Export of generic medicines to developing countries: compulsory licences

KEY POINTS

• The importing countries eligible to benefit from the scheme are:
  • the world's least developed countries;
  • those which have informed the World Trade Organization of their intention to do so;
  • those listed in the OECD development assistance committee list of low-income countries.
• The importing countries must confirm they will use the scheme for public-health purposes, not for industrial or commercial objectives.
• Any person who has failed to secure authorisation from the patent holder may submit a request for a compulsory licence to the relevant national authority.
• They must provide personal details, information on the product, the amount they intend to produce and the destination countries.
• This must be backed by a specific request from the country concerned, a non-governmental organisation or a United Nations body.
• The relevant national authority in the EU informs the rights-holder and verifies the validity of the request before taking a decision.
• Conditions attached to the compulsory licence determine the quantities involved and duration of the concession. Products made under licence must be clearly identifiable by specific labelling or marking.
• Products manufactured under a compulsory licence may not be reimported and sold in the EU. Any suspected of breaking the law may, initially, be detained for 10 days and ultimately seized.
• A licensee failing to respect the conditions of a compulsory licence may find it reviewed and even terminated.