What we do towards sustainability and environmental protection
Pharmaceuticals first and foremost serve the well-being of patients. However, their production ought not to pollute the environment, their residues ought not to pollute the water. Especially in the production of antibiotics, care must be taken to ensure that as few active substances as possible enter the environment. Otherwise there is a risk of bacteria developing resistance - a great danger for humans and animals.
We are committed to ensuring that the environmental consequences of the production, use and disposal of medicines are kept as low as possible. Namely with the following initiatives:
Membership in the AMR Industry Alliance
The large antibiotic-producing manufacturers among the member companies of Pro Generika are part of the so-called AMR-Industry-Alliance (Antimicrobial Resistance means antibiotic resistance) Anti-Microbial Resistance). The alliance is one of the largest associations with the goal of developing sustainable solutions to curb antimicrobial resistance. More than 100 companies and associations from various sectors, including generics, biotech, diagnostics and research-based pharmaceuticals have united here in the fight against resistance. They all want to make antibiotic treatments safe for patients in the future.
To achieve this, our members have defined common goals and commitments as well as effective measures to combat the spread of anti-microbial resistances, focussing on the following four areas: research and development, market access, designated usage as intended, and eco-friendly sustainable production of antibiotics.
In order to be able to record and classify the progress made, there is a biennial reporting procedure based on a comprehensive member survey (100 % response rate from generic manufacturers). The second report was published in January 2020.
The AMR Alliance is leading the way in the industry's fight against antibiotic resistance. The European generics association „Medicines for Europe“ has formulated compliance with the above-mentioned production framework and discharge targets as a prerequisite for membership in its association.
Initiative on Pharmaceuticals in the Environment (IAI PIE)
Within the framework of all European pharmaceutical associations, we are also involved in the association initiative IAI PIE (Inter-Association Initiative on Pharmaceuticals in the Environment). The association of European pharmaceutical associations wants to gain new insights into the environmental compatibility of pharmaceuticals and reduce their entry into the environment. This is done through a sound assessment of current and future measures, taking into account the needs of patients and ensuring access to medicines.
In this context, the concept of the Eco-Pharmaco-Stewardship (EPS) was developed. It considers the entire life cycle of a medicinal product and develops responsibilities for all stakeholders.
The principle is based on three pillars:
- Identification of the potential environmental risks of medicinal products in the environment through targeted risk assessments.
- Compilation of best-practice examples of industrial pharmaceutical production and wastewater management that manufacturers can use to minimise risks to the environment. This will include encouraging manufacturing companies to share practices to further develop their wastewater control systems.
- Further development of existing processes of Environmental Risk Assessments (ERAs) of pharmaceuticals in order to also include long-established pharmaceutical substances in the evaluation processes (currently products put on the market before 2006 are excluded from ERA processes).
In all three pillars, the aim is to gain new knowledge on the environmental impact of medicinal products and to reduce the input of medicinal products into the environment.
National Dialogue on Trace Substances
Together with a variety of experts, including water management, local authorities, federal state authorities, industry representatives and other pharmaceutical manufacturers associations, we have been actively involved since 2016 in the so-called stakeholder dialogue of the federal government, which aims to develop a strategy on how to deal with trace substances in bodies of water.
The goal is to identify a balanced mix of measures to reduce the entry of these substances into aquatic environments. A catalogue of such measures is to form the basis for a national strategy on trace substances.
Over the course of this stakeholder dialogue, criteria were developed to categorise the various trace substances from various sectors, including pharmaceuticals, biocides, pesticides, detergents, cosmetics, household and industrial chemicals, and classify them according to their impact on the environment. This forms a crucial basis for concrete measures to be taken to further reduce the occurrence of trace substances and pharmaceuticals in the environment.
The measures of the stakeholder dialogue are currently in a one-year test phase. An independent expert panel for the identification and relevance assessment of trace substances has been appointed.
The expert panel's substance proposals can then in turn be passed on to a Producer Responsibility Round Table in order to agree on measures to reduce inputs of relevant trace substances into water bodies. The stakeholders of the round tables include representatives of industry, drinking water supply and wastewater disposal associations, the competent authorities and environmental associations.
The Round Table on X-ray Contrast Media (RKM) initiated by the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety in December 2019 made the start and has since been very active in fulfilling its responsibility.
National Dialogue on Water
In October 2018, during the first year of the UN Water Action Decade, the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) together with the German Federal Environmental Agency (UBA) initiated the so-called National Dialogue on Water. Here, we are engaged with representatives from business, administration, practice, interest groups and science, among others, to develop concrete proposals on how to better approach pollutant levels in water and how to improve the use of technical innovations – and how the German water sector can be kept competitive in the process.
At the end of the dialogue process, a key issues paper will be developed, which will be fed into relevant other strategy processes and serve as a building block for the development of a national water strategy "Future Water" by the BMU.