Parallel trade is a well-established phenomenon in the Greek market of pharmaceutical products, due to the low prices of the medicines in Greece.
The result is that there are very often shortages of specific medicines. Each part of the distribution chain accuses the other part of this shortages.
The wholesalers say that the shortages are due to the decreased quantities that the pharmaceutical companies import in the Greek Market and the Pharmaceutical companies say that the wholesalers prefer to export the medicines to other countries and leave the Greek patients without medicines.
Our law firm has extensive experience on the topic of parallel trade of medicines and the problems of the shortage in the Greek market.
Stefanos Economou, our Managing Partner has presented this topic in the 2022 congress of Pharmaceutical Law held by Legal Library under the auspices of SFEE.
The Greek law provides several obligations for the wholesalers as well as for the Marketing Authorization Holders regarding the normal supply of the Greek Market.
We cite herein the most important of these provisions:
A/ The legal frame for the supply of medicines
- Article 12, Legislative Decree 96/1973, provides that:
“1. Manufacturers, dealers and importers are prohibited from making retail sales of the medicinal products they manufacture or import. They are under the obligation to sell their products at wholesale prices, and only to lawfully operating pharmacies, lawfully operating pharmaceutical warehouses, the State, and all types of hospitals and private clinics.”
- Article 107, Ministerial Decision 32221/2013, provides that:
“The marketing authorisation holder and licenced wholesalers ensure the appropriate and continuous supply of pharmacies and entities licensed to market medicinal products, so as to cover the needs of patients located in Greece.”
Further, article 12Α, Legislative Decree 96/1973, provides that:
“The Marketing Authorization Holders of medicines for humans use which are launched in Greece , ensure the appropriate and continuous supply of the market with such medicinal products, so as to cover the needs of patients located in Greece.
Article 112, of Ministerial Decision 32221/2013 provides the sanctions in case of violation of this obligation, as follows:
“In the event of a violation regarding the marketing of medicinal products or in the event of deficient implementation of correct distribution practice rules, there apply the penalties of article 19, Legislative decree 96/1973 as amended and in force, and the penalties set out in para. 2, article 175 of the present ministerial decision.”
These penalties are an administrative fine of up to 100,000 euro, plus criminal penalties.
Further, according to para. 3, article 12, Legislative Decree 96/1973:
“If there occurs a shortage of a medicinal product and it is due to a violation of the obligations of the licensed wholesaler or of the Marketing Authorisation Holder, there is imposed by decision of the Minister of Health, cumulatively with other statutory penalties, a fine upon the entity responsible each time amounting to thirty thousand (30,000) euro to one million (1,000,000) euro, depending on the gravity of the violation.”
B/ The relevant case law
The Greek Courts have often engaged in litigations which started from the refusal of a pharmaceutical company to satisfy all the orders received from a wholesaler because of the parallel trade and in order to be able to cover the needs of the Greek patients.
The Greek case law accepted that :
1/ “… a refusal of an undertaking to supply with its products wholesalers in a Member State who export these products to other Member States, exercising so-called parallel trade, may constitute distortion of the competition not only because such refusal impedes the activities of wholesalers in the market of that state, but also because it has a corresponding impact on the distribution of the same product in the markets of other Member States (decision of the ECJ on 13.11.1975, case 26/1975, … vs. …, EC, item 12)…
2/ “In order therefore to consider whether the refusal of a pharmaceutical company to supply with specific products wholesalers active in parallel exports of such products, as to which it holds a dominant position in the market, constitutes a means appropriate and proportionate to the threat represented by such exports for the defence of its lawful commercial interests, we must examine whether the orders to that company by the wholesalers for their supply with its pharmaceutical products in a specific Member State are out of the ordinary. To ascertain what ordinary orders are, their volume compared to the needs of the market in that Member State is assessed, as are the commercial relationships which the undertaking previously had with those wholesalers (ad hoc ECJ decision on 16.9.2008, joined cases C-468/06 to C-478/06 ………. vs. ……………. Medicinal Products, items 34-78; and Supreme Court 1387/2018, 1286/2011).”
The fact is that the parallel trade makes the pharmaceutical companies to loose millions of Euro in Greece for certain products and leaves the Greek patients without medicines only for the profits of certain wholesalers.