public health, innovation and intellectual property improving access to medicines through local...

Public Health, Innovation and Intellectual Property

Improving access to medicines

through local production:

Some New Development

I P C Meeting, Copenhagen (through VC)

Zafar Mirza

18 June 2015, Brussels


WHO/EC Project:

“Improving access to medical products in developing

countries through building capacity for local production

and related technology transfer” • Phase I - Identified main trends and

barriers to local production of pharmaceuticals, vaccines and diagnostics. Published 8 reports. (2009-2011)

• Phase II - Activities to promote greater policy coherence between government policies that affect the local production in order to improve access. (2012-2014)

• "We welcome the surge of interest in the manufacturing of essential health technologies in Africa. "

• "UNAIDS, UNIDO and WHO are working closely with the AUC to better coordinate inter-agency efforts to support African governments."

• "Africa’s development partners, especially the BRICS countries (Brazil, the Russian Federation, India, China and South Africa), have a special role in supporting this critical phase of African development."

WHO Bulletin, June 2014


WHO Director General's Strategic Grant for

local production

• To work with AUC and other development partners for implementation of Ppharmaceutical Manufacturing Plan for Africa (Business Plan)

• Provide assistance to countries on request in strengthening their pharmaceutical production for improving access

Framework for Local Production for

Improving Access

INDUSTRIAL POLICY

• Competitive

• Reliable• Innovative• Productive•

Responsible

• Strategic

HEALTH POLICY

• Access (Availability Affordable)• Quality• Supply• Rational

Use

SHARED GOALS HEALTH + INDUSTRY

• Strategic selection of essential medical products

• Pricing of local products

that governments & people can afford.

• Strict compliance to quality standards

• Effective NRAs.• Health security• Innovation.

Government Support

Direct support to reduce the cost of manufacture

Indirect support of local production for improving access

Pre-requisites for strengthening pharmaceutical manufacturing

1. Government political and financial commitment

2. Vision and coherent policy frameworka. With clear health and industrial policy objectivesb. Development of industry overtime along the value chain

Time-bound action plan

3. GMP roadmap and political guts to follow-up

4. Time-bound government incentive package

5. Ongoing monitoring and evaluation


Work with AUC and Interagency collaboration

for pharmaceutical manufacturing in Africa:

WHO is supporting development of Collaborative Framework for development partners to work with AUC & NEPAD in implementation of PMPA Current partners include: UNAIDS, WHO, UNFPA, UNDP, UNECA,

USP, ANDI, FAPMA, ADB, coordinated through UNIDO

A multi-year workplan is being developed

WHO is supporting PMPA Technical Committee Meeting in November


10 Year National Strategy & 5 Year Plan of Action for

Pharmaceutical Manufacturing Development in Ethiopia

Ministry of Health and Ministry of Industry are equal partners

The strategy and plan of action is directly feeding into next 5 year national development plan (GTP II 2015-20) and new Health Sector Transformation Plan

a comprehensive, visionary and ambitious program to transform the pharmaceutical sector in the country.

The vision is to progressively move pharmaceutical companies along the value chain and the goal is to achieve a vertically integrated, GMP compliant and R&D based pharmaceutical sector by 2025.

The government is recommended to provide a well spelled-out and time-bound incentives package to pharmaceutical companies


10 Year National Strategy & 5 Year Plan of Action for

Pharmaceutical Manufacturing Development in Ethiopia - II

Some key targets include e.g. by 2020, 60% local needs of essential medicines will be met by locally

produced medicines; there will be 8 to 10 new joint ventures; all companies will be fully GMP compliant by 2018; there will be at least 1 API manufacturing unit in place; exports of pharmaceuticals will be in excess of USD 30 million; there will be at least 200 trained professionals in industrial pharmacy

and regulatory

The Prime Minister of Ethiopia and WHO DG will be launching the S&PA during the UN Financing for Development Conference in Addis Ababa.

Thank you

For More Information and Accessing Publications:

http://www.who.int/phi/publications/local_production/en/



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