Will Data Protection in pharma benefit India?

DEBATE

While the innovators see Data Protection as an essential step to spur R&D, generics deem it as ploy to ensure monopoly by yet another name.

KEWAL HANDA,
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.

AMAR LULLA,
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.

DP means a generic company cannot use the data generated by the innovator for a fixed period of time. Even though DP seems a reasonable proposition as compared to DE, it is practcially an euphemism for DE. Regenerating existing data would mean a waste of time and research energy. Why should everyone be forced to reinvent the wheel? And what if the data so generated questions the safety and/or efficacy findings of the originator?

If DE/DP were to be enforced in India, generic companies would not be able to carry out the R&D of the generic versions in time. This would thwart the whole purpose of generics since it would not only delay their development, but will also make them unviable to develop.

India is currently allowed to export to 49 countries like Uganda, Tanzania, Zambia, Bangladesh and Ethiopia. Patent laws in these countries will not be implemented until 2016. If DE/DP was granted in India, exports to these countries will be delayed.

The demand for DE/DP emanates from Article 39 (3) of TRIPS agreement, which requires member countries to protect "undisclosed data" from "unfair commercial use" when it is submitted to the regulator for approval.

The TRIPS agreement fails to define "unfair commercial use" and "new chemical entities". It specifies no timeline for protecting data and members have extended the definition to include second indications, formulations and dosage forms. Also, it talks of protecting only "undisclosed data", while data disclosed already, as in this case, need not be protected.

It would also create a back-door entry for patents, especially where India doesn't provide patent protection. It will negate the current flexibilities under TRIPS, thereby impacting research and application of new uses of an existing drug and new dosage delivery forms. DP/DE will lead to patent "evergreening", thereby extending its normal life beyond 20 years. What kind of a research in generics would such retrograde steps induce? Innovators expend their resources, create the drug data and are rewarded in the form of "patents". Generics sit on no such privilege. If they don't have the cushion of big bucks in the form of patents, why burden them with the cost of generating data?

Much as the need for DE/DP is being whipped up in the name of TRIPS compliance, it remains a ploy to ensure, what I call, monopoly by yet another name.