “relationship” will be key. Will it be a long term affair or a quick holiday romance? Theresa May remains characteristically non-committal about what the future holds for medicines regulation but a system of mutual recognition, where the UK can swiftly adopt authorisations made by the EMA, seems to be the preferred route for both government and industry. Yet, while alignment may be the preferred approach for the UK, there is nothing to say EU negotiators won’t block harmonisation and that longed-for long term partnership.
Whatever the exact outcome of the negotiations, it’s hard to see how the disruption won’t lead to some delay in medicines access. This is bad news for patients, and a commercial and corporate challenge for pharma. A challenge further exacerbated by the numerous proposals for pricing and reimbursement of medicines, for example those set out in the Health Service (Costs) Medical Supplies Bill, which are set to further entrench the gap between medicines evaluation and scientific advances.
As senior politicians look to balance the domestic agenda of creating a sustainable health and social care system while navigating our exit from the EU, pharma will need to work hard to ensure the championing of life sciences doesn’t stagnate against competing priorities.
Having the right data to hand to demonstrate the societal, economic and personal value of the sector’s contribution to the UK and the health of its population overall is more important than ever. It is about creating a robust dialogue.
The consultative nature of the Modern Industrial Strategy discussions presents the sector with an important opportunity to do this. In particular, the focus on developing ‘home-grown’ skills should be harnessed to tell the sector’s value story in terms of its contribution to creating job prosperity and investing in a highly skilled workforce. As ever with these strategies, it will be a game of give and take. For those willing to show commitment and to bring the sector’s narrative to the table in a creative manner, the rewards are promising.
But engaging with the Industrial Strategy needs to be part of a much wider conversation about the current climate of medicines in the UK. The sector will need to continually make the case for a reimbursement system that appropriately rewards quality and investment. The devolved and fragmented nature of the NHS means major providers of products, medicines, and services to the health service must be cognisant of the varied budgetary, demand and clinical challenges felt by local system leaders and commissioners. To overcome this, pharma must invest in those on the ground – talking to payers day in day out, arming them with the right information and the bigger picture – so that understanding is deepened on both sides.
Conversations need to be happening at all levels so that a lasting relationship can be forged.