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Compulsory licensing and access to medicines

Published Jul 02, 2012 04:38pm


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(While in India cancer patients’ access to medicines is ensured through cheaper generics made possible under compulsory license, in Pakistan a generous subsidy is provided by multinational pharma companies to afford branded patents for the poor patients. The question is: should we follow the Indian example of compulsory licensing or do it the philanthropic way?)

Indian patent office’s action last month ending multinational pharma company Bayer’s monopoly over its product Nexavar – a drug used to treat cancer – made headline news across the world. It was argued that this compulsory license would set precedence for similar state intervention in cancer as well other areas of high public health impact including diabetes and heart diseases allowing cheaper local generic version manufactured and sold in India and elsewhere in developing world.

I have been looking ever since to find what has been happening on the Pakistani scene lately and how might such precedence affect us here. Research for the story took me to Peshawar and other places where I had to wade through the patchy records of pharma history in Pakistan. So, what has been happening on this front in Pakistan? In short: not much worth writing home about.

It would be instructive at this point, however, to quote Article 38(a) and (d) of the Constitution of Pakistan which says: "The State shall secure the well being of the people, irrespective of sex, case, creed and race, provide basic necessities of life such as medical relief for all such citizens as are permanently or temporarily unable to earn their livelihood on account of infirmity, sickness or unemployment.”

Therefore, the government here needs to take necessary steps to improve access to medicines as a basic necessity for sustaining life and quality of life. But let’s first look briefly at some of the primary facts regarding compulsory licensing.

Any member country of World Trade Organization (WTO) is eligible to benefit from the compulsory license provision. However, 33 developed countries have announced that they will not use the system, including: Australia, Austria, Belgium, Canada, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Slovak Republic, Slovenia Spain, Sweden, Switzerland, United Kingdom and the US. Another 11 other members announced that they would only use the system in situations of national emergency or other circumstances of extreme urgency, including: Hong Kong China, Israel, Korea, Kuwait, Macao China, Mexico, Qatar, Singapore, Chinese Taipei, Turkey, and United Arab Emirates. Other countries not on these lists, including India and Pakistan, may choose to use compulsory license at their discretion.

Though deadly opponents of compulsory licensing, Canada, United States and Germany have used it to their benefit in the recent past. On February 2006, Canadian generic firm Biolyse requested the ministers of health and industry to add Osteltamivir to the list of pharmaceutical products eligible for compulsory licensing for export. On July 2006, the Canadian government announced granting this license. In US, the anthrax scare in the fall of 2001 compelled it to build a large enough stockpile of ciprofioxacin (Cipro) to treat 10 million people. This quantity was far greater than the supply and the manufacturer of the patented product Bayer lacked the capacity to produce it in a timely manner. US granted compulsory licenses to generic manufacturers. In Germany a licensing agreement was reached between pharma companies Roche and Chiron. Roche had been attempting to get the German government to get it to issue a compulsory license for patents on "Blood screening HIV probe" held by Chiron.

Other licenses issued before the recent case of Nexavar include: Malaysian government issued a compulsory license to Indian companies to import generic variants of didanosine (ddl), zidovudine (AZT) and lamivudine+zidovidine (Combivir). Indonesia on October 5, 2004, issued a compulsory license to local companies for the manufacture of generic versions of lamivudine and nevirapine. Thailand on November 29, 2006, announced a compulsory license to import (from India) and locally produce Effavirenz. Cameroon on January 2005, issued compulsory licenses for HIV/AIDS drugs Nevirapine, Viramune Lamivudine (brand name 3TC*) and fixed dose combinations of Lamivudine and Zidovudine (brand name Combivirt). Ghana on October 26, 2005 issued compulsory license for importation into Ghana of generic HIV medicines. Eritrea on June 5 2005, issued a compulsory license for importation into Eritrea of generic HIV medicines. Zambia on September 21, 2004 issued a compulsory license for lamivudine, stavudine and nevirapine.

While it is clear now that many developing as well as developed WTO member countries have granted compulsory licenses for patented essential medicines, and many more would be considering doing so, it is crucial time that Pakistan undertake compulsory licensing to ensure availability and affordability to essential drugs in the domestic markets at affordable prices as lives and health of millions of its people suffering from diseases like cancer, hepatitis, and other chronic diseases depend on access to medicines.

But here is something very interesting happening in Khyber Pakhtunkhwa for the last six months which seems to have gone un-noticed. The provincial government and Novartis Pharma, a multinational pharmaceutical company, are jointly running a project since January this year in which blood cancer patients are provided free cancer medicine called Glivec (generic name imatinib) costing Rs150,000 per month for treatment. The project based in Hayatabad Medical Complex, Peshawar, has already registered about 600 cases to be treated with the drug. It is estimated that only in Khyber Pakhtunkhwa there were a total of 1,000 of such blood cancer patients out of a total 12,000 reported across Pakistan. The patients need to continue taking the medicine for the remaining course of their life.

Simple calculation would show that a yearly treatment of Glivec would cost Rs1.8 million per patient and Rs1080 million for the 600 registered cases in Khyber Pakhtunkhwa. The provincial government is presently contributing worth two months cost of the medicine in a year i.e. Rs0.3 million, from the annual development budget and the rest is contributed by the company in terms of free medicines.

While still at work on the calculator you can find out that Rs21.6bilion would be required every year if all the 12,000 likely cases of Glivec were to be treated. Compare this with the Rs7.0 billion allocated for development of health services in the country during 2012-13 fiscal year, and Rs 237 billion annual pharma sales in the country last year. Almost entire health care expense is out of citizen’s shallow pocket.

A senior health manager at the Hayatabad Medical Complex confided in me how proud the hospital and provincial health management felt about how this project was serving the ailing humanity through this novel arrangement. There were chances, I was told, that the model created in Khyber Pakhtunkhwa might be taken to the other provinces - the company was working on the feasibility of doing so.

Now here is the question again; should we follow the Indian example of compulsory licensing or continue to do it the philanthropic way? The results may not be very different but the process is.

Watch video blog on compulsory licensing in Urdu:

Ayyaz Kiani is a public health specialist. He heads Devnet - a network of development consultants. Based in Islamabad, he has travelled around the world and continues to do so to meet fellow travelers.

The views expressed by this blogger and in the following reader comments do not necessarily reflect the views and policies of the Dawn Media Group.


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The views expressed by this writer and commenters below do not necessarily reflect the views and policies of the Dawn Media Group.

Comments (9) Closed

Shubs Jul 03, 2012 07:50am
Sir, I don't think you have a clear understanding of patent laws and the generics pharma industry in India. Please leave aside nationalism for a minute and look at the issue from the author's perspective.
prafulla shrivastva Jul 03, 2012 06:54am
Dear Ayyaz, You have written a nice article on Generics Medicines. I have worked for 20 years in pharmaceutical industries & I have traveled remote part of India. I have seen how poor rural population suffering with various fetal diseases like Malaria, Cancer, Diabetes but now they are so much benefited with Generics Manufacturer as they can afford usual courses of these medicines. I trust situation of Pakistan is not much different than India & your government should encourage Pakistani Generics manufacturer to start marketing anti cancer & anti diabetics drugs for common people as they can afford generic medicines. Try to learn from big MNC Pharma companies as they teach everything while exploiting Asia Countries.
Ijaz Mir Jul 02, 2012 06:59pm
Mr Ayyaz Kiani ,your article is very comprehensive, congratulations.. After understanding the situation, My vote is to fallow the Indians.
BRR Jul 03, 2012 12:25am
How reliable and repeatable is a process where one has to depend upon the benevolence of a corporation? That should answer the writers (rather silly) question. Clearly, the ability to control prices of products for which there is no second source is vital, and India's approach provides an incentive for corporations to have a second source, instead of a monopoly, at least for their own propaganda.
jjj Jul 02, 2012 02:18pm
haha, pak is no india. first a foreign firm has to have business in pakistan to adhere to the paki patent laws. given the countires profile no pharmaceutical business will go for that and to get accountable for paki laws. so a question of following indian example never arises. india has 1.2 billion people due to which every pharmaceutical company has its presence. they do R & D in india, manufacture, and sells medicines. This is due to India's large scientific community, and market. Pak is no way a match to India. but pakis has a solution, they can buy the same medicines from india.
sudheer Jul 02, 2012 05:49pm
I don't know why there is no comment on this. Is it because nobody is interested in these issues? Compulsory licensing is a way ahead to save the people from the Pharma Giants. Very often they are taking super normal profit of several thousand times.
madrasi Jul 02, 2012 03:56pm
Though choice! A drug company has to get back the billions it spends on developing a drug and make profits to keep the shareholders happy. Otherwise the system shuts down. Ofcourse philantrapy on its behalf is great for patients but the unfortunate reality is that patients in developing countries have always been the exploited lot. Used during the development phase in all kinds of clinical trials ( some of which would never be allowed in the west) they then are sold the same drug at prices that would kill them quicker than the disease that requuires it. Cruel!!! I argue that any soverain country should be able to and indeed will do anything to ensure the health of its masses. The "compulsory license" leeway given by the WTO is precisely for these reasons.
Aziz Jul 03, 2012 11:23pm
Thanks for this insightful piece. I have heard that Novartis is running similar program in Karachi as well. It is, however, important to appreciate the inherent limitations of philanthropic approaches which generally target to relatively small number of patients. In my knowledge Gleevec patent has yet not been granted in Pakistan so theoratically speaking we should be able to get quality generics from India where its patent was rejected. Novartis does have a similar program in India i.e. Novartis' Glivec donation program but even then it could not survive the stricter scrutiny of Indian patent office and subsequently of the Madras High Court. In case of Bayer-s nexavar compulsory licence (CL), the company tried to avoid issuance of CL by showing its access window for poor patients but the same was rejected. Several studies and experiences show that donations, price discounts and even tiered pricing cannot substitute the robust market competition which generic producers can deliver in the absence of IP barriers.
BNS Jul 03, 2012 10:29pm
And can someone please explain: 1. What is meant by compulsary licensing (CL)? 2. What are the conditions under which CL are to be granted? 3. EWhat was the rationale used by the indian government to provide CL?