WHO’s initiative to ensure medicine quality suffers funding crunch

NEW DELHI: The World Health Organisation's initiative to ensure good quality of medicines for UN and for public procurement, the WHO Prequalification of Medicines Programme (WHO-PQP), is suffering from uncertainty of funding even though its annual budget is just $15 million. Despite large medicine procurers with billion dollar budgets, including governments and international organizations, depending on the WHO-PQP, few are contributing financially to the programme.

This was revealed in a paper published in the Journal of Public Health Policy which pointed out that the WHO-PQP ensured that "donor money was not wasted on products of unknown quality with potentially devastating effects for public health".

The authors of the paper which included many academics WHO have worked with the WHO's PQP, pointed out that the Global Fund to fight AIDS, TB, and malaria spent around $160 million per year on medicines and other pharmaceutical products and that the President's Emergency Plan for AIDS Relief (PEPFAR) spent 1.2 billion on medicine procurement over five years. "The $15 million annual budget of the WHO-PQP represents less than 2% of the annual amount spent on medicines by just these two organizations alone," stated the paper. It further urged that a consortium of public and private global health donors be created for a sustainable funding base for the programme.

The WHO-PQP survives almost entirely on support from the Bill & Melinda Gates Foundation and UNITAID as the WHO's own resources are not enough. The two contributed 80-90% of the WHO PQP budget in 2013. "A narrow funding base brings risks, including donor-driven priority setting," pointed out the paper. For instance UNITAID's mandate is to focus on HIV, TB, and malaria, but from a public health perspective, other priorities for prequalification, such as insulin and low-cost medicines for chronic diseases gets ignored.

There are several therapeutic areas where hardly any good-quality generic medicines are available in low- and middle-income countries, and whose national regulators lack experience in evaluating those products. The same problem exists for 'new' products produced or marketed only in countries without stringent regulatory agencies, such as the dapivirine vaginal ring, a microbicide to prevent HIV transmission.

As most large medicine procurement agencies like the Global fund and UN agencies started insisting on quality assurance for the medicines, it helped the growth and survival of the WHO PQP. Prequalification by the WHO became obligatory for pharma companies to compete in the international market. The WHO PQP has prequalified over 200 products for treatment of HIV/AIDS. Of 8 million people receiving treatment for HIV in 2012, 6.5 million were receiving WHO-prequalified ARVs.

According to its mandate to set international pharmaceutical norms and standards, WHO-PQP focused first on low-cost generic versions of medicines to treat HIV, tuberculosis (TB), and malaria. However, now the programme has expanded to make available quality and essential medicines for reproductive health, diarrhoea, and neglected tropical diseases (NTDs), quality control laboratories, active pharmaceutical ingredients (APIs), review of clinical research to prove the equivalence of generic medicines with their comparators and to build the capacity of medicines regulators and pharmaceutical manufacturers in developing countries of Asia and Africa.

The WHO-PQP which helped generics find acceptance in markets across the world has been criticized harshly by high income countries and multinational pharma giants for helping commercial generic producers gain access to new markets. At the same time it has often been criticized by activists "for having colluded with industrialized country interests to make the quality standards so high that generic products manufactured in low- and middle-income countries were largely excluded from prequalification".

To establish financial sustainability for WHO-PQP, WHO has introduced a fee-based system whereby companies applying for prequalification of their products may be charged a fee. However, the authors of the paper wondered if such a fee-based mechanism of funding would jeopardize WHO PQP's full independence.

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