MSF Experience with

Access to MedicinesJulia Hill

Maseru, LesothoCivil Society Consultation Meeting

August 12, 2014

Why an Access Campaign?

“Some of the reasons that people die from diseases like AIDS, TB, Sleeping Sickness and other tropical diseases is that life saving essential medicines are either too expensive, are not available because they are not seen as financially viable, or because there is virtually no new research and development for priority tropical diseases. This market failure is our next challenge." -- Dr. James Orbinski,

president of MSF’s International

Council, 1999 acceptance speech for

Nobel Peace prize

MSF Access Campaign

The problem still exists

“We did not develop this product for the Indian market, let’s be honest. We developed this product for Western patients who can afford this product…”

– Marijn Dekkers, Bayer CEO, onIndia’s issuing a compulsory licenseon Bayer’s cancer drug, sorafenib (2013)

MSF Access Campaign

UnavailableWhy don’t companies invest in R&D for certain diseases?

UnsuitableWhy aren’t medical tools adapted to the environments where MSF works?

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Unaffordable

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Why are some medicines so expensive?

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How to bring down prices?

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How does South Africa’s Patent System Affect Access to Medicines?

MSF Access Campaign

A decades-old conflict…

“Everyone has the right to have access to health care services” -Section 27 of the South African Constitution

MSF Access Campaign

…is still underway in South Africa

• “Fix the Patent Laws” campaign started in 2011, 10 years after the Doha Declaration was signed• Aims to have Dept. of Trade

and Industry include pro-public health language in national IP policy in order to take advantage of TRIPS flexibilities in national laws• Coalition: TAC, MSF,

SECTION27, and more!MSF Access Campaign

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Of identical applications, South Africa grants 100%, while US & European Patent

Offices reject ~40%.MSF Access Campaign Treatment Action Campaign SECTION27 MSF Access Campaign

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What does this mean for the cost of specific medicines?

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Cost comparison ARV regimens

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1st line (TDF / FTC / EFV) 2nd line (AZT / 3TC / LPR/r) 3rd line (DRV / RAL / ETR)0

200

400

600

800

1000

1200

1400

1600

Monthly Cost of Standard ARV Regimens in Public Sector(ZAR prices per person per month)

MSF Access Campaign

Aripiprazole

• Aripiprazole - anti-psychotic (for schizophrenia, bipolar disorder)—one of the top-10 selling drugs globally

• Could have been off-patent in U.S. in 2009 (extensions run to 2015)—South African multiple pending patents (Otsuka, BMS) could run until 2033.

• Cost of a 10mg tablet R35.60 in South Africa over 35x higher than generics available in India.

• SA price (R3.56/mg) 20% higher than in Japan (R2.84/mg)

• If SA had India’s prices, over R29 million in savings annually that could be realized on one drug alone

MSF Access Campaign

India (generics available) Japan (no generics available) South Africa (no generics available)

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

180,000

200,000

3,504

109,000

183,887

Lowest Possible Cost of aripiprazole 20mg dosage per day for 5 years (quoted in ZAR)

MSF Access Campaign

Oral contraceptive

• Bayer holds multiple patents on drospirenone clathrate/ethinyl estradiol (Yasmin)• Pharmadynamics 2011 launch of generic product at ~30% lower price

was halted through an interdict over secondary patent• SA court case continues, even though generics available elsewhere,

patent in question has been struck down in Europe and US.• Pharmadynamics has incurred over R10million in legal fees, millions

of rand in lost sales—will make it difficult to realize lower prices even if they are given right to launch product

MSF Access Campaign

Effect of IP on diagnostics

MSF Access Campaign

• Pfizer’s initial linezolid patent in SA expires 2014• No alternative generic registered yet—MSF special

access granted in June 2014.

Linezolid Access Barriers

Purchaser Supplier Price (600 mg tablet)

SA Government Pfizer R 287.9*

SA Private Sector Pfizer R 715.24**

MSF Hetero ~R70 ***

* Expired SA DOH antibiotics tender**Single Exit Price***only available to MSF in South Africa

With mark-ups, MSF in South Africa paid approximately R123,000 per patient for a 6-month supply of linezolidCould a compulsory license have helped?

Will Linezolid’s Story Repeat with new TB drugs?

What Reforms Could SA Enact?

Other countries have used these reforms to make their patent systems work in the interest of public health:

• Stricter patentability criteria• Patent examination system• Patent opposition • Broad research exception • Improve Compulsory Licensing & Parallel Importation

mechanisms• Publicly financed R&D, de-linkage principles

The Dept. of Trade & Industry released a “Draft Policy on IP” for public comment in September 2013, expressing the need for

these reforms

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The backlash: #PharmaGate

“The overall campaign is aimed at delaying the finalization of the IP policy…”

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Big Pharma’s Arguments

“Theme: Patents do not impede access to medicines…”“the draft…states ominously that IP protections ‘must not contradict public health policies’”

“We do NOT want a debate over individual drug prices to become the focal point”

“South Africa is now ground zero for the debate on the value of strong IP protection. If the battle is lost here, the effects will resonate.”

“Proposed IP Policy Hurts the South African Economy… innovation will stall” MSF Access Campaign

Economic rebuttals• IP ≠ investment: following adoption of TRIPS, 35 foreign pharmaceutical

manufacturing plants shut down in SA

• SA realised less FDI than countries with “weaker” IP: India proactively adopted TRIPS flexibilities that protect local industry– as such India’s domestic pharma industry realised FDI of US$1 billion from April-June 2013; Novartis expands ops

• Pharmaceuticals are 5th largest driver of SA trade deficit / R5billion spent on procuring pharmaceuticals by DOH in 2012

• Cost driven by branded products – despite the fact that in quantity the majority of medicines are imported from India and majority of API from China.

• Every Rand spent on branded medicines is money diverted from the wider health system

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“It’s not unrealistic to expect that new innovations ought to be priced at or below, in some cases, the prices that have pre-existed them.” --Andrew WittyCEO of GlaxoSmithKline London, 2013

“Great Myth” of the Industry: R&D costs $1 billion per drug

Source: http://reut.rs/WJNDcWMSF Access Campaign Treatment Action Campaign SECTION27 MSF Access Campaign

Who pays for R&D?

Industry60%

Public Sector30%

Other (incl. philanthropy)10%

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Novartis’ Gleevec:1. Early Research Costs:

• 50% National Cancer Institute• 30% Leukemia and Lymphoma Society• 10% Oregon Health Sciences university; • Only 10% Novartis

2. Tax Credits: Orphan Drug Credit for Novartis3. Product costs:

Sales of Gleevec in 2012: $4.6 billionEstimated Novartis Investment in R&D: $38-$96 million

Full return on investment every 13 days!!!

How many times do we pay?

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Medical Spending: IMS Institute for Healthcare Informatics “The Global Use of Medicines: Outlook Through 2016”

Amount re-invested in R&D: http://www.phrma.org/sites/default/files/pdf/phrma_industry_profile.pdf

“Re-Investing” in R&D?$600 Billion Spent on

Brand Name Medicines in 2011

Only 16% of that revenue

spent by phar-maceutical

companies on research and development

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What next? How can you help?

• Elections over—DTI, DOH have promised policy will be finalized.• What happens in SA has an impact

on products available in the region, and the battle for lower prices in “Middle Income Countries” like Lesotho• We need more partners and more

support!

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Access & Innovation Resources

• Book: The Global Politics of Pharmaceutical Monopoly Power• Patent Opposition Database• Fix the Patent Laws (South African campaign)

http://www.msfaccess.org/our-work/overcoming-barriers-to-accesshttp://www.msfaccess.org/our-work/driving-medical-innovation

Please be in touch!

http://www.msfaccess.orgJulia.hill@joburg.msf.org

@MSFJuliaHill

http://www.fixthepatentlaws.org@FixPatentLaw#PharmaGate

Thank you!

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