Health under discussion in the Council of Ministers
At the Council of Ministers of 9 May 2013, various measures for the field of health were discussed and approved.
Given the current economic and financial situation in which the country finds itself, certain measures were introduced which evidence the present state of budgetary containment and rationalisation in the Council of Ministers.
However, the proposed legislative bill for clinical research was not neglected and it will bring Portuguese legislation on scientific research in the area of health onto a new path, thereby bringing Portuguese law closer to European law.
A) Clinical Research Bill
1) Creates a new frame of reference for clinical research on humans in Portugal, within the scope of the concept of clinical trials,
2) The regime of appreciation of the ethics committee, of determining the responsibilities of the promoter, the researcher, the monitor and the clinical trials centre will be generalised, and their respective specific natures acknowledged,
3) Guarantees the transversal application of ethics assessment and transparency to all clinical research, by introducing rules for assessment processes and the holding of clinical trials in Portugal, regardless of their nature, methodology or subject of study,
4) Creates the National Clinical Studies Register, with the objective of facilitating and dematerialising the transfer of information in the authorisation process and the monitoring and conclusion of clinical trials.
B) The amendment of the legislation which establishes the conditions and requirements for the dispensing of medicine in post-outpatient surgery treatment
1) The kind of medicines to be dispensed will be expanded to include children and ophthalmology patients;
2) The quantity of medicines dispensed to the user after surgery is reduced, that is, only the amount of medicine necessary for seven days of treatment will be dispensed.
C) Legislation which raises the requirements for holding the position of director of medically-assisted procreation centres
1) Proven curriculum experience will now be required of the director of the centre;
2) The CV will be assessed by the National Council for Medically-Assisted Procreation;
3) This requirement applies to state and private centres, regardless of the technique used for carrying out medically-assisted procreation treatments.
Diana Abegão Pinto