International Initiatives for Regulating Access to Genetic Resources

In light of the various international instruments and international agencies that are actively engaged in resolving the issue of ABS, the present work tries to find an answer to the larger question how far the above agencies have succeeded in regulating access and make sure of benefit sharing. In this process, the work comprehensively analyses the work of different agencies involved in the process. It tries to find out the major obstacles that stand in the way of fulfilment of the benefit sharing objective and proposes the ways and means to tackle them. The study first traces the legal foundations of the concept of property in GRs and associated TK.For this, it starts with analysis of the nature of property and the questions related to ownership in GRs as contained in the CBD as well as in various State legislations. It further examines the notion of property before and after the enactment of the CBD and establishes that the CBD contains strong private property jurisprudence.Based on the theoretical foundation of private property right,Chapter 3 analyses the benefit sharing mechanism of the CBD, i.e. the Nagoya Protocol. It searches for a theoretical convergence of the notion of property as reflected in the two instruments and successfully establishes the same. It makes an appraisal of the Nagoya regime to find out how far it has gone beyond the CBD in ensuring the task of benefit sharing and the impediments in its way.Realizing that the ITPGRFA forms part of the CBD system, Chapter 4 analyses the benefit sharing structure of ITPGRFA as revealed through its multilateral system. This gives the work the benefit of comparing two different benefit sharing models operating on the same philosophy of property. This chapter tries to find out whether there is conceptual coherence in the notion of property when the benefit sharing model changes. It alsocompares the merits and demerits of both the systems and tries to locate the hurdles in achieving benefit sharing. Aware of the legal impediments caused by IPRs in the process of ABS, Chapter 5 tries to explore the linkages between IPRs and GRs and associated TK and assesses why contract-based CBD system fails before the monopoly rights under TRIPS. Chapter 6 analyses the different solutions suggested by the international community at the TRIPS Council as well as the WIPO (World Intellectual property Organisation) and examines their effectiveness. Chapter 7 concludes that considering the inability of the present IP system to understand the grass root realities of the indigenous communities as well as the varying situations of the country of origin, the best possible way to recognise the CBD goals in the TRIPS could be better achieved through linking the two instruments by means of the triple disclosure requirement in Article 29 as suggested by the Disclosure Group during the TRIPS Council deliberations. It also recommends that considering the nature of property in GR, a new section/chapter in the TRIPS dealing with GRs would be another workable solution.

Legal Protection for Consumer of Pharmaceutical Products

The overall focus of the thesis involves the legal protection for consumers of pharmaceutical products.The work on “Legal Protection for Consumers of Pharmaceutical Products” is undertaken to study the legal framework that is existing for this purpose and the functioning of regulating mechanism that is envisaged under it. The purpose of the study is to analyse how far these measures are effective in adequately protecting various aspects of consumer interest. Methodology adopted for the study is analytical.The present study revealed that the theory of freedom of contract is only an ideal relevant when the parties are assumed to be on equal footing.In a more complicated social and economic society, it ceased to have any relevance. Many countries in the world enacted legislations to protect the consumers of pharmaceutical products.The meaning of ‘consumers of drugs’ provided in the law is inclusive and not exhaustive one. The definition of ‘drug’ as interpreted by the courts is comprehensive enough to take in it not only medicines but also substances. The meaning of the word substances has been widened by the interpretation of the courts so as to include all the things used in treatment.The definition of the word ‘consumer’ has been liberally interpreted by the courts so as to provide protective net to a large section of the public.The studies subsequent to this report also revealed that there is a shortage of essential drugs necessary to cure local diseases like tuberculosis and malaria where as drugs containing vitamins and other combinations which are more profitable for the manufacturers are produced and marketed in abundance.The study of the provisions in this regard revealed that the duty of the drug controlling authorities is confined to scrutinize the data of the clinical test already conducted by the sponsor of the drug.Study of the clinical trial procedure under the U.S. law revealed that there is a continuous supervision over clinical trials and controls are provided on the treatment use of an investigational productStudy of the clinical trial procedure under the U.S. law revealed that there is a continuous supervision over clinical trials and controls are provided on the treatment use of an investigational product.the study of the provisions of the Drugs and Cosmetics Act and the rules framed under it revealed that the law in this regard is comprehensive to protect the consumer provided it is sufficiently supported by adequately equipped enforcement machinery.