Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-10-26-Speech-3-289-000"
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"Mr President, honourable Members, ladies and gentlemen, one of the greatest challenges facing modern medicine and public health is the emergence and spread of antibiotic-resistant strains of key pathogenic bacteria. Since the end of the 1990s, the problem of drug-resistant microorganisms has been growing at an alarming pace and giving rise to yet more clinical, epidemiological, socio-economic and political problems. A rise is being observed in the number of patients with increased susceptibility to infections with bacteria which are normally non-pathogenic for healthy people and in the number of people in care institutions, who constitute a significant reservoir of resistance.
Honourable Members, what is being planned for the future? All legislative proposals will be based on initiatives from the Commission. I am sure that Mr Dalli will want to say more about his plans for the future in this area. Naturally, the Council will consider favourably all proposals submitted by the Commission. The question of antimicrobial resistance will continue to be a priority for the Council. As far back as 2009, the Council asked the Commission to submit, before the end of 2011, a comprehensive action plan containing specific proposals for incentives to develop new effective antibiotics. We are expecting publication of this document next month. In addition, the forthcoming United States-European Union summit has plans for agreements concerning future cooperation in this area too.
The subject of antibiotic resistance is particularly significant from the point of view of the Council, and so it has been included in the catalogue of priorities of the Danish Presidency, our partners in the Trio. The Danish Presidency has planned a conference on the use of antibiotics, which will be held on 14-15 March next year. The conference will discuss the challenges and threats associated with antibiotic use.
Finally, I would like to note that this House, too, is planning to adopt a resolution on the public health threat of antimicrobial resistance. This will be a continuation of a previous resolution adopted in May, which focussed more on the use of antimicrobial agents in animals. These initiatives show clearly that the Council and the European Parliament are equally interested in this matter and that they also have the same objective: to halt the spread of microorganisms which are resistant to first-line antibiotics and to develop new antibiotics which are effective against resistant strains. In closing my speech, I would like to express my appreciation and thanks to you, the Members of the European Parliament, for discussing this issue – one which is so important for the health of the European Union’s citizens.
This situation is exacerbated by a fall in the interest of pharmaceutical firms in antibiotics which would be effective against multidrug-resistant bacteria. The effective treatment and control of commonly-occurring bacterial infections may be increasingly difficult in the future. The most urgent action which needs to be taken to combat the phenomenon of increasing drug resistance is to invest in scientific programmes aimed at developing new antibiotics and new strategies. The very strict registration requirements, the huge costs of conducting clinical studies and what the pharmaceutical industry considers to be insufficient profits have caused pharmaceutical firms to abandon work on new drugs over the last 20 years, and this has been extremely negligent. I would like to add that only two new molecules have been approved for therapeutic use in that period. Antimicrobial resistance is far from being a new phenomenon. The increasingly frequent occurrence of antimicrobial resistance and the emergence of new resistant strains represent a serious threat to public health. This situation was recognised by the Council as long ago as 1999, when it adopted a resolution entitled ‘A strategy against the microbial threat’ and conclusions on future actions in the framework of the strategy against antimicrobial resistance.
In many of the European Union’s Member States, strains of bacteria have emerged which are resistant to all available drugs. The list of these pathogens is constantly getting longer. We should not expect to see the approval of new and effective drugs against these bacteria in the near future. At least 10 years will be needed to achieve this. Infection with a drug-resistant microorganism significantly reduces the options for proven and safe therapy and requires the use of what are called ‘last-chance’ drugs, which have been failing with increasing frequency recently. Treatment with these antibiotics often has no scientific basis and leads to an increase in the number of adverse reactions and treatment failures. The increase in the costs of the health care needed by patients with multidrug-resistant microbial infections has many aspects. As well as the costs associated with the antibiotic therapy itself, there are also the costs of other drugs which are used in conjunction with these antibiotics, the costs of treating patients in intensive care units and the costs of infection control measures such as microbiological diagnosis, patient isolation and assigning personnel to care for individual patients. When hospital stays need to be extended it is not just the costs of health care which rise, because there are also greater costs associated with people being unfit for work for longer periods.
Since 2001, a huge amount of work has been done in the field of combating antibiotic resistance. I would like to mention several examples. Firstly, the second report from the Commission to the Council on the implementation of the Council recommendation on the prudent use of antimicrobial agents in human medicine, published in April 2010. This report contained an account of the progress made by the Member States under the many different initiatives undertaken since publication of the first report.
Secondly, specialised agencies of the European Union, and in particular the European Centre for Disease Prevention and Control, the European Medicines Agency and the European Food Safety Authority are working closely together in this area. For example, two Europe-wide surveillance networks are currently in existence: EARS-NET, the European Antimicrobial Resistance Surveillance Network, and ESAC, European Surveillance of Antimicrobial Consumption, which monitors consumption in human and to a small extent in veterinary medicine.
Thirdly, a series of measures has been put in place to fight antimicrobial resistance related to the food chain. For example, European Union law on feeding animals has prohibited the use of growth-stimulating antibiotics in animal feed since January 2006. Also being monitored are trends in antimicrobial resistance in animal disease and in infections transmitted from animals to humans and other factors which might pose a threat to public health.
Finally, at international level the European Union supported the adoption of a European strategic action plan on antibiotic resistance at the meeting of the Regional Committee for Europe of the World Health Organisation which was held in September this year. Together with the United States we have also set up the Transatlantic Taskforce on Antimicrobial Resistance.
On the question of the prudent use of antibiotics, the Council has invited the Member States several times to take action intended to ensure the prudent use of authorised antimicrobial agents in human and veterinary medicine, in particular in the conclusions on antimicrobial resistance adopted in June 2008. In these conclusions, the Council called on the Member States to strengthen surveillance systems and improve the quality of data on antimicrobial resistance and the use of antimicrobial agents, and also to promote the prudent use of antibiotics in both the human and veterinary sectors.
Development of new antimicrobial agents and the significant role played by systems which encourage investment in research are questions which are being considered by the Council. In its conclusions on innovative incentives for effective antibiotics adopted in December 2009, the Council called upon the Member States to strengthen incentives to conduct research and development of new effective antibiotics. It also called upon the Member States and the Commission to facilitate the development of new antibiotics for which a particular need exists in medicine and also to identify appropriate regulatory instruments to facilitate early approval for new antibiotics."@en1
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