India suffers from an unpredictable regulatory environment: John Castellani

Source: Business Standard

14 Jan 2015

John Castellani is president and chief executive officer of PhRMA (an American organisation of biopharmaceutical research firms). It comes here as part of US President Barack Obama’s delegation this month. In an interview withNayanima Basu & Digbijay Mishra, he said the new government needs to demonstrate through policy change that Intellectual Property Rights (IPRs) are taken seriously in the country. Edited excerpts:

India is soon going to bring out a National IPR Policy. What changes would you like in the pharmaceutical segment?

India should develop a more robust, predictable, and enforceable legal framework for the protection of IPRs through the proposed policy. Unfortunately, recent experiences of biopharmaceutical innovators offer several examples that, if unchecked, will continue to undermine rather than facilitate the building of a robust, innovative biopharma sector in India. A strong IPR regime could allow the country to make a major contribution to tackling health challenges, both domestically and around the world.

Will the (proposed) IPR think-tank effectively address concerns of the industry effectively?

The IPR think-tank has the critical task of developing a national IPR Policy that will advance the new government’s goals of fostering a spirit of innovation, entrepreneurship and growth in research and development (R&D). Ideally, the members would represent and seek a diverse set of perspectives, including that of patent holders, industry, and academia.

Do you see a change of position by the new government on IPR and patent protection?

PhRMA is encouraged by the increased level of engagement by the Indian government on challenging IP policies and practices. Real progress will only be achieved when India demonstrates through policy change that it does indeed value the importance of intellectual property, especially for the innovative treatments and cures of today and tomorrow.

India is contemplating issuance of more compulsory licences, to augment affordable health care. I understand it is a cause of concern for your members.

We fully support the objective of improving the access to innovative medicines. However, compulsory licences cannot solve India’s larger problems regarding access to medicines and health care. To truly improve access for patients, we will need to continue to work together to advance sustainable policy solutions to health care financing, infrastructure, and human resources challenges, among others, rather than focus on compulsory licences or other ways of undermining patent protection of innovative medicines.

Indian generic drug makers have faced the US regulator’s wrath for poor manufacturing practices in India. Does that make it difficult to do business with them in US?

PhRMA strongly supports the US regulator’s efforts to ensure the safety and quality of medicines sold in America. The priority for the pharmaceutical industry of any country should be, first and foremost, to protect and ensure patient safety. PhRMA member-companies are subject to the same regulations as their Indian counterparts. Good manufacturing practices apply to all companies, irrespective of where the medicines are produced.

Clinical trial regulations have been confusing for clinical research organisations. Is that a major concern which could be discussed with government of India? If yes, what are the remedies you hope for?

Clinical trials are a critical element in the innovation process for research-based pharma companies. India faces the consequences of a burdensome and unpredictable regulatory environment. We hope India will adopt predictable regulations for trial sponsors about the process for clinical trials approval and procedure in India. Greater predictability in the regulatory process for clinical trials, while ensuring the safety of patients, will improve the overall clinical research environment, as well as the availability of new treatments and vaccines for patients.

The issue of IPR and patents featured strongly during the recent US-India Trade Policy Forum. What’s your view?

We are encouraged by the increased level of dialogue between the US and Indian governments on challenging IP and trade policies. We hope they will strive through the joint work program to secure concrete outcomes from commitments made at the Trade Policy Forum. The innovative biopharma industry stands ready to engage with the two governments and all other relevant stakeholders on sustainable solutions to improve patient access to medicines, within a robust environment that promotes clinical research and patent protection.

Pricing controls have been a matter of concern for your member-companies operating in India. (India’s) National Pharmaceutical Pricing Authority has been adding drugs to price control and is considering bringing all lifesaving medicines under control, too. How would you react to that?

To focus only on the price of medicine, while ignoring its value to the patient, is short-sighted. The share of expenditure on medicines is a small component of the total cost of health care. These expenditures can and should be covered through adequate health insurance. To truly improve access to health care for Indian patients, the government must increase the amount of public financing spent on it, as no government pricing and patient access policy will be effective and sustainable without adequate health insurance.

What are the top priorities for PhRMA during the Obama visit?

We hope the visit to Delhi will be an opportunity for President Obama and Prime Minister Modi to identify areas of mutual cooperation, to further improve the US-India relationship. The recently released US International Trade Commission report documents the challenges US business faces in India, including IP protection and enforcement, but also the potential benefits to both economies from addressing existing trade barriers. We hope India will seize the opportunity for reform, consistent with Prime Minister Modi’s goals of increasing growth, investment, and innovation in India.

It is expected that US and EU will push for TRIP-Plus provisions in the pharmaceuticals trade with the onset of mega trade pacts such as the Transatlantic Trade and Investment Partnership (TTIP) and TransPacific Partnership (TPP). Your view on the likely impact on developing economies like India.

PhRMA supports robust intellectual property protections in both the TPP and the TTIP trade agreements, as both are intended to be gold-standard trade pacts. These agreements and the precedent set by the IP provisions in them have tremendous potential to benefit developing countries.  There is a strong, positive, and well-recognized correlation between reliable IP regimes and technologically sophisticated foreign direct investment.

This entry was posted in Clinical Trials, Compulsory Licensing, IP Rights, IPR Enforcement, IPR Think Tank, Patents, US pressure on India. Bookmark the permalink.

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