Socio-economic considerations

Council Directive 65/65/EEC (Approximation of Provisions Laid Down by Law, Regulation, or Administrative Action Relating to Proprietary Medicinal Products) laid down the principle... that [authorizations] for medicinal products and all Member States should be granted on scientific grounds of quality, safety, and efficacy, without regard to socio-economic considerations. See 1965 OJ (22) 269. 

Socio-economic considerations for measures aimed at achieving occupational or environmental protection set under legislative frameworks based on Articles 138 or 175 of the EC Treaty would be outside the scope of REACH. For standards under Directive 98/34 proportionality must already be demonstrated by the Member State through the notification procedure. 

Socio-economic considerations, such as jobs creation and other impacts (positive and negative) of the relationship between the economy and societal well-being ... 

While each of the above considerations nominally focuses on only two of the dimensions of sustainable development, it is in fact closely connected to all three. Environmental degradation or improvement, for example, is one important factor related to how economic activities affect societal well-being (a socio-economic consideration). Similarly, socio-environmental impacts have their related cost and economic implications. Further, judicious consideration of eco-efficiency may result in various societal advantages, including (a) the benefits derived from the products... 

Integrating the Socio-Economic Considerations. As discussed earlier in... 

Moreover, the application of this tool permitted to evaluate the effect and efficiency of combinations of measures. Using multi-criteria analysis during the decision-making process allows taking into consideration several criteria such as technical efficiency of the measures, cost of their application, political criteria and socio-economic issues. 

Under European chemicals legislation, proposals to restrict the production or use of chemicals, or to authorize the use of a chemical subject to the authorization procedures of REACH, are subject to a socio-economic analysis. The socio-economic analysis should include the following consideration of the commercial impacts on manufacturers, importers and downstream users the impacts on consumers the social impacts, such as effects on job security and employment the availability, suitability, technical and economic feasibility of alternative substances and/or technologies implications for trade, competition and economic development and the benefits for human health and the environment and the economic and social benefits of restrictions or refusal of authorizations (Regulation (EC) 1907/2006, Annex XVI). 

Environmental Impact Assessment (EIA) has evolved as a comprehensive approach to project evaluation, in which environmental factors, as well as economic and technical considerations (e.g. Cost Benefit Analysis), are given appropriate consideration in the decisionmaking process. The purpose of an EIA study is to determine the potential environmental, social and health effects of a proposed development. It attempts to define and assess the physical, biological and socio-economic effects, so that logical and rational decisions are made. The identification of possible alternative sites and/or processes may assist in the reduction of potential adverse impacts. 

This section introduced a methodology to move from a verbal description of biocomplexity to its numerical representation. In future studies it will be necessary to take into consideration bottom relief, climate trends, ice field dynamics, detailed components of the trophic pyramid, bottom sediments, and the structure of currents. Also, it will be necessary to add to Formula (6.31) elements describing anthropogenic impacts on the ecosystem considered in a socio-economic sense. 

Compared with analysing the socio-economic consequences of chemical production and use in terms of the impact on variables such as employment and industrial competitiveness, EU risk management decision-making clearly lacks a method to evaluate the consequence that perceived chemical risks have on perceptions of equity. Moreover, there appears to be little consideration of how decisions can affect trust in regulatory institutions. Yet, as described in Chapter 2 and explored in Chapter 4, these social dimensions of risk prove fundamental to regulation. 

Figure 6.1. Socio-economic, socio-environmental, and eco-efficiency considerations at the intersections of the triple dimensions of sustainability.

The general trend towards activation has been one of the major issues in recent welfare and labour market reforms in Europe and the US. In many of these countries this issue has dominated the socio-economic and legal debate. Despite considerable variation across national models with respect to the scope and intensity of activation, it is evident that redefining the link between social protection and labour market policies on the one hand and employment on the other has been a common issue in labour market reforms. 

The Committee takes case-by-case decisions for exairqjle when it has more up-to-date data available than those on which the Gentian MAK values are based or if for example the Nordic countries publish criteria documents justitying lower limit values. This is the place where socio-economic aspects are taken into consideration including technical feasibility and the pos le economic consequences for industry. 

The term binding occupational exposure limit value (BOELV) was introduced in article 3,4 of the chemical agents directive 98/24/EC. This type of Hmit is established in accordance to J 118 a of the European Treaty and is Hsted in the annex of this directive. According to the procedure for incorporation of limit values into national laws, the EU member states are required to adopt a national occupational exposure limit, which may be equal to or below the Hmit, but not higher than the BOELV. The procedure for establishing BOELV is quite complicated. Besides the toxicological properties, feasibility plays an important role. This includes technical aspects as well as considerations of the excess risk at estimated exposure levels. The acceptable-risk approach for genotoxic substances requires intense discussions on socio-economic factors between aU interested parties. 

Most important from our point of view, however, is how this case challenged the conditionality of the trust balance and exposed potential fragilities when critical issues about the socio-economic distribution of risk were at stake. The risk-cost-benefit considerations that were thus introduced involved rather complex questions What was really the magnitude of the risks involved How much risk reduction would be achieved by the variety of solutions available in different operational situations What were the compliance costs, and did they justify the (contested) risk reduction compared to alternative allocations of risk-reducing efforts And, of course, what was really the impact of welfare concerns for the workers in these requirements ... 

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