Protection of Clinical Trial Data: Health Concerns

‘Information’ is turning out to be one of the most valuable resources in today’s world. The information one exclusively holds provides a competitive edge over another in the context of trade and commerce. As a result, all possible attempts are made for propertisation of knowledge. However, certain kinds of information which are protected under the umbrella of property rights need to be revisited, particularly when they involve a larger interest of the public.

One such kind of information is the clinical trial data of a drug which is mandatorily required to be submitted before a regulatory agency in order to obtain marketing approval for the drug. In certain jurisdictions, such information is given exclusive property rights provided that it is a new drug, thereby preventing the agency from relying on the information while approving another similar drug for which similar set of data has to be submitted for obtaining approval. In other jurisdictions, the agency is allowed to rely on such data of a new drug for approval of generic drugs provided that the generic drug proves that it is a ‘bio-equivalent’ to the new drug.

Existing Mechanisms of Protection

Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) states that:

Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

Many eminent jurists have pondered over the interpretation of Article 39.3 and have provided different perspectives on the same. EU and US have till date argued that ‘Data Exclusivity’ has been contemplated under Article 39.3 of the TRIPS. In other words, the regulatory agency should not rely on such information for a certain period of time for approval of other drugs, provided it fulfills the criteria mentioned under Article 39.3. Prof. Shamnad Basheer proposes a ‘Compensatory Liability Model’ which provides adequate and fair means of compensation for relying on such data of an originator drug. A third approach argued and echoed by many others, is to permit the regulatory authority to rely on such data while approving other drugs proven to be bio-equivalent to the originator drug. It is more of a policy concern of a nation to decide which model to adopt. Article 39 is governed by the concept of ‘Unfair Competition’ provided under Article 10bis of the Paris Convention for the Protection of Industrial Property (1883). Whether the act of reliance on such data by the regulatory agency can be termed as an unfair commercial practice is a debatable question. However, one should not forget the space for public interest specifically provided in the concluding part of Article 39.3.

Article 7 & 8 of TRIPS

Jurisdictions which favor a strong IP regime often neglect the crucial articles of the TRIPS agreement which set out the objectives and principles of the agreement.  Concerns such as protection of public health and nutrition, promotion of public interest in sectors which have serious impact on a country’s socio-economic and technological development have been specifically incorporated in the agreement with a purpose and should not be neglected while looking into the interpretation of Article 39.3.

Other International Obligations

The Declaration of Helsinki drafted by the World Medical Association(WMA) condemns conducting of unnecessary trials on humans. Even though it is not a binding document unlike TRIPS, it holds a valuable position in the international arena. In a situation where each and every similar drug is required to submit their own set of clinical trial data, it would lead to a huge increase in the trials conducted which would run contrary to the objectives of the declaration.

Extended Protection

One needs to go back in history and look at the way developed nations increased the scope of patent protection with respect to the rights granted under a patent and also with respect to the term for which the patent was granted. By granting exclusive property rights to clinical trial data and preventing a regulatory agency from relying on that data in effect extends the market exclusivity afforded under a patent. In other words, generics would have to either spend time generating their own regulatory data or wait for the expiry of the term specified for data exclusivity. This in turn would provide extended market exclusivity for the originator drug.

India’s Concerns

India has till date taken the stand that Article 39.3 does not contemplate the ‘Data Exclusivity Model’ or any other model which restricts the freedom of a regulatory authority to rely on such data for the sole purpose of approval of other drugs.  It enables generic companies to launch their drugs in the market depending on whether the drug has a patent protection or not.

India is a sought out destination for the developed nations as far as clinical trials are concerned. People are lured towards clinical trials through money without knowing the consequences of such trials. The consent factor of such subjects of clinically trials are always disputable. In such a situation, taking any stand other than the existing one would prove to be prejudicial to the interests of the nation. India needs to constantly maintain its stand and not succumb to the pressures in the ongoing negotiations of the Regional Comprehensive Economic Partnership (RCEP) agreement.



Naveen Gopal is a Research Scholar at Inter University Centre for IPR Studies, CUSAT, Kochi. Email: naveengp.87@gmail.com

Views expressed are personal of the author. The Indian Jurist does not take responsibility for the views expressed or facts stated. 


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