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The Pharmaceutical Journal Vol 265 No 7109 p221
August 12, 2000 News

Spain approves generic substitution

Spain's ministry of health approved a decree on July 20 aimed at slowing down spending on drugs by promoting the dispensing of generic drugs.
The measure consists of a reference pricing system based on the current market prices of generics in the country. Under the new decree, due to come into effect on December 1, pharmacists will be obliged to exchange a prescribed branded medicine for its bioequivalent generic if the price of the brand is higher than the newly established reference price. The total price of the generic chosen by the pharmacist and dispensed to the patient must not exceed the reference price. However, the patient will still be able to obtain a given brand if he or she chooses to pay for it.
If the doctor considers that a prescription brand drug must not be substituted by a generic equivalent then a form "justifying the inappropriateness of that substitution" must be supplied to the pharmacist, along with the prescription.
The reference system includes 42 generic compounds which are paid for either partially or totally by the state health service (SHS). Although the generics market is still small in Spain, their prices are considerably lower than the branded equivalents. The SHS expects to save Pta19.5bn (£72.5m) in the first year after the decree comes into effect. There is no doubt that spending on drugs, which has increased markedly over the past few years, is the principal handicap of health authorities in Spain. At present, medicines represent 25 per cent of total health care expenditure, compared to the European average of 15 per cent.
Mr Manuel Domínguez, president of the Spanish Federation of Pharmacists, said that the reference pricing system was "not necessary to introduce generics to the market, since pharmacists would have collaborated with health authorities to back their use without need to look at a table, as is the case, for example, in France".
"At a first reading, pharmacists will be harmed by the decree, because pharmacists' benefit margins are calculated from the prices established by pharmaceutical companies. So, if reference prices are lower, then incomes are also lower," he added. - Xavier Bosch, Spain