Σύγκρουση κανόνων ανταγωνισμού και δικαιωμάτων που απορρέουν απο δίπλωμα ευρεσιτεχνίας : το ζήτημα των φαρμάκων
Λουκαδούνος, Ιωάννης Κ.
Μπασαγιάννης, Αθανάσιος Χρ.
Φάρμακα -- Ευρεσιτεχνίες Φαρμακευτική βιομηχανία Φάρμακα -- Δίκαιο και νομοθεσία -- Ελλάδα Φάρμακα -- Δίκαιο και νομοθεσία -- Ευρωπαϊκή Ένωση, Χώρες της Εμπορικές ρυθμίσεις Drugs -- Patents Pharmaceutical industry Drugs -- Law and legislation -- Greece Drugs -- Law and legislation -- European Union counties Trade regulation
Πάντειο Πανεπιστήμιο Κοινωνικών και Πολιτικών Επιστημών
The European Commission has proposed a regulation that will allow the export of cheaper, generic drugs to “countries in need” that lack the capacity to produce cheap drugs themselves. However, provisions for the prevention of re-importation remain hazy, and observers say the removal of drug marketing regulations may present health risks. The commission’s proposed regulation would activate a World Trade Organisation decision dating from last year, which allows national authorities are to grant compulsory licences for the production of generics, under certain conditions. One condition is that the destination country must have notified the WTO that it is seeking the medicine covered by the licence. The proposed regulation places no further restriction on the medicines and diseases to be covered. An issue that has formed part of the backbone of the pharmaceutical industry’s argument against the use of generics has been the risk of re-importation of generics into the domestic market, which would erode companies’ lucrative markets and infringe upon intellectual property rights. The commission says it has addressed this issue by prohibiting the re-importation of cheap generics into the European Union and says provisions have been made for customs authorities to take action against goods being re-imported. The patent holder will also be able to use existing national procedures to enforce its rights in the event of goods being re-imported into the EU. The commission has also stated that the compulsory licences awarded to the generic drug manufacturers could be terminated if re-importation occurred. However, at present, provisions to prevent re-importation remain hazy, and the bulk of the onus of regulation appears to fall on manufacturers of generic drugs and the patent holders themselves. Another area of controversy is the commission’s proposed removal of medical marketing requirements on generic drugs manufactured in the EU. Normally manufacturers of generic medicines are required to wait for eight years before they can obtain authorisations, using data from previous clinical trials. However, in order to fast track the process the commission has set out exemptions from the rules. Generic drug exports from the EU will not require a medicinal marketing authorisation for exported products. Instead, the commission advises importing countries to carry out their own quality controls in order to ensure that medicines are safe and effective. Under the proposed regulation, and provided the countries in need notify the WTO of the medicines they require, it will be up to generic companies alone to decide to apply for licences to manufacture the generic versions of drugs. Trade commissioner Pascal Lamy maintains that the proposal “leads the way in ensuring access to affordable medicines for poor countries”. He says the commission’s stance is proof that the EU is delivering on its promises in the Doha Development Agenda. The Doha declaration on trade and health addressed the difficulties raised by this restriction for developing countries with no manufacturing capacity. After long negotiations, WTO members agreed on a waiver giving these countries access to much needed generics.
Διπλωματική εργασία - Πάντειο Πανεπιστήμιο. Γενικό Τμήμα Δικαίου, ΠΜΣ "Δίκαιο και Ευρωπαϊκή Ενοποίηση", κατεύθυνση Ιδιωτικό Δίκαιο, 2009