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The Lancet Commission on Essential

Medicines for Universal Health Coverage

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Five key challenges the report addresses

1. Paying for a basket of essential medicines 2. Making essential medicines affordable

3. Assuring quality and safety of essential medicines 4. Promoting quality use of medicines

5. Developing missing essential medicines Cross-cutting -> measuring progress

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1. Paying for a basket of essential medicines

Per capita in low- and middle-income countries $13 - $25 per capita*

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2. Making essential medicines affordable

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2. Making essential medicines affordable

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2. Making essential medicines affordable

Procurement interventions

Pro‐generic policies

Pricing interventions

Quality use of medicines interventions

Trade‐Related Aspects of Intellectual Property Rights (TRIPs) flexibilities

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3. Assuring quality and safety of essential medicines

“Prescribers and patients cannot verify the quality, safety and efficacy of a product themselves; that is an essential public function”

Emphasis on international harmonization,

regional collaboration and WHO Prequalification Programme

Better quality assurance in procurement agencies

Redirect activities of FDA to those that add value

Less emphasis on national sovereignty

Focus on targeted enforcement (social media)

Involve other stakeholders and the general public in quality assurance, through new technologies

Promote transparency of information

Promote accountability, by independent assessment of the performance of FDAs

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4. Promoting quality use of medicines

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4. Promoting quality use of medicines

• Recent global discourse focused on access.

“Undertreatment improves but overtreatment does not”

• No single actor owns responsibility.

• Multiple actions needed at many levels

• Concerted, system-focused interventions are challenging to implement

• Success requires sustained engagement and

investment.

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4. Promoting quality use of medicines

• Governments and payers should establish independent pharmaceutical analytics units to generate information to promote quality medicines use, along with other objectives

• Pharmaceutical analytics units must collaborate with multiple stakeholders to increase engagement and

accountability, and to intervene jointly on medicines use problems.

• Engaged stakeholders, informed by data, should identify and prioritize medicines use problems and contributing

factors across the system, and develop and implement

sustainable, long‐term, multi‐faceted interventions.

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5. Developing missing essential medicines

The current problems

• R&D focus on modifying existing medicines Adds little therapeutic value

• Essential medicines and diagnostics with insufficient profit potential are not developed

E.g. antibiotics, neglected diseases (e.g. Ebola), paediatric formulations (e.g. HIV)

• Essential medicines abandoned for lack of commercial potential E.g. Benzyl penicillin, anti-venoms for snake bites

• New medicines are highly priced and widely patented E.g. oncology, hepatitis C, MDRTB, orphan drugs

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5. Developing missing essential medicines

The current effort

• New alternative incentives: push and pull E.g. UNITAID, GHIT Fund, Longitude Prize

• Regulatory incentives: mixed results PRVs, paediatric formulations

• Public funding

Often initial R&D publically funded but final steps by for-profit companies who gain IP rights

• Patent pooling

MPP (HIV, Hep C, TB)

• TRIPS flexibilities

Compulsory licensing, government use, LDC waiver on patents

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“The Commission presents this report in the strong belief that the world can get essential medicines right, promoting improved

performance and equity in health systems, while supporting UHC and enabling sustainable development”

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