New regulations intended to increase the uptake of generics have been introduced in Greece, with patient co-payments reported to have increased significantly.
IHS Life Sciences perspective | |
Significance | A major increase in patient co-payments for medicines has occurred as two new sets of regulations intended to promote the use of generics in the country have been introduced. |
Implications | The Greek authorities are under pressure to significantly increase the proportion that generics account for in the entire Greek pharma market, which lags far behind those of most European Union countries. |
Outlook | Protests are likely to continue in the wake of the introduction of the new regulations, with pharmacists especially concerned. However, with the troika's requirements seemingly unavoidable, the further deterioration of the operational environment for innovative pharmaceutical companies because of these regulations seems equally inevitable. |
From 14 July, a new method of calculating the co-payments due from patients obtaining medicines at open-care pharmacies in Greece has been established. Under this framework, for medicines under patent protection (and therefore with no generic alternative), instead of the difference between the reference price and the (higher) price of these drugs being shared by the insured patient and the Greek National Organisation for Healthcare Provision (with both paying 50% each), the patient is now obliged to pay the entire difference. Greek news provider typosthes.gr quotes Dionysis Eugenides, the secretary of the Pharmaceutical Association of Thessaloniki, stating that the changes signify that patients now face co-payments of between 40% and 70% of the cost of the drugs concerned.
Patients to pay difference up to EUR50 for on-patent drugs
Greek medical news provider Stithoskopio reports that under the changes, if the difference between the reference price and the higher price of the patent-protected is higher than EUR50 (USD67.6), then the patient will pay no more than EUR50 in a co-payment, with the social insurance fund covering the difference. Another Greek medical news source, Iatronet, reports that since the introduction of the measure, the average co-payment for medicines obtained by insured Greeks has gone up from 31.2% of the cost of the drug package to 35–36%. Iatronet also reports on the strong reaction from pharmacists' associations in Greece to the new changes, with 17 regional associations reportedly having issued a joint statement alleging that the amendments have sparked a "humanitarian crisis" and claiming that patients are simply opting to discontinue treatment, against the instructions of their doctors. They have also warned on the negative impact on pharmacies.
New obligations for pharmacists to dispense cheaper drugs
At the same time, the new Greek health minister, Makis Voridis, has brought a new regulation into effect. Under this regulation, pharmacists are required to have in stock the medical product with the lowest retail price in the case of each active pharmaceutical ingredient on the positive drug list and are obliged to notify the patient of the cheapest medicinal product with the lowest co-payment. If the patient chooses a more expensive product, then, as well as the patient paying the full difference, he/she will have to sign the prescription, on the request of the pharmacist, confirming that this was their choice. This information then needs to be entered into the electronic prescription system. The EOPYY is obliged to monitor the dispensing behaviour of each pharmacist, referencing this against predefined indicators, with penalties possible for pharmacists who do not comply with the rules. Among the potential penalties is the termination of the pharmacists' contract with the EOPYY for a period deemed appropriate considering the offence.
Troika underlines need to remain within budget
At the recent meeting on 18 July between the new Greek health minister and the representatives of the troika – comprising the European Central Bank, the European Union, and the International Monetary Fund – the latter are reported to have emphasised that there cannot be deviations from the drug budget, underlining the need to strive to reach the target of generics' consumption to 60% of the market in terms of value, while, at the moment, it is just 18–20%.
Outlook and implications
These new regulations represent further blows to the pharmaceutical industry in Greece, following on from the regulations on financial prescriptions for doctors' prescribing, which are also focused on increasing the use of generics in the country (see Greece: 9 July 2014: Pharma industry, doctors outraged at new financial prescribing limits in Greece). It appears that following these coercive regulations regarding doctors' prescribing, the Greek authorities are now applying something similar to pharmacists. Less coercive regulations intended to increase the use of generics appear not to be working to the extent that they had hoped for and therefore regulations limiting individual choice – as well as imposing penalties for non-compliance – are being introduced in order to ensure that the targets for the year are met.
Given the level of opposition to the measures – in particular from pharmacists – it can be expected that there will be an intense debate about them in the coming days and weeks. However, the bottom line remains the troika's requirement for the drug budget to remain within around EUR2 billion this year, and the Greek government is likely to go a long way to ensure this happens.