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Raised political focus on antimicrobial resistance - sufficient to incentivize Industry?

04 November 2013 Maria McGee

In March of this year, we published an in-depth analysis on AMR in a special report titled, "Are we losing the fight against antimicrobial resistance?" With the influenza season around the corner and bacterial infections such as Methicillin-resistant Staphylococcus aureus (MRSA) remaining a big concern in hospitals across Europe, we are reminded about the importance of addressing the issue of antimicrobial resistance (AMR).

Background to AMR AMR occurs when microbes change in ways that reduce or eliminate the effectiveness of drugs, essentially inhibiting the treatment effect or prevention of infection. With the prevalence of AMR has reached up to 25% in some European countries, and the changing pathogen strains constantly posing a threat to the creation of relevant medicine, the need for effective antimicrobial medicines is higher than ever before.

Let's take antibiotics as an example. We have enjoyed the availability of antibiotics for decades- ever since penicillin was developed by Alexander Fleming in the early 1900's. Up until the 1970's, 14 difference classes of antibiotics, with novel mechanisms of action, were discovered after which only five new classes have been introduced. Concerns about AMR began in 1943, just four years after mass production of penicillin began.

All scientific challenges aside, the innovative industry--among other sectors--is confronted with a number of obstacles within this wide and complex therapeutic area. The main barrier facing companies is that high research and development (R&D) costs will not be met by a corresponding return in revenue. Adding to this issue is the limited treatment duration and the prescribing restrictions associated with antimicrobial medicines. These disincentives have left us with a nearly empty pipeline and an urgent need to contain the spread of AMR. In September 2013, the United Kingdom's Department of Health's (DoH) published the "UK Five Year Antimicrobial Resistance Strategy 2013 to 2018" sending a strong message that AMR is on the agenda, at least the political one. But how is the industry incentivized to tackle AMR? Or better yet, are companies incentivized to build on their antimicrobial portfolio?

AMR Policy
The need to work collaboratively in tackling AMR has been acknowledged on a global policy level. In addition to the UK Strategy, countries such as France have taken specific measures to reduce AMR. In the case of France, by regulating the sales of allocated number of drug in order to reduce antimicrobial resistance. We should also note that in Sweden the government joined up with the industry and included the need to address AMR in its National Drug Strategy (NLS) for 2014.

We recently attended the 2013 National Institute for Health Research (NIHR) Conference in celebration of the 20th anniversary of its Health Technology Assessment (HTA) programme. It was evident that keynote speaker, Professor Dame Sally C. Davies, England's Chief Medical Officer, is committed to raising the AMR issue on the political agenda in this country. Professor Davies has previously been cited as comparing AMR mortality rates with that of road accidents and spoke avidly during the conference about the opportunities to collaboratively tackle AMR. As an example, the NIHR is reportedly allocating GBP 4 million to fund a new Research Unit focused on AMR strategy and healthcare-associated infections.

Indeed, Professor Davies vision has been echoed internationally. Sweden's Minister of Health and Social Affairs, Göran Hägglund, spoke in a similar vein during the session Antibiotic resistance - a threat to global health security and the case for action under the 66th World Health Assembly backed by the World Health Organisation (WHO), held in May earlier this year (2013). The meeting identified the central role held by the WHO's Global Task Force on Antimicrobial Resistance, in recognizing that increased global cooperation and partnership will "...identify and promote incentives needed to develop effective business models for development of new therapeutics..." Similarly in 2011, the European wide strategic paper European strategic action plan on antibiotic resistance 2011-2016 set out to work collaboratively to "stimulate the development of new drugs..." and to "promoting innovation and research on new drugs...". However, this raises the question of how this vision is actually being realized.

Efforts to Incentivize
One example of an effort to provide and incentive to the industry is the commitment made by the US FDA, whereby the regulator is granting exclusivity rights to companies in hoping this will "stimulate new antimicrobial drug development." Other efforts to increase research incentives in this area were jointly presented by the European Commission (EC) and the pharmaceutical industry's Innovative Medicines Initiative (IMI) which has allocated EUR223.7 million to tackle and speeding up the development of new antibiotics. The project is one example where governments, academia, and the industry work together to address the AMR issue. More specifically, the UK Governments' regional growth fund is supporting companies such as Redx Pharma and AstraZeneca (both UK) in the development of new antibiotic treatments.

Outlook
It was recognized in the UK's Five Year AMR Strategy that "antibiotic resistance cannot be eradicated". There is, nonetheless, a crucial research gap waiting to be explored, exploited, and funded. And in answer to the question, if a raised political focus is sufficient to incentivize industry, we can point to examples of regulatory and governmental attempts to ensure companies are involved in sharing their expertise and jointly developing the antimicrobial pipeline. However, the industry is struggling to contain its R&D costs while investing in this important area of medicine and one can only argue that, in the absence of unlimited resources, collaborative efforts is one way in which we can more adequately address this impending and increasing issue.

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