Will Data Protection in pharma benefit India?
DEBATE
Managing Director Pfizer Limited DP compels pharma companies to be more accountable for the safety of their products and be more responsible to the patients Article 39.3 of Trade-related Aspects of Intellectual Property Rights (TRIPS) states that countries must ensure that clinical data submitted for marketing approval is not relied upon by the regulator to grant subsequent marketing approvals to other companies. However, where it is necessary to protect the public, disclosure of such data is permitted. Many Indian companies, government officials and, above all, the research community recognise the benefits that will flow to India by adopting "protection" for commercially valuable clinical research data. Millions of Indian researchers will benefit with increased access to research activities for drug and agro-chemical development in India. Indian companies, patients, and other consumers stand to gain from partnerships that are possible only with incentives for innovation. |
| India has the potential to be a global leader in R&D-based industries. Furthermore, Indian scientists have demonstrated their critical research talent in biotechnology and pharmaceuticals. The current research outsourcing market (discovery and clinical research) is expected to be worth $20.4 billion, of which India can lap up $1 billion. |
| However, there are several myths, such as the belief that "Data Protection (DP) extends the monopoly term of the patent". DP is not dependent on the existence of a patent. It runs independent of the patent term, although concurrently. This lasts typically for only half or less than the balance duration of a patent. Since the development of a drug takes eight-12 years of the 20-year patent term, there is not too much time to protect data in any case. Thus, DP is not a way of extending the patent life. |
| Furthermore, the notion that a company would wait until the end of its patent term in the US to introduce the product in another country so as to gain an additional period of protection is foolish. The real time protection for a drug is limited and newer drugs with similar or improved therapeutic values would be introduced. Therefore, a company would logically introduce its new drug close to the international launch date. |
| Another myth is that DP blocks the manufacture and export of drug products from India. DP focuses on the marketing of pioneer drugs within the territory of a country. This does not affect the ability of any other company to manufacture the active ingredient of a drug, to formulate the active ingredient into a drug product, or to export the active ingredient or drug product, provided that drug product is not being sold within India. |
| Protecting valuable data in the clinical dossier submitted to regulatory agencies acts as an incentive for the innovator to conduct detailed clinical safety and toxicology studies. DP compels pharma companies to be more accountable for the safety of their products. |
Joint Managing Director Cipla
Regenerating existing data would mean a waste of time and research energy. Why should everyone be forced to reinvent the wheel?
The demand for Data Exclusivity (DE) or Data Protection (DP) by international innovator pharma shows a definite attempt to guard proprietary products from generic onslaught for as long as then can stall it. For starters, DE means that a generic company should regenerate all the drug data that the innovator had generated while submitting it for the regulator's approval. Right now, the generic companies have to establish "bio-equivalence" to the innovators drug.