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US aggression on pharma patents bodes ill for the world

Pillman | Thursday, May 21, 2009

For over six months, the Indian pharmaceutical industry has faced tremendous pressure from world bodies on issues like counterfeit drugs.

First, the European Union (EU) charged reputed Indian companies such as Dr Reddy’s Laboratories of circumventing local patent laws by routing medicines through Netherlands and a few other transit points.

Though no legal background exists for such bizarre claims, the EU has not agreed for safe passage of Indian pharmaceutical products. The Indian government, with no alternative left, is planning to take up this issue with the Dispute Settlement Body of the World Trade Organisation.

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While Indian companies had been sending goods to Latin America through the European Union for several years, it has now awakened on those authorities that sending goods through EU tantamount to infringement of the local patent laws.

To aggravate matters for Indian companies, pressure is also mounting on global patenting criteria from the US. Backed by a few other countries, the US is reportedly trying to formulate a legislation that would make it compulsory for countries to accept patents, if any two member countries of the World Intellectual Property Organisation agree to endorse the patents.

For Indian companies, this will perhaps be the most harmful move if not thwarted in time.

Also, it directly puts a question on the competence of the Indian patent authorities in determining the validity of a global patent. Remember, there are several instances where patents filed by multinational corporations (MNCs) in India have not been found to be inventive and come in the realm of the obvious.

International companies are known to be extremely powerful and play a critical role in shaping up healthcare policies of governments. With the US taking such aggressive stand, it could be easily deduced that multinational companies may be exerting pressure on the new US government to protect their own sagging revenues.

The international pressure to restrict Indian pharmaceutical industry does not stop here.
The US Trade Representative (USTR) has recently raised an alarm over the proliferation of counterfeit drugs in India and terms it as a “special concern for consumer health and safety.”

Without going into the specifics, the USTR has said, “A significant contributing factor in this problem is the unauthorised use of bulk active pharmaceutical ingredients to manufacture counterfeit pharmaceuticals.” By bracketing India with China and Russia, including a few smaller countries, the USTR has also put the country on “priority watch list” order.

All the above moves seem to be taken up in a concerted manner. Only recently, India could shoot down a World Health Organisation plan to label a majority of medical products from India as counterfeit or spurious drugs. These are signals that point at protective moves rather than a greater reason to make cheap drugs available.

There is every reason to believe that counterfeit drugs are a menace the world is facing today, but to prevent legitimate drugs from reaching the needy patients through questionable international legislations is completely unacceptable.

It is time the Indian government raised the ante and mobilised support from the global community with similar interests. Distinguishing quality products from spurious drugs should be the priority for every government, not just India’s.

In the US, multinational brands are very highly priced, but with the rapid spread of generics, the acceptability of copied drugs has been rising. Presently, more than 70% of the US prescriptions are for generic drugs. This is a direct threat to the big MNCs, which have been thriving on the back of growing demand for medicines and under several years of patent protection.

Now, the MNCs seem to be slowly realising that growth is tremendous in the Asian region, not just the US and Europe, and if they are to make a late dent in these markets, they will need to play up their quality card by indirectly maligning the generic companies.
MNCs have contributed immensely to the healthcare industry. They can retain their scientific edge and still make strong inroads into the growing markets. It will be good for them and for the generic industry to survive together. Many companies are actually forging those lasting relationships. But, a dual play may lead to erosion of trust and prospects of growing together.

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