Election fever in the UK: what it means to pharma
Campaigning for the UK General Election in May 2015 has stepped up since the dissolution of Parliament on 30 March. In the last few days the main parties – Labour, the Conservatives and the Liberal Democrats (Lib Dems) – have released their manifestos. So where do they stand on issues that affect industry?
Funding the NHS
Top of the list is funding of the NHS, simply because it trickles down to the reality on the front line and the fight about what to spend precious NHS pounds on, including the share for medicines.
The Lib Dems (currently in government as part of a coalition with the Conservatives) were the first to commit to giving £8 billion a year more to the NHS. This should come from a mixture of taxes on high earners and proceeds of economic growth. That's how much the head of the NHS, Simon Stevens, has asked for as part of the Five Year Forward View (essentially yet another new plan to make everything better in the NHS). Make no mistake, though, this is not that much, given expectations about rising demand. It won't avoid the need for the NHS to become much more productive.
The Conservatives have followed the Lib Dems and have now promised £8 billion more a year for the NHS too; although quite where they will find the money isn't clear.
"Labour looks like the poor man in comparison to both the Conservatives and the Lib Dems, promising only £2.5 billion a year more"
Labour looks like the poor man in comparison to both the Conservatives and the Lib Dems, promising only £2.5 billion a year more. This will come from a new 'mansion tax', stopping tax avoidance and fees for tobacco companies.
It is worth noting that the Lib Dems also say that they will shift full responsibility for care policy and funding to the Department of Health. That sounds like taking responsibilities for funding away from NHS England, the agency that has much of this remit at the moment. They will also commission a fundamental review of NHS and social care funding.
Business
Corporation tax has just dropped to 20 per cent for companies earning over £300,000 as a result of the last Coalition budget. Although both the Conservatives and the Lib Dems have been quiet on future plans for corporation tax, there are concerns that Labour could raise it – speculation has it at perhaps 6 per cent if they get into power. Labour says it'll still be the most competitive rate of corporation tax in the G7, but does not put a figure on it in its manifesto.
In perhaps a dig at the failed Pfizer takeover attempt for AstraZeneca, Labour has also said that it will change takeover rules and strengthen the public interest test.
Life sciences and innovation
Here Labour stands out with its intentions for change; it plans a 'new long-term funding policy framework for science and innovation'. It will support the work of the Health Research Authority (HRA) in streamlining the process for setting up clinical trials, as well as delivering on improvements set out in the European Clinical Trials Regulations.
The Conservatives and the Lib Dems have had their go at life sciences through the Innovation, Health and Wealth (IHW) initiative while in power. That seems to have stalled somewhat. An evaluation is underway and is due to report by the winter of 2017 (too late to have any impact?). So instead of talking about that, the Conservatives take the opportunity to commit to implementing the findings of the Innovative Medicines and Medical Technology Review (also known as the Accelerated Access Review, End to End Review or even the Freeman Review, reflecting its establishment by George Freeman as Minister for Life Sciences). That review is wide ranging; the Terms of Reference cover everything from regulation and reimbursement to uptake. That takes in the work of the Medicines and Healthcare Products Regulatory Agency (MHRA), including the Early Access to Medicines Scheme (EAMS), the National Institute for Health and Care Excellence (NICE), and the as-yet untested model for medicines, Evaluation through Commissioning (EtC) (also known the other way round as Commissioning through Evaluation) under NHS England (NHSE).
On the topic of reviews, the Conservatives will also take forward recommendations that will come from the O'Neill Review. This is looking at the issue of antibiotic resistance. That includes big issues about getting more research done, and how best to pay for new antibiotics.
The Conservatives also say that they will encourage large-scale trials of innovative technologies, as well as fostering research, innovation and jobs in the life science industry.
The Lib Dems talk up innovation too; they will support it alongside education, training, infrastructure and technology. They say that they will double innovation spend. Life sciences aren't name checked but are part of the ring-fencing of science spend that they promise.
National Institute for Health and Care Excellence (NICE)
On NICE, Labour says it will make sure NICE is fit for the future, so some tweaks could result. Guidance from NICE will be subject to "tougher rules", plus Labour wants to ensure that there is a clear route into routine commissioning for innovative medicines.
The Conservatives will take up the recommendations from the Accelerated Access Review that will undoubtedly cover NICE. Given the focus on speed, making NICE faster could well be on the cards.
The Pharmaceutical Price Regulation Scheme (PPRS)
The Conservatives have said nothing on the PPRS, not even pointing out the millions flowing back to the NHS arising from the guarantee that companies would pay back if NHS spend on branded medicines went over an agreed growth rate. Maybe it's simply to avoid a focus on their failed attempt to reform pricing from last time around?
Labour has committed to maintaining the PPRS, citing certainty on drug prices – which, actually, it doesn't do. What it does is indirectly influence price and, since the 2014 deal was struck, gives certainty on NHS spend on branded medicines.
Although the Lib Dems don't cite the PPRS, they do hint at change. They talk about their intention to "continue to ensure value for money for the NHS in negotiations on the cost of medicines". Again this is not quite a true reflection of the current approach, but with the role of Patient Access Schemes and 'deals' to stop de-listing on the Cancer Drugs Fund (CDF) you can see how it looks like negotiation, at least for some products. The Lib Dems also say that they'll promote the use of generics.
Cancer
The very political Cancer Drugs Fund (CDF) was an election pledge from the Conservatives last time around. Popular back in 2010, it's now a headache for politicians and industry alike, acting as a focal point for long-standing debates about fairness (why just for cancer patients?) and pricing (why such high prices for new cancer drugs?). Here Labour has suggested that the CDF should evolve into a Cancer Treatments Fund, essentially widening it to cover more. This would be part-funded by the PPRS payments from industry.
Just as in 2010, the Conservative manifesto this time simply pledges to keep the CDF. It points out that over 60,000 people who have benefitted from it. They also take the chance to link to the 100,000 Genome project, already underway and introduced during coalition government. The hope is that it will help boost research and help in developing personalised treatments.
The Lib Dems say they will set ambitious goals to improve outcomes in cancer, as well as goals for earlier diagnosis and improved aftercare. They also commit to providing support for public health messages in campaigns like Be Clear on Cancer.
Other diseases
The Lib Dems focus on mental health in their manifesto. They pledge a mental health research fund of £50 million to increase understanding and develop more effective treatments. Here, though, it's likely to be less about pills and more about other forms of care.
Dementia also features in the manifestos of the Conservatives and the Lib Dems. The Conservatives are aiming high; they say that they will "lead the world in...finding a cure for dementia". Quite how is not clear, but it will presumably build on their record of doubling funding for dementia research so far.
"The Lib Dems are, arguably, more realistic saying that they will work towards a global deal for a cure or preventative treatment for dementia"
The Lib Dems are, arguably, more realistic saying that they will work towards a global deal for a cure or preventative treatment for dementia. They also offer a more concrete proposal to double NHS research spend on dementia by 2020.
Labour doesn't actually touch on dementia specifically in its main manifesto, but it features in its health manifesto. They focus on making existing care more appropriate, rather than research and new treatments.
Subtle changes?
Overall, it doesn't appear, based on what's been said so far, that any party is looking for a major overhaul of their approach towards industry, either in industrial policy or health policy. Whether that's a relief or not is likely to depend on your views on just how badly the current system needs fixing.
NICE is clearly still a concern to industry (and patient groups too), as is an increasingly complex National Tariff, with uncertainties over just how pass-through costs for expensive medicines will be dealt with, both this financial year and in the future.
Also of concern is NHSE, which has upset people with its approach to the CDF and has been less than transparent over its approach to decisions on specialised services and the treatments that are part of these. In the spotlight, too, is whether the government is holding up its side of the bargain on the 2014 PPRS. These issues will probably still be on the to-do list for industry, whoever is in power.
What might be more of a challenge will be the subtle changes. A more local approach to health care, and experience with integration between Local Authorities and the NHS, as in the Manchester example, will mean that local relationships between companies and stakeholders will need to be developed irrespective of which party is in government later this year.
About the author:
Leela Barham is an independent health economist and policy expert who has worked with all stakeholders across the health care system, both in the UK and internationally. Leela works on a variety of issues: from the health and wellbeing of NHS staff to pricing and reimbursement of medicines and policies such as the Cancer Drugs Fund and Patient Access Schemes. Find out more here and you can contact Leela on leels@btinternet.com
Read more from Leela Barham:
Stay or go? The UK's PPRS and the statutory scheme for pricing branded medicines
And watch this webinar on the future of the NHS, featuring industry experts 'Staring into the abyss? Navigating the NHS post-election', which took place on 15 April.