Seizure of unpatented medicines, contrary to EU customs rules (Regulation (EC) No 816/2006)

11.2.2009

WRITTEN QUESTION E-1082/09
by Corien Wortmann-Kool (PPE‑DE)
to the Commission

Recently a consignment of unpatented blood-pressure medicines was seized in Rotterdam in the Netherlands. These were on their way from India to Brazil. This particular blood-pressure medicine does not come under patent protection in either India or Brazil and can therefore be freely traded between the two countries. On 14 November 2001 the World Trade Organisation’s Ministerial Conference issued a declaration on Trade Related Intellectual Property Rights (TRIPS), which offers the possibility of compulsory licences, when patented medicines are too expensive for developing countries to be able to adequately deal with sometimes massive public health problems, so third parties can make use of patented inventions. Developing countries’ access to generic medicines is thus guaranteed. In 2006 the EU, partly in response to the TRIPS declaration, published Regulation (EC) No 816/2006[1], which included the transport of generic medicines to developing countries. Despite this, the consignment seized in Rotterdam on 4 December was returned to India.

Has the Commission been informed of the seizure of the consignment of unpatented medicines from India that was on its way to Brazil, which in no way had the European market as its final destination?

Can the Commission indicate how far the seizure is in accordance with Regulation (EC) No 816/2006, which states that in the event of serious public health problems developing countries are entitled to have access to generic medicines so as to provide the poor with medicines?

Can the Commission, if necessary, clarify the regulation on this point, to prevent unpatented medicines not intended for the European market being seized again?

• [1] OJ L 157, 9.6.2006, p. 1.

OJ C 189, 13/07/2010