WHO Prequalification Team (PQT)

Structure of PQ fees and how it work

Dr Olexandr Polishchuk
Division of Health systems
and Public Health
WHO EURO
15 – 16 August 2018
Cairo, Egypt

WHO PREQUALIFICATION PROGRAMME

 New Funding Structure for PQ
• Background and process:
– Fees to WHO in place – vaccine since 1999, In-Vitro
Diagnostics since 2010 and medicines since 2013

– following a year of discussions between WHO, Industrial

groups and key partners

– The new fee structure for vaccines and medicines was

effective 01 January 2017, and in early 2018 for
diagnostics.

WHO PREQUALIFICATION PROGRAMME

 New Funding Structure for PQ (II)

• Objectives:
• ensure the financial sustainability of WHO’s PQ
• to make PQ better equipped to address current global quality challenges
• to lay the ground for strengthening and expanding services provided, and
• to improve financial predictability and transparency

• Fees structure:
• Designed to ensure equity among manufacturers modelled on the
practice of NRAs around the world

WHO PREQUALIFICATION PROGRAMME

 New Funding Structure for PQ (III)

• Fees principles and structure:

– product nature: active pharmaceutical ingredient (API) or finished
pharmaceutical product (FPP)

– type of assessment: full or abridged assessment of new application,

or assessment of major variation

– an annual maintenance fee tailored to whether the initial assessment

was full or abridged.

WHO PREQUALIFICATION PROGRAMME

 Medicines and APIs

WHO PREQUALIFICATION PROGRAMME

 Vaccines
For a vaccine, a single product is defined as a vaccine of a unique strength and
dose form. However, a single vaccine product may have several presentations
(1 dose, 2 doses,...20 doses). Typically, a single product would be associated
with a single entry in the WHO List of Prequalified Vaccines.

WHO PREQUALIFICATION PROGRAMME

 In vitro diagnostics
An IVD application may consist of one or more products provided they: detect
the same analyte, are of the same design, contain the same reactive
components (source, concentration, etc.), and have the same intended use. A
single application may include different packaging configurations (number of
tests, accessories, size of additional components such as buffer).

WHO PREQUALIFICATION PROGRAMME

 Immunization Devices

In general for immunization devices, a single application fee is applied to each

device with a unique manufacturer’s product reference number. The fee
applicable to an IMD application depends on the type of product as outlined in
table 5 below.

WHO PREQUALIFICATION PROGRAMME

 When are the fees payable?
• An invoice for the application fee will be issued after the
application has been screened and accepted for assessment
•

• Similarly, an invoice for the fee associated with a major variation will
be issued following screening and acceptance of the variation
application

• Payment should be made within 15 days of receipt of the invoice

from WHO

• An invoice for the annual fee will be issued by PQT on or before 1

October each year. The annual fee will be applied to all FPPs or
APIs that, by 1 September of that year, have been prequalified for
12 months or more

• Payment of the annual fee should be made before 30 November of

the calendar year in which the invoice was issued.

WHO PREQUALIFICATION PROGRAMME

 Products that have been indicated to
potentially have low profit margins

WHO PREQUALIFICATION PROGRAMME

 PQT – revised fee model

• The fees are structured to consider the type of product, complexity,

assessment procedure, and manufacturer sales (vaccines only)
• The model includes both an application fee and annual fee.
• The annual fee:
– for medicines and APIs is fixed, whereas for vaccines the annual levy is linked to sales
from PQ’d vaccines (PQ enabled sales).

– The annual fee will be invoiced on the 1 October each year for all products that have
been present on the list of prequalified APIs, or FPPs for 12 months or greater as of
the 1 September of that year.

• The Medicine and API fee covers both assessment and inspection activities,
whereas for vaccines assessment and inspection activities are charged
separately.
http://who.int/medicines/news/finance-arrangements-prequal-med/en/

WHO PREQUALIFICATION PROGRAMME

 12

Key performance Indicators (KPIs)

- Reasons & Advantages -

Reasons for introducing new performance metrics

Encouragement from the Gates Foundation for developing indicators measuring
performance (as opposed to project-related indicators)

Increased transparency for manufacturers and other stakeholders following the
introduction of the new fee model

Advantages of those new performance indicators

Following up the progress of applications throughout the PQ pipeline (as opposed to
only measuring timeline at the end of the PQ assessment)

Monitoring performance of the different components of the PQ assessment

Measuring performance of processes controlled by WHO PQ (limited external
influence on performance)

WHO PREQUALIFICATION PROGRAMME

 13

Key performance Indicators (KPIs)

- Reasons & Advantages -
First, the harmonization initiative…

Harmonization of terminology across product streams, for PQ and PQ-related product
and processes

Alignment of phases and steps of PQ processes across product streams, including PQ
assessment and post-PQ processes

New algorithm for calculating WHO and manufacturer time, now identical for all types
of products

... then, the new performance indicators

Development finalized, but full implementation pending the new IT system launch

… and finally the KPIs

KPIs are a subset of the application-based performance indicators to be reported
publicly

WHO PREQUALIFICATION PROGRAMME

 14

Key performance Indicators (KPIs)

Annual PQ cohort (products prequalified in a calendar year)

Time to prequalification (from acceptance for assessment to prequalification)  for applications accepted after 1 January 2015, 2016 for APIs
100 Number of products PQed - -
110 Median WHO PQ time - N/A
111 Median manufacturer PQ time - N/A
112 Median total PQ time - N/A
Full assessment:
270 calendar days, 350 calendar days for IVDs PQed
70%
% of products prequalified at or below target WHO without the alternative laboratory mechanism
KPI 1 (30% for
PQ time Abridged assessment:
APIs)
100 calendar days, 180 calendar days for IVDs PQed
without the alternative laboratory mechnism

Submission cohort (PQ applications submitted for PQ assessment in a calendar year)

Time to ‘screening first action’

200 Number of PQ applications submitted - -
210 Number of ‘screening first actions’ - -
% of 'screening first actions' taken at or below
KPI 2 80% 30 calendar days
target time

WHO PREQUALIFICATION PROGRAMME

 15

Key performance Indicators (KPIs)

Assessment cohort (PQ applications accepted for PQ assessment in a calendar year)

Time to 'first action’

300 Number of PQ applications accepted - -
310 Number of ‘dossier first actions’ - -
% of ‘dossier first actions’ taken at or below target 90 calendar days, 120 calendar days for FPPs & APIs
KPI 3.1 80%
time (due to fixed assessment sessions)
320 Number of ‘inspection first actions’ - -
% of ‘inspection first actions’ taken at or below
KPI 3.2 80% 210 calendar days
target time
330 Number of 'laboratory first actions’ - -
% of 'laboratory first actions’ taken at or below
KPI 3.3 80% 180 calendar days
target time

Change cohort (post-PQ change applications accepted for change assessment in a calendar year)

Time to ‘post-PQ change first action’

400 Number of post-PQ change applications assessed
410 Number of ‘post-PQ change first actions’
% of 'post-PQ change first actions' taken at or
KPI 4
below target time
- -
- -
APIMF|major (minor) amendment: 90 (60) calendar days
APIMF|immediate notification: 45 calendar days
FPP|major (minor) variation: 90 (60) calendar days
80%
FPP|immediate notification: 45 calendar days
IVD|reportable change: 90 calendar days
Vx|major variation, type A: 90 calendar days

WHO PREQUALIFICATION PROGRAMME

 THANK YOU!

WHO PREQUALIFICATION PROGRAMME