The Pharmaceutical Journal
Vol 273 No 7324 p673
6 November 2004

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Patented medicines will be allowed to be copied for use in developing countries

Generics manufacturers are to be allowed to make copies of medicines still protected under patent for export to under-developed countries. A proposed European Commission Regulation will implement a World Trade Organization agreement reached last year which is intended to help satisfy the need for affordable medicines in countries with no pharmaceutical industry of their own (PJ, 6 September 2003, p289).

Under the planned new rules, generics companies will have to try to negotiate licensing agreements with patent holders. If they cannot reach agreements on reasonable commercial terms they will be able to apply for compulsory licences. The new system will only apply to products for export to countries that have notified their needs to the World Trade Organization.

Products made under compulsory licences will have to be specially labelled and their reimportation into Europe will be prohibited. Medicines made in this way will also have to be a different shape or colour from the patented product, unless this is impossible or has a significant impact on price. Patent holders will be able to take legal action against the suppliers of any product that illegally reaches the European market.