a very short introduction to patents & access to medicines
TRANSCRIPT
A very short introduction to patents & access to medicines
Generic competition has allowed drops of HIV drug pricing by 99%
Source: MSF Untangling the Web of Antiretroviral Price Reductions, 15th Edition, July 2012
Vital Importance of affordable generic medicines
• Today, more than 98% of PEPFAR ARV purchases are generic - Generics saved PEPFAR $380 million in 2010 alone
• …and more than 91% of donor-funded pediatric ARVs are generics from India
• MSF is highly reliant on generic medicines to provide HIV/AIDS treatment but we are not alone - More than 80% of the donor funded AIDS drugs in developing countries are generics
Prices raising for next generation HIV Drugs
Source: MSF Untangling the Web of antiretroviral Price Reductions, 15 th Edition, July 2012
• Demand for second-line and third-line HIV treatments is growing
• The most affordable second-line regimen is more than twice as expensive as the recommended first-line regimen
• The price of a third-line regimen is more than 14 times higher than the recommended first-line regimen
Why?
Patented medicines are reaching developing countries
The world is changing
1995 World Trade Organisation (WTO) established an Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS)
- “minimum” standards of protection of intellectual property rights
- 20 year patents on pharmaceutical products & processes
2005 TRIPS Agreement - fully implemented & medicines become patentable everywhere (except LDCs)
Consequence: India and other developing countries have to start granting patents on medicines
© Sven Torrfin 2011
What are Patents & how they delay access to generics medicines
• A patent is an exclusive legal right given by governments to exclude others from making, using, or selling a claimed invention in a country without their consent.
• Patents are given for a fixed period of time (WTO says - 20 years).
• Patents allow the creation of monopolies - When patent barriers are removed, competition between manufacturers enables production of generic medicines
© Sven Torrfin 2011
Options in the current innovation system
I. Differential pricing for patented medicines: Pharmaceutical voluntary discounts not steep enough and not as effective as generic competition + many middle-income economies
II. ‘Voluntary’ licenses: Negotiated in secret, limited geographical scope and with restrictions that hamper effect of generic competitions by segmenting markets, trade in API... We need to carefully watch – Medicines Patent Pool trying to make a difference
III. TRIPS Flexibilities: LDC 2016 / Strict Patentability Criteria & patent oppositions/ Compulsory Licensing (Others: Competition Law, Limits on Remedies …)
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Doha Declaration“We affirm that the (TRIPS) Agreement can and should
be interpreted and implemented in a manner supportive of WTO Members' right to protect public
health and, in particular, to promote access to medicines for all.”
WTO Ministerial Declaration on the TRIPS Agreement and Public Health
November 14, 2001
Two of the TRIPS Flexibilities that REMOVE patent barriers
I. Patent opposition Defensive or offensive strategy – before or after patent office has decided to
grant a patent it can be challenged and (if successful) not granted Pre-grant patent oppositions usually preferable Depending on national law anybody can oppose a patent – even civil society
II. Compulsory LicenseOffensive strategy – If a patent exist, a government can authorize the
manufacturing/use of generic products without the consent of patent holder/pharmaceutical company
Under certain conditions. E.g. in exchange of a royalty payment + some times you have to negotiate first with patent holder
Remember: First Step is to check if TRIPS flexibilities are in your national law (and if not, ask for it – Fix Patent Laws)
Patents
= Monopolies = No Competition / No Generics = Higher prices
© Sven Torrfin 2011
Drug not patented
Drug patent Successfully Opposed
Patent compulsory License granted
Generic competition allowed
SUMMARY - Why ACTION is needed?
• Changed environment post-TRIPS - Newer products patented in developing countries– Prices will not come down automatically– IP barriers to the development of specific
formulations e.g. FDC• Deliberate action is needed to counter the
consequences of global pharmaceutical monopolies: – Use of the TRIPS flexibilities in patent law by governments
and civil society – E.g. compulsory licensing and patent oppositions
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Thank You!
Judit Rius SanjuanMSF Access Campaign USA
More Information: http://www.msfaccess.org