Patent Controversy - by Mr. Y.K. Sapru

Patent controversy (May 4th, 2008)

This refers to the article ‘In Defence of Patents’ (Apr 28), which I feel was full of inaccurate statements, exaggerations and facts which have totally no relevance to the conditions as they exist in a developing country like India.

Firstly, the claim that all discoveries of new drugs require phenomenal investments, and through patenting of drugs alone can the investment be recovered, is a gross exaggeration. The initial developmental work on new drugs is mostly done in research labs attached to universities which are funded by government agencies. Take the case of Glivec which was marketed by Novartis at Rs 1,25,000 for one month’s treatment. It was identified by Dr Brian Drucker at the laboratory of Oregon Health & Science University. Half the funding for this was done by the National Cancer Institute of USA government, 30% by Leukemia & Lymphoma Society (US-based NGO), and 10% by Oregon Health & Science Institute. Novartis has contributed only 10% to the total funding.

Similar is the situation for the vast majority of new compounds marketed by pharmaceutical MNCs. The major expenses that pharma companies pick up are for the clinical trials. These expenses, however much they may be, are way below what the companies recover in the very first year of launch. In case of Glivec, in the first year of introduction, the turnover for the product was around USD 2.5 billion. Similarly, Herceptin, another patented product marketed by Roche, which is a life-saving drug for around 1,00,000 women with a certain type of breast cancer, costs Rs 7-23 lakh for full treatment, depending on the stage of the disease. This product also grossed around USD 2.6 billion in the very first year of its introduction.

Similar is the case for other patented products where the amount recovered after patent due to exorbitant prices is way above the investment. Hence, while patenting of new products may be legitimate, the pricing of the patented drugs needs to be controlled so that there is sufficient incentive for MNCs to invest in research, and yet the patented products are priced at affordable rates.

That prices of patented drugs are high because of high excise duty and other tariffs which amount to 55% in India is also not correct. If a product like Glivec costs Rs 1.25 lakh for one month’s treatment, this figure is arrived at after adding to the net imported cost the company's mark-up, the discounts to distributors and retailers. The 55% tariff is not imposed on Rs 1.25 lakhs but on the basic landed cost, which in most cases, is less than half of the retail price. So to put the blame on high government tariffs for the high prices of patented products is absolutely wrong.

The basic mistake that MNCs are making in developing countries like India while marketing a patented product is to price it at the international cost, which when converted into local currency, amounts to lakhs of rupees. For a country like India which has virtually no health insurance, no government health schemes to cover treatment costs, and where over 75% of the population lives on a mere Rs 40 per day, to have patented drugs priced at lakhs of rupees for the complete treatment is cruel.

Intellectual property rights and patent protection for newly developed drugs is legitimate, but if it is not accompanied by reasonable pricing, thousands of Indians will die as they will not be able to afford life-saving drugs. And in such a situation the government will be forced eventually by NGOs, activists and public opinion to use the National Emergency clause under the New Patent Act 2005 and issue compulsory licenses to generic companies to market the same products at nominal rates or impose price control under the DPCO Act on patented products.

—Y K Sapru
CEO, Cancer Patients Aid Association
Mumbai

In Defence of Patents - Tim Wilson, Times of India, 28th April, 2008

Intellectual Property (IP) has always been a niche public policy areaunderstood best by policy wonks and lawyers. Unless there is a majorcontroversy, IP tends to escape public consciousness. But that is changing.Over the past few years cam­paigns to undermine IP have increased and arenow reaching a fever pitch.

IP is essential because it provides the property rights needed for researchand development to attract investment with the prospect of a long-termdividend. Under­mining IP is equivalent to the traditional socialist ethos-divvy the spoils of today's research and development, rather than focusingon expanding it. And a lot is at stake-­according to the most recent figuresfrom the United Nations, the Indian patent registry receives more than90,000 applica­tions for patentable inven­tions each year. In spite of thissignificant contri­bution, there has been a global campaign to undermine IPrights by a group of anti-market activists, self-interested politicians,vested interests, and more recently, the infiltrated World HealthOrganisation (WHO).

Innovative medicines have been one of the big targets. These activists haveargued that IP rights increase the cost of medicines for the world's poor.Yet they ignore that one of the biggest contributors to increasing costs isactually government imposed taxes and tariffs that raise the price oflife-saving medicines. For instance, in India the combined taxes and tariffson imported medicines are 55 per cent; in China, they are 28 per cent.

But this reality has not stopped governments acting to undermine IP. Inearly 2007, the then Thai military government waived the patents of threepatented medicines through a process called "compulsory licensing".Compulsory licensing is an instrument recognised under the World TradeOrganisation's Trade­ Related Aspects of Intellectual Property Rights(TRIPS) Agreement, and grants governments the ability to licence theproduction of patented products "in the case of a national emergency orother circumstances of extreme urgency or in cases of public non-commercialuse".

Now the WHO has waded into the debate. Last year, a WHO-designated teamassessed the Junta's actions and later issued a brief report legitimisingthe government's actions, which was followed by a how-to guide for countriesto waive their international obligations and issue compulsory licences.

This report is feeding into a WHO-initiated Intergovernmental Working Group(IGWG) on Public Health, Innovation and IP formed in 2006. From itsinception the IGWG has been an attempt for health bureaucrats and theactivists that advise them to rewrite - and undermine - global IP rules. The activists are now using their campaign against IP on medicines as aprecedent to continue their assault on IP; and global warming has become thenew battleground.

In a joint statement at the 2007 G8 summit, the governments of Brazil,China, India, Mexico and South Africa called for an agreement to assist incompulsory licensing the IP related to carbon dioxide emission-mitigatingtechnology being developed wealthy countries.

In subsequent media reports the officials argued an agreement is needed"paralleling the successful agreement on compulsory licensing ofpharmaceuticals". Similar themes appeared in a resolution passed by theEuropean Parliament in November last year recommending a study to assessamending TRIPS "to allow for the compulsory licensing of environmentallynecessary technologies".

And the tragedy is that those who are likely to suffer most are the world'spoor. Technology transfer is also vital for developing countries to growtheir economies and improve their standards of health and the environment. A 2006 World Bank study and a 1998 International Energy Agency /UNEP studyhave identified that strengthening IP rights assists in technology transfer.

The World Intellectual Property Organisation has designated 2008 as the yearfor "celebrating innovation and promoting respect for IP". With the IGWGconvening in Geneva in a few days' time and the assault on IP onclimate-friendly technologies, World IP Day - which was on Saturday -increasingly seems to be an occasion to reflect on IP's demise.

(The writer is director of the IP and Free Trade Unit at the Institute ofPublic Affairs in Melbourne.)

Current list of people who have joined our petition for Cheaper Drugs

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Swati D (Gurgaon,India) - Providing affordable healthcare and caring for the needy is the duty of every society. Lets aim to be an inspiration here and show the west what it really means to be developed.

Shashi Bansal (New Delhi, India) need to have cheaper medicines

Chethan.p (Bangalore, India) - Firstly thank u very much for yourr reply, but mam the patient whome i am referring is imatinib resistant patient she has to go for dasatinib to which no generics are currently available.... i jus researched upon the number of patients who become resistant after imatinib with a doctor who is my good frient he sujjests almost 1/3rd becomes resistant to imatinib. i feel so sorry for those who become so common and cant afford the next therapy which is so costly. i am not getting what will all those people do . well, thanks again for ur advice.

Raima Sen (Mumbai, India) - would like to help

Hema S Iyer (Mumbai, India) - My father has been diagnosed with lung adenocarcinoma and has been advised chemo every 3 weeks followed by blood tests and injections to increase wbc and haemoglobin.every month the costs cross 60000/ plus the anxiety and stress. atleast if the cost of drugs were reduced the trauma of cancer patients will be reduced. the patients go through bouts of depression thinking about the way finances are drained out because of them.the manufacturers and government must realise this and help the patients.

Mannan (Thane, India) - All cancer drugs including biosimilars should be available at cheaper price. I am a part of Biotech industry and know the exorbitant profit margins the manuafcturers keep. All Indians should come together for this cause and help poor cancer patients.

Neeraj Sani(Ghaziabad, India) - My name is Neeraj Saini. I am a law student but have no job right now. I belong to a lower class family. My wife has been detected with Blood Cancer. She is admitted in Sir Ganga Ram Hospital, New Delhi, India. Her doctor has advised us to arrange 10 to 15 lakhs for her treatment. I am unable to arrange that amount. Kindly help me any ways you or your organization can. I will be very much greatful to you for whole of my life

Jagadish Darimadugu(Hyderabad, India) - These costly Cancer treatment drugs not only affect the people but also the purses of the near and dear ones. In our country where you dont have insurances to be covered we need help from the Govt to regularize the prices so that these MNC's do not squeeze the common people. Govt' should come down and

Bhushan Chitaley (Jabalpur, India) - In countries like India, where cancer medication is out of the reach of most of the population, compulsory licensing can save a lot of lives

Asif Khan (Mumbra, Thane) - My Father has got cancer and I can't afford the expensive medicines. So, it is my humble request to all pharmaceutical companies to please reduce the charges for life-saving drugs.

Mrs Chitra (Gurgaon, India) Medicines should be avialable at subsidised prices.

Dr. P.S.K.Chaitanya(Navi Mumbai, India) I strongly support this campaign for lowering the prices of medicines for diseases like cancer.

Vivekanandan.N.S (Coimbatore, India)

Pankaj(Ballia, India) to stop t crrouption in this regard it very much required.plz keep it up.we all r with u.................thanks for your noble idea

Kumudini Rajaram (Bangalore,India)

V. Ramkumar(Chennai, India)

Sanjay Pagaria (Mumbai, India) The pharma companies can charrge as much as they want on beauty, anti-ageing and other life style drugs. Please spare life saving drugs because when a disease strikes, it does not see whether the victim is poor or rich.

Grishma Shah (Mumbai, India) I sign this petition. Life saving drugs should be made available to all.

Arpita (Mulund. Mumbai, India) pls make drigs affordable

Santosh Kadne (Mumbai, India) we are with you

Ramasamy Ganesan (Chennai, India) My wife Kohila Ganesan is affected by CLL. Dr advises to administer RITUXAN. But the cost of this medicine as quoted by the hospital is Rs. 80000/=, But if we buy from outside, I understand is available for only Rs. 40000/=. Since we take the treatment through mediclaim insurance, we are forced to burn the money, due to double the cost of the medicine the hospital charges.

Ravidutt Sharma (Bangalore, India) cancer drug price must be affordable to common man. there are people who simply drop the idea of living just due to the heavy price to be paid for drugs.

Saumyendra Mehra (Dubai) I would like to actively participate in this campaign that may help countless patients who suffer from this life threatening decease.

Baskar V (Pondicherry, INDIA) It is sad to see people dieing just because they are not able to afford for the treatment. Where are the regulators and governing bodies? Come do some thing before some more people die.

Rohit Kar (Gurgaon, India) Thanks very much for the moral support you have given me at this juncture where words give moral boosting and a healing touch. In fact I have been seeking help from govt agencies regarding the ailment (already communicated to CPAA) and in fact I have addressed my unforunate grievance to myvoicemytimes and times and times.trends of times group to know how does govt catagorises the people with this nasty disease as entilement of the facility to people who are BELOW POVERTY LINE (BPL) . Let me quote my example and your vauled hands should justify whether I need help from the govt agency or not. I have an earnings of Rs 400000/= per month. the cost of the medicine per day per tablet comes to Rs 12000/=and has to consume for 90 days without break this amount comes to approx 12 lacs.plus over head expenses like tests including ct scan every fortnightly,medecines as support to evercome side effects, to take care of old aged retired parents (from private co's),domestic overheads like house rent ,necessities of life with all expenses,vonveyance expenses, doctors fee etc.Keeping the said facts in view please you only can judge under what catogory I should come and have the financial benefits (in kind or cash) and other facility from the govt to over come the nasty disease.Till date I have exhausted all resources from all fronts on elimination of one kidney and expenses on the existing ailment, where should I go.What is the definition of BPL AND WHICH CATAGORY YOU/GOVT SHOULD CONSIDER IN MY CASE. I donot know how and in what form your valued hands can assisst me to over come this burning problem

Nitin Kochar (Noida, India) Cancer drugs should be made more affordable. The fight against this disease that kills millions of people worldwide should not be made emotionally & financially eroding to the person suffering from it & the family which goes through this torturous ordeal.

Victor (Dubai, U.A.E) Value human life! Treatment must be made affordable

Azhar Khan (Bangalore, India) My mother is suffering from gliblastoma Grade IV so i know the pain

Akshat (Lucknow, India) Cancer should be made cheaper

Manish Nair (Alappuzha, India)Drugs should be available to all at cheaper rates

A.S.Ali (Mumbai, India) like your posters in BEST buses

Madhu Talwalkar (Pune, India) Drugs for cancer treatment should be given free. I have seen people dying without proper supply of drug. The Central and State governments should help the poor people.

Dr. Kshiteesh Kirtikar (Mumbai, India) This is the least we can do

Seshan Subramaniam (Sydney, Ausatrlia) I support this petition to make the medicines affordable

Mrs. Tina Gonsalves (Mumbai, India) Its High time the Government wakes up and takes a firm stand....everybody has a right to get the best possible treatment at an affordable Cost.

Pooja Gyani (New Delhi, India) Cancer drugs should be available at affordable price to patients

P Karunakaran (Nerul,India) I endorse my full agreement and support to the cause of affordable medicines for critical illnesses.

Subhashis Sarkar (Manipal, India) i myself am aperson involved in R&D of anticancer drugs . Its really sad, i feel the pinch, and i have decided i will give my everything to support the compulsory licensing bill.. we cant take this for long!

Pushkar Mitra (Kolkata, India) In August, 2008 my mom was diagnosed with ca stomach (Adenocarcinoma grade III) and on 23rd November, 2008 i lost her forever.

Ravindra Gaikwad (Pune, India) I totally Agree costs of medicines should be minimum possible. My father in law suffering with blood cancer and we are also suffering financially a lot.

Pushpa Menon (Noida, India) Since the medicines are so costly ,even the middle class people find it difficult to purchase if they are not covered under CGHS. So the medicines should be cheaper so that many people can avail the facility and live a longer life.

Amna Javaid (London, UK) Extremely Worthy Cause

Sarang Joshi (Aurangabad, India) I strongly support to this campaign.

Nitin Shahdara (Delhi, India) Cancer medicines should be cheaper and within range of patient

Abhishek Tiwari (Allahabad, India) As I see my 12 year old student Medha going down against the battle of Cancer, the frustration rises.

Shailesh Waghmare (Pune, India) what does the petition say ?

Suja Nair (Ernakulam, Kerala, India) Having just finished my treatment, I know how expensive cancer drugs can be. I am with CPAA in this campaign all through the way. Every cancer patient should have the right to the best treatment available and cost should not be a hurdle.

Akhil Rai (Mumbai, India) There is a need to ensure availabliity of affordable cancer drugs to all who require it

Gaurav Pratap Solanki (Etah, India) Cancer drugs should be cheap so that ordinary people can buy them

Sameer (Faridabad, India) all hands for cancer patients

Arun Tomar (Dehradun, India) Medical research should be a mission not a business

S P Sarma (Kollam, India) I do agree that cost of medicines for the treatment for cancer should be made cheaper so that even a common man suffering from the disease will have a ray of hope for survival.

Daman Saluja (Delhi, India) Cancer drugs are expensive and out of reach of many in India and other developing countries. We really need to lower the price so as to make it affordable to save life.

Heraclio Archuleta (Luling, LA) I am appauled and sad at the unbelievable high price for the drug Gleevec or Glevic.I pay $470.00 dollars a month for our health insurance. My co-pay for gleevec is $1,364.00 dollars. Gleevec costs $7,000.00 dollars for a month supply. My wife and I live on between 35 & 40,000.00 dollars a year,depending if my wife works overtime or not. I am retired. The average household income in the state of Louisiana is around $35,000.00 a year.I did have help from our Veterans Administration,I served 2 years in the Army,however, now,after receiving a letter from the V.A.stating that our combined income is too much in order to receive my Gleevec from V.A.Help me,PLEASE,I need this medication in order to survive.I have Chronic Mylogenous Leukemia,since Jan.2008.I am 66 years of age.Why does Gleevec have to be so expensive? I have health insurance,but still can't afford it. In order for me to receive gleevec from the V. A.,they told me I have to make $10,000.00 a year less. That means my wife will have to quit her job and my bills will not be paid.At$1,364.00 a month,even couples making a sizable income would find this price difficult or next to impossible to pay. If there is some way you can help me and my wife,please let me know. I am desperate.

Dr. Hiran Vedan (Singapore)

Ms. Pratima Prasad (Bangalore) - Hope Thailand won't set a wrong example.

Mansoor Khan (Bangalore) - Please keep me informed about more such issues.

Sapna Upadhyaya (Lucknow) - in few words ,many of the children suffering from cancer,due to expensive medicine their parents does not afford,finally they quit from hospitals.find some solution because i never see in die situation.

Kumarendra Mallick (Hyderabad) - Patients should not be considered as customers in the Malls of so-called modern society.

Guruprasad (Bankura)

P.Srinivas (Pune) - Everything to fight cancer

Srikrishna S (Chennai) - I am with CPAA for this!

Pavan Chinthapanti (Secunderabad) - I hope and pray that every person has access to good medical facilities.

Sajitha (Bangalore)

Medha Mishra (Bangalore) - I whole heartedly support this campaign

Manoj Rawal (Rohtak) - we are with you

Sangeetha Mohan (Chennai) - Please keep me updated

Asha Rai (Bangalore) - "This an important step by CPAA. This information should be reached each and every corner of the country through any number of media...A letter with recommendations for the grant of compulsory license to be sent to a new Thai government which is right now on the hold towards granting compulsory licenses for cancer drugs in Thailand. This would be useful in influencing the Thai government towards taking right decision to save cancer patient's lives... "

Padmini Swamy (Mumbai) - please control cance drug prices by allowing generics

Vibha Rathi (USA) - Cancer drugs should be affordable for common man especially since many people in India do not have health insurance.

Tanmoyy Sarkar (Mumbai) - I support your campaign

Vimal Kamath (Mumbai) - All the best

Loon Gangte (New Delhi) - DNP+ will always support and fight for access to generic medicine.

Shibu Prabhakar (Bangalore) - I support compulsory licensing of life saving drugs

Harshda Dubey (Mumbai) - Life saving durgs for critical diseases like cancer must be made available to all at affordable prices.

Elizabeth Vallikad (Bangalore) - There is no alternative as unlike the people of India the majority of the people of Bharat earn less than one US$ per day and cannot afford health care expensives

P.vengadasubramanian (Chennai) - I support this campaign Dr.K.Bhandari - more affordable drugs can benefit poor people.

Lt Col U P Chattoraj (retd) (Pune) - I wish to render my services in detecting Oral Cancer

Paresh (Mumbai) - Cancer drugs should be as cheap as possible.Angika (Bangalore) - I am all in favor of making cancer drugs cheaper.

Hansa Dethekar (Mumbai) - affordable cancer drug will make cancer treatment less painful

Rajendra Vidwans (Pune) - CL is good but the dicovering companies also must be given their due price as one successful product launch costs 500 million dollars today after several unsuccessful attempts down the drain. Who will pay for those. So we must be fair to both , comapnies and patients.

Rammoha S.K.(Secunderabad) -
"Dear Sir/ Madam,
with ref to compulsory licencing- Our govt should go for compulsory licencing of life saving drugs- particularly cancer / Aids treatment drugs. As it is in our country their is no social security- at least Govt- should do their best to save patients and their families by stingent licencing policy with out bowing down to multinationals or pharma co's. I appreciate CPAA for their campaign in this matter.Great work my friends!!! to save lot of lifes.
regardsrammohan"

Dr. Nneka Nwobbi (Lagos) - "This so so welcomed. The idea of our organistion was born out of such need. A young friend of mine died because his parents could not afford 25,000 naira monthly for his treatment. Well done! "

Sanjay Kotak (Rajkot)

Sobhalatah Chappidi (Bangalore) - I support this.

Dr. Manash K. Paul (Chandigarh) - What I understand is that patented cancer drugs should be made more affordable as many Indian sons cannot buy the drugs to save their parents. I have undergone through a same situation and hence I support the campaign to the most.

Dr. Bharti Bisht (Mohali) - This move can make the drugs affordable and many more lives will be saved. Keep it up CPAA.

Roopak Vaidya (Mumbai) - Absolute necessity

Akshat Kumar (Mumbai) - I fully support this petition for making cancer drugs as cheap as possible.

Satheesh Raman (Chennai) - Please do make it more affordable.

Priya (Mumbai) - Cancer even if detected the treatment is not affordable to middle class & lower class people.ARe we workign towards a cancer free world ? or a cancer world.Cancer drugs needs to be made affordable n should not levy taxes..

Nagu Parasu (Richmond) - Any effort to make cancer medicines and treatment affordable to people should be supported. Also support cancer research.

Veena P (Mumbai) - Many patients do not receive timely treatment due to expensive drugs. I hope one day cancer drugs would be available for the least amount so it will benefit all.

Medha Mishra (Varanasi) - A humble request to all of you to join this campaign.…

Dr. B. B. Singh (Mumbai) - I support your Petition.

Jenith Silveira (Calangute) - Suffering from Uterus Cancer

Alok Jha (Mumbai) - Please keep me informed for any such issue or any help needed.

Mark Doray (Bangalore) - I support your campaign.

Anand Damani (Mumbai) - The prices need to become affordable. We need to do whatever it takes.

Ananya Bhattacharya (Kolkata) - Signed

Kunal Khandait (Nagpur)-Drugs are life saving.One must see it as not money making objects.I strongly support you. Poor people cannot afford costly medicine, and they are costly because of these kind of things..

Juhi Kachhap (Pune)-Cancer drugs should be made affordable.

Amber-I feel that the drugs that we give our cancer patients should be a little more less costly. Not everybody in this world has money, but the people who are battling cancer or know someone who is battling this awful disease, all want it to be less costly for their sake and for the patients sake. You only live once, so why not make the best of it and help other people who are in need. ?

Sudha Kapur (Paschim Vihar)-Would like to join in any other way.

Shiv Mohan (Kannauj)-I am in support of making drugs affordable for patients.Government should take care of this thing and make the laws for making drugs affordable for fighting from death.

Manish Sood (Manama,Bahrain)-Let's work together to ensure that easy and affordable treatement /medication is available for patients.

Amit S Kolkur (Kalyan)-Compulsory licensing must be done.

Omkar Prayag (Pune)

Prasanta Barman (Guwahati)-Yes cheaper medicine will make cancer affordable

Vamsi (Bangalore)-These life saving drugs should be at affordable rates

Vijaybabu (Bangalore)-Cancer drugs should be affordable.

Kamala Puparel (Mumbai)-This can make life a little more easy for the patient and the family.

Monica Sampson (Chennai)

Manisha Deshmukh (Pune)- I am interested in working for such type of organization.I am a doctor by profession.

Yogesh Prabhudesai (Mumbai)-I fully support the cause.

Bhavin Parekh (Mumbai)-This is a great campaign which shall benefit endless people.All the best.

Sushil Sancheti (Mumbai)-Tamedol (Fullford) 100 Mg costs Rs.35k for 5 tablets, is there any other equivalent tablet giving same results.

Asif Shaikh (Mumbai)-Chemotherapy should be made more affordable.

Tim Melon (New Orleans)

Shagufta Tabassum (Parbhani)-I support the CPAA. Me myself being a CML patient cant afford the expensive CML treatment.

Mahesh (Hyderabad)-With cancer treatements costing in lakhs,we have millions who cannot afford the treatment. Any effort to make the cost of drugs lesser will help.

Marrie Miller (San Antonio)-Such a shame that person already facing life or death should now have to worry about the medicine or light bill.Please work at making more affordable not only for my mother-in-law,but for everyone.

Rashmi Hangalur (Sheffield,United Kingdom)-I would support the issue of compulsory licensing for the cancer drugs.

Sudhindra (Bangalore)-The life of a poor is as important as that of a rich. Affordability should not be the cause for death of poor innocent people. I strongly support this cause and ready to render any help from my side.

Gianluca Reali (Genoa, Italy)-I want support the issue of compulsory licensing.

Bhavesh Somani (Mumbai)-I strongly feel that we should have cheaper drugs to curb menace of cancer in our country.

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