The Federal Institute for Drugs and Medical Devices is proud to welcome you to the Ninth International Conference of Drug Regulatory Authorities (ICDRA) in Berlin -the old and new capital of a reunited country. We are honoured at this unique opportunity to provide a discussion ground for this important event, and are overwhelmed by the attendance of participants from more than 120 nations. We are especially honoured by the presence of the Federal Minister of Health, Ms Andrea Fischer and the local Co-Chairman of the Conference, Professor Reinhard Kurth, President of the Paul-Ehrlich Institute. We would equally like to thank the German Foundation for International Development for its initiative in inviting to Berlin colleagues from Africa and the newly independent states, and for enabling them to participate at this Conference.

One aim of this Conference is to bring harmonization to an unharmonized world within our area of responsibility as regulators. We believe that this country, this city, and this Institute are especially suitable players in such an undertaking. The Federal Institute for Drugs and Medical Devices was established as an independent institution to enforce activities within our specific area of work and the professional experience we have gained will hopefully enhance the meeting. Our ultimate success, however, will depend upon the recommendations of the ICDRA, their realization and long-lasting effects. I am sure that you will find the programme prepared by the planning meeting to be wide-ranging and interesting. Important topics are addressed in sessions on good regulatory practice and future challenges, multinational harmonization versus specific group interests, counterfeit problems, accelerated drug approval and control, availability and access of drugs on a global and local basis, and the continuing revolution in communications and information. We are especially pleased to announce that the Director-General of WHO, will be with us to give a keynote address.

The main focus of our attention must be to guarantee the value of medicines to populations through the creation of close links among regulators and to continuously and consistently search for added value of medicines within the best quality parameters. The pharmaceutical industry is currently one of the few growing markets. In spite of the economic crisis in Asia, sales increased during the year by about 7%, and experts’ expectations for growth are for 8% per annum in the coming millenium. Best-performing companies reported operating profits of 30%, with an increase for the top ten of up to 37%. The German pharmaceuticals market increased in the first half of 1998 by US$8 billion, and approximately 49% of all drugs sold in Germany are produced nationally.

Because drugs have such a high market value, and because information is important in supplying them, their availability and accessibility are subject to the market forces of supply and demand. These forces are stronger than our resources to examine, decide, control, and provide information about drugs. However, as regulators, we cannot risk exempting drugs from market rules, nor can we limit these according to need. Rather, our task is to disseminate significant information about the rational value of drugs based on efficacy, safety, and quality, and to ensure the accessibility of good products and independent information.

The more we interact, the greater will become the possibility for making sound judgements as independent agencies. One positive example is the development within the EU of an independent and common authorization process. Since the beginning of 1998, it has not been possible for a new drug to be authorized under a national system unless it is to be marketed only in that particular country. This development has led not only to the creation of The European Agency for the Evaluation of Medicines (EMEA) but also to the strengthening and development of independent agencies within the EU.

The International Conference on Harmonization (ICH) process is another example of sharing information to the benefit of patients, doctors, and industry. Given the enormous market value of drugs, more efforts are needed to address the public health aspects of drug development. Among other measures, there must be a rational ethic which guarantees access, and strategies to respond to the over-growing need for relevant products.

To improve drugs and drug information, and to allow better access to them, we must increase and share our scientific standards, be flexible in the use of our limited resources, and create networks based on knowledge and methodology. Hopefully, this meeting here in Berlin will become a milestone in our readiness to think globally and act locally.