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Greek Doctors Revolt Against Prescription by INN Regulations; Pharma Warns of Ongoing Debt Non-Payment Consequences

Published: 20 February 2012

A new draft law foresees the introduction of prescription by international non-proprietary name in Greece, which has elicited the ire of Greek doctors, while the country's main drug makers' association has warned of the severe consequences of the ongoing pharma debt crisis.



IHS Global Insight Perspective

 

Significance

Greek doctors have reacted furiously to a new draft law that includes regulations introducing prescription by international non-proprietary name, while the main Greek drug makers' association, the SFEE, has warned of the dire consequences that are likely to result from the continued lack of resolution to the pharma debt crisis.

Implications

The situation in Greece is becoming steadily worse, and the volatility of the country's political situation means that the unhindered progress of new legislation should not be taken for granted.

Outlook

There is likely to be some considerable controversy and conflict surrounding the new draft bill's regulations regarding pharmaceuticals, with doctors threatening strikes. Meanwhile, the strong tone of the SFEE's statements regarding pharma debts points to a further deterioration in this area, which bodes ill for pharma in Greece, let alone Greek patients.

Prescription by INN Returns to Top of Agenda

The Greek Ministry of Health (MoH) has published a new draft law on various issues relating to the country's National Healthcare System, with particular reference to the provision of medicines. The full draft law can be accessed, in Greek, here. Within this new draft law, there are some major changes planned, which have already started to cause consternation and elicit strong opposition from the medical community in Greece. Among the main regulations set down in the new draft law are the following:

  • Doctors prescribing for patients insured under the EOPYY and the Social Security Institute (F??) are obliged to use the international non-proprietary name (INN) of a drug, and not the brand name.
  • Pharmacists dispensing these prescriptions on behalf of those insured under the EOPYY or F?? are obliged to dispense the cheapest product that has the INN written on the prescription in the specified dosage and formulation.
  • The electronic recording of all prescription drugs dispensed in pharmacies becomes mandatory, whether the prescriptions are handwritten or electronically written.
  • Greece's National Organisation for Medicines has a list of active substances that doctors must use on prescriptions, as well as therapeutic categories.

Greek Doctors Set for Strikes in Protest

The Doctors' Association of Athens (ISA) has issued a response to the draft regulations, as reported by Greek medical news provider Iatrikos Typos, stating that it constitutes a major risk to public health. The ISA is reported as saying that many of the generics available on the Greek market are of "questionable quality", and it considers that due to these regulations, doctors would not be properly able to undertake their responsibility for ensuring the safety of treatment. As a result, as the source reports, the ISA is planning to initiate strikes and similar actions in order to persuade the government not to bring these regulations into effect.

Debt Situation Is Critical, Says SFEE

Meanwhile, the Hellenic Association of Pharmaceutical Companies (SFEE) has published a press release warning of the dire consequences of the continued unpaid and accumulating debts of the Social Insurance Institute (IKA) and military hospitals. The full press release can be accessed, in Greek, here. According to the SFEE, the debts of these groups are approaching EUR500 million (USD657.2 million), and if there is no intervention from the state in resolving the problem, there is an immediate danger of restrictions in the supply of appropriate medicines.

The SFEE estimates that the IKA has pharma debts totalling EUR343.5 million, and reports that in 2011, the IKA's drug spending was EUR313 million, meaning that more than an entire year's debts are unpaid. In the case of military hospitals, the SFEE estimates that the debt is over EUR100 million, and as the annual spending of military hospitals on medicines is only around EUR40 million, more than two years' of debts have been clocked up.

Dennis Filiotis, the president of the SFEE, has stated that the combination of the new accumulated debt and the old debt, which he asserts may not be paid in the end because of the Public Sector Involvement, are set to cause complete havoc in the Greek healthcare sector, and he has appealed to the Greek government to resolve the situation before it is too late.

Outlook and Implications

Prescription by INN has been mooted in Greece on previous occasions, but this time it is part of a package of changes that are being demanded by the country's creditor organisations—the so-called "Troika" of the EU, European Central Bank and IMF. There has been a distinct feeling that pharmaceuticals have borne the brunt of the health-related measures, and this, combined with the opposition of doctors' organisations, points to a major controversy and conflict in the near future over these issues. It should also be emphasised that, having little culture of generics use to speak of in Greece, the country also faces considerably more serious problems than other EU countries in the field of counterfeit drugs, which has a major effect on the perception of generics there. Thus, perhaps the greatest challenge facing the Greek authorities is one of demonstrating the determination to ensure the safety of dispensed medicines, and electronic recording of prescriptions will not be sufficient to achieve this on its own, assuming its use can continue to be reliable and problem free.

As far as the debt situation is concerned, although most pharmaceutical companies would be loathe to pull out of Greece and withdraw their medicines, there is certainly a sense of a distinct reduction in operations in Greece by a number of companies; an example of this is Swiss major Roche, which was very open in its announcement that it had started a "cash-only" payment system in the case of some Greek hospitals. The medium-sized and larger pharmaceutical companies are not overly affected by the Greek crisis, although its place in a larger picture of pharma debt in southern Europe as a whole should also be recalled; the situation in Italy and Spain is looking increasingly perilous, too. For smaller companies, however, and for those reliant primarily on the Greek market (such as troubled Greek firm Alapis), the situation in Greece today is disastrous, while for patients, as stories abound of supply shortages, it is becoming steadily more dangerous by the day. The confluence of factors—the bad economy, the piling pharma debt, and the reduction in operations in Greece by global big pharmas—has drastically increased the risk of falling drug sales growth going forward.

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