Antibiotics: Research and Development

Julian Sturdy Excerpts

Tuesday 26th April 2016 Westminster Hall

[Julian Sturdy (York Outer) (Con)]

I beg to move,

That this House has considered incentivising research and development of new antibiotics.

It is a pleasure to serve under your chairmanship for the first time in this hall, Mr Evans. I am delighted to have secured the opportunity once again to introduce a debate on the increasingly urgent issue of antibiotic resistance. I first debated this issue back in October 2014, when I discussed the wide-ranging causes of antimicrobial resistance—AMR—and our urgent need to address the problem head-on.

Today, I will focus on the most pressing elements of the issue: the need to incentivise more research and development of new antibiotics so that we have new drugs coming on stream to meet our future needs. Before I discuss the development of a new funding model for antibiotics, I will briefly explain exactly why AMR is such a pressing issue. This is far from being a problem only for the future; it came as a shock when, before my last debate, doctors in my constituency told me that patients were already experiencing the devastating effects of AMR. Across the country, we are seeing an increasing number of patients in intensive care units who have resistant infections, meaning that there is no effective treatment available. Antimicrobial-resistant infections already kill some 50,000 people every year across Europe and north America, but sadly the reality of AMR today is nothing compared with the nightmarish scenario of the future. The initial paper of Lord O’Neill’s AMR review concluded that

“a continued rise in resistance by 2050 would lead to 10 million people dying every year”.

That is more than the number of people who will die of cancer, and it is double the number of people who will die of cholera, diabetes, diarrhoea, measles, tetanus and road traffic accidents combined. Some might say that AMR is the biggest threat to mankind.

We have also been warned that the secondary health effects of AMR could result in a return to the dark ages of medicine. Our national health service and other modern health systems across the world rely heavily on antibiotics. When surgery is undertaken, for example, patients are given antibiotics to reduce the risk of infection. In a world in which antibiotics do not work, surgery will become far more dangerous. Many routine procedures, such as hip operations, will become too risky for many elderly patients, depriving them of their mobility and their active lives. Cancer treatments such as chemotherapy supress patients’ immune systems, making them more susceptible to infections. Without effective antibiotics to prevent those infections, such life-saving treatment could no longer be an option. As Jeremy Farrar, a director of the Wellcome Trust, said:

“We are sleepwalking back into a time where something as simple as a grazed knee…will start to claim lives.”

Thankfully, medical opinion is, in the vast majority of cases, that the looming global crisis can be avoided if we take action, but it must be taken sooner rather than later. It is encouraging that there have been numerous positive developments since this topic was last debated in Westminster Hall. The £20-million Fleming fund was announced in March 2015, and it will support the delivery of action plans for AMR laboratory surveillance across the world, with a particular focus on low-income countries. Just before the 2015 general election, I was delighted that the Conservative party manifesto said:

“Antibiotic resistance is a major health risk so we will continue to lead the global fight against it, taking forward the recommendations of the independent review launched by the Prime Minister”.

I promise that that will be my last reference to party politics, because this issue has the support and attention of every party in this House. AMR is such a huge issue that it transcends party politics.

[Chi Onwurah (Newcastle upon Tyne Central) (Lab)]

I thank the hon. Gentleman for securing this debate on an important subject. Before he completely passes on from party politics—I agree that this issue cuts across all party politics—does he agree that the nature of antibiotics, and the fact that we want to use them as little as possible when they are discovered or invented, drives against the free market system, in which new products and services are used as much as possible? For that reason, the Government and the public sector must take action, because to be effective, antibiotics should be used not as much as possible but as little as possible.

[Julian Sturdy]

I agree with the hon. Lady’s last comments. She is right that antibiotics must be used as a last resort, which is why, as I will say, the current funding model for antibiotic research is broken, and why we have to correct it.

[Maggie Throup (Erewash) (Con)]

I take the point raised by the hon. Member for Newcastle upon Tyne Central (Chi Onwurah), with which my hon. Friend the Member for York Outer (Julian Sturdy) has just agreed. This is also about having the right diagnostic tests to ensure that people who need antibiotics receive them while ensuring that they are no longer handed out like sweets.

[Julian Sturdy]

My hon. Friend is right. Later in my speech, I will discuss the model of how antibiotics are used across the country. It is chilling how antibiotics are used in different parts of the country. Testing to find out resistance to certain antibiotics is also important before any antibiotics needed are used. It is not just a matter of how we bring new antibiotics to market, which can take 15 years; it is also about how we protect our existing armoury of antibiotics to buy us time for those new antibiotics to reach the market.

The £1 billion Ross fund was announced by the Chancellor in the spending review of November 2015. Some £350 million will be spent fighting AMR by strengthening surveillance of drug resistance and laboratory capacity in developing countries, and by delivering the new global AMR innovation fund with China. In January 2016, at the World Economic Forum in Davos, 85 major pharmaceutical and biotech companies agreed to the declaration on combating antibiotic resistance, which demonstrates the industry’s willingness to take up the challenge. Earlier this month, the Chancellor addressed the issue once again by highlighting the importance of AMR at the International Monetary Fund in Washington DC. He confirmed what the industry has long been telling us: that the reimbursement models for antibiotics are broken. I entirely agree that a global overhaul is required, and I will focus on that issue today.

Lord O’Neill has also backed proposals to change the way we develop new antibiotics for the marketplace. We all look forward to the AMR review publishing its final set of recommendations in the months ahead, and the Minister might be able to give us a firmer timescale for that review. In my previous debate on antibiotic resistance, I raised the key issues at stake in the growing challenge of this continuing problem. We know that using antibiotics inappropriately increases resistance and the risk associated with routine treatments. In the last debate on the subject, I mentioned that in India, many prescriptions are purchased over the counter to treat a wide variety of unsuitable illnesses, often with no professional diagnosis. Such practices compound the problem. However, it is greatly encouraging that many countries around the world have now woken up to the impending disaster that we could face if we simply do nothing.

As a consequence, things are starting to move forward, which must be seen as positive. However, the central challenge of getting new antibiotics on stream remains. As the Chancellor said earlier this month and as we have heard, the current funding model is no longer fit for purpose. The O’Neill report makes it clear that it typically takes about 15 years for an antibiotic to go from the initial research stage to final delivery to the marketplace. For that to happen, a large amount of money is required up front to fund the project, at a stage when the company has absolutely no idea whether the drug will succeed. Astonishingly, only about 2% of products, or one in 50 proposed new antibiotics, successfully make it to the marketplace. In the vast majority of cases, large sums of money are invested with no financial return whatever.

Although to a certain extent that is true of the manufacture of all new drugs, the problem is far worse for antibiotics. Conditions such as cancer or diabetes often closely follow demographic trends, so new drugs are also used as the medication of choice for cancer or diabetes, as they are more effective than the older prescriptions. In the case of antibiotics, however, generic products can treat infections as well as new drugs for far less money, except where there is resistance. Furthermore, in the attempt to slow the development of resistance, new antibiotics are often held back and are prescribed only when everything else has failed. That is the right thing to do. The market for new antibiotics is therefore limited to a small section of patients, as new drugs are used only when existing drugs are no longer effective. They will be required as a first-line treatment only many years after their introduction, by which time their exclusive patents have often expired.

That may explain why so many pharmaceutical companies have, sadly, exited the market over the years. Of the 20 pharmaceutical companies that were the main suppliers of new antibiotics back in the 1990s, only four remain. Furthermore, only five new classes of antibiotics have been discovered in the last 15 years. Sadly, some companies are waiting for resistance to rise before they even explore the viability of investing in a new product, which is clearly not in the best interest of patient health and wellbeing, or of the future of health care as we know it. Under the current funding model, the profitability of any new drug depends entirely on how many units are sold. As discussed, that is not suitable for the development of new antibiotics. Incentivising the increased use of antibiotics only increases resistance in patients, which can have devastating consequences.

The O’Neill review therefore proposes the creation of a more predictable marketplace that will sustain commercial investment in antibiotic research and development. A key proposal that has the full support of many pharmaceutical companies is for profitability to be de-linked from volume of sales for new antibiotics. That would guarantee developers an acceptable return on their investment when they produce a new antibiotic that fulfils an unmet clinical need. That is especially important when volume would not be sufficient to make the product commercially viable, despite its value to the NHS. A de-linked model also has the added benefit of eliminating any incentive to oversell antibiotics needlessly as cure-all miracle drugs, which, sadly, still occurs.

Before being elected as a Member of this House, as many know, I was a farmer—a farmer who produces food, not a pharma who is part of the prescription sector—so I do not pretend to know exactly what model is right for our national health service. However, it seems to me that an insurance-based approach that shares financial risk is certainly worth the Government’s consideration. Providing developers of the most important antibiotics with a fixed fee would remove the current financial uncertainty from the marketplace. It would also limit financial uncertainty for the NHS: if there were an outbreak of an infection requiring the antibiotic, the costs would be capped at an agreeable level.

I understand that AstraZeneca and the Association of the British Pharmaceutical Industry have been working closely with the Department of Health to develop such a model. We must continue to encourage innovation while doing what we can to remove the financial uncertainty of developing key new antibiotics. At the same time, it is essential that any new funding model provides the best possible value to the taxpayer. There should be no additional support in areas that are already adequately supported by the marketplace.

[Chi Onwurah]

I thank the hon. Gentleman for being generous in giving way a second time, and for making an excellent summary of the case. Although the state—the national health service—should share the risk, does that not mean that it should also share the benefits and returns? As the economist Mariana Mazzucato sets out in “The Entrepreneurial State”, where the state invests, particularly in services such as this one, there should perhaps be a return to us as well, so that the upside as well as the downside is shared.

[Julian Sturdy]

I do not disagree at all. There must be a return, in the first place, for the companies looking to develop drugs, or they will not come forward. Delivering new antibiotics must be viable. At the same time, it is absolutely right that if the Government, the NHS or, ultimately, the taxpayer invests in those drugs, they also must see the benefit and the return. When we talk about risk, we are talking about shared risk, and if we are talking about shared risk, we should be talking about shared return.

I hope to receive the Minister’s undertaking that he will continue to work closely with companies such as AstraZeneca and with the Association of the British Pharmaceutical Industry to develop a model that supports innovation and removes financial uncertainty. The industry has asked for a clear timetable of action on the development of a new funding model, as it is essential that we turn our positive words into meaningful change.

However, it is worth saying that pharmaceutical companies do not have a monopoly on innovation, and they alone cannot solve the colossal problem of AMR. Within our rich medical marketplace across the country, there are a range of other organisations that are well positioned to offer invaluable assistance in this exciting area of discovery. In fact, the O’Neill review makes it clear that the research and development of antibiotics must be opened up, offering new opportunities for small and medium-sized enterprises, academic research teams and not-for-profit entities to compete with established players in the market.

I am proud to say that one such charity is based in my constituency: Antibiotic Research UK, or ANTRUK, is the first charity in the world set up to tackle the challenge of the scarcity of new antibiotics to treat resistant bacterial infections. Some of the country’s leading scientific and clinical experts form part of this team, and they all share the same concern about the slow progress made in combating AMR, as well as a passion for taking practical steps to take up the challenge.

The charity has three key missions: first, to develop a new antibiotic therapy by the early 2020s; secondly, to educate both practitioners and the public alike about the threat of AMR; and thirdly, to provide support to patients with antibiotic-resistant infection. In less than two years, ANTRUK has raised over £400,000, and it is working towards a programme of developing antibiotic resistance breakers. This technique reverses the resistance and extends the life of existing antibiotics. ANTRUK believes that is the best hope of finding a way of breaking AMR in the short term. Basically, it is a way of buying us more time to develop new antibiotic drugs.

Charities such as ANTRUK are ideally placed to work with both the Government and large pharmaceutical companies in finding a solution to AMR. However, to maximise its effectiveness, ANTRUK needs our support. Despite being a new player in the industry, it is already demonstrating the innovative ways in which it can help to inform public policy on AMR, an issue touched on earlier in an intervention.

In co-operation with an analytic database company, ANTRUK has published a heat map of England that shows how the number of antibiotic prescriptions varies across the country. I am happy to show this map to interested Members. The results are absolutely fascinating. The research demonstrates that the number of antibiotic prescriptions being given is rising at an alarming rate in some of the most hard-pressed areas of England. The key findings are that there is a widening gap in antibiotic prescription. For example, doctors in London prescribe 20% less antibiotics than doctors in the north, and doctors in the most hard-pressed coastal towns in Lincolnshire, Norfolk and Essex are prescribing the most. In Clacton-on-Sea, the number of antibiotic prescriptions by doctors is almost double the national average. Furthermore, doctors prescribe almost 60% more antibiotics in December than they do in August. At first glance, that might not seem surprising, but many illnesses treated by antibiotics are not seasonal in nature. Is this another example of the potential misuse of antibiotics? On a positive note, it appears that the number of prescriptions peaked at 3.4 million in 2012 and has since dropped by more than 5%.

Such research is absolutely vital in the fight against AMR. It demonstrates how charities can complement the vital work of Government and the large pharmaceutical companies. Consequently, I would be most grateful to the Minister if he would agree to meet me and a delegation from ANTRUK to discuss how the Government can assist it with its mission to combat AMR. A key request is for a relatively small amount of funding from the £12 billion foreign aid budget to assist ANTRUK’s work, which could have a revolutionary impact across the world, particularly in developing countries.

I have already had one such meeting with the Under-Secretary of State for Health, my hon. Friend the Member for Battersea (Jane Ellison), who has responsibility for public health, along with my hon. Friend the Member for Thirsk and Malton (Kevin Hollinrake), who is also my neighbour. Sadly, he could not attend today’s debate. That meeting proved to be immensely helpful, and I hope that the Minister will agree that charities, and not just the large pharmaceutical companies, have a key role to play in the fight against AMR.

Ultimately, antibiotics are often woefully undervalued, in the sense that their price often bears no resemblance to their overall value to society. Since Dame Sally Davies published her report on the threat of AMR back in 2013, there has been an unprecedented focus on the need to change how we tackle the threat of resistance. However, this concern and the widespread discussion of the topic need to be translated into action if we are to tackle the problem head-on.

Antibiotics are the fire department of our health service, and they need a better funding model. We do not pay our firefighters only when they put out a fire; nor do we think that it is a poor return on our investment when they are not in action. Instead, we ensure that we have a well-funded fire service in place at all times, to protect us in our hour of need. It is a service that we all take for granted, and exactly the same is true of our use of antibiotics.

It is probably fair to say that whoever discovers the cure for cancer will go down in history, but the pioneer who prevents a return to the dark ages of medicine through a new antibiotic discovery will probably be forgotten. Nevertheless, the clock is now ticking, and producing positive noises without taking action is simply not an option. I hope the Minister will agree to publish a clear timetable on reforming the antibiotic funding model, and I also ask him to meet me and representatives of ANTRUK, who I know have so much to offer in furthering the process of making our next great discoveries.

I hope that the Minister will work with Departments across Government to give due consideration to the idea of allowing a greater proportion of our generous foreign aid budget to be used in this vital area of study. We have the potential to be world leaders in this field. I have heard, as other Members probably have, reports that Sweden is exploring options for changing its funding model. We must not let Sweden steal a march on us.

It was British innovation that ushered in the golden era of medical discovery. Without action, we risk squandering that legacy for future generations, who may not have the benefit of antibiotics as we know them today. It is absolutely right that global action is required to solve what is ultimately a global problem, as drug-resistant bacteria do not recognise national boundaries. We have the opportunity to safeguard the future of medicine as we know it. To achieve that goal, we must both set the standard and rise to the challenge, and hopefully the rest of the world will follow us.

[Several hon. Members rose—]

--- Later in debate ---

[Julian Sturdy]

I thank the Minister for his comments. He is absolutely right to say that 2016 is a crucial year. There have been many detailed and thoughtful contributions this afternoon, especially about the devastating impact of TB and drug resistance. I want to finish by going back to the firefighter analysis, just to please the hon. Member for Poplar and Limehouse (Jim Fitzpatrick). If we have a chip pan fire, we put it out to prevent a house fire. Antibiotics put out the chip pan fire by preventing the spread of infection, but they also go on to prevent a house fire, because without them we would have widespread outbreaks of infection. Without antibiotics, we could have widespread outbreaks running right across the country, uncontrolled, like wildfires. As many hon. Members have said, a world without antibiotics is a very—

Motion lapsed (Standing Order No. 10(6)).