The department of chemicals has come out with a draft report on data protection last week. The data protection debate revolves around the fact that the originator of a drug has to conduct extensive tests and clinical trials before concluding that a drug is safe and effective to use. The generation of this data involves considerable cost to the innovator. The regulatory authority needs to examine the raw data as well as the conclusions before granting approvals.
In India, the Drug Controller General of India (DCGI) can grant approvals to subsequent applicants of a drug similar to an earlier approved drug by placing reliance on the first applicant’s undisclosed data in another country. In effect, DCGI grants approvals for drugs without having the expertise or access to the data that has gone into determining whether the drug is safe and effective. It is, therefore, possible that approval for several generics may have been granted without independent data on their efficacy and safety. There is a recent incident where a patented drug has been withdrawn in the rest of the world due to side effects determined during post-marketing surveillance, but its generic copies merrily proliferate in India because there is no surveillance here by DCGI.
Apart from the above safety angle, there is the legal angle as well. The originator of the data needs to be protected against its use through prevention of unauthorized disclosure as well as prevention of unauthorized use. The recommendations of the committee address this issue in a limited way. The committee does recognize the obligations of fair trade and the need to protect against “unfair commercial use”. It, however, recommends only a calibrated approach. It suggests that unauthorized disclosure and unauthorized use should be controlled through the existing provisions of the Drugs and Cosmetics Act.
After an unspecified transition period, higher standards of data protection can be considered.
The industry, both national as well as multinational (barring the small players), would be very wary of a situation where, without reference to the mountains of clinical trial data, DCGI grants approvals based only on the summary results in the public domain. It is a pity that this debate has got mixed up with the interpretation of the trade-related aspects of intellectual property rights agreement and whether India needs to provide for it or not. In the national interest of availability of genuine clinically effective drugs, as well as growth of R&D, an important opportunity is being missed.
Two other articles in this paper last week revisit the debate on applicability of patenting laws to incremental innovation. The recent patent rejections emanating from the four offices (at most times triggered by pre-grant oppositions) demonstrate that the term efficacy is being construed in a “drug regulatory” sense and admittedly patent examiners are ill-equipped to appreciate efficacy standards. There are no clear and transparent guidelines defining “efficacy”. I had written earlier that it is somewhat paradoxical that Indian companies are seeking patents for incremental discoveries in other countries, but would like to deny themselves and others the right to do so in their own country. As many as 83 patents on stepwise innovations such as salts, esters and other modifications of existing patents are pending in Brazil, filed by Indian companies.
More importantly, the debate about patentability as well as data protection is getting intertwined with arguments about price and access. It is axiomatic that copies of patented drugs would be cheaper than the original, for they have no R&D costs to defray. Quite apart from efficacy issues, access to public health is not a function of drug prices alone. Public health management is a complex set of doctors, infrastructure, clinical regimen and drug delivery—of which the last is only one element. Unfortunately, there is a general belief in this country that if cheap drugs were available, the patients, with or without access to doctors, would administer them endogenously. This is a dangerous trend to perpetrate. This is perhaps the single reason that private health care—sometimes at exorbitant costs—is proliferating and indeed, there is a surge in development of these private hospitals, mostly for commercial gain.
This emerging trend is disturbing. Instead of policy taking a path forward to improve health care for all, there is a tendency to protect status quo, and in fact to strengthen it. The pricing and access to medicines issue can easily be addressed through a system of two-tier pricing that would have distinctive labelling and pricing for public health delivery systems, and an open market for others. On the other hand, there is need to encourage innovation, and to protect it. One has only to look at China to see how far our policies are being based on uninformed opinions.
S. Narayan is a former finance secretary and economic adviser to the Prime Minister of India. We welcome your comments at firstname.lastname@example.org