Industry’s legal challenge to ‘arbitrary’ pricing
pharmafile | October 27, 2003 | News story | |Â Â Â
European industry body EFPIA is seeking legal action against the Italian Government new reimbursement and pricing policy, which it believes unfairly targets pharmaceutical companies.
EFPIA took the unusual step of lodging a legal complaint with the European Union after an Italian decree was introduced to reclassify reimbursement categories and introduce price caps based on classes of pharmaceutical products.
The new system groups together all products with similar mechanisms of action into one price bracket. Products that exceed the price cap will not be reimbursed, potentially forcing considerable price cuts of many products.
"While EFPIA does not question the right of the Italian government to pursue a reimbursement policy and observe specific budgetary parameters, it objects to any reimbursement and pricing decisions that are based on arbitrary and obscure criteria," a spokesman said.
The industry body says the new system violates EC transparency requirements, and fundamental competition and free trade laws. It also claims the new arrangements contradict the principle of "legitimate expectations," a central part of EC law.
EFPIA hopes its complaint will lead the Commission to force the Italian Government to comply with these laws and revise its new national regulations.
"EFPIA deplores the lack of direction and predictability of Italian government policy as exhibited in a string of budgetary measures that have targeted the pharmaceutical industry in rapid succession. The number and extent of measures taken on pharmaceuticals is also disproportionate, compared to measures taken on other parts of the health care budget."
The EC has no powers over how member states finance their healthcare systems and consequently legal action is the only possible recourse the industry has. National control of healthcare is, however, a sensitive issue, and it seems doubtful whether the Commission would mount a legal challenge in these circumstances.
Government attempts to contain healthcare costs have preoccupied the industry in Italy for the last 18 months, and are of much greater concern in the country than reform of pharmaceutical regulation, currently underway in Brussels.
EFPIA warned: "The Italian government has plunged the industry in a state of uncertainty and is thus jeopardising Italian R&D activities, investment and jobs in the pharmaceutical industries."
