WHO Now Charging Fees For Drug Prequalification, Raising Access Fears

The World Health Organization, the United Nations health agency in persistent financial straits, has announced it must begin charging a fee to manufacturers seeking prequalification of their medicines and pharmaceutical components [corrected]. The announcement stirred concern among public health advocates that it might have a negative effect for procurement and access to life-saving medicines.

The new fee system for applications includes protections to alleviate access problems, but a key public health group said it may not be enough.

The WHO Prequalification of Medicines Programme (PQP) issued an announcement saying that it is externally funded and no longer can meet its costs.

“In the past we have been able to fund our activities through the generosity of our donor organizations,” the programme statement said. “However, in the current economic climate we can no longer afford to rely solely on donor funding for our on-going financial viability. WHO has been charging fees for the Vaccines and Diagnostics Prequalification Programmes for some time. We are not moving PQP toward a full cost recovery model, but we are looking to achieve a balance between external and internal funding. Please note that over the next few years WHO will continue to assess this balance and adjust it as needed.”

WHO anticipated the concerns over access and took preemptive measures: “[A]t this stage we are conscious of the potential disincentive that fees may pose to manufacturers who are considering seeking prequalification of their products. To this end, we have set the fees below those currently being charged by the WHO vaccines and diagnostics prequalification programmes. We have also introduced some flexibility, whereby manufacturers who provide adequate justification may be exempted from fees or charged a reduced fee,” it said.

The new fee table, effective 1 September, is available here [pdf].

Médecins Sans Frontiéres (MSF, Doctors without Borders), which uses the prequalification programme in its medicines procurement, raised concern.

“While this is clearly being done to help raise additional resources to support a necessary programme, we hope this won’t have a negative impact in discouraging necessary applications from manufacturers,” a spokesperson said in an email. “Ultimately WHO PQ has and remains an important component of the work of WHO in ensuring access to life-saving medicines, and the key to its future functioning and success relies much more on political and sustainable financial support from member states.”

Prior to 1 September, all applications were free. Now, it is free for first-time applicants, but could be up to $8,000 for subsequent applications. WHO said it would show flexibility for essential drugs, but, as an MSF spokesperson put it, “MSF and many other NGOs and drug procurers look to WHO PQ and stringent regulatory authorities for quality-assured generic medicines wherever possible.”

Dr Manica Balasegaram, executive director of MSF’s Access Campaign, said in a statement: “MSF hopes that the new PQ application fees do not act as a barrier to small and developing country manufacturers from submitting essential drugs for prequalification. Ultimately though, WHO PQ has and remains an important component of the work of WHO in ensuring access to life-saving medicines, and the key to its future functioning and success relies much more on political and sustainable financial support from member states.”