After the UK general election, what’s next for pharma?

In May the UK went to the polls and elected a Conservative government to replace the coalition that had been in power since 2010.

A lot has changed in the pharma industry over the past five years, and by the time the next election comes around in 2020 the healthcare landscape in the UK may well again look completely different.

Pharmafocus asked four industry leaders what the new government can learn from the coalition’s approach to pharma, and what it can to do make the most of the life sciences industry in the UK.

Steve Bates, chief executive, the BioIndustry Association (BIA)

How did the coalition government perform where pharma is concerned? What was their biggest achievement or disappointment?

In general, the previous government was positive for the bioscience sector. The publication of a life sciences industrial strategy, the appointment of a dedicated life sciences minister, and the Great Eight Technologies were all good policies with a good level of political profile for this important sector.

Their biggest achievement was the Biomedical Catalyst scheme, which provides competitive funding that can support companies at early research stages, bridging the so-called ‘valley of death’ for the translation of research. The scheme opened for applications on 30 April 2012 and is currently on its eighth funding round, providing vital support for early stage companies. The BIA sees this as a key policy success and wishes to see it continued under the new government.

The biggest disappointment, though, was the Early Access to Medicines Scheme (EAMS). This was introduced in March 2014 as part of the coalition government’s Strategy for UK Life Sciences. The BIA has been involved in the development of the scheme since its inception – a supporter of its potential to bring promising medicines to patients faster and also to help companies to demonstrate the potential of their products.

However, for the EAMS to benefit patients it needs to be centrally funded and reimbursed. Choosing not to fund the scheme inhibits its potential. We hope this is something the government will address in the Accelerated Access review which should now get underway following the election.

What should be the top three priorities for the new government that will help the industry?

Top priorities lie in securing the UK’s position as a global hub and as the best location for innovative research and commercialisation. Consistent focus and support must be maintained by successive governments in order to ensure the continued success of the sector.

A supportive tax and finance environment is essential for a successful life science sector. Current provisions including the Biomedical Catalyst, R&D tax credits and the Patent Box (which offers a 10% rate on profits derived from patents) provide vital support to innovative companies and must be continued. It is imperative that the revised Patent Box remains globally competitive.

In 2013 the government named several strategically important technologies – including regenerative medicine and synthetic biology – with great potential to benefit the UK economy. The focus on these areas is welcome and must continue.

The medical pipeline is increasingly comprised of biological medicines, which are expensive to develop and manufacture but can offer great benefits for patients. With limited healthcare budgets, ensuring patient access to the latest medical advances will require new flexible routes for licensing, evaluation, uptake and reimbursement.

What advice would you give the life sciences minister?

Keep the momentum and profile of life sciences policy high – it’s come far but has the potential to go much further.

What do you want to see changed by the next general election in 2020?

We want to see government support for the UK life sciences sector which provides the foundation for our vision of establishing the country as a top global cluster in life sciences by 2025.

Dr Eliot Forster, executive chair of biotech collaboration body MedCity

How did the coalition government perform where pharma is concerned? What was their biggest achievement or disappointment?

Over the past decade or so, we have witnessed the evolution of a proactively positive attitude to life sciences in both local and national government, based on the real understanding that a strong life sciences sector will deliver both economically and for our better health.

We now have a confident, ambitious, business-friendly sector that excels at R&D and translation, and has positioned itself as a magnet for industry worldwide. In particular I’d point to the establishment of Academic Health Sciences Networks in 2013, which are pivotal in bringing innovation to patients, and the growth of regional open collaborations to grow the sector – MedCity, the Northern Health Science Alliance, Life Sciences Hub Wales, and many others.

Patent Box is a significant signal that the UK is a place that values innovation and – along with other fiscal initiatives such as R&D tax credits, the Catapults and Catalyst funds, and the corporate tax rate – demonstrates that this is a place to do life science business. Most recently the reappointment of George Freeman as the world’s first and only minister for life sciences has brought an energy and focus to the sector like never before.

What should be the top three priorities for the new government that will help the industry?

With the caveat that government is only one of the partners it will take to make this happen, my main priorities are: Improve innovation adoption in the NHS.

The NHS is an amazing asset for UK life sciences – it is increasingly joined up with the research base, can facilitate access to a very diverse patient population, and is a great test-bed for industry through adoption of innovation and access to ground-breaking data and clinical trials.

But it’s also complex, and finding a route to market is one of the major challenges for life sciences businesses, in particular SMEs. This isn’t an issue that government alone can solve but the innovative medicines review announced in 2014 is a positive step that I hope will go forward speedily.

Second, show that the UK is open to business, investment, talent and collaboration – by word and deed. Maintain our attractive fiscal position for companies looking to expand, welcome talented entrepreneurs from around the world looking to develop new businesses, and make this the obvious place to set up a European HQ.

Protect the science budget, stay in the EU and have immigration rules that support the flow of talent – the labour market for life sciences is global.

Lastly, keep the post of life sciences minister – a great move in practice and in principal, giving the sector an informed champion in government and giving the world an unequivocal signal that we are serious about the industry.

What advice would you give the life sciences minister?

You will have the full support of the sector. Listen to us, use us as a resource, immerse yourself in the sector, and work with us to tackle the big issues – in particular, access to investment.

What do you want to see changed by the next general election?

Government support for life sciences is important but it’s only one part of the jigsaw. So looking forward to the next five years, my overriding wish would be for all of us – national and local government, industry, academia, NHS, healthcare sector, charities and the investor community – to work together to create a more streamlined path from research to patient.

We need greater flexibility in the development process for new drugs, using new technologies and genomics to identify patient cohorts for clinical trials. Stripping out costs from the product development process while maintaining safety and efficacy is a priority.

The higher education system is a vital part of the ecosystem and will have an increasingly important role given that the training grounds of big pharma don’t exist anymore. Universities can support the development of talent not just in research but also in pharma management and leadership.

Jonathan Day, medical director UK and Ireland, AstraZeneca

How did the coalition government perform where pharma is concerned? What was their biggest achievement or disappointment?

I was very pleased that the coalition continued the strong all-party support for life sciences investment. Its strongest achievements were the focal point provided by the cross-departmental Life Sciences Strategy along with the introduction of the Patent Box, even though we are seeing some competitive anxieties and challenges from other countries in regard to the latter.

The biggest challenge – and it is a longstanding one – has been the inability to improve patient access to new medicines, particularly those approved as cost-effective by NICE.

What should be the top three priorities for the new government that will help the industry?

They need to review the progress of the Life Sciences Strategy and refresh its recommendations to keep pace with industry developments and international competition.

Introducing a new reimbursement framework for specialised and personalised medicines with smaller patient populations, which will soon account for the majority of the industry pipeline, should also be front of their minds. We hope the Accelerated Access Review begun by the coalition will be completed swiftly by the Conservatives.

Finally, improve patient access to new medicines in all care settings, leveraging the opportunity presented by the PPRS agreement, which effectively caps the medicines bill for the next four years with industry paying back any spend above modest growth levels. There has not been a better time to reposition medicines expenditure as an investment towards sustained improvements in patient outcomes.

What advice would you give the life sciences minister?

I would advise him to work with the pharma industry as true partners, not just suppliers. Not only can the industry work with the NHS to support improved outcomes, but it makes an enormous economic and scientific contribution as well through R&D investment and exports, for example.

Second, I would say that it is one thing to make policy at the centre – the real challenge will be to translate that into meaningful actions in a greatly devolved NHS system with severe financial constraints. So please make sure any commitments are followed through on the ground and manage expectations accordingly.

Finally, quickly get out and visit the range of facilities and companies researching and manufacturing in the UK pharma sector – it’s a vital part of our economy as well as an integral part of our healthcare and academic research ecosystem and, to use an old phrase, ‘seeing is believing’.

Dr Virginia Acha, executive director of research, medicine and innovation, ABPI

How did the coalition government perform where pharma is concerned? What was their biggest achievement or disappointment?

The coalition recognised pharma as the ‘jewel in the crown’ of the British industry. The industry welcomed this support and the positive developments including the Biomedical Catalyst Fund; introducing the 70 day benchmark from successful research applications to patient recruitment to clinical trials; and the launch of the Clinical Practice Research Datalink.

These initiatives have improved the opportunities for clinical research and collaboration across the NHS, academia, industry and voluntary groups. A further key achievement was the creation of the role of life sciences minister. This senior leadership role has served to drive forward progress in life sciences policy in the UK.

A key concern for the industry remains the ability of patients in the UK to access the right innovative medicines for their care. Also, despite the creation of the post of life sciences minister, we are disappointed and concerned that clear commitment and senior leadership has not been better sustained in key policy areas including the Innovation, Health and Wealth agenda.

Although we welcomed the establishment of NHS England, through the Health and Social Care Act 2012, the industry has recognised that the trade-off has been a ‘stepping back’ by the government in terms of strong leadership and accountability.

Having this from the centre is vital to coordinating, pursuing and measuring implementation of a nation-wide strategy reliant on co-operation across organisational boundaries.

What should be the top priorities for the new government that will help the industry?

The Conservative government will be faced with continued pressures on public spending. The industry would therefore like to see the following priorities set at the heart of further support for the sector: Ensuring sustained advancement in the UK research base and opportunities for collaboration with industry.

Creating the right environment and incentives for clinical trials, adaptive regulatory review that rewards innovation and better patient access to medicines through improved NICE processes. Driving the industry’s contribution to the UK economy by reviewing the tax system and introducing new tax regimes to support the generation, retention and exploitation of intellectual property in the UK.

Giving real power to the body in charge of ensuring access to innovative medicines so that patients receive them as soon as they are available, alongside also changing the official definition of the value of medicines to make it align with the view of the public, patients and healthcare professionals.

What advice would you give the life sciences minister?

A key priority for the minister will be the Accelerated Access Review and the recommendations this will have for the research and health systems in the UK. The industry would like to see real and lasting positive change through the review including: patients being treated with medicines that improve health outcomes in line with the government’s and NHS’ health goals, and measurable progress over the next parliament towards new medicines usage that is akin to comparable countries.

The life sciences minister will have to help focus the energies of the new government, the NHS and other agencies to focus and renew their collective drive to delivering a clear approach, which puts the UK at the forefront of global research and health outcomes.

What do you want to see changed by the next general election?

Modern medicines can play an important role in transforming patients’ health and life chances, but a number of factors prevent fast and fair access to them for all patients, wherever they live. A key change therefore would be a holistic research and health system which supports both the development of research in parallel with faster patient access to modern medicines.

Other key areas of important progression would be accelerated progress in improving NHS clinical trial performance, maintaining support for the National Institute for Health Research (NIHR) Clinical Research Networks to further improve delivery of trials on time and on target, and successfully establishing public investment in science and innovation in the UK to reach OECD targets of three per cent.

The government must also ensure that the UK continues to be an attractive place for the high-value medicines manufacturing sector industry, through a competitive and transparent fiscal environment, a more demand-led and flexible supply chain, investment in new talent and support in adopting novel technologies.

Paul Greenland, vice president of biologics, Hospira

How did the coalition government do where pharma is concerned? What was their biggest achievement/disappointment?

In the last five years we’ve certainly seen some progress from our perspective. Hospira provides a range of generic and biosimilar drugs. They are intended to help lower costs of treatment, and also help improve patient access, and the work that has been done by the coalition to get NICE to a point where drugs are approved and available within 90 days has really been helpful.

The time it takes between being able to get a drug registered in Europe and then getting it available to UK patients often takes a long time, much longer in some cases than in other European countries – and I think the government has actually done quite a good job there in helping to speed up that access.

But on the downside I think there are still some challenges. They have probably missed an opportunity to more quickly drive the uptake of things like biosimilars. There’s work starting now to look at improving access to biosimilars but certainly that opportunity has been taken much more quickly in other European countries where we see a greater uptake of these drugs. So that’s something I think was a little disappointing, and hopefully we can see that improving with the next government.

What are the top three priorities for the new government that will help the industry?

Certainly looking at continuing accelerated access review, anything that can help drugs get more quickly approved, particularly the generic and biosimilar drugs. And also being able to look at ways of measuring adoption, incentivising in some way for the system to improve the uptake of cost-saving medicines.

A third thing I think is going to be really important is to try to improve the dialogue with industry as a key stakeholder. I think there is some dialogue with industry at the moment, but the government really needs to improve the way it brings all stakeholders together to make sure that they are working in the same direction to try to improve patient access to medicines, to improve treatments for patients, but at the same time make sure that these are cost effective.

Sometimes we see that this is very much individual stakeholder groups trying to drive their own agendas, and I think the government has a responsibility to try and pull all stakeholders together to make sure this is a co-ordinated approach. It’s only when we’ve got a coordinated approach that we’ll do the best thing for patients.

What advice would you give the life sciences minister?

Certainly the life sciences minister should continue this dialogue with the industry. We are a key stakeholder, we’re obviously not the only stakeholder but we need to be involved in the discussions as to how to help to improve the NHS, how to help to improve patient access, and how to help to make sure these are affordable.

I think we can only do that if we’re included in the dialogue at all levels, and I think we also need to make sure that dialogue helps to support the introduction of less expensive versions of medicines when it’s appropriate. It goes back to the point that sometimes the UK is quite slow in terms of the introductions of these medicines.

What do you want to see changed by the time the next general election comes around in 2020?

Well hopefully we see five years of stability, but I think in that time what we’d like to see is certainly that the dialogue, or at least the platform for dialogue between different stakeholders is improved –that we get a much greater alignment between all the industry stakeholders, between the physician groups, the patient groups, the other NHS groups. Hopefully we can see a much more joined-up approach to improving patient access and helping to reduce healthcare costs.

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