ABPI voices concerns over UK support for drug innovation

The UK healthcare system is failing to adapt to the new challenge of personalised medicines and, as a result, risks losing future pharmaceutical R&D investment, says the UK Association of the British Pharmaceutical Industry (ABPI) in a new discussion paper.

The paper – Securing a Future for Innovative Medicines – published on 10 April to coincide with the ABPI 2014 Annual Conference, highlights the emergence of specialised medicines as a key challenge for the UK pharmaceutical industry and calls for a fundamental shift in the Health Technology Assessment (HTA) approaches, such as those carried out for the UK's National Health Service.

Over half of the active products in the global industry research pipeline are personalised medicines, and the UK healthcare system is at risk of failing to adapt to this new challenge, the paper says.

Commenting on the paper, Stephen Whitehead, Chief Executive of the ABPI, said: 'This report sheds new light on the challenges facing the UK pharmaceutical industry. Whilst companies are refocusing their pipelines towards specialised and stratified medicines, a gap is opening up between the commercial environment in which the industry currently operates, and the new R&D environment the industry is moving towards. If we don’t address this gap soon, patients will be unable to access the best treatments and the UK economy will suffer.

'It is vital that our industry continues to work closely with the NHS and academia to ensure that we become a world leader in stratified medicine, as well as the location of choice for pharmaceutical R&D from across the globe.'

Many in the industry argue that current reimbursement models no longer work as drugs become more targeted and niche. Among the issues raised at the Conference were: clinical trials are too expensive and inflexible and need to be more adaptive; the regulatory framework is too complex and needs to be both simplified and harmonised; post launch monitoring of drugs will mean added costs for manufacturers, which need to be reflected in drug reimbursement.

The report says that changes are occurring both in the UK, and at a European level, in the form of pioneering joint-working initiatives involving the NHS and industry. It also points to NICE’s Highly Specialised Technology (HST) programme which has the potential to make a difference to how specialised medicines for rare diseases are evaluated.

At the Conference, Jeremy Haigh, European COO for R&D, Amgen, said: 'Advances in genomics and stratified medicine are changing the way we develop, trial, administer and pay for new drugs.'

He added that the conventional approach is too expensive and slow with the result that the current practice is making the UK 'a low and slow market for new medicines'.

Sir Andrew Dillion, Chief Executive of NICE, admitted that new therapies are a challenge to evaluate, but outlined initiatives that were underway at NICE, including the introduction of new quantitative terms of reference when deciding the value of treatments.

However, the shape of healthcare provision in future, with stratified medicine, products for self-diagnosing, and increasing use of telemedicine, are so radically different from what has gone before that steps need to be in place now to look at meeting drug industry reimbursement concerns.

Professor Sir Malcolm Grant, Chairman, NHS England, said that the NHS was undergoing massive change itself to stem the growing budget deficit which was in the long term unsustainable. He said the current model of primary care needs to change as it was originally designed for handling patients with single, straightforward diseases – not the complex multi-diseases of patients now presenting to hospitals.

Dr Doug Brown, Director of R&D at the Alzheimer's Society, talked of the need for greater patient involvement and particularly the need to involve patient groups early on in drug innovation, in order to get better support for innovative treatments.

In his closing remarks, outgoing ABPI President, Deepak Khanna, said that the ABPI had forged better relationships with NICE and the NHS over the past two years, but more needed to be done to transform patient access to new medicines: 'We need an environment to deliver innovation, and cutting drug spend is not the way to go about it,' he said.

Pfizer's Jonathan Emms now takes over from Khanna as ABPI president and will serve for one year, with the option of standing for re-election for a further year.