Transcript Access to Medicines - Honors 490 - Professor Penner

Access to
Medicines/TRIPS/Development
Health and Development
• Increased health is a sine qua non of development.
• Public health interventions are crucial to achieve
development ends (Acemoglu and Robinson, 2007.
tuberculosis, malaria, pneumonia, influenza, cholera,
typhoid, smallpox, whooping cough, measles, diphtheria,
scarlet fever, yellow fever, plague, typhus fever, and
dysentery.
• Disease and Development—much work showing positive
effect of interventions on other factors (Hookworm
eradication in the South increased literacy, school
attendance, income growth)
But..
• Disease Environments are not the same
globally
• Eradication programs are not equally
implemented
• Amount of resources that countries are
able to spend on disease prevention is
often small.
Global Health Equity:Two Main
Issues
• Development of Viable Medicine for
Neglected Diseases (sleeping sickness,
lymphatic filariasis, blinding trachoma,
leishmeniasis)(Incentive Framework).
• Access to Medicine for Low Income
Countries--About 10 million die every year
because they do not have access to
existing medicines and vaccines.(Legal/
Infrastructural Framework)
Neglected Diseases
Disease
Deaths per
Year
DALY
(1000s)
Diarrhea
2124032
62227
Malaria
1079877
40213
Measles
776626
27549
Pertussis (Whooping Cough)
296099
12768
Tetanus
308662
9766
Syphillis
196533
5574
Leishmaniasis (Orient Boils,Sandfly Disease)
40913
1810
Trypanosomiasis (Sleeping Sickness)
49668
1585
Top 10 brand names by function
Brand*
Segment
1.Lipitor
(Atorvastatin)
Cholesterol Reducer
2.Nexium
(Esomeprazole)
Heartburn
3.Prevacid (Lansoprazole)
Heartburn
4.Advair Diskus
(Fluticasone Propionate)
Asthma
5.Singulair
(Montelukast Sodium)
Asthma
6.Effexor XR
(Venlafaxine HCL)
Depression
7.Plavix
(Clopidrogel)
Heart Medication
8.Zocor
(Simvastatin)
Choleterol Reducer
9.Norvasc
(Amlodipine Besylate)
Blood Pressure
10.Lexapro
(Escitalopram Oxalate)
Depression
Proposals to Encourage Drug
Development
Michael Kremer
• Vaccine Precommitment
• Patent Buyout
(Gates Foundation)
Thomas Pogge
• Patent 2– recreate a market for patents
(payment for increase in DALY)
Jean Lanjouw
• Patent Policy Targeting
What did TRIPS do?
• The 1994 Agreement on Trade-Related Aspects of Property Rights
(TRIPs Agreement) :
• signatories are obliged to grant patents to pharmaceutical products.
(phased out for developing countries in 2005)
• Doha Round 2001- Article 30, allows States to restrict the exclusive
privileges granted by the patents. “limited exceptions” in Article 30 It
authorizes a third party to manufacture, use or sell a patented
invention without the authorization of the title-holder, under clearly
stated circumstances .
• Article 31 allows for the concession of compulsory license.
Compulsory licensing will be granted in case of national emergency,
or when a state wants the invention to have public use on
noncommercial grounds.
• Article 31(F). The member countries of the WTO will be able to
import medicines through compulsory licensing if domestic industry
proves unable to supply (THAILAND –KALETRA)
Source: *Drug Topics 2006, **Mediclik.com
Top 8 Brand Name Drugs by Dollars in 2006
Brand*
Patent Owner
Brand Available in India?
Molecule
available in
India? **
Was the
molecule
launched by the
patent owner in
India?
1.Lipitor
(Atorvastatin)
Pfizer
N
Y
N
2.Nexium
(Esomeprazole)
AstraZeneca
N
Y
N
3.Prevacid
(Lansoprazole)
Novartis
N
Y
N
4.Advair Diskus
(Fluticasone
Propionate)
Glaxo Smith Kline
Y
Y
N
5.Singulair
(Montelukast
Sodium)
Merck
N
Y
N
6.Effexor XR
(Venlafaxine HCL)
Wyeth
N
Y
N
7.Plavix
(Clopidrogel)
Sanofi-Aventis
Y
Y
N
8.Zocor
(Simvastatin)
Merck
N
Y
N
Price Differences
Drug
Price in
India
(INR)
Price in
Pakistan
(INR)
Atenolol 50 mg X 14
5.6
62.42
Dilitiazem 60 mg X10
30
50.23
17.9
39.9
Enalapril Maleate 5 mg X10
12
37.11
Amlodarone 200 mg X10
58
112.94
Amlodipine Besylate 5 mg X10
5.9
87.05
55.78
107.57
69
283.13
28.9
159.34
Simvastatin 10 mg X10
35
245.98
Atorvastatin 10 mg X10
24
483. 85
Lisinopril 5 mg X10
Terazosin 2 mg X10
Valsartan 80 mg caps X10
Lovastatin 20 mg X10
Question?
• Why not Price Discriminate? (Coca Cola
Does)
• Parallel Imports
• Public Outrage
More modest question
• How can the global intellectual property
rights framework be modified so that the
standards of proof for genuine drug
discovery are made more stringent, at
least globally, if not in the US; that
frivolous and weak patents are weeded
out rapidly and across countries quickly;
and that generic producers can bring their
products into the pipeline for invalid
patents quickly ?
Why problem?Evergreening
• If I'm a manufacturer and I can change
one molecule and get another twenty
years of patent rights, and convince
physicians to prescribe and consumers to
demand the next form of Prilosec, or
weekly Prozac instead of daily Prozac, just
as my patent expires, then why would I be
spending money on a lot less certain
endeavor, which is looking for brand-new
drugs? KPMG executive
Some Solutions
• Increase Information– Cross reference
patents
• Have system of maximum patentability
(i.e. if a patent is invalidated in, say the
UK, it is automatically invalidated
everywhere).
• Public Funding of Clinical Trials
New areas of conflict
• Given ability to undertake compulsory
licensing and cumbersome nature of
TRIPS:
• Bilateral Trade Agreements (Private
Enforcement)
• Data Exclusivity
• Political Movement– outcrop of AIDS
activism
• Spillover into TRIPS:NGO and Public
Interest Groups examined the impact of
multilateral agreements on access to
medicines (many fronts of battle, including
universities).
AIDS Battle
• Large Pharmaceutical Interests locked in
Battle with South African Government
about 1997 law which invalidated patents
• Were attacked on three fronts–
• Generics (CIPLA)
• University (Yale- BMS)
• AIDS activists