EU will keep HIV/AIDS/TB generic initiative, despite low take up
System should remain part of continuing EU policies to promote 'better access to medicines in poor countries', review concluded
A European Commission review of a 2003 regulation designed to help pharmaceutical firms supply cheaper HIV/AIDS/TB drugs to developing countries, with special labels preventing their re-export to the European Union (EU), has concluded that the system should stay in force.
This is in spite of the fact that manufacturers have not much used the system, preferring to use their own private actions preventing grey market supplies of these drugs.
The review concluded that as the system has delivered some cheaper medicines to needy patients and is comparatively easy to administer, it should remain part of continuing EU policies to promote 'better access to medicines in poor countries'.
The regulation (EC 953/2003) was evaluated according to its effectiveness, efficiency, coherence and relevance. The review concluded that it had effectively helped GlaxoSmithKline (GSK) export medicines to target countries between 2004 and 2008.
Its report added: 'Although the volume of HIV medicines that GSK sold under the Regulation declined significantly from 2009, more medicines overall were supplied thanks to licences granted to generic manufacturers. GSK’s medicines represented an important contribution to HIV treatment. In 2011, medicines sold under the regulation and by licensees represented a year’s supply for over a million people.'
It said some companies had been deterred from using the regulation because it capped the price of medicines registered under its rules 'even though the prices of their products were below the ceilings'. But the regulation 'may have contributed to dialogue between stakeholders on improving access,' it suggested.
While the regulation reduced the risk of medicines being sent back to the EU 'slightly', its 'costs were also limited' to adding a logo and registering new package designs.