EU could allow generics of patented drugs for countries in need
generic manufacturers to make drug products with in-patent active
pharmaceutical ingredients, provided that they are intended for use
in developing countries, reports Phil Taylor.
The move would bring the EU into line with World Trade Organisation recommendations that allow patented drugs to be copied and exported to poorer countries in the world that do not have the infrastructure in place to produce the drugs themselves.
Under this system, countries notify the WTO of the medicines they need, and generic manufacturers would be able to apply to meet the demand. This would involve contacting their national authorities for a 'compulsory license' from the holder of the drug's patent.
The WTO agreed last summer to extend the system of compulsory licenses to foreign manufacturers in order to improve access to medicines in the third world. Prior to this, only domestic companies could seek this form of patent suspension.
The system will make it possible for generic manufacturers to develop the processes required to make APIs and secure an immediate market for the products, ahead of the expiration of the originator's patents in Europe.
This could accelerate the introduction of generics once the intellectual property for a drug expires in Europe, but has also raised concerns that the products could be diverted from their intended recipients and re-imported for sale in the EU.
The Commission has suggested measures to prevent medicines produced under the compulsory licensing scheme from re-entering the EU. Customs authorities would be authorised to take action against the re-importation of goods and the patent holder could use existing national procedures to reinforce its rights, and the license could be terminated if re-importation occurs.
Meanwhile, the UK-based aid agency Oxfam has welcomed the move but says this legislative change will have to be monitored carefully to see how it works in practice.
"The legal mechanism agreed by the World Trade Organization is complex and, even if a developing country fights through the red tape, its market may not be large enough to allow generic companies to offer lower prices, " said the group in a statement.
Oxfam believes the proposal could be improved by doing away with time-consuming negotiations with the patent holder in the event of a public health emergency in a developing country.
The longer-term solution is for generic production to be the norm, and not the exception, in developing countries, said Oxfam, although it conceded that this development would require major reform of the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement.
