WHO experts give risk rating for urgently needed medicines

November 2012

Strict quality assurance policies for medicines have improved supply and quality but patients in developing countries still lack access to affordable medicines, particularly generics, that meet international standards.

Fast-track supply of urgently needed medicines

A novel quality risk assessment system coordinated by WHO is helping to fast-track supply of these urgently needed medicines.

Health workers sort through medical supplies in a warehouse in Banda Aceh, Indonesia
WHO/Jim Holmes

The Global Fund to Fight AIDS, Tuberculosis and Malaria – the world’s biggest financer of programmes to fight these three diseases – will normally only fund medicines that meet the high standards of WHO’s Prequalification of Medicines Programme or an internationally recognized stringent regulatory authority (most of which are in high-income countries).

Rigorous process of medicine assessments can take time

“We need to ensure that our programmes receive safe and effective medicines,” says Joelle Daviaud, quality assurance specialist at the Global Fund. “WHO prequalification is very important to the Global Fund.”

But the rigorous process of assessments and inspections required under prequalification can take months or even years.

“This can lead to serious shortages in quality medicines – particularly for malaria and TB,” adds Daviaud. “So three years ago, in 2009, the Global Fund charged WHO to set up a system to help speed up supply of needed medicines.”

Providing rapid advice

WHO responded by establishing the Expert Review Panel, made up of independent experts from around the world. Its task is to provide rapid advice to procurers on the potential quality, efficacy and safety of medicines while waiting for them to undergo full prequalification or stringent regulatory approval. The criteria assessed by the Panel include:

  • compliance with good manufacturing practice;
  • quality of the active ingredient;
  • the formulation process used; and
  • the extent to which the product remains stable in harsh climatic conditions.

Transparent risk-benefit assessment

Matthias Stahl, who coordinates the Panel at WHO, says that it provides a scientific and transparent risk-benefit assessment. “Procurers are aware that products might not be of the highest standard, but our advice helps them to balance possible risks with the urgent need to supply the medicine,” he says. “It provides immediate procurement opportunities for manufacturers while encouraging them to meet the expected standards within a reasonable period of time.”

Dossiers for pharmaceutical products are eligible for consideration by the Panel if there are less than two alternative products that meet international standards for the same formulation. Its advice is valid for 12 months during which time the product concerned is expected to progress to WHO prequalification or equivalent standard. As a further precaution, all products reviewed by the Panel undergo random quality control testing in WHO prequalified laboratories before shipment.

An efficient review process

Since 2009, the Panel has reviewed almost 600 products, mostly generic medicines for HIV, TB and malaria, but more recently oral contraceptives and some medicines for neglected tropical diseases. It can turn around dossiers in just a few days and all reviews are done within 4 to 6 weeks.

“The Expert Review Panel has been very effective in helping to support supply of needed medicines for which there were no or too few WHO-prequalified products,” says Daviaud. “So far the impact has been greatest for anti-TB medicines.”

Harmonizing the different quality assessment policies

It has also helped to harmonize the different quality assessment policies used by health agencies including the Global Fund, UNICEF, UNITAID, UNFPA and the Global Drug Facility for tuberculosis medicines. Now each product is reviewed once and the assessment results are shared, meaning a single application for manufacturers, an efficient process and one global set of standards for all.