Environmental impact assessment in the pharmaceutical industry

Abstract

Environmental Impact Assessment is a process for identifying the likely effects that a proposed development will have on the environment and mans health and welfare. The process was first introduced in the United States under the National Environmental Policy Act of 1969 which introduced legislation to protect the environment. The European Community set out in its second environment programme a requirement for the assessment of the effect of development projects on the environment and a Directive was approved in 1985 for this purpose. Member States were allowed 3 years to implement the Directive but the Irish Government did not introduce any new legislation for the purpose of implementing the Directive until the European Communities (Environmental Impact Assessment) Regulations 1989 were introduced. In the case of the pharmaceutical industry, the regulations required that an Environmental Impact Assessment be performed for all development projects prior to development consent being granted. Since 1988 twenty-eight Environmental Impact Statements have been submitted to the competent authorities covering developments in the pharmaceutical sector. Practically all of the EISs were prepared by consultants on behalf of the developer with 21 of these prepared by Eolas. Analysis of the EISs show that they comply well with the requirements of the regulations although a number of them are considered too long for public consideration of their contents. In general, the EISs stated that the developments would have little impact on the environment either due to the scale of the development or because of mitigating measures designed to eliminate any possible adverse impacts. The European Commission has assessed how Member States have implemented the Directive and plans to introduce an amendment to Directive 85/337/EEC which will introduce more formal scoping into the process. With the establishment of the Environmental Protection Agency and its role in the area of integrated pollution control licensing, there will be greater control over the pharmaceutical industry. The publication of guidelines by the agency for the preparation of EISs and its central role in the scoping process will lead to an improvement in the quality of EISs in the pharmaceutical sector.