Ten Years of the Doha Declaration:
The state of implementation
WIPO- South Centre/ KEI side meeting
14 November 2011
Michelle Childs
Director Policy Advocacy
Outline
• Access to medicines pre TRIPs
• Doha declaration on TRIPS and Public Health
• Access to medicines post TRIPS
• Suggestions for future access
The situation pre- TRIPS
• Until early 1990s, approx. 50 developing countries either excluded
medicines from patentability or provided shorter periods of
protection or operated conditions which restricted patent holders’
rights
• Brazil, No Pharmaceutical Patents
• Pharmaceutical products became patentable in West Germany,
1967; France 1967; Italy 1979; Spain 1992
• India Patents Act, 1970 no patents on Pharmaceutical products
(Based on German model)
• What did we learn from the past?
Generic Competition and HIV Treatment Scale-Up
$800
7
$700
6
$600
5
$500
4
$400
3
$300
2
$200
$100
1
$0
0
2001
2002
2003
2004
2005
2006
2007
2008
People in LMICs on treatment
Lowest generic price first line ARV regimen
Originator price of first-line ARVs
2009
2010
Millions
$2700 $10,400
Figure 2. Overall ARV market share (volume) for Indian generic, non-Indian generic,
and originator (brand) manufacturers, 2003-2008
100%
Market Share (volume)
19%
14%
23%
9%
3%
5%
88%
87%
8%
3%
1%
80%
13%
61%
60%
40%
83%
80%
64%
20%
Figure 4. Countries reporting purchases of Indian generic ARVs in 2008
39%
0%
2003
Indian Generic
2004
2005
2006
Non-Indian Generic
2007
2008
Brand
Countries reporting purchase of Indian
Source: Waning, Diedrichsen, and Moon (2010)
-produced generic
ARVs in 2008
Key role of Civil society
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
The Importance of the Doha Declaration
•
•
•
•
•
Clarified TRIPS provisions and gave political space to use of TRIPS
flexibilities :
The right to grant compulsory licences
Definitive green light for parallel importation
LDC’s may extend granting and enforcing drug product patents until at
least 2016
Left unresolved: production for export under CL-decision of August 30th
2003
•
Doha gave political recognition for first time that intellectual property
and trade rules had a negative effect on access to medicines:
•
Paragraph 3 “ we recognise that intellectual property protection is
important for the development of new medicines . We also recognise
the concerns about access to medicines”
•
That IP protection must take into account public health needs of society
as a whole rather than than only a mechanism to protect limited
commercial interests . Led to continuing debate about the role and
extent of IP in incentivizing Innovation and access for developing
countries
Access beyond 1st line
Conservative figures for lowest generic (provided) price
Middle income countries are not accessing these prices
Challenges
• Bridging the gap between the standard of care received in wealthy
countries and that in the developing world
• Improved 1st line drugs
• Access to 2nd and salvage (3rd) lines
Resistance MSF
in Khayelitsha,
South Africa:
First line 14% after
5 years
Second line 25%
after a further 2
years
Addressing rising costs
‘There’s no question that scaling up treatment is expensive. But thanks to
lower costs of drugs, bulk purchasing, and simple changes like shipping
medication by ground instead of air, we and our partners are reducing the cost
of treatment. In 2004, the cost to PEPFAR for providing ARVs and services to
one patient averaged nearly $1,100 a year; today, it’s $335 and falling.
Continuing to drive down these costs is a challenge for all of us—from
donors and developing countries to institutions like the Global Fund.’
Secretary of State Hillary Rodham Clinton Remarks on an AIDS-Free
Generation ; November 2011
Many countries not accessing lowest
prices
‘Middle Income Countries’ pay high prices
• TDF first line is priced over 1000 USD ppy, six times more than in
countries where the generic versions can be accessed
‘ LMIC and Middle income countries’ increasingly excluded
from differential prices
• ViiV and Merck ceased to offer “standardized price discounts”,
negotiation on case-by-case
• Abbott excludes ritonavir 100 mg heat stable tablet from
differential price policy in low and middle income countries
• Tibotec /Johnson &Johnson do not provide differential prices for
darunavir and etravirine
Untangling the web of price reduction (14th edition), MSF, Geneva, 2011
Health Before Patents
•
•
•
•
•
•
•
Exclusion from patentability- 2016. But not all countries using this.
Refining patentability criteria (Article 27)- 15 patent grant oppositions to Aids
medicines by Indian civil society.
But 3d in India under relentless attack from Novartis . Other countries have not
yet adopted.
Parallel importation (Article 6)- Use by MSF in Kenya but threatened by
overbroad definition of ‘counterfeiting’ in Kenyan Act
Compulsory licensing and Government use (Article 31)2001- 2007 - 52 developing and LDC’s issued post Doha compulsory licences (
Govt use and /or implemented non enforcement of patents) for production or
importation of generic versions of patent medicines* (mostly for ARV’s but also
for cancer and heart disease) . Generic producing countries face retaliation for
use.
BUT- Not static: use of flexibilities uneven. Under relentless attack from pharma
companies, and Governments through bilateral agreements e.g EU- India Free
trade agreement, TPP.
Other Responses
•
•
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
– Claim: selling ‘at cost’– but further significant price reductions,
once competition sets in.
– GSK recent announcement: 75% discount for LDCs- benefits as
for all drugs but
– Ten years ago, GSK cut price of Combivir from US$16.50 to $2
a day for African countries (88%). Rival manufacturers now sell
the medicine at $0.25 a day (98.5%).
‘Public-health driven voluntary licenses
– Medicines Patent Pool: improved licensing terms over existing
VL’s (NIH & Gilead licenses). Limitations of Gilead licenses
include geographical scope, only Indian generics and API
restrictions.
– MPP pro-public health actor brokering voluntary licensing
schemes. Call on companies to enter pool
– Government VL’s : increase local production V initial higher
costs?
Responses to Doha Declaration-
•
Use of CL’s but future problems for importing countries.
•
Currently most 1st line ARV’s are pre TRIPSs- not patented in producing countries . Single
CL’s and government use and non enforcement OK for import when not patented in county
of manufacture
•
This situation will change.
•
2016 looming: LDC’s will not be able to rely on non enforcement in 5 years time. Can
block regional production and supply ambitions within Africa unless workable solution to
overcome barriers.
•
•
Plus : August 30th decision - test set by Doha to find expeditious solution. Fails that test
MSF tested its use - after 4 years = 1 CL for single order for time limited period for single
country.
•
Unrealistic drug by drug country by country case by case decision making ignores :
economies of scale - low costs, high volumes generics model, need for stcckpiling, if extra
capacity cannot send to another countries sis need it. Practical issues of generics seeking
2 CL’s when no knowledge of importing country
•
CL threat has to be credible- if known to be unworkable left to negotiate with sole supplier .
Ongoing concerns
• Doha Flexibilities provide limited space for continuing to ensure
access
• But : fighting for shrinking policy space: does not replicate easy of
use of Pre TRIPS system
• Increased barriers create incentive on generics to stop providing
new medicines to developing countries: focus on off patent
medicines in developed countries
• Does not address needs for R&D for neglected populations.
• Sustainable system for Innovation and Access still missing.
• Need continued focus on core questions
• How can access be ensured?
• How can needs-driven R&D be financed?
• How should the burden be shared?
Where are we now?
•
•
Old/ new debates- effect on public health of patent protection- but renewed focus now because:
MSF sources 80% of ARV from Indian generics as do , GFATM, PEPFAR & UNITAID. Not just
low cost but adapted first FDC made by India generics. How will this continue?
•
Focus is back on treatment. MSF experience shows benefit to people living with HIV but also
broader community level effects- for example lower rates of TB infection. New science shows
treatment as prevention
•
TRIPS agreement in force in key generic producing countries and in LDC’s by 2016- effects now
being felt in rising drug prices for key medicines. Not just for HIV but for all new medicines,
vaccines and diagnostics. Not all countries implemented TRIPS flexibilities
•
Funding -decreasing funding from donors, but needs increasing. Developing countries facing
double burden of disease communicable and non communicable disease. Sharper focus on
enabling policies to enable affordable and sustainable access to life saving medicines.
•
Commercial- developing countries especially emerging economies seen as new market
opportunities. MNC innovation slowing, ‘facing patent cliffs’ patents on large money making meds
expiring facing greater competition from generics
•
Rise in TRIPS plus demands by developed countries Doha used as diversionary tactic to avoid
scrutiny of other harmful clause e.g : bilateral trade agreements, ‘anti counterfeiting’ legislation
Gains in HIV access but elsewhere? Doha declaration cut from UN HLM on NCD
•
Conclusions
•Changed environment post TRIPS era
•Newer products patented in developing countries
–Prices will not come down automatically
•Deliberate action needed to counter the consequences of global
pharmaceutical patenting:
Short to medium term:
•Solidify gains of 1999-2011: implementation and use of
flexibilities
•Extend 2016 deadline
•Review August 30th decision
•Align trade polices with Doha- remove TRIPS + IP provisions
•Try additional approaches to access: eg Medicine patent pool
Medium term:
• Explore revision of TRIPS- MSF meeting on 21st November
• Global framework for R&D/R&D treaty
Thank you!
For more information go to www.msfaccess.org