#EAPM - Impact of medicines on the environment to be tackled by Commission

A draft version of the European Commission’s Communication of pharmaceuticals in the environment is finally being circulated after a long delay, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

But despite the timeline, the Commission hasn’t been putting it to one side. Far from it: as well as encouraging less use of drugs to cut down on waste and stop the continuous seepage into water supplies, the EU executive is looking to use some of the cash available for its Horizon Europe programme to encourage production of medicines that degrade more efficiently.

The Commission also plans to urge member states into adopting laws that protect citizens from misleading advertisement claims and make sure that the pharmaceuticals are disposed of more efficiently.

Therefore, the available options include the stimulation of voluntary initiatives at EU or national level, as well as mandatory measures.

Also key is tackling antimicrobial resistance, which leads to medicines becoming ineffective.

On that topic, the Commission has recognized (certainly since 2014) that “the pollution of the environment by antimicrobials is accelerating the emergence and spread of resistant micro-organisms”.

It says that there is sufficient evidence that some pharmaceuticals are reaching the environment in quantities that could pose a risk, and that action should be taken to reduce this.

The Communication notes that many EU citizens are concerned that traces of pharmaceuticals are being found in drinking water, adding that some Member States and stakeholders “are already demonstrating commitment to tackle” the issues and with initial success being shown.

In support of these efforts, the Commission has said that it will encourage wider action by making best use of EU instruments and policies and “by facilitating the exchange of best practices between member-state authorities and encouraging the development of sector-specific strategies”.

The Commission has pledged to provide leadership on actions within its area of competence, and will stimulate dialogue on actions where others should take the lead, and says it will regularly review progress.

Meanwhile, it says it commits to initiating multilateral cooperation on reduction of the environmental pollution by antimicrobial medicines particularly from production facilities, adding that there would be less risk to the environment “if fewer pharmaceuticals had to be disposed of and the use of collection schemes increased”.

It acknowledges that environmental pollution by human and veterinary pharmaceutical substances is an emerging issue, and underlines the plan is to shore-up the Commission's “commitment to follow up existing work under the pharmacovigilance legislation examining the scale of the problem of pharmaceuticals in the environment” under the 7th Environmental Action Programme for a non-toxic environment”.

It cites evidence that the presence of antibiotics in the environment may contribute to the development and spread of antibiotic-resistant strains of bacteria is beginning to grow.

The Commission has also duly noted that water and other environmental pollution is trans-boundary, with around half of EU river-basin districts crossing national borders.

This, it has said, justifies action at European level.

Elsewhere it says that the main objectives will be to identify remaining knowledge gaps and uncertainties, and present possible solutions for filling them; explore how to address the challenge to protect the environment (and human health via the environment) while at the same time safeguarding access to effective and appropriate pharmaceutical treatments for human patients and animals.

The Commission approach aims to address pharmaceuticals in the environment generally, meaning largely, but not only, the water environment, it says, in order to cover the requirements in water and pharmacovigilance legislation, noting that the latter refers also to soils.

It notes that emissions of pharmaceutical substances to the environment occur during their whole lifecycle - from production through consumption to disposal.

The new draft says that “pharmaceuticals can be emitted to the environment from all stages of their lifecycle; during manufacturing, during use, and when disposed of as waste. They are found in surface and ground waters across Europe, and to a lesser extent also in drinking water”.

The Commission notes that it is required to propose a strategic approach to the pollution of water by pharmaceutical substances, stressing that it is delivering on that legal obligation.

The proposed approach, it says, has been informed by studies and reports, plus results of public and targeted stakeholder consultations that were launched last year.

The Commission notes that, usually, the active pharmaceutical ingredients (known as APIs) are the substances that cause concern. However, their metabolites and degradation products may be relevant, as well as some other substances present in medicinal products, including mercury-based thiomersal in some vaccine products.

Despite the studies, the Commission says that there are “still uncertainties for a large number of pharmaceuticals regarding their concentrations in the environment and what levels of risk those concentrations imply”.

This is because many pharmaceuticals that came to market several years ago were not subject to an environmental risk assessment as part of the authorization process.

A further reason, the draft Communication states, is that monitoring of pharmaceuticals in the environment is limited, although selected substances are monitored in surface and ground-waters under the Water Framework Directive.

There is also limited monitoring of what the Commission calls ‘hotspot’ locations, “such as those affected by hospital effluents”. Concentrations in soils are yet a further issue, with this not having been quantified for the most part.

The EU Executive estimates that less than 10% of pharmaceuticals on the market pose a risk through their individual presence in the environment, but that it is important to identify them in order the apply risk management efforts.

Unlike several years ago, these days, an environmental risk assessment must take place for all pharmaceuticals.

The draft goes on to note that the pharmaceutical sector is a strong and vibrant industry, with a constant drive to innovate, and can support what it dubs "green design”. This results in improving the recyclability of materials, and encouraging alternatives such as non-pharmaceutical therapies.

It adds that the approach proposed in the Communication “will contribute to the current Commission's first political priority of promoting jobs, growth and investment” while acknowledging that the issue of pharmaceuticals in the environment also has sources outside of the EU's borders, and that it is therefore important to, in tandem, address the international dimension.

The complex topic will be discussed at EAPM’s second annual Congress, to be held in Milan from 26-28 November.  To register for the congress, please click here.