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INN Prescribing in Greece–The New Generic Frontier?

29 November 2012 Brendan Melck

The Greek authorities recently implemented prescription by international non-proprietary name (INN), to much criticism and concern. We looked at the context of its implementation, and the chances of it gaining wider acceptance.

Almost on a daily basis, we are inundated with new information about the severe problems facing the public healthcare sector in Greece, and with each new agreement with the troika comes a new savings target or spending cut in the public healthcare sector (usually revolving around pharmaceutical reimbursement spending). The situation in the healthcare sector is a mirror of the wider problems of Greece's economy and society: huge unemployment and consequently large numbers of people without health insurance cover (as many as 40% of Greeks are reported to be without health insurance cover).

Troika Sets the Terms In March, the Greek government signed a memorandum of understanding with the troika. They are going to try to achieve savings of around EUR1 billion (USD1.3 billion) in outpatient pharmaceutical spending, through policies involving drug pricing and prescribing (aimed at ensuring the use of cheaper medicines and tighter control of prescribing and consumption), in order to punish fraud and inappropriate prescribing. Definite targets were set for the expansion of the consumption of generics, and the figure of EUR2.88 billion was decided on as the maximum level of pharmaceutical reimbursement spending for this year&emdash;compared with over EUR5 billion in 2009. Also included among the measures demanded by the troika are also mandatory generic substitution and compulsory prescription by international non-proprietary name (INN).

INN Prescribing Brought In
Most recently, in November, the INN prescribing system came into effect, and Greek doctors are now required to prescribe by INN, while they are permitted to prescribe by brand name in the case of 15% of prescriptions written. A number of groups of medicines are exempt from this where substitution is not "scientifically sound" or where the therapeutic range is too narrow. Exceptions can also be made in certain other cases, including medicines with a high toxicity levels. INN prescription should be used in the case of all newly diagnosed patients with chronic diseases, and exceptions should always be explained.

Lack of Generics Culture
The association representing Greek pharmaceutical producers, the PEF, and the Athens Medical Association, are among the organizations which have been very critical of the introduction of INN prescribing, with the perceived dangers of imported medicines from non-EU countries among the most commonly voiced concerns. This may stem from Greece's place as a country at the edge of the EU, which faces a higher volume of counterfeit imports than many other EU countries. Additionally, the uptake of generics in Greece is very low in European terms - IMS Health data from 2009 show that in 2009, just 32% of the off-patent sector, by volume, was accounted for by generics in Greece, while in the United States, this figure stood at 90%, and in the United Kingdom at 76%. Therefore, just as in the case of fellow Mediterranean country Italy, Greece lacks a strong, established generics culture, and like Italy, it is trying to fast forward the process of expanding the use of generics, due to reasons of cost-containment. And in Greece, it is also because there is little choice, on the basis of its agreement with its creditors.

E-prescribing System is "Greek Success Story"
One of the problems which has already been identified with the INN prescribing system is connected with the electronic prescribing system, which has been implemented as one of the main pillars of the country's pharmaceutical cost-containment efforts. Apparently, even though it is meant to be possible for doctors to prescribe brand names (up to 15% of prescriptions), the e-prescribing system automatically selects the INN. Faults with this are due to be corrected, while in general, the e-prescribing system generally appears to be a success story in Greece. The organization responsible for it, the IDIKA, has reported that already, 92% of prescriptions are completed electronically, saving social security funds millions every month. The IDIKA claims that Greece's e-prescribing system is one of the most effective in the world, and its prevalence among the various cost-containment measures implemented in the country is testimony to the level of the abuse of the system in the past which helped to create the massive debts which the Greek state is still paying off today.

Will prescription by INN be accepted?
In essence, Greece is implementing measures which are fairly commonplace in other EU countries - however, implementing any kind of reform in a crisis time, when new measures are picked on and conflated into wider political issue, is fraught with problems.

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