LVR – 25 juni – conferentie

Lector Karel van der Waarde houdt een voordracht als onderdeel van de conferentie:

The International Conference of
Applications of Information Design
25-28 June 2008
Mälardalen University, Eskilstuna,

Information about medicines for patients is strictly regulated within the European Union. The legislation was introduced in 1992 and states exactly which information must be mentioned on medicine boxes and in package leaflets. At the moment, the information about medicines is nearly uniform across all EU-countries. Although this could be interpreted as a success, it has a disadvantages as well. Uniform information does not take the contexts of use nor the activities of people into account. Much of the legally required information is therefore inappropriate, superfluous, or plainly incorrect.

The practical implementation of the European laws has lead to a stream of guidelines and templates that should make it easier to write, design and test information about medicines. These guidelines should also make it easier to check if the information is conform to all legal requirements. Unfortunately, the current guidelines and templates fail on both accounts. The laws and guidelines do not support the pharmaceutical industry to design appropriate information nor do they help the authorities to check if information follows all guidance.

The current system requires substantial flexibility of patients, industry and the authorities. Information about medicines is very hard to use, is very hard to develop, and is very hard to control.

At the moment, most stakeholders hesitantly consider alternative ways of providing information about medicines. For example, pharmacists develop printed leaflets, patient-organizations make websites and the pharmaceutical industry finds new ways of promoting their products. All these developments sidestep the current legal system.

The design of information about medicines in itself is not really problematic. The main problem is related to conflicting regulations, guidelines and templates. These lack a clear vision about an information strategy and a development strategy. However, based on these two strategies, it is possible to develop legislation and guidelines that support the development of suitable information. The ultimate aim is to provide information to patients that is relevant and appropriate. It is therefore necessary to ‘design the regulations’ before it is possible ‘design the information’.