procurement and supply activities essential medicines and ...€¦ · 2 ipc december, 2016 geneva...

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IPC December, 2016 Geneva

Procurement and Supply Activities

Essential Medicines and Health Products

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Global medicines market:

US$960 billion in 2012, reaching up to $1.4 trillion by 20201,3

Compounding growth of an average of 5% per year Historic increase in funding for support is relatively flat2

Demand on procurement and supply functions will increase in direct proportion

1-The Global Use of Medicines: Outlook through 2017. Report by the IMS Institute for Healthcare Informatics.

2-World Health Organization Global Health Expenditures database http://apps.who.int/nha/database

3- Statista 2016: https://www.statista.com/topics/1764/global -pharmaceutical-industry/

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300

600

900

1200

1500

2013 2014 2020

Historic increase in funding

Estimated growth of global market

Current environment: gap in support

Increases in support from major medicines supply initiatives in HIV/TB/Malaria, Vaccines, and RH products

http://apps.who.int/nha/database











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Increasing reports of stock outs and shortages

United States Food and Drug Administration accessed 22 October 2013 http://aspe.hhs.gov/sp/reports/2011/DrugShortages/ib.shtml

Example of trends from USA

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As demand for medicines increases, the curve shifts to the right. Prices for products

and supply management increase until production increases.

Demand1

Marginal Revenue

Monopoly price

Price/Cost

Quantity/Output

Demand2

Marginal Cost

Ideal competitive price when demand and supply are optimized.

Market stress on price-related shortages

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WHA 69.25 Key activities for 2017

• Finalization of technical

definitions

• Assessing the severity of the

problem

• Identifying medicines at high

risk for shortages

• Assessing potential

regulatory options to provide

a global reporting

mechanism

• Health Data Collaborative

efforts

Addressing global

shortages of medicines and

vaccine makes specific

requests to the Director

General

Progress to date:

• Harmonized definition of

shortages an stock outs

drafted from through

consultations

• Report to the EB

provided for comment

• Systematic review of

promising practices

identified from ISG

• Observations from

ICDRA

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Initial definitions from systematic review

Supply, main findings

from systematic review:

• mainly mechanisms through

NMRA;

• identification and planning of

strategies;

• time-bound reporting which

were different from country to

country;

• targeting management of

national level solutions for the

public health system;

• Data

Demand, main findings

from systematic review:

• referred mostly to procurement,

planning and supply chain

management related problems.

• included various types of

disruptions at various levels

• linked to the duration of the

stock-out; however measured

in terms of hours and days and

not in terms of consequences

to the patient of delayed

treatment;

• Data

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IPC December, 2016 Geneva definitions work

Core Definition Shortage: The supply of medicines, health products, and vaccines identified as essential by the health system is considered to be insufficient to meet public health and patient needs

Core Definition Stock-out: The complete absence of the medicine, health product or vaccine at the point of service delivery to the patient.

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ConsiderationsMeasurementSupply Chain Variables

Supply

Demand

Manufacturing: eg. Raw Materials, Active Pharmaceutical Ingredients, Products

Channels to Patients: eg. Central Stores, Health Facilities, Distribution Affiliates, Strategic Buffer

Amount of medicine delivered equals amount ordered

Inventory Metrics

Service Delivery Metrics

TimeframeClassification (VEN, Impact)

AlternativesPatient Centric

Temporary/PermanentProduct Temperature

InfrastructureContext

Developing vs Developed Member States

Economic ConsiderationsQuality Assurance

Data Availability and Data Quality

1. Actors

2. Audience

3. Actions

4. Consequences

1. Actors

2. Audience

3. Actions

4. Consequences

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Report to the EB Definitions of shortages and stock outs

of medicines and vaccines

English: http://apps.who.int/gb/ebwha/pdf_files/EB140/B140_19-en.pdf

On the supply side:

A “shortage” occurs when the supply of medicines,

health products and vaccines identified as essential by

the health system is considered to be insufficient to

meet public health and patient needs. This definition

refers only to products that have already been

approved and marketed, in order to avoid conflicts with

research and development agendas.

On the demand side:

A “shortage” will occur when demand exceeds supply

at any point in the supply chain and may ultimately

create a “stock out” at the point of appropriate service

delivery to the patient if the cause of the shortage

cannot be resolved in a timely manner relative to the

clinical needs of the patient.

http://apps.who.int/gb/ebwha/pdf_files/EB140/B140_19-en.pdf





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Assessing the at-risk medicines will be complex

• Informal review by WHO EMP of 4 databases

– US FDA

– Health Canada (http://www.drugshortages.ca/drugshortagehome.asp)

– TGA, Australia

– ASHP (http://www.ashp.org/menu/DrugShortages )

• Comparison to 19th WHO EML

Total products

listed as

shortage

EML/total

Canada (2012-current) 800 82/800

US FDA (current) 101 29/101

TGA (current) 150 19/150

ASHP (current) 160 47/160

Note: TGA total includes allergens for skin testing

http://www.drugshortages.ca/drugshortagehome.asp

http://www.ashp.org/menu/DrugShortages

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Observations from ICDRA Discussion/ Recommendations:

• Government-owned manufacturing in limited

situations for products not commercially viable

• Investigate further the impact of currency

exchange rate fluctuations, especially on API

and other costs of production

• Promote transparency on cost of production to

support prices adjustments when necessary

• WHO should identify products or APIs at risk of

shortage

• Promote dialogue between manufacturers,

regulators and supply chain actors

• Promote transparency from industry on

potential risk of shortages, especially through

dialogue with regulators

• Continue with supply chain interventions

• Consider contingency stocks to mitigate risks

for certain products

International Conference of Drug

Regulatory Authorities

Cape Town

29 November - 2 December 2016

Workshop 6:

Shortages of medicines: what can

regulators do to help?

Moderators:

Greg Perry, Medicines Patent Pool

Anban Pillay, DOH South Africa

Speakers:

Anders Vinther (Sanofi)

Gerald Heddell, UK

Ivan Knezevic, WHO

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Different products are in

shortage in different markets Commodity Number of manufacturers per commodity registered in 21 EWEC

countries REPRODUCTIVE HEALTH

Levonorgestrel 75mg Implant 8

Etonogestrel 68mg implant 4

Levonorgestrel 1.5mg tab 16

Levonorgestrel 0.75mg tab 25

MATERNAL HEALTH

Oxytocin inj. 10 IU 36

Misoprostol 200υg tab 21

Magnesium sulfate 500mg inj 16

NEW BORN HEALTH

Gentamicin Inj 40mg/ml 103

Ampicillin Injection 108

Ceftriaxone Inj 282

Dexamethasone inj. 4mg/ml 59

CHILD HEALTH

Amoxicillin dispersible tab 36

Zinc sulfate dispersible tab 20

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Procurement and Supply

Essential Medicines and Health Products

procurement and supply activities essential medicines and ...€¦ · 2 ipc december, 2016 geneva...

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