To meet the unmet needs of the patients and improve access to healthcare in India mere discovery of a new pharmaceutical entity is not enough. The journey from mind to market is indeed an arduous one.
For the patients’ sake:
From the viewpoint of patients, proper evaluation of the safety, quality and efficacy of medicines are critical. Towards this direction, substantial clinical data needs to be generated through extensive pre-clinical and clinical trials to satisfy the regulatory authorities for marketing approval of a New Molecular Entity (NME).
Reasons why the innovators data will need protection:
Irrespective of what has been indicated in Article 39.3 of TRIPS, Data Protection (DP) is justifiable on the following grounds:
a. Generation of data by the originator to ensure safety and efficacy of the drugs for the patients involves considerable cost, time and efforts.
b. Submission of detail clinical data is a regulatory requirement for the interest of the patients. Without such obligation to the Government, the data would have remained completely under control of the originator. It is, therefore, a reasonable obligation for the Government to respect confidentiality of the data in terms of non-reliance and non-disclosure.
c. Since the data is proprietary during the patent period, any access to such data for commercial use by the second applicant without the concurrence of the originator is unfair on grounds of propriety and business ethics.
d. Any failure by the Government to provide the required protection to the data would lead to “unfair commercial use”.
e. Without DP, the originator of the innovative drugs would be placed at an unfair commercial disadvantage as compared to their generic counterparts. Generic players do not incur similar huge costs for meeting the mandatory requirements of the regulatory authorities for NMEs.
Patent Protection and Data Protection – two different IPRs:
The distinctiveness of the two incentives, namely, Patent Protection and Data Protection or Data Exclusivity is recognized in countries which are leading in research and development in pharmaceuticals.
Data Protection will provide substantial benefits to the stakeholders:
Benefits to Patients:
DP ensures stringent evaluation of overall safety and efficacy of drugs launched in the market. Mere proving of Bioequivalence/ Bioavailability (sometimes on as low as 12 healthy volunteers in India) does not guarantee drug safety as the impurities profile of the duplicator’s drug is likely to be different than that of the originator.
Benefits to Doctors:
Doctors continuously seek scientific information. Clinical evaluation becomes valuable from this perspective. Once provisions for DP are made, comprehensive and quality data can be collected and the detail scientific information be provided to the doctors to update their knowledge for the ultimate benefits of the patients.
Benefits to Researchers:
Clinical researchers in India can win substantial share of this global market with DP as an effective driver in the evolving scenario. There will be increased R&D collaborations. India’s cost arbitrage, speed and skills in clinical trial and research could be leveraged more effectively.
An Expert Committee under the Chairmanship of Dr. R.A. Mashelkar, an eminent scientist, also highlighted the significance of DP, as follows:
“In order to ensure enabling environment, the regulatory division dealing with the applications concerning new drugs and clinical trials would be required to develop suitable mechanisms to ensure confidentiality of the submissions.”
Benefits to Pharmaceutical Industry:
Research is a key driver for the Pharmaceutical Industry. Scientists prefer to work in research laboratories in those countries which provide full-fledged protection to IPR. DP is one of the Intellectual Property Rights. Reversal of brain drain and retention of scientific talents will help the developing economies, like India intensify its R&D efforts. More Indian pharmaceutical companies, while globalizing the business, will engage themselves in partnerships and collaborations with research based global companies.
Indian scientists would need DP to protect their Intellectual Property as many Indian pharmaceutical companies have already started increasing their R&D budgets.
Benefits to Governments:
Once India moves from a stand-alone position to one which aligns itself with the world in terms of IPRs, including DP, India is likely to increase trade not only in ASEAN (Association of South-East Asian Nations), MERCOSUR countries (Argentina, Brazil, Paraguay & Uruguay) and NAFTA (North American Free Trade Agreement), but even in regulated markets like USA and Europe. There will be increase in scientific education, technology transfer and quality employment.
Could Data Protection affect the legal generics or delay their launch?
Unfortunately, a bogey is raised to create an impression that DP provisions will act as a barrier to the development of generics, adversely affecting the domestic and export business of the local players. Following facts will prove the irrelevance of the arguments propounded by this lobby:
• DP refers only to new products patented in India. It will not affect the generic drugs already in the market.
• USA is an outstanding example, which demonstrates that research based global companies and the generic industry can co-exist, offering dual benefits of innovative drugs and cheaper off-patent generic medicines to the patients.
• More number of patented medicines will ensure faster growth of the generic industry, after the former goes off-patent. In the USA which has a long standing DP regime, the market penetration of generics is amongst the highest in the world and stands at over half of all the prescriptions. After introduction of Hatch Waxman Act in 1984 that provided for a 5 year period of DP in the USA, there were spurt of development of New Drugs together with quicker entry of generics into the market.
• The apprehension that growth of the generic market will slow down with DP, is ill-founded. Indian companies, on the contrary, are aggressively seeking growth opportunities for generics in markets like the USA and Europe where DP is already in place.
• Domestic Indian companies will be dependent upon implementation of a fully compliant TRIPs regime, including DP for their business growth in these markets.
• DP does not prevent generic manufacturers from submitting their own pharmacological, toxicological and clinical data within the period of DP and thus gain marketing approval for their products.
DP controversy is based on a narrow perspective, as it is not an issue of “Generics vs. R&D based companies”. It is a much larger issue. DP and patents are important for all research based companies irrespective of their Indian or foreign origin.
Data Protection is not ‘Evergreening’:
DP is not ‘Evergreening’ either. In most of the cases, the period of patent protection and DP will run concurrently.
During the debate on the subject some people argue that DP and patents offer “double protection”. They do not. Fundamentally, these two forms of Intellectual Property are like different elements of a house which needs both a strong foundation and a roof to protect its inhabitants. DP cannot extend the life of a patent which is a totally separate legal instrument. While patent protects the invention underlying the product, DP protects the clinical Dossier submitted to the regulatory authority from their unfair commercial use. The duration of DP is typically half or less than that of a patent.
Most WTO member countries have Data Protection:
A review of National Laws relating to the protection of Registration Data in the major WTO Member-States reveals that most of the countries have recognized and appreciated the role of DP.
Although there is no uniform standard that is followed by the countries while enacting and implementing the Laws related to DP. The period of DP is typically between 5 to 10 years.
Dr. Satwant Reddy Committee Report, dated November 30, 2006, submitted to the Government of India, very clearly recommends that DP will benefit India, as it has done in many other countries of the world, including China. Unfortunately, the report does not specify a timeline for its implementation. Thus having accepted the importance and relevance of the DP, the Government should implement the same in the country, without any further delay.
Data Protection should be provided by making an appropriate amendment in Schedule Y of the Drugs Act to bring India in conformity with the practices of other WTO Members of the developing and developed countries.
By Tapan Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.