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Why should access to independent information on the risks of medicines be guaranteed?
Leaflet N°3
09 September 2002

Transparency of the management of drug safety issues in Europe must be ensured. Optimal risk management cannot be guaranteed unless access to information for patients, health professionals and citizens in general is improved. This will also mean fewer rumours, fewer doubts, less unjustified panic, and fewer lawsuits.

This is the meaning of Medicines in Europe Forum's amendments to the proposed European Directive and Regulation.


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While you are having your breakfast, you hear on the radio that a certain medicine (name not given) against cholesterol or against insomnia or pain has been taken off the market, that there have been some deaths, that the health authorities are aware of but have not yet divulged any information … This is not very reassuring for the patient who takes this medicine, or for the professionals who prescribe or dispense it!

These crises worry patients and generate confusion in doctors and pharmacists. They do not allow anyone to fully understand what the actual risk is, or what should be done to prevent other crises. They are detrimental to everyone involved, from the patient suffering from side effects to the pharmaceutical firm concerned.

To avoid these crises should be a primary objective. Why isn't it the case?

Among the identifiable causes, we note that:
-risk assessment is not a priority for the development of medicines, clinical trials focus predominantly on efficacy, instead of comparing benefits and side effects relative to those of existing drugs;
-post-marketing follow-up of risks is mainly passive, patients and health professionals are not encouraged to report side effects;
-manufacturers and regulatory agencies view information on risks as an umbrella to protect them against law suits, and not as a normal part of education on risk prevention;
-a tradition of secrecy in safety issues means that the bare minimum is divulged to health professionals and patients, that their strong involvement is not really welcome, on the pretext that they lack abilities or are going to be disturbed;
-the stock market repercussions of communication of risk are taken into account sometimes before the general interest.

Improvement could be achieved:
-by demanding more thorough assessment of unexpected side effects during the development of medicines;
-by organising an active follow up of side effects after marketing, which would involve patients and carers as responsible players, possibly through well conducted prospective surveys for the medicines not yet widely known;
-by providing better and more regular information, giving health professionals access to all information on the safety of medicines, so that they can speak frankly with their patients and make informed choices; by designing prioritised information leaflet for patients, to help them understand the most frequent and serious risks and how to avoid them.