The legal provisions regarding the pricing of pharmaceutical products have been amended several times during the last decade in an effort to address the issue of very high pharma expenditure and its impact on hospitals and the social security system and to create a stable and predictable reference pricing framework.
The last amendment in the legal provisions was introduced into the Greek legal system by a decision from the minister of health in May 2019.
According to the new provisions, the price of a reference medicinal product will be based on the average of the two lowest prices in the EU, amending the basis previously applicable, which was the three lowest prices in the EU. The price of generic products is 35% lower than that of reference products.
While the new system includes several provisions to ensure a control on the prices as well as to make sure that no product's price is increased more than 10% from its last price, the most important amendment from an IP perspective, is that the provisions existing in the former law, according to which the launch of a generic product in the Greek market would result in a 50% drop in the price of the reference product have been removed.
The launch of a generic product should therefore, contrary to what was applicable before May 2019, have no direct impact, from a statutory perspective, on the price of a reference product, which will be calculated on the basis of the mechanism provided in the new legal provisions.
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Constantinos Kilimiris |
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