Achievements and impacts of WHO prequalification to date

MSF perspectiveCarine Werder

MSF international pharmacist coordinator

Geneva, 11th February 2010

Public health benefits (1)

• Facilitated safe procurement of quality generics, especially for ARVs at the beginning of the HIV pandemics

• Demonstrates that WHO norms and standards are achievable

• Recognition of generic manufacturers as quality and safe suppliers

• Contributed to increased competition and reduction of price

Public health benefits (2)

• Encourage the development of new formulations (FDC, new pediatric medicines, etc.) and enabled scale-up

• Encourage donors to set up quality assurance criteria for purchase of medicines based on WHO PQ

• Capacity building for DRAs

Public health benefits (3)

Vaccines: • Complexity of the biological products

requires specific expertise• WHO PQ extends access to safe, effective

and quality vaccines • Strengthen regulatory authorities in

production countries

Impacts from MSF perspective

• Extend the list of manufacturing sites with adequate GMP standards, including for other medicines

• Reduce the workload for ARV, anti-TB and anti-malarial products to be assessed internally

• Prequalification status simplifies drug importation in certain countries

• Facilitates the hand-over and integration into national programmes

Continued improvements:

• Access to newer treatment options available timely

• Prioritization in product assessment (drugs and vaccines)

• Extension of WHO PQ (neglected diseases e.g. ampho B liposomal)

• Continual extension of available information for purchasers

Additional roles

• Quality of medicines in countries with large production capacity (e.g. China)

• Advocacy targeted to donors to include stricter QA criteria for the purchase of quality medicines

Diagnostics • The quality of IVDs depends not only on the quality of

production, but also of a series of steps towards the end-user.

• Critical importance should be made towards the development of strong post-market surveillance system.

• Short commercial life spans of IVD (average 5 yrs). • Available funding resources are significantly lower.

• Issues with current regulatory practices– Risk level and therefore stringency of

regulatory control for IVD based on public health importance of disease in country of submission. (Ex. Malaria diagnostics in non-endemic countries may be approved based on self declaration of manufacturer)

– Manufacturers may use same or similar product name for potential different quality levels (eg with and without CE marking)

– Approval based on validation by the manufacturer that does not necessarily predict performance of IVDs in the setting of use.

Benefits of Diagnostics PQ•Superiority of PQ Diagnostics programme:takes into consideration the country of use of the IVD, including RLS. Consideration is made based on region-specific reference panels and biological reference materials.

•Contribution in shaping new quality standards for IVDs used in RLS, notably through:

– technical WG providing information related to the assessment and prequalification of new technologies

– Significant contribution in the review of current regulatory and procurement practices towards the development of adequate regulatory requirements and QA standards for procurement.

but... more work is still needed to establish adequate

quality standards and procedures for IVDs

a significant increased support and resources to the PQ Dx programme is needed in order to reach well-defined standards as currently achieved for drugs and vaccines.

THANK YOU!