A recent decision of the Greek health minister Andres Xanthos, published in the official Government Gazette, aims to achieve 40% generics prescription in the ambulatory sector by the end of the year, while re-imposing financial penalties for violations
IHS Life Sciences perspective
The government is aiming to fulfil expectations in the recent bailout memorandum concerning the volume of generics prescriptions by the end of 2015.
The Greek authorities face an ongoing challenge with increasing the use of generics in a country where both doctors and patients are sceptical of these drugs.
On the basis of a decision by Greece's health minister Andreas Xanthos, published in Greece's official Government Gazette on 30 October, a previous ministerial decision (FEK 1117/2015) – which removed sanctions on doctors found to be prescribing in contravention of the prescription regulations of the Greek National Organization for Healthcare Provision (EOPYY) – is to be abolished, and the regulations introduced in 2014 on financial prescription limits per doctor, and per region, are to be reinstated and modified.
According to the text of the decision, the share of generics prescriptions in the ambulatory (community pharmacy) sector should be increased to 40% by the end of 2015. Pharmacists, meanwhile, are obliged to dispense a cheaper product with the same active pharmaceutical ingredient, dosage form, and package size, if available, than the prescribed product.
The decision contains new minimum percentages of generics prescriptions required for groups of medicines at anatomical therapeutic chemical (ATC) level 4, most of which are in a range of 40% – 60%; certain groups have higher percentages, including alpha and beta blocking agents (84.85%), while others have much lower percentages, including organic nitrates (17.33%). It also includes new caps on pharmaceutical spending per doctor, managed on the basis of the electronic prescription system, which is organised by region and by the season of the year, on the basis of statistics of usage from 2014.
As reported by Greek medical news source Iatronet, there are exceptions to the obligatory generic prescription quotas, and spending limits for certain disease areas and drug classifications, including those listed below:
- Chronic end-stage renal patients
- Patients with liver failure
- Transplant patients
- Thalassemia, cystic fibrosis and pulmonary hypertension
- Vaccines used in national immunisation programmes for children and adolescents
- Drugs which are administered by committees of the EOPYY (i.e. high-cost drugs)
- Drugs for which a closed budget is planned (i.e. high-cost drugs)
latronet reports that the following penalties and sanctions are to be imposed on doctors according to the minister's decision:
- Where a doctor prescribes medicines with a value of up to 20% higher than the limits allow for three months in succession, they will receive a written recommendation regarding the applicable limits;
- where the cost of a doctor's prescriptions are 20% over the limits for three months in a row, they will have to justify this to the EOPYY;
- where the doctor's explanation is not judged to be satisfactory, fines and administrative sanctions will be applied;
- a fine of up to EUR1,000 (USD1,100) will be imposed in the case of a deviation of between 20% and 25% above the limits over three months;
- a fine of up to EUR3,000 will be imposed in the case of a deviation of between 25.01% and 30% above the limits over three months;
- a fine of up to EUR5,000 will be imposed in the case of a breach exceeding 30.01% over a three-month period.
The health minister's decision can be accessed here, in full, in a link provided by Iatronet (in Greek).
Outlook and implications
The financial limits on prescriptions, and the mandatory quota of generic prescriptions according to disease area, were controversial when they were introduced in early 2014; these were successfully challenged and cancelled by the Greek Council of State, only to be reintroduced later in the year. It appears that before the recent elections, certain aspects of the law relating to the limits were amended, including the sanctions imposed on doctors; the reinstatement of this implies that in spite of the Syriza government's rhetoric against austerity measures in the healthcare sector, it will now pursue policies aimed at fulfilling Greece's commitments under its most recent bailout memorandum – including a target of increasing the proportion of prescriptions in the ambulatory sector (which include only the international non-proprietary name: INN) to 40% by the end of this year.
It could be expected that this goal will be easier to achieve in view of the fact that prices of generics have undergone considerable reductions in recent years, and are due to undergo another considerable reduction on the basis of other provisions of the bailout memorandum. However, it should be emphasised that the same goal of 40% was also set last year, and was far from being achieved. Generics currently account for just over 20% of the volume of medicines in the ambulatory sector – three times less than in most other European Union member states. The problem for Greece is principally one of training and tradition; while in countries such as the United Kingdom, the level of prescribing by INN is very high – being strongly emphasised during doctors' training, with no traditional scepticism towards generics – the opposite for both cases is true in Greece.