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$10,400$2700

Figure 4. Countries reporting purchases of Indian generic ARVs in 2008

Countries reporting purchase of Indian -produced generic ARVs in 2008

Source: Waning, Diedrichsen, and Moon (2010)

Figure 2. Overall ARV market share (volume) for Indian generic, non-Indian generic, and originator (brand) manufacturers, 2003-2008

39%

80%

64%

83%88% 87%

1%

13%

3%3% 8%

61%

19% 23%14%

9% 5%

0%

20%

40%

60%

80%

100%

2003 2004 2005 2006 2007 2008

Market Share (volume)

Indian Generic Non-Indian Generic Brand

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

‘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

Addressing rising costs

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