Directorate-General for Trade

Access to medicines

The 2001 Doha Declaration of the WTO committed WTO members to seeking ways to improve access to badly-needed medicines for developing countries. The EU has consistently led efforts to widen access to vital medicines in developing countries and to strike the right balance between the intellectual property rights of pharmaceutical companies and the need to ensure that medicines are available for poor countries facing public health crises.

Tiered pricing

In 2003 the EU adopted new rules on tiered pricing that prevented re-export to the EU of drugs sold by European pharmaceutical companies to developing countries at heavily discounted prices. This enabled European pharmaceutical companies to sell their goods to developing countries at prices cheaper than they charge in Europe (so-called 'tiered pricing') in the knowledge that those drugs could not be sold back into the EU market.

Compulsory licensing

The concept of compulsory licensing is written into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, signed by WTO members as part of the Uruguay Round in 1994. The principle of compulsory licensing allows a developing country facing a public health crisis, after consultation with the patent-holder, to grant a license to a domestic company without the approval of the patent-holder to produce a generic medicine patented by a foreign pharmaceutical company. This medicine is for the use of the domestic market and may not be exported.

In 2005, WTO members led by the EU agreed an amendment to the TRIPS Agreement that would extend this right to other countries so long as the medicine produced is solely for export to other developing countries with no or insufficient manufacturing capacities in the pharmaceutical sector. This amendment entered fully into force in 2007.

The EU has now integrated this amendment into its own law so that EU pharmaceutical companies can apply for a licence to manufacture, without the authorisation of the patent holder, pharmaceutical products for export to countries in need of medicines and facing public health problems. There is no specific restriction on the pharmaceutical products covered, although there is acknowledgement that they are products required to address public health crises.

The compulsory licensing system depends on a clear prohibition against re-exporting medicines produced under compulsory licenses to take commercial advantage of their heavily lowered prices. Not only does this undermine the balance behind the compulsory licensing principle, but it diverts the medicines from where they are most needed. Where this happens, compulsory licences can be terminated.

Non-governmental and international organisations are invited to be involved in purchasing procedures and are able to make requests on behalf of an importing country with that country’s approval. The safety and efficacy of medicines for export can be certified through the EU's scientific opinion procedure, or equivalent national procedures.

Customs Enforcement

Regarding the issue of customs detention of pharmaceuticals in transit, a statement has been published by EFPIA (European Federation of Pharmaceutical Industries and Associations).