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‘Set up fast track courts to address IPR disputes’

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The Organisation of Pharmaceutical Producers in India (OPPI), much like the rest of industry has high expectations of the new government and we hope that it will usher in a new era of economic growth for India. As the government shapes policies to put India back on the growth track, we look to it to prioritise healthcare and focus on universal health coverage for all Indians.

India needs sound policies that drive collaboration and incentivise the sustained development of modern medicine while addressing the challenges of infrastructure and talent to improve healthcare delivery. Our new government must lead the way, playing a pivotal role to strengthen our healthcare system and make quality healthcare accessible to all.

As an industry, we ask for dialogue between government and all stakeholders. We will come forward to play our part in finding sustainable solutions that balance the need for innovation with the need for more accessible medicines, within a robustIP environment.

On behalf of the research driven pharma industry, we make the following policy recommendations:

Stronger IP protection

Patent protection is necessary for continued investment in innovative life-saving drugs. To meet the challenges of existing and new diseases in India, much research is needed. The high investment required for the development of innovative medicines cannot be justified without policy conditions that protect intellectual property. If countries show scant respect for patent laws, the increasing health needs and expectations of patients in those very countries will not be met. The new government should exercise a careful balance between encouraging pharma innovation and expanding access to the fruits of that innovation for all patients in the country. To truly improve access to medicines in India, we must continue to work together toward policy solutions to address healthcare financing, infrastructure, and human resources challenges, among others.

Judicious use of compulsory licenses: Global experience shows that patents for innovative medicines are not a barrier to patient access and compulsory licenses (CLs) are not a solution to healthcare challenges. CLs must remain the exception rather than the rule.

Fast track IP courts to address disputes: We welcome the proposal to set up fast track courts as stated in the BJP manifesto, to address intellectual property related disputes in a time-bound manner.

Careful consideration of decisions taken under Section 3(d): Incremental innovation can play a fundamental role in improving health outcomes and delivers real benefits to patients.

Regulatory Data Protection (RDP): Regulatory Data Protection is an integral part of IPR. Lack of RDP provisions will be a disincentive to R&D-based companies and innovators.

Clear and transparent regulatory framework for clinical trials

It is in India’s interest to encourage clinical trials, with adequate safeguards. We need policies and regulations that will build confidence among innovators (domestic and foreign) carrying out such research in India.

To this end, it is important that we implement a robust and transparent process for conducting clinical trials in India, and to obtain regulatory approval for new drugs while supporting the government’s effort to create a compensation framework. Global best practices for clinical trials regulation should be adopted in India as well.

Improved access to quality healthcare

A study conducted on healthcare access by IMS Institute for Healthcare Informatics states that access to medicine extends beyond the issue of cost, to the proximity and functionality of the infrastructure that supports that access. More than affordability, the barrier to access is often the inability to pay out-of-pocket and the lack of insurance cover. OPPI looks forward to jointly exploring with the Government of India, ways to play a meaningful role in the nation’s new healthcare system and ensure sustainable access to modern medicine at Indian healthcare centres.

Increase healthcare resource allocation

Government should allocate more resources to building healthcare infrastructure in the next five years. It should look at developing simple, workable and well-equipped primary healthcare infrastructure across the country.

Enforcement of a Uniform Code of Pharma Marketing Practices

The Uniform Code of Pharmaceutical Marketing Practices (UCPMP) submitted by OPPI lays down guidelines for ethical behaviour in pharma marketing. The Department of Pharmaceuticals (DoP) took this up in March 2012 as a proposed voluntary code of marketing practices for the Indian pharma industry, with the intent to review it in six months. We would urge the new government to consider making this a statutory code, to inspire confidence among patients and to demonstrate India’s commitment to the highest level of ethics and compliance.

The Organisation of Pharmaceutical Producers of India (OPPI) will continue to support the Indian government’s quest for more accessible and affordable medicines and we welcome a more comprehensive dialogue among all stakeholders.

Ranjana Smetacek, Director General, OPPI

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