Export of generic medicines to developing countries: compulsory licences

SUMMARY OF:

Regulation (EC) No 816/2006 – compulsory licensing of patents relating to the manufacture of pharmaceuticals for export to countries with public health problems

SUMMARY

WHAT DOES THIS REGULATION DO?

It establishes a procedure for companies in the EU wishing to manufacture generic medicines for use in the developing world to apply for a compulsory licence from a patent holder, which allows their manufacture.

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.

FROM WHEN DOES THE REGULATION APPLY?

It entered into force on 29 June 2006.

BACKGROUND

The legislation is part of wider EU action to tackle public-health concerns that the world’s least developed and developing countries face, in particular access to safe, effective and affordable medicines.

• Access to medicines on the European Commission’s website

ACT

Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (OJ L 157, 9.6.2006, pp. 1-7)

last update 16.02.2016