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Creating a 21st century life sciences ecosystem

The UK’s life sciences minister on how government and pharma can encourage NHS uptake and innovation

George Freeman UK life sciences minister

George Freeman is the UK’s life sciences minister

In July 2014 the British Prime Minister David Cameron undertook a re-shuffle of his Cabinet and while many political changes made the headlines, the most significant for the pharma industry was overlooked.

This was the appointment of the Conservative MP George Freeman, who became the government’s new minister for life sciences – an entirely new position within government.

The creation of this new role alone makes a big statement about the government’s commercial science plans in general, but Freeman himself is the icing on the cake for pharma.

This is because he knows what he’s talking about, having worked in the life sciences and healthcare industry for most of his career as the former chief executive of Amedis Pharmaceuticals and the founder of the translational R&D biotech 4D Biomedical.

Who is George Freeman?

Freeman was elected to Parliament in 2010 after a 15-year career across the life sciences sector, in particular working with hospitals, clinical researchers, patient groups and biomedical research companies to pioneer novel healthcare innovations.

Following his election to Parliament in 2010, Freeman served as PPS to the minister of state for climate change. He was appointed government adviser on life sciences in July 2011, working closely with the Department of Health and coordinating the Government’s Life Science and Innovation, and Health and Wealth strategies (2011), and the Agri-Tech Industrial strategy (2013). Following that, he was appointed to the post of prime minister’s UK trade envoy.

On July 15, Freeman was appointed as minister for life sciences, a parliamentary under-secretary of state at the Department of Health and Department of Business, Innovation and Skills. His mission is to make the UK the best place in the world to discover and develop 21st Century healthcare innovations.

Freeman was elected to Parliament in 2010 after a 15-year career across the life sciences sector, in particular working with hospitals, clinical researchers, patient groups and biomedical research companies to pioneer novel healthcare innovations.

Following his election to Parliament in 2010, Freeman served as PPS to the minister of state for climate change. He was appointed government adviser on life sciences in July 2011, working closely with the Department of Health and coordinating the Government’s Life Science and Innovation, and Health and Wealth strategies (2011), and the Agri-Tech Industrial strategy (2013). Following that, he was appointed to the post of prime minister’s UK trade envoy.

On July 15, Freeman was appointed as minister for life sciences, a parliamentary under-secretary of state at the Department of Health and Department of Business, Innovation and Skills. His mission is to make the UK the best place in the world to discover and develop 21st Century healthcare innovations.

Freeman also helped put together the coalition government’s ‘Strategy for UK Life Sciences’ in 2011, a major piece of policy for the industry. Many politicians vie for government positions in order to climb up the greasy poll, but Freeman told PME he is “exactly where he wants to be”.

Although his appointment may be short-lived – the Conservative government (and Freeman) will have to fight to remain in power at next May’s general election – he is determined to create a 21st century landscape for the health and life sciences sector while he has the opportunity.

Market access

The biggest issue for pharma, and therefore for the government, is market access. A pharma company can spend as much as 15 years and more than $1bn developing a new medicine, have it pass through all the regulatory hurdles, but then be thwarted by England’s health technology assessor NICE, which decides which drugs the NHS should pay for.

“The current market access scheme is just not sustainable” Freeman admits. “But I think that frames both the challenge and the opportunity for this country – and my appointment as the first minister for life sciences.

“This is because we know that unless we [the government] can get the NHS, the care system and the ecosystem of health more conducive to supporting quicker access to drugs for patients, then we will struggle to be competitive in the global race to gain investment for the life sciences industry.

“We also know that what is absolutely key to the 21st century landscape is going to be clinical access into the clinical environment for research, but also for use in patients.”

His plan to encourage this is the early access to medicines scheme (EAMS), a new policy set up (and led by Freeman) this year that is looking to speed up the overall regulatory and HTA process for pharma companies. Part of the scheme involves a new ‘promising innovative medicine’ designation – similar to the FDA’s breakthrough designation – the first of which have started to be awarded.

Date Issued

Promising Innovative Medicine Designations

Details

September 2014

1

Northwest Biotherapeutics’ personalised immunotherapy DCVax-L

October 2014

1

“Commercially confidential”

EAMS could also see safe and effective drugs bypass phase III testing, in certain circumstances, and rely on the type of ‘rolling submission’ of data that the US regulator the FDA allows for.

“I’m focusing very heavily in this new role on that whole area of earlier access to innovative medicines,” he explains. He says he is actively looking at how to get the UK drugs regulator the MHRA and NICE working together to in order to speed up the entire licensing and cost-assessing process.

He says: “We in the government realise that if we don’t take time out of the traditional drug development process, the industry will struggle to continue to maintain its level of investment. We also need to look at new models to incentivise quicker adoption into the health system. So, where you do get a licensing approval, then a NICE recommendation, there isn’t such a long delay to get uptake.”

Pricing pressures

By speeding things up, Freeman is also adamant that this will have a knock-on effect on drug prices – something which has come under intense scrutiny this year as new drugs, and notably oncology medicines, are reaching the £100,000 per patient marker.

If pharma can spend less on its R&D and get its drugs out on the market more quickly, then Freeman says that this should translate into lower prices, as the need for re-investment would be lower. He is not yet, however, speaking to pharma directly about the rising costs of medicines.

Freeman says he will also not be seeking a political reform of NICE’s practices – something that the UK pharma lobby group the ABPI is calling for.

He’d rather see all the key stakeholders work together and use the EAMS project, rather than force major changes at NICE, or indeed the industry.

Freeman believes that what is key to issues around pricing and market access is helping to nurture the new 21st landscape of precision medicine.

He explains: “We need to make sure that we are giving the right drugs to the right patients by targeting better, and to also take time out of the development timeline – these are all major ‘value steps’ which will then allow us to have a conversation with the industry about how best to use the NHS budget to maximum effect.”

Tax inversions

This year nearly saw the loss to UK plc of two major pharma companies: AstraZeneca and Shire, both of whom were very nearly swallowed up by large pharma rivals (Pfizer and AbbVie respectively) in order for the bigger firms to cash in on the UK’s lower business tax status.

With the Shire deal now definitely dead in the water and the Pfizer-AstraZeneca merger (at least at the time of press) also now not going ahead, the UK government can let out a sigh of relief – although it was the actions of the US government that put a halt to these so-called ‘tax inversions’.

Freeman says he does not want to see the UK lose an AstraZeneca, a Shire or a GlaxoSmithKline through this type of deal.

But he says: “I think we need to recognise that this is a global sector, and that Britain must be competitive in what is effectively a global race. I believe that the most important thing I should be doing – and that the government should be doing – is focusing relentlessly on the issues such as: innovation adoption; procurement and reimbursement; research; so that we are one of the best places in the world. If we get that right, we will continue to see inward investment in the UK.”

He did not say however that he was looking to put a new law on the statute book to help stop these sorts of deals from going ahead in the future.

Brain drain

Since Freeman became an MP in 2010 there have been thousands of job losses across the UK as a number of companies, including GSK, Novartis, AstraZeneca and most notably Pfizer – which pulled its main European R&D site from Sandwich, Kent in 2011 – battle strong global headwinds and major patent expiries.

But Freeman dismisses that this is a ‘brain drain’ of British talent. “I don’t recognise the description of Britain suffering a life sciences brain drain”, he explains. “In terms of investment, the life sciences sector in the UK is at a seven-year high; in 2012, after a period in the doldrums, we attracted into Britain in 2013 around £60m early-stage investment into the life sciences; this year, it’s over £700m in the first six months [the latest data available].

“But what we’re seeing is this level of ‘recycling’ – you look at those people who left Pfizer in 2011 and now many of them are now running start-ups; are consulting in the sector; and generally bringing their experience back into the industry.”

This has been helped by the government establishing science hubs in many of pharma’s leftover sites – such as in Sandwich – that it is funding and encouraging those let go by the industry to create their own life sciences firms.

Freeman says: “I think you’re seeing a lot more people in the sector going on in their career – working in pharma, working for a small company; and I think that is a good thing that we keep the mixture of big companies, medium and small – that’s what is so key.”

He says that despite industry jobcuts, the government has been building an ecosystem to help those who are caught up in the global headwinds, and will continue to do so.

“The old plants of 20th century pharma R&D are transforming into new bits of modern structures – we just need to make sure that our innovation economy is vibrant and is evolving fast.”

Ben Adams
is a health and life sciences writer
19th December 2014
From: Research
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