Update on prequalification of essential medicines for reproductive health Dr Hans V. Hogerzeil...

Update on prequalification of essential medicines for

reproductive health

Dr Hans V. HogerzeilDirector

Medicines Policy and StandardsWHO, Geneva

Reproductive Health Supply CoalitionOctober 2006

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Department of Medicines Policy and Standards

Prequalification of essential medicines

The UN prequalification program is an action plan for expanding access for the hardest hit by

HIV/AIDS

Tuberculosis

Malaria

Reproductive Health

for ensuring quality, efficacy and safety of medicines all the way through the medicines supply chain.

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Why the prequalification of RH items is needed

Problems• Over 200 million of people do not have access to the RH items

they need and want• Increasingly decentralized funding and procurement of RH

medicines; more reliance on national procurement• Weak national regulatory and quality assurance systems• No harmonized quality assurance system available

Risks• Sourcing of poor quality products or even counterfeit

medicines risk to patients, treatment failure, resistance, reputation

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Prequalification: basic principles

Voluntary for participating manufacturers Legitimate - Procedure and standards approved through WHO

Expert Committee system, involving all Member States and governing bodies

Widely discussed • FIP Congress, Nice 2002 • ICDRA 2002 and 2004 (>100 national drug regulatory authorities)

Transparent: all information on http://mednet3.who.int/prequal/

Open to innovators and multi-source/generic manufacturers No cost for applicants

http://mednet3.who.int/prequal/

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Expected outcome of prequalification

List of products and manufacturers approved for UN procurement• Meeting international norms and standards on quality, safety, and efficacy

Better access to treatment• Fair procurement mechanisms (e.g. tender, competition)

Harmonization• DRAs, NGOs, procurement organizations• Ongoing monitoring of quality, safety & efficacy of essential medicines

Capacity building• DRA's: life-time learning experience in assessment and inspection• Manufacturers: free feed-back on performance and advice how to improve

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How prequalification is organized

Role of WHO:• Manage the project on behalf of the UN• Provide technical and scientific support and guarantee that

international norms and standards are applied all through the process of assessment, inspection and quality control

Partners: • UNICEF, UN Population Fund (UNFPA), UNAIDS and with the support

of the World Bank• Anti-malarial and anti-TB products: Roll Back Malaria and Stop TB

(Global Drug Facility); HIV/AIDS Department Actors:

• Assessors and inspectors of National DRAs as well as National Quality Control Laboratories of PIC/S and ICH member countries

• Increasing involvement of end-user countries

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Experiences with HIV/AIDS, tuberculosis and malaria

Good news Many products and suppliers comply with the standards Many suppliers appreciate feedback and are willing to improve Unique technical knowledge obtained about products, especially

about generic antiretrovirals and antimalarials

Bad news Only limited number of products have met the required standards Takes time to get into compliance: • data to be generated • tests to

be carried out • GMP upgrade needed Bad quality generics undermine public confidence in generics Quality has its price (e.g. TB)

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Quality can not be assessed, testedor inspected into the product

BUT

it has to be built into it!

More technical help to manufacturers in developing countries is needed

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Update on prequalification of RH items (Oct 2006)

3-year funding received from Gates Foundation (July 2006) RHSC selection of priority items:

Ethinylestradiol + levonorgestrel, tablet, 30/150 microgram levonorgestrel, tablets, 30, 750, 1500 microgram medroxyprogesterone acetate (DMPA) depot injection, 150mg/ml

5 staff recruited / under recruitment (programme manager, heads assessment and inspection teams, inspectors)

Expression of Interest issued and on the web Dossier assessments from Nov 2006; inspections from

early 2007

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What is now expected from RHSC members?

Encourage your suppliers to participate in the WHO/UN prequalification programme and submit dossiers

Inform all your suppliers officially that you will only procure prequalified products as soon as two products have bee prequalified

Inform your local suppliers that they can also receive technical advice from WHO in order to prepare for prequalification and improve quality where needed

Main message: Prequalification is a global support mechanism to improve their quality production, and will establish their international export potential

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Interagency List of Interagency List of Essential Medical DevicesEssential Medical Devicesfor Reproductive Healthfor Reproductive Health

Medicines Policy and Standards

Health Technology and Pharmaceuticals Cluster

RHSC meeting, Bonn 19-20 October2006

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Background

The development of an interagency list of essential medical devices for RH was agreed at the 1st Interagency Consultation on the Selection and Delivery of Reproductive Health Medicines and Commodities in December 2003

Availability of various lists of RH medicines and commodities UNFPA/UNAIDS/WHO medicines and commodities list Draft UNFPA/WHO essential drugs and other commodities

for RH services list 13th WHO Model List of Essential medicines

Medical devices on the lists discrepancies in terminology and content were identified.

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The Interagency List of Essential Medicines for Reproductive Health, 2006

Include 148 medicines Two proposed presentations:

by therapeutic group based on the WHO model list classification

by clinical group following previous interagency lists

Available in English and French Approved by International Planned Parenthood Federation

(IPPF), John Snow, Inc (JSI), PATH, Population Services International (PSI), UNFPA and the World Bank

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Interagency list of essential medical devices for RH

Achieving consistency in the minimum list of medical devices and supplies for common interventions in maternal and RH, including HIV/AIDS commodities

Drafted after 4 interagency consultations: By group of items, according to MNH interventions* Use UNICEF nomenclature (UNCCS)

Sent for final review process to major partners final draft prepared in June 2006 in collaboration with UNICEF The interagency list includes special notes and specifications

for each group of items*WHO/Making Pregnancy Safer document

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Interagency list of essential medical devices for RH: special notes

Technical comments to facilitate procurement selection, review lists and support technical review of tender offers

Special note for units and biomaterials used for medical devices Special note on packaging and labelling Special note on injection safety Special note on health care waste management Special note on surgical sutures Special note on standard precautions for health workers Special note on wearing protective equipment Special note for textiles used for linen and clothing Special note on surgical instruments stainless steel

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Interagency list of essential medical devices for RH

Product specifications

UNICEF technical specifications (80% of the list)

Development of additional specifications for 49 items

Specifications will be available on: WHO/RHR website UNICEF website: http://www.supply.unicef.dk/catalogue/

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http://www.supply.unicef.dk/catalogue/

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Interagency list of essential medical devices: Next steps

Receiving any comments on the final draft

Proposing endorsement of the interagency list

Posting on the websites

Update on prequalification of essential medicines for reproductive health Dr Hans V. Hogerzeil...

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