Health Systems in Transition

Health systems in transition

Portugal

Since 1990, several legislative changes have resulted f rom the

implementation of European Commission directives, such as that to guarantee

the quality and safety of pharmaceuticals. In addition, public information

and education programmes on the rational use of pharmaceuticals were

developed and cost-containment policies were adopted. INFARMED was

established in 1993. Since 1994, its remit has been widened to cover not only

pharmaceuticals, but also medical equipment and other medical products.

INFARMED is responsible for approving all pharmaceuticals to be reimbursed

by the NHS and for suggesting co-payment levels to the state secretary. It

has introduced some cost-effectiveness measures into the pharmaceutical

assessment procedures, and it can request cost-effectiveness studies to justify

the reimbursement of new pharmaceuticals. In 1999, the government issued

official guidelines about how best to carry out cost-effectiveness studies. This

initiative increased the utilization of efficiency criteria in reimbursement

decisions concerning pharmaceuticals.

The guarantee system for the quality and safety of pharmaceuticals is a

complex one and is not limited to the industrial process. Owing to the unique

features of the pharmaceutical market, decisions are not made under normal

market conditions. Pharmaceutical production is controlled by a strong system

of regulation. INFARMED’s responsibilities include:

•

to contribute to the national health policy, namely in the definition and

execution of pharmaceuticals, medical devices and cosmetics;

•

to regulate, evaluate, authorize, discipline, audit and verify, as the

National Reference Laboratory, and to ensure the surveillance and control

of R&D, production, distribution and sale of pharmaceutical devices and

cosmetic consumption;

•

to ensure the fulfilment of the regulations on clinical trials on

pharmaceuticals, as well as good clinical practice;

•

to guarantee the quality, efficacy and cost-effectiveness of

pharmaceuticals, devices and cosmetics;

•

to screen consumption and use of pharmaceuticals;

•

to ensure the adequate integration and participation in the network of

pharmaceutical devices and cosmetics, in the official Quality Laboratories

network, and with authorities in the European Union.

In recent years there have been a number of regulatory reforms directed

towards improving the cost-effective consumption of pharmaceuticals (see

section 5.6). To promote the use of generic drugs, the price of generic drugs