William (Bill) Haddad is a strong advocate of generics across the globe. In various media quarters he is often referred to as the 'father of generics' as he was instrumental in bringing generics entry to US in 1984. He is also Chairman & CEO of Biogenerics Inc.
Haddad has supported India in various IPR forums across the globe. Although Haddad understands the need for patents and market exclusivity, he also feels that the poor should not die out just because they can't afford the patented medicine. He is also non-supportive of an extension of the patent life or obtaining more than one patents on a product. He is also spearheading the campaign urging for the necessity of regulatory guidelines for bio-generics.
In an interview to Prabodh Chandrasekhar of Pharmabiz.com, William Haddad spoke in depth on generics and the problems concerning the generic industry. Excerpts:
Of late, a lot of IPR related battle is being fought between Indian generics manufacturers and the multinational companies (MNC). Cipla's fight with the MNCs is the best example of this. As a US-based entrepreneur and a generics advocate, how would you perceive the situation?
As a pro-generics advocate, I would support Cipla's stand. I will care more for hundreds of daily AIDS-related deaths around the globe compared to monopoly profiteering of a MNC. About 8,500 poor die daily due to their non-affordability of costly medicines of the multinationals. MNCs with their money power are playing close door games influencing governments and decision makers.
It is only due to the single-handed effort of Cipla's Dr Yusuf Hamied that the poor in the sub-Saharan Africa is able to get quality anti-AIDS drugs at about $ 140 per year compared to $ 12,000-15,000 three years ago. A common saying has emerged in the US - "Earlier 2 million used to die of AIDS. Now only 20, 000. Thanks to India."
India with its strong culture and talent pool is also a home to a large number of poor in the world. India is hope of the developing world. Many a time, I have felt that India is fighting a lone battle against the MNCs. However it should continue fighting.
Indian media has got a special role to play here to propagate the double standards of the MNCs to its population.
What is the validity of a patenting if you keep on challenging every patent filed by an MNC? Why don't you agree over MNCs right to market exclusivity as it is their intellectual property, which they have brought out after spending lot of energy and resources?
I'm only a generics advocate and not an MNC basher. The MNCs have every right to patent their innovations and take benefits out of it. They have the right to take the market exclusivity for the allotted patent life. However if the same drug is life saving and the public is dying on account of non-affordability of the drug, then the MNCs should be ready for the option of bringing the price to the level of the dying person's affordability. This specially implies to the poorest sections of the society. The MNC may also tie up with companies to market its products, for which it can charge royalty on the sale of such drugs. MNCs are striving to increase the patent life of their discoveries by another five years, which is not fair. They also seek an extension of patent life upon discovery of any new property of an already patented product. In this way a product gets more than one patent. The international authorities have to stop this. A new product should deserve only a single patent.
In the US, the public and the insurance companies support generics. After the successful entry of Ranbaxy, Cipla and Dr Reddy's in the US market, people's mindset on the quality of generics coming from India have also become positive.
What is your appeal to the Indian government with your visit to the country?
In the 2001 Doha WTO forum, India was leading the developing and the under developing countries. How come in the 2003 Geneva forum, the country was not considered a representative of developing nations? India should go back to Doha guidelines and making it as base it should strive for the postponement of the WTO deadline to 2016.
Medicines have to be included in the agriculture agenda, rather than fought separately.
Diseases like malnutrition, hunger, TB, AIDS, malaria, hepatitis-B is playing havoc with the population of the poor countries and India is every one's hope.
When US imposed sanctions on European steel, the latter did the same on US oranges from Florida. India has to do something similar to refrain US and other advanced countries from playing close door games with regulatory authorities.
Tell us about the evolution of generics industry in the US. Why have you been often referred to as the 'father of generics'?
I'm not the father of generics. However, I, along with others have spearheaded the growth of generics across the globe, especially in the US. Before the entry of generics, many people in theUS died due to non-affordability of quality medicines. In 1950s tetracycline used to be a miracle drug and people used to die for want of it. Even after its patent expiry in mid-60s, MNCs continued with tetracycline cartel that denied affordable miracle drug to poor nations.
Dr. John Nolan, the then economist punctured the cartel by making tetracycline in Columbia for 3 cents compared to 52 cents charged by the MNCs. However Nolan could not survive against the might of MNCs and he had to shut his plant down.
I was then working as a correspondent with the International Herald Tribune. The Tribune assigned me to write against the cartel. With our effort, two sets of cartels were caught in Latin America, for which the cartel members, led by Pfizer had to pay $ 2 million as fine.
Years later, using New York's subpoena power and legislative hearings, I was to learn that 160 essential drugs with expired patents had no competition. Further, I came across an academic report prepared by a famous university, which supported for the MNCs claims to increase the patent life by seven years. Above all, ninety Senators (out of a hundred) and two-thirds of our House of Representatives sponsored "remedial" legislation to extend the patent life.
Later, it was well proved that the academic report was secretly financed by the MNCs. Hearings were held and instead of the restrictive legislation, the Drug Price Competition and Patent Restoration Act emerged (Hatch-Waxman, named after its sponsors). That law created the US generic industry in 1984 and today serves as the model for most nations. Generic market share today forms 75 per cent of the US pharmaceutical industry compared to 5 per cent in 1984.
What are the problems concerning biopharmaceutical industry today? When do you expect a safe generics entry for bio-pharmaceuticals?
Today there are no regulatory pathways for bio-generics. As a result the bio-pharmaceuticals whose patent will expire in the next 2-3 years will still remain on-patent. In other words, the generic producers will not be able to make these products even after their patent expiry due to lack of supportive regulatory pathways or guidelines for R&D, manufacture, and marketing of biopharmaceuticals. The framing of the guidelines have been found difficult on account of difference in the nature and manufacturing process that separate a biopharmaceutical from a pharmaceutical product. Despite stiff MNC lobbying, generic manufacturers have been assured of firm support from a large section of politicians in the US and Europe, which makes me feel that by June-2005, pathways for bio-generics will be framed in the US.
In the next 2-3 years bio-generics like EPO, G-CSF and interferon would lose their patents. However, due to the lack of regulatory pathways, MNCs will continue with the monopoly of marketing these biopharmaceuticals in the advanced markets. Also they have every chance of winning litigations that come in their way.
These biopharmaceuticals are currently priced very high in the US. With the takeover of generic manufacturers, the price of these products would reduce to one-seventh of the current prices. The original patent holders would not like this to happen and would try their level best to stop biotech products to go generic. Even in a country like US, 40 million population find it difficult to pay for their primary healthcare needs.
India can help us here also. We found that the cost to manufacture quality biogenerics in India is cheaper by two-third compared to manufacturing in East European countries.
My company is in primary level talks with Indian authorities to manufacture biotech products like erythropoietin (EPO), G-CSF (Filgrastim), biotech products for arthritic diseases, and animal growth hormones.
What is the 'generics' situation in Canada?
The medicine prices in Canada are just 25 per cent of the prices prevailing in US. Generics are welcome there. There is also a provision for compulsory licensing in Canada. Legally and illegally people across US states bordering Canada try for accessing cheaper generics from there. Recently, the MNCs succeeded in bringing forth legislation against parallel imports. A lot of states are lobbying for parallel imports. Once that happens, the prices of medicines will considerably go down.