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Equitable Access the need for a new concept: The HIV Medicines Patent Pool Initiative

Med4all conference, Berlin 23 - 24 April 2009.

Ellen 't HoenSenior Adviser Intellectual Property and Patent PoolUNITAID, 20 Avenue Appia, 1211 Geneva 27, Switzerlandthoene@who.int

2006: Founding countries : Brazil, Chile, France, Norway, UK

2009: Supported by 29 countries and the Gates foundation

Innovative Partnership for Public Good

UNITAID's Mission

Is to contribute to scale up access to treatment for HIV/AIDS, malaria and tuberculosis for the people in developing countries by leveraging price reductions of quality drugs and diagnostics, which currently are unaffordable for most developing countries, and to accelerate the pace at which they are made available.

To fulfill its mission, UNITAID will use sustainable, predictable and additional funding to help generate a steady demand for drugs and diagnostics, thereby significantly impacting market dynamics to reduce prices and increase availability and supply. UNITAID will base its price reduction strategy on market competition.

Where intellectual property barriers hamper competition and price reductions, it will support the use by countries of compulsory licensing or other flexibilities under the framework of the Doha declaration on the Trade-Related Aspects on Intellectual Property Rights (TRIPS) Agreement and Public Health, when applicable.…

Any other innovative solution that may overcome limitations to market diversification in developing countries will also be pursued.

Source: www.unitaid.eu

An aircraft with 300 passengers on board leaving from Paris will cover the treatment for 1 person with multi drug resistant tuberculosis (approx. US $ 4.000) or 60 HIV-positive children for one year

A flexible 'air ticket solidarity tax'

HIV/AIDS: 49 countries

Malaria: 29 countries

93 countries receiving UNITAID medicines and diagnostics

TB: 72 countries

A new concept: President Obama on humanitarian licensing

• Increase Access to Affordable Drugs: Barack Obama and Joe Biden believe that people in developing countries living with HIV/AIDS should have access to safe, affordable generic drugs to treat HIV/AIDS. They will break the stranglehold that a few big drug and insurance companies have on these life-saving drugs. They support the rights of sovereign nations to access quality-assured, low-cost generic medication to meet their pressing public health needs under the WTO’s Declaration on Trade Related Aspects of Intellectual Property Rights (TRIPS). Barack Obama and Joe Biden also support the adoption of humanitarian licensing policies that ensure medications developed with U.S. taxpayer dollars are available off-patent in developing countries.

US public sector involvement in new drug development

"Between 1980 and 2008 107 drugs, vaccines and in vivo diagnostics that received FDA approval and 2 that received foreign approval were discovered in whole or in part in the course of research carried out at public sector institutions."

Jensen et al, presented at 2009 AUTM meeting,

Orlando Florida.

Humanitarian LicensingThe case of stavudine/d4T

• Developed by researchers at Yale University• Yale licensed the patent to BMS• 2000 Yale's royalties > 40 mill$ from BMS• BMS sold d4t in South Africa at 34x generic price • March 2001, prompted by CPTECH, Yale

students, researchers and treatment advocates launched a campaign renegotiation of the license agreement to ensure the availability of generic versions of D4T in developing countries.

Access to Generic Medicines

• 2007- 2008, 92% of patients on antiretroviral in low and middle income countries use generic drugs. Of them 99% uses d4T/3TC/NVP combination. (Source: WHO Global Price

Reporting Mechanism). • “Generics fuel Aids Programme”: Generics accounted for

57% of $131 million U.S. PEPFAR spending in 2007 (WSJ, 31 July 08)

• Until 2005 India ’s excluded pharmaceutical products

from patenting (1970 Patents Act)

Effect of Generic Competition

Source: http://www.msfaccess.org/fileadmin/user_upload/diseases/hiv-aids/Untangling_the_Web/Untanglingtheweb_July2008_English.pdf

Patent Barriers to Fixed Dose Combinations

New ARVs More Costly

Source: http://www.msfaccess.org

Responses 1

• Differential pricing– Discounts not steep enough and not as effective as

generic competition– No solution to patent barriers to the development of

FDCs and new formulations e.g. for children

• ‘Voluntary’ licenses– Restrictions that hamper full effect of generic

competitions e.g on trade in API, export markets– Rare and response to threats e.g CL or legal

action, e.g. TAC’s complaint at the South African Competition Commission and pre grant oppositions

Responses 2

• Compulsory licensing• Thailand => EFV price 1400 Baht (45$) to 615 Baht (19$) a

bottle. • Brazil ==> EFV 77% price drop ==> increase of patients from

23.300 to 75.000

• DC’s use “government use” powers to procure generics

• LDC’s exclude product patents when patented • India – strict patentability criteria

– 15 Patent-grant oppositions related to AIDS medicines by Indian civil society

• Changed environment post TRIPS era

• Newer products patented in developing countries

– Prices will not come down automatically

– IP barriers to FDC development

• Deliberate action needed to counter the consequences of global pharmaceutical patenting

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Medicines Patent Pool

• 2006 MSF and KEI proposed to UNITAID to set up a medicines patent pool.

• May 2008 WHO Global Strategy and Plan of Action Public Health, Innovation and Intellectual Property recognised the role of patent pools to increase access to medicines

• July 2008 UNITAID EB decided in principle to establish a voluntary medicines patent pool

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What is a Patent Pool?

• A Patent Pool is a portfolio of assets consisting of the entire set of patents and other relevant IP held by various actors (companies, universities, government institutions) related to a particular technology that are made available on a non-exclusive basis to third parties, (e.g. generic manufacturers) against the payment of royalties.

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WHO recommended improved 1st line ARVHigher price/multiple IP owners

• New WHO recommended 1st line regimen:– TDF/ 3TC or FTC/ EFV or NVP– 4 to 11 fold increase in price compared to

3TC/d4T/NVP

– TDF and FTC – Gilead– 3TC – GSK– EFV – Merck– NVP – BI– TDF/FTC/EFV – Gilead/BMS joint patent application

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Scope of the Medicines Patent Pool

• Voluntary• Existing ARVs

– Decrease price of newer 1st line ARVs by increasing the number of generic producers

– Decrease price of 2nd line ARVs

• 'Missing Essential ARVs'– Encourage the development of FDCs containing

'newer' ARVs for both 1st line and 2nd line by overcoming the patent barrier.

– Encourage the development of paediatric formulations for both 1st line and 2nd line.

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Patent Pool Process

• The 'standard' : Missing Essential ARVs– In collaboration with WHO HIV and Essential

Medicines Department

• Identify the relevant patents• Call for patents• Start of negotiations with patent owners• Establishment of the licensing agency

(The 'Pool')• Day to day operation of the Pool

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A Successful Pool will:

• Accelerate the availability of generic versions of new ARVs well before patent expiry

• Enable the development of FDCs of which the patents are held by different entities

• Enable the development of adapted formulations for children

• May provide a model for the future…

Is the Patent Pool Feasible?

• Political momentum - WHO GSPA paved the way• UNITAID commitment• NGO commitment• Companies’ initial responses positive:

– IFPMA “very interesting”– GSK willing to put licensed patents in the pool– Individual companies response positive e.g. Gilead:

'dipping the proverbial toe in the pool'.– European generics “interesting” – Indian generic industry endorsed the UNITAID board

decisison

Thank You!

For more information visit:

http://www.unitaid.eu/images/patent/new/ppinfo.pdf

http://www.unitaid.eu/images/patent/new/ppq&a.pdf