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World Health Day 2011 - Information for the pharmaceutical industry
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Bacteria that cause common and life-threatening infections are becoming increasingly resistant to antibiotics. This is largely due to the widespread overuse and misuse of antibiotics in humans and animals, and in other sectors. This urgent problem is threatening the health of the people in Europe and worldwide. The pharmaceutical industry can and should play a key role in tackling antibiotic resistance.
Every year in the European Union (EU), Iceland and Norway, an estimated 25 000 patients die as a result of a serious resistant bacterial infection, most of them in hospitals. Weak diagnostic capacity and incomplete data in the remaining countries of the WHO European Region mean that the overall number of deaths in the Region is not known, but is likely to be much higher.
The pharmaceutical industry, research institutions and academia bring new antibiotics to the market and can help ensure the prudent use of existing antibiotics, by avoiding irresponsible promotional marketing practices that could lead to the misuse and overuse of antibiotics.
Although the emergence and spread of antibiotic resistance can be slowed down by the rational use of antibiotics, also new products must be developed to prevent, diagnose and treat infections that are becoming increasingly difficult to treat or prevent with the antibiotics currently available. This requires urgent investment in research and development as well a dialogue on the use of antibiotics in human and animal health or food production.
Effects on the pharmaceutical industry
Without new antibiotics, and with increasing antibiotic resistance, society could return to the conditions of a pre-antibiotic era: simple infections cannot be tackled, and medical interventions such as organ transplants, surgery, or minimally invasive diagnostic interventions, would become almost impossible. Drug resistance is also a pressing problem in the treatment of tuberculosis, particularly in the WHO European Region, which counts 15 of the 27 countries in the world with a high multi-drug resistant tuberculosis burden.
There are a number of particular concerns.
* Very few new antibiotics have been developed in recent years owing to the relatively poor financial attractiveness of the market. Even where there are new public – private research and development partnerships on tuberculosis and HIV/AIDS, there is little in the pipeline for new antimicrobials.
* Some recently developed diagnostic and therapeutic agents have been slow in reaching intended users. This is due to regulatory bottlenecks, limited financing and weak logistics to get them to those in need: facilities and patients in the poorest communities.
* In many countries the factor making the greatest contribution to the emergence of antibiotic resistance, whether irrational use of antibiotics, poor quality of drugs, use of antibiotics in food animal industry, or lack of infection control, remains unknown. However in general, the overuse and misuse of antibiotics provide the opportunity for resistant bacteria to become dominant and to spread.
What you can do
* Continue efforts in research and development for new antibiotics by undertaking and stimulating basic research, exploring and developing new research and development financing approaches and pricing policies.
* Discuss, promote and explore collaboration with academics and other financing partners to support the development of new antibiotics. For public health reasons new antibiotics need to be used with great restraint as reserve antibiotics and their market and potential returns may therefore make research and development less attractive. Partnerships with academia and public research institutions can create further incentives for antibiotic research and development. Innovative financing mechanisms, such as advance market commitments, prize funds, and others as outlined in World Health Assembly resolution WHA61.21 on Public Health, Innovation and Intellectual Property, as well as public funding, may also create alternatives for promoting much needed research and development in antibiotics.
* Refrain from irresponsible promotion practices: promotional practices aimed at doctors and financial incentives for pharmacists may stimulate the unnecessary use and misuse of antibiotics by patients. Information aimed directly at patients may also create an unnecessary demand for antibiotics.
Strategic action
The WHO Regional Office for Europe has developed a seven point strategic action plan on how to tackle antibiotic resistance, which will be launched in September 2011. The first recommendation of the action plan focuses on national coordination of all areas related to antibiotic resistance. The plan points out the importance of monitoring antibiotic consumption and antibiotic resistance and also of controlling resistant bacteria in health care settings as well as in the veterinarian, agriculture and animal feed sectors. It also includes as a specific objective, addressing the need to invest in new antibiotic drugs and diagnostic tools.
The seven points of action are:
1. strengthening national multisectoral coordination on the containment of antibiotic resistance;
2. strengthening national surveillance of antibiotic resistance;
3. promoting national strategies for the rational use of antibiotics and strengthening national surveillance of antibiotic consumption;
4. strengthening infection control and surveillance of antibiotic resistance in health care settings;
5. preventing and controlling the development and spread of antibiotic resistance in the food chain;
6. promoting innovation and research on new drugs and technology; and
7. improving awareness, patient safety and partnership.
The pharmaceutical industry will be an important partner in helping to make this plan work and address the urgent challenge of antibiotic resistance across the European Region.
For further information on antibiotic resistance, please contact:
Dr Bernardus Ganter
Senior Adviser, Antimicrobial Resistance, Division of Communicable Diseases, Health Security and Environment
WHO Regional Office for Europe
Scherfigsvej 8
DK-2100 Copenhagen Ø
Denmark
Tel.: +45 39 17 14 23
E-mail: bga@euro.who.int
Dr Kees de Joncheere
Pharmaceuticals and Health Technology
WHO Regional Office for Europe
Tel.: +45 39 17 14 32
E-mail: cjo@euro.who.int
For further information and interview requests, please contact:
Ms Viv Taylor Gee
Regional Adviser, Communications
WHO Regional Office for Europe
Scherfigsvej 8
DK-2100 Copenhagen Ø
Denmark
Tel.: + 45 39 17 12 31
E-mail: VGE@euro.who.int