At the World Economic Forum in Davos, Switzerland, on 21 January 2016, 85 pharmaceutical, biotech, and diagnostics companies and nine industry associations signed a declaration on combating antimicrobial resistance.
IHS Life Sciences perspective | |
Implications | Among the most important aspects of the declaration were appeals for payors and policy-makers to change the approach to assessing the value of antibiotics. |
Outlook | In light of new developments, such as the spread of colistin-resistant E-Coli bacteria around the world, causing increased levels of concern, the issue of antimicrobial resistance is pushing its way up the list of major challenges governments are facing. The declaration is a positive and important step, but it needs to be backed with changes in approach from governments, in terms of increasing investment in combating antimicrobial resistance, and rewarding research into the development of new treatments. |
Eighty-five companies and nine industry associations signed the "Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance" at an event at the World Economic Forum in Davos, Switzerland, on 21 January 2016. The signatories include major multinational pharmaceutical firms, such as GlaxoSmithKline and AstraZeneca (both UK), and Merck & Co (US), companies that are already committing significant investment to the discovery of new antibiotics. The full declaration can be accessed here.
Calls for establishment of more predictable antibiotics market
In the declaration, the companies and associations stated that they were pleased with "'the increasing recognition'" that the amount paid for antibiotics was not a reflection of their benefit to society and did not provide adequate incentive to invest in the development of new antibiotics. The signatories appealed to governments to make the necessary funds available to establish a 'predictable' market for antibiotics while ensuring their effectiveness – limiting their use to rein in the proliferation of antibiotic-resistant bacteria.
Innovative ideas for rewarding investment welcomed
The companies and associations emphasised the need to improve the financial predictability of the antibiotics market for the pharma industry and healthcare systems, presenting this predictability as a precondition for sustainable investment in new antibiotics and diagnostics. They favoured reducing the link between the volume of consumption of new antibiotics and the financial revenues received from them, and welcomed ideas on how to achieve this reduction. These include a system of 'lump-sum market entry rewards' proposed by the Review on Antimicrobial Resistance (the independent United Kingdom-based research institute). The signatories asserted that the reduced need for promotional activities by producers was essential to all such approaches.
They also agreed that new antibiotics and diagnostics in developed markets should benefit from quick reimbursement decisions and be able to command prices that reflect their value, while stressing that measures must be implemented to prevent misuse.
Signatories make commitments
The signatory companies also made a number of commitments in the declaration. They pledged to invest in research and development (R&D) to develop new treatments and diagnostics, highlighting that companies were already engaged in such investment. They also promised to support collaboration between industry and public researchers to develop new antibiotics and diagnostics, pointing to existing projects such as the "Drugs for Bad Bugs" programme, part of the European Union's Innovative Medicines Initiative, as an example of such public-private collaborations.
Importantly, they also committed to working with payors and policy-makers to develop new valuation mechanisms that would better reflect the level of investment in developing new treatments and diagnostics, as well as their benefits to society.
Finally, they committed their support to the implementation of mechanisms that would make high-quality new and existing antibiotics available to patients around the world who need them, regardless of income. In connection with this, they suggested that a collaborative effort could be made in the case of antibiotics, in the same way as has been done for HIV, tuberculosis, and malaria.
Outlook and implications
The problem of antimicrobial resistance and the declining effectiveness of antibiotics has been near the top of the agenda of global health issues for some years now, but recent events have increased concern among governments about the threat it poses and the speed at which it is developing. The discovery in at least 17 countries (source: University of Minnesota Centre for Infectious Disease and Policy) of Escherichia coli (E-coli) bacteria with the MCR-1 resistance gene, making them resistant to the 'last-line' antibiotic colistin – mostly in animal samples, but also in some human samples – has raised the threat of the arrival of 'untreatable' bacterial infections.
In the Review on Antimicrobial Resistance's December 2014 report ('Tackling a crisis for the health and wealth of nations'), it predicted that antimicrobial resistance could kill 10 million people globally per year by 2050 if it continued to develop at its current rate, overtaking cancer as a leading cause of death. This outlook is starting to be taken seriously, and there are increasing instances of governments making funds available for R&D activities to combat the threat.
The signatories' commitment to backing greater efforts to increase the availability of existing antibiotics in countries with lower incomes relates to the fact that incomplete treatment, or treatment with poor-quality antibiotics, is seen as a major contributor to the spread of resistance to antibiotics.
As companies with employees and shareholders, pharma, biotech, and diagnostics firms need to ensure that their investment will be rewarded adequately. Since antibiotics are an exceptional type of drug, in that their use must necessarily be restricted, it is clear that the current model for assessing their value and setting their prices in healthcare systems needs to be overhauled in light of the growing crisis of antimicrobial resistance. It is hoped that there would be sufficient understanding and an equal level of commitment from payors and policy-makers to ensure the implementation of the necessary changes.