Changed IP Environment

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Transcript Changed IP Environment

Access to Medicines at the World
Health Organization
A quick 10 year overview
History Lesson
• ‘70ties Primary Health Care
• 1975 WHA resolution calling on WHO to assist
countries
• 1977 1st Essential Drugs List published –
contained 207 items
• Selection and provision of medicines core
function of government
Essential Drugs ’70 – ‘80
• “a peaceful revolution in international health”
(E. Lauridsen)
• Nevertheless a controversial concept
• Pharma concerns: gov intervention in freedom
to operate
• Decisions what to pay for
• IP – Andean countries excluded essential
drugs from patentability
Essential medicines
• 1977 WHO definition of “essential medicines” was that they were
‘of utmost importance, basic, indispensable, and necessary for the
healthcare needs of the population’
• Current: ‘Essential medicines are those that satisfy the priority
health care needs of the population. They are selected with due
regard to public health relevance, evidence on efficacy and safety,
and comparative cost-effectiveness. Essential medicines are
intended to be available within the context of functioning health
systems at all times in adequate amounts, in the appropriate
dosage forms, with assured quality and adequate information, and
at a price the individual and the community can afford. The
implementation of the concept of essential medicines is intended
to be flexible and adaptable to many different situations; exactly
which medicines are regarded as essential remains a national
responsibility.’
From EDL to RDS
• 1985 Nairobi conference on drug policy
• ED List – not enough. NGOs advocating for
:”access to medicines AND rational use”
• HAI: WHO medicines policy should go beyond
making lists and regulate how medicines are
marketed and used
• WHO DG Dr. Mahler promised: “Strategy for
strengthening WHO’s activities in support of the
action required to make drugs more rational
throughout the world”
Revised Drug Strategy
• May 1986 World Health Assembly adopted the
RDS which contained a series of strategies to
– Increase availability of essential medicines
– Improve the use of medicines (“Rational use of
Drugs”)
– Established the concept of “essential medicines”
– Rooted in the promotion of generics
Patents /IP issues not on the table!
Meanwhile at the GATT ….
• Drug companies established an elite, high
powered lobby group to ensure intellectual
property issues would be part of the GATT
framework
• Gatt became the …
1995
1995 Changed IP Environment
WHO and WTO
• 1996 WHA – health ministers for the first time
discussed effects of international trade
agreements on access to medicines
• Public health advocates called for a role of WHO
– Gatt negotiations carried out without regard to
health needs
• RDS resolution gave WHO mandate to work on IP
– but US and Europe continue to object
• 1998 Red Book …. Became the Blue Book
• 1999 IP was a core issue in RDS discussions at the
WHA
Seattle ‘99
Health at the WTO
• TRIPS Council
• 2001 Doha Declaration on TRIPS and Public
Health
• 2003 August 30 decision to amend the TRIPS
Effect of Generic Competition
Source: http://www.msfaccess.org/fileadmin/user_upload/diseases/hivaids/Untangling_the_Web/Untanglingtheweb_July2008_English.pdf
$$$
WHO and trade debates
• 1999 RDS changed to include work on trade (IP)
• 2001 Big Pharma vs. Mandela
• 2002 affordability criteria for inclusion in EDL
challenged by NGOs
• 2002 ARVs included in EML
• 2006 CIPIH Report Published
• 2006 – 2008 IGWG negotiations => GSPOA
adopted
• Implementation starts => eg. Medicines Patent
Pool
Where are we now?
• NGOs played a key role in pushing the agenda
both at WHO and WTO
• WHO no longer sole multilateral player in
health
• Progress on IP and health 
• I+A agenda needs shaping up
• New paradigms for R&D funding
Thank you!