400-500 case
LeahD
trips.pptx8.2: The Pharmaceutical Industry, TRIPS and Hepatitis C
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Exam Study Guide (1/2)
What are essential medicines, and the main barriers to accessing them in developing countries?
Main characteristics of “Big Pharma”
The main elements of TRIPS, Doha Declaration and TRIPS+ -- including how they affect access to medicines
Why some argue TRIPS are good for developing countries’ economies, and what the counter-arguments are (including evidence cited)
Explain the practice of Evergreening
Provide examples of how some countries are pushing back against Big Pharma and Intellectual Property (IP)
Exam Study Guide (2/2)
About Hepatitis C know:
Method of transmission and statistics on disease progressoin.
History of Hep C in the US and Egypt.
Why the new medications are so much better.
How Gilead is changing it’s approach to selling essential drugs outside high-income countries, and some critiques of their approach
Understand what role India is playing in access to essential medicines, and why India, in particular, is playing that role.
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“Big Pharma”
Refers to the top 20-25 multinational pharmaceutical companies
Pharmaceutical companies have some of the biggest profit margins of any industry:
Largest 25 drug companies, 20.1% profit margin in 2015
All other drug companies, 8.6%
E.g. roughly the same as software industry
Influences:
Doctor’s prescribing habits (e.g. Opioid epidemic)
Government policies
International legislation and patent law
Little research in “neglected diseases” that disproportionately affect low-income countries
1/3 of world lacks regular access to essential drugs
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The WHO’s Essential Medicines list
Mentioned in one of the 10 points of the Alma Ata Declaration
WHO publishes first list in 1977, now updated every 2 years
A guide; not a permanent list of must-have medicines
Each country determines their own list
Essential medicines must:
Satisfy the priority health care needs of the population.
Be selected with regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness.
Intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford.
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TRIPS: Trade-Related aspects of Intellectual Property Rights
TRIPS (1995) = a World Trade Organization (WTO) trade agreement that sets minimum standards for protection of intellectual property rights (IPR) in the world today
More than 150 WTO members today
Sectors covered include: health; agriculture and genetic resources; traditional knowledge, access and benefit sharing; geographical indications; software and the Internet
Minimum standards include:
Patents must be given for a minimum of 20 years
Patents may be given both for products and processes
Pharmaceutical test data must be protected against ‘unfair commercial use’
What, exactly, should be patented left up to individual countries (can lead to practice of evergreening)
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Is TRIPS good for developing countries?
Arguments for TRIPS:
Strong IPR legislation will enable developing countries to attract more investments because foreign companies won’t have to worry that their technologies will be copied
Based on the fact that a strong IPR system was essential for the industrial revolution in the 19th c. in Europe, US and Japan
Arguments against TRIPS:
Developing countries today have radically different social and economic conditions than did Europe, US and Japan when they were developing in the 19th century.
Studies suggest that during recent periods of economic development, many countries have had weak IPR regimes.
Protecting IP in advanced industrial fields (e.g. biotechnology, information and communications technology) will only benefit foreign businesses, since poor countries’ domestic firms lack the capacity to innovate in high-tech fields.
For more, see: http://www.scidev.net/global/policy-brief/trips-and-its-impact-on-developing- countries.html
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TRIPS and essential medicines in developing countries
Vagueness in what can be patented allows “Evergreening” – extending a patent for minor improvements or changes
Vagueness is a problem when countries are weak vis-à-vis a drug company or the country where they are based.
Brazil, Thailand and India have all pushed back against Evergreening
Prevents generic drugs from entering the market, so artificially keeps prices high. Limits competition and local manufacturing of drugs.
ARVs once cost 10,000/year, now they are roughly 100/year
No difference is made between life-saving medicines, consumer goods and “lifestyle” drugs
The danger is that TRIPS extends high drug prices for a longer period of time, and worsens the crisis of access to medicines
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Doha Declaration (2001)
“The public health clause” allows countries to determine their own public health crisis and make exceptions to patents held by other countries/companies
“TRIPS does not and should not prevent [WTO] Members from taking measures to protect public health”
The Doha Declaration reinforced the legality of all WTO members to issue “compulsory licenses” to produce medicines even when another country’s patent covered that medicine
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but… “TRIPS-plus” in practice
Because TRIPS are only minimum standards, countries are free to negotiate higher standards among themselves (that’s where the “plus” comes in)
In these bilateral trade agreements, developing countries might not be able to protect their right to uphold the public health clause
Developing countries are under pressure to enact tougher or more restrictive conditions in their patent laws – as part of bilateral trade negotiations with the US and the EU
Examples:
Extending the term of a patent longer than the twenty-year minimum
Introducing provisions that limit the use of compulsory licenses or that restrict generic competition.
Data exclusivity: Clinical trial results for a patented drug cannot be used when producing a generic (so the trial has to be conducted again!)
MSF: “Disastrous impact on access to medicines”
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Reviewing TRIPS
TRIPS (1995) introduces minimum standards to protect IPR that all countries agree to
But this is bad for developing countries! Especially their public health
“Flexibilities” in TRIPS allow developing countries some leeway, in theory
Can issue “compulsory licenses” to manufacture essential medicines
Can deny patent claims that represent “evergreening”
Doha declaration (2001) reinforced developing countries’ rights to these flexibilities but…
TRIPS plus provisions are becoming more widespread -- bilateral agreements that go beyond the minimum standards outlined in TRIPS, e.g.
Extending patents beyond 20-year minimum
New provisions that limit the use of compulsory licenses and restrict generic competition
Allow exclusive rights over test data, preventing generic manufacturers from relying on previous studies/clinical trials (which are expensive!)
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Hans Rosling at Global Health Beyond 2015:
https ://www.youtube.com/watch?v=8gY5BSFPlME
(Start at 18:30, watch for 3-4 min)
Pirates or Monopolists?
Start video at 18:30. Turn off after he says government can’t afford it…it’s really a problem. (a couple of minutes).
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Hepatitis C 101
Viral infection with no known vaccine for prevention
Transmission via blood:
most commonly by sharing needles
needlestick injuries by healthcare workers
moms transmit to their babies (6 per 100)
low risk for sexual transmission
75-80% of those with acute Hep C develop chronic Hep C, which can lead to liver cancer, liver failure, death.
1/3 of injection drug users age 18-30 are Hep C positive
Much higher among older injection drug users
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What’s it like to have Hep C?
One person's voice (watch min. 1-9)
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Hep C globally
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Hep C & HIV Prevention in the US
In the United States, 3.5 million with chronic Hepatitis C
In the 1980s, US banned funding for needle exchange programs out of a fear that they increased illegal drug use.
WHO research over 2 decades indicates needle exchange programs are effective to prevent HIV and Hepatitis, and do not increase rates of drug use.
In Dec. 2015 the ban was essentially lifted (on all expenses except the actual syringes, which don’t cost much)
Volunteer opportunity: Boulder County Public Health Department has a needle exchange program and they accept volunteers
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Egypt: 10% with chronic Hep C
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Hepatitis C treatment
Until recently, treatment was interferon plus other drugs (ribavirin, with possible addition of 2 protease inhibitors)
Side effects often severe
60-80% success rate
Sofosbuvir– discovered 2007– a direct-acting antiviral drug
Once daily pill; can cure the disease in 8-12 weeks
Manufactured by Gilead and patented in US 2013. Known as “Solvadi” in US.
In its 1st year on the US market, Solvadi earned Gilead > $10 billion!
2016, WHO puts Sofosbuvir on its essential medicines list
2015 US cost: $84,000 ($1,000 per pill)
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India: the battleground for drug patent law and access to essential medicines
After the fight over HIV drug access, the fight is turning to other essential drugs
India recently rejected Gilead’s application for a patent for Sofosbuvir
Gilead response:
Tiered pricing based on country’s economic status and volume of medicine
Allows 11 manufacturers in India to produce generic versions, for sale in 101 developing countries
Program with Egypt
BUT this does not reduce cost of Hep C medicines in middle-income countries
See: http ://www.nature.com/news/hepatitis-c-drugs-re-energize-global-fight-over-patents- 1.21558
Tiered pricing
e.g. 12-week course of Sofosbuvir:
US: $84,000
Turkey and Canada: $50,000
Brazil: $6,000
Egypt: $900
Generic manufacturing:
Manufacturers set prices, pay 7% royalties to Gilead
Retail is $300-900/treatment
E.g. Poland: to treat every infected person would cost 1.6 times annual expenditures on all medicines – costs 6x average annual income in Poland
See here: http://www.nature.com/news/hepatitis-c-drugs-re-energize-global-fight-over-patents-1.21558
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Gilead in Egypt
2014: Gilead introduces Sofosbuvir to Egypt at cheaper rates
$10/pill to government
Distributed free to patients
Strict rules:
All pills dispensed by government pharmacies
Patients must turn in an old bottle to get a new one
New bottles must be opened, unsealed and first pill taken in front of pharmacist
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India’s importance in the fight for fair drug patent laws
India’s domestic drugs market is the 14th-largest globally, but with growth of 13-14%
In US and Europe, law allows patents for updated versions of drugs (“evergreening”)
India limited patents on drugs with “previously known active ingredients,” unless the change shows clear therapeutic benefit (e.g. prevention of Evergreening)
Denied a patent to Novartis AG (Swiss company) for Glivec, a leukemia/cancer drug, on this basis
Novartis took the case all the way to the Indian Supreme Court, saying they defined innovation too narrowly; ultimately Novartis lost (2013)
Big Pharma then lobbied the US to impose trade sanctions against India
http://in.reuters.com/article/india-drugs-patent-novartis-glivec- idINDEE93000920130401
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Big Pharma’s response to the Glivec decision
The U.S. industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, said the decision reflected a deteriorating environment for innovation in India:
"Protecting intellectual property is fundamental to the discovery of new medicines," the group said in a statement. "To solve the real health challenges of India's patients, it is critically important that India promote a policy environment that supports continued research and development of new medicines."
Source: http ://in.reuters.com/article/india-drugs-patent-novartis-glivec- idINDEE93000920130401
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Cost effectiveness and socialization for scarcity
Cost effectiveness was used as a rationale for not treating people in poor countries with antiretrovirals (ARVs)
That paradigm changed due to:
Influx of money for HIV (PEPFAR & the Global Fund)
The development of generics (allowed under Doha Declaration.)
The study demonstrating that treating a person with HIV reduced the likelihood of transmission by 96% (so treatment = prevention)
In what other aspects of global health do we assume scarce resources and then limit care to the poor?
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