People's Health Movement Some Definitions Process Patents – Patents granted for processes which means multiple patents for the same molecule – competition

People's Health MovementSome Definitions Process Patents – Patents granted for processes which means multiple patents for the same molecule – competition - generics Product Patents – Patents granted for the product and all other processes are not allowed – Monopoly - Branded drugs Evergreening – A process of perpetual patenting by discovering new uses, indications or even dosages for an existing molecule. E.g. Aspirin which was earlier used for pain relief now also having blood thinning capabilities Pre-grant Opposition – Opposition by public health groups to a molecule before Patent is granted Post-grant Opposition – Opposition by public health groups after a Patent has been granted Voluntary Licensing – A generic company applying for a license with the patent holder for a commercial consideration

Cipla created history

People's Health Movement

Source: Médecins Sans Frontières cited in Correa (2007)

Research and Development (R & D) ?


2000, Source: Act Up. http://www.actupny.org/reports/drugcosts.html#chart_one

Marketing versus R&D :-


Story of top nine companies (2002) Spent $45.4 billion on marketing,

advertising and administration.

$19.1 billion on R&D the previous year

Highest paid executive made $75 million and top five executives got $183 million in compensation

In the top 15 profit making companies of the world, there were 6 pharma companies (Fortune 500 cited in Sengupta, 2001)


Research and Development (R & D) ? People's Health Movement

• Less than 10% of the drugs approved in the last 10 years have had some real therapeutic effect (FDA cited in Alok Ray, 2005)

New chemical Entities Source: FDA cited in Correa(2007)


Commission on Intellectual Properties, Innovation and Public Health (CIPIH) set up by the WHO to look into Innovation and Patents

“The incentive effect of intellectual property rights may be limited or non-existent”

“There is a need for other incentives and financial mechanisms to be put in place and for collaborative efforts between different stakeholders”

Neglected/Orphaned diseases: The Last Known TB drug discovered was in 1978!! Similarly no R&D for diseases like sleeping sickness, Kala Azar (Leischmaniasis). Out of the 1556 New Chemical entities between 1975-2004, only 17 have been for Neglected / Tropical diseases!! (Chirac et. al, 2006)

R & D for What ?

People's Health MovementIndian Patents Amendment

India Signed TRIPS agreement in 1995 and had 10 years, that is by 2005, had to change its patent laws from process patents for 7 years to 20 years of product patents

Indian Patents Amendment - A TRIPS Plus Product Patents for new forms of old medications Pre-Grant Opposition removed, only Post-Grant retained Compulsory Licensing procedures made cumbersome and TRIPS flexibilities not utilised. No fixed Royalty or time limit for voluntary licensing Export to LMICs made very stringent only under the condition that an LDC country issues a compulsory license. MLICs allowed time till 2015 to change their patent laws

People's Health MovementWhy the Indian Case Study?

• 85% of MSF's patients depend on Indian generic AIDS medicines

• 50% of PLWA (People Living With Aids) in the developing world depend on Indian generics

• 67% of medicines exports from India go to developing countries

• Approximately 50% of the essential medicines that UNICEF distributes in developing countries come from India

• 75-80% of all medicines distributed by the International Dispensary Association (IDA) are manufactured in India

• In Zimbabwe, 75% of tenders for medicines for all public sector health facilities from India.

1) TRIPS flexibilities – IGNORED

2) Doha declaration – IGNORED

3) Constitutional obligations - IGNORED

4) Several international studies - IGNORED.

5) Petitions of Mass organisations (both Indian & international) – IGNORED.

6) WHO / GAA / UNAIDS letters - IGNORED.

People's Health MovementIndian Patents Amendment


The Movement gave a “Global Call” against the Patents Amendment brought out by the Indian Government for Feb 26, 2005.

Response to the Global call at the Global Level:

The International Humanitarian Organisation Médecins Sans Frontières (Doctors without Borders) out a letter to the President of India, the Prime Minister of India and Ms. Sonia Gandhi opposing the Amendments. They had also released it to the Indian Media

Geneva: NGO Forum for Health sends a letter to the Indian Government through the Ambassador of India at the UN opposing the Amendments

Global Campaign against Indian Patents Amendment (GCAIPA)

People's Health MovementGermany: BUKO Pharma Campaign sent out protest letters to the various ministers and the Indian Embassy in Germany. German network against AIDS (where all major NGOs in Germany are part of) sent a fax to the Indian Embassy in Germany

Morocco: The Coalition for the Right to Care and Access to Medication in Marrakech, Morocco, issued a press release condemning the Amendments and also sent an open letter from an HIV/AIDS patient to the Indian Ambassador to Morocco

Burkina Faso: There was a rally taken out in Ouagadougou, Burkina Faso by people with AIDS who use Triomune a lot and some of the slogans were "Génériques toujours !" = "generics forever !" "Inde : sauveur hier, criminel aujourd'hui" = "India : saviour yesterday, criminal today"

People's Health MovementUnited States of America: The Association for India’s Development, Insaaf, Global AIDS Alliance and such other organizations organized a rally in front of the Indian Embassy in Washington. Some of the individual chapters of these organizations also sent out press notes to the Indian media

France: Act-up Paris, ATTAC and Solidarite Sida organized a protest Rally in front of the Indian Embassy in Paris.

South Africa: Treatment Action Campaign in South Africa picketed against the Patents Amendment and submitted a memorandum addressed to the President and Prime Minister of India.

South Korea: A group in Korea, People's Health coalition for equitable society and Human Right Advocacy Group NANURI+ in response to the Global Call submitted a memorandum to the Indian Ambassador


• WHO: WHO writes a letter to the Health Minister urging him

to make use of TRIPS flexibilities

• UNAIDS: UNAIDS writes a letter to the Commerce Minister

urging him to make use of TRIPS flexibilities


Build-up to the Campaign

21 Jan 2005 – Patents convention held in Chennai

9 Feb 2005 – A workshop for the Trade Unions in Mumbai

12 Feb 2005 – A city meeting on Patents held in Hyderabad

13 Feb 2005 – Patents issue discussed at a meeting of the

Western regional NGO's held in Mumbai

15 Feb 2005 – A workshop held in Kolkata

19 Feb 2005 - Patents Convention was held in Pune

20 Feb 2005 – A Patents Convention was held by FMRAI in

Mumbai

People's Health Movement20 Feb 2005 – A debate in the Television on patents issue

participated by Prasanna

21 Feb 2005 – A workshop with the Health Care workers held in

Bangalore and as a follow up a workshop was held separately at

St. John’s Medical College and NIMHANS

21 Feb 2005 – Dharwad: Dr. Gopal Dabade and others from

Drug Action Forum Karnataka met the 2 Members of Parliament

from Dharwad and detailed them about the issue and the MPs

have promised to look into it and raise questions on what the

Health Ministry has replied to the letter from WHO

25 Feb 2005 – A Protest Convention was held in Pune one day

before the Global Call


At a regional Level

10 Oct 2004 – T.N. Seetharam, the Director of a soap on TV

contacted and requested to bring in the Patents issue. Lots of

material given to him

21 Feb 2005 – Members of parliament from Bangalore, who

belonged to the opposition party contacted and handed over

information.

On 26 Feb 2005 – Rallies, picketing, memorandums were

submitted in all major cities of India like New Delhi, Mumbai,

Bangalore, Kolkata, Kerala, Hyderabad, Chennai, Goa, Pune,

Dharwar and even Washington in the US


Outcome of the Global Call

• We had a 'bad' bill from a 'Disastrous' bill

• Pre-Grant Opposition was restored

• Rejects Patents for new forms of earlier medications

• Tightened Compulsory Licensing provisions a little but still left

the questions of time and royalty open to endless negotiations

• Allowed for the continued manufacture of drugs in the market

after 1995

• Allowed for the export of medicines to the LDCs without any

Compulsory Licensing provisions in those countries

The Case of Gleevec

People's Health MovementNovartis Boycott Campaign

• Gleevec is the medicine of Novartis company for a Blood cancer called as Chronic Myeloid Leukemia (CML). The chemical is Imatinib Mesylate.

• Exclusive Marketing Rights (EMR) – An interim measure for patent applicants till India switched to Product patents in 2005

• Generic versions available in India at 1920$ per patient per year and that too for a chronic condition. Gleevec was granted an EMR in 2003 and Gleevec got a court injunction against the generic manufacturers' marketing

• The cost of Gleevec shot up to 30,000$ per patient per year nearly 15 times increase !!


In 2005, Grant of Patent to Gleevec opposed using the Pre- Grant opposition provisions In January 2006, Indian Patent Office rejects the patent application for Gleevec citing Section 3(d) of the Indian Patents Act. Section 3(d) of Indian Patents Act – Rejects Patents for new forms of earlier medications (prevent evergreening) Gleevec was just a salt form of an earlier gel form available Novartis drags Indian Government to court not only questioning the Patent office's ruling but also the validity of section 3(d) of the Act, thereby questioning the sovereignty of a nation to formulate policies in the nation's interest!!! Ex-law minister of India and a former solicitor general of India represent Novartis in the court, the power of the Corporates!!


Eminent people who joined the outcry for Novartis to drop the case Archbishop Desmond Tutu U.S. Congressman Henry Waxman European Parliamentarians Incoming Global Fund Director Michel Kazatchkine Former Swiss president and chair of the WHO

Commission on Intellectual Property Innovation and Public Health (CIPIH) Ruth Dreifuss

Former UN Special Envoy on AIDS in Africa Stephen Lewis

Author John le Carré, of “CONSTANT GARDNER” German Development Minister

Heidemarie Wieczorek-Zeul


Switzerland Government rejects Novartis' request to take India to WTO Dispute Settlement Board

Nearly half a million people around the globe sign the petition demanding Novartis to 'Drop the Case'

Finally a call given out by the Movement in India to boycott Novartis' products

Asking people to tell their Doctor not to prescribe any Novartis Drugs but alternative drugs, petitioning the doctor associations not to prescribe Novartis drugs asking the Chemists to not issue any Novartis Drug

To avoid over-the-counter sales of Novartis drugs member organisations told not to buy 2 major sellers of Novartis drugs Voveran (pain killer) and Calcium Sandoz


Success of this campaign

• On Aug 6th 2007, Chennai High court gives a ruling against Novartis upholding the constitutional validity of 3(d)!

• There was a drop in the sales of Novartis' Products in 2007-2008


• Patenting of Live Forms/ Microorganisms still under discussion in WTO because Genetically

• 'Modified' is still a modification of the original and not a 'new' invention, hence should not be patented

• Danger of traditional knowledge in the public being usurped for private greed

• A Canadian farmer, Percy Schmeisser, dragged to court by Monsanto for violating the patents of BT Cotton

• Basmati Rice patented in the US• Fungicidal properties of Neem plant (traditional

knowledge) patented• 'Thieves in your own farm'

People's Health MovementAgriculture (Live Forms)

• Most of the research on basic molecule (risky) done in publicly funded Universities

• More than 70% of the biotechnology research done with public money (Drahos et. al, 2002)

• The case of Gleevec, scientist Brian Drucker had to beg Novartis to develop the drug from the basic molecule STI571. The funding sources were: – 50% - National Cancer Institute– 30% - Leukemia and Lymphoma Society– 10% - Oregon Health and Science University– 10% - Novartis !!!

• Bio-piracy: Well known cases of Basmati and Neem in addition to Turmeric etc.,

• More recently the case of Avian flu viruses of Indonesia

People's Health MovementPiracy by whom?

• 'The Chill Effect' prevents countries from exercising the Compulsory Licensing (CL) option

• Countries like Thailand which have tried to use CL have had backlash. But at least Thailand has manufacturing capabilities for it to use CL

• If, for e.g. an LDC country issues a CL or a parallel importing clause for a curable drug for HIV, where will it import from in the absence of generic production? It has to wait 20 years!!

People's Health MovementCompulsory Licensing – A Dead End

People's Health MovementSo what are the Alternatives?

Needs based priority and essential health R & D by the governments (WHA Resolution 59.4, 2006) Open Source Models of the Software Industry - The ASAQ initiative of Drugs for Neglected Diseases Initiative (DNDi) where an anti-malarial drug was discovered and released without patenting (http://www.actwithasaq.org) Incentivised Mechanism for true Innovations and not for “me-too” Drugs Encouraging Voluntary Licensing by means of the threat of a stronger Compulsory Licence PPPs ? - The Verdict is mixed

• Glaxo smithkline Beacham forced to withdraw its patent application on an Antiretroviral Combivir as it was an Evergreen drug

• WHO's pro-active role post-2005 in the form of setting up CIPIH and Inter-governmental working group (IGWG) to counter the IPR effects.

• The WHA 59.4 resolution calling for R & D on essential drugs

• Data Exclusivity clause put on hold by the Indian government

• After 10 years of struggle patents on Neem plant, given to WR Grace company of US, was revoked in 2004

• Some of the patents on Basmati Rice has been withdrawn (still 3 strains are patented)

People's Health MovementOn a Positive Note!!

Polio Vaccine A Global Public Good

Salk: "Who owns my polio vaccine?

The people! Could you patent the sun?"


Join in the Struggle!!

People's Health MovementOn a Positive Note!!

Documents

People's Health Movement Some Definitions Process Patents – Patents granted for processes which means multiple patents for the same molecule – competition