India for sound legal solution on drug row

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Namrata Kath Hazarika | 23 Oct, 2010
The Indian government is quite clear that the proposed Anti-Counterfeiting Trade Agreement (ACTA) would bring potential challenges in the Indian pharmaceutical export industry, said Prof. Frederick M Abbot, Edward Ball Eminent Scholar, Professor of International Law, Florida State University College of Law, USA in New Delhi on Friday.

Dwelling views during the question and answer session in a FICCI conference, he said, "The objective in regard to the ACTA is something which the Indian government is quite clear about. The Indian government will regard this as highly problematic. In fact, ACTA has mandated to take activities, which India has taken such great trouble to prevent."

India has faced challenges to resolve the dispute with the European Union over confiscation of Indian generic drugs by countries such as the Netherlands and France. India Pharma firms were concerned about the drug seizure issues as they used Europe as a transit point for exports to Africa and Latin America.

"They (India) were contemporaneously settling the dispute and provision of the activity...," he said.

Further, he said, "At present, India is demanding a sound legal mechanism for the prevention of a recurrence of the problem. The settlement that India might enter into with the EU will reflect a sound basis for that."

He expressed that India will not accept any solutions which does not firmly redress the problem it has perceived.

However, Commerce Minister, Anand Sharma has recently said that the European Union has decided to amend its customs rules in favor India.

The ACTA is being negotiated among 11 countries which includes the EU, the US, Canada, Mexico, Switzerland, New Zealand, Morocco, Japan, Australia, Korea and Singapore. This agreement proposes to prevent pharma products that casts doubts on the quality, safety and efficacy of drugs from the developing countries.

It mandates for setting up higher standards for enforcement of intellectual property rights. The proposed legislation provides for seizures, confiscation and destruction of devices as well.

The final draft of ACTA have been released in the beginning of the month of October that follows the 11th and final round of the negotiations held in Tokyo last month.

Abbot added, "The proposed ACTA seeks to deliberately mix mercantile interests in blocking market competition and public health interests in assurance of drug quality, safety and efficacy."

He also said that that the proposed agreement extends 'counterfeiting' to cover legitimate generic drugs.

For instance, African legislation extends the concept of counterfeiting to any drug imported or marketed without the consent of the IP right holder regardless of territorial basis of the IP holding. This would subject the marketing in Africa of a drug patented in Europe without the consent of the European patent holder to civil and criminal penalties. It also establishes the customs authorities as the principal enforcement mechanism.

While the weak internal legal infrastructure in developing countries raises the risk of abusive legal action, it also forces the battle over 'semantics' as 'counterfeiting' would no longer be correlated to quality, safety and efficacy, he added.