Finally, after eight months of uncertainty, the contentious but debatable issue of TRIPs & Public Health has been resolved at the WTO, the General Council having given the green signal to the agreement

The world, including the Indian Government, calls the agreement 'Historic' but predictably, the Indian Pharmaceutical Alliance has denounced it as being too restrictive, impractical, vagaira, vagaira and thus totally unacceptable. However, more on this later.

It needs to be appreciated however, that access to drugs in the developing world does not depend on the cost of the medicines alone. Unfortunately Public Health is rarely a national priority in the area of economic development, in the developing world. Therefore Public Health systems are weak. Supply of drugs has to be supported by distribution, quality control, prescriptions, lack of personnel, patient-monitoring services etc. All this can be directly attributed to political incompetence. Countries could have enjoyed exemptions provided by the TRIPS agreement, but the possibility of using the appropriate procedures were simply overlooked.

In South Africa, political interference had earlier resulted in a denial of the link between HIV/AIDS virus and the epidemic, resulting in non-importation and non-distribution by the state. Thus providing drugs without setting up support measures would not be effective.

It would also be simplistic to say that reducing the cost of medicines would translate into resolution of health care problems in the developing world. Cost is at best, a relative factor. The cost of transportation in making drugs for malaria, typhoid, TB, etc., to the affected poor would probably be more than the cost of medicines. In the case of diseases like HIV/AIDS, the cost could be a relevant factor. Even if the drugs were supplied at cost plus, half of the world's 6 million affected patients would not gain access to them. It is estimated that only 0.3% of the patients infected with HIV/AIDS in developing countries have access to anti retroviral drugs, roughly about 200,000 to 300,000 patients.

Doha made people realize that the right to good health is primordial and must prevail over purely economic interests. But does the word 'people' include the 'Alliance'? I do not think so.

Let us analyse this statement to test its veracity:
1. The Alliance played a major role in mobilizing the support of African and sub-Saharan countries and through their 'Humanitarian' concerns managed to unite the whole world, with the exception of the US, making it look like a monster, only concerned with profiteering and not the health of the poor in developing countries.
2. The US was accused of blocking a deal in cheap drugs even though it was backed by all other WTO members.
3. Now when the same US has finally struck the deal with Brazil, South Africa, Kenya and India, the Alliance is again aggrieved.

They ask:
1. Why should patented medicines not be diverted to the originators country and the other developed countries?
2. Why should we be forced to change the size and shape of the tablets? Don't they know it costs so much?
3. Why should the obligation to negotiate royalty payable to the right holder on behalf of the importing country be imposed on the manufacturer? Don't they know it will not protect the generic manufacturer against the potential patent infringement litigation/damage claim in the importing or exporting countries?
4. Don't they know that the Best Practices Guidelines (BPG) which is said to serve as the 'most effective anti diversion measures' - special labeling, colouring, shaping, sizing etc., to differentiate products supplied though donor or discounted pricing programs from products supplied to other markets, are not in consonance with our own BPG?
5. Why cant the developed world be In Perfect Agreement to let us have our cake and eat it too. After all, Marie Antoinette offered cake to all her starving French subjects, hundreds of years ago even though she alone held the patent for cake in France?

Having said this I congratulate the Government of India and the Ministry of Commerce & industry for finally approving an agreement which I had welcomed as one which has been designed to ensure that poor countries have easy access to cheap medicines, but had also said that it is important to ensure that the needs of the innovators are not over looked and there should be adequate safeguards to ensure that the patent regime is not diluted.

In the same article the Director General of the Association of the Indian research based pharma companies had complained that if a 100 mg white and round tablet was required to be made in different dimensions, the alterations would require additional inputs to alter the size, coloring agent, and that any shape other than round would reduce the output of the machine. Inquiries with the Director in charge of manufacturing pharmaceuticals of an organized sector unit revealed that you require a different punch if you need to change the shape of a tablet from round to say triangular. Each punch costs Rs 900/- and there are around 25 punches in a tableting machine. The one time cost of changing the shape of a tablet would thus be only around Rs. 30,000/-. The output of the machine, I am told, would only be 5-10% lower in respect of any shape other than round.

The Advisor of a leading member of the same Alliance said he does not believe that the cost of manufacture would increase due to the new proposals. This he said, is due to the simple fact that the provisions are not practical. I am still trying to figure out the relation between the non practicality of any provisions with the cost differential. He is further quoted as having said that if a bulk drug was white in color, then the medicines made from it wold also be of the same color and it would not be possible to modify it. I wonder where film coating technology or the plethora of approved colors such as sunset yellow, erythrosine, etc. have disappeared. He would be well Advised to study the carton and the label claim of his own formulation of Zolpidem Tartrate BP 5 mg tablets, which reads: Each film coated tablet contains ………… Colours: Titanium Dioxide & Iron Oxide Red.

Such expertise in Spielspinning yarns would have been invaluable at the WTO earlier on, when the Multi Fibre Agreement was in doldrums.

It is heartening to note that Spindoctors have now graduated to Spieldoctors.

In the recent Supreme Court Judgement dated August 1, 2003 in Civil Appeal Nos. 3375 - 3384/2002 their Lordships have asked the National Pharmaceutical Pricing Authority to recover 50% of the amounts overcharged from several companies in respect of seven bulk drugs from 1995 up to 2000.

According to press reports one single company which won international acclaim for having offered to supply HIV/AIDS drugs to the poor sub-Saharan countries at a fraction of the price charged by the pharma companies of the developed world, has been ordered by the Supreme Court to deposit Rs 100 crore within one month with the National Pharmaceutical Pricing Authority. This means that the amount overcharged from 1995 to 2000 is Rs 200 crore. The NPPA will now be calculating the amount due from 2000 to date which would be probably be of the same magnitude.

This Judgement has squarely exposed the real 'Cancuncerns' behind the hype and hoopla of concern for Public Health and Access to Medicines by the poor.

It would be interesting to hear the views of the Director General of the Alliance on the cancuncept of " depriving poor Peter bhaiya to compensate poorer sub- Saharan Paul brother."

Can we condone this ? If the answer is in the affirmative then the possibility of institutionalizing this mechanism can be explored by India at the WTO. I also urge the Department of Industrial Policy and Promotion to incorporate enabling provisions in the Patents (Third) Amendment Act, 1970 and also the Department of Chemicals and Petrochemicals to amend the Drugs Prices Control Order 1995 to prevent the National Pharmaceutical Pricing Authority from taking any legal action in such instances.

Another such issue which is of great benefit to India is Data Exclusivity. But mercifully the GOI and of late even our astute and no-nonsense Hon'ble Minister of Health have understood that the very concept which our Spieldoctors had been projecting as most detrimental to the interests of India should indeed be urgently introduced if India wants to attract billions of Dollars in Clinical Research and Clinical Trials. But more about this later.

-- The author has recently retired as Director, Corporate Affairs, Ranbaxy Laboratories Ltd., and is an independent Pharmaceutical Consultant