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Life sciences – the "jewel in the crown" of the 2020s?

Not many years ago, there was growing confidence that the UK was emerging strongly from the economic crisis. In particular, the life sciences sector was seen as a key part of a remodelled, innovation-based economy that would support the UK into the future. Is that still true?

December 2019

On 14 October, as Her Majesty the Queen settled down to deliver her traditional speech to both Houses of Parliament on the government's legislative agenda, one thing was missing. More specifically, as the Queen announced measures to implement the National Health Service's Long Term Plan in England and establishing the United Kingdom as a world-leader in scientific capability with increased investment, among other things, the eyes of Parliament were drawn to Her Majesty's gracious head. There was no crown – the jewel-encrusted Imperial State Crown was missing. Was this symbolic of the current state of national affairs? Former Prime Minister David Cameron once described the UK's life sciences sector as the "jewel in the crown". Has that jewel also been lost?

Concerning the Queen's jewels, there is no need for concern: aged 93, the 1 Kg weight of the crown is just too heavy for her. By and large, the news is just as good for life sciences and confidence in the sector has proved well-founded. Now, as we head into the 20s, what are its prospects? Will the jewel be tarnished or burnished?

We see three defining issues facing the UK life sciences sector in the next year and beyond. One is scientific, one political and the third is essentially legal.

Using AI and data will boost drug discovery

Much has been predicted about the use of artificial intelligence (AI) on just about every aspect of life. What impact will it have on life sciences research specifically? This already seems clear. Take, for example, the announcement in April 2019 that AstraZeneca and BenevolentAI have formed a long-term collaboration to use AI (essentially sophisticated algorithms and machine learning) for the discovery and development of treatments for chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF). And, then again, in September, BenevolentAI teaming up with Novartis's precision medicine team to investigate further their existing oncology pipeline.

These diseases are complex and the underlying disease biology is not clearly understood. Research requires the interrogation of vast datasets. Both collaborations are therefore intended to combine known biomedical, genomic, clinical and molecular data, which has been extracted and contextualised using BenevolentAI's proprietary 'knowledge graph', with a target identification platform. This uses relation inference models to help predict potential non-obvious disease targets. They then generate drug-like molecules with optimised treatment properties, for synthesis. In other words, computational techniques are being used to identify biological features, or 'biomarkers', that suggest certain drugs can be used for particular indications and/or subsets of patients within a particular disease group, and working out what those drugs are.

The use of AI in combination with large datasets therefore promises to drive new and more targeted treatments. It is a trend that is not going to be reversed. Indeed, BenevolentAI claims that 90% of the world's data was produced in the last two years alone.

Right on trend, NHS England also has plans to use the wealth of data that it has accumulated over 70 years, once anonymised, to identify groups of people who are vulnerable to health risks and predict which individuals are likely to benefit from healthcare interventions. The NHS also expects this data to be beneficial to companies within the life sciences sphere, as it makes it available to industry with the aim of driving research and innovation.

Moreover, Matt Hancock, the Health Secretary, has the ambition to launch a "genomic revolution" in which all children will be offered genome sequencing at birth, as a matter of routine. This could allow parents the choice to be alerted to specific disease risks, with the potential for the NHS to offer more personalised treatments: "Predictive, preventative, personalised healthcare – that is the future of the NHS – and whole genome sequencing and genomics is going to play a huge part in that."

Then there is what is being claimed as the world's largest genome sequencing project. Announced on 12 September, a consortium of UK Research and Innovation (a UK government agency), The Wellcome Trust, and four pharmaceutical companies (Amgen, AstraZeneca, GSK and Johnson & Johnson) is to fund the genome-sequencing of 500,000 individuals at UK Biobank in Manchester.

Such is the speed at which an individual's DNA can be sequenced that the results of this work are expected in Spring 2020, after which the four companies investing in it will have a nine month period of access before the data is opened up for public access.

It should not be forgotten, however, that there is a lot of work and risk that lies between identification of a drug target and bringing a new treatment to market. But the ambition is that data will boost the possibility of finding the root causes of disease in specific, and smaller, groups rather than 'merely' addressing the symptoms of whole populations.

It is also hoped that, the 'in-silico' methods offered by BenevolentAI and others, will increasingly replace the costly and time-consuming traditional 'wet-lab' techniques for drug discovery, and the costs of drugs will come down. This is important, because one side-effect of providing treatments for ever smaller groups of patients is that the price of treatment increases per individual in order to cover the high research cost. This has already become a significant political issue.

Two political visions

The cost of medicines has been on the agenda of the two political parties most in contention to form the next UK government after the 12 December general election. In particular, the recent case of Orkambi, a treatment to alleviate the symptoms of cystic fibrosis, was picked up by Jeremy Corbyn, leader of the Labour Party, in his conference speech at the beginning of October 2019. With a price of more than £100,000 per patient per year Orkambi was initially too expensive to be funded by NHS England. The government, led by the Conservative Party, has since brokered an agreement to fund the treatment with the drug's maker, Vertex. However, the issue serves to illustrate how the two leading contenders for government take very different political approaches to medical research.

The approach of the Labour Party is to essentially solve problems top-down, by government intervention and ownership, even if it means overriding private property rights. Hence, invoking very rarely used powers for the Crown to bypass patent protection, Mr Corbyn said at the Labour Party Conference that his government would use compulsory licensing to secure generic versions of patented medicines. Patents are intended to provide the market exclusivity necessary to recoup the investment made when developing innovations in the life sciences sector. They are, therefore, the fundamental assets around which the business models of life sciences sector companies are generally built. While the details of this policy are currently unknown, in particular how a candidate for compulsory licence would be identified, it is likely to be criticised as risking a counterproductive, cooling effect on medicine development.

The Labour leader has also suggested creating a new publicly owned generic drugs manufacturer to supply cheaper medicines to the NHS. This would apparently happen in competition with private generics, where there is no other competition and prices are regarded as artificially high. He has not gone so far as to suggest that this would include discovery and development of new medicines. Mr Corbyn also stated that if drugs companies want to continue to access existing public research funding then they will have to make their drugs affordable for all.

The Conservative Party political philosophy is directed more at a bottom-up approach: creating the conditions for boosting research and development to allow market forces (within limits) and new technology (like AI) to solve problems such as high cost and treatment options. The relaxation of certain regulations is also seen as a tool for this purpose. Indeed, in the context of agriculture, the leader of the Conservative Party, Boris Johnson used his very first speech as Prime Minister to pledge to abandon EU environmental rules. Mr Johnson says these have imposed a restriction on the development of genetically modified crop plants (referring to the 'precautionary principle' which requires the producer, manufacturer or importer to prove the absence of danger from genetically modified products).

The Prime Minister has also given instructions to government departments to work with the scientific community to develop a new fast-track visa route for the brightest and best to come to the UK with a view to the UK's continued role as a "global science superpower", and to "develop and export our innovation around the world." This is at one with the ideas of his special adviser, Dominic Cummings, who has written that the UK needs to turn to scientists and engineers and "reasonable people…should pressure their MPs to take their responsibilities to science x100 more seriously than they do".

One of these parties is expected to win the election, either as a minority or majority government. Whichever one it is, there will be very different consequences for the life sciences sector.

London life sciences branch of the UPC

The broader political backdrop to the general election is of course Brexit. In the life sciences area, this gives rise to legal questions concerning the proposed Unified Patent Court and, in particular, its central life sciences division in London.

It is a fact of life in the life sciences sector, given its value and competitiveness, that disputes frequently happen between companies which either want to challenge another's patent or enforce their own. It was therefore highly significant when, in 2013, the "human necessities" section of the central division of the planned Unified Patent Court (UPC) was secured for London. This section would be pivotal to patent disputes covering biotech, pharmaceuticals and other health products.

As currently proposed, any revocation action filed against a European patent or one of the new Unitary Patents (which will be introduced at the same time as the UPC), must be filed in the London branch. Because of the pan-European jurisdiction of the UPC, a revocation of a patent here will have effect across most of the Member States of Europe (unlike the present system where a revocation in a national court only has effect in the Member State for which the patent is registered). The UK therefore has in its midst the convenience and kudos of the most important forum for the resolution of life sciences patent disputes in Europe.

The UPC has, however, hit two major snags. The first is that it cannot be ratified (as it must be) by Germany, until a complaint that was filed against it in the German Constitutional Court has been resolved. Current expectations are that this decision will be made in 2020, but this is not certain. If ratification of the UPC is given the go-ahead in Germany, it is still possible that the court could open in 2020.

The second snag is whether the UK can participate in the court, after Brexit. This is because, although the UPC is not an EU body, it is designed only to admit contracting parties from the EU Member States. The question is whether the UK can legally participate when it is no longer an EU Member State. Debate continues to focus on this question and a number of opinions have been expressed on the issue, with different conclusions. The most recent analysis, however, comes from an EU institution itself – JURI, the Legal and Parliamentary Affairs Committee of the European Parliament. One of the report's conclusions is that "…the jurisprudence of the CJEU is not expressly excluding [sic] the possibility to allow a non-EU Member State forming part of the UPCA."

Rather than seeing a legal bar to UK participation, the analysis instead focuses on how it expects the politics of Brexit to be an obstacle: "Maintaining the UK within the UPCA would need innovative legal solutions, as the UPC is an international court applying EU law – and the reason for Brexit was all about not applying EU law anymore." However, the UK Government has already said that it will explore whether it would be possible to remain within the UPC and Unitary patent after Brexit. The narrow scope of application of CJEU rulings to patent disputes, referred by the UPC rather than a UK court, may not be the political problem that the JURI analysis supposes.

The analysis goes on to admit that "one can only guess that the willingness of the Heads of State and Government will depend on the outcome of the negotiations on the Brexit", but it also recognises that the UPC, as based on an international agreement, can only be modified by unanimous decision of all the contracting states, including the UK. This means that the life sciences section of the Central Division cannot be removed from London without the UK's consent. Should the UK decide it wishes to participate in the UPC, and keep the London life sciences branch, the upshot of the JURI analysis is that it may be in a strong position to negotiate this as part of the future partnership between the UK and the EU.

Burnished or tarnished?

By this time next year, there will be a new government in place, more genomic data available than ever and – hopefully – a decision from Germany on the UPC. By then, it should be clearer quite how brightly the UK life sciences jewel in the crown continues to gleam or whether, like the Imperial Crown, it has lost its place.

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life sciences
Paul England

Paul looks at three defining issues facing UK life sciences innovation in 2020.

"The use of AI in combination with large datasets promises to drive new and more targeted treatments."