The use of generic drugs opens up great potential for cash-strapped healthcare systems, but a leading expert has warned of the “danger of a decline in treatment quality and in potential savings” if such policies are not carried out correctly.

“Ultimately, it is all about safety,” Professor Nikos Maniadakis, associate dean of Greece’s National School of Public Health told the annual European Health Forum in Gastein, Austria, this month.

In terms of effectiveness and compatibility, a generic should not differ from the originator drug, and this presupposes a high degree of care on the part of the approval authorities, he said. However, major quality problems have recently been found with generics in a number of countries – “in some cases, the products were quite simply fakes,” Prof Maniadakis told the Forum.

Moreover, in many cases the conditions under which a generic drug is allowed to replace the originator product are not clear. A recent study involving 65 countries has shown wide variations between them in terms of how they define the term “generic,” he said, and called for more research to be conducted urgently to guarantee safety in what is “usually a very simple approval process for generic drugs.”

Nor is the economic advantage of using generics automatically guaranteed, Prof Maniadakis added. These products “really have to be much cheaper to be worthwhile,” he said, and while regulation can certainly be helpful in achieving this, it is not a guarantee. 

An international comparison study conducted by Prof Maniadakis and colleagues has revealed that regulation brings no cost advantages past a certain point and that it is also “not useful” in widening the use of generics. Freedom of choice and market mechanisms are important prerequisites for achieving this, while procurement based on a tender system, as is used in Scandinavia, has a negative effect, he said.

Under such systems, huge quantities of a drug are purchased centrally, which naturally causes the price to fall initially. But at the same time, the system forces other suppliers from the market and creates monopolies which, in the longer term, have an unfavourable impact on prices, he warned.

Generally, “incentives yield better results than coercion,” and this is particularly true of patients’ perceptions; frequently, they have lower levels of trust in generics than in the originator products, and their adherence to treatment can suffer as a result, he said.