05/14 Professor Kurth: BfArM fit for the futureMain priority: Patient protection
Press release 14/2005
The Federal Institute for Drugs and Medical Devices (BfArM) in Bonn is “fit for the future“ now that the phase of re-structuring is completed – these are the words of the head of the institute, Prof. Dr. Reinhard Kurth, at the press conference of the Federal Ministry of Health and Social Security (BMGS) in Berlin in July 2005. “With self-confidence and competence“, the German drug licensing authority “will enter the competition with the other European authorities“. Professor Kurth, who is also the president of the Robert-Koch-Institute in Berlin, pointed out that figures alone would illustrate how important it was for the BfArM to keep up with the others in the European competition: In 2003 the German pharmaceutical industry had a turnover of more than € 23 billion, the medical devices industry of more than
€ 20 billion. Almost 200,000 well qualified specialists are employed in these two branches. The added value and export rates achieved there are high, their research results are internationally competitive thus contributing essentially to the high-quality health care system in Germany. Against this background industry rightly expects excellent internationally competitive service in authorisation and certification of products.
Another factor deserving our full attention is that the enlarged EU currently has 42 institutions assisting the European drug agency, EMEA. Dissipating expert knowledge rather than concentrating it is not very economical. The EU Commission is now planning to reduce the number of contributing national agencies to a few centres of excellence.
Success requires ever new efforts of us and our readiness for a critical review of procedures and structures and even for re-organisation where necessary. BfArM has uncompromisingly gone the way of re-organisation – not an easy task – in order to become a modern, internationally competitive national licensing authority for Germany and in Europe. It will be a scientifically proficient authority where drug safety is strengthened and consistent decisions are reached within the regulatory time frame.
Extensive re-organisation and re-structuring was begun last year and has largely been completed by now, July 2005. A new and flexible top management, in line with international standards, is expected to ensure fast and qualified decisions. Let me mention a few catchwords here: flat hierarchy; lean structure; clear assignment of competencies and responsibilities; further improvement of staff expertise; installation of a continuous and effective change management system (organisation, control, planning, etc.); regular benchmarking of the entire institute and not only of the EU-unit as previously planned.
As can be seen from our organisational structure, in terms of daily routine this means project related processes. The newly formed departments 1 to 4 are responsible for the authorisation of chemically defined products, while department 5 handles the alternative medicinal products (herbal pharmaceuticals, anthroposophicals and the like) in parallel.
In a first step, all authorisation, renewal and variation procedures – national and European alike – are reviewed for completeness in department 1 and forwarded to the respective departments according to the type of processing they will have to undergo. Procedures not requiring any review of content (abridged procedures such as parallel imports and doublets) are finalised in department 1. Procedures requiring scientific review are forwarded to departments 2 to 4 or 5, depending on the proposed indications. In each of the departments interdisciplinary teams evaluate the documentations for quality, efficacy and safety.
The interdisciplinary teams (the so-called Fachgebiete) have been established to treat the application dossiers in an integrated way. The Fachgebiete are specialised in indications in such a way that teams of about ten scientists are concerned with all aspects of their special indications so that the work of these teams will eventually result in integrated assessments. At the same time the scientific quality assurance group networks the experts of the Fachgebiete within their own special fields so that the expertise available in one single Fachgebiet is multiplied and may be resorted to in cases of very complicated issues.
The introduction of process management units in departments 1 to 5 (Verfahrensmanagement) is also new. These units are in control of the authorisation procedures including adherence to the time limits.
The re-structured drug authorisation will warrant effective on-schedule authorisation and registration of medicinal products, thus strengthening drug safety. Patient protection will be given absolute priority in all our decisions. And last but not least, in the authorisation of new products we will place more emphasis on the aspect of preventive health protection.
Note:
A survey of the new BfArM organisation and the new organigram can be found on our website.
Year of issue: 2005