WHAT IS SUDDEN?

The environmental impact of pharmaceuticals is a growing problem that affects the entire globe. As societies become urbanised and the world’s population grows and ages, the use of medicinal products along with their chemical load on the environment increases.

The problem is multi-faceted and involves all phases of the lifecycle of medicines. First of all, a large proportion of raw materials used for pharmaceuticals are produced in developing countries where the control of environmental emissions that result from production processes is often deficient.

The challenge in drug development is that environmental friendliness and medical effectiveness do not always coincide. A certain drug may be an effective means to combat disease in humans but contaminates the environment. The environment is burdened when discarded drugs or compounds traced to the metabolisms of humans and animals end up in wastewater or in nature.

The disposal of unused medicine is also a significant  problem. In addition, pharmaceutical packaging often uses environmentally problematic materials, such as aluminium and polyvinyl chloride (PVC), which are currently difficult to recycle. When not recycled, these materials increase the consumption of depleted natural resources to an unnecessary extent.

SUDDEN, or Sustainable Drug Discovery and Development with End-of-Life Yield, is a multidisciplinary research consortium dedicated to reducing the environmental impact of pharmaceuticals and supporting sustainable growth in the pharmaceutical industry. The project, which is running between 2018-2021 and 2022-2023, is funded by the Strategic Research Council of the Academy of Finland. The initiative is being carried out by the University of Helsinki, University of Eastern Finland, Lappeenranta-Lahti University of Technology, Aalto University, the Finnish Environment Institute and think tank Demos Helsinki.

We research the most critical aspects of the drug lifecycle from a sustainability perspective and seek answers to the following questions:

1.

How can we make pharmaceuticals as environmentally friendly as possible?

Director: Henri Xhaard, University of Helsinki

The use of pharmaceuticals results in large quantities of drug residues being discharged into wastewater, not all of which can be removed by current wastewater treatment methods. The pharmaceutical industry is therefore interested in the development of biodegradable or otherwise harmless drugs. The challenge is that biodegradable drugs rarely have sufficient quantities of chemical preservatives, which in turn weakens their medicinal qualities.

In Work Package 1, we address the problem through predictive computer modelling. We screen existing data on chemicals used in drugs and model the environmental impact of the compounds. We examine the active ingredients of medicines to identify ecotoxic properties – that is, those harmful to the environment and to organisms. We also examine biodegradable chemical compounds. The identification of the least environmentally harmful compounds will enable the development of more environmentally friendly medicines in the future.

2.

How can the environmental risks of pharmaceuticals be better anticipated?

Director: Tiina Sikanen, University of Helsinki

In addition to the active ingredients of pharmaceuticals, their biological conversion products, or so-called human metabolites, end up in wastewater and burden the environment. However, the adverse effects of the conversion products on the environment are not yet well known.

Drug residues in the environment may accumulate through the food chain in organisms that may not be as effective as the human body in eliminating them. Some species are more susceptible to the effects of drug residues than others. These effects can be lethal or even alter population levels.

In Work Package 2, we focus on a more comprehensive assessment of the environmental risks of medicines. We collect information from previous risk assessments and review them with research literature on the topic. We aim to identify issues related to environmental risk assessment and to develop tools to improve assessment effectiveness.

Our goal is to be able to predict the ecotoxic (ie. harmful to the environment and organisms) effects of drugs at the beginning of the drug’s lifecycle using modern in vitro test methods. Less environmentally harmful but equally potent candidates could then be selected for further development instead of those with a heavy environmental burden.

3.

How can we support sustainable growth in the pharmaceutical sector?

Director: Mirella Miettinen, University of Eastern Finland

The manufacturing of medicines is strictly regulated. Production must comply with Good Manufacturing Practice (GMP) requirements, which are based on EU directives and regulations. However, the guidelines do not include specific environmental requirements, nor do they cover the final stages of the lifecycle of medicinal products such as the monitoring of pharmaceutical residues in nature.

Currently there are no financial incentives to maximise environmental friendliness. At the moment, the environmental impact of drugs is assessed mainly based on the properties of the active ingredient.s  This does not motivate manufacturers to invest extensively in environmental friendliness at different stages of product lifecycles.

In Work Package 3, our objective is to promote environmentally sound decision-making and to support sustainable actions in the pharmaceutical sector. We are reviewing the national and international regulation of drug production chains and consumption to identify gaps in the environmental impact of medicines. We are responding to current shortcomings by producing recommendations and reports that support decision-making.

We will also look at the views of consumers and pharmaceutical professionals on manufacturing drugs in more environmentally friendly ways. We will also study how much consumers would be prepared to pay for sustainability. We aim to promote the introduction of an environmental classification system for medicines in Finland to better take into account the environmental impact of prescribing, purchasing, pricing and reimbursement practices. A system encompassing the environmental impact of a drug’s lifecycle would offer new business opportunities for responsible but profitable drug development.

4.

How can we improve the removal of drug residues from wastewater and promote the recycling of pharmaceutical packaging materials?

Director: Mika Mänttäri, Lappeenranta-Lahti University of Technology

Even the most advanced wastewater treatment plants cannot completely remove all the chemicals that end up in the sewerage system because of the use and incorrect disposal of medicines. Furthermore, medicine packaging is currently not recycled at all. The sensible use and disposal of medicines and the recycling of packaging would save energy and prevent water contamination at all stages of the product lifecycle.

In Work Package 4, we examine the recycling of pharmaceutical packaging materials, especially plastics and metals. We are developing new best practices and policy recommendations on how to best recycle pharmaceutical packaging waste. We are also building a database to model the behaviour of pharmaceuticals in wastewater treatment plants. A database could potentially be used to design new water purification technologies to remove harmful chemicals from water more efficiently.