Consumers International 

KILEN Consumer Institute for Medicines and Health



To the Chairman of Committee A 

Consumers International would like to request permission to speak at Committee A, agenda item 13.9, Quality of care: patient safety, EB 109 R16. 

On behalf of Consumers International and KILEN Consumer Insitute for Medicines and Health we would like to make the following statement: 

In recent years it has become obvious that we need more knowledge about the quality, safety and cost-effectiveness of methods used in health care systems. An important part of this knowledge must be built on the examination of adverse events. We cannot prevent or treat a problem until we know its nature and proportions.

A crucial part of the necessary work to be done is to improve the safety of medicines by reporting adverse effects. In this respect two things seem to be of great importance. 

" The system should be global and accessible to everybody.

" The system should involve the end-user, the consumer, of medicinal products both as a reporter of adverse effects and as a partner in the work for safe and rational use of medicines.

It is important to recollect that concepts of "safety", "quality" and "rational use" are not necessarily the same seen from the point of view of the consumer and from that of the physician or the health authority.

 Today we have an excellent database at the WHO Programme for International Drug Monitoring. This database contains over 2.7 million case records of suspected adverse drug reactions (ADRs) dating back to 1968.

 The WHO Programme became established and the database moved to Uppsala in 1978. There are now 67 countries submitting case data, and it is the largest international database of suspected adverse reactions world-wide. It is a unique resource.

 At the outset, because of the experimental nature of the work, there was an agreement to keep the data confidential to the collaborating countries only. This agreement is still in operation.

Over the years, attitudes to confidentiality have changed and the principle of the work is no longer experimental.

 Now, 49 countries have allowed open access to the data and 18 are opposed to it.

 Secrecy is not compatible with public confidence, and there should be open access to the WHO data by any responsible person or group.

 Today we have a situation where the consumers are in possession of unique experiences of medicines and the WHO database is in possession of a likewise unique collection of data from professionals. If these two flows of knowledge could be brought together the work for safety and quality in health care will take more than one step forward. 

We recommend WHO to take action for to  

" Allow open access to the WHO database for International Drug Monitoring.

" Promote consumer participation in all relevant aspects of the work for quality of care and patient safety.


Geneva May 16, 2002 

Jan Albinson Lena Westin

co-founders of KILEN