PROGRESS
REPORT
JUNE 2013
WHO
PREQUALIFICATION
CONTENT
WHO PREQUALIFICATION: ASSURING THE QUALITY OF KEY PRODUCTS......................................................................................................p 1
VACCINES ........................................... p 2 MEDICINES ......................................... p 6 DIAGNOSTICS AND
MEDICAL DEVICES ..............................p 10
FUTURE THINKING ............................................................................................................................................................................................p 14
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WHO PREQUALIFICATION:
ASSURING THE QUALITY OF KEY PRODUCTS
The World Health Organization’s Prequalification Programme ensures that key health products are safe, appropriate
and meet stringent quality standards for international procurement. It does so by assessing product dossiers,
inspecting manufacturing and testing sites, organizing quality control testing of vaccines and medicines, validating
the performance of diagnostics, and verifying that the products are suitable for use in the destination countries.
Every year, more than 2.5 billion
doses of vaccines are used
globally to immunize children
under 10 years old.
Prequalified vaccines are used
to immunize 65% of infants
worldwide.
Outcomes of a WHO site audit led
to a supply suspension of a vaccine
through UN systems in 2012.
The manufacturer proactively
quarantined products in transit
and developed a corrective action
plan. Alternative sources of
prequalified vaccine were available
to ensure continued supply.
Prequalification creates global competition for quality-assured products.
Prequalification detects and addresses quality failures.
Prequalification provides assurance that products meet consistent quality standards, every time.
Comprehensive information on prequalification and quality issues is available at:
www.who.int/immunization_standards/
vaccine_quality/pq_system/en/index.html
www.who.int/prequal www.who.int/diagnostics_laboratory/
evaluations/en/
VACCINES
The Prequalification of Vaccines
Programme was created in 1987
to assure the quality of vaccines
distributed by UN purchasing
agencies.
It prequalifies a wide range of
traditional as well as combination
and novel vaccines, and identifies
other possible future candidate
vaccines.
MEDICINES
The Prequalification of Medicines
Programme was created in 2001
to prequalify antiretrovirals (ARVs)
meeting WHO norms and standards,
as a contribution to combating the
HIV epidemic. The Programme’s
mandate was later extended to
also cover medicines for malaria,
tuberculosis, reproductive health,
neglected tropical diseases,
influenza and diarrhoea.
DIAGNOSTICS
The Prequalification of Diagnostics
and Medical Devices Programme
evolved from the test kit evaluation
programme created in 1988. It
became operational in 2010 and
is aligned with current regulatory
requirements.
It covers diagnostics and medical
devices for priority diseases, such
as HIV/AIDS, malaria and hepatitis
B and C.
The majority of the 9.7 million
people currently on HIV
treatment in low- and middle-
income countries are taking
prequalified ARVs. Over 280 million
treatment courses of prequalified
artemisinin-based combination
therapies (ACTs) were sold in 2011
to treat malaria.
In 2012, prequalified HIV rapid
diagnostic tests (RDTs) accounted
for 85% of the 58.7 million tests
procured by key stakeholders.
Prequalified CD4 technologies
suitable for district and point-
of-care level represent the vast
majority of the global market for
such products.
In September 2011, falsified copies
of a prequalified ARV product
were found in an African country.
WHO immediately investigated
the matter and published full
information and recommendations
for procurers and treatment
providers.
The Programme works closely with
regulatory and other partners to
monitor the quality of prequalified
products.
In 2011, a WHO Field Safety Notice
resulted in an unprecedented
recall of 14 lots of a widely used
HIV RDT. This event triggered
global measures to secure a
continued quality-assured supply
of needed tests.
The manufacturer improved its
quality management and lot
release systems. The product
was re-introduced on the list of
prequalified products in 2013.
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WHO PREQUALIFICATION
OF VACCINES
Vaccination is one of the most cost-effective health interventions.
Prequalification of vaccines aims to facilitate universal access to vaccines of assured quality
to National Immunization Programmes in countries in most need.
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Prequalification of vaccines is linked to the maturity of
regulatory oversight and to the availability of international
standards. Due to the inherent variability of biological
products, standardization is key, as is the need for strong
regulatory oversight. On the other hand, constant technical
advances present continuous challenges for all stakeholders
in assuring the quality of vaccines to the highest attainable
standards.
The Programme prequalifies a wide range of vaccines
according to a biennial prioritization list which takes into
account the demand in UN-supplied markets, programmatic
needs and strategies, and supply security.
Evaluation principles
Functionality of the national regulatory authority (NRA)
of the producing country
Dossier assessment
Assessment of suitability for use of the vaccine in the
intended settings
Good manufacturing practice (GMP) inspections
Random quality control (QC) testing
Monitoring of complaints and adverse events
Fees
As specified on the Programme’s website
A wide choice of prequalified vaccines is produced in 21
different countries, including some emerging economies.
The top five countries by number of products prequalified
are India, Belgium, France, Indonesia and the Republic of
Korea.
A streamlined procedure was introduced in 2012 to
reduce assessment timelines and make best use of limited
resources through the following approaches:
> Recognition of regulatory assessment and inspection
reports and test results for vaccines approved in USA,
Europe, Canada, France, Belgium, Italy or Australia, or
by the European Medicines Agency under Article 58
> Review of manufacturers’ Vaccine Product Annual
Reports for each prequalified vaccine
> Risk-based re-assessment schedule taking into account
NRA functionality, QC test results, complaints and
adverse events history, and the number and scope of
variations.
Prequalified vaccines
129 prequalified vaccines listed on the Programme’s
website
Pipeline
Total of 14 vaccines under assessment
7 new submissions in 2012 — one completed,
six ongoing
Variation control
53 manufacturers’ annual reports reviewed in 2012,
giving rise to review of 448 variations
Guidance on variations and variation reporting by
manufacturers published for comment in February
2013
Re-assessment
12 prequalified vaccines reassessed in 2012
ACHIEVEMENTS
RESULTS
(as of June 2013, or for full years as stated)
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The quality of prequalified products is monitored on an
ongoing basis through QC testing as well as monitoring
of complaints and adverse events following immunization
(AEFI). Serious issues are fully investigated and followed
up as appropriate by additional lot testing, site audits and
other measures; if they are not remedied the vaccine may
be removed from the prequalification list.
Investigation outcomes are published on the web, providing
safety signals to the Global Advisory Committee on Vaccine
Safety.
Random testing
154 vaccine lots tested by WHO-contracted
laboratories in 2012
Follow-up of potential quality issues
15 complaints investigated in 2012
9 reports of AEFI communicated to WHO in 2012 (7 in
2011), of which 7 were serious. None was linked to a
quality defect, 3 were due to programmatic error
Manufacturers are encouraged to meet with the Prequal-
ification Programme before submitting applications for
prequalification to gain a clear mutual understanding of
product characteristics and development plans, maximizing
the chances for success in prequalification.
In addition, detailed guidance on prequalification processes
is provided on the Internet.
Meetings with manufacturers are also held to ensure con-
tinued supply and to identify alternative sources where
needed.
Consultations
119 one-on-one meetings held with manufacturers in
2012 (71 in 2011)
Consultative meeting with IPV/OPV manufacturers held
in October 2012
Briefing workshops in India and China for a total of
18new manufacturers in 2012
Guidances
Guidance on Master Formulae and on environmental
monitoring of clean rooms published in 2012
The Programme collaborates closely with responsible
NRAs that oversee the quality of prequalified vaccines. It
conducts regular consultations, and concludes collabo-
ration agreements with the NRAs of countries exporting
prequalified vaccines.
Representatives of the Developing Country Vaccine Regu-
lators Network (DCVRN) — funded by member countries
with donor support, and coordinated by the Prequalifica-
tion Programme — participate in clinical reviews for pre-
qualification, with significant benefits for harmonization
and capacity-building.
Since 2006 a facilitated procedure exists for national reg-
istration of imported WHO-prequalified vaccines such as
MenAfriVac
®
, a vaccine developed to address the yearly
meningitis epidemics in the meningitis belt.
Collaboration with NRAs
109 meetings with NRAs in 2012
Confidentiality and collaboration agreements with
6 NRAs in 2012
Developing Country Vaccine Regulators Network
(DCVRN)
One meeting held in Thailand in 2012
One webex-based meeting held in 2012
Annual 3-month secondments of 2 DCVRN
representatives to Geneva (from Thailand and
Indonesia in 2012)
Facilitated national registration
26 NRAs trained in 2011 using the example of
MenAfriVac
®
in 2012 and 2013
Support in target countries for introduction of
MenAfriVac
®
in 2012 and 2013
ACHIEVEMENTS
RESULTS
(as of June 2013, or for full years as stated)
Through its emphasis on NRA functionality in the producing countries the Programme is promoting effective regulatory
oversight of prequalified vaccines in the long term.
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Good quality medicines are a key element of global efforts to combat the pandemics of HIV infection,
tuberculosis, malaria and other diseases which threaten public health, yet some products are still
out of reach of patients in countries with limited resources.
Prequalification of medicines aims to facilitate access to medicines that meet unified standards of
quality, safety and efficacy for all who need them.
WHO PREQUALIFICATION
OF MEDICINES
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Prequalification of medicines is underpinned by compre-
hensive WHO norms and standards, combining stringent
harmonized regulatory standards as used in Europe, Japan
and the United States with a practical focus on the technical
aspects that are most relevant in developing countries. The
Programme’s small team of 30 works with an external pool
of regulatory assessors and inspectors from all settings.
The Programme invites Expressions of Interest for pre-
qualification of key medicines identified by WHO disease
programmes. Since 2001, the programme has assessed
close to 1000 products.
Evaluation principles
Prequalification of products and services at several
stages of the production chain
Dossier assessment and variation control
Inspection of manufacturing sites, contract research
organizations (CROs) and quality control laboratories
(QCLs)
Recognition or consideration of other stringent
assessment outcomes
Fees
To be introduced for selected services in 2013
A competitive market for prequalified finished pharma-
ceutical products (FPPs) is now in place for most needed
HIV-related and antimalarial medicines, and the prices of
some products have reached minimum sustainable levels.
Prequalification has been extended to reproductive health
products and other categories. 2012 saw the prequalifica-
tion of the first zinc product to help treat diarrhoea in mal-
nourished children. In July 2013 the Programme released
an Expression of Interest for medicines to treat neglected
tropical diseases such as lymphatic filariasis, soil-trans-
mitted helminthiasis and schistosomiasis.
Prequalified products of additional medicines are continu-
ously needed. To bridge the gaps until prequalified or oth-
erwise stringently assessed products become available,
the Expert Review Panel (ERP) — coordinated by the Pro-
gramme since 2009 — gives risk-based technical advice to
procurers about products which can be procured while still
under stringent assessment. A recent example is the first
ERP-reviewed generic linezolide — a product for treatment
of drug-resistant tuberculosis — that became available in
June 2013 at 10% of the originator price.
Prequalified FPPs (since 2001)
397 FPPs prequalified over time
347 prequalified FPPs listed on the Programme’s
website
48 FPPs prequalified in 2012 (35 in 2011), including
16 “firsts” i.e. product types not previously prequalified
(20 in 2011)
Re-assessment and variations
44 prequalified FPPs undergoing requalification review
521 variation submissions to prequalified FPPs and
80 variations to API master files assessed in 2012
Pipeline
Over 150 products under assessment
82 new applications received in 2012 (68 in 2011),
73 accepted after screening
21 ERP-reviewed products listed on Global Fund
website in June 2013
ACHIEVEMENTS
RESULTS
(as of June 2013, or for full years as stated)
An increasing choice of prequalified active pharmaceutical
ingredients (APIs) has opened up new opportunities for
production of affordable, good quality medicines, and has
shortened the time to prequalification for the finished
products that use them.
Similarly, acceptance of the first semi-synthetic (non-
plant-derived) artemisinin in May 2013 is expected to
stabilize the supply of starting material for the ACT market,
making treatment available to more patients.
Prequalified APIs (since 2011)
39 prequalified APIs from India (31), China (7) and Italy
(1) listed on the WHO website
20 APIs prequalified in 2012 (8 in 2011)
Important “firsts” in 2013:
- Prequalification of a contraceptive API (June)
- Acceptance of semi-synthetic artemisinin (May)
Pipeline
38 applications received in 2012
42 APIs under assessment
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Prequalification helps to detect and protect patients from
poor medicines quality, which can occur at any time and may
be linked to problems in manufacture, storage or distribution.
The Programme follows up quality issues as part of its own
evaluations and on behalf of other stakeholders. Its exten-
sive network and the high number of inspections conducted
annually provide added opportunities for on-site follow-up:
in 2012 the Programme inspected 25 FPP manufacturing
sites; 34 API manufacturing sites; 9 CROs and 7 QCLs in a
total of 15 countries.
Quality control testing
3 multi-country surveys conducted since 2006 on a
total of over 1500 samples
Ongoing testing for prequalification and post-
prequalification surveillance
Support to global quality monitoring
Risk-based sampling and testing of prequalified
antimalarials in 2012 in response to reports of quality
defects; retention samples of all batches alleged to be
defective were shown to meet specifications
Prequalification of QCLs throughout the world supports
regulators, procurement agencies and specific public health
programme implementers in testing whether pharmaceu-
tical products meet the specifications defined for them.
Relationships with prequalified laboratories greatly stim-
ulate collaboration on medicines quality issues such as
investigating substandard medicines or combating coun-
terfeit medicines.
Prequalified QCLs (since 2004)
Total of 27 prequalified laboratories in all six WHO
regions listed on the Programme’s website
5 laboratories prequalified in 2012 (6 in 2011), including
the first one in China
Pipeline
33 laboratories working towards prequalification
5 expressions of interest for laboratory prequalification
received in 2012
“Capacity building was almost universally considered a
major positive impact of the PQ Programme.”
(Presentation of WHO-PQP external review results at the
6
th
consultative stakeholders meeting, April 2011)
Strengthened GMP guidelines in China, better control of
APIs in Malaysia and faster prequalification of manufac-
turers’ subsequent (compared with their first) submis-
sions show that the process builds regulatory and organi-
zational capacity.
Capacity-building and information-sharing
31 technical assistance missions in 2012
27 workshops organized or co-organized in
2012, reaching more than 1000 manufacturer
representatives, more than 300 regulators and 150
other stakeholders in all WHO regions
Comprehensive information updated daily on the
Programme’s website
Involvement in prequalification has built regulators’ trust
in the Programme’s standards and activities, enabling suc-
cessful introduction of collaborative procedures for joint
inspections and for joint assessment.
In 2013 WHO approved a collaborative procedure for regis-
tration of prequalified products in participating countries:
manufacturers can request the Programme to share full
prequalification information with a participating NRA, which
will then issue its independent registration decision within
90 days. This is a bonus for prequalification holders and a
relief for overloaded NRAs.
Collaboration with NRAs
Annual 3-month rotational fellowships for 4 assessors
from NRAs to work at the WHO Prequalification
Programme in Geneva
16 assessors and 13 inspectors from well-resourced
or resource-poor NRAs; contributed to prequalification
in 2012
Collaborative registration (see left):
- 11 participating NRAs
1
- 7 marketing authorizations granted within 90 days of
information-sharing
- 10 evaluations ongoing, others in preparation
ACHIEVEMENTS
RESULTS
(as of June 2013, or for full years as stated)
Prequalification has profoundly changed the global markets of some key medicines. The prequalification model can be
used by regulatory authorities of all WHO Member States to evaluate other nationally important medicines,
such as life-saving antibiotics, to international standards.
1
Botswana, Ghana, Kenya, Kyrgyzstan, Namibia, Nigeria, Tanzania,
Uganda, Zambia, Zanzibar, Zimbabwe
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In what has been termed “the decade of diagnostics”, access to quality-assured products, adapted to
resource limited settings, will be decisive for the success of health programmes.
Prequalification of diagnostics and medical devices aims to promote and facilitate access to safe and
appropriate products of good quality in an equitable manner.
WHO PREQUALIFICATION
OF DIAGNOSTICS AND
MEDICAL DEVICES
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Prequalification of diagnostics and medical devices is in
line with international standards fostered by the Global
Harmoniza tion Task Force, a group of regulatory and
industry representatives from Europe, Japan, Australia and
North America, now succeeded by the International Medical
Device Regulators Forum (IMDRF).
Regulatory best practice for in-vitro diagnostics and other
medical devices is evolving and converging in high-income
countries, but remains virtually non-existent in many low-
and middle-income countries.
Diagnostics, in particular point-of-care tests, are composed
of a number of diverse components, and the quality of each
component, as well as the composition of the product, need
to be understood and assessed.
The WHO prequalification process was redesigned from
the predecessor evaluation mechanism in order to address
new challenges, be more closely aligned with international
regulatory principles, and ensure a fair and transparent
process for all applicants.
Evaluation Principles
Dossier assessment, to gain an understanding of the
design, its validation and manufacture of the product
Variation control and review of different regulatory
versions
Site inspections to assess the quality management
system (QMS) under which the product is
manufactured
Laboratory evaluation by WHO Collaborating Centres
to assess performance , lot-to-lot variation and ease of
use characteristics
Focus on customers in intended use settings,
appropriateness for point of care and lower levels of
the health care system
Recognition or consideration of other stringent
assessment outcomes under the fast-track procedure
Monitoring of complaints and adverse events
Fees
As specified on the Programme’s website
The Programme focuses on diagnostics and medical
devices for the prevention, diagnosis and treatment
initiation and monitoring of priority diseases such as HIV,
malaria and viral hepatitis. A wide range of diagnostics that
are most suited for resource-limited settings have been
prioritized and assessed, including HIV rapid diagnostic
tests (RDTs) with the largest market share, HIV antigen/
antibody RDTs, CD4 and HIV viral load technologies and
diagnostics for early infant diagnosis of HIV.
HIV programmes in East and Southern Africa lack surgically
trained staff for performing conventional male circumcisions,
as an additional prevention measure, at the scale needed.
Adult male circumcision devices have the potential to make
procedures safer, easier, quicker and more acceptable.
Prequalified diagnostics — medical devices
25 prequalified products (with a total of 107 catalogue
numbers) listed on the Programme’s website
Important “firsts” in 2013:
- Adult male circumcision device
- Test for HIV early infant diagnosis
The fast-track procedure has been applied to 10 of the
25 prequalified products
Inspections/re-inspections of the site of manufacture of
24 products were conducted in 2012 ( 21 products in 2011)
Approximately two-thirds of the products submitted for
prequalification have not under gone any form of stringent
assessment by a regulatory authority, prior to entrance into
the Programme.
Additional priority categories under prequalification
assessment include HIV oral fluid RDTs, combined HIV/
syphilis RDTs, and hepatitis B and C enzyme immunoassays
and RDTs.
To accelerate market entry of needed products, a time-
limited approval process is being introduced based on a
risk assessment by an Expert Review Panel.
Pipeline
Applications for 180 products received since 2010, of
which 120 were accepted for assessment
77 products currently under assessment
21 new applications received, in the first six months of
2013 (12 in 2012)
Evaluation of new product categories (HBsAg and HCV)
commenced in 2012
Advisory visits for new innovative diagnostics, i.e. point-
of-care CD4 and HIV viral load/early infant diagnosis
starting July 2013
ACHIEVEMENTS
RESULTS
(as of June 2013, or for full years as stated)
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The Programme’s review of quality management sys-
tems in manufacturing provides assurance, in principle,
that products continue to conform to agreed international
standards. In some circumstances, WHO inspections have
revealed poor manufacturing practices for diagnostics,
leading to public issue of a WHO Notice of Concern, with
all products in the prequalification pipeline produced at
the respective sites on hold until issues are rectified in a
satisfactory manner. In such cases the Programme follows
up quality issues on site and maintains public information
and Notices of Concern on its website.
Quality monitoring in the field is carried out through a
mechanism for complaints reporting, with appropriate
follow-up action by the Programme and possible issuance
of Field Safety Notices. Capacity for lot testing at country
level is being increased.
Identification of quality risks
Notices of Concern on 2 manufacturing sites issued in
2012, affecting several HIV and malaria RDTs procured
by international procurement agencies
One product delisted due to serious quality issues,
facilitated remedial measures in collaboration with
stakeholders, leading to re-listing in 2013
5 complaints handled in 2012
Lot testing of HIV RDTs ongoing in selected countries
Post-market surveillance of male circumcision devices
will be rolled out as programmes expand
Prequalification is conducted in collaboration with external
consultants, regulatory and diagnostics production special-
ists and WHO Collaborating Centres. A small group of 11
core staff coordinates the Programme’s activities, which
require a wide range of expertise, including a thorough
understanding of Quality Management Systems, auditing
skills against ISO 13485 and other standards, expertise in
immunology, microbiology, market dynamics, public health
issues and other fields.
Being collaborative, most of the Programme’s activities
have a capacity-building effect for regulators, assessors,
inspectors and manufacturers.
Participation by regulatory experts
19 external assessors
22 external inspectors
Participation by local inspectors and from low- and
middle-income countries
Stakeholder information and consultation
Periodic update newsletter published
(8 issues since 2008)
9 key events organized or co-organized since 2008
21 visits or teleconferences with manufacturers in 2013
Collaboration and harmonization are being stepped up
as international procurement agencies globally harmo-
nize their quality assurance mechanisms and more clearly
communicate the requirements and outcomes. This will
incentivize manufacturers to ensure a sustained production
that meets transparent, stringent quality requirements.
The Programme’s role as a technical reference group is
essential in this regard. The updated technical information
on the Programme’s website supports partners in product
selection (including accessories and regulatory versions),
and tracking quality issues.
As a quality-assured supply of key donor-funded diagnos-
tic product types is emerging, international organizations
are expanding their quality policies to additional product
categories, such as tuberculosis and syphilis diagnostics,
which will also be assessed by the Programme.
“The recall of these widely procured rapid diagnostic tests has
been a wake-up call for us all.”
Elliot Cowan, regulatory expert and Chair of the Global Fund
diagnostics QA policy review meeting, Geneva, April 2013
Collaboration for global quality monitoring
Active member of the interagency group on diagnostic
product quality issues in international procurement
Participation in IMDRF meetings and contributions to
its working groups
Detailed public assessment reports for all prequalified
products published on the Programme’s website
ACHIEVEMENTS
RESULTS
(as of June 2013, or for full years as stated)
By ensuring that products are acceptable for use in all WHO Member States, prequalification of diagnostics and medical
devices fills a significant gap that regulatory review cannot fill.
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WHO prequalification was established to assure the quality
of health products supplied to patients in all WHO Mem-
ber States. It has achieved this goal: prequalification has
significantly increased the availability of health products
that meet unified quality standards, enabling international
organizations to procure unprecedented volumes of key
products meeting international quality standards.
After a major expansion of funding for health in the past
decade, resources are now shrinking, since governments
have competing priorities. The budget constraints of WHO
Member States also affect WHO’s financing and ability to
obtain expert support. This means that both the WHO pre-
qualification programme and NRAs globally are faced with
growing challenges in sustaining their operations, and are
seeking new ways to achieve the greatest possible impact
with limited resources.
The demand for quality-assured products is expanding.
For vaccines, technical advances and evolving national and
global strategies will guide priority-setting. For medicines,
beyond infectious diseases, reproductive health, and ne-
glected and tropical diseases, potential focus areas include
treatment of non-communicable diseases such as cardio-
vascular conditions, cancer, asthma and diabetes, which
are taking an increasing toll on developing countries. For
diagnostics, there will be a wave of innovation with a greater
range of products for use at point-of-care.
With available resources, prequalification will not be able
to cover all these needed products. Its impact has been
greatest in those markets where the large majority of buy-
ers enforce harmonized stringent quality policies. For ex-
ample, it has enabled the creation of a competitive market
for quality-assured ARVs, which are now priced at lowest
possible levels and in fact need to be protected from fur-
ther downward pressure on pricing. On the other hand for
other essential products, while there may have been some
positive spill-over effect, quality assurance can represent a
competitive disadvantage for manufacturers and can pose
serious dilemmas for buyers who are forced to balance
product quality against cost.
Prequalification is not intended as a permanent mechanism
to replace regulatory control of health products. Its most
durable contributions to global public health are the unified
quality norms and standards which underpin it, and the
practical guidance for their implementation, which has pro-
moted regulatory convergence among WHO Member States.
At a time of global economic crisis, regulatory work-sharing
has become a must. The most important continued role of
WHO is to support regulators in all WHO Member States to
jointly assume the full range of their regulatory functions.
WHO has an assessment tool for regulatory authorities, and
effective regulatory oversight by functional authorities is a
prerequisite for vaccines prequalification. Building on these
approaches, the establishment of regional networks for
specific regulatory functions — such as inspection capacity
close to major production sources, assessment of generic
essential medicines to international standards and vigilance
systems to identify and address quality failures — could be
first steps on the way towards transferring full responsibility
for stringent quality assurance to the national authorities.
Ultimately, a supply of safe and efficacious products at fair
prices can be sustained only with effective regulatory over-
sight, countering the effects of purely price-driven markets
and incentivizing both manufacturers and buyers to invest
in product quality. Whether that will succeed depends on
how highly the quality of health products is rated as a com-
mon good.
FUTURE THINKING
WHO PREQUALIFICATION PROGRAMME
20, Avenue Appia
CH-1211 Geneva 27
