Italian court rejects Schering-Plough's challenge to generics list

Schering-Plough's legal challenge to Italy's official list of generic equivalents has been thrown out by an administrative court.

The company described the list, which pharmacies are obliged to use in informing patients of generic alternatives, as illogical and contradictory.

Its lawyers argued that including its betamethasone corticosteroid products in a category with others was wrong because they had been chemically modified in different ways and had pharmaceutically different forms - cream and ointment based on gentamicin or betamethasone. Schering-Plough claimed that the erroneous inclusion of other products as generic equivalents would harm the sales of its own products and have negative effect on public health.

The lawyers also contended that the list created the possibility for pharmacists to abuse their power and interfere with the intention of doctors in their prescription of medicines.

Schering-Plough applied to the court to have the list annulled. But Tar di Lazio, the administrative court in Rome, disagreed. In its ruling it decided that as long as the safety and efficacy of the generic drug is the same as the one prescribed by the doctor, pharmaceutical differences should not necessarily be considered to be significant.

The decision could be important as other pharma companies in Italy are said to be pursuing their own legal challenges.

The list, which was introduced through a new law in July 2005, was designed to make patients aware of cheaper alternatives to prescribed medicines. It obliges pharmacies to make known the equivalent medicines to patients arriving with prescriptions for branded products.

Since its introduction there has been a rise in generic sales in Italy, although they still remain low by most European standards.

The court said its analysis of the jurisprudence regarding the issues and the interpretation of the rules led it to reject Schering-Plough's case. In particular it referred to EEC regulations and directives and the interpretation of them in other European countries.

These led it to conclude that the strict interpretation of the rules was to ensure that equivalent medicines had the same level of efficacy and safety.

It also concluded that obliging pharmacists to make known generic equivalents to patients did not interfere with doctors' capacity to prescribe the correct drugs.

The doctor, according to the court, still has the power to prescribe drugs that cannot be substituted if that is required.

It rejected Schering-Plough's recourse and ordered the company to pay Euro 2,000 in costs.