Time for access to new drugs should have deadlines

By TPN/Lusa, in News · 17-11-2019 18:00:00 · 0 Comments

Hospital administrators are calling for the creation of guaranteed maximum response times for the approval processes of innovative medicines, to improve access and avoid inequalities.

Currently, in the area of health, there is already a definition of maximum response times guaranteed for consultations and surgeries, which are basically times considered clinically acceptable depending on the severity or urgency of the situations.

Alexandre Lourenço argues that the definition of maximum response times for the approval processes of innovative medicines will also serve to monitor what is happening in the various therapeutic or treatment areas.

The definition of these times, the representative of the hospital administrators said, should be a joint work of the hospitals, the medical association, the pharmacist association and led by the medicines authority - Infarmed.

The maximum response times should be defined for the various stages of approval of an innovative hospital medicine: approvals before the marketing authorisation, before the financing decision by the National Health Service and then when the medicine enters its normal circuit already with the market approval and the financing decision.

He also said that hospitals should create more convergent or similar drug approval models, a kind of "more agile drug approval manual", which takes into account the definition of maximum response times.

Alexandre Lourenço points out that there is a great asymmetry between hospitals in their deadlines and in the administrative or bureaucratic stages in the approval of drug innovation, reaching units in which more than seven departments or hospital services intervene before a request for a new drug is even submitted to Infarmed.

According to the study National Index of Access to Hospital Medicines, in 54% of NHS hospitals between four and five different departments or services are involved before a request for the use of a drug is submitted before a marketing authorisation is granted.


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