Last updateTue, 17 Mar 2015 2pm

Patents and Statistics: The Life and Times of Dr Yusuf Hamied

For a man frequently described as a "pirate" and a "thief" - albeit a Cambridge educated one - Dr Yusuf Hamied is surprisingly genial and gracious.

The former Managing Director of the £3 billion Indian pharmaceutical major Cipla flits between various people, eager and chatty, slipping from a conversation about complex patent laws to trying to recall whose (tremendously funny) idea it was to name the company's generic variant of Viagra, "Erecto" (it wasn't his idea).

The 76-year-old's charm is deceptive as beneath the garrulous facade lurks a battle-hardened social activist.

The plundering-inspired monikers are what the heads of Western pharmaceutical companies have given Dr Hamied for his half-century long quest to reverse-engineer prohibitively expensive branded drugs for a plethora of diseases - from Tuberculosis to HIV/Aids - and make them available at a fraction of the cost.

That quest means he is seen very differently by millions in India and Africa.  Ajit Dangi, former director at American pharmaceutical giant Johnson & Johnson, once said: "In Africa, Cipla is a temple and Dr Hamied is a God."

His messiah-like status is the culmination of a story that stretches back to 1920, Dr Hamied is fond of explaining, when his nationalist father Khwaja Abdul Hamied first came under the aegis of Mahatma Gandhi.   Inspired by Gandhi's call for India to be self-sufficient, the elder Hamied would go on to establish The Chemical, Industrial & Pharmaceutical Laboratories (Cipla) in 1935.
During the Second World War, stirred on by Britain's promise of independence if India supported the fight against the Nazi's, Cipla supplied the Allies with vital drugs for trauma, dysentery and diarrhoea, among other things.

Khwaja Abdul Hamied's fight against British Imperialism rubbed off on his son who has spent his adult life fighting a not dissimilar form of imperialism; the hegemony of Western pharmaceutical multi-nationals over the dissemination of life-saving drugs in the Third World. 

That fight involves making cheaper, 'generics' of costly drugs for everything from erectile dysfunction to influenza and, far more crucially, drugs that combat cancer, various forms of hepatitis, HIV/Aids and other diseases that claim tens, if not hundreds, of thousands of lives every day. 

The defining moment of Dr Hamied's life and career came in 2001 when he declared, "I don't want to make money from Aids" and "sucked the breath out of the international pharmaceutical business" by announcing a cocktail of drugs meant for Aids patients in Africa, priced at just over $300, just three percent of the cost of the cheapest existing combination of medicines. 

Dr Hamied's cause has been made a little easier by patent laws in India which cover the manufacturing process rather than the product itself.  Even so, international trade regulations mean that Cipla is a business that, whilst making Dr Hamied a man of not-inconsiderable wealth, is locked in a seemingly never-ending process of litigation against the likes of Glaxo Smithkline, Roche, Pfizer and Bayer, to name but a few. 

His motivations and the ethical and moral arguments of patent laws and trade regulations are not as relevant as the fact that he exists in the first place for it is beyond any doubt that this gifted scientist - who still uses his old Cambridge notebooks in 'deconstructing' drugs prior to manufacture - has helped save millions of lives around the world.

What's more, and despite advances in medicine, governments and nations face ever greater challenges from myriad, constantly-evolving health threats.  So whilst he may have stepped down as the Managing Director of Cipla earlier this year, Dr Hamied's services are more vital than at any time during his illustrious, 52-year career.

During a recent meet-and-greet with members of the Indian Journalists Association in London, Dr Hamied spoke extensively and passionately about his work and his hopes for the future.

In the Beginning...
"One of the first lessons my father taught me was that a country like India has to be self reliant and self-sufficient.  I left Cambridge and returned to work for Cipla in India in 1960.  I had a lot of hopes and plans for the company and our country.  But whatever I wanted to do was blocked.  In 1960 India was following the British Patent Act of 1911, which was very archaic.

It took Cipla and other companies twelve years to convince the Indian government to change the patent laws.  Finally, in 1972, the Government of India declared that there would be no product patents on health products or food products.  At the time, Multi-National Companies (MNC's) controlled over 80% of the Indian healthcare market. 

After September 1972, companies like Cipla could manufacture and market, in India,  any internationally known drug that was useful for India at a fraction of the cost.  In 1972 the total business in India in pharmaceutical drugs was less than $1 billion.  Today, exports alone are more than 10 billion dollars while the local business is approximately $13 billion.  We are targeting $24 billion in exports by 2020. 

What gives me the greatest amount of satisfaction is that in 2001 barely 2000 to 4000 people in Africa could afford anti HIV-Aids drugs.  Today that number stands at more than nine million.  Cipla and a host of other Indian generic drug manufacturers are producing these life-saving drugs.  92 percent of all drugs used in the treatment of AIDS today are produced in India.  Their value? $1 billion.  The balance 8% by MNC's  Value?  $16 billion.  That goes to show the power of monopoly.  I'm a scientist and I respect science, invention and innovation.  We have never fought against those things.  Since 1960 we have been fighting against monopoly." 

The World Trade Organization's 'Doha Declaration' (which states that WTO member states must be allowed to permit companies to produce patented drugs without the consent of the patent holder in a crisis situation).
"Healthcare in India today is a permanent crisis.  We have 110 million mentally ill people, 80 million asthmatics and people with other cardiac problems, 60 million diabetics, 50 million with hepatitis B while one in three Indians have latent Tuberculosis.  The 2001 Doha Declaration allows countries to decide for themselves their own destiny.  India's destiny should not be orchestrated in Washington or London or Paris.  We should decide for ourselves what is in our best interests.  Unfortunately, no one listens to our concerns.  The powers that be repeatedly tell us that we should not do anything that would upset the international community. 

By way of illustration, in 2001 149 countries agreed to the Doha Declaration which stated that a country can decide for itself that there would be no patents on medicines for TB, Malaria, HIV-Aids and other epidemics. 

Two years later, when the Declaration came up for ratification, the Americans objected to the words "Other Epidemics".  When the Declaration was put to a vote, 148 countries voted for it with the Americans voting against.  That US veto means that the Declaration remains in limbo to this day.  Ratification would have given countries like India and the Third World the complete legal freedom to manufacture and market drugs that are needed for these specific diseases. 

As Amartya Sen recently wrote, India's policies on healthcare have a direct bearing on billions of people around the world because we are the largest maker of generic drugs in the world."

On "Compulsory Licensing"
"One of the things that is important to the debate surrounding patents is the scheme of 'compulsory licensing'.  I don't like the word compulsory.  I personally think it should be 'obligatory licensing' whereby companies like Cipla can pay a 4% royalty to the patent holder.  If a company has invented something then we don't mind paying a suitable royalty to the patent holder who invented it.

But there is a big difference between 'invention' and 'discovery'.  Invention means that it is something entirely new.  But if I make a Sulphate using some hydrochloride and salt that's no novelty.  I have always been vehemently against patents on 'incremental' innovations and minor modifications to drugs.  This kind of patenting is allowed in the United States and Europe but not under Indian law. 

One of the things that I have asked the Indian government to do is study a Canadian law, first introduced in 1969.  The law was in effect until 1992 when Canada joined NAFTA (North American Free Trade Area).  The legislation stipulated that Canadian companies could copy any drug they wanted and pay the patent holder 4% royalty.  Now if it was good enough for Canada - and at that time no one objected to the Canadians doing this - why is it not good enough for us?  It was entirely legal.  When India changed its patent bill in 2005, the clauses relating to compulsory licensing were not changed. 

Another thing is that drugs become obsolete.  For example, the cocktail of drugs that Cipla manufactured for HIV in 2001 is no longer used.  Today there are newer versions of drugs for HIV, Hepatitis C and other diseases but we as Indians are impotent owing to international laws.  We must educate the international community about what the Third World requires.

Ninety percent of the profits made by MNC's in the pharmaceutical sector are made in the developed world.  We are categorical in saying that we don't want to encroach on these highly regulated and profitable markets.  But leave the Third World to us.  We would be happy to pay a reasonable royalty but don't deprive millions of people life-saving drugs.  As Indians we have to safeguard the health sector and the food sector because by 2050 we are going to be a country of 1.65 billion people."  

The New Frontier: Cancer Drugs
"Cipla manufactures about 23 different types of cancer drugs.  Those that are off patent are freely available.  The monopoly of the big pharma companies comes into effect only on the patented drugs.  That's where the price wars take place as well.  Another factor is that even if we cross the hurdle of patents, the regulatory hurdle is there.  For instance, there's a drug that Cipla has been working on with an eminent scientist for the last seven years.  It is patent and he is willing to come to a suitable agreement with us.  But then we have to meet the horrendous regulatory requirements.  If you take asthma drugs as an example, in the United States they will ask for clinical trials with 16000 patients which will take five years to conduct and cost fifty million dollars.  it is prohibitive." 

On the Transfer of Technology
In 2000, we offered Cipla's technology and know-how to the Third World, including India, completely free.  No one has taken up the offers.  Having said that, what one needs to consider is that you have to pay a price to become self-reliant.  For instance, if Malawi puts up a factory today without a background in the pharmaceutical business, it is going to be much, much more expensive. 

The other factor is the raw materials required.  It is far cheaper and feasible for Indian companies to manufacture and market drugs to countries in Africa because we produce the active raw materials that go towards filling capsules and injections.  India is called the world's pharmacy because we produce the raw materials.  80% of the raw materials used in production in America and Europe come from India and China.  If these two countries stopped supplying these vital materiel, the global pharmaceutical industry would collapse.

On Standards
Standards differ from country to country.  One country will say that impurity levels in drugs should be no more than 0.2 percent of composition while another will give a figure of 0.4 percent.  All that while the international standard stipulates a threshold of no more than 0.1 percent.  India has its own standard which Cipla abides by.  The problem arises when we attempt to supply to other countries.  For instance, we've had arguments with The Bill & Melinda Gates Foundation over the anti-retroviral drugs because even though we supply them the medicines for distribution in Africa I have to meet American standards for those drugs because the foundation is a US-registered charity!  To put that into further context, the top-selling HIV drug in the world today costs $24,000 per patient, per year in America.  We sell a generic variety of the drug in Africa for $96 dollars per patient, per year.  Another drug taken by people who are at higher risk of contracting HIV costs $13,000 in the US.  Our price?  $72 per patient per year.  

- Compiled and Edited by Viji Alles



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