Pharmaceutical Technologist - July 2007 - (Page 8)

News // Antibiotic development crisis More people will die from previously treatable infections unless urgent action is taken to treat antibiotic resistance, according to a new report. The European Academies Science Advisory Council’s Tackling antibacterial resistance in Europe, highlights the increasing problem of drug resistance in pathogens, such as MRSA, Clostridium difficile, E-coli and infectious diseases such as TB, pneumonia and meningitis. Hospital-acquired infections alone already account for 175000 deaths each year in Europe, with many attributable to antibiotic resistance. “Our concern is that the European policy makers are not doing enough to stimulate the development of new antibacterial drugs and encourage information sharing between member states,” said Professor Volker ter Meulen, president of the Leopoldina Academy of Sciences and chair of the group of experts compiling the report. Short-term measures recommended by the report include better awareness of the issues, improved surveillance, wiser use of antibiotics and containing the spread of resistance. However, for this to work, drug companies will need to be given incentives to continue antibiotic research, compared with treatments for long-term chronic illnesses, which provide greater financial returns. The report calls for the development of cheap and simple diagnostic tools to identify specific infections as early as possible. To strengthen the science base in basic and clinical research, links between universities and their associated hospital services must be built upon, with the experts also calling for greater input from the social sciences. The reports concludes by recommending measures to help the pharmaceutical industry with this issue including supplemental intellectual property protections, tax incentives for R&D, guaranteed market, liability protections, SME-specific support and a new independent body to prioritize discovery research objectives and to target incentives. www.easac.eu Greater regulatory co-operation EU and US regulatory bodies have revised their relationship to create an improved method of exchanging information, enabling a more unified regulatory system for the pharma industry. At a June meeting this year, EMEA, the EC and FDA reviewed the past year’s activities under the existing Implementation Plan for the confidentiality agreement. The bodies agreed to expand their current co-operative activities, strengthening existing frameworks and implementing strategies to enable smooth interactions between the continents. The focus was on regulating paediatric and orphan drugs, although the agencies improved understanding and clarity on how future interaction between the regulatory bodies should be recorded and conducted. The greatest change was the implementation of a ‘Principles of Interactions’ document, detailing regulatory requirements of co-operation and transparency between the US government and the EC for paediatric therapeutics. Such legislation on these medicines was only introduced in Europe this year, with the meeting bringing it into full force. The aim is for a frequent exchange of scientific, ethical and other information on relevant development programmes in Europe and the US to avoid exposing children to unnecessary trials, and to ultimately implement global paediatric development plans, compatible for both agencies. New areas of transatlantic co-operation were discussed, specifically on medical devices, with talks continuing during the coming months. Also targeted was co-operation on new medicines legislation, and further planning was made on a Transatlantic Workshop on Administrative Simplification in Medicines Regulation to be held in November this year. These educational workshops are aimed at increasing understanding of the processes used by the corresponding authorities. According to an official press release from the bodies, the collaboration has allowed “each side to share common experiences and gain an understanding of each other’s regulatory system,” with each side striving to reduce “unnecessary differences in regulations and reduce associated costs to the consumer and industry”. www.ec.europa.eu www.emea.europa.eu 8 July 2007 l pharmaceutical technologist http://www.easac.eu http://www.ec.europa.eu http://www.emea.europa.eu

Table of Contents for the Digital Edition of Pharmaceutical Technologist - July 2007

Contents
Editor's Comment
News
Morpheus
Market Watch
Market Trends for Self-Injection Technologies
Special Delivery
Q&A

Pharmaceutical Technologist - July 2007