Life Sciences

The right to health protection according to the Constitution of Greece

The right to health protection is a typical individual right which includes the obligation of the state and of every other public or private subject to abstain from any behavior possible to offend the physical or mental wellness of individuals or to restrain their freedom of self determination to decide themselves on issues that concern their personal health. When the offence derives from state bodies, this specific individual right is based on article 5, paragraph 2 and 5 of the Constitution, which protects life, health and genetic identity from bio-medical interventions, and article 7, paragraph 2, which forbids physical injuries or health damages or the use of psychological abuse. In the cases that health offences do not come from state bodies, the right to health protection is based on the provisions of article 25, paragraph 1 and article 2, paragraph 1 of the Constitution, regarding the obligation of the state to ensure the unobstructed and effective use of the rights through the implementation of appropriate administrative measures, taking into account the individual’s value and dignity. The personal right to health protection as a personality element is ensured for each individual.

PRICING OF PHARMACEUTICAL PRODUCTS
Regime: a brief overview

Pharmaceutical pricing in Greece is state regulated and, albeit constantly undergoing significant changes, is currently governed by the Ministerial Decision (hereinafter “MD”) Nr. 90552/2016 “Provisions on the pricing of medicinal products”, as amended and in force today.

The general rules which pertain to the pricing of pharmaceutical products in Greece, may be summarized as follows. The price of on-patent products (id est maximum ex-factory price) is calculated by reference to the 3 lowest prices in EU member states which publish reliable data. Yet, so as for a pharmaceutical product to be priced for the first time in Greece, it must have been previously priced in at least three other EU member states. Notably, until the aforesaid requirement is met, a new pharmaceutical product may not be priced in Greece, exception made only as to orphan drugs. As regards off-patent products,
their maximum ex-factory price (when a generic has also been marketed in Greece) is reduced automatically either to 50% of the last price that the reference product had under patent protection or to the average of the 3 lowest prices in EU; whichever lowest. Likewise, the ex-factory price of biologics and bio-similar products is defined as the average of the 3 lowest prices in EU. Regarding the pricing of generic pharmaceutical products (not biosimilars), these maintain the 65% of the resulting wholesale price of the reference product (off patent), calculated on the basis of the aforesaid regime.Ιn relation to domestically
produced pharmaceutical products which cannot be exactly matched to the form or content of a reference product, their prices are calculated on the basis of cost estimates as to their, inter alia, production, packaging, administration, sales and promotion costs, as determined by corresponding tables which are drafted on the basis of the corresponding average costs of the industry. Finally, as regards OTC products, their pricing regime is provided in detail in Law 4472/2017, as amended and in force and in MD 38152/2017. The average of the 3 lowest prices of EU member states is still applied as a basic rule, while in accordance to the MD an indicative retail price may be set on the basis of the aforesaid price (median of 3 lowest EU prices) plus 30% plus the relevant VAT.