Antibiotics: Research and Development

Maggie Throup Excerpts

Tuesday 26th April 2016 Westminster Hall

[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.

--- Later in debate ---

[Maggie Throup (Erewash) (Con)]

It is a pleasure to serve under your chairmanship, Mr Evans. Like my hon. Friend the Member for York Outer (Julian Sturdy), I have also held a debate—an Adjournment debate—on the subject of AMR to look at the use of antibiotics in primary care. The UK, as we all know, is the envy of the world when it comes to research and development into new drugs and new drug technology. Antibiotics have been widely used to treat infections for more than 60 years. Without doubt they have saved many millions of lives, as my hon. Friend said. I doubt whether there is any hon. Member who has not taken antibiotics at some time in their life. It is extensive use that has created the problem that we have today.

Although new infectious diseases have been discovered nearly every year over the past 30 years, very few new antibiotics have been developed in that time. This means that the existing pool of antibiotics are used to treat more and more infections. My hon. Friend the Member for York Outer has eloquently outlined the problems in developing new antibiotics, but one of the consequences of their widespread availability and the relatively low cost of the current antibiotics is the extensive inappropriate prescribing of the drugs for conditions on which they will have no effect. That adds to the increasing resistance to these life-saving drugs.

In preparing for the debate today, I found out that treatment-resistant bacteria are responsible for approximately 25,000 deaths across Europe each year—similar to the number of deaths from road accidents. The “National Risk Register of Civil Emergencies” estimates that a widespread outbreak of a bacterial blood infection could affect 200,000 people in the UK, and if this could not be treated effectively with our existing drugs, approximately 40% of those affected could die: 80,000 people.

There is an urgent need for action to slow the spread of antimicrobial resistance. My hon. Friend the Member for York Outer referred to buying time to allow for the development of new antibiotics to catch up with need. I talked about the number of deaths due to road traffic accidents. We have seen widespread campaigns for road safety, and we need more campaigns to highlight the dangers of the overuse of antibiotics.

In the UK, 74% of antibiotics are prescribed in a primary care setting, and a staggering 97% of patients who ask for antibiotics are prescribed them whether they need them or not. Studies have shown that antibiotic resistance rates are strongly related to use in primary care. They have also shown that more than half of the antibiotics used in primary care are for respiratory tract infections, most of which are either viral in nature or self-limiting.

As this debate indicates, one method of tackling antimicrobial resistance is by incentivising research and the development of new antimicrobials. My hon. Friend made an excellent case for that. That obviously takes time and a huge amount of financial investment. We should also look at the role that diagnostics can play. Diagnostic tests can often be carried out rapidly, giving results in minutes. This allows immediate diagnosis and treatment choices. Such tests also prevent the need for over-prescribing and ensure that patients have the right drugs at the right time.

A couple of years ago, the chief medical officer described the threat of antimicrobial resistance as being

“just as important and deadly as climate change and international terrorism.”

On that basis, and taking all the evidence into consideration, it is vital that the Government do whatever they can to tackle this major threat. If I may be so bold, I will suggest to the Minister that in addition to measures such as incentivising research and development of new antimicrobials, the Government should consider improving access to diagnostic tests in primary care, and focusing research and development funding on diagnostics as well as on drug development.