Not facing any significant IPR challenges in India: Abbott

American pharmaceuticals giant Abbott has told the US government that it is not facing any significant challenge with respect to intellectual property rights, as is being alleged by a section of the US industry, especially from the pharma sector.

"India is an investment priority and fundamentally important to the future of Abbott," Abbott's senior officer Jason Grove yesterday wrote in a submission to the US International Trade Commission that is conducting an investigation into Indian trade practices and policies and its impact on American businesses.

"Abbott is not currently facing any significant challenges with respect to intellectual property protection in India," Grove said.

"We have had a positive experience in India, are committed to a long-term presence, and remain optimistic about our future because our diversified product offering makes us uniquely able to meet the health needs of Indian citizens," said Abbott, which has been present in India for over a century now.

In 2010, Abbott acquired both the pharmaceutical business of Solvay, which had a presence in India, and Piramal Healthcare Solutions, which was part of Piramal Group. These transactions made it one of the largest health care companies in the country. It now employs approximately 14,000 people in India, making it our largest employee base outside the United States.

"Abbott's experience in India has been positive," Grove said in his five page submission to USITC.

"India remains a great opportunity for companies like Abbott. We take a long term view of the market and understand local needs. We have worked to establish a meaningful dialogue with key Indian stakeholders, including government, patients, physicians and civil society groups, to address those needs," he added.

Observing that it is critical that processes provide a meaningful opportunity for outside input and the decisions are based on a rigorous review of the scientific and health economic data available, Abbott said "in its our experience in India, the government has demonstrated its capability to provide this type of procedural fairness."

"For example, when the Central government recently revised the National List of Essential Medicines (NLEM), it pursued a transparent and deliberative approach, formally soliciting the views and comments of over 60 different stakeholder groups in the country," it said.

As a result, the government developed a balanced policy that identifies essential medicines for all patients. The NLEM combined with the recently revised DPCO makes essential medicines more affordable while also encouraging the continued development of new medicines to meet emerging patient needs, the pharma company said.

Abbott said it is important that these principles of transparency and due process be institutionalised government-wide for the regulatory approval and reimbursement of health care products.

"In the past, there have been instances where decisions were made without an official notice or opportunity for stakeholders to comment or understand the methodology used by the government as the basis for the decision," it noted.

"If the government were to formalise a transparent and fair process for reaching these decisions, it would go a long way toward increasing investor confidence," Abbott said.

"IP protection is another consideration. The Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement provides an important framework for that protection and it is important that all WTO members meet their obligations under TRIPS," Grove said.