UNIDO and pharmaceutical sector development … NATIONS INDUSTRIAL DEVELOPMENT ORGANIZATION Big three pandemics (HIV/Aids, Malaria, TB): persisting/growing gap between drug needs and

UNITED NATIONSINDUSTRIAL DEVELOPMENTORGANIZATION

UNIDO and pharmaceutical sector development

Programmes and Activities

In Focus Global Project: Strengthening the local production of essential generic drugs

in LDCs/DCs –

Nadine Vohrer

27 Sep 2010UNICEF Pharmaceutical Supplier Meeting


Outline of presentation

1. UNIDO at a Glance

2. UNIDO and public health

3. Ongoing UNIDO “global generics” project –

context and key features


UNIDO AT A GLANCE

Founded 1966; UN specialized agency since 1986

Lead role within UN system on industrial development

Constitutional mandate: Promote sustainable industrial development in developing countries and economies in transition

UNIDO is the only UN specialized agency promoting the creation of wealth and tackling poverty through industry/ manufacturing

Is not a funding institution

• Staff on board: ca. 650• Budget bi-annium

2010/11: € 381 m

• Project expert app’ts p.a.:2,850

• Technical Cooperation 2009:€ 103 m


- As a global forum, UNIDO generates and disseminates knowledge related to industry and provides a platform to enhance cooperation, establish dialogue and develop partnerships

- As a technical cooperationagency, UNIDO designs/ implements programmes to support its clients. It also offers tailor-made specialized programme development support

Three inter-related thematic priorities

Poverty reduction through

productive activities

Trade capacity building Energy and Environment

Two core functions:

UNIDO AT A GLANCE


Reducing exposure to hazardous and toxic materials,

Provision of locally manufactured health products (incl. pharmaceuticals)

Selected current activities: Strengthening the local production of essential generic drugs in (L)DCs

Montreal Protocol: Plan for the terminal phase out of Carbon Tetra Chloride (CTC) - support to pharmaceutical companies

Rwanda One UN: Support textile company in the production of impregnated mosquito nets

UNIDO-International Centre for Science and High Technology (UNIDO/ICS), Trieste/Italy: Rational Drug Design and Development - Research component, workshops,

training courses and fellowship program

Member of Interagency Pharmaceutical Coordination Group (IPC) chaired by WHO (UNICEF, UNDP, UNOPS, Global Fund, World Bank, etc.),

• UNIDO co-hosted IPC Sub-group Meeting on Local production of essential medicines in Sept 2009

UNIDO AND PUBLIC HEALTH


ONGOING UNIDO “GLOBAL GENERICS” PROJECT –

CONTEXT AND KEY FEATURES


Big three pandemics (HIV/Aids, Malaria, TB): persisting/growing gap between drug needs and availability – too little, too expensive.

MDGs: Health high on the international agenda (MDG 4 Child mortality, 5 Maternal health, 6 Combat HIV/Aids and Malaria).

Big pandemics: large amounts of funding for drugs procurement available

DC/LDC producers largely excluded from these donor markets.

Advocacy for full use of TRIPS Flexibilities favouring DC/LDCs(OECD Norwijk Agenda, WHA).

Views on feasibility of local production: shift to more differentiated view (IFC, The Business of Health in Africa).

Focus on production is a unique perspective in an environment dominated by “public health mindsets”.

Help overcome “disconnect” between health and economic/industrial development agenda in many countries.

SUPPORTING PHARMACEUTICAL PRODUCTION IN (L)DCs:

CONTEXT


Strategic importance increasingly attested to pharmaceutical sector

Security/continuity of medicines supply (beyond donations),

Knowledge-intensive industry,

Retention of donor money in the economy,

Conduit to combat counterfeit medicines (easier regulatory oversight on quality),

Mitigate supply shortages and ad-hoc procurement

Growing political attention to local/regional manufacturing

High on policy agenda: AU “Pharmaceutical Manufacturing Plan for Africa”, SADC, COMESA, ECOWAS, etc.

SUPPORTING PHARMACEUTICAL PRODUCTION IN (L)DCs:

CONTEXT (cont’d)

UNIDO working at the interface of public health and economic/ industrial development

Mandate to enhance activities is expected from Board decision in Nov 2010


CURRENT GLOBAL UNIDO PROJECTStrengthening the local production of essential generic drugs in developing countries (DCs/LDCs) through the promotion of SMEs, business partnerships, investment promotion and South-South cooperation

Project title

Duration 2 phases: 01/2006 – 12/2011Further extension until 2013 under preparation

Budget Euro 3.3 m - Co-funded by Germany (EUR 2.48 m) andUNIDO (EUR 0.82 m)

Objective To support the establishment and/or expansion and upgrading of SMEs in 3-4 target (L)DCs for the local manufacturing of essential generic drugs

Focus Medicines against HIV/Aids, malaria and tuberculosis, selected neglected tropical diseases (NTDs)

Guiding criteria Commercial viability Int’l quality standards (GMP, WHO PQ)


THREE INTERVENTION LEVELS

• Policy advice: Improvement of business, legal and regulatory environment

• National multi-stakeholder public-private dialogue and/or sector strategy formulation

• Awareness raising/networking workshops

8 sector profile: LES, NIG, SEN/ MAL, UGA, ZAM, ZIM; CMB,Lao PDRGlobal Market Study/IMS HealthNational Dialogue:CMB, Lao PDR, TAN, GHA Reg. WS: TAN, THA, SEN, ZAM

• Institutional capacity-building: Pharmaceutical manufacturers associations and other organizations

• Training Institutions: support training in industrial pharmacy for the industry

• Quality infrastructure: Support to regulatory authorities, drug testing laboratories, etc.

Associations: GHA, Southern African Generic Medicines Association (SAGMA)Other institutions:TAN: SLF Industrial Pharmacy Advanced Training

• Enterprise level: Technical and managerial assistance

• Initial SWOT analysis

• Business plan advice, (Pre)Feasibility analysis, cGMP & PQ coaching, other

• Business Partnership Brokering (Concept: UNIDO Pharmaceutical Production Partnership Platform [U4P])

CMB, Lao PDR, CAM, GHA, UGA, LES, BOT, BGD

ACHIEVEMENTS TO DATE


Specific activity - Example 1: Policy level

GHANA - PHARMACEUTICAL SECTOR STRATEGY AND ROUNDTABLE

Work with Pharmaceutical Manufacturing Association of Ghana (PMAG) to arrive at a shared vision for the development of the sector,

Institutionalize national public-private dialogue among all relevant stakeholders,

Pharmaceutical sector roundtable (June 2009)

Overcome disconnect between Ministries of Health and of Trade & Industry as well as the private sector,

Joint problem analysis under the lead of Ministry of Industry,

Next steps development of strategy to overcome problems


Specific activity - Example 2: Institutional level

TANZANIA- INDUSTRIAL PHARMACY ADVANCED TRAINING (IPAT)

Offer Industrial Pharmacy Advanced Training at Kilimanjaro School of Pharmacy/ Saint Luke Foundation, Moshi. Tanzania together with Purdue University and Howard University,

To strengthen human resource base for pharmaceutical manufacturing in the EAC region,

Participants from pharmaceutical manufacturers and medicines regulatory authorities as well as universities,

Course provides in-depth level training in the important aspects of Drug Development, Drug Manufacturing, Regulatory and Quality Compliance in the Pharmaceutical Industry.

22 participants “graduated” until August 2010, currently 18 further students are enrolled in the programme.

Tailor-made courses for companies possible at the facilities


Specific activity - Example 3: Enterprise level

Needs to be business driven: standing invitation to submit business concepts/plans for (L)DC firms planning to start/expand production of drugs fighting target diseases,

Cameroon: Technical assistance/training to pharmaceutical manufacturer; Company Inauguration in April 2010,

Botswana: Support business plan preparation for a new manufacturing plant (ongoing),

Ghana: Managerial assistance/business plan advice to achieve commercial viability with high standard facilities and technical assistance to achieve WHO Prequalification.

Precondition: Quality and economic viability i.e. convincing business plan and commitment to quality and realistic prospects


UNIDO Pharmaceutical Production Partnership Platform (U4P)CONCEPT

Systematize relationship with the private sector – given positive board decision

RATIONALE

Support Upgrading of (L)DC firms through partnering up with experienced producers and other stakeholders

OBJECTIVE

Mobilize know-how and experience of pharmaceutical producers in industrialized (and more advanced developing) countries for increasing the capabilities of pharmaceutical manufacturers in developing countries.

OVERALL NATURE:

Mechanisms for brokering mutually beneficial business partnerships

Possible range: technology transfer/licensing agreements, contract manufacturing, joint procurement and/or marketing arrangements, full-fledged equity joint venture.


Honest/Impartial broker No business interests; UN Global Compact (CSR Initiative)

Possible contributions Identification of developing country firms with realistic upgrading

potential Co-funding of feasibility studies in cases where crucial for promising

partnership Technical assistance to improve production capacities of developing

country partners to qualify them for partnership (GMP/PQ upgrading support)

Complementary advisory support (policy level) and institutional capacity-building assistance

U4P: UNIDO’S ROLE


Questions for discussion

Is there nterest of manufacturers (from North and South respectively) in technology transfer and partnerships?

Where do you see the role of a broker such as UNIDO? What are bottlenecks from your views? What would be the most valuable input from a broker?

In the procurement process are there specific difficulties for companies from the South that could be overcome with external advisory assistance?


Thank you!

Juergen REINHARDT, Project Manager, PTC/BITPhone: +43-1-26026-3405Fax: +43-1-26026-6864E-mail: [email protected]

Nadine VOHRER, Associate Industrial Development Expert, PTC/BITPhone: +43-1-26026-5089Fax: +43-1-26026-6864E-mail: [email protected]

UNIDO, POB 300, A-1400 Vienna, AUSTRIAWebsite: www.unido.org

Alastair WEST, Senior Technical Advisor, PTC/BITPhone: +43-1-26026-3882Fax: +43-1-26026-6864E-mail: [email protected]

Documents

UNIDO and pharmaceutical sector development … NATIONS INDUSTRIAL DEVELOPMENT ORGANIZATION Big three pandemics (HIV/Aids, Malaria, TB): persisting/growing gap between drug needs and