Going desi

Going desi

Generic versions: mainstay of the poor



The issue of 'generics' has been hot for some years now. In 2001, 30 drug companies filed case against the South African government when it decided to override their patents and buy cheaper, generic drugs from countries like India, to fight the hiv/aids disesase.

The fact was, that under Indian patent law, its pharmaceutical companies like Cipla and Ranbaxy could manufacture drugs, which were under patent protection abroad, if they had modified the process of manufacture. So Cipla made an audacious offer to African governments and the global humanitarian group, Doctors Without Borders. Cipla said that it could supply the triple therapy aids drug for us$350 a year, per patient. The going cost of the same combination-drug therapy was us$10,000 to us$15,000 per patient. The drug combination included: two tablets of stavudine, whose patent was held by Bristol-Myers Squibb of the us , two tablets of lamivudine, patent held by Glaxo-Wellcome of Britain and two tablets of nevirapine, patent held by Boerhinger Ingelheim of Germany. In 2000, Cipla had already tried to sell Duovir, its generic version of Glaxo's Combivir at us$1.74 a day. Glaxo responded with threats to sue Cipla, but also with price cuts, from us $16 per patient to us $2.

But the matter did not end here. This possibility of sourcing cheaper drugs from developing countries led to changes in the trips agreement. In the trips agreement, one clause, which can be used by governments to regulate access and prices of drugs, even patented drugs, is compulsory licensing. Under this provision, a license without the agreement of the patent owner can be granted, but this can only be done if the owner is not willing to grant a voluntary license on 'reasonable' commercial terms within a 'reasonable' period of time. trips, under compulsory licensing also, allows countries, with limited domestic manufacturing capacity, to import a generic (patented-copycat) version of the same drug for a public health emergency.

In late 2004, the us Senate's Government Accountability Office found after detailed investigation, that the government was paying twice as much for many of its drugs in its global aids programme, because "it would not buy cheaper versions of the India-made drugs because they violate us patent laws, which do not allow copies of the brand-name products."

us companies fought back saying that the issue was not price but safety. Finally, it was agreed that the administration for its aids relief programme would buy the generic version of the drug, but only after approval from the Food and Drug Administration and only for distribution in Africa and the Caribbean countries.

This is not to say that the generic business is not growing in the world. Consumers want it. But companies do not. So, the compromise is that drugs, which are off patents, can be sold as generics. In other words, they can be sold under other names, other than their original brand name. When the drug goes off patent, the price can drop as much as 80-90 per cent. This still brings down the price. France, for instance, has taken steps to encourage generic medicines in order to bring down costs of healthcare. It empowered chemists to sell a generic medicine even if the doctor had prescribed a branded drug. In 2002-2003, the generic market in France was estimated to grow at 45 per cent per annum.

Basically, this generic business rides on the marketing of the branded drugs, while the other, now 'illegal' generic drug, was based on the r&d development costs of the inventor company. But in both businesses, as price comes down, it's the patient who stands to gain.

What about us?
Once the 3rd amendment is passed by the Indian Parliament, the business of generics would be out. The fact is that Indian companies have come to dominate the market in the past 30 years -- from a market share of 30 per cent in 1972 to controlling over 72 per cent of the domestic medicine market in 2004. Cipla's turnover, for instance, crossed Rs 2,000 crore in 2003-2004, a staggering 27 per cent increase in that year. Ranbaxy's turnover is much higher at Rs 5,000 crore. These earnings were predominantly from the 'generics' business but now strategies would need to change to meet the new situation.

The critical issue here is what all this would do to prices of drugs in a poor country like India. The fact is that Indian drug prices, which were among the highest in the world in the pre-1970s are among the lowest in the world currently. The fact also is that India is confronted with a double burden of disease -- traditional diseases like malaria to modern diseases like cancer. It has extremely poor people and with high health costs , it needs to worry about the 'affordability' of its medicines.

What's unclear is how the 'product patent' will affect vast numbers of people in the country. The supporters of big pharma say that the 3rd amendment will not mean much, because most people do not depend on 'patented' drugs for their ailments. They say, in fact, that the 3rd amendment will protect Indian companies that invest in discovering new products. Indian r&d in medicine will prosper. The country will become a global player in the pharma business and also comply with wto and not face the wrath of the us . All win-win they say.

But there are many greys. Nobody seems to know what all this will do to people's health, for there are no reliable estimations of the cost of drugs in relation to healthcare cost.

The fact also is that nobody really knows how many drugs will go under patents. The problem is that this will also depend on the definition of what can be patented and from the year when the patenting of the drug for its 20 year period begins. This is further complicated in the global world of global business we live in today. For instance, GlaxoSmithKline filed a patent for rosiglitazone -- an anti diabetic drug -- in the us; it was granted this in 1987. Technically, its patent would have run out in 2007. But the company filed and got a patent for the same drug in Brazil in 1997. Now, if the company were to use the validity of its Brazil patent to ask for a patent in India, and say it got this from the date of its application in 1997, the same drug could continue to be sold till 2017.

Evergreening the patent
'Evergreening' is another problem. The same company, which holds the original patent, can add something new in the composition or change its mixture, which could allow it to get another patent for the same modified product. In 1992, the anti-diabetic drug of Glaxo secured a patent for its modified version under 'rosiglitazone maleate' and so extended the life of its original 1987 patent by another 5 years. While the first version would expire in 2007 in the us market, the second evolved version would expire in 2012. The us has adopted the practice (a loosely defined law helps) where, when a patent is close to expiry or even midway, the patent holders can develop different salts, mixtures, polymorphs, metabolites, hydrates, isomers and derivatives of the same molecule and extend the life of the patent. Low Cost Standard Therapeutics (locost), a Vadodara group working on consumer rights in the context of patents, feels, "Most research and development spending goes into producing 'me too' drugs -- these are slight variations on existing drugs which can then be patented as 'new' drugs and sold at high prices. Often these variations are no better than molecular manipulation or a mere addition of other unnecessary ingredients."

Lack of clarity in Indian law means that evergreening will happen in India as well. And the ambiguity that exists in definitions leaves the crucial decisions to the discretionary powers of the patent examiners, who are not prepared at all to deal with vast numbers of patent applications (see box : Indian Patent Office ). Lack of clear guidelines will only result in endless litigation, with every decision being challenged. The potential for this has already been seen with Exclusive Marketing Rights (emr), where four out of five decisions taken by the patent office are embroiled in high court cases. (An emr is similar to a patent; granted for a shorter duration, about 5 years; India was obliged to provide them as an interim measure prior to introducing product patents). Products involved in such litigation include imatinib mesylate, Novartis' anti-cancer drug and rosiglitazone, GlaxoSmithKline's anti-diabetic drug. Novartis was granted an emr , Glaxo wasn't. Yet, both cases managed to end up in court.

This is why the 'wording' of the patent amendment bill becomes critical. How does the amendment bill define the term 'innovation'? How does the amendment bill provide for 'compulsory licensing' so that there is restricted monopoly in the areas of health? 12jav.net12jav.net