Medicines Patent Pool Executive Director Calls for Faster Regulatory Approval for HIV Medicines in Developing Countries
APRIL 2013: The Medicines Patent Pool exists to ensure that HIV medicines are available and affordable for people who need them.
Within the realm of access to HIV medicines, the focus is often directed towards intellectual property issues, overcoming distribution barriers and concerns on adequate funding. All of these issues are critical – and the MPP works directly on licensing to share intellectual property – but a missing piece of the access puzzle that is not often addressed is the need for speedy regulatory approvals of quality drugs.
Discussing this matter recently at the first Euro-Africa Health Investment Conference (EAHIC) in London, UK, participants acknowledged the importance of ensuring quality medicines.
The MPP works with the WHO Prequalification Programme [pdf] and ensures manufacturers using MPP licences are certified by the WHO or another stringent regulatory authority, such as the US Food and Drug Administration.
Several participants at the EAHIC cited delays in national level registration as a sticking point along the path to ensuring more timely access to medicines in developing countries.
One way to increase the speed of registration is through training and coordination of drug regulatory authorities. WHO has introduced a special collaborative procedure which enables structured collaboration and information sharing between the prequalification programme and national regulators to speed up the registration. HIV medicines manufacturers are encouraged to cooperate with WHO and national authorities to achieve this common goal.
The MPP supports this procedure and will work with various stakeholders, including the WHO and national medicines authorities, to facilitate these kinds of activities.