DEAR FRIEND OF CPAA

Dear Friend of CPAA,

On the 18th of March, the Indian government announced a new plan towards cancercontrol. This new initiative was to double the number of cancer treatment centres inthe country. While praiseworthy in itself, it actually hides a larger problem whichmust be solved before it can work.

The problem is the availability of affordable drugs. To give you an idea of theproblem, I have listed below some drugs presently prescribed by doctors and theircost:

Herceptin-Rs. 13-15 lakhs
Tercava-Rs. 6 lakhs
Glivec-Rs. 1.25 lakhs/month for the rest of your life
Mabthera-Rs. 10-12 lakhs
Avastin-Rs. 5.25 lakh
Erbitux-Rs. 5 lakh
Lenalid-Rs. 1.5 lakh
Xeloda-Rs. 60,000
Geftinat-Rs. 6 lakh
Sutent- Rs 8.24 lakh

How many patients can afford to pay such sums? Most Indian patients do not haveinsurance and there is no government help either. In such a situation, we have seenpatients sell their jewelry, property, their business to get drugs for their lovedones. In the words of one family head, "I love my brother, but how can I mortgagenot only my family's future but that of our future generations?"

While we are pleased that so many new therapies have been approved, we are concernedabout the high cost of cancer therapies in the current environment. We hear dailyfrom patients who are forced to choose medical alternatives when costs become toohigh. The time has come to take a stand. We appeal to pharmaceutical companies and thegovernment to help ensure that therapies are available to all who need them and arenot out of reach because of price.

To show your solidarity, go to CPAA's website and sign on this letter which will be sent to the Ministry of Health.

Forward this mail to all your concerned friends and ask them to do the same.

India's Ministry of Health- Data exclusitivity not required by TRIPS and will affect

USTR seeks to influence the position of the Indian Ministry of Health

New Delhi, 7 April '08: Representatives of the United States Trade Representative(Ms. Tanuja Garde USTR, Washington D.C.) on behalf of multinational pharmaceuticalcompanies and the US government has already met with the Indian Ministry of Health.This is to try and influence a change in the Health Ministry's position that DataExclusivity is not required under Article 39.3 of the TRIPs Agreement and anamendment to the Indian Drugs and Cosmetic Act canhave a serious impact on the approval and availability of affordable, low costgeneric versions of essential drugs.

Another meeting with USTR is slated to happen this month before representatives ofthe Ministry leave for Geneva. The Indian Ministry of Health is one of the keycountry delegations at the Intergovernmental Working Group on Public Health,Innovation and Intellectual Property (IGWG) established by WHO in 2006 and whichmeets in Geneva at the end of this month to discuss and negotiate an action plan forresearch and development that prioritizes the health needs of developingcountries.

Developing countries feel that the draft action plan being negotiated in Genevashould set out several underlying 'principles' for a global strategy on health andinnovation, among them the notions that the "right to health" trumps commercialinterests, and that intellectual property rights should not become an obstacle toaccess low cost generic medicines. One such specific principle is that DataExclusivity is not required under TRIPS and also from the perspective of publichealth and access to medicines, it is preferable for developing countries not togrant data exclusivity.

India's Ministry of Health does not favour Data ExclusivityAs you may be aware the Indian Ministry of health till date has not been in favourof data exclusivity as it feels that it will interfere with the work of a governmentbody (the drug regulator) that relies on clinical trial data to approve ofaffordable generic essential drugs. It favours the alternative i.e. 'dataprotection' or the non - disclosure of clinical trial data to third parties. Thisaccording to the Ministry of Health will be TRIPS compliant and will allowcompetition to take place and thus avoid giving monopoly rights to the innovatordrug companies on the new drugs (not patented) and thus help keep a check on theirprices.

However this can change if USTR is successful in influencing the Ministry of Healthto implement TRIPS PLUS provisions. In the past, USTR has on behalf of multinational pharmaceutical companiessuccessfully pressurised many developing countries to implement Data Exclusivity,even though it is not required by the TRIPS Agreement and can seriously affectaccess to low cost essential medicines by delaying generic competition even in caseswhere the medicines are not patent protected.

WHO Report does not recommend Data Exclusivity

This position of the Ministry of Health is supported by the report of the WorldHealth Organization's Commission on Intellectual Property Rights, Innovation andPublic Health, which, states this veryclearly:

Article 39.3, unlike the case of patents, does not require the provision of specificforms of rights. [.] It does not create property rights, nor a right to preventothers from relying on the data for the marketing approval of the same product by athird party, or from using the data except when unfair (dishonest) commercialpractices are involved.

Data Exclusivity will further limit India's role in supplying essential drugs todeveloping countries

In the last decade generic production in India has emerged as crucial for the supplyof quality affordable medicines to the developing world, especially for newer drugssuch as antiretrovirals (ARVs) for the treatment of HIV. Already in 2005, the Indian Parliament under obligation to implement WTO's Agreementon Trade Related Aspects of Intellectual Property Rights (TRIPS) amended its PatentsAct to allow for the granting of pharmaceutical product patents - something Indiahad not done since 1970. Patents being granted by the Indian Patent Office foressential/life saving drugs, include newer antiretrovirals (such as Etravirine)which could prove to be crucial in the treatment of AIDS. This is already causingconcern about the future of millions of people living with HIV/AIDS dependent fortreatment on affordable generic drugs from India.

In addition to patents, data exclusivity will effectively prevent marketing approvalof essential drugs for several years even if patents applications on these arerejected, for example when a pharmaceutical does not meet the standards forpatentability (e.g. because it is not new).

Data Exclusivity i.e. a certain length of time during which the Regulatory Authorityis prohibited from relying on the available clinical trial data in order to registera generic version of the same product.

As Indian generic manufacturers are directly involved in making available affordabledrugs in India and other developing countries, patients and treatment advocacygroups are considerably concerned that a delay in registration i.e. marketingapproval of generic drugs can seriously impact the lives of people living withHIV/AIDS who face the threat of drug resistance every four years and are thereforedependent on generic manufacture in India to access newer drugs and treatment ataffordable prices.

They also remain highly susceptible to other infections; for instance HIV and TBco-infection is of increasing concern for persons living with HIV/AIDS. Access toaffordable essential drugs for opportunistic infections is also critical in ensuringlong, healthy and productive lives for persons living with HIV/AIDS.

Experience shows Data Exclusivity in other countries has effectively created amarket barrier that is difficult for generic manufacturers to overcome.

Public Interest Groups oppose Data Exclusivity

In the last few years, several public interest groups including the Indian Networkfor Persons living with HIV/AIDS (INP+), the Medico Friends Circle, the Jan SwasthyaAbhiyan (Peoples Health Movement), the Global AIDS Alliance, Torchbearers (mentalillness advocacy group), MSF's Campaign for Access to Essential Medicines, theBangalore HIV & AIDS Forum and the Lawyers Collective HIV/AIDS Unit have alsowritten to the Prime Minister and the health ministry outlining their opposition toData Exclusivity for drugs as it can have a serious impact on the approval andavailability of generic versions of essential drugs in the future.

Please write to the Ministry of Health:

Once again write to the Ministry of Health to take into consideration public healthneeds of patients in India and other developing countries and actively provideleadership in ensuring that intellectual property does not hinder access to drugs.

Please urge the government to not consider Data Exclusivity proposed by USTR andensure that generic competition remains viable and possible in India. So manypatients are depending on it for access to affordable medicines worldwide.

Write to:

Naresh Dayal
Secretary Dept. of Health and Family Welfare Ministry of Health and Family Welfare Government of India
Nirman Bhawan, New Delhi - 110 011
Tel: +91 11 23061863, +91 11 23063221
Fax: +91 11 23061252
Email: http://anywheremail.qlc.co.in/src/compose.php?send_to=secyhlth%40nb.nic.in

Aradhana Johri Joint Secretary
Dept. of Health and Family Welfare Ministry of Health and Family Welfare
146-A, Nirman Bhawan New Delhi - 110 011
Tel: +91 11 23061195,
Téléfax: +91 11 23061842
Email: http://anywheremail.qlc.co.in/src/compose.php?send_to=aradhana.johri%40nic.in

Debasish Panda,
Joint Secretary
Ministry of Health and Family Welfare
Nirman Bhavan, New Delhi - 110 001
Téléfax: 91-11-23061447
Email: jsrch@nb.nic.in

For more information contact:
Leena Menghaney
Campaign for Access to Essential Medicines (MSF)
New Delhi, India
Tel: + 91 9811365412
Email: leena.menghaney@gmail.com

Gopa Kumar
Centre for Trade and Development
Email: gopa.kumar@centad.org

The report is available at http://www.who.int/intellectualproperty/documents/thereport/en/index.html

SERIOUS CRISIS DUE TO UNAFFORDABLE ANTI-CANCER DRUGS

SERIOUS CRISIS DUE TO UNAFFORDABLE ANTI-CANCER DRUGS

I want to bring to your notice a serious situation that has arisen of late due tounaffordability of life saving anti cancer drugs. Every day we see hundreds ofcancer patients being denied life saving anti-cancer drugs as they are beyond themeans of even the so called rich in India. Also we in CPAA are also not able to givethese drugs free to our patients as their cost goes way above our budget. Hence weare seeing everyday hundreds of cancer patients dying even when their cancer iscurable because they cannot afford life saving anti-cancer drugs.

Around 1,00,000 women with a type of breast cancer for example need to be prescribedthe life saving drug Herceptin (Roche) which costs Rs.7 - Rs23 lacs for fulltreatment depending on the stage of the disease and other factors. Same is the typeof money one needs for drug therapy alone for cancers of mouth, throat, ovaries,rectum, stomach, leukemia's etc.

Obviously it means that 98 out of every 100 Indians are destined to die if cancerstrikes them as the cost of treatment is out of their means, there is no governmentsupport as not even 2% of India's population is covered by any health insurance andNGO's like ours are unable to foot the bills of such expensive drugs. As we cannot be silent spectator to these huge number of deaths of cancer patientsdue to unaffordability of life saving anticancer drugs which we think is a nationalemergency which as time goes by and more anticancer drugs get patented will onlybecome worse.

I strongly feel that it is time for us to act. Whether we should seek fromgovernment of India (a) price control on all anti-cancer drugs which areunaffordable (b) grant of Compulsory License under the clause of national emergencyfor all unaffordable anti-cancer patented drugs along with price control onexpensive drugs not patented but yet very expensive. Or may be we need to knock atthe door of courts for justice. I am not sure which route we should take but I amconvinced that it is time to act.

Perhaps creating awareness through use of massmedia about this national emergercy could result in putting pressure on governmentparticularly at the time when elections are very close & could work in our favour.

Please do let me have your views on what we need to do on an urgent basis to stopthis crises situation faced by cancer patients in our country.

Yours Sincerely

Mr. Y. K. Sapru
Founder Chairman & C.E.O.
Cancer Patients Aid Association
Mumbai,India
www.cpaaindia.org

India Cancer Patients Seek To Use Courts For Access To Patented Drugs

Posted by William New @ 1:37 pm

By Tatum Anderson for Intellectual Property Watch

One of the most vocal voices for the interests of cancer patients in Indiasays it will use the courts to force the Indian government to declare cancera national emergency, in an attempt to make cancer drugs affordable tosufferers.The Cancer Patients Aid Association (CPAA) wants the Indian government toissue permits, called compulsory licences, for a number of drugs it hasdeemed unaffordable. Such permits would allow generic pharmaceuticalcompanies to manufacture the drugs instead of the patent holders.

It believes that the prices would then drop considerably.Under Indian patent law, no one can apply for a compulsory licence for thefirst three years after a patent has been granted, unless the governmentdeclares one of four emergency criteria: a national emergency, extremeurgency, a case for public non-commercial use or a patentee has employedanti-competitive practices. (After three years anyone can apply for alicence under much broader set of criteria.)

The idea, said Y K Sapru, CEO and founder of the 38-year-old organisation,is to establish the exact meaning of a national emergency. "The act says acompulsory licence can be given when there is a national emergency, then theissue of what that national emergency is can be debated."

The CPAA thinks cancer is a national emergency because cancer drugs are soexpensive that Indian cancer sufferers die because they cannot afford them.Some drugs can cost several thousand or even hundreds of thousands of rupeesper month, while many sufferers live on less than 40 rupees (about $1) perday, it said."Our contention is that the manufacturers are pricing the products at aninternational price," said Sapru. "And as 98 percent of India's populationis not covered by any form of health insurance, many who suffer from thecancer will die because they won't have access to the life-saving drugs."

The association has compiled a list of 20 medicines it feels are vital butprohibitively expensive for most cancer patients . Theyinclude drugs made by international companies like Pfizer and Novartis.Interestingly, the list also includes drugs made by some domestic genericscompanies.First, CPAA plans to send a letter shortly to the country's Ministry forHealth and Family Welfare requesting that it declare such an emergency.Later it will turn to the courts if no action is taken.

The CPAA's actions are taken seriously in India. It has filed formaloppositions against countless patent applications at the Indian patentoffice, negotiated cheaper prices for some drugs and was a key member of theopposition in a court case brought by Swiss manufacturer Novartis last year( <http://www.ip-watch.org/weblog/wp-trackback.php?p=712> IPW, PublicHealth, 7 August 2008).

The strategy is a considerable departure from CPAA's traditional role offighting individual patents - like the one filed by Novartis - on the basisof frivolous patenting.That method is used throughout the industry. India's generic manufacturerCipla is currently arguing that it should be able to manufacture copies ofSwiss manufacturer Roche's Tarceva on this basis. Cipla last week won theright to continue manufacturing the drug until the case is settled. Calling for price controls and compulsory licences is essentially afast-track way of trying to reduce prices of several drug prices en masse,rather than the lengthy process of opposing patent applications one at atime.

The plan is to take this particular compulsory licence initiative as far asit will go, to the Supreme Court if necessary, said Sapru. "If they [thehealth ministry] don't think that it is a national emergency then we willtalk about the constitutional rights of a human being above any other rightthat the constitution will give because he owns the patent," he said.

Tahir Amin, a lawyer from I-MAK specialising in Indian public health, saidhe believes that CPAA could mount a challenge under the constitution,specifically under Article 21 - the right to life.The criteria under which compulsory licences can be issued are being hotlydebated. World Trade Organization rules on intellectual property rights havebuilt-in flexibilities in public health situations.

Nevertheless, Thailand's decision to grant compulsory licences for cancer drugs on the basis ofpublic non-commercial use within the country's public sector health systemhas drawn huge criticism from those who believe compulsory licences shouldonly be used as a last resort.At home, India may be heading for more controversy as its patent officeconsiders whether to grant a compulsory licence to Indian generic companyNatco that would allow it to export a copy of Roche's cancer drug Tarceva,to Nepal.

Opponents say although compulsory licences were designed for use in nationalemergencies, cancer should not be classed as one.Guy Willis, a spokesman for the International Federation of PharmaceuticalManufacturers and Associations (IFPMA) which represents originatorcompanies, told Intellectual Property Watch that cancer patients do not haveaccess to adequate drugs because the Indian government has not investedenough in its public healthcare infrastructure. This is not a problem that emergency compulsory licences can fix, he said."

It is the systematic failure of the Indian government to give enoughresources and I don't think you can classify a systemic failure as anemergency," he said. "It implies something that is very deep-seated and isnot going to be addressed by emergency measures."In addition, Willis adds that enabling generic manufacturing does notnecessarily lead to more affordable prices. "The generic versions of cancerdrugs are cheaper perhaps than the originator versions but the cost of ayear's treatment is still several multiples of the average Indian salary.They don't improve access," he said.

CPAA's list of unaffordable drugs contains medicines made by genericcompanies including, ironically, Natco, which has applied for a compulsorylicence under another provision within the Indian law.CPAA's Sapru said the association also will be trying to convince the Indiangovernment to apply existing pricing control regulations to drugmakersproducing cancer drugs (such controls have already been imposed on Cipla foranother drug). "We are not even making a distinction between themultinationals and the generics because there are some generic drugs whichare also expensive," he said.

Tatum Anderson may be reached at info@ip-watch.ch.The Cancer Patients Aid Association's List of 20 Vital but ProhibitivelyExpensive Cancer Medications

SIGN OUR PETITION FOR CHEAPER DRUGS

Compulsory licensing can make patented cancer drugs more affordable

Compulsory licenses (CLs) overcome the barriers posed by patents in accessing life-saving medicines, as they enable the procurement of more affordable generic drugs. Although these are entirely legal measures, backed up by international trade law, Thailand has come under intense political pressure to withdraw the compulsory licenses on cancer drugs.But if Thailand does turn its back on its cancer patients, they are not the only ones who stand to suffer. This could well set a very bad precedent. If Thailand backs down, other countries like India will think twice before issuing compulsory licenses. Compulsory licences are the only way to ensure affordable sources of medicines exist in the future. Be a part of this campaign by signing our petition. Click here.

Public health activists should take note, and should come out in force to support of cancer patients in Thailand. See CPAA statement

For More information on compulsory licensing see briefing document.

World Health Organisation-led mission has this month confirmed the legitimacy of compulsory licensing. The policy “is one of several cost-containment mechanisms that may be used for patented essential medicines not affordable to the people or to public health insurance schemes,” said the team, which also included representatives of the World Trade Organisation, the United Nations Development Programme and legal experts. See Report of the WHO Mission - Improving Access to Medicines in Thailand.

This document has great relevance to India where we are beginning to face a similar problem of unaffordable patented drugs for life-saving diseases particularly cancer.

Compulsory licensing can make patented cancer drugs more affordable

Dear Reader,

As more and more new life saving drugs (in the treatment of cancer) are gettingpatented in India, the prices of life-saving drugs for cancer are getting out ofreach for 95% of India's population. In the write-up available through the web linkgiven below, we have spelt out CPAA's position on this most critical issue and alsowhat needs to be done to correct it. I strongly urge you to read this write-up whichI assure you will be an eye opener to you.Click here http://www.cpaaindia.org/infocentre/CL.htm

Regards,

Mr. Y.K. SapruCEO & Chairman

Cancer Patients Aid Association

Mumbai,India

www.cpaaindia.org

WELCOME

Dear Friends,

Our website has been operational since 1998. You have been writing into us since then. We want to know more. This feature is being introduced to provide a board for you to express your feelings, your problems, your successes and failures. Please feel free to share your experiences with cancer here.

Shubha Maudgal