Local Solutions to ARV Access

“Affordable access to Quality medicines”

Agenda

Brief Introduction to QCIL (4 slides)

Product capability (1 slide)

Local Solutions to ARV Access (1 slide)

Benefits of Local Manufacturing (3 slides)

Partner Considerations (1 slide)

MISSION:

To assist in the provision of sustainable,

quality, affordable regional solutions to

regional health concerns.

VISION:

To become a centre of excellence in

manufacturing quality and affordable

medicines for Sub–Saharan Africa.

MAJOR CERTIFICATIONS

World Health Organization (WHO) Good Manufacturing Practices for

plant and product accreditation.

International Committee of Red Cross (ICRC) certification

Drugs for Neglected Diseases Initiative (DNDI) certification

National Drug Authority GMP

Kenya Pharmacy and Poisons Board GMP certification.

Tanzania Food and Drugs Administration (TFDA) GMP certification

Completed registration in Rwanda and Burundi.

WHY SET UP QCIL?

The problem in Africa: 80% of all malaria sufferers

Majority of all HIV/AIDS sufferers

African only produces less than 1% of the required

remedies.

To mitigate the adverse effects of TRIPS TRIPS: World Trade Organisation agreement on

Trade Related Aspects of Intellectual Property Rights

Reduce adverse effects on access to affordable,

newer and safer medicines by the poor.

PRODUCTS MANUFACTURED Current products Anti-malarial products

Lumartem Tablets (Artemether and Lumefantrine)

Anti-retroviral products

Duovir-N (Lamivudine, Nevirapine and Zidovudine fixed dose combination

Duovir ( Lamivudine and Zidovudine)

Effavir (Effavirenz)

Nevimune

New products Tenofovir based combinations;

- Tenofovir + Lamivudine

- Tenofovir + Emitricitabine + Efavirenz

- Tenofovir + Lamivudine + Efavirenz

Lumartem Forte (Double strengths ACT i.e Lumartem forte)

Artesunate + Amodiaquine (Falcimon)

Local Solutions to ARV Access

Strengthening local supply chains

Regional production bolsters downstream parts of the supply chain

Local procurement has added-value factor from working with in-country stakeholders to ensure product distribution

Local firms are not just closer, but tied to and vested in the immediate effect to the success of patients

Society demands Corporate Responsibility to solve the problem and the firm has Social Accountability for it.

Benefits of Local Manufacturing

Improved access to essential medicines through reliable

and regular supply:

Faster response to spikes in need, during emergencies

and disasters

Solve shipping’s long lead-times

Mitigate expiration issues

Avoid situational stock-outs

Benefits of Local Manufacturing

Learning from the “Ghana Model”:

Successfully addressing health with policy

1. Grow local pharmaceutical manufacturing to reduce

economic burden of imports

2. Reduce the high level of counterfeit drugs

◦ Significant reduction in prevalence of sub-standard and

counterfeit products

Continued Benefits: Economic Effects

Job creation and skills upgrading at regional level.

Reduction of foreign exchange spent on imports vs trade

imbalances

Boosting of export potential

Long-term solution to reduce donor dependency

Promoting regional self-reliance

Partner Considerations 1. As African ARV coverage succeeds, other ailments

will grow. ◦ Will outside manufacturers produce for all Africans? ◦ Will it only come when situations turn dire?

2. Request to champion policy changes to support

sustainable local production in heavily affected areas.

3. Solutions for 2015 and beyond, consider the paradigm shift for “Big” Development versus “little” development.