Innovative incentives are urgently needed for the development of new antibacterials, as the problem of bacteria that cannot be treated with conventional antibiotics is growing, while at the same time the level of research into – and the development of – new effective antibiotics is decreasing, the Swedish Presidency of the European Union (EU) has said.

Last week, the Presidency held a meeting of experts in Stockholm which discussed the findings of a new report on the situation prepared by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMEA) with the international network Action on Antibiotic Resistance (ReAct).

The report reveals that resistance to antibiotics is high among Gram-positive and Gram-negative bacteria that cause serious infections, reaching 25% or more in several EU member states, and is increasing among certain Gram-negative bacteria, such as E coli. Each year, at least 25,000 patients in the EU die from an inflection related to multi-drug-resistant bacteria, and these infections result in additional healthcare costs and productivity losses of at least 1.5 billion euros each year.

15 systemically-administered antibacterial agents with a new mechanism of action or which are directed against a new bacterial target are now under development and have the potential to meet the challenge of multidrug resistance, but most of these are in early phases and have been primarily developed against bacteria for which treatment options are already available, the meeting heard.

Moreover, there is a particular lack of new agents with novel targets or mechanism against multidrug-resistance gram-negative bacteria, with just two such treatments identified as being in early phases of development, the report notes.

Bo Aronsson, who is responsible for the EMEA’s part of the study, warned that, without stimulating R&D into new antibiotics, an increasing number of infected patients will be without effective treatment. In this situation, patients suffering from healthcare-associated infections will be particularly hard hit, added his counterpart at the ECDC, Dominique Monnet.

The conference also discussed a report commissioned by the Swedish Presidency from Elias Mossialos, professor of health policy at the London School of Economics (LSE), which says that the potential for an impending health crisis due to the lack of new antibiotics would justify “some intervention” by a public body.

Prof Mossialos has, with David Brogan of the Mayo Clinic, USA, devised a Call Options for Antibiotics (COA) model of incentives for R&D, under which a potential purchaser could, during a drug’s development, buy a right to purchase a specified amount of the drug at a later date for a specified price. If the drug never comes to market, the purchaser pays only a premium equal to the cost of the initial “option” contract. A fair valuation of an option will make the current value of the premium equal to the expected future profile from holding the option, and this means the purchaser is protected from the full risk associated with development, while the developing company is given an additional, earlier incentive to continue develop, say Prof Mossialos and Dr Brogan.

However, they add, the greatest challenge will be to persuade companies to invest in a market with low returns.

They also believe that while reimbursement and price re-structuring could have a significant effect on investment in antibiotic R&D in Europe, this would need a standardized EU-wide approach to assessment of such products in order to succeed and would be essentially a longer-term approach. However, in the short term, even minor price-restructuring within EU member states could help pull in vital investment into antibiotics research, they add.