Antibiotics are among the most under-valued of medicines. The ability to treat infection is a good in itself, but it also underpins many hospital-based procedures that we take for granted - such as transplantation and the care of pre-term babies. Antibiotics are not the only way that we can address the risk of infection, but they remain a vital part of our armoury. Despite this, we have a trend in new antibiotics reaching the market - which shows a decline in quantity and diversity. And, most surprisingly, a lack of drugs to treat the most serious threats.
This is a pattern which seems to have developed over the last 30 years and it is reinforced by figures showing how many companies used to be active in the area and how many are active now. As a result, we are now at the point of having few if any alternatives to treat infections that are becoming increasingly common. At first glance, it is hard to understand this trend. Pharmaceutical companies remain committed to developing and marketing medicines that address serious unmet need. However, the industry depends on having the right framework in which to operate. What we lacked was an integrated approach. Public authorities assumed that the industry would continue to produce new antibiotics, while also being concerned to better control the use of new antibiotics. Meanwhile, the industry was progressively deterred by diminishing returns and difficult science – and at the same time staying focused on its existing business model and not looking at alternatives. We are now moving past that point and are taking the first steps in putting a new strategy in place.
A first step is to look at how we can make the research and development process more efficient. Our existing partnership with the European commission - the innovative medicines initiative - will announce a programme in the antibiotic area later this year or in early 2012. We are seeing this as the first step in putting the new business model in place so it is not intended to be a one-off project, but a pilot for how we might work differently in the long term. As well as advancing collaboration in research, we also believe there is scope to enhance the medicines regulatory process through better application of new technologies. The wider challenge concerns the way antibiotics are commercialised and distributed. The industry business model relies on volume sales. This approach does not work for new antibiotics, where it is important to manage use to conserve effectiveness - so we will need to find alternatives which still preserve business incentives for investing in R&D.
There are many ideas for promoting innovation and we need to examine these. Our preliminary thoughts are that there is no "one size fits all", which applies to every area of innovation. Policymakers want a mix - greater numbers of new antibiotics, greater diversity, minimal financial impact on health systems, incentives to conserve rather than promote and global access. What is needed is a collection of incentives that address the multiple obstacles to success. The type of approach is one important building-block. To reverse the decline, companies must want to invest in this area - but new business model also needs to meet society's expectations. The most obvious of these is that it delivers safe effective antibiotics. It can also be expected that public support for antibiotic research will be conditional on ensuring equal access to all citizens of the world.
One idea on which we would welcome comments is a global compact among all stakeholders, governing how medicines will not be introduced and used. Above all - a worldwide deal would require that not only industry but also governments, physicians and pharmacists and others join forces to preserve the new medicines that future generations need. This must be a joint endeavour. The goal is to ensure that we have a sustainable R&D platform with public and private sector elements, which can deliver the ability to treat infection as and when new challenges emerge. In the pharmaceutical industry, we are committed to being an active part of the solution in collaboration with other stakeholders. We cannot afford to be back here in 10 years, looking at a continuation of current trends in research and development.
This is a pattern which seems to have developed over the last 30 years and it is reinforced by figures showing how many companies used to be active in the area and how many are active now. As a result, we are now at the point of having few if any alternatives to treat infections that are becoming increasingly common. At first glance, it is hard to understand this trend. Pharmaceutical companies remain committed to developing and marketing medicines that address serious unmet need. However, the industry depends on having the right framework in which to operate. What we lacked was an integrated approach. Public authorities assumed that the industry would continue to produce new antibiotics, while also being concerned to better control the use of new antibiotics. Meanwhile, the industry was progressively deterred by diminishing returns and difficult science – and at the same time staying focused on its existing business model and not looking at alternatives. We are now moving past that point and are taking the first steps in putting a new strategy in place.
A first step is to look at how we can make the research and development process more efficient. Our existing partnership with the European commission - the innovative medicines initiative - will announce a programme in the antibiotic area later this year or in early 2012. We are seeing this as the first step in putting the new business model in place so it is not intended to be a one-off project, but a pilot for how we might work differently in the long term. As well as advancing collaboration in research, we also believe there is scope to enhance the medicines regulatory process through better application of new technologies. The wider challenge concerns the way antibiotics are commercialised and distributed. The industry business model relies on volume sales. This approach does not work for new antibiotics, where it is important to manage use to conserve effectiveness - so we will need to find alternatives which still preserve business incentives for investing in R&D.
There are many ideas for promoting innovation and we need to examine these. Our preliminary thoughts are that there is no "one size fits all", which applies to every area of innovation. Policymakers want a mix - greater numbers of new antibiotics, greater diversity, minimal financial impact on health systems, incentives to conserve rather than promote and global access. What is needed is a collection of incentives that address the multiple obstacles to success. The type of approach is one important building-block. To reverse the decline, companies must want to invest in this area - but new business model also needs to meet society's expectations. The most obvious of these is that it delivers safe effective antibiotics. It can also be expected that public support for antibiotic research will be conditional on ensuring equal access to all citizens of the world.
One idea on which we would welcome comments is a global compact among all stakeholders, governing how medicines will not be introduced and used. Above all - a worldwide deal would require that not only industry but also governments, physicians and pharmacists and others join forces to preserve the new medicines that future generations need. This must be a joint endeavour. The goal is to ensure that we have a sustainable R&D platform with public and private sector elements, which can deliver the ability to treat infection as and when new challenges emerge. In the pharmaceutical industry, we are committed to being an active part of the solution in collaboration with other stakeholders. We cannot afford to be back here in 10 years, looking at a continuation of current trends in research and development.
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