A holistic approach, that balances the need for innovation with the necessity for more accessible medicines within a robust IP environment, is needed to re-vitalise the Indian pharma industry. On behalf of the research-driven pharma industry, we would like to propose the following policy recommendations for the Government’s consideration.
The top five areas are:
1. Strong IPR protection: OPPI believes that strong patent laws will encourage, stimulate and sustain innovation in the research-based and technology-intensive pharma industry. Adherence to and implementation of world-class patent laws will encourage foreign direct investment and technology transfer, stimulate local research by Indian and international companies and benefit the Indian pharma industry, as well as the people of India, leading to the availability of newer and better medicines. There is a huge unmet need in cancer, in diabetes, in mental illnesses, for which we need to continue research to bring in innovative drugs.
a. Patentability
OPPI believes that, apart from NCEs, all other forms should be patentable as long as they meet the criteria of patentability such as novelty, non-obviousness and commercial applicability. Section 3(d) of the Indian Patent Act restricts patents for incremental innovation unless there is therapeutic advantage and greater efficacy, but the Indian Patent Office does not define |efficacy. This section has been misused by the courts and the Indian patent office because it allows for a subjective interpretation.
b. Pre and post grant opposition
Opposition before and after filing of an application for a patent have been introduced, allowing oral hearings. Opposition can be filed any time after the date of publication of the patent application till the date of grant. OPPI does not approve of pre-grant opposition as this could result in several pre-grant oppositions being filed, causing delay in the patent granting process. In addition, serial pre-grant oppositions may cause further delay in the grant of patents.
c. Patent linkages
OPPI believes that patent linkages will help India safeguard the rights of legitimate patentees. In India, marketing approval is sought from the Drug Controller under the Ministry of Health and patent approval is granted by Indian Patent Office. Currently, they are not interlinked which is detrimental in protecting the rights of a legitimate patentee and this has been used to violate patent rights.
d. Compulsory licensing
Compulsory licencing should remain the exception, in order to preserve patent protection that would allow the development of additional innovative therapies for treatments.
While India should have the flexibilities available under TRIPS, including the compulsory licensing of innovative medicines, this flexibility should be used judiciously only for humanitarian, non-commercial use in treating HIV/AIDS, TB, malaria and similar diseases, and not for cancer which does not fall in the category of epidemic or communicable diseases. The Government should exercise a careful balance between encouraging continued pharma innovation and expanding access to the fruits of innovation for all patients in the country.
e. Regulatory data protection (RDP)
RDP is an integral part of IPR. Lack of RDP provision will be a disincentive to R&D-based companies and innovators. A committee chaired by Satwant Reddy, Secretary, Department of Chemicals and Petrochemicals, Government of India, has already submitted its report on Regulatory Data Protection. The report is inconclusive and recommends a calibrated approach for RDP through a transition period.
OPPI has asked for a minimum of five years of RDP after grant of marketing approval in India.
2. Improved access to quality healthcare: OPPI supports the Indian government’s quest for more accessible and affordable medicines and welcomes a more comprehensive dialogue between private and government stakeholders. 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 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 and means to build that infrastructure and ensure sustainable access to modern medicine at Indian healthcare centres.
We look forward to more collective CSR activity, bringing best practices and identifying and creating the critical infrastructure needed to achieve a good health development index. This will also improve policy relationships with local, state and central government agencies through Public Private Partnerships for the long-term benefit of Indian patients and make a significant impact in India. A healthier India will be a more productive India. OPPI is committed to partnering with all relevant government agencies and regulators to help meet national healthcare challenges in the interest of patients.
3. Ethics – Uniform code of pharmaceutical marketing practices: The DoP has issued the Revised Draft Uniform Code of Pharmaceutical Marketing Practices (UCPMP) on March 26, 2012 as a voluntary code of marketing practices for the Indian pharma industry, with the intent to review it six months from the date of its issue. If not implemented effectively by pharma companies, the Government was to consider making it a statutory code. We would like the Government to follow through on its intent, both to inspire confidence among patients and to demonstrate India’s commitment to a high level of ethics and compliance.
While it is important to achieve results, how we achieve them is equally important. Being a patient-focused industry, our members are committed to product safety and quality. In our interactions with the medical community, we are committed to following ethical promotional practices in our interaction with healthcare professionals and patients. We believe there must always be confidence that prescription decisions are made ethically and to benefit the patients.
The OPPI Code of Pharmaceutical Practices 2012 is based on the model International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) code and lays down guidelines for ethical behaviour in pharma marketing. The implementation of a universal code across the industry can level the playing field and be meaningful only with the coordinated effort of all pharma companies, cooperation from the medical community and support from the Indian Government.
4. Clinical trials: Clinical trials and the data they generate help doctors and pharma companies, Indian and global, gain a better understanding of how India’s diversity responds to new therapies. Given that as the Indian economy grows, more and more people will have access to modern medicine, it is in India’s interest to encourage clinical trials, with adequate safeguards. This forms part of the research in the development of new medicines and thus a part of the intellectual property. We need policies and regulations that will build confidence among innovators (domestic and foreign) carrying out such research in India, because it will help leverage scientific talent in India and enable the country to benefit financially from its vast clinical material. We must have a robust and transparent process for the conduct of clinical trials to obtain regulatory approval for new drugs to benefit patients, while supporting the Government’s effort to create a compensation framework.
5. Adherence to regulatory guidelines on biosimilars: The Government of India through its two agencies involved in the regulation of biological products viz. Department of Biotechnology (DBT) and the Central Drugs Standard Control Organization (CDSCO) have prepared the ‘Guidelines on similar biologics: Regulatory requirements for market authorization in India.’ These guidelines clearly outline the data requirements for the production process, characterisation, preclinical studies and clinical trials of biosimilars. Currently, pharma companies do not comply with the rules laid down in these guidelines. As an association of research based pharma companies, we seek full compliance with all applicable regulatory requirements before a company gets approval for marketing a drug in the country.
– Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India