The right to health and
access to patented
medicines – role of the
Medicines Patent Pool
Ellen ‘t Hoen
PIJIP Conference on IP and Human Rights,
Washington DC, 21 – 22 February 2013
Human Rights and Access to
Medicines
• Access to safe and effective medicines are an essential
component of the fulfillment of the right to health
• Access to medicines requires state action
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Selection of essential medicines
Quality assurance
Procurement and supply
Rational use
• The development and production of medicines is largely left
to the commercial private sector
• Leads to rationing or non availability if medicines are priced
out of reach of people’s/communities’ ability to pay or not
developed at all.
Trade agreements and ATM
• ‘77 WHO Essential Medicines Concept – selection and
provision core function of government
• Rooted in human rights principles (‘78 Alma Ata ‘Health for All’)
• ‘95 WTO TRIPS agreements have taken away policy options for
governments
• Pre-TRIPS Andean region excluded patents for medicines listed on
their national essential medicines lists
• At the time the Uruguay Round launched in 1986, 49 of the 98
members of the Paris Convention excluded pharmaceutical products
from patent protection, 10 excluded pharmaceutical processes and
22 excluded chemical processes
• Late nineties HIV/AIDS access crisis provoked international
action
• 2001 Doha Declaration effort to rebalance rights and
obligations
Right to Health in the court
“The richness of practice is also critically relevant for
understanding the concept and reach of human rights”
Amarya Sen
Enforcement of ATM as part of RTH
• Hogerzeil et al Identified 73 cases from 12 LMIC countries (9
Latin America, India, Nigeria, South Africa)
• 59 cases access to essential medicines as part of the
fulfillment of the right to health was enforced through the
courts
• Majority of cases HIV/AIDS related
Source: Hogerzeil etal.,Is access to essential medicines as part of the fulfilment of the right to health
enforceable through the courts?, Lancet 2006, 368:305-11
47 Human Rights Guidelines for
Pharmaceutical Companies in
Relation to Access to Medicines
• 2008 the UN Special Rapporteur on the right to health,
submitted to the United Nations General Assembly the
“Human Rights Guidelines for Pharmaceutical Companies in
relation to Access to Medicines” They include:
• responsibilities for transparency, management, monitoring and
accountability, pricing, and ethical marketing, and against
lobbying for more protection in intellectual property laws,
applying for patents for trivial modifications of existing
medicines, inappropriate drug promotion, and excessive pricing.
• Guidelines 26–32 address patents and licensing, including
the vital role of commercial and noncommercial voluntary
licences.
Source:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pme
d.1000330
The Medicines Patent Pool
7
UN Framework of the Pool
• 2008 UN Special rapporteur Health and Human Rights guideline on licensing
• 2008 WHO Global Strategy and Plan of Action on Public Health Innovation and
Intellectual Property:
..examine the feasibility of voluntary patent pools of upstream and downstream
technologies to promote innovation of and access to health products and medical
devices;
• 2010 UNITAID – a WHO hosted multilateral financing mechanism – following a
feasibility study decided to establish the Medicines Patent Pool
• United Nations General Assembly Political Declaration on HIV/AIDS 2011:
“Voluntary use, where appropriate, of … patent pools benefiting all developing
countries, including through entities such as the Medicines Patent Pool, [is
encouraged] to help reduce treatment costs and encourage development of new
HIV treatment formulations, including HIV medicines and point-of-care diagnostics,
in particular for children.” 2012 WHO CEWG: The public health impact was
potentially high
• MPP integral part of WHO’s five year HIV/AIDS strategy
• WHO CEWG recognised MPP as a promising mechanism for access and
innovation
Patents on HIV Medicines
Medicines Patent Pool
Advantages
• Negotiates licenses from a
public health perspective
• Transparent and predictable
• Active engagement with
generics to ensure uptake
• Works on development of
recommended formulations
• Quality assurance important
focus (WHOPQ)
• UNITAID strategic partner in
creating market
limitations
• Participation by companies
voluntary
• T&C result of negotiations –
no power to force e.g.
country scope
• Limited to HIV
Medicines Patent Pool
Advantages
• Negotiates licenses from a
public health perspective
• Transparent and predictable
• Active engagement with
generics to ensure uptake
• Works on development of
recommended formulations
• Quality assurance important
focus (WHOPQ)
• UNITAID strategic partner in
creating market
Limitations
• Participation by companies
voluntary
• T&C result of negotiations –
no power to force e.g.
country scope
• Limited to HIV
In conclusion
• Medicines Patent Pool an important mechanism to ensure access to
HIV medicines - an essential component of the fulfillment of
people’s right to health.
• The Pool has some limitations.
• When medicines patents holders refuse to license their patents
under public health friendly terms and conditions,
trade/IP/competition law and the human rights framework offer
powerful tools for governments to intervene
• Tools for citizens to demand government action incl through the
courts or competition authorities
• Refusal to license on reasonable terms
• Ultimately, access to essential medicines [as a key component of the
fulfilment of the right to health] depends on the willingness of
governments to act. This should include exploring access friendly
ways to finance R&D.