Parliamentary panel opposes data exclusivity proposal
IT'S BUSIESS AS USUAL FOR DOMESTIC PHARMACEUTICAL MAJORS
| In a letter to Prime Minister Manmohan Singh, the committee said, providing data exclusivity would have serious implications for domestic pharmaceutical and agrochemical enterprises. |
| The committee said if the US demand on data exclusivity is conceded, domestic enterprises will not get marketing approvals on the basis of data submitted by originator companies which had generated and submitted the data for marketing approval. |
| "Even if the domestic enterprise has been granted compulsory license to use the patented subject matter, they will not be able to get marketing approval during the period in which data exclusivity is in operation, thus the stipulation under of TRIPS agreement is rendered unimplementable and competitive environment which could be created, would also be lost," the letter stated. |
| The standing committee's letter to the Prime Minister is significant as the Centre is under pressure from multi national companies and the US government to concede to the demand of data exclusivity. |
| The committee says during the Uruguay round of GATT negotiations, the demand of the US government and other developed countries for data exclusivity was rejected and only specific provision was incorporated in section 7 of the TRIPS agreement for the protection of 'Undisclosed Information'. |
| The committee had noted in the letter that the world Health organisation, after thoroughly examining the issue, has recommended the developing countries would be well advised to keep the IPR and drug regulatory systems separate and to reject any attempt to connect the two. |
| The committee has called for an urgent intervention of the PMO so that TRIPS plus measures are not pushed by the ministries concerned for legislation. |
| Data protection is the protection provided by governments against the unfair commercial use of information generated in the pre-clinical and clinical testing of a drug product. |
| This information is generated and submitted to a regulatory agency to obtain authorisation to commercially market a new drug product. |
| Data exclusivity provides exclusive use of the data by the inventor for certain period as stipulated by the law. |
| Sources from the Organisation of Pharmaceutical producers of India, which is largely represented by multinational pharmaceutical companies in India, said data protection is mandated by the TRIPS Agreement, and that at least pharmaceutical and agrochemical products using new chemical entities should come under its purview. |
| "Generating evidence that a new drug product is safe and effective is a time consuming, difficult and expensive process," they said. |