The European Court of Justice ruled on April 22 that financially incentivizing physicians to prescribe generic drugs (and to switch patients from branded medicines) is legal – but it remains illegal for innovator companies to engage in similar practices.
In its ruling, the ECJ said that EU legislation banning pharmaceutical companies from offering financial incentives to doctors does not prevent public health bodies, like UK Primary Care Trusts, from implementing schemes that offer doctors financial inducements for switching patients to a specific, named, medicine.
The switching of large numbers of patients in one area of the UK from a branded statin to generic simvastatin was believed to have been one of the triggers for the original court case, currently being heard in the UK High Court; it was this court that referred the questions decided by the ECJ in its ruling.
But, to understand the unintended consequences of such actions, it’s also imperative to consider what happens when such switching occurs. Case in point, The Health Improvement Network (THIN) study-- an observational study of a large United Kingdom primary care database showed that patients who were switched from established Lipitor therapy to generic simvastatin experienced a 30% increase in relative risk of cardiovascular events or death compared to patients who remained on Lipitor therapy.
The data, which included records from October 1997 to June 2005, were generated from a retrospective analysis of a medical database of anonymous patient records entered by general practitioners in the United Kingdom. The analysis included 11,520 patients (2,511 patients who had taken Lipitor for six months or more and were switched to simvastatin vs. 9,009 patients who were taking Lipitor for six months or more and then remained on Lipitor therapy).
While the reasons these patients were switched is not known -- it is certainly not inconceivable that it might have had something to do with ... short term costs to the system.
Now there will be another reason – direct payments.
And what of Article 94 of EU Directive 2001/83 which bans the practice. Specifically, "Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy."
Do different rules apply to government incentives? In the EU it looks like this is just the case. Another lesson we need to learn as we move forward into the uncertain world of Uncle Sam, MD.
