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The effects of a pharmaceutical treatment have until now been evaluated by the field of Health Economics on the patient health benefits, expressed in Quality-Adjusted Life Years (QALYs) versus the monetary costs. However, there is also a Human Health burden associated with this process, resulting from emissions that originate from the pharmaceutical production processes, Use Phase and End of Life (EoL) disposal of the medicine. This Human Health burden is evaluated by the research field of Life Cycle Assessment (LCA) and expressed in Disability-Adjusted Life Years (DALYs), a metric similar to the QALY. The need for a new framework presents itself in which both the positive and negative health effects of a pharmaceutical treatment are integrated into a net Human Health effect. To do so, this article reviews the methodologies of both Health Economics and the area of protection Human Health of the LCA methodology and proposes a conceptual framework on which to base an integration of both health effects. Methodological issues such as the inclusion of future costs and benefits, discounting and age weighting are discussed. It is suggested to use the structure of an LCA as a backbone to cover all methodological challenges involved in the integration. The possibility of monetizing both Human Health benefits and burdens is explored. The suggested approach covers the main methodological aspects that should be considered in an integrated assessment of the health effects of a pharmaceutical treatment.

The nutritional value of food and its environmental impact have received considerable attention, however an assessment of environmental sustainability of catered meals is lacking. We therefore assessed the nutritional value and resource consumption of a specific catered meal, pork tenderloin with potato croquettes, carrots and mushroom sauce (‘Canteen Pork’). The outcomes are compared with that of an identical meal cooked at home (‘Home’), for which ‘Low’ and ‘High’ scoring hypothetical alternatives were defined (e.g. whether or not frying oil as a waste product was reprocessed or recycled), as well as with that of a vegetarian alternative: Quorn™. The resource consumption impact is assessed from cradle-to-disposal, expressed as the Cumulative Exergy Extraction from the Natural Environment (CEENE). Exergy is the amount of useful energy. The CEENE approach accounts for all resource types and is unique since it considers the deprived natural net primary production (expressed in exergy) as the impact for human land occupation, highly relevant for crop and thus food production. The food production, processing and packaging stage accounts for the largest amount of resource consumption compared to food preparation and waste management. The ‘Home Pork High’ scenario has the highest resource consumption at 83 MJex meal−1. ‘Home Pork Low’, ‘Home Quorn™ High’, ‘Canteen Pork’, ‘Home Quorn™ Low’ and ‘Canteen Quorn’ have a 15, 18, 26, 32 and 40% lower resource consumption compared to ‘Home Pork High’, respectively. For all scenarios, biomass resources contribute 52–64% of the total CEENE, mainly through land occupation. The nutritional analysis, via nutritional density scoring (the higher the better), resulted in a score of 18.1 and 31.2 for the ‘Home Quorn Low’ and ‘High’, 10.4 and 23.4 for the ‘Home Pork High’ and ‘Low’ scenario and 17.0 and 27.3 for the ‘Canteen Pork’ and ‘Canteen Quorn™’, respectively. To conclude, the vegetarian meal scores best on both attributes, however, this effect diminishes considerably if one considers outcomes per energy or protein amount. With regards to catered vs home cooked meals, resource consumption is lower in canteen prepared meals than in the case of the home-cooked meal. However, the nutritional value can be lower or higher depending on consumer behaviour, namely the extent of the use, type and application of butter is key in altering this result.

The pharmaceutical and fine chemical industries are eager to strive toward innovative products and technologies. This study first derives hotspots in resource consumption of 2839 Basic Operations in 40 Active Pharmaceutical Ingredient synthesis steps through Exergetic Life Cycle Assessment (ELCA). Second, since companies are increasingly obliged to quantify the environmental sustainability of their products, two alternative ways of simplifying (E)LCA are discussed. The usage of averaged product group values (R(2) = 3.40 × 10(-30)) is compared with multiple linear regression models (R(2) = 8.66 × 10(-01)) in order to estimate resource consumption of synthesis steps. An optimal set of predictor variables is postulated to balance model complexity and embedded information with usability and capability of merging models with existing Enterprise Resource Planning (ERP) data systems. The amount of organic solvents used, molar efficiency, and duration of a synthesis step were shown to be the most significant predictor variables. Including additional predictor variables did not contribute to the predictive power and eventually weakens the model interpretation. Ideally, an organization should be able to derive its environmental impact from readily available ERP data, linking supply chains back to the cradle of resource extraction, excluding the need for an approximation with product group averages.

The formulation and scale-up of batch processes is one of the major challenges in the development of pharmaceutical dosage forms and at the same time a significant resource demanding process which is generally overlooked in environmental sustainability assessments. First, this paper proposes general trends in the experience curve of cumulative resource consumption of pharmaceutical tablet manufacturing of PREZISTA® 800 mg through wet granulation (WG) at four consecutive scales in both R&D and manufacturing environments (resp. WG1 = 1 kg/h, WG5 = 5 kg/h, WG30 = 30 kg/h and WG240 = 240 kg/h). Second, the authors aim at evaluating the environmental impact from a life cycle perspective of a daily consumption of PREZISTA® 2× 400 mg tablets versus the bioequivalent PREZISTA® 800 mg tablet which was launched to enhance patient compliance. Environmental sustainability assessment was conducted at three different system boundaries, which enables identification, localization and eventually reduction of burdens, in this case natural resource extraction. Exergy Analysis (EA) was used at process level (α) and plant level (β) while a cradle-to-gate Exergetic Life Cycle Assessment (ELCA) was conducted at the overall industrial level (γ) by means of the CEENE method (Cumulative Exergy Extraction from the Natural Environment). Life cycle stages taken into account are Active Pharmaceutical Ingredient (API) production, Drug Product (DP) production and Packaging. At process level (α), the total resource extraction for the manufacturing of one daily dose of PREZISTA® (800 mg tablet) amounted up to 0.44 MJex at the smallest scale (WG1) while this amount proved to be reduced by 58%, 79% and 83% at WG5, WG30 and WG240 respectively. Expanding the boundaries to the overall industrial level (γ) reveals that the main resource demand is at the production of the Active Pharmaceutical Ingredient (API), excipients, packaging materials and cleaning media used in DP production. At the largest scale (WG240) the use of cleaning media during DP production contributes considerably less to the total resource extraction. Overall, the effect of scale-up and learning on resource consumption during DP production showed to possess a power-law experience curve y = 2.40 * x−0.57 when shifting from WG1 (smallest lab scale) to WG240 (industrial manufacturing). Tablet dosage (2× 400 mg versus 1× 800 mg) did not significantly affect the absolute environmental burden. However, the relative contribution of resource categories did change due to the different production technology. It could be concluded that in meeting social and economic demands by launching the PREZISTA® 800 mg tablet, no trade-off in environmental burden occurred. On the long term, future research should strive to take into account R&D processes and all services related to pipeline activities taking place prior to market launch and eventually to allocate impacts to the final product.

In the pharmaceutical industry, there is always a desire to identify better synthesis pathways and technologies. Chemistry can be changed resulting in safer reactions, higher yields, better recyclability, etc. Also new technologies as for e.g. continuous flow reactors can be used allowing better heat transfer and better reaction efficiencies compared to batch reactors. It is these innovations that make green chemistry actually happen. However, according to the principle “you can only manage what you can measure”, also measuring methods are required for the evaluation of the innovative improvements. Many chemistry related measuring methods are available for the evaluation of the greenness, eco-efficiency or even sustainability of new developments. In this article, exergetic life cycle assessment is used on a real case from the pharmaceutical industry (three generations of Galantamine·HBr synthesis) to illustrate the importance of the continuous search for improved chemical processes and technologies and of using measuring methods in order to support, quantitatively, the decision making towards new, greener and more sustainable processes and technologies. From this case, it can be concluded that a reduction in the overall resource consumption can rise up to 41% by optimizing the first generation pathway by new chemistry and by a new technology, i.e. continuous flow reactors.