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EFA at EMA meetings

On 30th November EFA board member Lina Buzermaniene and EFA COPD advisor Michael Wilken took part in the Patients and Consumers Working Party (PCWP) meeting at the European Medicines Agency (EMA), which gathered those eligible to work with EMA.

Guido Rasi, new EMA executive director, introduced himself and expressed his positive view on patient involvement in health policy. A general update on the implementation of the new pharmacovigilence legislation, which will allow patients to directly report adverse reactions, was provided. Patients and consumer organisations were consulted on the medicines which will be under additional monitoring and how this could be communicated on package leaflets.

Further legislation introduced in the pharmaceutical field was also discussed, including information on the anti-falsification legislation. A WHO report in 2006 stated that globally, 10% of medicines may be falsified and 50% of falsified medicines are bought on the internet. This problem is associated with weak regulatory systems and legislative measures will be taken, like provisions for import of active substances, safety features, good distribution practise, more security for internet sales etc.

A representative of the European Commission presented a proposal for legislation on information to patients, which is described below.

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